Pfizer, Starboard, GSK, Medicare news – hassteveclarkresignedyet

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Good morning, this week is full of profits. Going straight to the Pfizer and Novartis reports this morning.

Things to know this morning

Crescent Biopharma did his debut on public markets by reverse merger with the non-existent one Glycomimetics. Backed by $200 million in new funding from a long list of prominent biotech hedge funds, Crescent is developing a cancer antibody that targets PD-1 and VEGF, similar to a drug owned by Summit Therapeutics and Akeso.
Biogen named Daniel Quirk as his new chief medical doctorreporting to Priya Singhal, current Head of Drug Development. Quirk joins Biogen from Bristol Myers Squibb. Biogen said Monday that CFO Michael McDonnell is retirement in February 2025. He will be replaced by current chief accounting officer Robin Kramer.

Pfizer earnings rise amid Starboard criticism

This morning, Pfizer reported earnings that significantly beat analysts’ expectations. Adjusted earnings per share in the third quarter were $1.06 per share, compared with analysts’ expectations of $0.60 per share. The company’s shares rose in premarket trading.

It’s the company’s first earnings report since activist investor Starboard bought a $1 billion stake in the pharmaceutical giant and began putting pressure on its board and CEO.

In a note yesterday, Mizhuo analyst Jared Holtz wrote that Pfizer could use its earnings announcement to “refute” Starboard’s arguments or “at least show why its prospects are better than investors think.”

Novartis delays filing for MorphoSys

Novartis raised its earnings forecast this morning, saying it expects full-year operating profit to grow by a percentage point in the mid-teens, compared to its previously forecast mid-to-high-teens range.

In addition, CEO Vas Narasimhan said it would be “a few more years” before the company could submit to regulators an experimental drug for a rare bone marrow cancer that was the centerpiece of a nearly $3 billion deal for biotech MorphoSys. This morning’s update confirmed previous reporting according to STAT.

Novartis had originally hoped to file for approval of the drug this year, but ongoing questions about the data profile have yet to be resolved. The company also said it took an $800 million write-down of the purchase price of MorphoSys.

Venture capitalists are using American startups to hedge bets on Chinese drugs

U.S. venture capitalists are increasingly building companies in the U.S. from scratch to license and eventually try to commercialize drugs developed in China.

Chinese biopharmaceutical companies are very interested in receiving new financing from American venture capital. And for American investors, the deals are a way to hedge their bets when it comes to partnering with Chinese firms. With rising U.S.-China tensions, the threat of legislation that could make it more difficult for American companies to invest in China, and uncertainty about the impact of the U.S. election, some venture capitalists see the idea of establishing new companies in the U.S. as a strategic opportunity.

Read more by STAT contributor Brian Young.

GSK buys autoimmune drug candidate

From STAT’s Andrew Joseph: The biotech boom is trying adapt cancer immunotherapy for autoimmune diseases seems to be attracting the attention of pharmacists.

GSK said this morning that it has acquired an experimental therapy from Chimagen Biosciences that is aimed at testing different forms of lupus and possibly other autoimmune diseases. GSK paid $300 million upfront for a “T-cell recruitment” therapy called CMG1A46, which Chimagen is already testing in phase one trials in leukemia and lymphoma. The agreement provides for additional interim payments if certain targets are met.

GSK said it plans to develop therapies for autoimmune diseases caused by abnormal B cells, including lupus erythematosus and lupus nephritis, and that it hopes to start phase 1 lupus trials next year. The pharmaceutical giant said the addition of another drug candidate to its immunology pipeline highlights the need for other approaches in the field, especially for patients who are not benefiting much from current treatments.

“CMG1A46 offers exciting potential that we are excited to pursue to address the unmet need in lupus and related autoimmune diseases,” said Tony Wood, GSK’s Chief Scientific Officer.

Who to watch in the booming cancer vaccine industry

After years of disappointing results, recent data on new personalized cancer vaccines have begun to show some promise, marking a turning point in the field.

Biotechnology and pharmaceutical companies are actively involved in this field of research, and new science is emerging about various targeted vaccines, as well as the science of developing cancer vaccines for more types of cancer.

My colleague Angus Chen has put together a list of key figures to watch out for as this field rapidly evolves. It includes Catherine Wu of Dana Farber, BioNTech co-founders Ugur Sahin and Ozlem Tyureci, and Vinod Balachandran of Memorial Sloan Kettering.

What’s Behind Medicare’s Drug Price Negotiations?

Meena Seshamani, director of the Center for Medicare and Medicaid Services, explains in today’s article how CMS conducted the first round of drug price negotiations under the Inflation Reduction Act.

CMS consulted with FDA staff to consider how to incorporate real-world data into its deliberations, she said. During the negotiation meetings, the agency listened to the drug manufacturers and “each side adjusted the proposals accordingly as part of the negotiation process.”

On five drugs, CMS reached agreement during the negotiation period, with the agency agreeing to the negotiated prices offered by the manufacturers in four cases, she wrote. According to her, for the other five drugs, all manufacturers have accepted the final CMS proposals.

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