| Spectrum Pharmaceuticals, Inc. (SPPI)
|" Spectrum Pharmaceuticals, Inc., " Graph source Edgar Online Pro on April 21st, 2006
The Following data is sourced from Yahoo Finance & the ANNUAL REPORT ON FORM 10-K for Fiscal Year Ended December 31, 2005 The overview of the company was:
Spectrum Pharmaceuticals, Inc., ,a specialty pharmaceutical company, engages in the acquisition, development, and commercialization of prescription drug products for the treatment of cancer and related disorders. The company has eight drug candidates under development, including Satraplatin for hormone refractory prostate cancer and nonsmall cell lung cancer; EOquin for superficial bladder cancer; Elsamitrucin for refractory nonhodgkin’s lymphoma; Ozarelix for hormone dependent prostate cancer and benign prostatic hypertrophy; Lucanthone for radiation sensitization; RenaZorb for end-stage renal disease and chronic kidney disease; SPI-1620 for adjunct to chemotherapy; and SPI-205 for chemotherapy induced neuropathy. Its Satraplatin product is in phase III clinical trial; EOquin, Elsamitrucin, Ozarelix, and Lucanthone products are in phase II clinical trials; and RenaZorb, SPI-1620, and SPI-205 products are in preclinical trials. Spectrum also develops generic drug portfolio, including injectable and ophthalmic products. The company has strategic alliances with GPC Biotech AG; Johnson Matthey PLC; Bristol-Myers Squibb; Zentaris GmbH; Altair Nanotechnologies, Inc.; Chicago Labs; J.B. Chemicals & Pharmaceuticals, Ltd.; FDC Limited; and Shantha Biotechnics Pvt., Ltd. Spectrum was founded as Americus Funding Corporation in 1987 and changed its name to NeoTherapeutics, Inc. in 1996. NeoTherapeutics changed its name to Spectrum Pharmaceuticals, Inc. in 2002. The company is headquartered in Irvine, California.
Highlights of Risks Related to Our (SPPI) Business
For further detail please review the 10 K Form in detail.
Risks Related to Our (SPPI) Business:
1. Our losses will continue to increase as we expand our development efforts, and our efforts may never result in profitability.
2. Our business does not generate the cash needed to finance our ongoing operations and therefore, we may need to continue to raise additional capital.
3. Clinical trials may fail to demonstrate the safety and efficacy of our proprietary drug candidates, which could prevent or significantly delay obtaining regulatory approval.
4. The development of our drug candidate, satraplatin, depends on the efforts of a third party and, therefore, its eventual success or commercial viability is largely beyond our control.
5. We may not be able to obtain co-promotion rights in the United States with regard to our drug candidate, satraplatin, under our co-development and license agreement with GPC Biotech AG which may adversely affect our ability to timely establish our own sales force in the United States, if and when we choose to do so.
6. The development of our drug candidate, ozarelix, may be adversely affected if the development efforts of Zentaris GmbH who retained certain rights to the product, are not successful.
7. From time to time we may need to license patents, intellectual property and proprietary technologies from third parties, which may be difficult or expensive to obtain.
8. The inability to retain and attract key personnel could significantly hinder our growth strategy and might cause our business to fail.
9. Our collaborations with outside scientists may be subject to change, which could limit our access to their expertise.
10. We are dependent on third parties for manufacturing and marketing our proposed proprietary products. If we are not able to secure favorable arrangements with such third parties, our business and financial condition could be harmed.
11. We may rely on contract research organizations and other third parties to conduct clinical trials and, in such cases, we are unable to directly control the timing, conduct and expense of our clinical trials.
12. We may have conflicts with our partners that could delay or prevent the development or commercialization of our product candidates.
13. Our efforts to acquire or in-license and develop additional proprietary drug candidates may fail, which would limit our ability to grow our proprietary business.
14. We are a small company relative to our principal competitors and our limited financial resources may limit our ability to develop and market our drug products.
15. Our proprietary drug candidates may not be more effective, safer or more cost efficient than competing drugs and otherwise may not have any competitive advantage, which could hinder our ability to successfully commercialize our drug candidates.
16. We are dependent on a third party to market, sell and distribute our generic products.
17. Intense competition from a large number of generic companies may make the marketing and sale of our generic drugs not commercially feasible and not profitable.
18. Price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible and not profitable.
19. Failure to obtain timely approval of our generic product candidates by regulatory agencies, including the Food and Drug Administration, may make it difficult to capture enough market share to make a profit.
20. We may not be successful in establishing additional active pharmaceutical ingredient or finished dose generic drug supply relationships, which would limit our ability to grow our generic drug business.
21. Our supply of drug products will be dependent upon the production capabilities of contract manufacturing organizations (CMO’s) and component and packaging supply sources, which may limit our ability to meet demand for our products and ensure regulatory compliance.
22. GlaxoSmithKline filed suit in United States federal court asserting that we have infringed one of their patents for Imitrex ® injection by filing our ANDA for sumatriptan injection, the generic form of Imitrex ® injection. This challenge may prevent us from commercializing sumatriptan until after the patent has expired and may require us to incur the significant effort of technical and management personnel.
Risks Related to (SPPI) Our Industry
1. Rapid bio-technological advancement may render our drug candidates obsolete before we recover expenses incurred in connection with their development. As a result, our drug products may never become profitable.
2. Competition for patients in conducting clinical trials may prevent or delay product development and strain our limited financial resources.
3. The ability of branded competitors to successfully limit or delay competition for certain generic products through legislative, regulatory and litigation efforts, may limit our ability to generate revenue from the sale of our generic products.
4. We may not be successful in obtaining regulatory approval to market and sell our proprietary or generic drug candidates.
5. Our failure to comply with governmental regulations may delay or prevent approval of our product candidates and/or subject us to penalties.
6. The discovery of previously unknown problems with drug products approved to go to market may raise costs or prevent us from marketing such product.
7. Our failure to comply with advertising regulations enforced by the FDA and the Federal Trade Commission may subject us to sanctions, damage our reputation and adversely affect our business condition.
8. Legislative or regulatory reform of the healthcare system and pharmaceutical industry may hurt our ability to sell our products profitably or at all.
9. Our corporate compliance program may not ensure that we are in compliance with all applicable “fraud and abuse” laws and regulations, and a failure to comply with such regulations or prevail in litigation related to noncompliance could harm our business.
10. If we are unable to adequately protect our technology or enforce our patent rights, our business could suffer.
11. Intellectual property rights are complex and uncertain and therefore may subject us to infringement claims.
12. Intellectual property litigation is increasingly common and increasingly expensive and may result in restrictions on our business and substantial costs, even if we prevail.
13. We may be subject to product liability claims, and may not have sufficient product liability insurance to cover any such claims, which may expose us to substantial liabilities.
14. The use of hazardous materials in our research and development efforts imposes certain compliance costs on us and may subject us to liability for claims arising from the use or misuse of these materials.
Risks Related to Our (SPPI) Stock
1. There are a substantial number of shares of our common stock eligible for future sale in the public market. The sale of these shares could cause the market price of our common stock to fall. Any future equity issuances by us may have dilutive and other effects on our existing stockholders.
2. The market price and volume of our common stock fluctuate significantly and could result in substantial losses for individual investors.
3. Provisions of our charter, bylaws and stockholder rights plan may make it more difficult for someone to acquire control of us or replace current management even if doing so would benefit our stockholders, which may lower the price an acquirer or investor would pay for our stock.
4. We do not anticipate declaring any cash dividends on our common stock.
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