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gtcb from rodman
ATRYN RECEIVES POSITIVE CHMP OPINION GTC Biotherapeutics announced today that the Committee for Medicinal Products for Human Use (CHMP)of the European Medicines Agency (EMEA) has adopted a positive opinion on the market authorization application (MAA) for ATryn for the prophylaxis of venous thromboembolism surgery of patients with congenital antithrombin deficiency. ATryn may be given in combination with heparin or low molecular weight heparin, which are used during these surgeries. EMEA routinely accepts recommendation of CHMP. Therefore, we expect final market authorization by the E.U. in about three months. ATryn, once approved, will be the first antithrombin product approved for use in all 25 countries of the E.U.
ATRYN - FIRST EVER TRANSGENIC PROTEIN LIKELY TO BE APPROVED - A SIGNIFICANT MILESTONE FOR THE INDUSTRY The positive CHMP opinion is an unusual reversal following a review of GTC's petition of re-examination of a prior negative opinion. While congenital antithrombin deficiency is a very small indication from which GTCB will not derive significant commercial value, ATyn approval is in fact a milestone achievement for GTCB. This is the first time ever that a transgenic goat product is approved for any indication, which serves to validate GTCB's proprietary technology platform. LEO Pharma, GTCB's European partner, will be responsible for the commercialization of ATryn in the E.U. for the approved indication and has selected disseminated intravascular coagulation (DIC) as an acquired antithrombin deficiency indication to develop a large market opportunity for ATryn in the E.U. Leo is expected to start a Phase II trial by YE06. Future success of ATryn in an acquired indication will be critical to the long-term prospects of GTCB.
Raising GTCB to Market Outperform. We are greatly encouraged by the reversal of CHMP's opinion regarding the approvability of ATryn. It not only validates the technology platform but also greatly increases our confidence in the company management's ability to execute with regard to regulatory maters. We are strong believers in GTCB's technology platform and expect more companies to adopt it as a way to produce complicated protein therapeutics. We believe the decision by Leo Pharm to move forward with ATryn in DIC, a large acquired antithrombin deficiency indication, is definitely a positive development for GTCB. Using the sales multiple of 6X our 2013 ATryn revenue estimate of approximately $226 MM and a 30% annual discount rate that we believe adequately compensates investors for the risks associated with GTCB, we derive a 12-month price target of $4.
KEY RISK US ATryn trial setback
Navdeep S. Jaikaria, Ph.D. Managing Director Sr Biotechnology Analyst 212 356 0538 .......