Biotech Values

[drbio45]

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:: [phone]
> Fax:: [phone]