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Britannia Pharmaceuticals Limited Closes 2003 With Several New Partnership Agreements And Significant Clinical Progress



10/19/2005 5:09:45 PM

LONDON--(BUSINESS WIRE)--Jan. 22, 2004-- Goals for 2004 include pursuing strategic partnerships to further develop innovative powder treatment for asthma

Britannia Pharmaceuticals Limited reported today that 2003 was a landmark year for the company, marking significant clinical advancements and strategic partnership development as well as considerable growth in key markets. Over the course of the year, the company signed three major partnership agreements, made progress in clinical trials for three of its six areas of clinical research, and continued expansion into the Unites States and other target markets.

"2003 was truly an incredible year for Britannia. We are thrilled with the progress we have made on all fronts - in our business relationships and in all of our treatment areas," said Max Noble, Managing Director of Britannia. "These results are a tribute to the extraordinary commitment of the entire Britannia team to our products, technology and mission. "

Noble continued, "One of Britannia's key goals for 2003 was to secure a U.S. partner to further develop and launch our drug addiction treatment, BritLofex, in the United States. We met this goal when we signed a licensing agreement with US WorldMeds in November. Having completed this critical partnership, we will shift our focus in the new year to securing partners for several of our other treatments - most notably, our unique asthma therapy, Pumactant. Other out-licensing targets include our treatment for surgical adhesions, our Apomorphine nasal powder for Parkinson's disease, and our dihydroergotamine nasal powder for migraines."

Below are selected milestones for Britannia in 2003:

New Partnerships

-- Britannia signed a licensing agreement with US WorldMeds, LLC. Under the terms of the agreement, US WorldMeds will further develop and launch Britannia's non-addictive drug addiction treatment BritLofex (Lofexidine Hydrochloride) in the United States.

-- Britannia signed an agreement with Bespak plc (LSE: BPK) to accelerate the development of AdSurf(R), a novel clinical approach to the prevention of surgical adhesions that has been in development at Britannia since 1997.

-- Britannia announced an agreement with Novartis Pharmaceuticals Limited, a subsidiary of Novartis AG (NYSE:NVS), to accelerate the development of dihydroergotamine (DHE) nasal powder for the treatment of migraines. An advanced and patented formulation of DHE has been in development at Britannia since 2001.

Clinical Progress

-- Lofexidine for Drug Addiction: A pilot study performed at Yale University School of Medicine showed that opiate addicts treated with a combination of lofexidine and the opiate antagonist naltrexone are more likely to remain opiate-free without relapse and without significant adverse effects.

-- Apomorphine for Erectile Dysfunction: Britannia completed a Phase I study of Apomorphine nasal powder for erectile dysfunction. The trial results indicated that the nasal powder product has the potential to be an optimised delivery system for Apomorphine in the treatment of erectile dysfunction and a considerable improvement over currently marketed products. In addition, no significant side effects were reported. A Phase II proof of principle study is planned for the near future.

-- Apomorphine for Parkinson's Disease: Britannia is currently developing a nasal powder formulation of Apomorphine for Parkinson's disease based on its injectable Apomorphine treatment, which is marketed in the UK as APO-go(R). Successful Phase II trials investigating the nasal powder formula were reported, and a Phase III program is scheduled to start in Q2 2004. Launch of this product in the UK is anticipated in Q1 2006.

-- Pumactant for Surgical Adhesions: Britannia made substantial progress in two Phase III trials for its Pumactant therapy for surgical adhesions. Final results for the Brisbane study and interim results for the UK multi-center study are expected Q1 2004. Patents were granted in both the US and EU.

-- Pumactant for Asthma: Results of a study published in the European Respiratory Journal showed that Britannia's Pumactant powder has the potential to be a significant advancement in the prevention of asthma attacks for the millions of asthma sufferers worldwide. A patent was granted in the EU (the corresponding US version was granted in 2002).

Other Key Developments

-- Britannia has a licensing agreement with Bertek Pharmaceuticals Inc., the branded products subsidiary of Mylan Laboratories Inc., to bring its Apomorphine therapy for Parkinson's disease to market in the United States. In January 2003, Bertek's NDA for Apomorphine subcutaneous injection was accepted for filing by the FDA with Fast Track status.

-- The FDA took action on the application on July 2, 2003 by issuing an approvable letter. Final approval is pending the FDA's review of Bertek's response to the approvable letter.

About Britannia Pharmaceuticals

Founded in 1981, Britannia Pharmaceuticals Limited is a United Kingdom-based pharmaceutical firm whose mission is to become a leading supplier of innovative products for niche medical conditions. The company has pioneered new treatments for some of the world's most debilitating conditions including asthma, Parkinson's disease, drug addiction, erectile dysfunction, migraine, and surgical adhesions. In addition to these treatments, Britannia has also developed nasal and respiratory drug delivery technologies that are applicable to a wide range of treatments. Britannia is a Forum Bioscience Company. The website address is www.britannia-pharm.co.uk.

Contacts

For Britannia Pharmaceuticals: Nicole Cottrill, 617-443-9933 x329 ncottrill@rasky.com


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