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All Penny News: Advaxis Aims for Orphan Drug Status in Cervical and Head and Neck Cancers


Mississauga, ON -- (SBWIRE) -- 06/11/2013 -- Media, Inc. ( announces its latest article titled “Advaxis Aims for Orphan Drug Status in Cervical and Head and Neck Cancers.”

Companies mentioned in this article include Advaxis, Inc. (OTCBB:ADXS) and Sanofi (NYSE:SNY).

Article Excerpt:

The U.S. Food and Drug Administration has several special designations for expediting development or protecting drugs that meet areas of great unmet medical need. The Orphan Drug Act provides for a special designation for therapeutic candidates treating rare diseases or conditions typically affecting fewer than 200,000 people in the United States. Designation of Orphan Drug status provides a company with several benefits, such as clinical protocol assistance from the FDA, seven-year marketing exclusivity, tax credits, marketing applications that are free of a prescription drug user fee and more.

Some may initially think that the small populations of patients in the rare disorder category may limit revenue potential, but these therapeutics can command high margins. Biotechnology legend Henri Termeer helped build Genzyme into a pharma giant through biologics (that are not easily copied by generics) targeting rare genetic disorders. Genzyme was eventually bought by Sanofi (NYSE:SNY) for $20.1 billion in 2011.

Upstart biotech Advaxis, Inc. (OTCBB:ADXS) is certainly not a comparable to a behemoth like Genzyme, but the clinical stage company is beating down the path of Orphan Drug designations with their immunotherapy therapeutics that seems worth an investigation. Advaxis is in the midst of six clinical trials, including three Phase II trials for cervical cancer and Cervical Intraepithelial Neoplasia, or CIN. All tallied, the company has 15 immunotherapies in development for cancers and infectious diseases.

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