As Blueprint Medicines preps for the U.S. and EU approvals of its RET inhibitor, the company is bringing its research and clinical development work under one roof and putting Bristol Myers Squibb veteran Fouad Namouni, M.D., in charge. Namouni arrives after a 20-year career at the Big Pharma, which included leading the teams behind immuno-oncology stars Opdivo and Yervoy.
As president of research and development, Namouni will oversee the whole drug development cycle, from discovery through approval. Chief Scientific Officer Marion Dorsch, Ph.D., and Chief Medical Officer Andy Boral, M.D., will continue to lead research and clinical development, respectively, within the newly combined organization.
“We are excited to welcome Fouad, a seasoned drug developer and portfolio strategist, to broaden our ambitious R&D vision, as we complete the evolution of Blueprint Medicines into a fully-integrated, multi-product, global biopharmaceutical company this year," Blueprint CEO Jeff Albers said in a statement.
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Namouni will lead the company’s efforts to develop Ayvakit (avapritinib) and pralsetinib, ramp up its preclinical pipeline and “prioritize new targets and technologies,” for its future work, Albers added.
He joins soon after Roche forked over $775 million in cash and equity for the rights to pralsetinib outside the U.S. and China. Through its Genentech unit, Roche will co-promote pralsetinib with Blueprint in the U.S, while CStone Pharmaceuticals holds the rights to pralsetinib in greater China.
The drug is under review by the FDA and European Medicines Agency as a treatment for RET fusion-positive non-small cell lung cancer (NSCLC). It won’t be the first treatment for patients with RET-mutated cancers, however— to Eli Lilly’s Retevmo (selpercatinib), picked up in its $8 billion acquisition of Loxo Oncology, won that distinction in May. Retevmo is approved for the treatment of NSCLC and two types of thyroid cancer, the same indications Blueprint is targeting.
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As for Ayvakit, the kinase inhibitor became the first targeted treatment for patients with a type of stomach cancer called gastrointestinal stromal tumor (GIST) who carry a (PDGFRα) exon 18 mutation. The company had been seeking a nod as a fourth-line treatment for a broader GIST population, but the FDA rejected the drug in that indication as it did not beat Bayer’s Stivarga at staving off tumor progression or death in a phase 3 study.
Despite the setback, Blueprint is pushing Ayvakit forward in a rare blood disorder called indolent systemic mastocytosis (iSM), which is characterized by uncontrolled mast cell growth and can cause debilitating symptoms such as allergic reactions, fatigue and bone pain. In March, the company reported phase 2 data showing the drug topped placebo at reducing iSM symptoms. It is taking the lowest tested dose forward into the pivotal trial.
Editor's note: This story was updated to clarify details of Blueprint's partnership with Roche.