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ACE in the hole
CAMBRIDGE, Mass.—Aimed at developing ACE-536 to treat anemia, Acceleron Pharma Inc. has formed a lucrative joint development and commercialization deal with Summit, N.J.-based Celgene Corp. ACE-536 is poised to enter Phase I clinical trials in the fall.
The collaboration, announced Aug. 3, is not only expected to bring $25 million upfront to Acceleron, but also double-digit royalties on global net sales of up to $217 million in development, regulatory and commercial milestone payments, the companies report.
The co-development deal for ACE-536 follows a 2008 agreement the two companies made around another anemia treatment, called sotatercept (ACE-011). That deal was predicted to bring a potential $1.9 billion to Acceleron.
Acceleron will be responsible for conducting Phase I through Phase III clinical trials, as well as manufacturing of the drug candidate for the first two trial studies, while Celgene will make ACE-536 for the Phase III clinical trials. While the two companies will share development costs through 2012, Celgene will absorb all the costs after that time period.
ACE-536 is scheduled to enter its first clinical trial in September. It is made to block a member of the TGF-beta superfamily of proteins that are involved in the late stages of red blood cell formation. Animal studies have shown the drug can promote red blood cell growth when there is no sign of the usual erythropoietin around.
Co-founded in 2004 by biotech wunderkind Christoph Westphal, the privately held Acceleron is backed by Advanced Technology Ventures, Alkermes, Bessemer Ventures, Celgene, Flagship Ventures, MPM BioEquities, OrbiMed Advisors, Polaris Ventures, QVT Financial, Sutter Hill Ventures and Venrock. Westphal is also founder of Sirtris Pharmaceuticals Inc. and president of GlaxoSmithKline PLC venture investing arm SR One.
"Acceleron has uncovered an exciting new approach to treating disorders of erythropoiesis, and we are pleased to broaden our successful partnership with Celgene," John Knopf, CEO of Acceleron, stated in a news release. "Acceleron and Celgene can now combine our strengths to develop molecules to treat a broad array of underserved diseases and conditions in which patients suffer from anemia. To that end, we look forward to initiating the Phase I clinical trial of ACE-536 within the next few months. ACE-536 is our fourth internally discovered and developed drug to enter the clinic."
Tom Daniel, president of research at Celgene, added, "Celgene and Acceleron have a strong partnership that continues to advance innovative therapies in areas of great unmet medical need. The work we will embark on with ACE-536 is a natural extension of our strong presence in hematology. We look forward to exploring the potential of ACE-536 for patients with anemia worldwide."
Greg Geissman, associate director of public relations for Celgene, tells ddn, "We are constantly looking for novel and innovative science to pursue both internally and externally through collaborations like this. Anemia is a fit due to our area of focus in hematology and blood cancers. Also, our focus in oncology makes the research into chemotherapy and cancer-induced anemia a strong complement.
"As with our other collaborative project, Acceleron will manage the clinical program through Phase II, at which point we will assume the clinical development of the compound," he continues. "Right now, we can say that we are looking forward to the nearer-term clinical progress with both programs."
The partnership could make Acceleron and Celgene the main rivals for a large piece of the global anemia treatment pie. Notably, the partnership could challenge biotech giant Amgen for the global anemia market. Amgen developed a drug in the 1980s for treating anemia, and despite some setbacks, Amgen's anemia product generated $5 billion in worldwide sales for Amgen last year.