| Sponsored by | | | | Hello from Day 1 of the 2023 J.P. Morgan Healthcare Conference. Here's the latest from rainy San Francisco, courtesy of our reporters on the ground — Adam Feuerstein, Matthew Herper, Allison DeAngelis, Jonathan Wosen, Jason Mast, Bob Herman, and Mohana Ravindranath. | | |  A momentary reprieve from the rain. (Adam Feuerstein) JPM kicks off with a flurry of (modest) mergers and acquisitions Within the first hours of J.P. Morgan, four pharma companies had already announced about $4.5 billion total in acquisitions, STAT’s Jonathan Wosen and Allison DeAngelis report. A modest sum? No question. But life science observers are desperate for any indication that deals could be on the rise after a lackluster 2022, during which two acquisitions accounted for two-thirds of $60 billion in total deal flow. The recent deals include AstraZeneca’s $1.8 billion pickup of CinCor, which will give the U.K. pharma giant access to an experimental blood pressure drug it plans to combine with a diabetes drug AstraZeneca already owns. Other acquisitions include Italian pharma firm Chiesi Farmaceutici expanding its rare disease program by acquiring Irish firm Amryt Pharma for $1.48 billion, and French pharmaceutical company Ipsen purchasing rare disease company Albireo for close to $1 billion. And Qiagen is spending $150 million to buy San Diego firm, Verogen, which uses next-generation DNA sequencing to support forensic labs. Read more. | Life inside the Westin Dare we say, the traditionally cozy — ahem — confine of the J.P. Morgan Healthcare Conference felt relatively spacious today. It’s been awhile since we’ve roamed these rooms and hallways, but the square footage remains the same. Fewer people? Perhaps. Masks? Almost non-existent. Not judging. In some of his first extended comments since taking over as Biogen’s CEO, Chris Viehbacher talked up the imminent launches of two new drugs — the Alzheimer’s treatment Leqembi and the depression drug zuranalone — as significant growth opportunities for the company. The medicines are partnered with Eisai and Sage Therapeutics, respectively. But Viehbacker also acknowledged that he has about six months of internal work ahead of him to fix the company’s cost structure. “We’re making $5 billion less in profits today than we did in 2019, and that hasn’t completely percolated through the company yet.” Novartis CEO Vas Narasimhan strode to the stage in the Grand Ballroom wearing dark selvedge jeans, a brilliant white shirt open at the collar, and a navy blue jacket. It was a TED Talk wardrobe for a guy pitching Novartis, freshly shorn of its older corporate appendages, as the “next, pure-play innovation medicines company.” He repeated those buzzwords frequently. Sarepta Therapeutics CEO Doug Ingram said in his presentation that “2023 will be a bellwether not only for Sarepta, but for families with Duchenne muscular dystrophy, and for the promise of gene therapy.” The burning question: Will the FDA grant accelerated approval to SRP-9001, Sarepta’s gene therapy on May 29, based on preliminary evidence that the treatment makes the crucial muscle protein called dystrophin — and before data from a confirmatory study are ready later in the year? The company’s dystrophin data submitted to the agency are “compelling, to say the least,” Ingram said, exuding confidence that a quick approval will come. FDA approval was also the question most on the minds of investors attending the Apellis Pharmaceuticals presentation. CEO Cedric Francois was unflappable in the face of questions about the ongoing review of the company’s treatment for geographic atrophy — a chronic eye disease and a leading cause of blindness in older people. The review was extended once already to review more data, submitted voluntarily by Apellis, Francois said, not because agency staff have concerns. The approval decision is expected on Feb. 26. | Sponsored insight by Amgen 5 ways biotech can help support patients and their communities As a company, Amgen’s mission is to serve patients, and while innovating new medicines may be at the core of what they do every day, staff are always excited for new ways to serve not only patients, but also the communities where they live and work. Learn more about how the people of Amgen came together in 2022 to help patients, families and communities live happier, healthier lives. | One way to grade CEOs … … is to look at how a company’s stock trades when they step down. Novavax’s share price rose about 15% on this morning’s news that longtime leader Stanley Erck would soon resign, a micro-referendum on the company’s tumultuous recent performance. As STAT’s Matthew Herper reports, Erck, who led Novavax for 11 years, will be replaced by John Jacobs, who recently left his role as the CEO of Harmony Biosciences, a developer of rare disease drugs. Jacobs inherits a company that repeatedly fumbled opportunities to cash in on an effective vaccine for Covid-19, missing deadlines and struggling to manufacture doses. Novavax’s stock price tells the story. In late 2019, before the pandemic began, the company traded at $4. It rose to a peak of $170 in July 2020 and then peaked again at $289 in February 2021. Now Novavax trades at around $12. The board’s decision to recruit an outsider, instead of promoting a member of the company’s current executive team, would seem a clear indication that it is hoping that Novavax will set a new direction. Read more. | Is Regeneron’s cash cow in trouble? Eylea, the ocular medicine that accounts for more than half of Regeneron Pharmaceuticals’ business, has suddenly wobbled. In an earnings preview disclosed this morning, Regeneron said it made $1.5 billion from Eylea in the fourth quarter. That represents 8% annual growth, but it’s nearly 10% below Wall Street’s estimates. And that has some analysts wondering whether there’s cause for concern in Tarrytown. As STAT’s Jason Mast reports, Regeneron’s stock fell about 8% on the news, a drop that translates to around $6 billion in lost market cap. The company blamed Eylea’s miss on some “short-term” issues that have already started to reverse, adding that the drug still has a 75% share of the market for branded treatments of its kind. But biosimilars could bring new competition as soon as 2024, as Regeneron’s patents on the drug begin to expire this year. And last year, Roche won approval for a drug called Vabysmo that has more flexible dosing than Eylea. Read more. | More reads - Moderna plans to follow in Pfizer’s footsteps, charge up to $130 for Covid-19 vaccine in U.S., STAT
- CureVac appoints new CEO, Financial Times
- Arrowhead RNA treatment improves liver scarring in patients, but so does a placebo, clouding study results, STAT
That's all for today. See you tomorrow! | | | |
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