BioCryst Pharmaceuticals Inc. is expanding development and marketing for its lead product, Fodosine, through a potential $190 million oncology deal with Mundipharma International Holdings Ltd.

BioCryst is licensing exclusive development and commercialization rights to Mundipharma for Europe, as well as markets in Asia and Australia, including Japan, New Zealand, China and India. In exchange, BioCryst will receive a $10 million up-front fee, plus up to $155 million in milestone payments. Mundipharma also agreed to fund up to $10 million to assist with BioCryst's ongoing development work on Fodosine, and another $15 million for near-term development efforts in Europe.

"So they're going to be helping us finance our development program here, as well as financing their own development program in Europe," said Charlie Bugg, chairman and CEO of Birmingham, Ala.-based BioCryst. "And, in addition to the direct payments, there's going to be a lot of indirect benefit."

The companies will share development data, and Mundipharma intends to immediately begin investigating Fodosine's activity in certain leukemias and lymphomas "that we haven't been able to focus on yet," he added.

BioCryst is awaiting a special protocol assessment from the FDA to begin a pivotal Phase IIb study of Fodosine in patients with relapsed or refractory T-cell leukemia later this year. Beyond that, the company is studying Fodosine, a purine nucleoside phosphorylase (PNP) inhibitor, in cutaneous T-cell lymphoma, chronic lymphocytic leukemia and acute lymphoblastic leukemia.

"It's very important for us to get development of Fodosine expanded to Europe and Asia," Bugg told BioWorld Today. "We believe that it's the perfect partner, with its strong commitment to developing an oncology franchise, and its position right now to give a lot of attention to Fodosine."

In addition to the up-front and milestone payments, BioCryst also is entitled to receive royalties on any product sales. Though the specific royalty rate was not disclosed, Bugg called it a "competitive rate for an oncology program that's close to entering a final trial."

BioCryst retains commercialization rights in North America and other areas not included in the Mundipharma deal.

Based in Cambridge, UK, privately held Mundipharma has a sales force of about 800 and 1,500 representatives in Europe and Asia, respectively, and a development team focused on the oncology market. The company has one approved cancer product, Depocyte (controlled-release cytarabine) for lymphomatous meningitis.

A final part of the agreement provides Mundipharma with the right of first negotiation for any new PNP inhibitors BioCryst develops in oncology, with the exception of BCX-4208, a Phase I-stage PNP inhibitor that's the subject of a collaboration with F. Hoffmann-La Roche Ltd. in transplant rejection and autoimmune disorders.

BioCryst entered the potential $560 million deal with Basel, Switzerland-based Roche in late November. (See BioWorld Today, Dec. 1, 2005.)

"When you block this [PNP] enzyme, you block the activation of T lymphocytes," Bugg said, "and if you look at the number of T-cell mediated diseases, there's a long list of potential indications."

Elsewhere in its pipeline, BioCryst has peramivir, an inhibitor of influenza neuraminidase that recently received fast-track designation to treat influenza infections. The company recently received approval to begin Phase I testing of an intravenous formulation.

It's also finishing up preclinical work with its hepatitis C polymerase inhibitor, BCX-4678, with plans to file an investigational new drug application sometime this year.

"We're really hitting on all cylinders now," Bugg said. "We have several programs that have hit exciting stages pretty much simultaneously."

BioCryst has not yet released fourth-quarter earnings, but the company reported a net loss of $7.6 million for the third quarter. As of Sept. 30, its cash, cash equivalents and short-term investments totaled $30.8 million, though the firm brought in an additional $30 million through a direct offering in December.

Shares of BioCryst (NASDAQ:BCRX) closed at $19.29 Thursday, up 12 cents.

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