As the J.P. Morgan Healthcare Conference rolls on Wednesday, Teva, Merck KGaA, Amarin and others are slated to present.
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UPDATED: Wednesday, Jan. 11 at 9:10 p.m. ET
In November, Viatris jumped head first into the ophthalmology market with a pair of buyouts worth between $700 million and $750 million. With Oyster Point Pharma and Famy Life Sciences under its belt, the company has built a “world class” eye division, said Jeffrey Nau, the head of Viatris eye care division and former CEO at Oyster Point. There’s no “global leader” in eye care, Nau said. There are “people who play in eye care,” but all are focused on other sectors, according to the Viatris exec. However, there's no lack of innovative smaller companies and startups that need leaders in the space and Viatris is “really excited” to step up to the plate.
UPDATED: Wednesday, Jan. 11 at 7:15 p.m. ET
Manufacturing COVID therapies for AstraZeneca, Eli Lilly and GSK kept Samsung Biologics busy for the last couple years. Now that those products have largely been shelved, is the company at risk of declining revenue? Not to worry, said CEO John Rim Wednesday at the J.P. Morgan Conference. “The way we structured our contracts is they’re interchangeable,” Rim said. “If those products diminish, they get replaced by a substitute product by the client. So we really don’t see much impact.” Similarly, Samsung is not concerned about building too much capacity. It has a unique setup in Korea, with a sprawling campus of four massive plants and plans to replicate the complex on a plot of nearby land the size of “50 soccer fields,” as Rim described it. In addressing that concern, he recalled a “back of the envelope” calculation he made a few years ago speculating about the potential of manufacturing oncoming monoclonal antibody treatments for Alzheimer’s disease. He figured if Samsung were to serve 10% of the 15 million Alzheimer’s patients in the U.S., it would require two more 180,000-leter plants. “We recently had the whole neurology marketplace open up with lecanemab,” Rim said. “We could see a whole new category within the mAB sector open up with significant growth."
UPDATED: Wednesday, Jan. 11 at 4:20 p.m. ET
After a year marked by launches such as Mounjaro in diabetes, Eli Lilly is gearing up for another “unprecedented year,” chief financial officer Anat Ashkenazi said during the company’s JPM presentation. On top of up to four new drug launches, Mounjaro is expected to net a highly anticipated label expansion in obesity. The company has already initiated its rolling FDA submission and expects a U.S. launch late this year or early next year, Ashkenazi said. Story
UPDATED: Wednesday, Jan. 11 at 2:30 p.m. ET
Don’t call WuXi a CMO. And don’t call it a CDMO. The China-based company is a contract research, development and manufacturing organization (CRDMO). That was the central theme of the company’s presentation at the JPM conference on Wednesday. CEO Chris Chen emphasized WuXi’s research work with CD3 bispecifics, which have drawn the attention of companies such as GSK. Speaking of a specific molecule in the works that GSK has signed on to manufacture and commercialize, Chen speculated on its success. “We’ll be receiving about $800 million of milestone payments and we will receive royalties that will be twice or three times the profit of commercial manufacturing,” Chen said. “That’s why we believe our business model is very powerful.” Performing research in house allows for a smooth connection between R&D and manufacturing, Chen said. Meanwhile, with the long-awaited opening of China after two years of travel restrictions, WuXi will be in better position to continue its growth. “The FDA can come and inspect us, and our clients can visit us,” Chen said. “This is the first kind of tailwind for us in 2023.”
UPDATED: Wednesday, Jan. 11 at 1:51 p.m. ET
Even as Teva welcomes a new CEO and works to settle its opioid litigation, the drugmaker has its eye on the large generics and biosimilars industries worldwide. Over the next five years, the company expects $188 billion in total branded losses of exclusivity in key markets, chief financial officer Eli Kalif said Wednesday, citing IQVIA data. In the company’s pipeline, Teva’s biosimilars to AbbVie’s Humira and Roche’s Lucentis are undergoing regulatory reviews. Meanwhile, the company’s own branded meds Austedo and Ajovy are each growing sales (PDF) at more than 20% year over year, Kalif said. Teva has guided for 2022 sales of around $1.4 billion total for the two products.
UPDATED: Wednesday, Jan. 11 at 11:52 a.m. ET
Over the years, AbbVie has created “a very strong foundation,” CEO Rick Gonzalez said. That foundation is going to come in handy come later this month when the event the company has been “long planning for” comes to fruition: Humira’s loss of exclusivity. The company is confident it is ready to absorb the impact from the loss of exclusivity and “quickly return to strong growth” in 2025. As Humira competes against biosimilars for formulary access, price reductions will hit throughout this year. There will be “a certain level” of price erosion in the first half of the year, but a higher level during the second half, when many biosimilars enter mid-year, Gonzalez said. Story
UPDATED: Wednesday, Jan. 11 at 11:10 a.m. ET
After GSK pulled its cancer drug Blenrep right on the heels of a confirmatory trial failure, industry watchers wondered whether there would be a new benchmark for withdrawals going forward. But in an interview on the JPM sidelines, FDA commissioner Robert Califf said it's more of a case-by-case basis. Not all confirmatory trial failures should warrant an immediate product pull, he said. At the same time, the agency wants to get more control over the controversial regulatory pathway. Story