PIPELINE PREVIEWS

Roche has announced that the FDA approved Zelboraf^TM (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma, as well as the cobas 4800 BRAF V600 Mutation Test, a diagnostic test developed by Roche to identify patients eligible for treatment. Zelboraf^TM is the first FDA-approved personalized medicine shown to improve survival in people with BRAF V600E mutation-positive metastatic melanoma. It is designed to target and inhibit some mutated forms of the BRAF protein found in about half of all cases of melanoma.

The FDA approval of Zelboraf^TM is based on results from two clinical studies (BRIM3 and BRIM2) in people with BRAF V600E mutation-positive, inoperable or metastatic melanoma as determined by the cobas BRAF Mutation Test. BRIM3 is a global, randomized, open-label, controlled, multicenter, Phase III study that compared Zelboraf^TM to dacarbazine chemotherapy, a standard of care, in 675 patients with previously untreated BRAF V600E mutation-positive, unresectable (inoperable) or metastatic melanoma. The endpoints of BRIM3 were overall survival (OS) and investigator-assessed progression-free survival (PFS). Other endpoints included confirmed investigator-assessed overall response rate. BRIM2 is a global, single-arm, multicenter, open-label Phase II study that enrolled 132 patients with previously treated BRAF V600E mutation-positive, unresectable or metastatic melanoma. The primary endpoint of BRIM2 was confirmed overall response rate as assessed by independent review.

Zelboraf^TM will be available in the United States within two weeks of approval. Roche has also submitted new drug applications for Zelboraf^TM in the EU, Switzerland, Australia, New Zealand, Brazil, India, Mexico, and Canada. While Roche seeks regulatory approval of Zelboraf^TM in other countries, a global Expanded Access Program (EAP) is available for people with previously treated or untreated BRAF V600 mutation-positive metastatic melanoma.

The FDA recently banned 23 skin whitening products for exceeding the national regulatory limit of 1 ppm for mercury in cosmetics, expanding the list of proscribed products to 50. Eleven of these 50 were tested recently by the EcoWaste Coalition, a toxic watchdog group, and were found to contain mercury from 1,085 ppm to 28,600 ppm.

According to the FDA advisory signed by Director Suzette Lazo, the banned items “pose imminent danger or injury to the consuming public and the importation, selling, or offering for sale of such is a violation of Republic Act 9711 or the FDA Act of 2009.”

In response to recent clinical trials, which have linked a subclass of biologics used to treat psoriasis, including ustekinumab (Stelara^® ) and briakinumab, to an increased risk of heart attack and stroke, a study out of Baylor Research Institute suggests there is no such link. The study, published in the Journal of the American Medical Association, analyzed previous research and found no measurable evidence that Stelara^® or briakinumab harm the heart, although the researchers caution that more extensive studies will be needed to confirm this conclusion because the pool of patients was too small to draw firm conclusions, and because none of the clinical trials lasted more than 12 weeks.

The FDA has approved Stelara^® for psoriasis patients, but briakinumab is not yet available. The FDA does not require Stelara^® or any other approved biologic to carry a warning about cardiovascular risk.

Syneron Beauty has announced that it has received 510(k) clearance from the FDA to market the new Taenda^TM Luxe Light Emitting Diode device to consumers. The new device is a nextgeneration evolution of the Taenda Regenerate, and is cleared by the FDA for over-the-counter treatment of wrinkles, rhytides and fine lines around the periorbital region. Syneron Beauty expects to begin commercialization of the Taenda Luxe wrinkle treatment device in the fourth quarter.

A new bill, titled the Safe Cosmetics Act of 2011 (H.R.2359), that was recently introduced in the U.S. House of Representatives aims to ensure that all personal care products are safe by establishing a system to assess the safety of cosmetics ingredients and to phase out the most harmful substances that are suspected of causing cancer, reproductive harm, or other adverse health effects.

The Act requires companies to provide existing safety data on the cosmetic ingredients they are using to the FDA. It also requires suppliers of cosmetic ingredients to make available to manufacturers purchasing those ingredients a full listing of the chemicals in fragrance and preservatives and information regarding the toxicological properties and the safety — including any safety tests they've conducted — of those ingredients.