- A group of eight leading biotech executives are criticizing a little-known Florida drugmaker for dramatically increasing the price of an injectable drug, penning a public letter that questions the company's attempts to justify its actions.
- The executives, which include Alnylam Pharmaceuticals CEO John Maraganore, Ovid Therapeutics' Jeremy Levin and Global Blood Therapeutics CEO Ted Love, were co-authors of a statement published last month in STAT and signed by over 200 biotech and pharmaceutical leaders that attempted to set out a "new industry commitment" to patients.
- Among the commitments agreed to is a pledge to speak out against companies that "abuse policies aimed at fairly rewarding innovation." The executives' letter criticizing Belcher Pharmaceuticals, the Florida drugmaker, is the first time signatories to the new commitment have spoken out against a company.
A year and a half ago, Belcher Pharmaceuticals won Food and Drug Administration approval for Ablysinol, an injection of dehydrated alcohol that's used in a non-surgical heart procedure known as septal ablation.
Ablysinol is not a new drug per se, but rather a reformulation of a discontinued treatment that was first approved in 1946.
Belcher's application — known in industry as a 505(b)2 application — was based on 38 studies the company identified in published literature that showed the benefit of using ethanol as an ablative agent in adults with a certain type of heart condition.
Notably, the FDA granted Belcher an Orphan Drug Designation for Ablysinol, conferring seven years of market exclusivity and shutting out older versions made by other manufacturers.
Belcher, according to a report by STAT, launched Ablysinol at $9,950 for a 10-pack of 5-milliliter vials — significantly more than the $1,295 Akorn Pharmaceuticals and Seton Pharmaceuticals had previously charged.
The move caught the attention of the biotech executives who, through their January statement, had called on the drug industry to do a better job of pricing drugs at levels reflective of clinical innovation and value.
"Executives at Belcher have justified this price escalation by arguing that it invested 'multiple millions of dollars,'" wrote the eight executives, who are acting on behalf of the larger group of signatories.
"That said, in our view, seven years of exclusivity based on existing published research and knowledge is a misuse of the [Orphan Drug Act], and serves as new fodder for the arguments around fair and equitable drug pricing by biopharma companies," they wrote.
In a statement on LinkedIn, Codiak BioSciences CEO Douglas Williams called Belcher's pricing "unsupportable." The other executives who signed the letter include Ron Cohen, CEO of Acorda Therapeutics; John Crowley, CEO of Amicus Therapeutics; Paul Hastings, CEO of Nkarta Therapeutics; and Rachel King, CEO of GlycoMimetics.
The executives speaking out against Belcher, of course, have their own interests in distancing their companies from actions taken by drugmakers like Belcher. It's a strategy many top pharmaceutical CEOs have followed over the past several years in calling out "bad actors" like Martin Shkreli.
But less often have biotech executives criticized specific price increases taken by specific companies, making the letter against Belcher more unusual.
Whether public pressure results in any action from Belcher or others contemplating steep price hikes is another matter, and it's not yet clear if executives who signed last month's industry commitment will be willing to speak out against more well-known biotech or pharmaceutical companies.