Novartis, Bausch & Lomb to promote pSivida blindness treatment

By Helen Schuller
Friday, 10 February, 2006

Perth-based bio-nanotech company pSivida's (ASX:PSD, NASDAQ:PSDV, Xetra:PSI) Retisert will be co-promoted in the US by Novartis Ophthalmics.

Retisert is an intravitreal drug implant for the treatment of the sight-threatening inflammatory disease uveitis which was approved as a single-indicated orphan drug by the US FDA in April 2005 and launched in June last year.

Under the terms of the agreement, Novartis Ophthalmics, a business unit of Novartis Pharmaceuticals Corp, will promote Retisert to its network of retinal specialists in the US, supplementing the efforts of licensee Bausch & Lomb's US pharmaceutical sales representatives. Bausch & Lomb remains responsible for Retisert marketing and product strategy.

"This new co-promotion deal with Novarits demonstrates the therapeutic value and market potential of Retisert and further justifies the acquisition of Control Delivery Systems in the US," said pSivida's investor relations manager, Brian Leedman.

Retisert is currently priced at US$18,250 for a treatment period of 30 months.

"Our collaboration with Novartis will provide an expanded nationwide sales force, allowing more rapid distribution of this innovative technology to retinal specialists and their patients who are suffering from posterior segment uveitis," said Michael O'Rourke, vice president and general manager of Bausch & Lomb's US Pharmaceuticals business in a statement.

pSivida purchased Retisert's developer Control Delivery Systems for US$104 million (AUD$139 million) in October 2005 and pSivida now receives royalties for the drug from Bausch & Lomb.

Control Delivery Systems produced Vitrasert, the first FDA approved treatment for the back of the eye for cytomegalovirus (CMV) retinitis, a sight threatening disease caused by complications of AIDS. Retisert is a next generation product which is being marketed for the treatment of chronic noninfectious posterior segment uveitis, however it has applications for treating other eye diseases.

"It is a cup and spoon design -- inserted into the back of the eye. The pressure on the device causes small amounts of drug to be released over a period of up to 30 months. The alternative for sufferers of this disease are regular monthly injections into eye," said Leedman.

In January pSivida announced it had signed new evaluation agreements for its third generation back of the eye treatment Medidur with three of the five largest pharmaceutical companies in the world.

Medidur is currently in phase III clinical trials in a co-development licensing deal with US based Alimera Sciences for diabetic macular edema (DME), which is the leading cause of blindness in the US. Medidur can also be used for a variety of other eye diseases which may lead to further licensing agreements in the future. Medidur is injected into the back eye via an in office procedure rather than surgically inserted as is the case with Retisert and it is able to release drugs over a period of up to three years.

The ASX responded favourably to the news of the co-promotion. At press time pSivida shares were trading up more than 7 per cent at $0.645.

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