|Healthcare Review: Ariad Pharmaceuticals, Oramed Pharmaceuticals, BioCryst Pharmaceuticals, Jazz Pharmaceuticals, Amarin|
|By Staff and Wire Reports|
|Friday, 20 December 2013 19:49|
Ariad Pharmaceuticals ($ARIA) says the FDA has approved a revised USPI and a REMS for Iclusig. The move "allows immediate resumption of its marketing and commercial distribution." The drug, which was suspended in October, is now indicated for "T315I-positive chronic myeloid leukemia or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia and chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ acute lymphoblastic leukemia for whom no other tyrosine-kinase inhibitor therapy is indicated."The boxed warning is revised and now features an alert regarding "the risk of vascular occlusive events." There's also "a new warning for heart failure."
BioCryst Pharmaceuticals ($BCRX) jumps 5.7% after the company has submitted a NDA for IV peramivir in acute uncomplicated influenza in adults. BCRX got a small business waiver for the application fee.
Oramed Pharmaceuticals ($ORMP) rises 34% after the company says "patient responses positively correlated with administered doses, as did the duration of the effect," in a study testing the pharmacokinetic dose response of ORMD-0801 in type 1 diabetes. ORMP will "continue to move forward with this indication" along with studies in type 2 diabetes.
Shares of Jazz Pharmaceuticals ($JAZZ) are 7% higher on the heels of the company's Gentium (GENT) acquisition. The deal gives the company Defitelio — the sVOD treatment that also has an Orphan designation in the EU for GvHD — which JAZZ says "is highly complementary to [the company's] experience in and focus on orphan diseases in the area of hematology/oncology."JAZZ expects the deal to be immediately accretive.
The FDA has indefinitely delayed a ruling on Amarin's ($AMRN) request to expand the use of of the company's Vascepa drug, which lowers triglyceride fat in blood. Under the new "ANCHOR" indication, the therapy would be used to treat people who take statins to cut cholesterol and have a high risk of coronary heart disease. The FDA was due to issue its verdict today, but the agency put off the ruling as it's still considering Amarin's request to re-instate the ANCHOR Special Protocol Assessment (SPA) agreement. Under the SPA, the FDA had said that the design of an uncompleted Phase III trial was acceptable to support a marketing application to widen Vascepa's use case. However, the agency rescinded that SPA in October and initially denied Amarin's appeal over the matter.