BMS extends fibrosis focus with $1.25bn Promedior deal

Bristol-Myers Squibb (BMS) has been steadily building its position in fibrotic diseases for some time, but accelerated its efforts this week with a $1.25 billion deal giving it the right to buy Promedior and another clinical-stage drug candidate.

The transaction includes an upfront fee of $150 million and will give BMS a worldwide licence for PRM-151, a recombinant form of human pentraxin-2 protein which is in development for the treatment of idiopathic pulmonary fibrosis (IPF) and myelofibrosis (MF) and is due to start phase II trials within the next few weeks.

Fibrosis is the formation of excess fibrous tissue that can impair the function of an organ, and has been a target for some time for BMS, which has lead candidate BMS-986020 – a lysophosphatidic acid (LPA1) receptor antagonist – in phase II testing for IPF.

In November 2014, BMS reached an agreement to acquire Galecto Biotech in a deal valued at up to $444 million, giving the drugmaker an option to acquire the company as well as another experimental IPF therapy, called TD139, which is an inhaled inhibitor of galectin-3.

Since then the US drugmaker has bolstered its early-stage research in fibrosis via academic partnerships with the California Institute for Biomedical Research (Calibr) and the Medical University of South Carolina (MUSC).

PRM-151 is classed as an orphan drug with fast-track review status in the US for MF, and an orphan drug for IPF, which leads to shortness of breath, cough and can cause fatal complications such as heart failure. Meanwhile, in Europe, it has been designated an orphan drug for both indications.

While estimates vary, it is believed that IPF could affect approximately 130,000 patients in the US and approximately 76,000 patients in Europe, with MF diagnosed in around 18,000 people per year in the US.

For years, patients with IPF had no approved therapies available other than corticosteroids and immunosuppressive drugs, although that changed recently when Roche’s Esbriet (pirfenidone) and Boehringer Ingelheim’s Ofev (nintedanib) were approved for marketing, providing the first treatments that can address underlying disease mechanisms in fibrosis.

Meanwhile, other drugs in development for IPF include AstraZeneca/MedImmune’s tralokinumab and Roche’s lebrikizumab – both of which are interleukin-13-targeting antibodies – as well as Gilead Sciences’ LOXL2 inhibitor simtuzumab, Biogen Idec’s alpha V beta 6 integrin inhibitor STX-100 and FibroGen’s connective tissue growth factor (CTGF) blocker FG-3019.

Pharma’s interest in fibrosis stems from the realisation that so many different diseases feature the formation of fibrous tissue, with other examples including atherosclerosis, asthma, liver cirrhosis, non-alcoholic steatohepatitis (NASH), chronic kidney disease (CKD) and scleroderma.

“BMS 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 the company’s chief scientific officer Francis Cuss.

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

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