- On Friday, Roche announced plans to acquire private drug developer Promedior for its small pipeline of anti-fibrotic medicines. The deal includes $390 million in upfront cash as well as $1 billion in potential milestone payments.
- Researchers are evaluating Promedior's main asset, PRM-151, across liver and kidney diseases, bone marrow cancer, and a hard-to-treat lung condition known as idiopathic pulmonary fibrosis. Phase 2 studies of PRM-151 are ongoing in myelofibrosis and IPF, while a Phase 3 IPF trial should begin by year's end, according to the company.
- Roche's Esbriet is one of two drugs approved to treat IPF, and came under the Swiss pharma's control through its $8.3 billion purchase of InterMune in 2014. Though Esbriet has become a blockbuster product, fetching sales just over $1 billion in 2018, its orphan drug exclusivity runs out in 2021.
IPF has proven itself a challenging target for drugmakers. In just a few recent examples, Biogen, Gilead and Global Blood Therapeutics each reported clinical failures with their respective treatments.
Esbriet (pirfenidone) offered a rare success story both for the industry and patients living with the lung disease. Yet its time in the spotlight was short lived. On the same day the Food and Drug Administration approved Esbriet, the agency also cleared for market a rival therapy from Boehringer Ingelheim called Ofev.
Across the last couple years, Ofev sales edged higher than Esbriet. In 2018, they totaled 1.1 billion euros, or around $1.3 billion, reflecting a nearly 29% increase from 2017 after adjusting for currency. Roche's drug, meanwhile, notched 19% growth over that period under a constant exchange rate.
Esbriet's orphan exclusivity is close to expired, pushing Roche to find a new offering. PRM-151, which is a recombinant form of a protein thought to help reverse fibrosis, seems to fit the bill.
Phase 2 results showed that, after 28 weeks, patients treated with PRM-151 had significantly lower declines on a measure of lung function than those given placebo. Patients also performed significantly better on a six-minute walking test after treatment with Promedior's drug.
James Sabry, global head of Roche Pharma Partnering, noted in a Friday statement how Roche's experience with Esbriet and hematology drugs should help the company as it continues developing PRM-151 for IPF and myelofibrosis. Among Roche's deep oncology portfolio are the blood cancer drugs Gazyva (obinutuzumab), Polivy (polatuzumab vedotin) and Venclexta (venetoclax).
Outside of IPF and myelofibrosis, PRM-151 is in human testing a treatment for non-alcoholic steatohepatitis and fibrotic kidney disease. Promedior's pipeline also includes a preclinical compound, PRM-167, that the company sees as a potential therapy for age-related macular degeneration.