Gossamer Bio has experienced numerous ups and downs over the years, including a clinical setback and significant staff reductions. Now, as it pursues potential approval for a heart drug, the company has enlisted the expertise of Bob Smith, a veteran from Merck and Actelion, to oversee its commercial unit.
Smith most recently led Merck’s sotatercept U.S. pre-launch work, a drug that is on the cusp of a potential FDA approval for pulmonary arterial hypertension (PAH) after getting an FDA priority review in September—the exact label Gossamer is gunning for with its experimental med seralutinib.
He will now run the seralutinib commercial work for the biotech, which remains an R&D biotech hoping to turn into a commercial biopharma. The drug is, however, further back in the regulatory stakes than sotatercept: Merck’s drug has a PDUFA for next March, while Gossamer's med is still in trials.
Smith has some major experience, having spearheaded two successful blockbuster PAH drug launches, namely Opsumit and Uptravi, which ultimately led to the purchase of his former company Actelion by Johnson & Johnson in 2017 for $30 billion.
Smith served as the leader of U.S. sales operations for Actelion, concluding his 11-year tenure in 2018. Subsequently, he assumed the role of president at LTM Pharma Consulting. During this time, he played a pivotal role in developing strategic plans for brand launches and organizational structures for pre-commercial rare disease companies. In the early part of the current year, Smith transitioned to Merck.
“With Bob’s arrival, Gossamer is well-positioned to transition itself from a pre-commercial, clinical-stage biotechnology company to a fully integrated commercial organization focused on bringing seralutinib to patients with pulmonary hypertension,” said Faheem Hasnain, chairman, co-founder and CEO of Gossamer.
“Given his distinguished experience as a senior commercial leader at both Merck and Actelion, and having launched significant PAH brands, we are confident that Bob is the best person for this key role, and we appreciate the confidence that such an accomplished commercial professional has shown in seralutinib by joining Gossamer Bio.”
Gossamer has had a tricky few years. One year ago to the day, seralutinib met the primary endpoint in the phase 2 Torrey trial, but it failed to excite analysts and investors. On the day of the data drop, its shares dropped by a major 70% as the market questioned just how well it could compete against Smith’s former drug sotatercept.
Most recently in April, Gossamer was forced to end development of a lymphoma med after reports of two deaths and other serious adverse events in a phase 2 trial. A month later, it cut 25% of its staffers and stopping work on all other candidates to free up money for a final roll of the dice on a phase 3 trial for seralutinib.