GSK Pursues Futura Medical's OTC Topical NSAID Under Development

GlaxoSmithKline's relationship with Futura Medical is on again as the pharmaceutical giant agrees to fund development of Futura's novel topical pain reliever TPR100.

GSK Consumer Healthcare "will fully fund and be responsible for all clinical and regulatory development" of TPR100, and will make "modest annual payments" to Futura while drug development continues, Futura announced June 30.

The deal gives GSK a second chance to market the drug, which, if approved for nonprescription sale, would expand the firm's rapidly growing consumer health business and add a new pain reliever to its portfolio.

In a previous deal with Futura that did not pan out, GSK forfeited its chance to exclusively distribute globally TPR100, a nonprescription topical non-steroidal anti-inflammatory pain reliever that uses Futura's proprietary DermaSys transdermal gel delivery technology.

GSK paid Futura £150,000 in April 2007 ($297,875 under conversion rates for April 15 that year) for a one-year agreement to negotiate global distribution rights for TPR100 during which time Futura would study the use of DermaSys to deliver the pain relief drug topically.

However, GSK let the deal expire a year later, ostensibly because Futura did not complete its study of TPR100 within the agreed-upon timeframe.

Futura announced in April 2008 it was extending its clinical studies of TPR100 "to complete formulation optimization," and it would continue commercial negotiations "on a non-exclusive basis."

GSK may have missed its chance at exclusive global distribution rights, but the firm may have another chance. Futura's release says the companies "expect to enter into a commercial distribution agreement in due course."

Such an agreement hinges on "satisfactory clinical outcomes and regulatory approval," Futura says.

Clinical tests so far show TPR100 delivers 30 to 40 times greater bioavailability than "the market-leading product," with none of the side effects of oral NSAID products, such as gastrointestinal bleeding, according to Futura's website.

While Futura did not name specific competitors, if approved in the U.K., TPR100 would compete in that market against Reckitt Benckiser's topical Nurofen 5 percent gel (ibuprofen).

Futura added in its 2009 financial report, "TPR100's speed of permeation brings potential benefits including rapid onset of action of pain relief."

Futura anticipated in its financial report released in March 2010 that the regulatory pathway for TPR100 "in a number of key commercial territories is relatively straightforward as the active compound is well-characterized and has already been approved in both oral and topical form for the indication of pain relief."

The firm added that minimum requirements to satisfy European Union regulators likely will be a phase I trial of around 24 healthy volunteers to demonstrate a lack of skin irritation or sensitization and a "pivotal" phase III trial of 250 subjects to demonstrate non-inferiority to the market-leading topical pain relief product.

Futura did not say whether it would sell TPR100 over-the-counter in the U.S., nor did it indicate what studies might be necessary to meet FDA standards.

Currently FDA has approved one OTC topical analgesic NDA, Hisamitsu's Salonpas Pain Relief Patch, containing the NSAID methylsalicylate. There are no other topical analgesics containing other NSAIDs approved for OTC use, but there are approved prescription topical analgesics that contain other NSAIDs, an FDA spokeswoman said.

However, she said, salicylates are allowed as a topical analgesic under the OTC Drug Review.

Topical analgesics available OTC in the U.S. include Sanofi-Aventis' Aspercreme cream (trolamine salicylate) and Johnson & Johnson's Ultra Strength Bengay cream (methylsalicylate, camphor and menthol).

Last summer, FDA sent letters warning firms to stop marketing topical creams with ibuprofen - one of several NSAIDs - as OTC products in the U.S. because the ingredient is not included in an OTC monograph and the firms did not have approved new drug applications for the products (¹ (Also see "Ibuprofen Topicals Draw Unapproved New Drug Warnings" - Pink Sheet, 24 Aug, 2009.)).

Futura expects commercial partners to fund additional necessary studies on TPR100, according to the report.

An unidentified "major pharmaceutical company" paid Futura £50,000 in July 2009 ($81,378 at that time) for exclusive rights to conduct in vitro studies of TPR100, and paid an additional £50,000 ($81,266) upfront in December 2009 while the commercial terms of a licensing agreement were negotiated, according to Futura. The company expected to complete the negotiations, which could include commercialization rights "in certain territories," by the end of June.

GSK's deal with Futura is the latest in a line of recent agreements designed to expand GSK's consumer portfolio. Glaxo added two cold sore treatments to its dermatology portfolio, including Medivir's cold sore cream Xerclear on June 21 and Labtec's topical patch to treat cold sores on June 23 (² (Also see "GSK Expands Consumer Business With Acquisition Of OTC Cold Sore Products" - Pink Sheet, 28 Jun, 2010.)).

CEO Andrew Witty prioritized expanding GSK's consumer health business, especially in emerging markets, when he joined the firm in 2008 as a way to balance the company's reliance on prescription drugs with other businesses (³ (Also see "Under New CEO, Glaxo Will Leverage OTCs In Emerging Markets" - Pink Sheet, 5 May, 2008.)).

Additional OTC On Futura's Horizon

Futura is preparing to launch in the U.S. an OTC sexual control product that also relies on its proprietary DermaSys AquaFree delivery system.

Futura is in "discussions with potential partners" to launch PET500 in the U.S. "as soon as possible," the company said in its 2009 financial report.

The firm says it recently reformulated PET500, which uses DermaSys to deliver a "well-known mild topical anesthetic compound" included in FDA's monograph for male genital desensitizers to delay ejaculation.

"The product can therefore be marketed immediately in the USA without any further regulatory approval or clinical data," Futura said in the report. It cited positive results from a Phase I clinical study of 20 healthy volunteers who used the product.

- Elizabeth Crawford ( ⁴ [email protected] )