Pipeline Previews

Genentech has announced that it has submitted a New Drug Application to the FDA for vemurafenib (RG7204, PLX4032), a potential treatment for people with BRAF V600 mutation-positive metastatic melanoma. Vemurafenib is a BRAF-inhibitor designed to selectively target and inhibit a mutated form of the BRAF protein found in about half of all cases of melanoma.

In addition, Genentech's parent company, Roche, submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for vemurafenib. Roche has also submitted an application for the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic as well as a Premarket Approval Application (PMA) for the cobas 4800 BRAF V600 Mutation Test in the U.S.

The submissions are based on results from two positive clinical studies (BRIM2 and BRIM3) that evaluated vemurafenib in people with BRAF V600 mutation-positive metastatic melanoma. BRIM2 is a global, single-arm, multicenter, open-label, phase II study that enrolled 132 patients with previously treated BRAF V600 mutation-positive metastatic melanoma. The study showed that vemurafenib shrank tumors in 52 percent of trial participants. People who participated in the trial lived a median of 6.2 months without their disease getting worse (median PFS).

BRIM3 is a global, randomized, open-label, controlled, multicenter, phase III study that compared vemurafenib to dacarbazine chemotherapy, a current standard of care, in 675 patients with previously untreated BRAF V600 mutation-positive, unresected or locally advanced metastatic melanoma. The study showed that participants who received vemurafenib lived longer (overall survival) and also lived longer without their disease getting worse (progression-free survival or PFS) compared to those who received dacarbazine chemotherapy.

Topix Pharmaceuticals, Inc. has released Replenix^® ResurFIX Skin Barrier Healing Ointment, a topical treatment designed to help protect, heal and preserve the skin, relieve discomfort, reduce redness, oozing, crusting, itching and extreme dryness after treatment that disrupted the epidermal barrier. Topix advertises that the product is effective in treating a wide variety of wounds, protecting the skin from further breakdown; accelerating reepithelialization of wounds; soothing radiation burn and alleviating chronic erythema and pruritus. Use of Replenix ResurFIX Skin Barrier Healing Ointment reduces the chance of post-inflammatory hyperpigmentation after reepithelialization has occurred.

Topix further touts Replenix ResurFIX Skin Barrier Healing Ointment for use in skin repair after mechanical, chemical and thermal damage, cold and freezing injuries, as well as post-traumatic and postoperative damage, such as: laser surgery; superficial wounds; minor abrasions; dermal ulcers; minor burns (1st and 2nd degree burns, including sunburns, and radiation dermatitis); laser resurfacing; microdermabrasion; chemical peels; post-aesthetic, post–procedure and post-burn treatment; and stressed skin conditions such as chapped, wind-burned, cracked, dry or chafed skin.

According to Topix, Replenix ResurFIX Skin Barrier Healing Ointment has been shown to be effective in trials for prevention and treatment of inflammation, stage I ulcers, and stage II pressure ulcers.

Alma Lasers Ltd., has announced the launch of a new iPixel series of pixel modules for aesthetic fractional laser resurfacing. The two new modules–the iPixel CO₂ and the iPixelEr–each feature Alma's roller-style technology. This design is intended to allow a physician to glide the laser along the patient's skin and deliver precise and effective ablative treatment more quickly than other treatments. The new iPixel series modules can be used with existing Alma systems, enabling treatment providers the opportunity to provide additional treatments without the need to purchase new systems.

The iPixel CO₂, for use with the Pixel CO₂ system, channels 70 watts of energy into seven pixels and pulses are released as the roller wheels turn, regardless of the speed at which the handpiece is moving. For a limited time, the HarmonyXL is available with all three applicator tips: the iPixelEr, the 7x7 stationary and the 4 mm Erbium.

Syneron Medical Ltd. announced the global launch of several new devices during the opening of the World Congress of Dermatology.