|Market opportunities for Spectrum's ZEVALIN may expand significantly|
|Friday, 11 September 2009 04:28|
Following the presentation by Spectrum Pharmaceuticals (NASDAQ:SPPI), which was held in front of a standing room only crowd of institutional investors, hedge fund managers and Wall Street banker types at the Rodman & Renshaw Healthcare Conference in New York, Dr. Andrew Sandler was mobbed with questions from members of the investment community in the hallway outside.Dr. Andrew Sandler, who is responsible for all medical affairs, regulatory, and clinical operations for the company's entire portfolio of drug candidates, confided that he could not have been happier with the relationships that he and his team have developed at the FDA during these past few months and even more recently after the approval of the company's radio-immunotherapeutic Zevalin. "They are the ones calling us with suggestions to help improve the labeling. And they're being very supportive of all of our pipeline efforts," said a smiling Sandler.
Proof of that support may be seen in the FDA's recently granted Fast Track Designation for the investigation of apaziquone (EOquin®) for the treatment of non-muscle invasive bladder cancer. The company is also feeling very positive expect a favorable regulatory decision about for FUSILEV(TM) in Metastatic Colorectal Cancer, which is expected in less than four weeks (October 8th).
In addition, Dr. Sandler was happy to report that the company is finding that "education" meetings with oncologists have been showing some very productive results for the company's re-tooled marketing efforts. "We're finding that doctors are far more likely to prescribe Zevalin after we sit down with them." During the public presentation, the company confirmed that they had made significant progress in stabilizing, and growing sales for Zevalin.
According to insiders, the agency has taken a very active hands-on approach to dealing with the company's entire product pipeline and has been communicating with the company about not only helping to lift some regulatory issues that had previously cast shadows on the drug's marketing efforts, but the agency also granted the company a much less restrictive label than the one assigned to them by the EMEA- the European equivalent of the FDA.
While many investors were looking for some sort of confirmation regarding any number of rumored buy-out offers during the presentation, the company opted to keep quiet about the situation in public. After the presentation, officials did take several face to face meetings with various players in closed door sessions, however and one person familiar with the situation told BioMedReports that those private engagements had been "terrifically prouductive."
One development of note included the approach by one group interested in speaking to the company about the use of Zevalin in treating incidences of AIDS-related non-Hodgkin's lymphoma.
Currently, only 1 million of the estimated 42 million people infected with HIV worldwide are receiving treatment using Highly Active Antiretroviral Therapy (HAART)- which was introduced in the mid-1990s and has had an enormous impact on the treatment of HIV in terms of overall survival, incidence of opportunistic infections and quality of life. Still, the effects of HAART on NHL are less clear although some cohort studies suggest a modest non-significant decline in the incidence, according to published deails in the Oxford Medical Journals.
Given the known association between NHL and both congenital and iatrogenic immunosuppression, the documentation of an increase in the incidence of NHL in the HIV-seropositive population any developments and fruits of those discussions could be incredibly far reaching and positive for both the company and AIDS infected patients.