| ADOLOR CORPORATION (ADLR)
|" ADOLOR CORPORATION" 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:
Adolor Corporation, a development stage biopharmaceutical corporation, engages in the discovery, development, and commercialization of prescription pain management products primarily in the United States. It is developing Entereg, a small molecule mu-opioid receptor antagonist intended to selectively block the unwanted effects of opioid analgesics on the gastrointestinal tract. The company’s other products under development include a sterile lidocaine patch, a Phase 2 clinical development product for treating postoperative incisional pain; and Delta opioid agonist, a preclinical development stage product for the treatment of moderate-to-severe pain conditions. Adolor was founded in 1993 and is headquartered in Exton, Pennsylvania.
Highlights of Risks Related to Our (ADLR) Business
For further detail please review the 10 K Form in detail.
1. We are highly dependent on achieving success in the clinical testing, regulatory approval and commercialization of our lead product candidate, Entereg ® , which may never be approved for commercial use.
2. Although we received an approvable letter from the FDA for Entereg ® in POI, our NDA for Entereg ® may not be approved. Study 314 results may not satisfy the FDA requirement for additional evidence of efficacy to support approval of our NDA.
3. Certain results from Phase III clinical trials showed that the differences in the primary endpoint analyses between Entereg ® and placebos were not statistically significant.
4. Unfavorable results or adverse safety findings from any clinical study will adversely affect our ability to obtain regulatory approval for Entereg ® .
5. Entereg ® may not be successfully developed for chronic use.
6. If we are unable to commercialize Entereg ® , our ability to generate revenues will be impaired and our business will be harmed.
7. Patient enrollment may be slow and patients may discontinue their participation in clinical studies, which may negatively impact the results of these studies, and extend the timeline for completion of our and our collaborator’s development programs for our product candidates.
8. We may suffer significant setbacks in advanced clinical trials, even after promising results in earlier trials.
9. Our stock price may be volatile, and your investment in our stock could decline in value.
10. We have been named in a purported class action lawsuit and related derivative lawsuits.
11. If we continue to incur operating losses for a period longer than anticipated, we may be unable to continue our operations.
12. We are dependent on our collaborators to perform their obligations under our collaboration agreements.
13. We have limited commercial manufacturing capability and expertise. If we are unable to contract with third parties to manufacture our products in sufficient quantities, at an acceptable cost and in compliance with regulatory requirements, we may be unable to obtain regulatory approvals, or to meet demand for our products.
14. If we are unable to fully develop sales, marketing and distribution capabilities or enter into agreements with third parties to perform these functions, we will not be able to commercialize products.
15. We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approval and depend on third parties to conduct our clinical trials.
16. Our ability to enter into new collaborations and to achieve success under existing collaborations is uncertain.
17. We may not be able to successfully develop in-licensed product candidates, which could prevent us from commercializing any such candidates.
18. Because our product candidates are in development, there is a high risk that further development and testing will demonstrate that our product candidates are not suitable for commercialization.
19. The concept of developing peripherally acting opioid antagonist drugs is relatively new and may not lead to commercially successful drugs.
20. Reduction in the use of opioid analgesics would therefore reduce the potential market for Entereg ® .
21. If competitors develop and market products that are more effective, have fewer side effects, are less expensive than our product candidates or offer other advantages, our commercial opportunities will be limited.
22. Our Delta agonist IND has been put on clinical hold by the FDA.
23. Our business could suffer if we cannot attract, retain and motivate skilled personnel and cultivate key academic collaborations.
24. Companies and universities that have licensed technology and product candidates to us are sophisticated entities that could develop similar products to compete with products we hope to develop.
25. If we breach our licensing agreements, we will lose significant benefits and may be exposed to liability for damages.
26. Because we are not certain we will obtain necessary regulatory approvals to market our products in the United States and foreign jurisdictions, we cannot predict whether or when we will be permitted to commercialize any of our products.
27. If we market products in a manner that violates health care fraud and abuse laws, we may be subject to civil or criminal penalties.
28. The federal Controlled Substances Act might impose significant restrictions, licensing and regulatory requirements on the manufacturing, distribution and dispensing of certain of our product candidates.
29. We may not obtain FDA approval to conduct clinical trials that are necessary to satisfy regulatory requirements.
30. It is difficult and costly to protect our intellectual property rights, and we cannot ensure the protection of these rights; we may be sued by others for infringing their intellectual property.
31. Our ability to generate revenues will be diminished if we fail to obtain acceptable prices or an adequate level of reimbursement for our products from third-party payors.
32. If we engage in an acquisition or business combination, we will incur a variety of risks that could adversely affect our business operations or our stockholders.
33. If product liability lawsuits are successfully brought against us, we may incur substantial liabilities and may have to limit or cease commercialization of our products.
34. If we use biological and hazardous materials in a manner that causes injury or violates laws, we may be liable for damages.
35. Certain provisions of our charter documents and under Delaware law may make an acquisition of us, which may be beneficial to our stockholders, more difficult.
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