Pharma Focus Asia

Acceleron and Fulcrum Therapeutics Announce Pulmonary Research and Discovery Collaboration Agreement

Tuesday, December 31, 2019

Acceleron Pharma Inc., a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, and Fulcrum Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases, today announced they have entered into a collaboration and license agreement to identify small molecules designed to modulate specific pathways associated with a targeted indication within the pulmonary disease space.

“This collaboration brings together Fulcrum’s skill in identifying drug targets based on modulation of genetic pathways associated with disease and Acceleron’s deep expertise in TGF-beta superfamily signaling in an effort to generate potentially disease-modifying therapeutics,” said Habib Dable, Chief Executive Officer of Acceleron Pharma. “With this agreement, along with the advancement of the Acceleron-discovered assets sotatercept—in Phase 2 trials in pulmonary arterial hypertension—and ACE-1334, we underscore our growing commitment to the development of novel therapies for patients with pulmonary diseases of high unmet medical need.”

Under the agreement, Acceleron will have access to Fulcrum’s unique, proprietary product engine and target identification platform with the potential to identify small molecules that control the expression of genes known to impact specific pathways associated with a pulmonary disease of interest. Acceleron and Fulcrum will collaborate on the identification of therapeutic targets and small molecule drug candidates for those targets. Acceleron will be responsible for all development and commercialization activities for any potential therapeutics identified via this platform. Fulcrum will receive a one-time, upfront payment of $10 million as well as reimbursement for relevant R&D costs. Fulcrum will also be eligible to receive research, development and commercial milestone payments of up to $295 million for a first product commercialized and up to a maximum of $143.5 million in additional milestone payments for all subsequent products commercialized. Fulcrum will additionally receive tiered royalty payments in the mid-single-digit to low double-digit range on net sales.

“We are very pleased to partner with Acceleron on this important research initiative,” said Robert J. Gould, Ph.D., Chief Executive Officer of Fulcrum Therapeutics. “This collaboration builds on and extends the proven potential of our platform to identify therapies that can address the root cause of diseases, including our progress with losmapimod, currently in a Phase 2 clinical trial for FSHD and extensive pre-clinical and early stage research targeting other genetically defined diseases. This new opportunity to screen and identify pulmonary disease-specific therapies is another reflection of the broad potential applications of the Fulcrum platform in gene modulation.”

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