Thecollaboration, announced Aug. 3, is not only expected to bring $25 millionupfront to Acceleron, but also double-digit royalties on global net sales of upto $217 million in development, regulatory and commercial milestone payments,the companies report.
Theco-development deal for ACE-536 follows a 2008 agreement the two companies madearound another anemia treatment, called sotatercept (ACE-011). That deal waspredicted to bring a potential $1.9 billion to Acceleron.
Acceleronwill 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 thetwo companies will share development costs through 2012, Celgene will absorball the costs after that time period.
ACE-536is scheduled to enter its first clinical trial in September. It is made toblock a member of the TGF-beta superfamily of proteins that are involved in thelate stages of red blood cell formation. Animal studies have shown the drug canpromote red blood cell growth when there is no sign of the usual erythropoietinaround.
Co-foundedin 2004 by biotech wunderkind Christoph Westphal, the privately held Acceleronis backed by Advanced Technology Ventures, Alkermes, Bessemer Ventures,Celgene, Flagship Ventures, MPM BioEquities, OrbiMed Advisors, PolarisVentures, QVT Financial, Sutter Hill Ventures and Venrock. Westphal is alsofounder of Sirtris Pharmaceuticals Inc. and president of GlaxoSmithKline PLCventure investing arm SR One.
"Acceleronhas uncovered an exciting new approach to treating disorders of erythropoiesis,and we are pleased to broaden our successful partnership with Celgene," JohnKnopf, CEO of Acceleron, stated in a news release. "Acceleron and Celgene cannow combine our strengths to develop molecules to treat a broad array ofunderserved diseases and conditions in which patients suffer from anemia. Tothat end, we look forward to initiating the Phase I clinical trial of ACE-536within the next few months. ACE-536 is our fourth internally discovered anddeveloped drug to enter the clinic."
TomDaniel, president of research at Celgene, added, "Celgene and Acceleron have astrong partnership that continues to advance innovative therapies in areas ofgreat unmet medical need. The work we will embark on with ACE-536 is a naturalextension of our strong presence in hematology. We look forward to exploringthe potential of ACE-536 for patients with anemia worldwide."
GregGeissman, associate director of public relations for Celgene, tells ddn, "We are constantly looking fornovel and innovative science to pursue both internally and externally throughcollaborations like this. Anemia is a fit due to our area of focus inhematology and blood cancers. Also, our focus in oncology makes the researchinto chemotherapy and cancer-induced anemia a strong complement.
"As withour other collaborative project, Acceleron will manage the clinical programthrough Phase II, at which point we will assume the clinical development of thecompound," he continues. "Right now, we can say that we are looking forward tothe nearer-term clinical progress with both programs."
Thepartnership could make Acceleron and Celgene the main rivals for a large pieceof the global anemia treatment pie. Notably, the partnership could challengebiotech giant Amgen for the global anemia market. Amgen developed a drug in the1980s for treating anemia, and despite some setbacks, Amgen's anemia productgenerated $5 billion in worldwide sales for Amgen last year.
