Drug Development

The Medicines Company touts fresh evidence that their PCSK9si can durably bat down LDL

John Maraganore, Alnylam

John Maraganore, Alnylam

The executive crew at The Medicines Company say that they remain on track with an early-stage PCSK9 that reliably knocked down levels of bad cholesterol, clearing one more hurdle in a long journey aimed at delivering a new therapy that can beat out the pioneers in the field with a drug that will only need to be administered two, three or four times a year.

There’s nothing new about PCSK9 drugs, designed to slash LDL. Amgen and the Regeneron/Sanofi team delivered back-to-back therapies that do the same thing. But The Medicines Company believes it can roll up the market with a new and better approach in-licensed from Alnylam that will be much easier to remain compliant on.

Clive Meanwell, The Medicines Company

Clive Meanwell, The Medicines Company

The top-line interim analysis showing that PCSK9si was continuing to look effective at the 90-day market — along with an absence of safety issues — stoked fresh hopes that the biotech company could be onto something. And the company is promising an even more advanced peak at the data at the big AHA meeting next month.

“Mgmt cites the data as “robust” and that the LDL curves are ‘tight,'” telegraphed Evercore ISI’s Umer Raffat Tuesday morning.  “Company plans on heading into an aggressive Ph 3.”

That was encouraging enough for investors to drive shares of The Medicines Company $MDCO up 6% this morning.

Last year, The Medicines Company CEO Clive Meanwell and Alnylam CEO John Maraganore outlined plans for a years-long effort aimed at disrupting what is widely expected to become a large market for these PCSK9 cholesterol drugs. And Maraganore has told Endpoints that he believes their drug is a sure-fire blockbuster in the making.

Medicines Company CEO Clive Meanwell had this to say today:

“These compelling interim data affirm PCSK9si’s highly-competitive profile and validate PCSK9si’s game-changing potential. We look forward to presenting results from the ORION-1 study, including Day 180 follow-up for up to 200 patients, at the AHA meeting on November 15, 2016.”

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