Old drugs are often repurposed, or re-entered into the pharmaceutical market, for their potential to treat medical afflictions in a new way. With Belcher Pharmaceuticals and their recent actions concerning Ablysinol, a dehydrated alcohol solution used in certain heart procedures, this is not the case.
In a statement on LinkedIn, Codiak BioSciences CEO Douglas Williams and seven other biotech CEOs singled out Seminole, Florida-based Belcher Pharmaceuticals, based on the Food and Drug Administration approval earlier this month of Ablysinol (dehydrated alcohol), an old drug used in certain heart procedures. The company received the approval not by conducting clinical trials on its own, but through a pathway known as 505(b)(2), whereby it was based on a review of data from 38 publications by other parties.
A Price Increase of Nearly $9,000
While Belcher’s executives claimed to have invested multiple millions of dollars into Ablysinol’s approval, the pathway they took was relatively cheaper than it would have been if they had discovered and developed the drug on their own. Nevertheless, as reported by STAT, the company received seven years of market exclusivity under the Orphan Drug Act and raised the price of the drug from $1,300 to $10,000 for a pack of 10 vials.
Belcher did not respond to a request for comment.
An All-Too-Common Occurrence
It’s a story that should be familiar to anyone who followed the rise and fall of Shkreli, who drew widespread scorn when, as CEO of Turing, he dramatically raised the price of a decades-old drug used to treat toxoplasmosis. Shkreli is currently in prison on unrelated charges. Other companies have done the same, such as Canada-based Valeant Pharmaceuticals.
“To be sure, drug innovators should be able to attain a fair price, reflective of the added value they bring to patients and the healthcare system,” the statement read. “There can be an important place for incremental improvements in older drugs, sometimes through abbreviated and (relatively) inexpensive approval pathways, but the price of these improvements should be consistent with the benefits they bring to patients, not a mechanism to achieve a windfall.”
Why Others are Making a Statement
Other signatories to the statement included Ron Cohen, Acorda Therapeutics; John Crowley, Amicus Therapeutics; Paul Hastings, Nkarta Therapeutics; Rachel King, GlycoMimetics; Ted Love, Global Blood Therapeutics; Jeremy Levin, Ovid Therapeutics; and John Maraganore, Alnylam Pharmaceuticals.
The eight CEOs were also among the 215 signatories to a statement published in STAT last month calling for what they called a “new commitment” to patients and the public, which included working to ensure access to medicines and to act with integrity and responsibility. Those who signed on included biotech and pharmaceutical executives and board members, as well as executives from financial and venture capital firms and academics.
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