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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 > > > <<GTCB 06-02-06 Upgrade Final.pdf>> > > Navdeep S. Jaikaria, Ph.D. > Managing Director > Senior Biotechnology Analyst > H<http://www.rodmanandrenshaw.com/>H > Tel:: 212 356 0538 > Fax:: 212 356 0546