Knobias Clip Report (01-30-2008)
Submitted By Knobias ClipReport
PVCT: Management Comments on Importance of Recent Patent Allowance in India
Provectus Pharmaceuticals, Inc. (PVCT) recently received an allowance of its patent application in India covering its lead dermatology agent, PH-10, along with a number of related agents. The pending patent covers topical products for treatment of skin diseases such as psoriasis and eczema. Additionally, a range of active compounds are protected, each related to the active ingredient in PH-10.
The CFO of Provectus, Peter Culpepper, told Knobias on Wednesday, “The allowances of Provectus’ patent applications in India are important for several reasons. Most importantly, this provides control over competitors that might wish to manufacture our products in India for sale in India or elsewhere in the world, including the U.S. and Europe. Since pharmaceutical manufacturing is a global business, such control is crucial. Secondly, it protects the Company’s domestic market in India, where the rapidly expanding middle class already outnumbers the population of the U.S.”
“These allowances also demonstrate that Provectus is global-reaching in its strategy and is successful in executing that strategy. Such scope provides value directly to Provectus and for any potential partnerships Provectus may develop for co-development, manufacturing, sales or distribution of the covered products.”
“We have been aggressively pursuing protection of our intellectual property assets in major markets worldwide, including the U.S., Mexico, Canada, the EU, India, China and Japan. Each of these markets represents an important opportunity for the Company’s products. It is likely that marketing and distribution to these markets will occur via partnership with one or more major pharmaceutical partners.”
The Company is currently conducting a Phase 2 clinical trial of PH-10 for psoriasis. PH-10 is a topical gel that contains Rose Bengal, the active ingredient in PH-10. Rose Bengal is “photoactive” and reacts to light of certain wavelengths, increasing its therapeutic effects because it selectively treats diseased tissue with negligible potential for side effects in healthy tissue.
In a Phase 1 study, PH-10 was applied topically to psoriatic plaques and then illuminated with green light. In the first study, a single-dose treatment yielded an average reduction in plaque thickness of 59% after 30 days, with further response noted at the final follow-up examination 90 days later. Further, no pain, significant side effects, or evidence of “rebound” (increased severity of a psoriatic plaque after the initial reduction in thickness) were observed in any treated areas.
There is no known cure for psoriasis at this time. The majority of psoriasis sufferers, those with mild to moderate cases, are treated with topical steroids that can have unpleasant side effects. None of the other treatments for moderate cases of psoriasis have proven completely effective. The 25-30% of psoriasis patients who suffer from more severe cases generally are treated with more intensive drug therapies or PUVA, a light-based therapy that combines the drug Psoralen with exposure to ultraviolet A light. While PUVA is one of the more effective treatments, it increases a patient’s risk of skin cancer.
The Company also has an oncology product in Phase 2 development for the treatment of metastatic melanoma. PV-10, a sterile injectible form of Rose Bengal for direct injection into tumors, is retained in diseased or damaged tissue but quickly dissipates from healthy tissue. The Company believes it can develop therapies that confine treatment to cancerous tissue and reduce collateral impact on healthy tissue. Provectus expects to commence a Phase 1/2 liver cancer trial during the first half of 2008. It also expects a recently expanded Phase 1 breast cancer trial to be completed in fourth quarter of 2008.
The Company’s first commercially available products were directed into the OTC market. These products include the Pure-ific(TM) line of products with two quick-drying sprays, Pure-ific and Pure-ific Kids, that immediately kill up to 99.9% of germs on skin and prevent regrowth for 6 hours. GloveAid(TM) is a hand cream with both antiperspirant and antibacterial properties, to increase the comfort of users’ hands during and after the wearing of disposable gloves. Provectus also anticipates developing OTC products for the treatment of mild to moderate cases of acne and other blemishes.
Pure-ific competes in the market with other hand sanitizing products, including Purell (owned by Johnson & Johnson); Avagard D (manufactured by 3M); and large number of generic and private-label equivalents to these market leaders. Hand sanitizers comprise a $100 million market. GloveAid represents a new product category that has no direct competitors; however, other types of products, such as AloeTouch(R) disposable gloves (manufactured by Medline Industries) target the same market niche. The worldwide market for disposable gloves is more than $3 billion.
According to Dr. Craig Dees, CEO of Provectus, “We have never been in a stronger position, either financially or technically. For instance, we successfully increased our year-end cash position to its highest level ever, primarily through non-dilutive conversion of warrants issued in prior years; thus, affording us sufficient capital reserves for the next eighteen months. This estimation accounts for all current and planned clinical trials, as well as other key operational milestones.”
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