Nuon Therapeutics has formed a licensing, supply and collaboration agreement with tranilast innovator Kissei Pharmaceutical that will enable the start-up to tap the Japanese firm's expertise as it develops the mature drug in new autoimmune indications, Nuon CEO Rodney Pearlman explained in an interview with "The Pink Sheet" DAILY.
Matsumoto, Japan-based Kissei has marketed tranilast as Rizaben in Japan and Korea for bronchial asthma since 1982. Indications for keloid and hypertrophic scar were added in 1993, and an ophthalmic solution for allergic conjunctivitis was added to the franchise in 1995.
"We have our own independent [intellectual property]," Pearlman stressed. "We have filed our own IP around new indications for tranilast, and those indications are for autoimmune disease."
"What we decided to do is to work with Kissei because ... they're the company that made the drug, and even though it's off patent, we'd rather work with [the innovator] because they're very knowledgeable, they've got a lot of experience."
The agreement, announced July 23, enables the privately held San Francisco firm to take the compound into Phase II studies first as a potential oral, small-molecule therapy for multiple sclerosis, Pearlman said. The company will decide after the compound has shown efficacy in the clinic whether to seek a U.S. development partner in that indication or raise capital to take it forward, the exec said.
Nuon also has discovered that the molecule "has interesting properties in pain," and the company will be "developing ways to evaluate the efficacy of the drug in clinical trials in those indications," the exec said.
"We are developing it on our own, and they have an option to license the technology at a later date," said Pearlman. Under the agreement, Kissei has an exclusive option right for research, development and marketing of tranilast in Japan and Korea for autoimmune diseases, including MS.
Nuon has a license and supply agreement with Kissei to supply tranilast for the trials. "We're very happy to have that because that gives us such a lead to have a drug that's manufactured to GMP and a drug with a long history," Pearlman said.
"We are also collaborating with them on second-generation analogs," the exec said. "We're not saying anything about [the next-generation compounds]; it's just part of the agreement."
"Tranilast's mechanism of action is involved in properties focused on mast cells primarily, and that's why it's used in asthma, the indications they use in Japan or Korea," Pearlman explained.
"We've found that the molecule has got a dual nature, and part of that nature is a metabolite of tryptophan, which affects the T-cell and B-cell population. It is a means of altering that autoimmune function of T-cells, in particular, and also B-cells. It's a way of really turning down the T-cell reaction that occurs in autoimmune disease. Those are all new findings that are very different from the experience that Kissei has with the molecule," he said.
Tranilast is thought to act in allergic diseases as a mast cell stabilizer, an inhibitor of cell proliferation/migration and inflammation.
- Shirley Haley
This article is reprinted from "The Pink Sheet" DAILY – July 24, 2007
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