The Medicines Company Acquires ApoA-I Milano From Pfizer
Product Has Potential to Reverse Plaque Buildup in Arteries
PARSIPPANY, NJ and NEW YORK, NY -- December 22, 2009 -- The Medicines Company (NASDAQ: MDCO) today announced the exclusive worldwide licensing of ApoA-I Milano from Pfizer Inc. (NYSE: PFE). ApoA-I Milano is a naturally occurring variant of a protein found in human high-density lipoprotein (HDL) that has the potential to reverse atherosclerotic plaque development and reduce the risk of coronary events in patients with acute coronary syndrome (ACS).
Under the terms of the agreement, Pfizer will recei
ve an up-front payment of $10 million for ApoA-I Milano and will receive additional payments upon the achievement of certain clinical, regulatory and sales milestones up to a total of $410 million. Pfizer will also be eligible to receive single-digit royalty payments on worldwide net sales of ApoA-I Milano. The Medicines Company will also pay $7.5 million to third parties.
"The acquisition of ApoA-I Milano provides The Medicines Company with a significant asset that fits well within our current areas of business," said Clive Meanwell MD, PhD, Chairman and Chief Executive Officer of The Medicines Company. "By mimicking the actions of HDL, ApoA-I Milano has been shown in an early clinical study, published in JAMA, to rapidly reduce the size of atherosclerotic plaques. This is an area of cardiovascular medicine that is not yet served by currently available therapies -- and the potential to provide disease modification for patients with high risk atheroma and associated acute coronary syndromes represents a major innovation opportunity."
"We are very pleased to partner with The Medicines Company to advance the ApoA-I Milano program as part of our strategy of out licensing programs that Pfizer no longer pursues internally. The ApoA-I Milano program has the potential to become a valuable and innovative medicine for the treatment of cardiovascular diseases. We look forward to seeing it progress, thanks to The Medicines Company's experience in conducting large clinical trials in cardiovascular patients as well as their expertise in treating critical and intensive care patients," said David K. Rosen DVM, Head of Out Licensing for Pfizer Inc.
About ApoA-I Milano
ApoA-I Milano is a naturally occurring variant of apolipoproteinA-I (ApoA-I), the main protein component of the HDL lipoprotein particle. The variant has been found in approximately 45 individuals from Limone sul Garda, a small village in northern Italy. Carriers of this variant appear to have reduced risk of cardiovascular disease. Patented by the University of Milan and Pharmacia, ApoA-I Milano was licensed to Esperion Therapeutics. Esperion was subsequently acquired by Pfizer in 2004. Since that time, Pfizer has moved development forward with improvements to the original manufacturing process.
In multiple non-clinical models, ApoA-I Milano rapidly removed excess cholesterol from artery walls, thereby stabilizing and regressing atherosclerotic plaque. A phase I-II study in 36 patients demonstrated statistically significant reductions on coronary plaque volume by 4.2% in 6 weeks. These findings were published in the Journal of the American Medical Association and continue to be widely referenced and discussed.
MDCO-216
Product Overview
In December of 2009, we obtained an exclusive worldwide license to MDCO-216 (ApoA-I Milano), an investigational product. MDCO-216 is a naturally occurring variant of a protein found in human high-density lipoprotein (HDL). Based upon multiple non-clinical studies and a Phase 1/2 clinical trial of MDCO-216 conducted prior to our license of this product candidate, we believe that MDCO-216 has the potential to reverse atherosclerotic plaque development and reduce the risk of coronary events in patients with ACS. We have completed the technology transfer for the drug and expect to commence clinical studies sometime in 2011.
Uit deze info afkomstig van de website van The Medicines Company maak ik op dat zij de ontwikkeling van het produkt overnemen van Pfizer en het naar een volgende klinische fase gaan brengen. Ik vermoed dat het hier gaat om een fase 2B, waarbij de dosering (Octoplus)onderzocht gaat worden. Gezien de milestones afgesproken met Pfizer ($410 miljoen ) gaat het om een zeer groot toepassingsgebied (markt) voor dit produkt.