PRESS RELEASE: European approval granted for Pexion(R) - innovative treatment for canine epilepsy discovered by BioCrea, developed and launched by Boehringer...

BioCrea / European approval granted for Pexion(R) - innovative treatment for canine epilepsy discovered by BioCrea, developed and launched by Boehringer Ingelheim . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

Radebeul, Germany, May 06, 2013 - BioCrea GmbH (BioCrea), the first-in-class CNS drug discovery specialists validated through pharma partnerships, announced that Pexion(R) (Imepitoin) has been recommended for marketing authorisation by the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA). Imepitoin was discovered by Dr Tom Kronbach, Chief Executive Officer at BioCrea, and his team in 1995. Following a 2004 in-licensing agreement, Pexion(R) was further developed and launched by Boehringer Ingelheim.

In December 2012, the CVMP adopted a positive opinion to recommend the granting of a marketing authorisation for the veterinary medicinal product Pexion(R) 100mg and 400mg tablets, intended for the reduction of the frequency of generalised seizures due to idiopathic epilepsy in dogs.

Imepitoin is a centrally acting anti-epileptic substance, which inhibits seizures via potentiation of GABAA receptor-mediated inhibitory effects on the neurons. In addition, Imepitoin has a weak calcium channel blocking effect.

Pexion(R) has been launched by Boehringer Ingelheim in Europe in April 2013.

"This recommendation by the CVMP is excellent news for our partner Boehringer Ingelheim and for dog owners, whose pets suffer epilepsy," said Dr Tom Kronbach, Chief Executive Officer of BioCrea GmbH. "Fundamentally, CVMP concluded that Pexion(R) has a favourable efficacy profile and demonstrated a superior safety profile compared to current standard treatments[1]. Moreover, this recommendation is proof that our discovery engine and approach defines small molecule drugs that do reach the market."

"Until now, the two most common treatments were sedatives that have been in use for more than 100 years", said Dr Joachim Hasenmaier, responsible for the Corporate Board Divisions Animal Health and Consumer Healthcare at Boehringer Ingelheim. "Therefore, we are very proud to provide a real innovation in this therapeutic area that significantly improves upon the current standard treatment."

About BioCrea

BioCrea is the Radebeul-based first-in-class drug discovery specialist validated through pharma partnerships. The company boasts a provable track record in effective drug discovery driven by knowledge, flexibility and extensive experience. BioCrea's expertise is founded on the continuing discovery and optimization of selective ion channel and enzyme modulators - agents that offer significant potential for maximizing the efficacy and tolerability of new therapeutics. BioCrea was awarded Top Innovator status of the "Top 100" Most Innovative Companies in Germany, 2012 by compamedia GmbH.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 140 affiliates and more than 46,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Contact

Dr. Tom Kronbach

CEO, BioCrea GmbH

Tel.: +49 351 / 4043 3332

Fax: +49 351 / 4043 3216

tom.kronbach@biocrea.com

[1] European Public Assessment Report (EPAR): Pexion (Imepitoin). London: European Medicines Agency; 2013. Available at: www.ema.europe.eu.

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Source: BioCrea via Thomson Reuters ONE

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BioCrea

BioCrea GmbH Radebeul Germany

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   May 06, 2013 03:01 ET (07:01 GMT)- - 03 01 AM EDT 05-06-13