- The Medicines Company scuppered further development of an experimental heart drug on Monday, citing poor top-line efficacy data from a proof-of-concept study.
- Resources freed up by the decision to discontinue development of MDCO-216 will instead be reallocated for use in clinical testing of the company's PCSK9 synthesis inhibitor, said company CEO Clive Meanwell.
- The Medicines Company had acquired exclusive rights to MDCO-216 from Pfizer back in 2009, paying $10 million upfront with another $410 million in potential milestones.
The Medicines Company painted the decision to discontinue MDCO-216 as an opportunity to invest "substantial additional capital" into its PCSK9 synthesis inhibitor.
According to regulatory filings, the company had already begun to rein in R&D expenses associated with MDCO-216, spending $8.1 million less in the third quarter. Terminating MDCO-216 development could also clear the books of $412 million in potential obligations owed to Pfizer.
"In spite of promising earlier research findings, and impressive progress with manufacturing development and safety, in the light of these efficacy data and in view of the potentially enormous opportunity and highly-favorable risk-reward profile presented by our PSCK9 synthesis inhibitor, we have been decisive in immediately terminating the MDCO-216 development program," said Meanwell.
While the PCSK9 market has yet to live up to its lofty expectations, the company believes its PSCK9si will be highly competitive and offer significantly more attractive dosing. Positive, albeit vague, results from a Phase 2 trial demonstrated "significant and durable" reduction of LDL-C through 90 days, the company said in October.
And the Medicines Company's PCSK9 hopes, while still some ways from fruition, may have received a boost earlier this month when Pfizer dropped its own PCSK9 inhibitor bococizumab. Pfizer had invested a substantial amount of resources in R&D, testing the drug in six Phase 3 trials.
An evolving market and uncertainty over the drug's ability to reduce cardiovascular events prompted Pfizer to pull the plug, according to a company statement.
The Medicines Company is clearly excited about the prospects of PCSK9si. Yet with sales of the company's marketed drugs dropping precipitously, a pared-back pipeline only raises the stakes for delivering a hit.