Advanced Life Sciences Announces ALS-357 Granted FDA Orphan Drug Designation for Metastati...(phan Drug Designation underscores the ne...),Health

Dr. Flavin added "While our focus as a company is on moving our lead product, cethromycin, toward FDA approval and into the market, we have taken steps to advance our pipeline to the next level. The ALS-357 program opens up a new opportunity for Advanced Life Sciences."

About FDA Orphan Drug Designation

The U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. Orphan Drug Designation may be obtained by requesting that FDA grant such designation for a particular drug for a particular disease or condition that affects fewer than 200,000 Americans. This designation provides Advanced Life Sciences with financial and regulatory benefits, such as eligibility for a seven-year period of orphan drug exclusivity upon approval for ALS-357, potential tax credits for research, potential grant funding for research and development, assistance with clinical trial protocol review, and excepts Advanced Life Sciences from paying the application user fee for a marketing application for ALS-357 for metastatic melanoma.

About Metastatic Melanoma

The American Cancer Society estimates that there are approximately 55,000 new cases of melanoma diagnosed annually in the United States and an estimated 8,000 deaths occur annually as a result of melanoma. Melanoma occurs in melanocytes, a type of cell in the skin that produces the pigment that gives skin its natural color. Melanoma occurs when melanocytes become malignant, which can occur on any skin surface. When melanocytes spread to form a new tumor, it is called a secondary, or metastatic tumor. In such cases, the cancer cells in the new tumor are still melanoma cells, and the disease is called metastatic melanoma rather than liver, lung, or brain cancer
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