BioPharma

Sorry, Martin Shkreli: FDA approves first generic version of Daraprim

The drug, used to treat toxoplasmosis infection, became the subject of notoriety in 2015 when manufacturer Turing Pharmaceuticals, then led by Shkreli, raised the price from $13.50 to $750 per pill, making it a poster child for the issue of high drug prices.

The Food and Drug Administration slaughtered Martin Shkreli’s former cash cow Friday as it approved the first generic version of a drug used to treat toxoplasmosis that a company he previously ran had marketed.

The FDA announced Friday that it had approved the first generic version of Vyera Pharmaceuticals’ – formerly Turing Pharmaceuticals – Daraprim (pyrimethamine) for the treatment of toxoplasmosis, when used with sulfanomide. The manufacturer is Valley Cottage, New York-based Cerovene.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

The drug gained notoriety in 2015 when Turing, under Shkreli’s leadership, increased the list price from $13.50 to $750 per pill, making it a poster child for the problem of high drug prices. The price of the generic version was not disclosed, making it unclear how much cheaper it will be. Cerovene could not be immediately reached for comment.

Despite having been on the market for decades, the drug had no generic competition. Last month, the Federal Trade Commission filed charges against Turing’s successor company, Vyera, claiming that it had used deals with distributors to thwart generic competition, keeping samples out of the hands of generic drugmakers so they could create their own versions. Vyera has said the charges are without merit.

“Through the FDA’s Drug Competition Action Plan, we’ve worked to remove barriers in generic drug development by not only taking actions that improve the efficiency of the development, review and approval of generic drugs, but also by closing loopholes that allow brand-name drug companies to ‘game’ the rules in ways that delay generic competition that Congress intended,” FDA Commissioner Stephen Hahn said in a statement, calling the approval important for patients susceptible to toxoplasmosis infection, such as pregnant women and people with HIV/AIDS. “Empowering patients and promoting choice and competition are top priorities for the FDA.”

Shkreli is currently serving a seven-year sentence in federal prison after being convicted of fraud and conspiracy in August 2017 after bilking investors out of $10 million in connection with another former company of his, Retrophin. But that didn’t stop him from trying to continue conducting business from behind bars. In March of last year, The Wall Street Journal reported that he had been using a contraband cell phone to run a new drug company, Phoenixus, out of prison, in violation of prison regulations. Forbes subsequently reported that Shkreli had been placed in solitary confinement following the news report.

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Photo: Timothy A. Clary, AFP, via Getty Images