Acceleron Pharma ($XLRN) is in Phase III testing for its lead candidate that’s partnered with Celgene ($CELG). Now, it’s brought in a top commercial executive from Bayer ($BAY), Habib Dable, to lead the company as it aims to plan for a marketed product.
Dable will replace Acceleron co-founder, President and CEO John Knopf as of Dec. 1, when the latter is set to retire. Knopf helped start the Cambridge, MA-based biotech in 2003, which as a private company went on to raise about $115 million and snag a 2008 deal with Celgene that was further built upon in 2011.
He led it through a 2013 IPO to a current valuation of about $1.5 billion. Knopf came to Acceleron from Wyeth, where he had been the Cambridge, MA, site head and VP of metabolic and respiratory disease.
Incoming Acceleron head Dable was most recently the president for pharmaceuticals at Bayer in the U.S. In that role, he managed several new product launches across a number of therapeutic areas. He’s been with Bayer for more than 20 years and prior to that spot was the global head of specialty medicine for Bayer HealthCare Pharmaceuticals.
Acceleron’s lead candidate is luspatercept, a TGF-β family ligand trap that promotes late-stage erythropoiesis; it’s in Phase III testing in lower-risk myelodysplastic syndrome (MDS) and in beta-thalassemia.
The company won’t be responsible for commercialization of this candidate, though. Celgene has worldwide rights to luspatercept with Acceleron receiving a low- to mid-20% royalty on net sales. Celgene is also responsible for conducting Phase III luspatercept clinical studies; for earlier R&D funding, Celgene had paid Acceleron a total of $81.6 million through June 30.
Next, Acceleron stands to receive a $25 million milestone from Celgene upon FDA or EMA acceptance of a BLA for luspatercept.
Luspatercept was a subject of the 2011 Celgene deal, while the 2008 deal centered on candidates including sotatercept, a TGF-β family ligand trap that promotes late-stage erythropoiesis and bone mineralization. It’s currently in Phase II, and Celgene has similar terms on it with worldwide rights and a low-to-mid 20% royalty on net sales. Celgene had paid $43.3 million in R&D funding for sotatercept through June 30; next it could receive a $10 million milestone based on a Celgene start of a Phase III trial for it in chronic kidney disease (CKD).
Celgene is entirely responsible for the worldwide development costs for both of these programs and has been since the start of 2013.
"With two Phase 3 trials underway and a strong proprietary pipeline, Acceleron is on the cusp of a key inflection point, and is adding critical commercial competencies to its core strength of research and development," said Acceleron board chairman Dr. Francois Nader in a statement. "Habib is the right person to take Acceleron forward into this next stage of growth as a company … .He is a strategic thinker with excellent leadership and communications skills that will help Acceleron deliver on our vision of becoming a leading biopharmaceutical company."
Acceleron holds full rights to Phase II dalantercept, which is being tested in renal cell carcinoma, and Phase I ACE-083 to treat focal muscle disorders; it’s slated to move into Phase II testing during this half.