Spectrum Pharmaceuticals Receives $2 Million From GPC Biotech on Launch of Phase 3 Registrational Trial of Satraplatin
Monday October 13, 8:00 am ET
IRVINE, CA--(MARKET WIRE)--Oct 13, 2003 -- Spectrum Pharmaceuticals, Inc. (NasdaqSC:SPPI) today announced that it received $2 million from GPC Biotech AG pursuant to their co-development and licensing agreement for satraplatin. The payment was triggered when the first patient in the satraplatin Phase 3 registrational hormone-refractory prostate cancer trial was treated last month.
"With the receipt of these proceeds, Spectrum now has more than $25 million in cash on hand to fund the development of our phase 2 oncology products, Eoquin and elsamitrucin, and move forward the expansion of our generic drug portfolio," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "We will also continue to look for attractive additional oncology drugs for in-licensing, consistent with our strategic plan to expand our oncology portfolio."
Under the terms of the satraplatin co-development and licensing agreement, Spectrum received a $1 million cash license fee and a $1 million investment from GPC Biotech in Spectrum common stock upon the dosing of the first patient. The purchase price of the common stock was based on a 50 percent premium to a 20-day average of closing prices, which equated to $7.79 per share. The common stock to be issued to GPC Biotech has not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States without a registration statement or exemption from registration.
Spectrum entered into the co-development and licensing agreement with GPC Biotech in September 2002, and has received $4 million in licensing fees to date under the arrangement, including the $2 million received this month. GPC Biotech is fully funding development and commercialization expenses for satraplatin, and has committed to pay Spectrum up to an additional $18 million upon the achievement of milestones related to regulatory filings, approvals and commercialization of satraplatin. Upon commercial sale of satraplatin, Spectrum will be entitled to receive royalty payments based upon net sales, and may co-promote satraplatin in the United States.
Satraplatin is a member of the platinum family of compounds, but unlike platinum compounds currently on the market, satraplatin is orally administered. A registrational Phase 3 trial for satraplatin in HRPC has now been initiated following successful completion of a Special Protocol Assessment (SPA) by the FDA. Positive results from a randomized, 50-patient study in HRPC were recently presented at the ASCO Annual Meeting in June 2003. These data demonstrated statistical significance in time to disease progression, doubling progression-free survival in the satraplatin-treated group vs. control group. Additionally, Phase 2 trials have been successfully completed in HRPC, as well as in other tumor types, including ovarian and small-cell lung cancer. Further information on satraplatin can be found in the Product section of the Company's Web site at www.spectrumpharm.com.
Prostate cancer is the most common cancer among men in the U.S. Over 220,000 new cases are projected for 2003, and an estimated one in six men is expected to develop prostate cancer in his lifetime. An estimated 100,000 patients in North America, Europe and Japan combined have hormone-refractory prostate cancer. For those patients failing hormone therapy, treatment currently involves a limited number of options, including chemotherapy. These options are usually only marginally effective. For those patients who fail first-line chemotherapy, there are currently no approved treatment regimens.
Spectrum Pharmaceuticals' primary focus is to develop in-licensed drugs for the treatment and supportive care of cancer patients. The Company's lead drug, satraplatin, is a phase 3 oral, anti-cancer drug being co-developed with GPC Biotech AG. Elsamitrucin, a phase 2 drug, will initially target non-Hodgkin's lymphoma. Eoquin™ is being studied in the treatment of superficial bladder cancer, and may have applications as a radiation sensitizer. The Company is actively working to develop, seek approval for and oversee the marketing of generic drugs in the U.S. Spectrum also has a pipeline of pre-clinical neurological drug candidates for disorders such as attention-deficit hyperactivity disorder, schizophrenia, mild cognitive impairment and pain, which it is actively seeking to out-license or co-develop. For additional information, visit the Company's web site at www.spectrumpharm.com.
This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to payments by GPC Biotech AG and the use of proceeds from these payments, the expected market size for prostate cancer treatments and any statements that relate to the intent, belief, plans or expectations of the company or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include our lack of revenues and need for additional financing, the possibility that our existing drug product candidates may not prove to be safe or effective, our limited experience in establishing strategic alliances, our limited experience with the generic drug industry and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission.
For further information, please contact:
Spectrum Pharmaceuticals, Inc.
(949) 788-6700, ext. 247