Lacklustre debut for Regenera

Perth-based opthamology specialist Regenera (ASX:RGA) experienced a lacklustre debut on ASX today. After opening at $0.47 and trading as high as $0.50, it fell below its issue price and at time of writing was trading at $0.49.

Regenera will use the $10 million in capital it raised in its IPO to develop its key product, Visagen, a therapy for age-related macular degeneration (AMD).

Regenera's therapy involves injecting a steroid, triamciolone acetomide (TA) into the back of the eye every six months. TA is currently approved for human use, so Phase I trials will not be necessary. It is already used off-label to treat AMD. However, Regenera holds the patent for this application, which runs until 2015.

Non-executive chairman Tony Fitzgerald said he hopes the company will generate revenue from licensing these patent rights within 12 months.

Regenera will also undertake a Phase III trial in order to establish the efficacy of Visagen for retinal diseases, and file for registration with the Therapeutic Goods Administration and the US Food and Drug Administration.

"We think [TGA] approval is realistic in a 24-month time horizon," said Fitzgerald. He said he anticipated these additional clinical trials would be conducted in the US in collaboration with an industry partner.

Fitzgerald said the Visagen formulation of TA will be likely to have fewer side effects than the current formulation -- manufactured by Bristol-Meyers Squibb – as it will be preservative free. The current known side-effects include a rise in intra-ocular pressure, which can be treated with antihypertensives. Tolerance and resistance to TA are not known to be problems.

US-based biotech Eyetech is also developing a drug, called Macugen, to treat AMD. It was the subject of a US$745 million deal with Pfizer, and is currently being considered by an FDA advisory panel. Macugen inhibits vascular endothelial growth factor, a protein which stimulates blood vessel production, limiting proliferation of blood vessels in the retina.

Eyetech said recently it anticipates approval and launch of the injectable in the first half of 2005.

Fitzgerald noted that Macugen appeared to be very short-acting, requiring injections every six weeks. Triamcinolone acetonide has a long duration of action and lasts in the eye for 90 to 120 days.

Eyetech is also undertaking trials with TA as are US biotechs Allergan and QLT, which is sponsoring a trial at the National Eye Institute in the US. Fitzgerald said Regenera is in the process of notifying these companies of Regenera’s patent position and will also look at striking licensing deals to gain reference rights to the data generated in these trials for use in FDA filings.