|Healthcare Review: Gilead Sciences, Impax Pharmaceuticals, AbbVie, Creative Edge Nutrition, Regado Biosciences|
|By Staff and Wire Reports|
|Friday, 11 April 2014 13:08|
After consulting with outside advisers, the Texas Health and Human Services Commission mulls changing its recommendation to Medicaid that Gilead Sciences' ($GILD) Sovaldi be restricted to the sickest hepatitis C patients due to its high cost. The plan's July start is now on hold while the agency examines its options. Also on hold is the state's plan to make supplemental payments to insurers to partially offset the drug's cost. Insurers in California and Florida have also asked their states to pay them directly so they can avoid losing money in their contracts. California is still evaluating the issue while Florida has no plans to carve out the drug.
Impax Pharmaceuticals ($IPXL) resubmits its NDA for RYTARY (IPX066), an extended release formulation of carbidopa and levodopa for the treatment of Parkinson's disease. The resubmission includes updated information on the product's safety and stability. The FDA sent the company a CRL in January citing the need to re-inspect its manufacturing facility subsequent to a May 2011 warning letter. Consensus estimates for Q1 and Q2 are earnings of $0.04/share on revenues of $108.7M and earnings of $0.26/share on revenues of $145.5M, respectively. Consensus views for 2014 and 2015 are earnings of $0.68/share on revenues of $536.5M and $0.88/share on revenues of $566.5M, respectively.
AbbVie's ($ABBV) three-drug combo for Hepatitis C cured 96.2-96.3% of patients in two Phase III trials, known as Sapphire-I and Sapphire-II. The subjects in Sapphire II included those who hadn't responded well to previous treatment. The regimen includes an Enanta (ENTA) inhibitor.
Creative Edge Nutrition ($FITX), CEN Biotech and RXNB terminate their agreement with Growlife (PHOT) in the wake of the SEC's trading suspension announced yesterday. CEN will utilize an alternative source to fund its Lakeshore, Ontario project for $20M in exchange for a 25% equity stake.
Regado Biosciences ($RGDO) offers 10M shares of common stock for public sale at $6/share. Underwriters over-allotment is 1.5M shares. Closing date is April 16. Proceeds will be used for the continued development of REG1 and for general corporate purposes.