- The annual meeting of the American Heart Association is shaping up to be a major inflection point for The Medicines Company, with updates planned on the New Jersey pharma's two cardiovascular pipeline programs.
- Speaking on an earnings call Wednesday, CEO Clive Meanwell was circumspect in discussing details on the recently announced, positive topline results for the company's PCSK9 synthesis inhibitor. Still, Meanwell said the company anticipates moving into Phase 3.
- The Medicines Company's R&D efforts have become even more important as sales continue to drop precipitously. Global revenues fell 34% year over year in the third quarter to $37.6 million.
Earlier this month, The Medicines Company announced topline data from a Phase 2 study of its PCSK9si drug, which the pharma touted as "highly competitive" to the two drugs in the class already on the market.
While specific numbers were not disclosed, the company said an interim analysis showed "significant and durable" responses in LDL-C through 90 days.
Given the success, many analysts on Wednesday's earnings call were interested in the company's development plans for the drug moving forward. While Meanwell and other executives deferred much to AHA next month, Meanwell did indicate the company would initially look to target a smaller, more-needy subset of the broader patient population needing cholesterol-lowering drugs.
The Medicines Company believes the recent Phase 2 results confirm the potential for a triannual, or even biannual, dosing of the PCSK9si dosing. Such a regimen would certainly be more convenient than that of Amgen's Repatha or Sanofi/Regeneron's Praluent.
However, this spaced out dosing could raise new issues. John LaMattina, a former head of R&D at Pfizer and a contributor to Forbes, recently wrote that the Food and Drug Administration might be wary to approve such a drug without long-term safety data.
Meanwell indicated the company plans to present one year worth of data among 2,000 patients and two years worth for 1,000 patients. "We believe that, assuming there were no untoward safety findings, in which case all bets are off anyway, that would be a reasonable data base for NDA review by the agency," Meanwell said.
As of September 30, the company had roughly $600 million in cash and equivalents, which Chief Financial Officer William O'Connor, said would be sufficient to fund operations over the next 12 months.
Asked about potential partnering for a future Phase 3 program, Meanwell expressed confidence in the company's ability to carry out a study independently but indicated the company would be open to partnering for global trials and ex-U.S. markets.