pSivida and Pfizer sign ophthalmic research and licensing agreement

Australian drug delivery technology company, pSivida, has signed an exclusive worldwide research and license agreement with US drug giant, Pfizer, for applications relating to the formerís controlled drug delivery technology, Medidur, in ophthalmic applications.

Medidur is a tiny injectable, non-erodible, intravitreal device for the treatment of Diabetic Macular Edema (DME), which can lead to blindness. The implant is injected into the back of the eye in an office setting rather than a surgical one. It releases a constant amount of drug and lasts between 18 to 36 months.

There is currently no approved drug therapy for DME, so Medidur has been granted fast track status by the FDA and pSivida expects European registration filing expected in H1 2009. The product is currently in phase III clinical trials in combination with fluocinolone acetonide and is a collaboration with Alimera Sciences, a US-headquartered specialty pharmaceutical company focused on ophthalmic drugs.

Per the agreement, pSivida will receive up to USD 155m in development and sales related milestones. The two companies will work together on a joint research programme aimed at developing ophthalmic products using pSividaís sustained drug delivery technology.

Pfizer also will fund the cost of the joint research programme and benefit from an exclusive license to market all products developed as part of this research collaboration in ophthalmic applications and will pay pSivida a royalty on net sales of those products. Pfizer may terminate the agreement on 60 days notice without cause.

Pfizer agreed to invest USD 5m in ordinary shares of pSivida when it entered the license agreement, the proceeds of which will be held in escrow until they can be used to redeem an outstanding convertible note. Pfizer has also agreed to invest an additional USD 5m in pSivida common equity in the future, subject to certain conditions.

Dr Paul Ashton, pSividaís managing director, said: "We believe this collaboration is another significant validation of the drug delivery systems that pSivida has been developing since its founding. We plan to pursue development and additional collaborations exploiting our innovative drug delivery technologies in other parts of the body."

Pfizerís reasons for partnering with pSivida are unsurprising. With a number of its pipeline products due to go off-patents and recent high-profile products failing at late clinical stages, Pfizer is looking to extend the lifecycles of existing or threatened products with pSividaís drug delivery technology, of which Medidur is just one.

The main draw for Pfizer in partnering with pSivida is its expertise in nano-encapsulation, which could rescue many of the small molecule drugs which have failed in clinical trials. pSividaís most well-known technology is its biosilicon nanospheres, which are based on nano-structured porous silicon. Biosilicon is being examined for potential treatments in cancer by five undisclosed global pharmaceutical companies for the controlled release of compounds from injectable formulations.