When Johnson & Johnson acquired nipocalimab as part of the $6.5 billion takeover of Momenta Pharmaceuticals, the hype surrounding the therapy was focused on its potential as a treatment for the hot disease area of myasthenia gravis. But a top-line phase 2 readout for the drug in a fetal disorder is a reminder that nipocalimab could have a far broader reach.
Homegrown pharma firm Natco on Wednesday said Johnson & Johnson and Momenta Pharmaceuticals have filed a patent infringement lawsuit against the company and its marketing partner Mylan Pharmaceuticals Inc, along with others, in the US.
Hillson joins as Provention looks to beef up its leadership team while it awaits a Type A meeting with the FDA to discuss lead drug teplizumab, which was rejected by the regulator in July. The agency asked for more data on the Type 1 diabetes drug. The biotech expects to meet with the FDA later this month, Provention said in its third quarter earnings on Nov. 4. After that meeting, Provention will work with the FDA to see what the drug's commercial path looks like.
Johnson & Johnson’s $6.5 billion takeover of Momenta Pharmaceuticals came out of the blue last month. Yet, behind the scenes, the companies had been circling each other for more than 18 months, culminating in a drawn out due diligence process that drove Momenta to issue J&J an ultimatum.
Momenta had been talking to J&J for well over a year about a potential partnership when it was due to release Phase II data for its lead drug, nipocalimab (M281), in myasthenia gravis. Having established a line of contact during the 2019 JP Morgan conference, Momenta CEO Craig Wheeler raised the possibility of a buyout in October. For months, J&J kept asking more questions about both nipocalimab and a second compound, M254.
CAMBRIDGE, Mass., July 28, 2020 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA) today announced that its novel drug candidate, nipocalimab, has received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for the prevention of hemolytic disease of the fetus and newborn (HDFN). Additionally, FDA granted nipocalimab orphan drug designation in HDFN. HDFN is a serious blood disorder in a fetus or newborn that occurs when red blood cell incompatibility exists between the blood types of a mother and fetus in utero.
CAMBRIDGE, Mass., June 15, 2020 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA), a biotechnology company focused on discovering and developing novel biologic therapeutics to treat rare immune-mediated diseases, today announced positive topline data from an interim analysis of its Phase 2 Vivacity-MG study of nipocalimab (M281) in generalized myasthenia gravis (gMG). All four treatment arms showed efficacy in the myasthenia gravis activities of daily living (MG-ADL) score, the primary endpoint. Additionally, all dosing arms showed strong safety and tolerability profiles.
Momenta $MNTA had a few things to prove going into its interim analysis of a Phase II study for its drug nipocalimab (M281) in treating generalized myasthenia gravis.