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Merck's potential cholesterol pill succeeds in late-stage studies
The company is searching for its next blockbuster candidate as its major revenue driver, Keytruda, is expected to lose patent protection by the end of the decade.
Merck's non-statin cholesterol drug, enlicitide decanoate, is being tested for the treatment of hyperlipidemia, a condition that causes elevated buildup of fat in the blood vessels and can lead to heart attacks and strokes.
Enlicitide works by blocking PCSK9, a protein that plays a crucial role in regulating cholesterol levels, while statins block an enzyme the liver uses to make cholesterol.
BMO Capital Markets analyst Evan Seigerman said Merck's drug could potentially provide a "multi-billion dollar opportunity" that expands the PCSK9 market beyond current injectable therapies.
The drug showed meaningful reductions in LDL-C cholesterol, commonly referred to as "bad cholesterol", when compared to placebo and other oral non-statin therapies, Merck said.
However, Leerink analysts have noted that Astrazeneca's AZD0780 is a "credible threat" as it has shown a 50.7% reduction in LDL-C levels during a trial.
Merck has not given the details on LDL-C reduction for enlicitide.
The drug was tested in patients who have a history of, or are at risk for a type of heart disease, and were treated with a statin.
Shares of Merck were up 2% in premarket trading.
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Economic Times
5 days ago
- Economic Times
Tata, Merck explore exclusive chemical deal for Dholera semiconductor facility
ETtech Tata Electronics is in discussions with German chemicals giant Merck for a potential exclusive long-term agreement, people aware of the developments told ET. The deal would see Merck become a primary supplier of specialty chemicals and materials essential for semiconductor manufacturing at Tata's upcoming Dholera facility. The Dholera fab, a 91,000 crore ($11 billion) project, is a joint venture with Powerchip Semiconductor Manufacturing Corp (PSMC) of Taiwan. It's a cornerstone of India's ambitious push to establish a domestic semiconductor ecosystem. As construction progresses and the plant gears up for production by 2026, securing a steady and reliable supply of ultra-pure chemicals is paramount. A potential partnership with Merck will help seal this gap, analysts said. 'Tata Electronics is in active negotiations with Merck,' said one of the persons. ' Tata is evaluating the offer and is yet to sign on the dotted line but securing a chemicals partner is very much on their agenda. It will boil down to whether they agree to the exclusivity.' Semiconductor manufacturing uses more than 150 chemicals and over 30 gases and minerals in the production processes. Analysts said this exclusive partnership would provide Tata Electronics with supply chain stability, a critical factor in the volatile global semiconductor market and will help Merck make a foray into India's burgeoning semiconductor industry.'We have been monitoring semiconductor manufacturing developments in India for the past couple of years,' a Merck spokesperson said. 'We believe that India is becoming an increasingly important partner in the global semiconductor ecosystem. However, at this time it is too early to talk about concrete plans for India. We continue to closely follow opportunities that align with our strategic goals.'Tata Electronics didn't respond to queries. Merck is a global leader in specialty chemicals and serves as a crucial ancillary supplier for both existing and future chipmakers, said Neil Shah, vice president of research at Counterpoint Research. It provides a comprehensive portfolio of high-purity materials, including chemicals, gases, and metrology and inspection solutions. 'These offerings support chipmakers throughout various stages of manufacturing, from deposition and etching to final quality control,' he explained. 'An exclusive agreement between Merck and Tata Electronics would create significant strategic advantages for both companies. For Tata Electronics, an exclusive partnership would ensure a consistent, prioritized, and uninterrupted supply of critical materials, mitigating supply chain risks. Having a special price lock-in often comes with exclusivity.' It will allow Tata Electronics to leverage Merck's extensive supplier experience and R&D capabilities. It could thus lead to the development of robust processes, improved manufacturing yields and an accelerated timeline for their chip production.'For Merck, partnering with Tata Electronics, a key player in India's emerging semiconductor landscape, would be a major strategic win,' Shah said. 'As India becomes a more important market for chip manufacturing, this partnership would provide Merck with significant scale and a strong foothold. This position would enable Merck to expand its operational base in India, invest in local R&D, and potentially benefit from government incentives.'Merck will require a robust ecosystem to establish a successful chemicals plant in Gujarat. This includes not only reliable infrastructure--electricity, water, security, logistics--but also a well-developed upstream supply chain with local partners in raw materials to packaging. Shah said this 'holistic ecosystem' is essential to support and sustain Merck's was the first to report in February that Merck was looking to set up a specialty chemicals facility in India. In May, Union minister for electronics and information technology Ashwini Vaishnaw highlighted that Merck, among other companies, was gearing up for the growth of India's semiconductor industry. Elevate your knowledge and leadership skills at a cost cheaper than your daily tea. Tariffs, tantrums, and tech: How Trump's trade drama is keeping Indian IT on tenterhooks Good, bad, ugly: How will higher ethanol in petrol play out for you? As big fat Indian wedding slims to budget, Manyavar loses lustre As 50% US tariff looms, 6 key steps that can safeguard Indian economy Stock Radar: JSPL forms Ascending Triangle pattern on weekly charts, could hit fresh 52-week high soon Nifty and business are different species: 5 small-cap stocks from different sectors with upside potential of up to 30% F&O Radar | Deploy Bear Put Spread in Nifty to play index's negative stance amid volatility Wealth creation: Look beyond the obvious in some things; 10 fertilizer sector companies worth watching
The Print
11-08-2025
- The Print
Blockbuster semaglutide set to go off patent, Indian pharma sees a multi-billion-dollar opportunity
The patent expiry on oral and injectable versions of semaglutide has paved the way for manufacture and availability of its generic versions, which may slash cost of the drug by 50-70 percent starting next year. Available under the brand names Rybelsus (in pill form), and Ozempic and Wegovy (injectables), semaglutide was the world's second bestselling drug in 2024, second only to Merck's anti-cancer drug Keytruda. The market for it is estimated to be growing at 40 percent annually. New Delhi: As the patents on semaglutide, a popular diabetes and anti-obesity drug that earned its Danish maker Novo Nordisk nearly USD 30 billion in FY25 alone, expire in nearly 100 countries next year, at least 10 Indian drugmakers have sought regulatory approvals to conduct late-stage clinical trials for generic versions of the drug. Additionally, this will also lead to the drug's availability in emerging markets and developing countries and territories where it had not been able to reach yet due to supply constraints. In India, the once-weekly injection of semaglutide, launched in June this year, costs between Rs 17,345 and Rs 26,045 per month, depending on dose strength. Among the countries where the blockbuster obesity drug is going off patent, the biggest markets are India, Canada, China, South Africa, Brazil and Turkey and UAE. These countries have nearly 33 percent of people globally that can be classified as obese, according to a report by market research firm IQVIA. 'Given the scenario, Indian pharmaceutical exporters are seeing a big opportunity here and if they manage to capture even 10 percent of its current annual sale, it will be huge,' Bhavin Mukund Mehta, vice-chairman of Pharmaceuticals Export Promotion Council of India (Pharmexcil), an agency under the Union Ministry of Commerce and Industry, told ThePrint. Semaglutide belongs to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists and is called a GLP-1RA drug. It mimics the GLP-1 hormone that is released in the gastrointestinal tract in response to eating. One role of GLP-1 is to prompt the body to produce more insulin, which reduces blood glucose (sugar), and in higher amounts, it interacts with parts of the brain that reduce appetite and signal a feeling of fullness. Lower strengths of the drug, such as Rybelsus and Ozempic, are prescribed for type 2 diabetes but can also support weight loss, while Wegovy is indicated for those categorised as obese even in the absence of diabetes. IQVIA has estimated that at least 1 in 3 people living with obesity in the world will live in a country with access to off-patent semaglutide from 2026. Experts say that while Novo Nordisk has not been able to supply the drug in a large number of countries due to extremely high demand in developed countries despite its high price, the availability of its copycat versions could completely change the dynamic. Also Read: This experimental lung cancer drug outperforms blockbuster medicine Keytruda. But there's a catch Potential to disrupt anti-obesity market Ever since its launch in 2017 in the US, the drug has been a runaway success, and has propelled Novo Nordisk—a relatively lesser-known Danish drugmaker mainly identified with insulin production earlier—into becoming the most valuable corporation in Europe within a couple of years of the medicine's roll out. In 2024-25, the drug alone brought nearly 70 percent of the company's turnover. Now, several Indian pharmaceutical companies—including Biocon, Dr Reddy's, Cipla, Zydus, Alkem, Shilpa Medicare, Natco, and Aurobindo Pharma—are in the race to hit the markets with copies of semaglutide, the day it loses patent. 'India being the largest supplier of generics with more than 20 percent share has the potential to disrupt the existing market segment with high quality semaglutide generics,' Vivek Tandon, vice president of management consultancy firm Primus Partners, told ThePrint. Indian pharma giants have been gearing up for this opportunity for many years now, he added. The global anti-obesity market was estimated to be around $11 billion this year but is expected to grow to over $100 billion over the next decade, fuelled by changing lifestyle and dietary patterns worldwide. In India, the anti-obesity drug market is currently valued at Rs 3,000-3,500 crore, and is projected to grow nearly eightfold to Rs 25,000 crore by 2030. The country saw the launch of two drugs exclusively to treat the condition, Wegovy and another similar drug Mounjaro by US pharma giant Eli Lilly & Company, this year, while oral semaglutide Rybelsus arrived here in 2022. Market analysts say that globally, lower manufacturing costs will lead to price reduction of semaglutide due to intense competition. The introduction of cost-effective, high-quality generic substitutes has the potential to lead to greater adoption of anti-obesity medications, changing them from expensive specialised treatments to accessible first-line interventions, Tandon underlined. Govt push for drugs going off-patent A total of 24 blockbuster drugs, with global sales worth $ 251 billion, are going to lose patents in the US during the period of 2022-2030, offering major business and growth opportunities for Indian pharma companies, a report by the Centre's Department of Pharmaceuticals said last year. The report named mega-selling anti-rheumatic drug Humira, anti-cancer drugs Keytruda, Opdivo, Revlimid and Avastin and anti-diabetic and obesity drugs Victoza, Januvia and Trulicity, apart from semaglutide, in the list. A senior DOP official who did not wish to be named told ThePrint that the government's Production-Linked Incentive (PLI) scheme, which incentivises domestic manufacturing, had also spurred significant interest from leading domestic pharmaceutical companies in developing their own version of semaglutide. 'Indian drugmakers have done exceptionally well over the last few weeks by supplying high-quality, cost-effective generic versions of drugs for conditions such as HIV/AIDS and cancer. There is now a chance to repeat that again,' the official said. Industry experts agreed. 'I think it's a big win for Indian generics in price-sensitive markets. Indian semaglutide copies could dominate the anti-obesity market mirroring past successes in HIV, hepatitis, and oncology generics,' pharmaceutical analyst Salil Kallianpur told ThePrint. But the impact in the US and European Union, where the patent on the drug is not ending before 2030, will be limited as Novo's patent extensions mean no near-term generics in these lucrative markets, he added. The anti-obesity market will grow faster but with lower margins due to generics, pushing big pharma towards innovation (oral GLP-1s or combo therapies). Indian drugmakers need to move fast (as Chinese generic makers are also eyeing the copycat semaglutide market), secure partnerships, and invest in manufacturing scale to capture this multi-billion-dollar opportunity, Kallianpur said. Top companies maintained they are excited at the prospect. 'Semaglutide presents a timely opportunity to provide an effective solution for the growing obesity and diabetes burden in India,' Vikas Gupta, CEO of Alkem Laboratories, a leading Indian drug manufacturer that makes bestsellers such as Pan and Pan D, told ThePrint. We aim to leverage our strong research and development capabilities and extensive distribution network across the country to address this demand, he said. 'We are geared up to be among the first ones to launch a generic version of semaglutide in India once the patent expires. Our strategic focus will remain on India, given the scale of unmet need and our stronghold in the market, but we are exploring opportunities in some emerging markets as well for launching this drug,' he added. (Edited by Nida Fatima Siddiqui) Also Read: How semaglutide is emerging as A-Z drug, helping with diabetes, alcohol cravings & more
Time of India
08-08-2025
- Time of India
Struggling US healthcare stocks endure rough 2025 but draw some bargain hunters
New York: Woes for U.S. healthcare stocks have worsened this year driven partly by Trump administration policies, although some investors are betting that the beaten-down shares are now becoming too much of a bargain to pass up. The S&P 500 healthcare sector -- which includes pharmaceutical companies , biotechs, health insurers and medical equipment makers -- has slumped 5% in 2025, lagging the over 7% gain for the overall index. Pressure to bring down U.S. prescription drug prices to overseas rates, tariffs targeted at pharmaceuticals and cuts to areas such as health research funding and Medicaid are among the Trump administration actions clouding the outlook for the shares this year, investors said. Regulatory obstacles are compounding issues, including expiring drug patents and setbacks for bellwethers including UnitedHealth Group. "You have got this constant overarching political and regulatory overhang that doesn't really seem to subside with any administration," said Jared Holz, healthcare sector strategist at Mizuho Securities. "When you have so much nebulousness around the sector, it turns people off rather than invites them to the party." In another sign of the group losing favor, healthcare exchange-traded-funds have seen 12 consecutive months of net outflows as of July for a total outflow of $11.5 billion in that time, more than for any other sector, according to State Street Investment Management. The performance picture is even dimmer over a longer period. While shares of massive technology companies pushed the benchmark S&P 500 up over 50% the past three years, the healthcare sector is little changed in that time. That gap has put the 60-stock sector at nearly its biggest discount to the broader market in 30 years, which some investors hope is an inflection point for the battered group. "The valuation is extremely cheap and the relative performance is at an extreme," said Walter Todd, chief investment officer at Greenwood Capital, whose healthcare holdings include diversified giant Johnson & Johnson and medical device maker Stryker. "So at this point, it seems like a pretty decent setup to get some outperformance." The price-to-earnings ratio for the healthcare sector, based on earnings estimates for the next year, has fallen to 16.2 times from nearly 20 a year ago, according to LSEG Datastream. Meanwhile, the S&P 500's rally to records has driven the index's P/E ratio to over 22 times -- giving the broader market a significant premium over the healthcare sector. 'BAD NEWS IS PRICED IN' Some high-profile healthcare names are at even cheaper valuations. For example, Merck is trading at a forward P/E of 8.7, against its long-term average of 14.5, while fellow drugmaker Bristol Myers Squibb trades at 7.4 against its average of 15.8, according to LSEG. Year-to-date, shares of both Merck and Bristol Myers are down roughly 20%. The group is drawing bets from some value investors such as Patrick Kaser, portfolio manager at Brandywine Global, whose portfolio is overweight the sector including owning shares of CVS Health and European drugmakers GSK and Sanofi. "Our perspective is a lot of this bad news is priced in and then some," Kaser said. "To bet against the sector from here, you're essentially continuing to bet on the valuation gap, which is already large, continuing to widen." The group's decline means the total market value of the S&P 500 healthcare sector is about $4.8 trillion, not much higher than the $4.3 trillion value of Nvidia, the semiconductor company that has symbolized the artificial intelligence boom. Indeed, some investors said a shift in capital away from Nvidia and other massive tech companies could spark healthcare shares. Such a move appeared to occur in the first quarter, investors said, when the healthcare sector rose 6% while declines in tech and megacap stocks dragged indexes lower. Fears of an economic downturn also could help healthcare shares, at least on a relative basis. The group is often viewed as a defensive area in rockier economic times. Economic fears flared following last Friday's weaker-than-expected employment report, while some strategists say the market could be due for a pullback after surging over 20% since its April lows. "During the first quarter, healthcare did great even as tech rolled over, as the fears of an economic slowdown got to more economically sensitive stocks," said Chris Grisanti, chief market strategist at MAI Capital Management, adding he expects healthcare "will perform better in a more difficult market." More clarity on regulatory issues, including tariffs, also could support healthcare, investors said. But some value investors are hesitant to dive into the group. Michael Mullaney, director of global markets research at Boston Partners, said he is wary some healthcare shares could be "value traps," preferring to overweight areas including industrials or financials. "There's been just so much of an overhang in the sector," Mullaney said. "There are better places to go with cleaner stories."
