Adding to its pipeline of cancer drugs, Novacea Inc. licensed exclusive North American rights to an oral version of vinorelbine sold in Europe by French company Pierre Fabre Medicament SA.

The deal moves the privately held South San Francisco-based firm "toward the goal of bringing effective therapeutics to improve patients' lives," said Novacea CEO Brad Goodwin.

Oral vinorelbine, which is sold in most European countries to treat breast cancer and non-small-cell lung cancer, was designed by Pierre-Fabre to demonstrate similar clinical results to the intravenous formulation of the chemotherapy drug. Vinorelbine I.V. is a semi-synthetic derivative of a vinca alkaloid.

"The concern among patients is often the ease of administration," Goodwin said, adding that few oral chemotherapies have been approved in North America.

Specific financial terms were not disclosed, though Novacea expects to pay up-front and milestone fees, as well as royalty payments. The company also will provide reimbursement for manufacturing, which will be conducted at Pierre-Fabre's facility.

In terms of the prospective market for oral vinorelbine, Goodwin said "it's a little early for us to forecast those specifics," though he added that the drug, which has been administered to more than 1 million patients in oral and intravenous forms, already has accumulated substantial safety and efficacy data.

"Our first step will be to finalize a development plan, and then meet with the FDA to plan a Phase III trial," he told BioWorld Today. Novacea anticipates meeting with the regulatory agency by the end of the year.

Testing likely will begin in patients with breast cancer, Goodwin said.

Meanwhile, Pierre-Fabre will continue developing and commercializing oral vinorelbine outside of North America, where it retains rights across the remaining global market, with the exception of Japan. The Paris-based company began working on the oral version about seven years ago in an attempt to accommodate an apparent patient preference for therapeutics that could be self-administered, said Alain Benoit, vice president of corporate licensing for Pierre Fabre.

For example, a study published in the Journal of Clinical Oncology in January 1997 reported that 89 percent of cancer patients would rather take oral therapies.

"Patients don't have to go to the doctor every day or every week" to get their medications, Benoit said. "Compliance is much greater."

Benoit said that since oral vinorelbine entered the European market, it has taken about 25 percent of vinorelbine I.V.'s market share. Pierre Fabre markets, directly or through licensees, the intravenous formulation in more than 80 countries.

The partnership with Novacea is intended to help Pierre Fabre expand its global reach. In 2004, the company signed an agreement with New York-based Bristol-Myers Squibb Co. for the clinical and commercial development of Javlor (vinflunine), a new generation cancer product, and also entered a partnership with Merck Sharp & Dohme Pty. Ltd., the Australian subsidiary of Whitehouse Station, N.J.-based Merck & Co. Inc., for the development of F50035, a monoclonal antibody targeting the IGF-1 growth factor.

For Novacea, oral vinorelbine will be the third product the company has licensed since it was founded in 2001.

Novacea's lead product, DN101, a calcitriol-based drug, recently completed a Phase II/III trial in combination with Taxotere (docetaxel, Sanofi-Aventis Group) in men with androgen-dependent prostate cancer in which it showed statistical significance in survival compared to placebo.

A second product, AQ4N, is in a Phase I dose-escalating study in advanced malignancies and in a Phase I/II in patients with non-Hodgkin's lymphoma or chronic lymphocytic leukemia. AQ4N, a cytotoxic prodrug, was licensed from Cambridge, UK-based KuDOS Pharmaceuticals Inc.

Goodwin said Novacea raised $83 million through three rounds of financing, and still has about half of that in the bank to support ongoing trials, as well as upcoming studies with oral vinorelbine.

"We'll be well funded for the next year," he said.

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