EMEA adopts new scientific advice procedure

July 1, 2006

The European Medicines Agency (EMEA) has completed its "New Framework for Scientific Advice & Protocol Assistance", which outlines changes in the way it will provide scientific advice on the research and development of new medicines.

The new framework includes:

The provision of advice to sponsors is a key priority for the EMEA and is an essential part of the Agency's response to the EU strategy for improving the competitiveness of European-based research and development into pharmaceuticals. By speeding up the process it is hoped that patients will gain quicker access to new medicines.

Allergan wins lawsuit

Allergan and Syntex won a patent infringement lawsuit in 2004, against the defendants who had filed an Abbreviated New Drug Application (ANDA) to market a replica of Allergan's non-steroidal, anti-inflammatory drug, Acular (ketorolac tromethamine ophthalmic solution). The Court of Appeal ruled in June 2006 that the defendants' ANDA infringed US Patent no. 5,110,493, owned by Syntex and licensed by Allergan. As a result the defendants' ANDA may not be put forward for approval until the current patent expires in 2009.

Acular is indicated for the relief of ocular itching and for the treatment of postoperative inflammation after cataract surgery.

NicOx & Pfizer partnership strengthens

NicOx has announced an increase of its share capital reserved for a company of the Pfizer group.

The equity investment forms part of an agreement between Pfizer and NicOx that was announced in March of this year. It granted Pfizer exclusive rights to apply NicOx' proprietary nitric oxide-donating technology across the whole field of ophthalmology. So far NicOx has received €8 million and is likely to receive total potential milestones of at least €300 million, plus royalties for each resulting marketed product.

The share capital increase was approved at a meeting of shareholders in June of this year and involves the issuance of just under 1.5 million new shares. The settlement delivery of the new shares took place in June 2006 and represents 3.55% of the share capital.

Coalition against retinotherapy

The JDFR, which funds research into finding a cure for type1 diabetes and its complications, will provide payments of up to $1 million over two years based on research achieving specific technical milestones.

All parties believe that the partnership will offer a good opportunity to accelerate the progress of potential treatments for diabetic retinopathy.