Roche has agreed to acquire Promedior for up-to-$1.4 billion, Promedior said today—a year after previous suitor Bristol-Myers Squibb (BMS) opted not to exercise its right to acquire the developer of treatments for fibrotic diseases for $1.25 billion.

Roche’s deal will give it full rights to Promedior’s entire portfolio of molecules for serious fibrotic diseases—a pipeline anchored by PRM-151, a recombinant form of human pentraxin-2 (PTX-2) protein that earlier this year generated positive Phase II results in idiopathic pulmonary fibrosis (IPF) and myelofibrosis (MF).

In IPF, Promedior on May 20 published positive safety and efficacy data from a 76-week open-label extension study of PRM-151 in The Lancet Respiratory Medicine, and presented the data at the American Thoracic Society 2019 International Conference. IPF patients randomized to placebo who were switched to treatment with PRM-151 showed both a significant reduction in the rate of decline of forced vital capacity (FVC), and 6-minute walking distance (6MWD).

The rate of decline in FVC percent predicted reduced from -8.7% per year while on placebo to -0.9% per year on PRM-151. 6MWD improved from -54.9 m per year on placebo to -3.5 m per year on PRM-151.

Last year Promedior trumpeted positive Phase II IPF results published in JAMA from a 28-week, 117-patient trial (NCT02550873) showing that patients who were treated with PRM-151 every four weeks for 24 weeks exhibited a change in FVC percentage of predicted value of -2.5% compared with -4.8% with placebo—a statistically significant difference that indicated a slower decline in lung function, according to the company.

In MF patients that either failed (76%) or were ineligible for Incyte’s marketed drug Jakafi® (ruxolitinib), whose indications include MF, a separate Phase II study (NCT01981850) showed that PRM-151 reduced bone marrow fibrosis in 28% of patients, thus demonstrating clear evidence of biologic activity, Promedior stated on June 17.

Promedior has said the anti-fibrotic mechanism of PRM-151 has therapeutic potential in other fibrotic diseases—one of several disease areas of interest and experience for Roche.

“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,” Promedior CEO Jason Lettmann said in a statement.

Planned BMS buyout

Promedior sought to position itself for a big pharma buyout in 2015 when it gave BMS exclusive acquisition rights as well as worldwide rights to PRM-151. The up-to-$1.25 billion price included $150 million cash upfront for both the right to acquire Promedior and as payment for services in support of the MF and IPF Phase II clinical trials.

Promedior’s drug candidates have been developed through the company’s platform based on Pentraxin-2 (PTX-2), an endogenous human protein that is specifically active at the site of tissue damage. PTX-2 is designed to work as an agonist that acts as a macrophage polarization factor to initiate a resolution process for prevention and potential reversal of fibrosis, thereby acting as a master regulator upstream in the fibrosis cascade.

According to Promedior, studies by the company and collaboration partners have confirmed the ability of pentraxin-2 therapeutics to act as upstream agonists across many major tissue types and in several models of fibrotic disease, strongly supporting its potential as a novel anti-fibrotic agent.

“With over a decade of research, development, and investment, Promedior has demonstrated the unique ability of its pentraxin-2 platform to deliver disease-modifying potential in fibrotic disorders,” Lettmann added.

James Sabry, MD, PhD, global head of Roche Pharma Partnering, in a statement, cited his company’s success in developing the IPF treatment Esbriet™. The drug generated CHF 813 million ($821.8 million) in sales from January–September 2019, up 9% from a year ago.

“With our proven track record in IPF with Esbriet as well as in hematological cancers, we are well-positioned to leverage our clinical and commercial expertise to bring PRM-151 to patients as fast as possible,” Sabry said. “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.”

Roche agreed to pay $390 million cash upfront, and up to $1 billion in payments tied to achieving development, regulatory, and commercial milestones. The acquisition is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.

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