Forget coronavirus, homoeopathy can’t cure anything. It’s a placebo, at best

Pfizer Scraps One Weight Loss Drug In Race To Develop Ozempic Rival

June 26 (Reuters) - Pfizer Inc (PFE.N) said it is scrapping its once-a-day experimental obesity pill because of concerns about liver safety, but will continue developing its other obesity pill, the twice daily treatment danuglipron, as it races to rival the success of other weight loss treatments.

The company's shares fell more than 5% in early trading on Monday as Pfizer said it would stop developing its therapy lotiglipron after patients who took the drug in clinical studies were shown to have elevated levels of liver enzymes.

Pfizer CEO Albert Bourla has said an obesity pill could eventually be a $10-billion-a-year product for Pfizer. The company's shares have dropped around 29% so far this year as it works to develop its strategy past the COVID vaccines and therapeutics that drove revenue and earnings for the past few years. The NYSE Arca Pharmaceutical index, which tracks drugmakers, is down around 1% over the same period.

The company said it expects to finalize plans for the danuglipron late-stage program by the end of the year, and is also developing a once-daily, modified release version of that drug. Pfizer has been developing both pills in parallel, but had said all things being equal its preference would be for the once daily lotiglipron.

The news comes days after competitor Eli Lilly (LLY.N) released promising data for its own once-daily experimental pill, orforglipron.

Truist Securities analyst Robyn Karnauskas said Lilly is now ahead in the race for a once-a-day obesity pill.

"We believe while (twice a day) has advantages, we really need a (once daily) formulation for weight loss," she said in a research note.

Pfizer said last month that danuglipron helped patients lose weight on par with Novo Nordisk's (NOVOb.CO) Ozempic in a mid-stage study that tested it in patients with Type 2 diabetes.

U.S. Demand for Wegovy and Ozempic, the brand names for Novo Nordisk's once-weekly injections for treating obesity and diabetes respectively, has soared recently.

The enormous demand for treatments like Wegovy could support as many as 10 competing products with annual sales reaching up to $100 billion within a decade, mostly in the United States, industry executives and analysts have said.

None of the patients in the lotiglipron trials reported liver-related symptoms or side effects, there was no evidence of liver failure and none required treatment, Pfizer said.

Liver enzyme elevations observed in lotiglipron trials have not been seen in patients enrolled in danuglipron trials, the company added.

Reporting by Manas Mishra and Leroy Leo in Bengaluru, and Michael Erman in New Jersey; Editing by Pooja Desai, Jason Neely and Deepa Babington

Our Standards: The Thomson Reuters Trust Principles.

CDC Advisors Offer Lukewarm Endorsement Of GSK, Pfizer RSV Vaccines. What To Know.

Text size

A production line at a GSK research and development center in Belgium. Ksenia Kuleshova/Bloomberg

In a surprising decision that could undermine the blockbuster sales expectations for Pfizer and GSK 's new respiratory syncytial virus vaccines, the Centers for Disease Control and Prevention's influential vaccines advisory committee gave only a lukewarm endorsement of the shots late Wednesday.

In a series of votes, the Advisory Committee on Immunization Practices backed a policy saying that adults aged 60 and up "may receive" an RSV vaccine, if they and their physician agree it's right for them. The decision didn't distinguish between the GSK and Pfizer shots.

In a presentation earlier in the day on Wednesday, a committee working group had suggested that the advisors issue a stronger endorsement for adults aged 65 and up, saying that adults in that age group "are recommended" to get the vaccine. The working group had suggested the softer "may receive" endorsement only for adults aged 60 to 64.

The switch came after a lengthy discussion among committee members, in which some advisors aired worries about efficacy of the vaccines in adults over the age of 75, who were underrepresented in trials. Others raised safety concerns, and some complained that the manufacturers hadn't disclosed final prices for the vaccines.

The committee makes recommendations to the CDC's director, Dr. Rochelle Walensky, who will make a final determination. On Thursday morning, GSK 's (ticker: GSK) American depositary receipts were down 1.4%, while Pfizer (PFE) shares were down 0.5%.

The two vaccines, GSK's Arexvy and Pfizer's Abrysvo, are the first RSV vaccines to receive Food and Drug Administration approval. RSV is a common seasonal respiratory virus that can cause severe illness in older adults and infants.

A number of other companies are also developing RSV shots, including Moderna (MRNA) and Bavarian Nordic (BNRY). Sanofi (SNY) and AstraZeneca (AZN) are waiting on an FDA decision on Beyfortus, a monoclonal antibody administered to newborns to prevent RSV infection, after an FDA advisory committee said it had a favorable risk-benefit profile earlier this month.

Both GSK and Pfizer have set up their RSV vaccines as likely blockbusters. In a presentation late last year, Pfizer said that it expected annual revenue of "more than $2Bn" from its RSV vaccines for older adults and expectant mothers. GSK's CEO Emma Walmsley said in January that she saw "multi-billion pound Shingrix-like annual potential" in her company's RSV vaccine, referring to the company's blockbuster shingles vaccine, which sold $3.6 billion globally last year.

Pfizer's projections, as laid out in last year's presentation, were based on an assumed peak vaccine uptake of 50% to 60% among older adults in the U.S. Whether the shot can still hit those numbers with a less-enthusiastic endorsement from the CDC remains to be seen.

The CDC says that it gives the "may receive" recommendation, known as "shared clinical decision-making," when "individuals may benefit from vaccination, but broad vaccination of people in that group is unlikely to have population-level impacts."

Wall Street analysts seemed unconcerned. "We continue to view PFE's RSV vaccine as one of the most important near-term commercial launches," Goldman Sachs analyst Chris Shibutani wrote on Wednesday. He said he expects 2030 revenue of $2.3 billion for the older adult and the maternal RSV vaccine, which is not yet FDA approved.

GSK, in a statement late Wednesday, said that "shared clinical decision making empowers patients in consultation with their healthcare providers to determine whether RSV vaccination is appropriate for them."

Thursday morning, in a separate statement, Pfizer's chief medical officer for vaccines/antivirals and evidence generation, Luis Jodar, said that the company welcomed the committee's recommendations. "It underscores the important role ABRYSVO may have in helping to alleviate the significant burden of RSV in older adults," Jodar said.

In a presentation to the committee early on Wednesday, GSK said that a single dose of its vaccine remained effective after two RSV seasons, but that revaccinating with an additional dose after the first 12 months didn't increase the vaccine's efficacy. 

Corrections & Amplifications: The FDA is scheduled to issue its decision on approval of Sanofi and AstraZeneca 's Beyfortus by the third quarter of this year. An earlier version of this article incorrectly said that Beyfortus had already received FDA approval.

Write to Josh Nathan-Kazis at josh.Nathan-kazis@barrons.Com

Pfizer CEO Pulls Out Of Testifying To EU Parliament COVID Panel

Pfizer Chief Executive Albert Bourla has pulled out of an appointment to testify before the European Parliament's special committee on COVID-19, at which he was expected to face tough questions on how secretive vaccine deals were struck.

The decision follows an audit report into the EU's vaccine procurement strategy published earlier in the month that raised new questions about contact between Bourla and European Commission President Ursula von der Leyen that preceded a multibillion-euro vaccine contract.

The head of the U.S. Pharmaceutical giant, the largest supplier of COVID-19 vaccines to the EU, was scheduled to appear before the panel on October 10. The committee is meeting with key officials involved in the EU's vaccine procurement process to draw lessons on how to respond to future pandemics. Other pharmaceutical executives have addressed the committee, including the CEO of Moderna and senior officials from AstraZeneca and Sanofi.

The committee's chair, Belgian MEP Kathleen Van Brempt, told POLITICO she "deeply regrets" the decision taken by Pfizer.

After a visit to BioNTech's headquarters last week, Van Brempt had said in a written statement that she looked forward to discussions "with other CEOs" including "Mr. Albert Bourla, the CEO of Pfizer" on October 10.

The report, by the European Court of Auditors, found that von der Leyen had been directly involved in preliminary negotiations for the EU's biggest vaccine contract, for up to 1.8 billion doses of the BioNTech/Pfizer vaccine, which was concluded in May 2021. This was a departure from the negotiating procedure followed with other contracts, where a joint negotiating team made up of officials from the Commission and member countries conducted exploratory talks.

The EU watchdog also noted that the Commission refused to provide records of the discussions with Pfizer, either in the form of minutes, names of experts consulted, agreed terms, or other evidence.

Already in 2021, the New York Times reported on the seemingly-cozy relationship between Bourla and von der Leyen, with the two exchanging text messages in the run-up to the deal.

Contacted by POLITICO, a spokesperson for Pfizer said the company's president of international development markets, Janine Small, would attend the committee hearing. "She has been identified as best placed to support the committee in meeting their objectives," the spokesperson said.

---