Dive Brief:
- The Medicines Company is clearing the decks to put more resources behind Phase 3 development of its PCSK9 synthesis inhibitor inclisiran, announcing Wednesday it would restructure the company to reduce employee headcount below 60 people.
- In addition, the company continues to look for divestment options for its infectious disease business, hoping to sell or otherwise monetize the unit before the end of the year. Taken together, the two moves will help fund the 3,400 patient study of inclisiran going forward.
- Freeing up cash has been made all the more important by falling sales of The Medicines Co. legacy portfolio. Net revenues in the third quarter hit $16.9 million, down more than half from the same period last year due to generic competition to Angiomax.
Dive Insight:
Drug development is a costly business, especially for biologics, and The Medicines Company is having to face this head on — particularly with little income coming in from Angiomax (bivalirudin).
Inclisiran, an RNAi therapeutic designed to turn off PCSK9 synthesis in the liver, is The Medicines Company main hope. While positive mid-stage data showed impressive LDL lowering ability, getting the drug approved requires a quite large, nearly two-year Phase 3 study. In addition, the company will need to conduct a 14,000 patient cardiovascular outcomes study, although that will not be part of any initial New Drug Application.
The Medicines Company's way out of this financial challenge is through a major restructuring to muster its resources behind inclisiran. In January, the biotech announced it would sell its infectious disease business, including the marketed therapeutics Orbactiv (oritavancin), Minocin (minocycline for injection), and the now newly-approved Vabomere (meropenem/vaborbactam).
"We continue to expect to announce the transaction to divest the business before the end of the year," said company CEO Clive Meanwell. "Given where we are, we’re not going to provide any additional details on the process, on the potential terms or value that might result from a transaction or any greater detail about timing today." Meanwell said there are no current plans to sell equity in The Medicines Company.
Restructuring will also mean a major headcount reduction, with layoffs for nearly 300 people
Meanwell says the cutbacks will give the company a strong enough financial position to advance inclisiran through development to a readout of final data from the Phase 3 LDL-C lowering trials in the second half of 2019, along with the parallel execution of the outcomes trial.
"We are comfortable [the restructuring] will fund the company's needs going forward to the NDA of the Inclisiran program," said Meanwell.
"[The restructuring will create] a company focused on developing inclisiran with a headcount less than 60," he said. "It’ll obviously be a much smaller company, but one that's focused on a significantly bigger asset."
Despite high expectations and strong LDL-lowering ability, PCSK9 inhibitors have struggled to gain a foothold due in part to insurer pushback over high list prices and low numbers of patients filling prescriptions — likely as a result of high copays.
Despite this, Meanwell remains upbeat about the market.
"We remain confident in the development of the PCSK9 market opportunity as colleagues who are commercializing monoclonal antibodies continue to make evident progress, growing this important and potentially block buster class of new medicines," said Meanwell. "We remain very, very comfortable that this is going to be a blockbuster marketplace, albeit at a slower rate than some had hoped."