August 31, 2015
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Bristol-Myers Squibb Company struck a deal worth up to $1.25 billion to acquire the rights to buy Lexington, Mass.-based Promedior Inc. and its lead product to enhance the company’s early-stage fibrosis portfolio, the company announced this morning.
Suzanne Bruhn, Promedior’s chief executive officer, told BioSpace she expects data from the Phase II trials to be available in 2017. In early trials, PRM-151 was able to reverse the bone marrow pathology in about half of the patients, which provided the incentive to move forward, Bruhn said.
“We’re really excited about the potential for PRM-151. There’s still unmet need and we think PRM-151 will be able to meet that,” she said in a telephone interview to BioSpace.
Promedior’s lead candidate, PRM-151, is a recombinant form of human pentraxin-2 protein currently in Phase II development for the treatment of idiopathic pulmonary fibrosis (IPF) and myelofibrosis (MF). Myelofibrosis affects the bone marrow and prevents the normal production of blood cells, which leads to anemia, fatigue and increased risk of bleeding and infection. There are approximately 18,000 people diagnosed with MF each year in the U.S. It is classified as a rare disease by the U.S. National Institutes of Health. The only drug approved by the U.S. Food and Drug Administration (FDA) to treat myelofibrosis is Incyte Corporation ‘s Jakafi, which generated $258 million in sales for the first six months of 2015, Reuters reported.
PRM-151 received Fast Track designation by the U.S. Food and Drug Administration in 2014. The designation covered the drug’s treatment of Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, and Post-Essential Thrombocythemia Myelofibrosis.
The only potentially curative treatment is allogeneic bone marrow transplant, which results in reversal of fibrosis and normalization of blood counts, but is a realistic option for only a small number of patients. In addition to Fast Track designation in the U.S., PRM-151 has also been granted orphan designation in both the U.S. and Europe.
“PRM-151 will complement our growing early-stage fibrosis portfolio, and we are excited by its potential to address multiple fibrotic diseases,” Francis Cuss, Bristol-Myers’ chief scientific officer said in a statement.
Suzanne L. Bruhn, Promedior’s chief executive officer, said her company will strategically fit within the BMS family.
“We intend to continue to move PRM-151 forward rapidly as a new treatment option to address the unmet needs of patients with myelofibrosis, idiopathic pulmonary fibrosis, and other fibrotic diseases,” Bruhn said in a statement.
Under terms of the deal, BMS will provide $150 million in an upfront payment. The remaining money will be aggregated as consideration for both the right to acquire Promedior and as payment for services in support of the MF and IPF Phase II clinical trials.
Data from earlier clinical trials has shown PRM-151 is able to regulate monocytes and macrophages at areas of tissue damage to prevent and reverse fibrosis, including IPF, acute and chronic nephropathy, liver fibrosis, and age-related macular degeneration.
The drug will fit with other fibrosis medications BMS is developing. The company’s portfolio includes BMS-986020, a lysophosphatidic acid 1 (LPA1) receptor antagonist in Phase II development for the treatment of idiopathic pulmonary fibrosis. Additionally, the company is focusing on other areas of research, including nonalcoholic steatohepatitis (NASH), systemic sclerosis and chronic kidney disease.
In addition to the acquisition of Promedior’s PRM-151, Bristol-Myers is also eying other deals, including a $444 million option to acquire Galecto Biotech AB, a company with an inhaled inhibitor of galectin-3 in Phase I development for the treatment of idiopathic pulmonary fibrosis, a research collaboration and license agreement with the California Institute for Biomedical Research and a translational research collaboration with The Medical University of South Carolina.
