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Pharmaceuticals

Rose Bengal Research

February 8, 2010 | A version of this story appeared in Volume 88, Issue 6

In his letter to the editor, "Why Rose Bengal Isn't Available," Harold Fritz McDuffie states that the Food & Drug Administration has not approved rose bengal for medical use against cancer "because the U.S. patent law says that it is not patentable, thus, no pharmaceutical firm can make large profits from it" (C&EN, Nov. 16, 2009, page 4). As chief executive officer of Provectus Pharmaceuticals, I want to set the record straight.

Provectus Pharmaceuticals has received multiple patents from the U.S. Patent & Trademark Office covering therapeutic uses of rose bengal, and we have recently completed patient accrual for a large Phase II clinical trial for PV-10, our injectable formulation of rose bengal. We believe that PV-10 is a viable treatment for metastatic melanoma as well as for other forms of cancer, including liver cancer and recurrent breast cancer. We have been granted orphan drug designation by the FDA, which affords Provectus marketing exclusivity for PV-10 to treat metastatic melanoma in the U.S., upon FDA approval of the drug.

Patient accrual has also been completed for two separate Phase II clinical trials for PH-10, another one of our drugs whose formulation is based on rose bengal. These clinical trials are evaluating PH-10 for psoriasis and atopic dermatitis.

There have been no approved new treatments for metastatic melanoma for more than 10 years. We firmly believe these studies demonstrate the significant commercial value of rose bengal, a very old molecule that when properly formulated and administered has great potential to treat not only deadly cancers, but serious, chronic dermatological diseases as well.

Craig Dees
CEO, Provectus Pharmaceuticals
Knoxville

Fritz McDuffie should consider that it costs $300 million to $800 million to prove to FDA that a drug is safe and effective. I doubt even the Veterans Administration would take that financial hit for a drug that could be sold by someone else as a generic the day after it was approved. It seems like Ralph Nader claimed the $300 million figure was vastly inflated when he was criticizing big pharma during his presidential run. Maybe McDuffie should contact Nader about getting it approved on the cheap?

Alfonse Del Guercio
Norcross, Ga.

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