Japan’s Kyowa Hakko Kogyo says that its US subsidiary has submitted a New Drug Application to regulators for KW-6002 (istradefylline), its investigational compound for Parkinson's disease.

Kyowa explained that the symptoms of Parkinson's are treated primarily by dopamine replacement therapy with levodopa or dopamine agonists, but long-term therapy with levodopa is associated with motor complications such as the development of a shortening response to each dose, which is called "wearing-off phenomenon", and involuntary movements.

Kyowa has conducted Phase II and III clinical studies with KW- 6002 in patients experiencing the aforementioned "wearing-off phenomenon" on treatment with levodopa alone or levodopa administered concomitantly with other Parkinson's disease medications and filed the drug, which has a specific antagonistic action on the adenosine A2A receptor in the brain, as adjunctive therapy to levodopa and carbidopa.

Kyowa revenues flat for the year

The company also announced its financial results for the year ended

March 31 which showed a 20.2% rise in net income to 30.6 billion yen, around $256 million, though revenues were flat at 354.2 billion yen and net income fell 22% to 12.6 billion yen, due in part to losses on the sale of subsidiaries' shares.

Pharmaceutical sales fell 12% to 131.5 billion yen sales, hit by price cuts of 6.7% introduced in Japan in April last year and a steep decline in revenues from the oral antifungal Itrizole (itraconazole). Kyowa also suffered a decline in sales of its antihypertensive Coniel (benidipine), but the anti-allergy drug Allelock (olopatadine) and the anticancer agent Navelbine (vinorelbine) performed well.

Cancer deal signed with ArQule

Kyowa also announced that it has entered into a pact covering Japan and parts of Asia with the USA’s ArQule to develop the latter’s cancer compound ARQ197.

ARQ197, which is in Phase I, inhibits the activity of c-Met, a receptor tyrosine kinase which is believed to control multiple signal transduction pathways involved in tumour growth and metastasis. Under the terms of the deal, the agreement will see Kyowa pay $123 million in milestones, including a $30 million upfront cash payment and if the drug makes it to market, ArQule will receive double-digit royalties. Kyowa will be responsible for clinical development and commercialisation of the compound in Japan, China, South Korea and Taiwan.

Stephen Hill, ArQule’s chief executive, said that “Kyowa is able to leverage an impressive array of clinical development, manufacturing, sales and marketing capabilities that will help realize the full potential of ARQ 197 and deliver its benefits to cancer patients in Asia”.