Bristol-Myers Squibb Company and Promedior, Inc., have entered into an agreement that grants Bristol-Myers Squibb an exclusive right to acquire Promedior and gain worldwide rights to its lead asset PRM-151, a recombinant form of human pentraxin-2 protein in phase 2 development for the treatment of idiopathic pulmonary fibrosis (IPF) and myelofibrosis (MF).

PRM-151 has been granted Fast Track designation in the US and Orphan designation in the US and Europe for the treatment of MF and Orphan designation in the US and Europe for the treatment of IPF. Promedior is a clinical stage immunotherapy company pioneering the development of targeted therapeutics to treat fibrotic diseases. Total aggregate payments to Promedior under the agreement have the potential to reach $1.25 billion, which includes an upfront cash payment for the right to acquire Promedior, an exercise fee payable if Bristol-Myers Squibb elects to exercise its right to acquire the company, and subsequent clinical and regulatory milestone payments.

“Bristol-Myers Squibb continues to invest in building a diverse specialty portfolio, focusing on innovative approaches that can transform the treatment landscape for patients with serious diseases,” said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb.

PRM-151 will complement our growing early-stage fibrosis portfolio, and we are excited by its potential to address multiple fibrotic diseases.”

“We are pleased that Bristol-Myers Squibb has recognised the value of Promedior’s clinically validated approach to directly address the underlying pathology of diseases involving fibrosis,” said Suzanne L. Bruhn, Ph.D., president and chief executive officer of Promedior.

“With the strong strategic fit between our companies, 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.”

PRM-151 has been shown in multiple preclinical models 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. Promedior has advanced PRM-151 into clinical trials focused on two orphan fibrotic diseases (MF and IPF).

Bristol-Myers Squibb is developing an early stage fibrosis portfolio that includes BMS-986020, a lysophosphatidic acid 1 (LPA1) receptor antagonist in phase 2 development for the treatment of idiopathic pulmonary fibrosis. Other areas of focus include nonalcoholic steatohepatitis (NASH), systemic sclerosis, and chronic kidney disease. Additionally, the company has executed a series of agreements aimed at further advancing its fibrosis development programme, including an option to acquire Galecto Biotech AB, a company with an inhaled inhibitor of galectin-3 in phase 1 development for the treatment of idiopathic pulmonary fibrosis, a research collaboration and license agreement with the California Institute for Biomedical Research (Calibr), and a translational research collaboration with The Medical University of South Carolina.

Under the terms of the agreement, Bristol-Myers Squibb 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. The companies have agreed on a development plan that will be executed by Promedior. It is anticipated that the phase 2 trials in MF and IPF will be initiated in the coming weeks. Bristol-Myers Squibb can exercise its right to acquire Promedior upon completion of either of these trials.

Fibrotic diseases are characterized by the formation of excess fibrous connective tissue in an organ or tissue, compromising function and ultimately leading to organ failure. Idiopathic pulmonary fibrosis is a chronic, progressive form of lung disease characterized by the scarring of lung tissue for which there are limited treatment options. While estimates vary, it is believed that IPF could affect approximately 130,000 patients in the US and approximately 76,000 patients in Europe. Myelofibrosis 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. Myelofibrosis affects 18,000 people per year in the US, and available therapies have minimal, if any, impact on the underlying fibrosis.