From the Spectrum Pharmaceuticals, Inc. 2007 Annual Report
May 8th, 2008
On March 7th, 2008 Spectrum reached an important milestone – the New Drug Application (NDA) for its first proprietary anticancer drug was approved by the FDA. This was the result of tireless efforts on the part of our employees and their deep understanding of the requirements of the FDA. There are hundreds of small biotech companies that never achieve an FDA approval, even after spending hundreds of millions of dollars and years of work. We are truly excited about the team we have built and the potential of our portfolio.
The FDA approved our NDA for Levoleucovorin for Injection, which we plan to launch in June 2008. LEVOleucovorin is a folate analog indicated for rescue after high-dose methotrexate therapy in osteosarcoma. LEVOleucovorin is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. To expand the potential of LEVOleucovorin, we plan to file two additional regulatory submissions with the FDA. First, we plan to file an NDA amendment for an oral tablet formulation. The Oncology Drug Advisory Committee has already voted affirmatively that the oral formulation is safe and effective when used in the rescue of high dose methotrexate. Second, we plan to file a supplemental NDA for its use in colorectal cancer with 5-fluorouracil containing regimens.
LEVOleucovorin has been on the market in Europe and Japan for more than ten years, where it is marketed by Takeda, Wyeth and Sanofi-Aventis among others. This product sells approximately $200 million outside the U.S. We see this as a large test market and are optimistic about its prospects in North America. Our Company is currently building an internal commercial infrastructure to support LEVOleucovorin. We are committed to becoming a commercial-stage company with revenues and profits from the sale of our own drugs. With a pipeline of promising products, we believe this is the right strategy.
Profits from the sale of LEVOleucovorin will be used to help fund the clinical development of our pipeline. Our most advanced programs include:
- EOquin®, which is currently enrolling patients into two registrational Phase 3 clinical studies for the treatment of non-invasive bladder cancer in the United States and Canada;
- Ozarelix, which is being studied in patients with benign prostate hypertrophy; and
- SPI-1620, which is in a Phase 1 clinical trial as an adjunct to chemotherapy for solid tumors.
We added $20 million of cash to our balance sheet on April 30th, 2008, without diluting our existing shareholders. Not a single share of stock was issued. We sold our share of the profits from sumatriptan injection to Par Pharmaceutical Companies. Sumatriptan injection has provided us with more than $25 million in non-dilutive funding since 2006, when we saw an opportunity outside of our core business in the field of oncology and urology. This $20 million cash infusion represents approximately 60% of our estimated 2008 net use of cash for operations. Not only does this cash infusion obviate the need to raise cash anytime soon, it adds to our ability to successfully launch LEVOleucovorin and carry out our business plan without having to worry about the financial markets at this time.
Our core expertise is in acquiring, developing and commercializing a diversified portfolio of drug candidates, with a focus mainly in the fields of oncology and urology. We are proud to have a team of experienced, committed and passionate people who have a track record of success. This, in my experience, is rarely seen at a Company of our size. These are the four pillars of our strategy:
1. Advancing our diversified portfolio;
2. Establishing a commercial organization;
3. Building a “Culture of Success” that allows our people to thrive; and
4. Leveraging the expertise of partners around the world to assist us in the execution of our strategy.
We are committed to success at Spectrum Pharmaceuticals. Today, May 1, 2008, we have approximately $65 million in cash, one approved drug, nine drugs in development, and more than 70 employees working every day to bring new treatments to those who currently don’t have many
options available. We are truly excited about our future.
On behalf of the Board of Directors and employees, I would like to thank you, our shareholders, for your continued support.
Sincerely,
Rajesh C. Shrotriya, M.D.
Chairman, CEO and President
Spectrum Pharmaceuticals, Inc.
