EUSA Finds Japanese Partner For Lead Product In Generics-turned-innovator Ohara

TOKYO - In-licensing firm EUSA Pharma established its first partnership in Japan, behind similar deals in South Korea and China, for its acute lymphoblastic leukemia treatment Erwinase (erwinia L-asparaginase).

Referring to itself as a transatlantic specialty pharma, EUSA granted Erwinase's Japanese development and commercialization rights to Ohara Pharmaceutical. Ohara is primarily a generics manufacturer, but is making an effort to expand into the innovative space, with a focus on oncology and orphan drugs.

For EUSA - a private equity company seeking to reach IPO - there may be some risk in taking its lead product into a new market with a partner once focused on generics, which is still the primary source of Ohara's revenue. But EUSA CEO Bryan Morton felt that of all of the potential partners he met with, including innovative large pharma, Ohara was the most impressive in terms of its due diligence in understanding the regulatory process and treatment protocols for Erwinase's indication.

"With all the people we talked to in Japan, Ohara was clearly ahead in links with key opinion leaders. They were very, very convincing," Morton told PharmAsia News. "[Ohara CEO] Dr. Seiji Ohara is in a very good position in oncology."

EUSA is currently in active negotiations with a large Japanese pharma for an undisclosed product, according to Morton.

EUSA has made quick strides in expanding its market access since its founding in 2006. Oxford-based EUSA acquired Princeton, N.J.-based Cytogen in 2008 to establish a commercial base in the U.S. Erwinase is already available in the EU and is pending approval in the U.S., where it can be prescribed currently by doctors under a treatment IND (Also see "EUSA Pharma Gains Foothold In U.S. Market With Cytogen Acquisition" - Pink Sheet, 11 Mar, 2008.). Treatment INDs allow doctors to prescribe drugs currently being investigated in clinical trials or seeking marketing approval by requesting permission from U.S. FDA for patients who fulfill defined criteria.

Erwinase is already on the approval track in Asia. In South Korea, pharmaceutical importer BL&H is seeking regulatory approval for the drug, and in China, NovaMed inlicensed the drug and is seeking fast-track status (Also see "Novamed In-Licenses Products from Iroko and EUSA To Strengthen Cardiovascular And Oncology Pipeline" - Scrip, 15 Jul, 2009.).

Asked about the strategy for establishing partnerships for Erwinase in South Korea and China ahead of Japan - still the world's second-largest pharma market - Morton said the decision comes down more to finding the right partner that is ready to do the right deal. Part of that process is "Getting comfortable with the regulatory experience of the partner," Morton said.

In May, EUSA completed U.S. FDA-required pharmacokinetic/pharmacodynamic trials in the U.S., which Morton said provided "excellent data" which will supplement global applications for Erwinase.

EUSA hopes to file the BLA with FDA in the next few months, where it is was granted a fast-track review. The U.S. BLA will form the basis of submissions for many countries, Morton said.

Erwinase is recommended for second-line treatment behind asparaginase and pegaspargase.

- Daniel Poppy ([email protected])