Pfizer OKs others to make and market anti-smoking pill that it couldn’t sell itself

Pfizer Inc. said Tuesday that it will allow other companies to make and market an anti-smoking drug when the U.S. Food and Drug Administration decides not to approve the pill for sale.

Pfizer’s COVID-19, which is sold under the brand name Vuevia, has had a history of poor performance in clinical trials and has been an object of patent litigation.

The government had said it planned to drop its opposition to Pfizer’s patent claims, provided the drugmaker would stop the patent lawsuits. The pharma giant’s decision to let other drugmakers make its pill could shift the business of tobacco prevention, which has suffered from reduced spending since the addition of other smoking cessation treatments.

“That allows other manufacturers to come into the market and compete, and that helps to keep up with what the market’s looking for in a brand,” said Mark Riddell, an analyst with Moody’s in New York.

That allows other manufacturers to come into the market and compete, and that helps to keep up with what the market’s looking for in a brand. — Mark Riddell, Moody’s

The U.S. government had been in the process of amending its regulations to allow allowing other companies to manufacture the pill after the end of Pfizer’s patent protection. But it said it would reach a different decision in the intellectual property case as a result of the company’s move. “The Court concluded that Pfizer’s agreement with the FDA confers the authority to permit other manufacturers to produce COVID-19,” the FDA said in a statement. The drugmaker is not the only company that has been selling products containing coenzaprine and has filed patents related to those products.

The company decided to allow others to produce it when the FDA signaled it would not consider delaying its deadline to approve the drug, according to company executives. Pfizer said Tuesday it was still waiting to hear from the FDA on when the agency will decide on COVID-19.

During testing, COVID-19 showed “unacceptable clinical efficacy,” and its sales slipped by 33 percent over the past year, as sales of its usual oral-counseling pill rose, according to the drugmaker. The pill’s sales could start sinking unless sales growth resumes, Morgan Stanley analysts wrote in a note to investors this month.

A competing pill from Merck that acts via a different mechanism had been competing in the market since 2017, according to the New York Times.

Merck’s prescription-supplements unit, which makes the lower-cost version of COVID-19, Nektar Therapeutics, owns patents related to the drug. While its sole product on the market, Andexxa, is still being studied by the FDA, Merck believes the results of those studies show Andexxa performs similarly to COVID-19.

Pfizer, on the other hand, said that the late-stage studies of Andexxa showed that COVID-19 performed better.

Whatever the outcome of the ongoing court case, Pfizer noted that it could eventually seek reimbursement from Merck for its sales of Nektar’s version.

Pfizer plans to defend its COVID-19 patents in court until 2022, at which point it will seek an extension. That means competitors have four years to block Pfizer from limiting competition to its pill.

“In terms of the ongoing litigation, we can’t comment on future results until we file the next appeal,” a Pfizer spokesman said.

Read the full story at the New York Times.

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