By Alan Sverdlik
Albany Molecular Research Inc. and Cubist Pharmaceuticals Inc. entered a research and licensing agreement for the discovery of a new class of anti-infective drugs designed to break through the resistance of stubborn microorganisms.
The deal, which entails the use of AMRI¿s biocatalysis technology and Cubist¿s lipopeptides, is designed to identify antibiotics to treat infectious diseases. It entitles AMRI, of Albany, N.Y., to success-based milestone fees and royalties from products that come out of the collaboration. In return, Cambridge, Mass.-based Cubist obtains worldwide rights to develop and market resulting drugs.
Neither side would discuss financial specifics of the partnership, but both praised the synergies that it exemplifies.
¿Using our approach, we can make a wide variety of modifications to lead molecules,¿ said Pete Michels, senior director of AMRI¿s biocatalysis division, which will derive new compounds from Cubist¿s lipopeptides, the name for a family of anti-infective agents. ¿From there we provide analogues that supplement what Cubist has already produced.¿
David Albert, AMRI¿s communications director, said, ¿The research will begin with a three- to five-month Phase I program and could be expanded to Phase II.¿
¿The driving force of the collaboration is the application of AMRI¿s collection of enzymes,¿ said Scott Rocklage, Cubist¿s CEO. ¿We have two technologies, one that is chemistry based, one that is biosynthesis based. Essentially, AMRI offers us a third arm.¿
What makes a large pool of lipopeptide derivatives so critical is that microorganisms, among them bacteria and fungi, are always developing resistance to existing ones, both companies said. Michels called the resistance factor ¿one of the main challenges in antibiotic therapy.¿
Should that be accomplished, the beneficiaries will be anyone who is hospitalized with a serious illness, particularly the elderly and those with compromised immune systems. ¿All have their bodies under stress, which reduces the body¿s ability to fight disease,¿ Michels said.
AMRI will provide a series of derivatives for screening. If the initial results are promising, the research program will be expanded to include scale-up, lead optimization studies and analytical testing by AMRI for each lead molecule selected by Cubist.
Cubist¿s in-house lipopeptide development program already has a track record, with its lead product, Cidecin, in Phase III trials for complex skin and soft-tissue infections. Preliminary data from the initial trial, completed in April, will be out in mid-October, while a second study in that indication is ongoing.
Cubist also has a Phase III trial for community-acquired pneumonia, and plans to consolidate all the Cidecin data in a new drug application with the FDA by mid-2002, said Jennifer LaVin, senior director for corporate communications.
A product launch in the first half of 2003 is possible, she said.
Potentially, Cidecin will be used as an intravenous medication in hospital and long-term care settings for transplant patients and those with life-threatening illnesses, Rocklage said.
Rocklage said that by developing Cidecin with its own technologies, Cubist has been able to build a large portfolio of derivatives, out of which will soon emerge the ¿next-generation preclinical candidate.¿
However, an assist from AMRI will be helpful, he said. ¿We are excited at this opportunity to expand upon our lipopeptide franchise through access to AMRI¿s proprietary technologies,¿ he said.
In trading Monday, Cubist (NASDAQ:CBST) closed up 15 cents at $35.05 and AMRI (NASDAQ:AMRI) lost 35 cents to close at $23.65.