Target $72
Wednesday, July 3, 2019
Glaxo launches late-stage development of RA med otilimab
GlaxoSmithKline (NYSE:GSK) announces the start of its Phase 3 program evaluating otilimab, an anti-granulocyte macrophage colony-stimulating factor (anti-GM-CSF) monoclonal antibody, in patients with moderate-to-severe rheumatoid arthritis (RA) who have failed to respond adequately to disease-modifying antirheumatic drugs (DMARDs) or targeted therapies.
The program, called ContRAst, will include head-to-head comparisons with current treatments across all studies, including Pfizer’s (NYSE:PFE) XELJANZ (tofacitinib) Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi’s (NASDAQ:SNY) KEVZARA (sarilumab).
The primary endpoint for the pivotal trials will be the proportion of patients achieving at least a 20% improvement in RA symptoms (ACR20).
GSK owns exclusive global rights to otilimab under a 2013 agreement with MorphoSys AG (NASDAQ:MOR).
Shares are up 1% premarket on the European nod for ViiV Healthcare’s Dovato for HIV-1 infection.
Ligand Pharma out-licenses OmniAb platform to Millennium Pharma
Ligand Pharmaceuticals (NASDAQ:LGND) has entered into an OmniAb commercial platform license and services agreement with Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceutical (NYSE:TAK).
Under the license, Takeda and its affiliates will be able to use OmniAb platform rodents and birds in campaigns to discover antibodies as well as therapies using engineered cells and OmniAb-derived binders.
LGND is receiving annual access fees and will receive milestone payments and tiered single-digit royalty payments for each product incorporating or delivering an OmniAb antibody and any scientific services provided. Takeda will be responsible for all costs related to the programs.
RedHill Bio’s Talicia nabs accelerated review status
The FDA has accepted for review RedHill Biopharma’s (NASDAQ:RDHL) NDA for Talicia (RHB-105) for H. pylori infection. The NDA has also been granted Priority Review designation.
PDUFA action date is November 2, 2019.
If approved, Talicia would be eligible for eight years of U.S. market exclusivity.
Talicia (RHB-105) is an oral capsule combination of two antibiotics, rifabutin, and amoxicillin, and a proton pump inhibitor, omeprazole.
Shares are up 3% premarket.
Centene boosts stake on Spanish healthcare provider to 90%
Centene (NYSE:CNC) has increased its stake in València, Spain-based Ribera Salud Group to 90% (from 50%) via a transaction with partner Banco Sabadell.
Nu Skin -6% after USANA warning
Nu Skin (NUS -5.7%) falls sharply after traders latch on to the weak guidance posted by USANA Health Sciences yesterday after the market closed.
Jefferies warns that the comments from USANA management on China don’t bode well for Nu Skin.
Shares of Nu Skin are only about a dollar away from the 52-week low of $44.36.
Shire prevails in Mydayis patent challenge
Takeda’s (TAK +0.2%) Shire plc is the winner of a challenge to two patents protecting long-acting ADHD med Mydayis by a would-be generic competitor. The USPTO’s Patent Trial and Appeal Board ruled that KVK-Tech failed to prove that the patents, covering the method of releasing the drug, are invalid.
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