Roche has agreed to pay $390m upfront to buy Promedior and its portfolio of fibrosis-targeting drugs, including a phase 2 candidate with FDA breakthrough status.
All told, the deal could be worth almost $1.4bn, with a $1bn pledged to Promedior’s shareholders tied to development, regulatory and commercial milestones.
The lead asset in the deal is PRM-151, a recombinant form of human pentraxin-2 protein that has generated positive mid-stage results in idiopathic pulmonary fibrosis (IPF), a disease associated with scarring of the lungs, as well as early-stage results in myelofibrosis.
PRM-151 was previously partnered by Bristol-Myers Squibb in 2015, but that agreement – which included a $150m upfront payment and acquisition rights – was called off last year in the build-up to BMS’ $74bn acquisition of Celgene.
At the moment, the only approved therapies for IPF are Roche/Shionogi’s Esbriet (pirfenidone) and Boehringer Ingelheim’s Ofev (nintedanib), which are both blockbuster drugs with sales in excess of $1bn in 2018.
There are dozens of candidates for IPF coming through the industry pipeline however, including Galapagos’ oral autotaxin inhibitor GLPG1690 and FibroGen’s intravenous CTGF inhibitor pamrevlumab – both in phase 3 – and Pliant’s oral integrin inhibitor PLN-74809 in phase 2.
In March, the FDA said PRM-151 warranted breakthrough status on the back of data showing that a monthly infusion of the drug slowed the decline in lung function in IPF patients compared to placebo.
Promedior’s pipeline is all linked to pentraxin-2, a plasma protein that is thought to switch on a molecular pathway that stimulates macrophage white blood cells to break down fibrotic tissue, at the same time as dampening down the inflammation and other processes that lead to scarring.
That mechanism suggests PRM-151 could have potential in a range of diseases characterised by fibrosis, including myelofibrosis – a haematological cancer that results in scarring of the bone marrow and severe anaemia.
The only marketed therapies for myelofibrosis are currently Incyte/Novartis’ Jakafi (ruxolitinib), a $1.4bn JAK 1/2 inhibitor first approved in 2011, and Celgene’s newer JAK inhibitor Inrebic (fedratinib) which was cleared by the FDA in August.
Some analysts think Inrebic could become a $1bn product for myelofibrosis, despite a black-box warning on its label for a serious and life-threatening brain reaction – Wernicke’s encephalopathy – that was seen in a little over 1% of patients treated with the drug in trials.
“With our proven track record in IPF with Esbriet as well as in haematological cancers, we are well-positioned to leverage our clinical and commercial expertise to bring PRM-151 to patients as fast as possible,” said Roche’s head of pharma partnering James Sabry.