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Sopherion Therapeutics Inc. raised $47 million in a Series B venture financing and, at the same time, entered a licensing deal with Zeneus Pharma Ltd. for Myocet, a breast cancer therapy approved in Europe and Canada.

The new money - made possible by investor enthusiasm over the Myocet deal - means Sopherion, of New Haven, Conn., is "good for at least two years," said Ronald Goldfarb, president and CEO. "We certainly were going forward with the Myocet opportunity,"

A liposome-encapsulated doxorubicin-citrate complex, Myocet is a first-line therapy to be used in combination with cyclophosphamide for patients with metastatic breast cancer.

Goldfarb pointed out that doxorubicin is the most commonly used cancer agent in the U.S., and the last to be approved by itself for use as first-line therapy against metastatic cancer. But doxorubicin has "significant problems, including cardiac toxicity, which preclude its meeting its full potential," Goldfarb said.

That's where Myocet's liposomal formulation comes in.

"It's not a typical targeted drug mechanistically, but in this case it targets the [doxorubicin] away from the heart and toward the tumor," he said, adding that gastrointestinal toxicity also is moderated while efficacy is maintained.

Sopherion intends to launch Myocet in Canada no later than the second quarter of 2005. Zeneus, of Oxford, UK, markets the drug in Europe and retains worldwide rights outside the U.S., where Sopherion will manage the regulatory process and sell the drug. The company plans to meet with the FDA within the next month and will file a new drug application as soon as possible.

Myocet was discovered by The Liposome Co., of Princeton, N.J., a company that was acquired in 2000 by Dublin, Ireland-based Elan Corp. plc. in a stock deal valued at about $575 million. Marc Ostro (also managing director at TL Ventures, of Wayne, Pa., which led Sopherion's Series B) was co-founder, president, vice chairman and chief scientific officer of The Liposome Co. and worked on the development of Myocet. (See BioWorld Today, March 7, 2000.)

"As an academic, I did a lot of work on doxorubicin," Goldfarb said, adding that Ostro "told me about Myocet about three years ago. From time to time we chatted over the years." Myocet previously had been "packaged with a large number of other drugs, the cost of which would have been prohibitive for a company like Sopherion," he said.

Zeneus acquired Myocet from Elan. Sopherion then "went into a competition, if you will, with a number of other companies" to get the U.S. rights, Goldfarb told BioWorld Today.

There is product competition as well, namely Doxil, a form of liposomal doxorubicin from Ortho Biotech Products LP, a subsidiary of New Brunswick, N.J.-based Johnson & Johnson. The product is marketed in the U.S.

"I believe Myocet has a superior profile," he said. "The major difference is that it doesn't hang around as long [in the body]," thus potentially allowing for an increase in the number of treatment cycles that can be given. "Patients reach a severe limit of how much [doxorubicin] they can take," Goldfarb said.

He said pegylated Doxil's efficacy is "quite good," and cardiotoxicity is reduced with the drug, but unlike Myocet, the J&J compound brings such side effects as mucositis, stomatitis and "hand-foot syndrome" - skin rash, peeling and inflammation.

Sopherion, which started operating about three years ago, has 18 employees and expects to grow to between 30 and 40 in the next year, with 70 to 90 staffers likely on board in the next two years, Goldfarb said. The company raised $26 million in its first-round financing last year. (See BioWorld Today, March 10, 2003.)

The financing included The Sprout Group, of Menlo Park, Calif.; ProQuest, of San Diego; Canaan Partners, of Rowayton, Conn.; HealthCap, of Stockholm, Sweden; NewSpring Ventures LP, of King of Prussia, Pa.; Commerce Health Ventures (a capital fund of NewSpring); and Seaflower Ventures, of Waltham, Mass.

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