Acceleron Pharma, a leading biopharmaceutical company in the discovery and development of TGF-beta therapeutics to treat serious and rare diseases, announced it has amended the sotatercept development and commercialization collaboration agreement with Celgene Corporation, originally executed on February 20, 2008. The amended agreement provides Acceleron with global access to sotatercept for development and commercialization in pulmonary arterial hypertension (PAH).
“We are very pleased to announce the execution of this amended agreement alongside our long-time collaboration partner, Celgene. Sotatercept shows tremendous potential to be a groundbreaking therapy for pulmonary arterial hypertension, and we expect sotatercept, as a Phase 2-ready compound, to be the lead molecule in our new pulmonary disease franchise,” said Habib Dable, Chief Executive Officer for Acceleron. “Our mission with sotatercept, as we move to initiate a Phase 2 trial in the first half of 2018, is to improve the lives of those living with pulmonary arterial hypertension.”
“While many therapies are approved for the treatment of pulmonary arterial hypertension, these therapies all focus on a mechanism of vasodilation and the prognosis for patients remains poor,” said Eric Austin, M.D., Director, Vanderbilt Pediatric Pulmonary Hypertension Program. “Sotatercept’s mechanism is intended to rectify the deficits in molecular signaling that underlie both the familial and idiopathic forms of this disease. The preclinical data with sotatercept is very encouraging, and I look forward to seeing data from clinical trials.”
“This amended agreement unites Acceleron’s scientific leadership in the TGF-beta superfamily with Celgene’s commitment to advance novel molecules, such as sotatercept, for patients in therapeutic areas of high unmet medical need,” said Scott Smith, Chief Operating Officer for Celgene.
Under the amended and restated collaboration agreement, Acceleron has the right to fund and conduct all research and development activities for sotatercept in the pulmonary hypertension field. Should sotatercept be approved for an indication in the pulmonary hypertension field, Acceleron will be responsible for global commercialization and Celgene will be eligible to receive royalties on global net sales in that field. The original collaboration deal terms will remain in place with respect to development and commercialization outside of the pulmonary hypertension field.
Acceleron also updated its cash guidance, announcing that its existing cash, cash equivalents and investments will be sufficient to fund projected operating requirements into mid-2019, versus its earlier guidance of the second half of 2019.
Sotatercept is an investigational product that is not approved for use in any country.
Filed Under: Drug Discovery