|Healthcare Review: Cardiovascular Systems, Questcor Pharmaceuticals, Rosetta Genomics, Forest Laboratories, Novartis|
|By Staff and Wire Reports|
|Tuesday, 22 October 2013 13:33|
Cardiovascular Systems ($CSII) soars after the FDA grants PMA approval for the company's Diamondback 360 Coronary Orbital Atherectomy System to treat severely calcified coronary arteries. This is the "first new coronary atherectomy system in more than two decades," the company notes, adding that "CSI will begin a controlled commercial launch of its Diamondback 360 Coronary OAS immediately." (PR)Here's Benchmark's Jan Wald: "We believe this is an important milestone for the company, as it allows CSII to enter the $1.5B market to treat severely calcified coronary lesions with a differentiated product."
Questcor Pharmaceuticals ($QCOR) is set to begin a Phase 2 study of Acthar for Acute Respiratory Distress Syndrome.
QCOR's IND for the study is now active. Primary endpoint: Determination of Acthar's ability to "increase the number of ventilator-free days during the 28-day treatment period."
Rosetta Genomics ($ROSG) receives a U.S. patent for a test that differentiates between lung squamous carcinoma and other non small cell lung cancers. From the description: "The invention provides specific nucleic acid sequences for use in the identification, classification and diagnosis of specific lung cancers. The nucleic acid sequences can also be used as prognostic markers for prognostic evaluation of a subject based on their expression pattern in a biological sample."
Forest Laboratories ($FRX) jumps 3.8% after handily beating estimates on the bottom line for Q2.Net sales rise 17.3% Y/Y.By product: Namenda, +7.8% to $396.3M; Namenda XR, $11.5M; Viibryd, +18.9% to $47.4M; Daliresp, +25.4% to $24.5M; Tudorza, $16.7M; Bystolic, +22.1% to $130M; Linzess, $34.4M; Savella, -10.4% to $23.5M; Teflaro, +48.9% to $14.9M.Contract revenue comes in at $36M versus $54.3M in Q2 2012.FY14 guidance: $0.95-1.15/share against consensus of $0.96/share.
Novartis ($NVS) reviewing units that don't have "global scale and critical mass." The company's pharmaceutical, Alcon eyecare and Sandoz generics divisions fulfill these requirements; in the other businesses, Novartis is "looking at ways to either strengthen them or to think about other opportunities," says CEO Joseph Jimenez. Sales breakdown: Pharmaceuticals +1% to $7.9B, boosted by higher prices and sales volume; Alcon +3% to $2.5B, helped by sales of surgical products; Sandoz +11% to $2.3B, pushed up by the acquisition of Fougera in 2012. Vaccines +2% to $594M; consumer health +11% to $1B.