LONDON - Botanicals specialist Phytopharm plc announced positive results in a trial of P7, its patented treatment for canine atopic dermatitis, and said it is in license discussions with three leading animal health companies.

CEO Richard Dixey told BioWorld International the granting of the license should bring the company through to break-even. "This is potentially a very big market. Around 15 percent of dogs get the disease, but not many are treated because the only option is steroids."

There are approximately 100 million dogs in the U.S., and similar numbers in Europe and Japan. "It could be a US$50 to US$60 million market in the U.S., and we have the only non-steroidal therapy," he said. "But even if we only get the current market we will break even on this deal." The company reported a loss of #3.2 million (US$4.7 million) in the last fiscal year.

In the randomized, double-blind, placebo-controlled trial of 47 dogs with atopic dermatitis (as confirmed by positive skin allergy tests), 24 dogs received daily treatment with P7 and 23 with placebo, for eight weeks. The outcome measures included skin redness and scratching, and the owners' assessment of response.

Owners reported that 38 percent of the treated dogs were improved or markedly improved, compared to 13 percent on placebo. Furthermore, 57 percent of dogs in the placebo group were withdrawn from treatment due to worsening of their condition, compared to 25 percent of dogs in the P7 group. The trial was carried out at the Department of Small Animal Clinical Sciences at the University of Minnesota.

One of Phytopharm's potential partners wants to develop P7, a mixture of extracts from three plants, as a nutraceutical. "This would be an interesting development, because no one has previously launched a patented nutraceutical based on a herb," Dixey said. The two others want to develop a prescription product, which would require a further trial. "We will be guided by our partners on how we take the development forward. If it is developed as a nutraceutical it could be on the market in 12 to 18 months, whereas a pharmaceutical will take another two to three years. However, we would expect higher milestones for pharmaceutical development."

Phytopharm, based in Godmanchester, Cambridge-shire, is a leading botanicals company, with 11 products, nine of which are in clinical development. Dixey says the portfolio is attracting far more attention now that the FDA has published its guidelines on botanicals for consultation.

"People are finally crystallizing their views as to how to develop these medicines. The publications of the guidelines is raising more interest, and making more companies consider botanicals."

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