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Wednesday, May 22, 2024

Gossamer, Chiesi Ink $486M Collab Deal

BIOPHAMA: Promising Phase 2 Results for PAH Drug

SAN DIEGO – Gossamer Bio, Inc. (Nasdaq: GOSS) is partnering up as it enters the final stretch of clinical trials for its pulmonary arterial hypertension (PAH) therapy seralutinib.

The company announced last week it had entered into a global collaboration and license agreement with Parma, Italy-based Chiesi Farmaceutici S.p.A to develop and commercialize seralutinib.

Faheem Hasnain
Gossamer Bio

“They are uniquely capable of really taking us to that next level in terms of commercialization in Europe,” said Gossamer CEO Faheem Hasnain, adding that Chiesi also has “expertise in relationships with pulmonologists. And they’ve got a huge desire to enter into the U.S. market, which made us attractive to them,”
Hasnain described Chiesi as a mid-size biopharma group with around 7,000 employees that sells about $3 billion a year worldwide.

“Doing this deal brought the capital and resources to expand our market potential substantially,” he added.

The capital and resources from the deal come as seralutnib’s Phase 3 global clinical trial for PAH is underway, with results expected in 2025. Gossamer in 2025 will also begin a Phase 3 study of seralutinib for a second indication – pulmonary hypertension associated with interstitial lung disease (PAH-ILD).

“Seralutinib is a potential paradigm shifting therapy in PAH and PH-ILD, and we could not be more excited to partner with Gossamer to develop and bring this therapy to patients world-wide,” said Giuseppe Accogli, Group CEO of Chiesi.

“Gossamer shares Chiesi’s commitment to using innovation to promote the health and well-being of people around the world and we are proud to add this collaboration as a key pillar to our next phase of growth.”

Giuseppe Accogli
Group CEO

Under the terms of the agreement, Gossamer will continue to lead global development of seralutinib in PAH and PH-ILD, and the companies will evenly split development costs, except with respect to the Phase 3 study of PAH for which Gossamer will remain financially responsible. However, as part of the deal Chiesi paid Gossamer a $160 million development reimbursement for work it has completed in advanicing seralutinib.

In the U.S., the companies will evenly share commercial profits and losses.

Gossamer will lead commercialization and book sales for PAH and PH-ILD in the U.S., with both companies contributing 50% of commercial efforts. Chiesi will lead U.S. commercialization in additional indications.

Chiesi will have the exclusive right to commercialize seralutinib outside of the U.S. and will pay Gossamer an escalating mid-to-high teens royalty on net sales.

Additionally, Gossamer will be eligible to receive up to $146 million in regulatory milestones and $180 million in sales milestones.

Promising Clinical Results

The collaboration and license deal announcement came just days after Gossamer announced results of its Phase 2 study of seralutinib for PAH.

“We clearly saw a drug that has the potential to be really effective for these PAH patients,” Hasnain said.

PAH affects somewhere between 30,000 and 50,000 people in the U.S. and has a similar prevalence in Europe. The disease damages the lungs in a way that cuts off oxygen to the right heart which can lead to right heart failure and death. Only 50% of patients “get past five years,” Hasnain said. “It’s an incredibly progressive disease with no cures.”

The only treatment currently available for PAH is an old class of drug called vasodilators. Gossamer’s seralutinib will be a substantial improvement over them because it targets the “path of physiology” of PAH,” Hasnain said. “Our drug is affecting the underlying mechanisms that causes that occlusion and fibrosis of this disease.”

The results of the Phase 2 study showed physiological improvements in lung and right heart of PAH patients and long-term data showed them “getting better out to week 72, so we seem to have a durability effect as well,” Hasain said.
“The data we generated in our Phase 2 really got us excited that we have a drug here that could potentially be used early in the course of therapy and hopefully prevent long-term disability,” he added.

Gossamer is now hoping to see similar results in its clinical trials of seralutinib for PAH-ILD which has the same underlying mechanisms at play as PAH but has a patient population three to four times the size. “That is exactly why we did this deal – to bring in the capital to expand the market potential of this drug.,” Hasnain said.

Gossamer Bio, Inc.
CEO: Faheem Hasnain
BUSINESS: clinical-stage biopharmaceutical company focused on the development and commercialization of seralutinib for the treatment of pulmonary hypertension
STOCK: GOSS (Nasdaq)
MARKET CAP: $168.75 million
FUNDING: More than $1.3 billion raised to date ($100M Series A, $230M Series B, $317M IPO, $125M equity FO in May 2020, $200M convertible bonds in May 2020, $120M PIPE in July 2022, $212M PIPE in July 2023)
NOTABLE: If approved, Gossamer’s seralutinib will be one of the first disease-modifying drugs for PAH.


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