OSI/PRP partnership to develop sustained release Macugen

March 1, 2006

PR Pharmaceuticals and OSI Pharmaceuticals have entered into an exclusive agreement to develop a sustained release formulation of the neovascular AMD treatment Macugen (pegaptanib sodium injection).

PR Pharmaceuticals and OSI Pharmaceuticals have entered into an exclusive agreement to develop a sustained release formulation of the neovascular AMD treatment Macugen (pegaptanib sodium injection).

The agreement provides OSI and its Macugen development partner, Pfizer, with exclusive rights to PRP's proprietary ProPhase encapsulation technology for use in ophthalmology. Meanwhile, PRP will be responsible for developing the formulations and manufacturing the test article for non-clinical and clinical trials. Eyetech (OSI's eye disease unit) will then be responsible for clinical development, manufacturing and commercialization of any resultant product.

PRP has received an undisclosed, upfront payment from OSI as a result of the agreement and will also receive payments upon achievement of certain milestones and royalties on net sales of any products resulting from the collaboration.

Alcon became the next big name to show an interest in the new area of RNA interference (RNAi) research, when it agreed to collaborate with Dharmacon, a business unit of the Fisher Biosciences group, on the development of this class of agents for ophthalmic conditions.

Recently, small interfering RNAs (siRNAs) have continued to demonstrate efficacy as therapeutic agents in specifically targeting and treating a number of ophthalmic conditions. As a result, much interest has been generated in this class of therapeutics and their ability to specifically, safely and effectively target conditions for which there is no effective treatment.

Dharmacon brings its proprietary siRNA chemistries and SMARTselection technology to the deal whilst Alcon will add its global expertise and reputation in research, development and marketing of ophthalmological products.

Together, the firms will select and prioritize disease-related gene targets and Dharmacon will be responsible for the design and chemical modification of siRNAs that could potentially be developed into ophthalmic drug candidates.

Financial terms of the agreement were not disclosed.

Allergan and Sirna join forces to tackle AMD

Currently undergoing Phase I testing for the treatment of wet AMD, Sirna-027 is a chemically modified short interfering RNA (siRNA) that targets Vascular Endothelial Growth Factor Receptor-1 (VEGFR-1).

The trial underway is designed to measure the safety, tolerability and biological activity of Sirna-027 following a single intravitreal injection.

Under the terms of the agreement, Allergan will assume full development and future commercialization responsibilities for Sirna-027 and will provide their proprietary ocular drug delivery technologies for the administration of RNAi-based therapeutics. Meanwhile, Sirna will receive an initial payment of $5 million and be eligible for development milestones of up to $245 million in addition to research funding and royalties on worldwide sales of products resulting from the alliance.

Alcon appeals decision ruling in patent case

A federal judge in Delaware has ruled in favour of Advanced Medical Optics (AMO) in a patent infringement lawsuit. AMO had claimed that Alcon infringed its US patent nos. 5,700,240 and 6,059,765 challenging certain features of Alcon's Infiniti Vision Sytem and the Advantec and Everest software upgrades to Alcon's legacy cataract system. The patents related to AMOs Sovereign machine used in cataract surgery.

As a result of the ruling, AMO was awarded $213.9 million in damages.

Alcon is appealing the decision. During the appeals process, Alcon will still be able to sell and distribute its Infiniti vision systems and Infiniti FMS cassettes and customers are able to use the equipment without disruption.

Meanwhile, Alcon is continuing to develop an alternative design of its Infiniti FMS cassette, which is expected to be available during the first half of this year.

Inspire halts retinal disease programme

Inspire Pharmaceuticals has discontinued all clinical trials for its investigational macular oedema treatment, denufosol tetrasodium intravitreal injection (INS37217 Ophthalmic), because of its failure to demonstrate efficacy in the treatment of retinal disease.