Presidential candidate Hillary Clinton has been outspoken about her opposition to the 5,000 percent price hike of the antiparasitic drug Daraprim, produced by Turing Pharmaceuticals. Clinton made an announcement earlier this week urging the Food and Drug Administration (FDA) to hasten approval of generic alternatives to the drug.
Imprimis – a California-based pharmaceutical manufacturer – has stepped up to the challenge and announced that it will begin offering a generic alternative to Daraprim. The drug will contain the same active ingredient as Daraprim – pyrimethamine – but unlike the latter, the generic will be priced as low as $99 for 100 capsules.
Imprimis has also announced their intention to start an initiative to work with purchasing groups, pharmacy benefits managers and payers to offer personalized formulations “at prices that ensure accessibility.” According to a statement released by the company, “The move is in response to Turing’s recent price hike from $13.50 a table to $750.”
The drug isn’t an exact formulation match of Daraprim; Imprimis has added an additional ingredient – leucovorin – which they say could counteract some of the negative effects of pyrimethamine on bone marrow. CEO of Imprimis Mark Baum, has also expressed interest in developing generics to other pricey older medications.
Baum said in a statement, “This is not the first time a sole supply generic drug – especially one that has been approved for use as long as Daraprim – has had its price increased suddenly and to a level that may make it unaffordable.” He went on to say that Imprimis will “soon identify” alternative, compounded versions of other high-priced pharmaceuticals.
Some say that Imprimis will face challenges in getting its new compounded drugs to market. Regulations on distribution of compounded pharmaceuticals are strict, as a reaction to the meningitis outbreak of 2012 that was linked back to the New England Compounding Center.
Additionally, since compounded drugs aren’t approved by the FDA, they fall under strict dispensing rules which could limit their patient reach. Imprimis will offer the Daraprim alternative direct-to-consumer, with a prescription from a physician.
- Compounder targets Turing’s now-pricey Daraprim with $1-per-pill alternative – http://www.fiercepharma.com/story/compounder-targets-turings-now-pricey-daraprim-1-pill-alternative/2015-10-22