suprelorin media announcement

Peptech Limited (ASX:PTD; AIM:PTDx ), the Australian biotechnology company announced today that its wholly-owned subsidiary Peptech Animal Health Pty Limited (PAH), has received a recommendation to grant approval in Europe for Suprelorin®, a veterinary contraceptive product.
PAH has been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Veterinary Use (CVMP) has recommended the grant of a European Marketing Authorisation for Suprelorin®.
Cyton Biosciences, PAH’s regulatory partner in Europe for Suprelorin® said that a positive opinion from the CVMP provides an almost certain indication that a European Marketing Authorisation, granted by the European Commission, will follow within the next three months. With this opinion, the CVMP has reached a positive conclusion on the safety and efficacy of Suprelorin® for rendering healthy, non-castrated, sexually mature male dogs as temporarily infertile for a period of six months.
Suprelorin® is anticipated to become commercially available throughout Europe during the second half of 2007
The product has been successfully marketed in Australia since December 2004 and New Zealand since September 2005. In addition, PAH is currently pursuing a registration application with regulatory authorities in the US.
Dr John Chiplin, CEO of Peptech said: ” The European market for Suprelorin® offers considerable growth opportunities for sales of the product with the canine population estimated to be over 60 million, more than fifteen times the size of the Australian market but with a much lower rate of surgical castration”.
“Importantly, the European attitude towards castration of pets is far more polarised compared with Australia. An illustration is that surgical castration for reproductive control in dogs is banned in Norway. As a result, we anticipate an enthusiastic response to the launch of Suprelorin® in Europe.”
“We are confident that our search for a suitable European marketing partner will gather increased momentum in recognition of this recommendation for approval. Furthermore the recommendation also makes the Animal Health business much more attractive to prospective acquirers as it gives more certainty to the business’s potential”.
ENDS