Biotech Values

[DewDiligence]

ATryn – A Safe Drug Without Use of Donor Blood

[This PR from Leo Pharma, the European partner of GTCB, announces the launch of ATryn in the UK for acute use in patients with hereditary antithrombin deficiency. The average selling price per day of treatment is $22,600 (£11,000), but this is a small market. A much bigger potential market for ATryn is disseminated intravascular coagulation (DIC) secondary to sepsis, an indication in which Leo is conducting a phase-2 trial.]

http://biz.yahoo.com/bw/071126/20071126005544.html

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Monday November 26, 8:57 am ET

BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma launches a new, safe drug, ATryn®, for preventing blood clots in patients. It concerns patients who, due to a genetic defect, cannot produce enough of the protein antithrombin III or whose antithrombin III is not sufficiently efficient. Antithrombin is a protein that is a key part of managing the coagulation process in the bloodstream.

This hereditary fault (Hereditary antithrombin Deficiency, HD) means that the patients e.g. when in surgery can be in danger of dying from thrombosis if not treated for the lacking antithrombin III.

With ATryn®, the HD patients now get access to a new, safe and technological remarkable treatment without the use of donor blood. ATryn® is the world’s first approved drug which is produced in transgenic goats. Human antithrombin is expressed in the milk of these goats and then processed into a highly purified product.

In 2005, LEO Pharma and the American GTC Biotherapeutics Inc. (NASDAQ: GTCB www.gtc-bio.com) concluded a development and marketing agreement for Europe, Canada and the Middle East concerning ATryn® (#msg-8316050).

LEO is responsible for the marketing and sales in the mentioned areas for the HD indication as well as further developing ATryn® for new indications. GTC is responsible for supplying the product.

In August, LEO Pharma began a clinical phase II study in which patients with DIC (Disseminated Intravascular Coagulation) are treated with ATryn®. DIC is serious condition during which the blood coagulates in the blood vessels and occurs in connection with serious sepsis. In the EU and Canada, the number of patients stricken by sepsis and DIC each year is estimated to be about 125,000 – 30-60% of these ends fatally.

“ATryn® is a new, exciting drug with interesting perspectives if it can be used for the treatment of other indications. This could e.g. be for the treatment of DIC at patients with severe sepsis. ATryn® fits well with our existing anticoagulation business which among other things includes Innohep®, Heparin LEO® and Protaminsulfat LEO Pharma®,” says Ernst Lunding, CEO of LEO Pharma.

The ATryn® phase II study concerning DIC will prove the drug’s safety, effect and optimal dose against future phase III study.

About LEO Pharma

LEO Pharma is an independent research based company with headquarter located in Ballerup, Denmark. LEO Pharma is 100% owned by the LEO Foundation and is one of the world's leading companies in dermatology and parenteral treatment of tromboemboli. LEO invents, develops and manufactures safe and efficacious pharmaceutical drugs and markets them globally – 96% of the turnover is generated outside Denmark. LEO Pharma is represented in more than 90 countries and has around 3,000 employees around the world; 1,200 of these in Denmark.
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