Having leapt the cardiovascular (CV)-risk hurdle set by the FDA for Contrave (naltrexone/bupropion) with early results from the Phase III trial known as the Light Study, Orexigen Therapeutics Inc. can start to resubmit its new drug application (NDA) for the obesity drug, which could be approved in the U.S. by next summer.
Wall Street fell short of rejoicing when Regeneron Pharmaceuticals Inc. popped the lid off Phase III data with sarilumab that met all endpoints in rheumatoid arthritis (RA), and the firm’s chief scientific officer, George Yancopoulos, said he knows why.
First to benefit from a deal between Glaxosmithkline plc (GSK) and Avalon Ventures that will launch as many as 10 new companies is Sitari Pharmaceuticals Inc., funded with $10 million in Series A money to pursue early work targeting the transglutaminase 2 (TG2) pathway.
“It’s nice to make money with people you like,” said Antoine Papiernik, managing partner at Sofinnova Partners, about the $200 million-up-front deal engineered between Clovis Oncology Inc. and Ethical Oncology Science SpA (EOS).
As expected, Biomarin Pharmaceutical Inc.’s Vimizim (elosulfase alfa), an enzyme replacement therapy for mucopolysaccharidosis (MPS) Type IVA, also called Morquio A syndrome, sailed through an FDA advisory panel with positive voting.
Less than a week after Cell Therapeutics Inc. (CTI) snagged a handsome deal with Baxter International Inc. for its Janus kinase (JAK) inhibitor pacritinib – adding another industry vote for the approach – Sanofi SA disclosed safety problems with its JAK inhibitor fedratinib and ended the Phase III effort, which sparked a new look at the class.
Likely breathing easier ahead of Tuesday’s FDA advisory committee meeting is Biomarin Pharmaceutical Inc., with Vimizim (elosulfase alfa) slated to undergo scrutiny as an enzyme replacement therapy (ERT) for mucopolysaccharidosis Type IVA, also called Morquio A syndrome.
Epizyme Inc.’s Phase I study, designed mainly to determine the safety of EPZ-5676, an inhibitor of the DOT1L histone methyltransferase (HMT) for the treatment of acute leukemia with rearrangements in the mixed lineage leukemia gene (MLL-r), ended up showing treatment effects in four of eight patients.
Synta Pharmaceuticals Corp.’s new money from a public offering – about $52.5 million in gross proceeds – will fuel an expanded Phase III push with the heat-shock protein 90 inhibitor ganetespib in non-small-cell lung cancer (NSCLC).
The FDA altered its view of Sarepta Therapeutics Inc.’s data with exon-skipping therapy eteplirsen for Duchenne muscular dystrophy (DMD) after Prosensa Holding NV’s failure with exon-skipper drisapersen for the condition, but Sarepta CEO Chris Garabedian hopes the agency can still be brought around.
