BridgeBio (BBIO.US) Accuses Pfizer (PFE.US), Alnylam (ALNY.US) of Using “Controversial Strategies” to Compete in the Billion-Dollar Cardiology Market

The Zhitong Finance App learned that BridgeBio Pharma (BBIO.US) is competing with Pfizer (PFE.US) and Alnylam Pharmaceuticals (ALNY.US) with a heart disease drug. The company claims its drugs are more effective and less expensive, but at the same time accuses competitors of using “controversial strategies” to compete in this multi-billion dollar market.

The focus of controversy stemmed from a video broadcast by Pfizer at a medical conference this month — in which it said that its drug Vyndamax was the “first and only approved treatment” to treat a type of fatal heart failure, yet it deliberately conceals two key facts: BridgeBio's competitor was marketed in November 2024, and similar Alnylam drugs have been in use since March of this year. BridgeBio CEO Neil Kumar (Neil Kumar) also pointed out that at another recent conference, Pfizer's comparison between its drugs and BridgeBio drugs “is not based on fair and comparable standards.”

Kumar said in an interview that the way Pfizer presented the data was “like comparing your best running day with my worst day” rather than making a fair comparison based on average levels.

At the heart of this competition is competing for a “leading position” in the treatment of ATTR cardiomyopathy (a type of heart failure once considered rare). Today, ATTR cardiomyopathy has been proven to be a major disease with “major drug market potential”, attracting not only large pharmaceutical giants, but also sparking an investment boom in innovative startups. According to analysts' forecasts, the drug Vyndamax, which was first approved by Pfizer in 2019, is expected to reach approximately US$6.6 billion in revenue this year.

In response to the allegations, Pfizer responded that the above video was “misbroadcast,” and stated that it had promptly notified the conference organizer and BridgeBio after discovering the problem. A company spokesperson emphasized, “Pfizer is committed to providing physicians with the best data and information related to their medications.”

A footnote in the conference handbook shows that the Pfizer drug Vyndamax is the only approved treatment in the US “as of September 2024.” Furthermore, Pfizer still insisted on its description of the efficacy of the two drugs in the conference, saying that the relevant statements were “accurate,” and cited a study conducted by Scripps Research Institute (Scripps Research Institute) researchers in 2020 as a basis.

However, Kumar of BridgeBio said that in the face of such propaganda, the company's competitive path is difficult.

“What is happening now is completely unreasonable,” Kumar said, adding that of all the doctors he has worked with in this field, “there is not a single person who doesn't think that BridgeBio's drug is currently the most effective.”

BridgeBio said that the drug Attruby developed by it has sufficient scientific data support to become a “standard treatment plan” for the disease, but the intensity of market competition far exceeds expectations. Analysts predict that Attruby's sales will exceed 300 million US dollars this year, and annual revenue is expected to rise to 2.1 billion US dollars by 2030; while Alnylam's drug Amvuttra (which can also treat a related neurological disease) is expected to reach about 6 billion US dollars by the end of this decade.

Kumar pointed out that attruby is currently the only drug that can achieve “almost complete stability” of TTR protein — in patients with ATTR cardiomyopathy, TTR protein deforms and damages the heart. He stressed that this efficacy claim is critical to this type of drug: BridgeBio has invested a lot of effort in persuading the US Food and Drug Administration (FDA) to prove that the drug can effectively stop TTR protein from deforming, so only then did the FDA allow the inclusion of the curative effect description of “protein stability” in the drug's official instructions.

“And Pfizer claims the same efficacy everywhere in every conference and every sales material,” Kumar said. According to the official website of Pfizer Vyndamax, the drug can “achieve almost complete stabilization of TTR protein,” but this statement did not appear in the “official instructions” regulating the promotional content of the drug.

A Pfizer spokesperson responded that all of the company's educational materials relating to the drug were “developed in strict accordance with FDA regulations” and were subject to internal compliance procedures.

Alan Minsk (Alan Minsk), a partner at Arnall Golden Gregory (Arnall Golden Gregory), said it's not uncommon for pharmaceutical companies to “promote products in ways that may be viewed as misleading.” However, Minsk (who himself does not provide services for BridgeBio, Pfizer, or Alnylam, and is an expert in the field of promotion and advertising in the pharmaceutical industry) pointed out that most companies will set up internal audit teams to avoid making propaganda claims with legal or regulatory risks. Typically, pharmaceutical companies include a disclaimer in smaller font next to the promotional content.

For pharmaceutical companies, medical conferences are “high-risk, high-reward places” to promote products — because most of the core customers (doctors) who issue prescriptions attend such meetings.

The FDA's “Office of Prescription Drug Promotion” (OPDP for short) is responsible for overseeing drug advertisements. Minsk said that OPDP usually only becomes aware of problematic drug promotion practices after a competitor or doctor has filed a complaint. Kumar, on the other hand, said that BridgeBio has submitted a letter to OPDP regarding Pfizer's promotion activities, but has yet to see the agency take action.

Earlier this year, OPDP staff was drastically reduced following large-scale FDA layoffs. In May, Senator Dick Durbin (Dick Durbin) wrote to FDA Director Marty Makary (Marty Makary) questioning whether OPDP is still capable of carrying out its duties.

“OPDP has lost a large number of personnel,” Minsk said, and the office “simply cannot handle all the complaints received.” He pointed out that there are “thousands” of promotional materials regulated by OPDP, and “if they issue 10 to 15 warning letters a year, that's already a lot.”

An FDA spokesperson said in a statement that the layoffs earlier this year “did not affect any OPDP staff responsible for reviewing advertising and promotional labels.”

What made Kumar even more dissatisfied was the “New England Journal of Medicine” (New England Journal of Medicine) previous research paper on the Alnylam drug Amvuttra. The study was funded by Alnylam and published last year. A chart in the article shows that Amvuttra showed “survival benefits” (i.e. reduced risk of death for patients) compared to placebo after about 18 months of use.

However, according to supplementary materials to the paper, these data are the result of “adjustments.” According to Kumar, the standard practice in this field is to refer to “unadjusted mortality data,” and this part of the data was placed on page 43 of the appendix — the data showed that Amvuttra's survival benefits were not apparent until the 30th month of the trial, which made Alnylam's drug efficacy not as good as BridgeBio's Attruby (the latter had shown survival benefits at month 20).

“We're just asking for a level playing field,” Kumar said.

Pushkal Garg (Pushkal Garg), head of research and development at Alnylam, said in an interview that Kumar's dissatisfaction with the “New England Journal of Medicine” paper was “just a big joke,” and emphasized that the company has always been committed to transparency. He explained that part of the reason the data was adjusted was to show drug efficacy more clearly, and “both adjusted and unadjusted data are included in the paper.”

Galger believes that competing pharmaceutical companies should focus on “discovering and treating patients.” Galger said, “We should be proud to have developed a number of drugs that will completely change the way we treat such diseases.”