April 29th – May 5th
In general news, Israel made an air strike into neighboring Syria, as the Syrian civil war escalates. In the U.S., the monthly jobs report was better than expected, adding 165,000 jobs, and unemployment dipped to 7.5%. Also, Richard Branson fired the rocket engines on his Virgin Galactic passenger spaceship, in a low altitude test, making commercial space flight closer.
In healthcare business, earnings seasons continued, with more signs of lower demand for drugs and devices. PFE lowered guidance, and sales of HCV drugs for MRK and VRTX were down. AUXL continues to be unable to launch Xiaflex, and MDT cut 230 jobs in the spine divisions. In banking M&A, Bayer will buy Conceptus (CPTS) for $1.1 B, to get into the contraceptive business. Lastly, MRK and PFE entered into a partnership to market ertugliflozin for Type 2 DM.
On the data front, Gilead (GILD) announced important news with the success of the LONESTAR trial of sofosbuvir (7977) and ledipasvir, which cured 95% of HCV patients after 8 weeks of therapy. GILD earnings were strong as well. Regeneron (REGN) stock was up on bad news for rival drug DARP-in made by Allergan (AGN). AGN’s bimatoprost to treat baldness also failed.
From the FDA, the “morning after” birth control pill was approved to be sold without a prescription to 15-yo girls. Merck’s (MRK) combo-cholesterol drug, Liptruzet (Generic Lipitor plus Merck’s Zetia), was approved. Raptor Pharmaceutical’s (RPTP) Procysbi was approved for orphan disease nephropathic cystinosis. Bristol-Myers (BMY) received Breakthrough status for their three-drug regimen (daclatasvir, asunaprevir, BMS-791325) to treat HCV, giving it a possible time advantage over Gilead’s sofosbuvir (7977). Also, JNJ’s Sedasys system that delivers anesthesia during colonoscopies was approved.
Lastly, in the bad news category, Titan’s (TTNP) Probuphine was rejected, as were Gilead’s two HIV drugs. A panel advised against approval of AVEO’s tivozanib and the stock imploded 50% and a panel also advised against Delcath’s (DCTH) chemo system, the Melblez Kit.