Bristol-Myers Squibb (BMS) is paying the biotech company Promedior $150 million to have exclusive rights to acquire the company following the completion of phase 2 studies that Promedior will undertake with its lead compound of PRM-151, a recombinant form of human pentraxin-2 protein for the treatment of idiopathic pulmonary fibrosis (IPF) and myelofibrosis (MF).
PRM-151 has been granted orphan drug designation in the United States and Europe for both MF and IPF. The drug has also been given Fast Track designation in the United States for MF.
The companies have agreed on a development plan that will be executed by Promedior, starting with the initiation of phase 2 trials in MF and IPF in the coming weeks. BMS can exercise its right to acquire Promedior upon completion of either of these trials. Under the terms of the agreement, BMS will make payments aggregating up to $1.25 billion that includes an upfront cash payment of $150 million as consideration for both the right to acquire Promedior and as payment for services in support of the MF and IPF Phase 2 clinical trials. Preclinical studies also indicate that the drug may be effective in other fibrotic conditions.
Idiopathic Pulmonary Fibrosis (IPF)
IPF is a chronic, progressive fibrosing interstitial pneumonia that does not have a clear cause. In most cases, the disease is fatal within 2-3 years of initial symptoms and treatment options are limited.
Current treatments included oxygen therapy, pulmonary rehabilitation, lung transplant and/orthe orphan drugs Esbriet (pirfenidone) and Ofev (nintedanib). Approximately 130,000 patients in the United States have IPF.
MF is a serious, life-limiting blood cancer, characterized by fibrosis of the bone marrow which prevents the normal production of blood cells, leading to anemia, fatigue, and increased risk of bleeding and infection.
At present, the only approved orphan drug for MF is Jakafi (ruxolitinib) and the only potential ‘curative’ treatment is allogeneic bone marrow transplant. Average survival time for patients with MF is 5 years. Approximately 18,000 patients in the United States have MF.
Bristol-Myers Squibb Enters Agreement Providing Exclusive Right to Acquire Promedior, Inc. and its Novel PRM-151 in Development for Fibrotic Diseases [news release]. New York NY and Lexington MA: Bristol-Myers Squibb Company and Promedior Inc; August 31, 2015. http://www.businesswire.com/news/home/20150831005212/en/Bristol-Myers-Squibb-Enters-Agreement-Providing-Exclusive-Acquire#.VeRoJM7ney0