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<keyword id="6444828" type="General" weightage="100" keywordseo="gland-pharma" source="Orion">Gland Pharma</keyword> on Monday announced that it would be investing ₹400 crore to create additional capabilities in its existing facility at Genome Valley here to manufacture biologicals, biosimilar, antibodies and recombinant <keyword id="48003" type="General" weightage="50" keywordseo="insulin" source="Orion">Insulin</keyword>. An official release from the state government said the expanded facility will have employment generation potential of more than 500 numbers of qualified, skilled and semi-skilled workforce to be recruited, mostly from nearby places. The company established their biopharmaceutical facility in February last year at Genome Valley with an investment of ₹300 crore to manufacture vaccines, biologicals, biosimilar, antibodies and others. The expanded site is envisaged to meet the national and international regulations to be followed in the manufacturing of the biological products as applicable and shall be built under the GMP guidelines applicable for the respective product lines, it said. The announcement was made after <keyword id="2554387" type="General" weightage="50" keywordseo="telangana-industries" source="Orion">Telangana Industries</keyword> Minister KT <keyword id="82835" type="General" weightage="80" keywordseo="rama-rao" source="Orion">Rama Rao</keyword>'s meeting with the Managing Director and Chief Executive Officer of Gland Pharma <keyword id="10242761" type="General" weightage="50" keywordseo="srinivas-sadu" source="Orion">Srinivas Sadu</keyword>. Srinivas Sadu said, "We are delighted to collaborate with the Government of Telangana on its vision of making the State a hub for global pharmaceutical requirements, by expanding our Bio-CDMO facilities in <keyword id="238799" type="General" weightage="50" keywordseo="shamirpet" source="Orion">Shamirpet</keyword>. This project investment is estimated to be about ₹400 crore and expected to generate employment to about 500 personnel." Rama Rao said, "I am delighted that Gland Pharma will be investing ₹400 crores in expanding their footprint in Hyderabad and will create 500 more jobs in Telangana." SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/finance/news/cereal-prices-likely-to-remain-elevated-going-in-fy24-crisil/articleshow/98093985.cms">Cereal prices likely to remain elevated going in FY24 : Crisil</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/business/news/india-inc-breaks-silence-on-adani-hindenburg-row/slidelist/98093730.cms">India Inc breaks silence on Adani-Hindenburg row</a>

Gland Pharma to invest ₹400 Cr to expand its Telangana plant

<ul><li>Gland Pharma, which debuted on the share market last year, has doubled its share price in a little over 6 months.</li><li>The IPO priced at ₹1,500 was subscribed twice over and the stock listed at a 20% premium to the issue price.</li><li>In the last three months alone, the company’s shares have surged by over 44%.</li></ul>Investors who stuck with Gland Pharma despite the ₹6,480 crore initial public offer (IPO) receiving a tepid response have reason to celebrate – their initial investment has doubled in a span of a little over 6 months. Shares of the pharma company rallied on May 18, surging by nearly 8%. The <keyword id="10219475" type="UNKNOWN" weightage="20" keywordseo="Gland-Pharma-share-price">Gland Pharma share price</keyword> was hovering around ₹3,011 at 11:00 am, more than ₹200 up from its previous closing price of ₹2,793. <div type="image" title="Gland Pharma 20_11_20 to 18_05_21." msid="82732400" hostid="261" caption="&amp;lt;p&amp;gt;Gland Pharma share price&amp;lt;/p&amp;gt;"></div> Gland Pharma was listed on the stock exchanges on November 20, 2020. Compared to the issue price of ₹1,500, this is a 100% gain till date. Nearly half of the surge in Gland Pharma’s shares has come after the slump on February 1 – since then, the share price has increased by over 44% till date. May alone has contributed to a 14% increase in the share price of the company, in the run up to its March 2021 quarter results. As a result of this rally, Gland Pharma’s total market capitalisation has crossed ₹45,000 crore. And there could be a further rally. “Gland Pharma reported a good set of numbers in Q4FY21, with good revenue growth in export as well as domestic market,” said a report by Angel Broking, adding that the company is capitalising on the demand for COVID-19 related products. A report by Kotak Institutional Equities Research highlighted the positives that outline Gland Pharma’s growth prospects. “Gland Pharma ended FY2021 on a strong note with new launches and expansion into other geographies driving robust revenue growth. A strong pipeline of products, healthy filing rate, entry into new markets, potential for increasing market share in recently launched products along with higher traction in Covid-related products provide solid medium-term growth visibility,” the report said. <table style="border-width: initial; border-style: none;"></colgroup><tbody><tr><td style="border-left:solid #000000 0.5pt;border-right:solid #000000 0.5pt;border-bottom:solid #000000 1pt;border-top:solid #000000 0.5pt;vertical-align:bottom;padding:0pt 5.75pt 0pt 5.75pt;overflow:hidden;overflow-wrap:break-word;">Brokerage </td><td style="border-left:solid #000000 0.5pt;border-right:solid #000000 0.5pt;border-bottom:solid #000000 1pt;border-top:solid #000000 0.5pt;vertical-align:bottom;padding:0pt 5.75pt 0pt 5.75pt;overflow:hidden;overflow-wrap:break-word;">Target price </td><td style="border-left:solid #000000 0.5pt;border-right:solid #000000 0.5pt;border-bottom:solid #000000 1pt;border-top:solid #000000 0.5pt;vertical-align:bottom;padding:0pt 5.75pt 0pt 5.75pt;overflow:hidden;overflow-wrap:break-word;">Upside </td><td style="border-left:solid #000000 0.5pt;border-right:solid #000000 0.5pt;border-bottom:solid #000000 1pt;border-top:solid #000000 0.5pt;vertical-align:bottom;padding:0pt 5.75pt 0pt 5.75pt;overflow:hidden;overflow-wrap:break-word;">Recommendation </td></tr><tr><td style="border-left:solid #000000 0.5pt;border-right:solid #000000 0.5pt;border-bottom:solid #000000 0.5pt;border-top:solid #000000 1pt;vertical-align:bottom;background-color:#d9d9d9;padding:0pt 5.75pt 0pt 5.75pt;overflow:hidden;overflow-wrap:break-word;">Motilal Oswal </td><td style="border-left:solid #000000 0.5pt;border-right:solid #000000 0.5pt;border-bottom:solid #000000 0.5pt;border-top:solid #000000 1pt;vertical-align:bottom;background-color:#d9d9d9;padding:0pt 5.75pt 0pt 5.75pt;overflow:hidden;overflow-wrap:break-word;">₹3280 </td><td style="border-left:solid #000000 0.5pt;border-right:solid #000000 0.5pt;border-bottom:solid #000000 0.5pt;border-top:solid #000000 1pt;vertical-align:bottom;background-color:#d9d9d9;padding:0pt 5.75pt 0pt 5.75pt;overflow:hidden;overflow-wrap:break-word;">9% </td><td style="border-left:solid #000000 0.5pt;border-right:solid #000000 0.5pt;border-bottom:solid #000000 0.5pt;border-top:solid #000000 1pt;vertical-align:bottom;background-color:#d9d9d9;padding:0pt 5.75pt 0pt 5.75pt;overflow:hidden;overflow-wrap:break-word;">BUY </td></tr><tr><td style="border-left:solid #000000 0.5pt;border-right:solid #000000 0.5pt;border-bottom:solid #000000 0.5pt;border-top:solid #000000 0.5pt;vertical-align:bottom;padding:0pt 5.75pt 0pt 5.75pt;overflow:hidden;overflow-wrap:break-word;">Share Khan </td><td style="border-left:solid #000000 0.5pt;border-right:solid #000000 0.5pt;border-bottom:solid #000000 0.5pt;border-top:solid #000000 0.5pt;vertical-align:bottom;padding:0pt 5.75pt 0pt 5.75pt;overflow:hidden;overflow-wrap:break-word;">₹3040 </td><td style="border-left:solid #000000 0.5pt;border-right:solid #000000 0.5pt;border-bottom:solid #000000 0.5pt;border-top:solid #000000 0.5pt;vertical-align:bottom;padding:0pt 5.75pt 0pt 5.75pt;overflow:hidden;overflow-wrap:break-word;">1% </td><td style="border-left:solid #000000 0.5pt;border-right:solid #000000 0.5pt;border-bottom:solid #000000 0.5pt;border-top:solid #000000 0.5pt;vertical-align:bottom;padding:0pt 5.75pt 0pt 5.75pt;overflow:hidden;overflow-wrap:break-word;">BUY </td></tr></tbody></table> “Our ability to respond to changing market demands during COVID-19 was visible bearing the registered growth in markets of the U.S, Europe, Canada and Australia and back of new launches and volume growth in existing portfolio, supported by our increased capacity,” said Srinivas Sadu, chief executive at Gland Pharma. However, there are some concerns that could impact the company’s performance, so there could be wisdom in being cautious. “The company’s profitability and growth are very reasonable. It has 45-50% of its revenue coming from a few large clients, and that does present some kind of concentration risk. But just the breadth of the business allows the company to continue to do well,” Chakri Lokapriya, managing director at TCG Asset Management, <a href="https://economictimes.indiatimes.com/markets/expert-view/can-gland-pharma-stock-see-more-upside/articleshow/79338981.cms">told Economic Times</a> after Gland Pharma’s IPO last year. SEE ALSO: <a href="https://www.businessinsider.in/business/telecom/news/airtels-india-business-is-back-in-the-black-after-a-very-long-time/articleshow/82709100.cms">Airtel's India business is back in the black after a very long time</a> <a href="https://www.businessinsider.in/business/telecom/news/mukesh-ambanis-reliance-jio-is-making-less-money-off-its-subscribers-than-it-did-12-months-ago/articleshow/82331233.cms">Reliance Jio is making less money off its subscribers than it did 12 months ago</a> <a href="https://www.businessinsider.in/tech/apps/news/whatsapp-responds-to-privacy-criticism-by-alleging-other-apps-like-zomato-ola-aarogya-setu-zoom-google-and-other-apps/articleshow/82570897.cms">WhatsApp responds to privacy criticism by alleging that other apps and tech companies also show disdain for user privacy</a>

A super hit IPO from 2020 has finally doubled investors' money

<ul><li>The shares of Gland Pharma were trading 18% higher at ₹2,143 apiece on November 23 at 10:20 am. </li><li>The IPO has made its initial investors $1.05 billion richer in the past two days. </li><li>The experts believe that its strong financials have been the reason investors ignored its Chinese promoter.</li><li>While you may have missed the listing gains, the investment experts believe there are a lot more lies ahead for the <keyword id="10317201" type="UNKNOWN" weightage="20" keywordseo="Gland-pharma-investors">Gland Pharma investors</keyword>. </li></ul>The shares of Gland pharma are seeing a stellar demand from investors post the IPO listing. The IPO has made its initial investors 22% richer in the past two days — gaining over ₹7748 crore ($1.05 billion) since its debut to the current market capitalisation of ₹35,669 crore. <div type="image" title="Gland Pharma share (2)" msid="79363622" hostid="261"></div> Despite the muted response from investors during the initial public issue, the shares listed at a premium of 13% and closed 21% higher on the first day of the debut. And, the stocks were trading 18% higher at ₹2,143 apiece on November 23 at 10:20 am. This was the 13th company to list this year and the largest ever a public issue in the Indian pharma industry. The party may not be over yet! While you may have missed the listing gains, the investment experts believe there are a lot more lies ahead for the Gland Pharma investors. Chakri Lokapriya, CIO &amp; MD, TCG AMC <a href="https://economictimes.indiatimes.com/markets/expert-view/can-gland-pharma-stock-see-more-upside/articleshow/79338981.cms">told Economic Times</a>, that “the company’s profitability and growth are very reasonable. It has 45-50% of its revenue coming from a few large clients, and that does present some kind of concentration risk. But just the breadth of the business allows the company to continue to do well. I think there is still upside from the current levels for Gland Pharma.” <div type="image" title="Gland Pharma profit and revenue (2)" msid="79363627" hostid="261"></div> The experts believe that its strong financials have been the reason investors ignored its Chinese promoter. “The stock is trading above its midcap pharma peers but higher valuations justified by the last 3-year revenue growth and PAT growth of 27% and 55% CAGR respectively. Any dip in price can be a good opportunity for long-term investors,” said Yash Gupta, Equity Research Associate at Angel Broking. The company has its business spread over 60 countries and a great track record of revenue delivery and profitability across the United States, Europe, Canada, Australia, India and the rest of the world. Some of its top B2B clients include Sagent Pharmaceuticals and Apotex as well as Fresenius Kabi USA and Athenex Pharmaceutical Division in the United States and the rest of the world. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/top-stock-movers-ril-future-retail-ujjivan-sfb-pfizer-cg-power-and-others/articleshow/79362432.cms" data-type="tilCustomLink">Top stock movers — RIL, Future Retail, Ujjivan SFB, Pfizer, CG Power, and others</a> <a href="https://www.businessinsider.in/tech/apps/news/how-to-earn-money-at-home-from-googles-task-mate/articleshow/79362215.cms" data-type="tilCustomLink">Google is testing ‘Task Mate’ in India, which lets users earn money for doing tasks on their smartphones</a>

Gland Pharma IPO investors made more than a billion dollars in just 2 days

<ul><li>The basis of allotment for <keyword id="9553483" type="UNKNOWN" weightage="20" keywordseo="Gland-Pharma-IPO">Gland Pharma IPO</keyword> will be announced on <a href="https://www.chittorgarh.com/ipo/gland-pharma-ipo/1072/">November 17</a>, and the shares will hit the bourses on November 20. </li><li>The issue received bids for 62 million shares against the offer size of 30 million shares</li><li>Here’s how to check <keyword id="6444828" type="ORGANIZATION" weightage="20" keywordseo="gland-pharma">Gland Pharma</keyword> IPO allotment status on NSE, BSE, and the registrar website.</li><li><a href="https://www.businessinsider.in/">Check out the latest news and updates on Business Insider.</a> </li></ul>After receiving a tepid response from investors, the ₹6,480 crore IPO of Gland Pharma closed on Wednesday. The issue was oversubscribed by 2.05 times — which is lower compared to some of the recently concluded IPO like Mazagon Dock Shipbuilders, Chemcon Speciality Chemicals and others. The issue received bids for 62 million shares against the offer size of 30 million shares. <table style="border-width: initial; border-style: none;"></colgroup><tbody><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Gland Pharma IPO </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Qualified Institutional Buyer </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Non-institutional Investor </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Retail Individual Investor </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Total </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Shares Offered </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">8,639,394 </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">6,479,546 </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">15,118,939 </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">30,237,879 </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">No. of times issue subscribed </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">6.40 times </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">0.51 times </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">0.24 times </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">2.06 times </td></tr></tbody></table> The basis of allotment for Gland Pharma IPO will be announced on <a href="https://www.chittorgarh.com/ipo/gland-pharma-ipo/1072/">November 17</a>, and the shares will hit the bourses on November 20. Here’s how to check Gland Pharma IPO allotment status: If you subscribed for the Gland Pharma IPO, you could check your allotment status by following these simple steps: To check on the stock-exchange website: <ul><li>To check the Gland Pharma IPO allotment status, go to the<a href="https://www.bseindia.com/investors/appli_check.aspx"> BSE website</a> or <a href="https://www1.nseindia.com/products/dynaContent/equities/ipos/ipo_login.jsp">NSE website</a> here.</li><li>On BSE, Select ‘Equity’ and then from the dropdown, select ‘ Gland Pharma’. </li><li>Now, enter your application number and PAN.</li><li>Click on ‘Search’.</li></ul>Please note the details will only be available once the shares are allotted. You can also visit the Registrar website (Linkintime) to check your application status. <ul><li>Visit the registrar’s website <a href="https://www.linkintime.co.in/IPO/public-issues.html">here</a>.</li><li>Click on ‘Select company’ and click on ‘ Gland Pharma-IPO’. It will only appear post allotment on November 17.</li><li>Once the company is selected, you will have to enter either your PAN detail, the application number, or client ID.</li><li>Enter the captcha and click ‘submit’. </li></ul>Once you hit ‘submit’ the status of your application will appear on the screen. Please ensure the details that you provide are correct. It will show the number of shares that you subscribed to and the number of shares that have been allotted to you. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/jpmorgans-quant-chief-shares-5-trade-recommendations-following-pfizers-vaccine-game-changer/articleshow/79225732.cms" data-type="tilCustomLink">JPMorgan’s quant chief shares 5 trade recommendations following Pfizer’s vaccine ‘game-changer’</a> <a href="https://www.businessinsider.in/stock-market/news/how-to-invest-in-tech-stocks-a-risky-but-fast-rising-segment-of-the-market/articleshow/79217830.cms" data-type="tilCustomLink">How to invest in tech stocks, a risky but fast-rising segment of the market</a>

Gland Pharma IPO allotment: Here’s how to check share allotment status

<ul><li>Gland Pharma has set an issue price band of ₹1490 -₹1500 per share. </li><li>The company is backed by China’s Fosun Pharma, making it one of the biggest offerings by a company with a Chinese parent in India.</li><li>The recent geopolitical tension between India and China remains a big risk factor, and may not play out well for Gland Pharma. </li></ul>The ₹6,500 IPO of Hyderabad-based Gland Pharma is now open for subscription. The company is backed by China’s Fosun Pharma, making it one of the biggest offerings by a company with a Chinese parent in India. Gland Pharma has set an issue price band of ₹1490 -₹1500 per share. While most analysts have a ‘subscribe’ call on it, some advise caution due to the stretched valuation. Ahead of the IPO, the company already raised ₹1,944 crore from anchor investors at the price of ₹1,500 per equity share. Some of the marquee names among the anchor investors include the Government of Singapore, Nomura, Goldman Sachs, Morgan Stanley, SBI Mutual Fund and Axis Mutual Fund. Investment experts recommendations for <keyword id="9553483" type="UNKNOWN" weightage="20" keywordseo="Gland-Pharma-IPO">Gland Pharma IPO</keyword> <table style="border-width: initial; border-style: none;"></colgroup><tbody><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Brokerages </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Recommendations </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">GEPL Capital </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Subscribe </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Sharekhan </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Subscribe </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Kotak Securities </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Not Rated </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Choice </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Subscribe with Caution </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">BP Wealth </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Subscribe </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Axis Securities </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Not Rated </td></tr></tbody></table> The company said the proceeds from the issue would be utilised for funding incremental working capital requirements, capital expenditure requirements and general corporate purposes. And, it is worthy to note while the company will not receive any money from the offer for sale portion. Post the IPO, the promoter shareholding will fall to 58% from current 74%.The offer for sale comprises 1.93 crore shares by promoter Fosun Pharma Industrial, and 1 crore equity shares by Gland Celsus Bio Chemicals, 35 lakh shares by Empower Discretionary Trust and 18 lakh by Nilay Discretionary Trust. <div type="image" title="Gland Pharma share holding" msid="79125202" hostid="261"></div> In the offering, no more than 50% of the stake will be given in qualified institutional placements (QIP), while at least 35% will be available for retail investors and the rest will be available for non-institutional bidders. Here’s what makes the share sale attractive Business spread over 60 countries With its business spread over 60 countries, the company has a great track record of revenue delivery and profitability across the United States, Europe, Canada, Australia, India and the rest of the world, according to Axis Securities. As of June 30, the company earns nearly 63% of its revenue from the US and nearly 15% from India — these two countries are the biggest market for Gland Pharma. The expansion in various other countries helps in offsetting the slowdown impact in a particular region or a country. <div type="image" title="Gland Pharma Revenue break up" msid="79125221" hostid="261"></div> The sector is poised to grow, and its listed peers are proof of that The coronavirus pandemic has already shown how important the pharma industry is. And, from here onwards the sector is slated to touch new high heights. According to Sharekhan, the global formulations market grew at a compound annual growth rate of 5.8% from 2014 to reach $1,096 billion in 2019. The market is further estimated to clock a CAGR of 4.4% to reach $1,359 billion by 2024. The gains in other listed Indian pharma stocks are proof of safety that investors have found in the sector. <table style="border-width: initial; border-style: none;"></colgroup><tbody><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Stocks </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Gains since March 31 </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Cipla </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">81.00% </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Aurobindo Pharma </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">88% </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Lupin </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">56% </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Cadila Healthcare </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">61% </td></tr><tr><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Dr Reddy </td><td style="border-left:solid #000000 0.9907650000000001pt;border-right:solid #000000 0.9907650000000001pt;border-bottom:solid #000000 0.9907650000000001pt;border-top:solid #000000 0.9907650000000001pt;vertical-align:bottom;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">57% </td></tr></tbody></table> The company’s strong customers base and diversified revenue base, which make it an interesting bet for investors Gland Pharma has a successful track record of operating a B2B model with leading pharmaceutical companies such as Sagent Pharmaceuticals and Apotex as well as Fresenius Kabi USA and Athenex Pharmaceutical Division in the United States and the Rest of the world. It also has 7 manufacturing facilities that are situated in southern India including 2 sterile injectables facilities, 1 dedicated Penems facility, 1 oncology facility and 3 API facilities. According to Axis Securities, the company’s revenue base is diversified by the business model as well as by key customers and markets. Its top 5 customers in Fiscals 2018, 2019 and 2020 and the 3 months ended June 30, accounted for 49.92%, 47.86%, 48.86% and 44.45%, respectively, of the total revenue from operations for the relevant period. <div type="image" title="Gland Pharma profit and revenue (1)" msid="79125244" hostid="261"></div> Risk factors to consider before subscribing Geopolitical tension in the Asia region The recent geopolitical tension in the Asia region between India and China may not play out well for Gland Pharma. However, the company denied any impacts on its business because of having a Chinese promoter. But Choice research report highlighted that anti-Chinese sentiment after the recent geopolitical tension in the Galwan valley may disrupt its business. Fierce competition in the industry Although the pharma sector is deemed to grow, what remains challenging is the cut-throat competition in the industry. “The markets in which Gland Pharma sells its generic injectable products are highly competitive. According to the IQVIA Report, injectable manufacturers face entry barriers such as high capital investments, operational costs, manufacturing complexities, stricter compliance requirements (because of the sterile nature of products) and high-quality standards resulting in limited competition in the market,” the Sharekhan report said. SEE ALSO: <a href="https://www.businessinsider.in/politics/world/news/kamala-harris-indian-ancestral-village-celebrates-her-victory-as-she-becomes-vice-president-of-the-united-states/articleshow/79117206.cms" data-type="tilCustomLink">Kamala Harris' Indian ancestral village celebrates her victory as she becomes Vice President of the United States</a> <a href="https://www.businessinsider.in/tech/news/hyperloop-pod-carries-two-humans-through-a-tube-at-over-160-kmph-for-the-first-time-ever/articleshow/79121765.cms" data-type="tilCustomLink">Hyperloop pod carries two humans through a tube at over 160 kmph for the first time ever</a> <a href="https://www.businessinsider.in/tech/news/top-cyber-espionage-groups-that-have-india-in-their-crosshairs/slidelist/79120867.cms" data-type="tilCustomLink">Top cyber espionage groups that have India in their crosshairs</a>

China’s Fosun-owned Gland Pharma IPO opens today— Here’s all you need to know about India’s largest pharmaceutical IPO

<ul><li>India may receive the first batch of Russia’s <keyword id="9739267" type="UNKNOWN" weightage="20" keywordseo="Sputnik-V">Sputnik V</keyword> COVID-19 vaccine is time for it to open up vaccinations for everyone above the age of 18 years.</li><li>The head of the <keyword id="1397612" type="COMPANY" weightage="20" keywordseo="Russian-Direct-Investment-Fund">Russian Direct Investment Fund</keyword> (RDIF) told Reuters that the vaccine will reach India by May 1.</li><li>The company plans to manufacture 850 million doses of Sputnik V annually in India, but a lot of that will depend on the momentum of technology transfer.</li></ul>India will receive the first batch of Russia’s Sputnik V COVID-19 vaccine by May 1. This is just in time for the country to open up vaccinations for everyone above the age of 18 years. “The first doses will be delivered on May 1,” the head of the Russian Direct Investment Fund (RDIF), Kirill Dmitriev, told <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/india-receive-first-batch-russias-covid-19-vaccine-may-1-interfax-2021-04-26/">Reuters</a>. However, he did not disclose the number of doses that will be a part of the first batch or where they will be manufactured. Sputnik V, developed by Moscow’s Gamaleya National Research Institute of Epidemiology and Microbiology, is the third vaccine after the Serum Institute of India’s (SII) Covishield and Bharat Biotech’s Covaxin to get approval from the Drug Controller General of India (DCGI). <div type="ExtQuote" text="“Following approval in India, it [Sputnik V] will be approved for use in 60 countries with a total population of over 3 billion people.”" auname="Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF) told reporters on April 14 after Sputnik V got the Drug Controller General of India’s (DCGI) approval"></div> RDIF is in charge of marketing the Sputnik V vaccine globally and has already signed agreements with six leading Indian manufacturers — Hetero Biopharma, Gland Pharma, Stelis Biopharma, Panacea Biotech, Virchow Biotech, and Shilpa Medicare. In this collaboration, RDIF hopes to manufacture over 850 million doses of the vaccine annually. By summer, it plans to hit 50 million doses a month and continue increasing output from there. A lot of this will depend on the momentum of technology transfer to allow Indian manufacturers to produce the vaccine. Virchow Biotech, for instance, is expected to complete its technology transfer between April to June, according to RDIF. Only then will it be able to commence full-scale commercial production of Sputnik V. The vaccine has also been approved by many of India’s neighbours including Sri Lanka, Myanmar and Pakistan. Russia is also lending a helping hand when it comes to Remdesivir. Pharmasyntez, a Russian company, announced that it is ready to ship up to 1 million packs of Remdesivir by the end of May, once it receives the prerequisite approval from the Russian government. <div type="Article" hostid="261" msid="82210121" title="Inside the treacherous black market for Remdesivir in India— from private hospitals to distributors" mstype="2" mssubtype="0"></div> In India, the stocks of Remdesivir have been in short supply as demand for the anti-viral drug increased alongside the surge in cases. This is despite the fact that the <keyword id="6356311" type="COMPANY" weightage="20" keywordseo="World-Health-Organisation">World Health Organisation</keyword> (WHO) has reiterated that there is no conclusive evidence to support the fact that Remdesivir is effective in the treatment of COVID-19. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/the-pace-of-infections-and-test-positivity-in-maharashtra-is-slowing-down-but-it-is-too-soon-to-celebrate/articleshow/82256149.cms">The pace of infections and test positivity in Maharashtra is slowing down — but it is too soon to celebrate</a> <a href="https://www.businessinsider.in/india/news/india-covid-19-first-wave-versus-second-wave/articleshow/82216963.cms">'We're in a much better situation' claims India's Principal Scientific Advisor as COVID-19 claims more lives than ever before</a>

India will receive the first batch of Sputnik V COVID-19 vaccine by May 1 — in time for the third phase of its vaccination drive

<ul><li><div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"></div></div></div>The effectiveness of <a href="http://markets.businessinsider.com/stock/Mallinckrodt-Quote">Mallinckrodt Pharmaceuticals</a>' blockbuster drug H.P. Acthar over cheaper alternatives is being questioned by an Oregon State University study.</li><li>The drug is prescribed by a small number of doctors, and many of them received speaker fees from Mallinckrodt.</li><li>Mallinckrodt depends on Medicare for nearly half of Acthar sales, raising a risk for investors. President Donald Trump has proposed allowing Medicare to negotiate prices.</li><li>Mallinckrodt is conducting studies to demonstrate Acthar's effectiveness.</li></ul>Tell me if this makes sense to you.In 2015 the US government <a href="http://www.businessinsider.com/achtar-drug-shows-flaws-in-drug-pricing-payment-system-2017-2">spent over half a billion dollars</a> on a <a href="https://www.goodrx.com/h.p.-acthar">$38,000</a> non-lifesaving drug with a wide range of cheaper alternatives, making it one of the top 20 expenses for Medicare Part D, a prescription drug program.What's more, according to a study by doctors at Oregon State University, this drug is prescribed by less than 1% of doctors in the US. The drug is called H.P. Acthar, and it is a blockbuster for <a href="http://markets.businessinsider.com/stock/Mallinckrodt-Quote">Mallinckrodt Pharmaceuticals</a>, the company that acquired it in 2014. But it is also old enough that it never went through the clinical trials the government requires of a new drug today. Its main use is to treat infantile spasms, but Medicare - a program for the elderly - spent $504 million on it because it is also prescribed as a treatment for 18 other diseases, including multiple sclerosis.What caught the attention of researchers at Oregon State was how much more expensive the government-subsidized Acthar was than some of its competitors - sometimes tens of thousands of dollars more. The researchers wanted to know why such a small number of doctors had come to prescribe such a costly drug to sick adults. Their study is offering fresh ammunition for <a href="http://www.businessinsider.com/achtar-drug-shows-flaws-in-drug-pricing-payment-system-2017-2">critics of Mallinckrodt and its model for Acthar.</a>Those critics include short sellers who are profiting as Mallinckrodt's shares get crushed. <h2>'Who are these people?'</h2>There are some explanations for why the prescriptions could be concentrated among a small number of doctors. Acthar is used only by specialists, and Mallinckrodt says it's a third- or fourth-line treatment, meaning patients using it have tried other options (and perhaps have sought out the doctors willing to prescribe it). <div class="KonaFilter image-container display-table float_left"><div><div class="image on-image"></div></div></div>The researchers who looked into it don't find this or other explanations convincing justifications for the expense to the government.The study into Acthar prescriptions was conducted by Dennis Bourdette, the chair of neurology in the Oregon Health and <keyword id="41551" type="ENTERTAINMENT" weightage="60" keywordseo="science">Science</keyword> University School of Medicine, and Daniel Hartung, an associate professor in OSU's College of Pharmacy."The list of indications from the FDA are infantile spasms, multiple sclerosis, and then all these other indications that the neurologist and rheumatologist prescribe it for," Bourdette told Business Insider. "There have never been any designed controlled trials or any basis that show that it's superior to synthetic steroids, which brings up the question - who are these people and why are they prescribing this when we have synthetic steroids that work?"<h2>Dosage question</h2>Since Mallinckrodt purchased the drug in 2014, the drug's sale to Medicare Part D patients has exploded. The $504 million the program spent on the drug in 2015 was up from $263 million in 2013, and the increase seems to have come from a jump in the number of doses per patient, <a href="https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Dashboard/2015-Medicare-Drug-Spending/medicare-drug-spending-dashboard-2015-data.html">government data shows</a>. <div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"></div></div></div>While just more than 3,100 Medicare Part D users take the drug, the amount of the drug they're taking is steadily increasing.Acthar patients were getting about 23.7 units each in 2015, according to the most recently available government data. In 2013, about 2,400 Medicare Part D users were taking the drug, and they were getting 17.5 units on average.This is way over the dosage guidelines that the <a href="http://www.acthar.com/pdf/acthar-pi.pdf">prescription information</a> for Acthar suggests. Bourdette said most patients should be getting only a handful of doses.We also asked Bourdette, though, whether the doctors who were prescribing Acthar heavily were simply big on prescribing drugs across the board. He disputed that idea, too."According to the Medicare database these doctors do tend to prescribe more medications," Bourdette said. "But that doesn't explain Acthar because when it comes to Acthar they're prescribing 100-fold more."<h2>Age before efficacy</h2>Acthar was basically grandfathered into approval by the US Food and Drug Administration because the government didn't require clinical trials the way it does today when the drug was brought to market back in 1952.Now it's classified as an "<a href="https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/ucm2005525.htm">orphan drug</a>" - a drug that treats rare diseases that affect fewer than 200,000 people in the country - but Mallinckrodt bought it with the intention of expanding its use."Mallinckrodt's goal has been - and continues to be - to acquire under-resourced, under-utilized products like H.P. Acthar Gel, which are utilized in areas of high unmet medical need, typically in narrow patient populations, and then for Mallinckrodt to invest significantly in those products," a representative for the company told Business Insider in an email. "The Company invests by building an even larger body of evidence to demonstrate which patients can benefit most from the drug and shares that information with physicians and payers to ensure those patients can get access to the product."<div class="KonaFilter image-container display-table float_left"><div><div class="image on-image"></div></div></div>These tactics have come under fire since 2015, when the 5,000% price increase of an AIDS-related treatment called Daraprim - by a tiny firm run by a former hedge fund manager named Martin Shkreli - shocked the US public.Mallinckrodt knew what it was getting into with Acthar before it bought it. Like Daraprim, its price has been hiked substantially - to $38,000 from as little as $1,650 before 2007, something that made the drug the target of a <a href="http://www.nytimes.com/2012/12/30/business/questcor-finds-profit-for-acthar-drug-at-28000-a-vial.html">New York Times profile</a> that raised questions about its efficacy and noted that at least one major insurer - Aetna - was unwilling to pay for it to treat anything but infantile spasms.Scrutiny of drug pricing and orphan drugs is far more intense now than it was in 2012, and it has come from lawmakers including President Donald Trump, who has suggested that Medicare should negotiate with drugmakers, and Sen. Chuck Grassley, an Iowa Republican who is looking into the orphan drugs and their privileged status.That is why the investors who previously loved companies that bought old drugs and jacked up their prices are fleeing this business model.<h2>'Marketing ploy'</h2>Mallinckrodt and Acthar's previous owner, Questcore, have yet to produce any studies showing that Acthar is superior to its cheaper alternatives. In the case of MS, that alternative is methylprednisolone, an intravenous treatment that cost $1,000 to $2,000 as opposed to Acthar's $40,000.The Mallinckrodt representative told Business Insider that the low number of physicians prescribing Acthar was "proportional" to the roughly 9,000 people who take it as a third- or fourth-line treatment when other medications fail. The person said that number "is growing as Mallinckrodt continues to generate data and introduce it to a whole new generation of physicians."Bourdette doesn't buy that. Whether Acthar is a second-, third-, or fourth-line therapy, he still doesn't see why the drug should cost so much or be as widely used as it is."If they're using it to treat relapses, you would be an incredibly rare patient," he said in a phone call with Business Insider. "If you've got somebody resistant to steroids, there are so many more noncortical therapies."Mallinckrodt, which has only owned Acthar for a little over two years, is conducting four company-sponsored controlled trials related to the drug's efficacy. Details on the studies, however, reveal that only one of them compares Acthar to alternative treatments.Bourdette is skepical of such phase four (post-FDA-approval) trials anyway. In the past some companies have used them to entice doctors to use their product, and doctors can even make a profit off of the studies if they're designed to come in under cost.In these cases, Bourdette said: "It's not really a scientific research study - it's a marketing ploy."<h2>Paid speakers</h2>Mallinckrodt, like a lot of other drug companies, also <a href="https://www.mallinckrodtspeakerbureau.com/Account/LogOn?ReturnUrl=%2f">has a speakers program</a> through which it can book and pay doctors to talk about its drugs.Typically, the top prescribers of Acthar not only have received payments from Mallinckrodt but also "are typically getting larger payments from companies that are developing disease-modifying therapies," Bourdette told us.Business Insider reached out to the top 10 prescribers of Acthar, but they either did not respond to our requests for comment or would not comment on the drug.One of these doctors is Robert Baughman, a professor of internal medicine at the University of Cincinnati who is <a href="https://clinicaltrials.gov/ct2/show/results/NCT02188017">collaborating with Mallinckrodt on a study</a> on Acthar's efficacy curing patients with sarcoidosis, a disease that affects the lungs and lymph glands. This is part of the "investigator-initiated research," which Mallinckrodt supports financially through grants.Based on his prescription behavior, Baughman clearly believes in the drug. He was the third-most-frequent <a href="https://projects.propublica.org/checkup/drugs/8004">prescriber of Acthar back in 2014</a>, ProPublica's prescriber database shows. He has also received $21,625 for promoting Acthar from 2013 to 2015 (that's out of $116,000 for speaking and promotion fees for drugs during that period)."Thanks for offer, but will have to say no," he said via email when we asked him to speak about the drug.That said, <a href="https://www.ncbi.nlm.nih.gov/pubmed/26626451">what he's published about Acthar</a> is not encouraging. Of 47 patients, 18 discontinued the program because of "cost (four patients), death (two patients), or drug toxicity (eleven patients), or noncompliance (1 patient)."Only 11 of the 29 remaining patients saw some improvement in one or more organs after taking Acthar for three months.Another top prescriber who does think Acthar is effective is Regina Berkovich, an assistant professor of clinical neurology at the University of Southern California. She published a paper back in 2013 arguing that Acthar was a good <a href="http://www.pri-med.com/DigitalAssets/Shared%20Files/Syllabus%20Files%20Spring%202013/C&amp;E/West/Track%201-Session%203_MS_Updates-West_ONLINE.pdf">second-stage treatment for multiple sclerosis</a>.That same year she accepted $23,895 for talking about Acthar. That's out of $142,978 in speaking and other fees she collected that year.The top prescriber of Acthar (making up 1% of all prescriptions) is an Ohio rheumatologist named David Mandel. He also did not respond to Business Insider's request for comment on the drug, and Acthar does not appear on his website's "<a href="http://dmandelmd.com/ground-breaking-therapies/">treatments</a>" page, though its competitor Humira does. From 2013 to 2015, Mandel has received $22,762 in speaking and other fees from Mallinckrodt for promoting Acthar, according to government disclosures.<h2>Risk management</h2>Speaker programs are turning into a new kind of risk for investors as they come under scrutiny by federal officials around the US.Last year Salix, a pharmaceutical firm purchased by Valeant in 2015, paid a <a href="https://www.google.com/url?sa=t&amp;rct=j&amp;q=&amp;esrc=s&amp;source=web&amp;cd=1&amp;cad=rja&amp;uact=8&amp;ved=0ahUKEwi3xtaSotTSAhVJwGMKHTJzCkgQFggaMAA&amp;url=https%3A%2F%2Fwww.justice.gov%2Fusao-sdny%2Fpr%2Fmanhattan-us-attorney-announces-54-million-settlement-against-salix-pharmaceuticals&amp;usg=AFQjCNG1pkkTWDaTSRYpXRHnrA5_OsuTZg&amp;sig2=EiJZStoo2vwFxH1TA2EuCw&amp;bvm=bv.149397726,d.amc">$54 million settlement to the Justice Department</a> over its speakers program. Specifically, it was accused of using the programs "as a mechanism to pay kickbacks to doctors to induce them to prescribe SALIX drugs and medical devices that were reimbursed by federal healthcare programs." Forest Laboratories paid a<a href="https://www.google.com/url?sa=t&amp;rct=j&amp;q=&amp;esrc=s&amp;source=web&amp;cd=2&amp;cad=rja&amp;uact=8&amp;ved=0ahUKEwi3xtaSotTSAhVJwGMKHTJzCkgQFgggMAE&amp;url=https%3A%2F%2Fwww.justice.gov%2Fopa%2Fpr%2Fforest-laboratories-and-forest-pharmaceuticals-pay-38-million-resolve-kickback-allegations&amp;usg=AFQjCNHwJmXQBcYRYd8bNwwJI_7xsHK6Sw&amp;sig2=jOuu5vc4GYSCG1Sh8UF4uw&amp;bvm=bv.149397726,d.amc"> $38 million fine</a> for a similar offense.And two Alabama doctors now <a href="http://www.al.com/news/mobile/index.ssf/2017/02/mobile_doctors_found_guilty_in.html">face up to 20 years in prison for running an opioid</a> "pill mill" out of their two Mobile clinics. They were discovered, in part, because back in February of last year a sales rep for Insys Therapeutics, the company that makes the powerful opioid fentanyl, admitted to paying them illegal kickbacks disguised as speaker fees.Nobody is suggesting that Mallinckrodt is doing anything wrong. The company representative reiterated that the company's speaker program was "designed to be consistent with applicable legal and regulatory requirements, the PhRMA Code and industry best practices," referring to the drug-industry lobby.And Mallinckrodt does acknowledge that the fact that its drug hasn't been tested is a danger to its business."Clinical trials demonstrating the efficacy for Acthar are limited," the company wrote in its annual report. "The absence of such clinical trial data could cause physicians not to prescribe Acthar, which could negatively impact our business, financial condition, results of operations and cash flows."Until the drug has been tested against cheaper alternatives, and until the results of any such tests are published, investors, legislators and doctors will remain skeptical of Acthar's price tag and the system that allows for it. <div class="margin-top"> <h3>NOW WATCH: <a href="http://www.businessinsider.com/white-marks-on-nails-health-2017-3">Here's what those white marks on your nails say about your health</a></h3> <div> <div> <div class="ooyala-video-player" data-video-autoplay="false" data-video-id="E5Njg3YTE6C6pYa0VSWutGEM6ff88xwu" data-player-variable="ooyalapopvideo" id="ooyalaplayer_popvideo" style="width:1280px;height:720px"></div> </div> </div> </div>

Something weird's going on with the doctors prescribing one of pharma's most controversial blockbuster drugs

Think Initial Public Offers (IPOs) are a sure-shot, quickfire method to make a quick buck? If so, then investing in some of India's biggest IPOs to date would have created multiple millionaires. However, if the data is to be believed, 18 out of India's top 30 IPOs by way of size have failed to deliver on the returns front. Recent data from Capitalmind PMS suggests that of all the mega IPOs India has seen in the past 2 decades, only 12 IPOs i.e. stocks of 12 companies have delivered more returns that what you would have received, had you bought and held your investments in Nifty500(which invests in biggest 500 companies by market size). Infact, Paytm (54%), <keyword id="20024191" type="General" weightage="20" keywordseo="Reliance-Power" source="keywords" meta.keywordsubtype="org" meta.entityname="Reliance Power" meta.hostid="261" meta.entityid="Reliance Power">Reliance Power</keyword> (81%), General Insurance Corporation (2%) actually generated negative total returns to date. The only outliers in the list of top 10 IPOs were Zomato (listed in July 2021) and Coal India (listed in April, 2010), which managed to generate excess returns i.e. more than what was generated by Nifty500. While Zomato's total return to date, which is considered a comprehensive gauge of a stock's profitability, stands at 265%, Coal India total returns are a massive 443%. In these cases, had you simply bought and held the Nifty500 index for a similar duration, your returns would've been 73%, and 435% respectively. Also, 5 of the biggest IPOs India has ever seen (Bajaj Housing Finance, Bharti Hexacom, Brainbees, Ola Electric) have come in the last 2 years. In some cases, having stayed put in your index investments would have yielded you far better returns. Consider this, FSN E-Commerce, Nykaa's parent company, listed on the exchanges on November 2021. Its total returns till date have been 2%, while had you invested in Nifty500 index, your returns would've been 53%. Similarly, the total returns to date on Bandhan Bank's stock, which listed in March 2018, was a negative 43%. But, the index has delivered a whopping 163% returns during the same time. Hits and Misses <table class="redcator-table-advance"><tbody><tr><td>Company Name</td><td>Total Returns to Date (In %)</td><td>CNX (Nifty500) Returns (In %)</td></tr><tr><td>Reliance Power (Feb 2008)</td><td>-81</td><td>961</td></tr><tr><td>Zomato (July 2021)</td><td>265</td><td>73</td></tr><tr><td>Gland Pharma (November 2020)</td><td>14</td><td>124</td></tr><tr><td>NHPC (September 2009)</td><td class="se-table-selected-cell">389</td><td>961</td></tr><tr><td>Indian Railways Finance Corporation (January 2021)</td><td>582</td><td>109</td></tr></tbody><tbody></tbody><tbody></tbody><tbody></tbody></table>Source: CapitalMind PMS <h2>Surge in IPOs? Not really </h2>It is impossible to overlook the sheer number of public offerings seen in the Indian markets over the past 2 years. Around 600 share sale offers have already hit the market since 2023. Out of these, 335 have come in this year, as of October 2024. While over Rs 50,000 crores have been raised by these share sales so far since 2023, only 22% of these funds raises have come from companies who are hitting the market for the first time i.e. bringing out their IPOs. The rest have come from already listed companies seeking to raise more funds. The biggest IPO that India has seen to date, that of <keyword id="19906087" type="General" weightage="20" keywordseo="Hyundai" source="keywords" meta.keywordsubtype="org" meta.entityname="Hyundai" meta.hostid="261" meta.entityid="Hyundai">Hyundai</keyword> Motor India, closes for subscription today. With an offer size of Rs 27,870.16 crore, it is 35% bigger than the previous biggest IPO in the country(LIC in May 2022). As of 12:30 pm today, Hyundai's offer had been 87% subscribed, with significant interest from QIBs and employees. At 0.43x, participation of retail investors remained largely subdued. Notably, an IPO is considered cancelled and withdrawn, if it fails to meet the 90% subscription threshold.

Do large IPOs guarantee large returns? Data suggests that 18 of India's biggest 30 IPOs did not generate solid returns

US-based <keyword id="6361813" type="General" weightage="20" keywordseo="brain" source="Orion">brain</keyword> interface startup, Synchron, backed by <keyword id="18635" type="General" weightage="70" keywordseo="amazon" source="Orion">Amazon</keyword> founder <keyword id="16586160" type="TOPIC" weightage="70" keywordseo="Jeff-Bezos" source="TOPIC" sourcekeytype="panache-people-101" meta.keywordsubtype="Entrepreneur" meta.seopath="magazines/panache/panache-people-101/jeff-bezos" meta.entityname="Jeff Bezos" meta.hostid="153" meta.entityid="79278871">Jeff Bezos</keyword> and <keyword id="10387" type="General" weightage="50" keywordseo="microsoft" source="Orion">Microsoft</keyword> co-founder <keyword id="16586161" type="TOPIC" weightage="60" keywordseo="Bill-Gates" source="TOPIC" sourcekeytype="panache-people-101" meta.keywordsubtype="Entrepreneur" meta.seopath="magazines/panache/panache-people-101/bill-gates" meta.entityname="Bill Gates" meta.hostid="153" meta.entityid="79020550">Bill Gates</keyword>, is working on technology designed to transform daily life for people with paralysis. Synchron is part of an emerging crop of companies testing technology in the brain-computer interface industry, reports CNBC. The Synchron Switch is implanted through the blood vessels and allows patients to operate technology using only their minds. So far, the experimental technology has been tested on three patients in the US and four in Australia, according to the report. "I've seen moments between patient and partner, or patient and spouse, where it's incredibly joyful and empowering to have regained an ability to be a little bit more independent than before. It helps them engage in ways that we take for granted," Synchron CEO Tom Oxley was quoted as saying. Synchron, founded in 2012, is a member of the burgeoning brain-computer interface (BCI) industry, the report said. A BCI system decodes brain signals and converts them into commands for external technologies. As per the report, Synchron BCI is inserted through the blood vessels, which Oxley refers to as the "natural highways" into the brain. Stentrode, a Synchron stent, is fitted with tiny sensors and delivered to a large vein near the motor cortex. The Stentrode is linked to an antenna that sits under the skin in the chest and collects raw brain data that it sends out of the body to external devices, the report added. Synchron's technology can help patients with severe paralysis or degenerative diseases like amyotrophic lateral sclerosis (ALS), regain their ability to communicate with friends, family, and the outside world, whether through typing, texting, or even accessing <keyword id="15308890" type="TOPIC" weightage="60" keywordseo="Social-media" source="TOPIC" sourcekeytype="business,investopedia" meta.keywordsubtype="null" meta.msid="92974849" meta.seopath="s/social-media" meta.entityname="Social media" meta.hostid="153" meta.entityid="social-media">social media</keyword>. In December last year, the company announced a $75 million funding round, with participation from the investment firms of Gates and Bezos. The US Food and Drug Administration granted Synchron the Breakthrough Device designation in August 2020, which is reserved for medical devices that have the potential to improve treatment for debilitating or life-threatening conditions. The company has yet to generate revenue, and a spokesperson said that Synchron will not comment on how much the procedure will eventually cost, the report stated. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/finance/news/cereal-prices-likely-to-remain-elevated-going-in-fy24-crisil/articleshow/98093985.cms">Cereal prices likely to remain elevated going in FY24 : Crisil</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/business/news/gland-pharma-to-invest-400-cr-to-expand-its-telangana-plant/articleshow/98094407.cms">Gland Pharma to invest ₹400 Cr to expand its Telangana plant</a>

Jeff Bezos, Bill Gates-backed startup testing mind-controlled computing on humans

<div class="KonaFilter image-container display-table"><div><div class="image on-image">REUTERS/Stefan WermuthGene and cell therapies are taking off.</div></div></div><ul class="summary-list"><li>The hottest <a href="https://www.businessinsider.com/fda-cber-director-peter-marks-on-developing-rare-disease-gene-therapies-2019-3">new area of medicine</a> today is a cutting-edge technology that leverages the body's own cells to treat disease. </li><li>Companies have been pouring in and <a href="https://www.businessinsider.com/avexis-sma-gene-therapy-manufacturing-drove-9-billion-novartis-deal-2019-3">investing billions</a>. But they're encountering one big challenge: actually making the treatments. </li><li>New gene and cell therapies are encountering years-long backlogs, and delays keep potentially <a href="https://www.businessinsider.com/stanford-ethicist-on-bill-gates-worries-about-gene-therapy-2019-3">lifesaving medicines</a> away from patients.</li><li><div dir="ltr"><a href="https://www.businessinsider.com/?hprecirc-bullet">Visit BusinessInsider.com for more stories.</a></div></li></ul>For the biotech company <a href="https://meiragtx.com/company/board-of-directors/#bod-data-lg-2">Meira Gtx,</a> a 29,000-square-foot factory in central London is the solution to a problem that has bedeviled its entire industry.The $660 million startup develops cutting-edge gene therapies, which tinker with the <a href="https://www.businessinsider.com/gene-therapy-treats-disease-but-prices-could-strain-us-health-system-2019-2">body's DNA</a> in hopes of treating serious illnesses. Meira focuses on a number of diseases of the eye, salivary gland and brain. The company had only just started in 2015 when a huge opportunity opened up, to lease a drug <a href="https://meiragtx.com/our-strategy/manufacturing/">manufacturing facility</a> from a leading UK eye hospital. Meira jumped at it, quickly hiring pharma veterans to build out its capabilities and take over manufacturing, snapping up its new head of quality from the Swiss drug giant <a href="https://www.businessinsider.com/avexis-sma-gene-therapy-manufacturing-drove-9-billion-novartis-deal-2019-3">Novartis</a>. Gene therapy is the <a href="https://www.businessinsider.com/fda-cber-director-peter-marks-on-developing-rare-disease-gene-therapies-2019-3">hottest area in medicine,</a> offering up the potential to treat or even cure devastating rare and not-so-rare diseases. Gene therapy and a sister field, cell therapy, attracted more than <a href="https://alliancerm.org/publication/2018-annual-report/">$13 billion</a> in global financing last year, by an industry group's count. Some products have already been <a href="https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/default.htm">approved</a> in the US, and many more are in the works, with more than <a href="https://alliancerm.org/publication/2018-annual-report/">1,000</a> research trials ongoing. But first, companies have to <a href="https://www.businessinsider.com/avexis-sma-gene-therapy-manufacturing-drove-9-billion-novartis-deal-2019-3">make the medicines.</a> In a field so new, trendy, and intensely complicated, manufacturing has become a crucial, costly and time-consuming challenge, with a surge of new interest forcing biopharmaceutical companies to either build their own multimillion-dollar facilities or else wait on lines for years for others to manufacture them. Meira's enviable capability has sparked requests from other companies to make their products. And it could well explain an up to <a href="https://investors.meiragtx.com/news-releases/news-release-details/meiragtx-enters-strategic-collaboration-janssen-develop-and">$440 million partnership</a> the biotech inked with Johnson &amp; Johnson's Janssen earlier this year, focused on both research and improving manufacturing."Manufacturing is critical to us," <a href="https://www.linkedin.com/in/zandyforbes/">Alexandria Forbes</a>, Meira Gtx's president and CEO, said in an interview with Business Insider. "It's an industry-wide issue." The biotech deliberately focused on disease areas where it wouldn't need to make huge amounts of the product, Forbes said. But other companies are facing the challenge on a much bigger scale."If you don't control your manufacturing, you don't control your fate," <a href="https://genetherapy-conference.com/">said</a> <a href="https://www.linkedin.com/in/katherine-high-b50baab1/">Katherine High</a>, Spark Therapeutics' co-founder, president and chief scientific officer, speaking at the <a href="http://genetherapy-conference.com">Gene Therapy for Rare Disorders</a> conference in Boston, Massachusetts last month. Spark is currently being acquired by Swiss drug giant Roche for <a href="https://www.businessinsider.com/how-roche-bought-biotech-spark-therapeutics-for-48-billion-2019-3">nearly $5 billion</a>.The challenge has also prompted deals among third-party companies that manufacture gene therapies, including one this week. On Sunday, <a href="https://www.wsj.com/articles/contract-drug-manufacturer-catalent-to-buy-paragon-bioservices-in-1-2-billion-deal-11555277951?shareToken=stf73c9092566048f38a5dbee281dbbaf2">The Wall Street Journal</a> reported that the manufacturer Catalent is buying privately-held Paragon Bioservices in an all-cash deal for $1.2 billion. Read more: <a href="https://www.businessinsider.com/spark-bluebird-avexis-executives-on-safety-for-gene-therapy-companies-2019-3">Billions of dollars are pouring into gene-therapy startups. Top execs at 3 companies described the biggest challenge the new field faces.</a><h2>Bottlenecks, backlogs, and millions of dollars in the balance</h2><a href="https://www.linkedin.com/in/tony-khoury-7470755/">Tony Khoury</a>, vice president of client and technical services at the consulting firm <a href="https://projectfarma.com/">Project Farma</a>, turns to an analogy to explain why it's so hard for companies to make gene therapies.Imagine you're a successful home baker, turning out dozens of warm cookies each weekend for friends and family to enjoy. To put out 12,000 cookies instead, your homegrown operation, with its little mixing bowl and standard apartment oven, would need to change dramatically.Except in gene therapy, you can't just multiply the recipe.Companies are working with viruses or living cells, so "it's not an exact <keyword id="41551" type="ENTERTAINMENT" weightage="100" keywordseo="science">science</keyword>" in the same way, he said.Whether companies are vying for slots at the contract manufacturing organizations (CMOs) that make the very specialized medicines, or trying to build their own factories, manufacturing has become a bottleneck for companies.Both routes are expensive. Hiring an outside organization can run in the neighborhood of $7.4 million just to get to the point where a company is able to test its products in humans, while doing the work in-house can come to about twice that, or $14.7 million, <a href="https://www.mustangbio.com/">Mustang Bio </a>Chief Technology Officer <a href="https://www.linkedin.com/in/knutniss/">Knut Niss</a> estimates.It's better to choose the in-house route if a company is doing a lot of manufacturing and research, Niss said last month at the Boston gene therapy conference.Read more: <a href="https://www.businessinsider.com/fda-cber-director-peter-marks-on-developing-rare-disease-gene-therapies-2019-3">The FDA's top official overseeing gene therapy had these 5 suggestions for startups flooding into the billion-dollar industry</a>Companies are also encountering long wait times to get their products made or to buy the requisite, ultra-specialized equipment."When everyone decides to order 600 hyperstacks, you can suddenly have some challenges. And some of us have experienced that," said <a href="https://www.linkedin.com/in/chriskmurphy/">Christopher Murphy</a>, chief operations officer at Brammer Bio, which is being acquired by Thermo Fisher for about <a href="http://thermofisher.mediaroom.com/2019-03-24-Thermo-Fisher-Scientific-to-Acquire-Brammer-Bio-a-Leader-in-Viral-Vector-Manufacturing">$1.7 billion</a> in cash.Murphy was referring to an essential piece of <a href="https://bioprocessintl.com/bioprocess-insider/hyperstack-shortage-caused-by-gene-therapy-surge/">equipment</a> employed in gene and cell therapy manufacturing.With any delay, lifesaving medicine is on the line. On one collaboration Project Farma did <a href="https://www.businessinsider.com/avexis-sma-gene-therapy-manufacturing-drove-9-billion-novartis-deal-2019-3">with Novartis's AveXis,</a> delays of even a day mean that "hundreds of babies are potentially not going to have the ability to get this treatment," Khoury said. "The queue in contract manufacturing is actually slowing down investigating these therapies and getting these therapies to patients," said the US Food and Drug Administration's <a href="https://www.businessinsider.com/fda-cber-director-peter-marks-on-developing-rare-disease-gene-therapies-2019-3">top official overseeing gene therapy</a>, Dr. <a href="https://www.fda.gov/AboutFDA/CentersOffices/ucm481936.htm">Peter Marks</a>. <h2>A field pioneered by academics 'then had to work backwards'</h2>It wasn't always obvious that treating disease at the genetic level would even be possible. Two decades ago, at least one high-profile <a href="https://abcnews.go.com/Health/story?id=3421869&amp;page=1">patient death</a> in a research trial of a gene therapy prompted skittishness from companies and investors. Pioneering work by university researchers ultimately powered the field's success today. But that background has contributed to its struggles, too. Once the data was promising, researchers "then had to work backwards, figuring out the manufacturing and controls," said <a href="https://www.linkedin.com/in/brian-kaspar-ba8b0ba/">Brian Kaspar</a>, chief scientific officer of Novartis's AveXis, who was one of those researchers before he joined industry.AveXis has invested heavily in its manufacturing capacity, which it has long seen as <a href="https://www.businessinsider.com/avexis-sma-gene-therapy-manufacturing-drove-9-billion-novartis-deal-2019-3">crucial for its future,</a> Kaspar said.Manufacturing is such a broad problem that industry group <a href="https://alliancerm.org">Alliance for Regenerative Medicine</a> (ARM) is working on a how-to guide spelling out the process, which it's calling "A-Gene."The group was also motivated by recent history. A group of drugs known as monoclobal antibodies, which fight cancer and treat conditions like rheumatoid arthritis, are now among the world's top-selling treatments. But when the drugs first hit the market, pharma companies encountered complex <a href="https://www.ncbi.nlm.nih.gov/pubmed/19234897">manufacturing challenges</a>, limiting how many could be made and making those that could be manufactured more costly. Using a model from that time as a guide, ARM started "A-Gene" in May of last year. Many companies have been involved in the effort, and the group expects to hammer out a draft by the end of the year.<h2>'For 10,000 patients, that means 10,000 batches'</h2>Around the world, 300,000 to 400,000 people are born with sickle cell disease, an inherited blood disorder that causes <a href="https://www.marketwatch.com/story/this-could-be-the-next-1-billion-drug-if-patients-get-on-board-2018-02-26">serious pain episodes</a> and can lead to an early death. The biotech Bluebird Bio believes its new experimental treatment <a href="https://www.businessinsider.com/biotech-bluebird-bio-suggests-installment-plan-for-gene-therapy-lentiglobin-2019-1">LentiGlobin</a> could make a big difference for those who have sickle cell disease.Read: <a href="https://www.businessinsider.com/biotech-bluebird-bio-suggests-installment-plan-for-gene-therapy-lentiglobin-2019-1">A biotech is proposing a plan to pay for its pricey rare-disease treatment the same way you'd buy a TV or dishwasher. Here's the inside story.</a>But developing LentiGlobin hasn't been easy. Bluebird Chief Technology and Manufacturing Officer <a href="https://www.linkedin.com/in/derek-adams-16793b4/">Derek Adams</a> calls it "the most complicated process I've ever seen."LentiGlobin entails taking a patient's blood plasma, modifying those cells outside of the body, and then re-introducing them into the patient by way of an infusion. Manufacturing gene or cell therapies can thus be a highly individualized, bespoke process, more like a one-of-a-kind boutique than a mass-market chain of stores."The patient starts the manufacturing process. That whole manufacturing process centers around the patient," Adams said at the Boston gene therapy conference. "That doesn't seem so bad until you realize that if you want to do this for 10,000 patients, that means 10,000 batches." <div class="margin-top"> <h3>NOW WATCH: <a href="https://www.businessinsider.com/spacex-falcon-heavy-elon-musk-second-launch-video-2019-4">Watch SpaceX launch and land Falcon Heavy, the world's most powerful rocket</a></h3> <div> </div> </div>

'This is the most complicated process I've ever seen': As billions flow into the hottest new area of medicine, top execs say a crisis is brewing

<div class="KonaFilter image-container display-table float_right"><div><div class="image on-image">GECancer cells, as viewed with GE's MultiOmyx technology.</div></div></div>For some cancer patients, a new group of drugs has led to remarkable remissions with few side effects. But others have tried them, only to find little benefit and a lot of discomfort.The treatment, broadly speaking, is called cancer immunotherapy. These drugs - many of which have become available in the past few years - have led to cautious optimism among oncologists who often had few options for treating certain cancers. Cancer researchers see promise. Drug companies see potential for a new group of mega moneymakers. <a href="http://www.businessinsider.com/cancer-treatment-as-investment-2015-11">Investors</a> and billionaires, like former <a href="http://www.businessinsider.com/r-bloomberg-others-give-125-mln-for-immunotherapy-cancer-research-2016-3">New York Mayor Michael Bloomberg</a> and <a href="http://www.businessinsider.com/why-napster-billionaire-sean-parker-just-invested-in-cancer-immunotherapy-2016-4">Silicon Valley billionaire Sean Parker</a>, have invested hundreds of millions into researching new treatments.Yet it's still early days, and there's as much hope as confusion over the new treatments true potential and possible risks.<h2>The promise</h2><div class="KonaFilter image-container display-table float_right"><div><div class="image on-image">AP/Mark HumphreyFormer US President Jimmy Carter.</div></div></div>In August 2015, former US President Jimmy Carter, then 91, announced he had cancer. The diagnosis was metastatic melanoma, and it had spread to his brain. He <a href="http://www.businessinsider.com/ap-carter-thought-he-had-just-weeks-to-live-during-cancer-fight-2016-8">thought he had merely weeks to live</a>.Just four months later, he made headlines again, <a href="http://www.businessinsider.com/jimmy-carter-says-cancer-is-gone-2015-12">revealing he had tested cancer-free</a>. Before long, doctors said he no longer needed treatment.That remarkable turn came from a combination of a traditional therapy, radiation, and a new one, an immunotherapy drug called Keytruda, which was delivered intravenously once every three weeks. Keytruda had only been approved for about a year at that point.New drugs such as Keytruda are a type of immunotherapy called checkpoint inhibitors. Most people have a type of protein that stops their immune systems from fighting the cancerous cells. Keytruda and similar drugs block those proteins. It's like taking down a guard tower, allowing the body's own immune system force to flood past a barrier, where it then gets to work killing and clearing away the cancer cells.Checkpoint inhibitors were first approved to treat melanoma but have since gone on to tackle lung cancer, bladder cancer, blood cancers, and other cancers.Dan Chen, vice president and global head of cancer immunotherapy development at Genentech, told Business Insider that he considers Genentech's checkpoint inhibitor, Tecentriq, to be the foundation of the company's cancer immunotherapy program. It's the first FDA-approved immunotherapy for Genentech, and the company's already started looking for ways to combine Tecentriq with other cancer immunotherapy drugs that activate the body's immune system in different ways."This is a critical program for us. It allowed us to learn an enormous amount about cancer immunity," like how the drugs work to inhibit the checkpoints, Chen said.<div class="KonaFilter image-container display-table float_right"><div><div class="image on-image">Courtesy Bob and Frances SchoenbauerFrances and Bob Schoenbauer.</div></div></div>Genentech points to patients like Bob Schoenbauer to show why the company is "investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer."Schoenbauer had been diagnosed with late-stage inoperable lung cancer in 2013. Soon after, Schoenbauer was connected with a clinical trial of Tecentriq out of Georgetown University."Almost immediately, the cough was going away," his wife, Frances, told Business Insider. "It worked so fast, I couldn't believe how good he was feeling."Schoenbauer, who still gets Tecentriq every three weeks, is active and walks to the mall in his Maryland town every morning. He's in remission and says he hasn't experienced any major side effects from the drug.But even with this level of excitement, and anecdotal cases like Carter and Schoenbauer, there are some major caveats. First, not everyone is responding to the drugs - for advanced stages of melanoma, the number of people still alive after two years <a href="http://www.businesswire.com/news/home/20161008005027/en/Merck-Announces-Longer-Term-Follow-Up-Survival-Data-KEYTRUDA%C2%AE">was about 35%</a>, compared to 29.7% over the same time for those taking chemotherapy. And sometimes new checkpoint inhibitors under development fail key trials. In August, Bristol-Myers Squibb, a company with a checkpoint inhibitor called Opdivo said the drug failed a key <a href="http://www.businessinsider.com/bristol-myers-stock-down-on-failed-cancer-trial-2016-8">lung-cancer trial study</a>.<h2>Side effects</h2>Just like chemotherapy and radiation, immunotherapy can have side effects, but they tend to look very different than those from the other treatments. That's because they originate in the immune system.Those checkpoint inhibitors act as "checkpoints" for a reason. In a normal body, they keep the immune system from going after healthy cells. So manipulating them, while it might help kill cancer cells, can at times be a blunt instrument. The newly freed immune system can, in some cases, start attacking healthy organs in the body, including the kidneys, liver, adrenal and pituitary glands, and, in some cases, the heart, <a href="http://www.nytimes.com/2016/12/03/health/immunotherapy-cancer.html?_r=0">The New York Times reports</a>.For example, a person on immunotherapy might experience gastrointestinal problems, such as diarrhea, that could get more serious and turn into the <a href="https://www.niddk.nih.gov/health-information/digestive-diseases/ulcerative-colitis">autoimmune disease colitis</a>."We are playing with fire," UCLA oncologist Dr. John Timmerman <a href="http://www.nytimes.com/2016/12/03/health/immunotherapy-cancer.html?_r=0">told The Times</a>.Immunotherapy nonprofit Cancer Research Institute CEO Jill O'Donnell-Tormey told Business Insider in October that many of these side effects can be controlled with steroids, but it takes good communication between doctors and patients.Because it is still so new compared to chemotherapy, understanding and knowing how to treat all these side effects is still a challenge. Researchers are trying to figure out why some people, such as Bob Schoenbauer, don't seem to have any side effects while others have serious responses, and can the side effects be caught and treated early."We follow the <keyword id="41551" type="ENTERTAINMENT" weightage="100" keywordseo="science">science</keyword>. We try to think through the safety and clinical profiles, and we do think about pros and cons," Arun Balakumaran, an executive director at Merck told Business Insider regarding how Merck thinks about side effects for Keytruda.<h2>Beyond checkpoints</h2><div class="KonaFilter image-container display-table float_right"><div><div class="image on-image"><a href="https://www.flickr.com/photos/niaid/5950870236">NIAID / Flickr</a>A healthy human t-cell in a scanning electron micrograph image.</div></div></div>The field of checkpoint inhibitors has exploded. Take, for instance, Balakumaran at Merck. Two years ago, he said, he was a one-man show at the American Society of Hematology, a major industry conference in December, where data from blood-cancer treatments often debuts. This year, the Merck team had much more data to show, including results from two clinical trials.Researchers are looking into how those checkpoint inhibitors can be combined, either with chemotherapy or other immunotherapies as well, which <a href="http://www.businessinsider.com/the-rising-cost-of-cancer-treatment-2016-6">could get expensive</a>.But it's not the only approach researchers are taking to harness the body's immune system.One promising route is <a href="http://www.the-scientist.com/?articles.view/articleNo/42462/title/The-CAR-T-Cell-Race/">CAR T-cell therapy</a>. Short for "chimeric antigen receptor" T-cell therapy, the treatment takes a person's own cells, takes them out of the body, reengineers them, then puts the cells back in the body where they can attack a particular cancer cell.There are a couple of companies leading the charge in developing these treatments.<ul><li>Novartis plans to file for FDA approval in early 2017 for its therapy, called CTL019. At ASH, <a href="http://www.businessinsider.com/r-novartis-says-82-pct-of-leukemia-patients-in-remission-after-car-t-2016-12">Novartis presented clinical data that showed</a> that the treatment eliminated acute lymphoblastic leukemia, an aggressive blood cancer, in 82% of the patients treated.</li><li>Kite Pharma, a company with a rival therapy to Novartis, also hopes to file with the FDA by the end of the <a href="http://www.fiercebiotech.com/biotech/rivals-kite-and-novartis-post-new-car-t-data-as-both-plot-fda-approval">first quarter in 2017</a>.</li><li>Bluebird Bio is developing gene and therapies for diseases including multiple myeloma, another form of blood cancer that affects plasma. "Basically we sent a T cell in to attach to the myeloma cells, and then basically blow them up," Bluebird CEO Nick Leschly told Business Insider.</li></ul>But anytime you're "blowing up" cancer cells, there can be some major risks. Juno Therapeutics, another biotech company working on these cell therapies, <a href="http://www.businessinsider.com/juno-jcar015-patient-trial-put-on-hold-2016-11">stopped its leading CAR-T clinical trial</a> after patients died while on the trial.At the end of November, Bluebird gave results from its six-person phase-one trial in patients with myeloma who hadn't responded to other treatments. Of the patients who got a higher dose of the gene therapy, 100% saw tumor shrinkage.Mark Alles, CEO of Celgene, the biotech company that teamed up with Bluebird on this myeloma treatment, called the response from these patients exceptional. At the Forbes Healthcare Summit on December 1, he continued, saying it's important to keep in mind how small this trial was: "That's the caveat, always the caveat, let's be careful not to get ahead of ourselves." <div class="margin-top"> <h3>NOW WATCH: <a href="http://www.businessinsider.com/do-not-ignore-ingrown-hairs-pimples-skincare-2016-12">Here's one type of pimple you should pay attention to</a></h3> <div> <div> <div class="ooyala-video-player" data-video-autoplay="false" data-video-id="N1b2ZxMzE6iB_l2W7_vTKnz1OfutxStO" data-player-variable="ooyalapopvideo" id="ooyalaplayer_popvideo" style="width:1280px;height:720px"></div> </div> </div> </div>

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