Orphan Drug Status Given to Advanced Life Sciences For Metastatic Melanoma (ADLS)

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Advanced Life Sciences Holdings, Inc. (Nasdaq:ADLS) has announced that the FDA has granted an ‘Orphan Drug Designation’ to its oncology product, ALS-357, for the topical treatment of metastatic melanoma.  ALS-357 is entering phase I/II clinical development that has demonstrated potent anti-tumor activity against malignant melanoma. Rapid tumor regression has been shown in a mouse model and no observable toxicity was seen even at high doses.

Phase I/II studies are scheduled to commence in early 2008.  Its Cethromycin is Advanced Life Sciences lead product candidate, so this is a different program than most of the prior news that has been released from the company in recent months.

An FDA Orphan Drug Designation comes with financial and regulatory benefits, such as eligibility for a seven-year period of orphan drug exclusivity if approved, potential tax credits for research, potential R&D grant funding, assistance with clinical trial protocol review, and exemption to paying the marketing application fee.  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 is the 6th most common new cancer cases with only 4% of new skin cancer cases butresponsible for 79% of skin cancer deaths.

Advanced Life Sciences closed at 41.65 yesterday and shares are indicated higher pre-market.  The 52-week trading range is $1.29 to $3.97, and its market cap was actually about $46.7 million as of yesterday. Advanced Life Sciences is still very much in the clinical stages and therefore pre-revenue stage.  As of June 30 it had about $13.4 million cash on the books and its current liabilities were $15.6 million.

Jon C. Ogg
August 28, 2007