Pfizer, Scripps Sue to Block Copy of ‘Most Expensive’ Heart Drug

Pfizer Inc. and the Scripps Research Institute allege in a new lawsuit that a copy of Vyndamax proposed by Dexcel Pharma Technologies Ltd. infringes three patents for the blockbuster heart drug, an increasingly important source of Pfizer’s revenue.

Pfizer and Scripps “together own all substantial rights” to the patents, according to a complaint filed Thursday in the US District Court for the District of Delaware. Two were assigned to Scripps and one to Pfizer.

Vyndamax is used to reduce the risk of death and hospitalization from a rare heart condition called transthyretin amyloid cardiomyopathy, or ATTR-CM. The disease is caused by a buildup of proteins in the heart.

The average survival time for untreated ATTR-CM patients ranges from 2.5 to 3.5 years, but studies have shown that patients who take tafamidis—Vyndamax’s active ingredient—tend to live nearly five years after diagnosis.

Dexcel didn’t immediately respond to a request for comment.

The drug has an annual wholesale cost of more than $240,000, Bloomberg Intelligence analyst Marc Engelsgjerd wrote in a note last October. In the wake of its May 2019 approval by the US Food and Drug Administration, researchers critical of its cost—then $225,000 a year—called Vyndamax “the most expensive cardiac medication in history” and said older adults were struggling to afford it.

Both of the Scripps patents—US Patent Nos. 7,214,695 and 7,214,696—cover methods of treating ATTR-CM using Vyndamax. The ’696 patent will expire in December 2023, followed by ’695 in April 2024, according to the entry for Vyndamax in the FDA’s registry of approved drugs, the Orange Book.

Pfizer’s US Patent No. 9,770,441, covering a crystalline form of tafamidis, will expire in August 2035. The three are the only Orange Book-listed patents for Vyndamax.

Vyndamax had US sales of $818 million during the first six months of 2023—46% higher than the $561 million it had in the same period in 2022, Pfizer said in its quarterly earnings report. The growth, Pfizer said, was “largely driven by continued strong uptake of the ATTR-CM indication, primarily in the US and developed Europe.”

Excluding revenue from Comirnaty and Paxlovid—Pfizer’s Covid-19 vaccine and antiviral pill, respectively—Vyndamax and its European and Japanese counterparts accounted for Pfizer’s fourth-highest revenue of any drug in 2022. The family of medicines together had sales of $2.45 billion last year, 2.4% of Pfizer’s revenue, according data compiled by Bloomberg LP. Of that, Vyndamax’s US sales were $1.25 billion.

Williams & Connolly LLP and Morris, Nichols, Arsht & Tunnell LLP represent Pfizer and Scripps.

The case is Pfizer Inc. v. Dexcel Pharma Techs. Ltd., D. Del., No. 23-cv-879, complaint filed 8/10/23.