Regenera closes oversubscribed in tough market

Perth-based opthamology specialist Regenera has prevailed in an increasingly tough IPO market, closing its IPO today AUD$2 million oversubscribed, having raised in excess of AUD$10 million.

"We have had a very good response in a difficult market," said non-executive chairman Tony Fitzgerald. He said there had been significant Australian investment and that a number of international opthamologists were also supporting the company.

Regenera will use the capital to develop its key product, Visagen, a therapy for age-related macular degeneration (AMD). An estimated 800,000 Australians suffer from AMD, a condition in which damage to the retina causes visual impairment.

Regenera's therapy involves injecting a steroid, triamciolone acetomide into the back of the eye every six months. Triamcinolone acetonide is already used off-label in the US to treat AMD. However, Regenera holds the patent for this application, which runs until 2015.

"Effectively the market is there, but [we've] got to start enforcing the patent," Fitzgerald said. "There is little knowledge amongst either practitioners or companies that these rights were held."

Regenera will 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.

The first drug to treat AMD, Macugen, is being developed by US-based biotech Eyetech. It was the subject of a blockbuster 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 last week it anticipates approval and launch of the injectable in the first half of 2005.

Fitzgerald believes Pfizer's interest in Magugen illustrates the value of an effective treatment for AMD.

He 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.