Avanir Makes a Comeback With FDA Marketing Approval
A recognized financial analyst said Maxim Pharmaceuticals Inc.’s recent acquisition of another San Diego-based biotech firm will position it for future success.
Maxim, a San Diego-based biopharmaceutical firm, announced June 6 it bought Cytovia in an all-stock deal.
“It’s a real fit for both companies,” said James McCamant, editor of the Berkeley-based Medical Technology Stock Letter.
Maxim is getting ready to apply for marketing approval for its cancer drug, but has no other research going on, McCamant said.
The smaller firm has promising drug candidates for cancer, oral mucositis and heart disease to be tested in clinical trials.
Maxim has the money to finance the trials, which for Cytovia would have been difficult.
In return for financing the drug development, Maxim gets to add promising technology.
Cytovia screens enzymes called caspases that are involved in programmed cell death, or apoptosis.
That complements Maxim’s own technology.
Maxim said positive results of a Phase III study , the last of three required studies , for a combination malignant melanoma treatment will be sufficient for the San Diego-based biopharmaceutical firm to seek Food and Drug Administration approval.
Maxim said a 305-patient study testing the firm’s experimental treatment Maxamine combined with interleukin-2, an agent that detects and then destroys tumor cells, prolonged patients’ survival rate by 25 percent within two years .
That compares to a 17 percent survival rate in two years for patients being treated with interleukin-2 alone, Maxim reported May 30.
“This is the first well-controlled, multi-center Phase III trial to show a significant increase in survival among patients with advanced metastatic melanoma,” said Dr. Sanjiv S. Agarwala, who led the investigative study at the Melanoma Center at the University of Pittsburgh Cancer Institute.
Preliminary results showed the combined treatment was safe, well tolerated and less toxic to patients than the high-dose regimens under which interleukin-2 was originally approved, Maxim said.
The company presented study results at a melanoma conference in Pittsburgh last week.
A company spokesman said Maxim will be filing the new drug application in July.
It will be under priority review, which means the drug could be approved as soon as January 2001.
Maxim hopes to launch Maxamine during the first quarter of 2001.
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More Promising Results: After several years of inner turmoil, near fiscal disaster, and repeated setbacks with the Food and Drug Administration, San Diego-based Avanir Pharmaceuticals is on the verge of success.
“What they have accomplished with the Food and Drug Administration is unique,” said McCamant considering the FDA declined to approve the Avanir’s oral herpes drug, docosanol, in 1998.
Avanir announced in a June 1 company statement that the FDA said its oral herpes treatment is “approvable for marketing in the United States.”
That typically means the drug will be approved. The FDA established docosanol is safe, but needs to resolve some labeling issues, said Gerald Yakatan, president and CEO of Avanir.
Yakatan hopes the drug will be approved within weeks and be on the market six months following FDA approval.