Huh. This would appear to be a next generation of Xigris, which was explored for indications other than sepsis, but they weren't pursued to my knowledge. For example, a sutdy of Xigris in coronary artery thrombosis was done in dogs in 2000, but despite decent looking results, they haven't pursued that or any other indications for Xigris. At least, I don't think so.
Can't find diddly on this one (though I haven't tried patents yet) beyond the PR below, which is more detailed than the DJ teaser. No abstracts, no trials enrolling, nada. Calling clinical stage seems a bit of a stretch at the moment.
Anybody got thoughts on this inlicensing? Why is Lilly letting it go?
>>VANCOUVER, April 30 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that it has signed an exclusive in-licensing agreement with Eli Lilly and Company ("Lilly") for LY458202 ("GED-aPC"), a clinical-stage drug candidate, whereby Cardiome has been granted exclusive worldwide rights to GED-aPC for all indications.
GED-aPC is an engineered analog of recombinant human activated Protein C (aPC) with enhanced anti-inflammatory, anti-thrombotic and strong binding to endothelial protein C receptor properties, and has broad potential across multiple indications. Cardiome intends to initially develop GED-aPC in cardiogenic shock, a life-threatening form of acute circulatory failure due to cardiac dysfunction, which is a leading cause of death for patients hospitalized following a heart attack.
"The scientific community is increasingly recognizing the role of inflammation in cardiovascular disease, and we have been searching for a drug candidate with the capacity to address cardiovascular disease through anti-inflammatory and anti-thrombotic mechanisms," said Dr. Charles Fisher, Executive Vice President and Chief Medical Officer of Cardiome. "GED-aPC is a pluripotent molecule with multiple mechanisms of action targeting key counter-regulatory pathways, and we believe that these engineered characteristics make it a highly desirable drug candidate for cardiovascular indications."
Lilly has successfully completed a 46-person Phase 1 single-dose placebo-controlled safety study in healthy volunteers for GED-aPC. Cardiome intends to meet with the FDA in the near future regarding plans to conduct multi-dose Phase 1 studies commencing in the second half of 2007. Pending successful completion of these studies, Cardiome intends to initiate one or more Phase 2 studies in the first half of 2008.
Under terms of the agreement, Lilly will also provide Cardiome with access to intellectual property related to manufacturing of GED-aPC, and facilitate access to clinical and commercial production capacity at an established third party manufacturing facility for a defined period of time. Included in the transaction is an initial supply of GED-aPC, which is expected to be sufficient for completion of the contemplated Phase 1 program.
Financial terms of the agreement include an upfront payment of US$20 million payable to Lilly and development milestones not to exceed US$40 million contingent on achievement of certain pre-defined late-stage clinical milestones. Lilly will also be entitled to royalty payments if the molecule is ultimately commercialized. Cardiome estimates that clinical expenditures on the GED-aPC program will be approximately US$5 million in 2007.
"We believe strongly that the unique profile of this drug will be effective in treating several forms of cardiovascular disease," stated Bob Rieder, Chairman and Chief Executive Officer of Cardiome. "Success in our industry arises from bringing benefit to patients. This drug, with its excellent mechanistic and clinical pedigree, offers great promise to patients suffering from various forms of cardiovascular disease for which few effective treatments are available."
Cardiome will hold a teleconference and webcast on Monday, April 30, 2007 at 1:00pm ET (10:00am PT) to discuss the transaction. Please dial 800-814-4859 or 416-644-3433 to access the call. There will be a separate dial-in line for analysts on which we will respond to questions at the end of the presentation. The webcast can be accessed through Cardiome's website at www.cardiome.com. Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through May 30, 2007. Please dial 877-289-8525 or 416-640-1917, and enter code 21231012 followed by the number sign to access the replay.
About Cardiogenic Shock (CS)
Cardiogenic shock is a state of inadequate bloodflow to the body's tissue caused by the failure of the heart to pump effectively, most commonly following acute myocardial infarction (heart attack). In 2006, more than 870,000 people suffered a heart attack in the U.S., with approximately 6% of them developing cardiogenic shock. Mortality rates for patients with cardiogenic shock remain high, ranging from 40% to 70%. There are currently no approved drugs to treat this indication.<<
snip
Guess we have to listen the CC, which was held 15 minutes after this PR was released. I wonder how many participants they got with such short notice.
Cheers, Tuck |
