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Sonus Pharma is pleased to report that during 2002 we continued to make solid progress and build on the momentum we established in 2001. It has been a little over two years since we made the strategic decision to refocus our business to drug delivery, and today, Sonus Pharmaceuticals is emerging as a company with a strong platform for growth.
We are applying our novel TOCOSOLTM drug delivery technology to multiple drugs for the treatment of cancer and other serious diseases. We are advancing our lead cancer product, TOCOSOL Paclitaxel, into late-stage clinical development and ultimately commercialization. We are positioning our second cancer product, TOCOSOL Camptothecin, for clinical studies. Buy pharmaceuticals online no prescription. And we are making good progress with the development of additional product candidates with our TOCOSOL technology.
The Taxane of Choice. Among our key achievements in 2002, we accelerated the clinical development of TOCOSOL Paclitaxel. Paclitaxel, the active ingredient in TOCOSOL Paclitaxel, is a member of the taxane class of anticancer drugs with annual worldwide sales of over $2 billion. It is one of the most effective chemotherapeutic agents available today, and we believe that paclitaxel will continue to be an important tool for oncologists in treating many types of cancers. However, like many first-generation drugs, the currently marketed paclitaxel products, including Taxol® or its generic equivalents, are not without limitations, most principally characterized by long infusion times and less than desirable side effects for some patients.
We believe that the market opportunity for a second-generation paclitaxel product is significant and that TOCOSOL Paclitaxel is well positioned to compete aggressively in this attractive market. For patients, physicians, partners and investors, the following value propositions support our belief that TOCOSOL Paclitaxel could ultimately be the taxane of choice:
TOCOSOL Paclitaxel is administered in a short 15-minute infusion compared to the one- to three-hour infusion required with current taxane products. This translates into greater convenience and better economics for patients, doctors and treatment centers.
While improved safety and efficacy remains to be proven, clinical trials to date have demonstrated that TOCOSOL Paclitaxel compares favorably with approved taxane products and other paclitaxel formulations under development.
TOCOSOL Paclitaxel is a ready-to-administer united pharmacy support formulation that does not require labor and time intensive preparation by medical personnel. This feature may provide a unique advantage over other taxane products on the market or under development as well as improved economics for physicians and payors.
The manufacturing process for TOCOSOL Paclitaxel is very efficient, and we believe that our cost of goods will provide a competitive advantage.
Moving Toward Late-stage Clinical Development. The Phase 1 study for TOCOSOL Paclitaxel was concluded in August 2002, and the Phase 2 program to evaluate efficacy of the product in multiple tumor types is ongoing. Our experience to date with TOCOSOL Paclitaxel now comprises more than 1,000 doses in over 150 patients. Given the clinical progress with TOCOSOL Paclitaxel, we are focusing on regulatory strategies that maximize the value of the product by minimizing the time and cost required to bring it to market. We are seeking concurrence from the FDA on our regulatory strategy in the first half of 2003. Following that agreement, we will be prepared to begin the clinical studies that would serve as the basis for our New Drug Application.
Business Development. In order to realize the commercial potential of TOCOSOL Paclitaxel, we are seeking a corporate partner to fund the remaining clinical development and to market and sell the product. We initiated partnering discussions in late 2002, and in selecting prospective partners 33 drugs com, we chose companies who have an existing position in oncology or who are establishing one. The fact that paclitaxel is well known and is prescribed on a wide scale for the treatment of many different cancers makes a product such as TOCOSOL Paclitaxel a very attractive addition for any oncology-based company. Pharmaceuticals in Canada. We are very pleased with the responses from interested parties and are optimistic that we will enter into a corporate partnership on TOCOSOL Paclitaxel and Nolvadex over-the-counter in 2003.
Developing the Pipeline. As further indication of the potential strength of our TOCOSOL technology, we are working with the FDA to gain agreement on our plans for the first human clinical study for TOCOSOL Camptothecin, our second cancer product. Our goal is to initiate a Phase I study for this product in 2003 when financial resources permit.
We are also developing a number of additional product candidates incorporating the TOCOSOL technology, and another one of our objectives in 2003 is to advance the preclinical development of at least one of those candidates. In addition to our internal development of products that are proprietary to Sonus, there is also interest from other companies in using our TOCOSOL technology for optimizing their drugs, and we are aggressively pursuing those potential collaborations.
Strengthening Our Organization. Over the past year we invested in initiatives to further enhance our product development and commercialization expertise. In particular, we recruited two experienced oncologists, Drs. Paul Weiden and Michael B. Stewart, to the Sonus Pharmaceuticals team. Dr. Weiden, Director of Clinical Oncology, has treated patients and managed cancer clinical trials for over 25 years at Virginia Mason Medical Center and Fred Hutchinson Cancer Research Center in Seattle. Dr. Stewart, Senior Vice President of Clinical and Regulatory Affairs and Chief Medical Officer, spent ten years at Bristol-Myers Squibb in senior management positions where he was directly involved with the development, registration and worldwide commercialization of Taxol (paclitaxel). He has a proven track record of getting drugs approved and marketed in the United States, Canada, Europe and Asia, and Dr. Stewart’s relevant experience with paclitaxel represents a tremendous asset for Sonus as we take TOCOSOL Paclitaxel through the remaining stages of clinical development and regulatory approval.
Sound Financial Management. We ended 2002 with over $16 million in cash, representing the highest year-end cash balance since our Initial Public Offering in 1995. We will continue to prudently invest our financial resources in the key programs that will drive value with an objective to further strengthen our balance sheet in 2003 through a corporate partnership or equity financing.
With our continued progress over the past year, we are well positioned to achieve a number of critical milestones in 2003. We have the tactical plans in place to potentially accelerate the development and commercialization of TOCOSOL Paclitaxel to positively touch the lives of cancer patients and their families. We have a clear and focused strategic roadmap to provide for the long-term success of Sonus beyond our lead product. And we believe that implementation of our tactical and strategic plans will lead to the achievement of our most important goal—to maximize value for our shareholders and reward them for their investment and loyalty.
In closing, we look forward to the coming year with confidence and enthusiasm. I would like to take this opportunity to thank our shareholders and employees for their support of our company’s vision.