RARE Daily

Roche Beefs Up Its Fibrosis Pipeline in $1.4 Billion Deal to Acquire Promedior

November 18, 2019

Rare Daily Staff

Swiss biopharmaceutical Roche has entered into an agreement to acquire privately-held U.S. biotech Promedior, obtaining full rights to Promedior’s entire portfolio of molecules for serious fibrotic diseases, including idiopathic pulmonary fibrosis and myelofibrosis.

Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, irreversible, and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis, or scarring, in the lungs that hinder the ability of lungs to absorb oxygen. Current therapies slow the decline but are limited in their ability to improve function or halt disease progression. The median survival time from diagnosis is two to three years. There are no cures and treatment options are limited.

Myelofibrosis (MF) is a serious, life-limiting cancer that is characterized by fibrosis of the bone marrow. Replacement of the bone marrow by scar tissue prevents the normal production of blood cells, leading to anemia, fatigue, and increased risk of bleeding and infection. Production of blood cells shifts to the spleen and liver, which become enlarged, causing severe discomfort, inability to eat, and weakness. The only potentially curative treatment is allogeneic bone marrow transplant while other currently available therapies address the symptoms but have minimal if any impact on the underlying fibrosis.

Roche has agreed to pay Promedior shareholders $390 million in cash upfront, plus additional contingent payments of up to $1 billion based on the achievement of certain predetermined development, regulatory and commercial milestones.

“Due to Roche’s strong expertise in IPF, hematological cancer, and other fibrotic disorders, we believe Roche is ideally positioned to bring the potential of our platform to patients and provide new treatment options within these areas of urgent unmet medical need,” said Jason Lettmann, CEO of Promedior and general partner of Lightstone Ventures.

Promedior’s lead asset PRM-151 is a first-in-class recombinant human pentraxin-2 (PTX-2) protein that is specifically active at the site of tissue damage. PRM-151 has been shown to provide a significant benefit on lung function on top of current therapies. A randomized phase 2 study in IPF demonstrated that PRM-151 slowed the decline of lung function and stabilized six-minute walk distance, which suggested potential benefit in overall functional decline. The open-label extension data further demonstrated evidence of a sustained benefit out to 76 weeks. Positive data from the mid-stage study in MF highlighted PRM-151’s ability to reduce bone marrow fibrosis.

Roche markets Esbriet (pirfenidone), one of two therapies currently approved to treat IPF, which while having reached blockbuster status, will soon lose its orphan drug exclusivity and also faces stiff completion from Boehringer Ingelheim’s Ofev.

“We are excited to combine Promedior’s portfolio with our drug development capabilities to further advance PRM-151 in fibrotic diseases, including IPF and MF,” said James Sabry, global head of Roche Pharma Partnering.

Photo: Jason Lettmann, CEO of Promedior and general partner of Lightstone Ventures

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