Pfizer, Starboard, GSK, Medicare news

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Good morning, it’s a busy earnings week this week. Let’s get straight into reports from Pfizer and Novartis this morning.

The need-to-know this morning

Crescent Biopharma made its public markets debut through a reverse merger with the defunct GlycoMimetics. Backed by $200 million in new financing from a long list of prominent biotech hedge funds, Crescent is developing an antibody for cancer that targets PD-1 and VEGF, similar to the drug owned by Summit Therapeutics and Akeso.
Biogen named Daniel Quirk as its new chief medical officer, reporting to Priya Singhal, its current head of drug development. Quirk joins Biogen from Bristol Myers Squibb. On Monday, Biogen said Chief Financial Officer Michael McDonnell is retiring in February 2025. He will be replaced by current Chief Accounting Officer Robin Kramer.

Pfizer earnings beat amid Starboard criticism

Pfizer released earnings this morning that handily beat analyst expectations. Adjusted earnings per share in the third quarter were $1.06 per share compared with analyst expectations of $0.60 per share. The company’s stock rose in pre-market trading.

This is the company’s first earnings report since activist investor Starboard took a $1 billion stake in the pharma giant and began putting pressure on its board and CEO.

In a note yesterday, Mizhuo analyst Jared Holz wrote that Pfizer might use its earnings announcement “to push back” on Starboard’s argument or “at least show why its outlook is better than investors currently believe.”

Novartis pushes off submission for MorphoSys drug

Novartis this morning increased its earnings guidance, saying it anticipates full-year operating profit to grow by a percentage in the high teens, up from the previously forecasted mid- to high teens.

Separately, though, CEO Vas Narasimhan said it would be a “couple 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 the biotech MorphoSys. This morning’s update confirmed previous reporting by STAT.

Novartis had originally hoped to file for the drug’s approval this year, but ongoing questions about its data profile have yet to be resolved. The company also said it had written off $800 million of the purchase price of MorphoSys.

VCs use U.S. startups to hedge bets on Chinese drugs

American venture capitalists are increasingly building U.S.-based companies from scratch to license and ultimately try to commercialize medicines developed in China.

For Chinese biopharma companies, there’s keen interest in securing fresh funding from American VCs. And for U.S. investors, the deals are a way to hedge their bets when it comes to partnering with Chinese firms. Amid growing U.S.-Chinese tensions, the looming threat of legislation that could make it harder American companies to invest in China, as well as uncertainty over the impact of the U.S. elections, some VCs see the notion of setting up new companies stateside as a strategic opportunity.

Read more from STAT contributor Brian Yang.

GSK acquires autoimmune drug candidate

From STAT’s Andrew Joseph: The boom of biotechs trying to adapt cancer immunotherapies for autoimmune disease is getting attention from pharma, it seems.

GSK this morning said it had acquired an experimental therapy from Chimagen Biosciences that it aims to test in different forms of lupus, and possibly other autoimmune diseases. GSK paid $300 million upfront for the “T-cell engager” therapy, called CMG1A46, which Chimagen is already testing in Phase 1 trials in leukemia and lymphoma. The deal includes additional milestone payments if certain targets are met.

GSK said it planned to develop the therapy for autoimmune diseases driven by aberrant B cells, including lupus erythematosus and lupus nephritis, and that it hopes to start a Phase 1 lupus trial next year. The pharma giant said adding another drug candidate to its immunology pipeline signaled the need for different approaches in the field, particularly for patients who don’t benefit much from current treatments.

“CMG1A46 offers exciting potential which we are pleased to take forward to address unmet need in lupus and related autoimmune conditions,” Tony Wood, GSK’s chief scientific officer, said in a statement.

Who to watch in the booming field of cancer vaccines

After years of disappointing results, recent data on new personalized cancer vaccines have started to show some early promise, triggering a turning point for the field.

Biotechs and pharma companies are jumping into this area of research, and new science around different vaccine targets is also emerging, as is science to develop cancer vaccines for more types of cancer.

My colleague Angus Chen compiled a list of the key figures to watch as this field grows rapidly. It includes Dana Farber’s Catherine Wu, BioNTech co-founders Uğur Şahin and Özlem Türeci, and Memorial Sloan Kettering’s Vinod Balachandran.

What’s behind Medicare’s drug price negotiations?

Meena Seshamani, director of the Center for Medicare, explains in an opinion piece today how CMS executed the first round of drug price negotiation as part of the Inflation Reduction Act.

CMS consulted with FDA staff to consider how to incorporate real-world data in its deliberations, she said. In the negotiation meetings, the agency listened to the drugmakers and “each side adjusted offers accordingly as part of the negotiation process.”

For five of the drugs, CMS reached an agreement during the negotiation meeting period, with the agency agreeing to negotiated prices that manufacturers proposed in four of the cases, she wrote. For the other five drugs, all manufacturers accepted CMS’ final offers, she said.