Pipeline Previews

According to an FDA review of Year 5 of the iPLEDGE^™ program (3/1/10 – 2/28/11), over 400,000 attempts to fill isotretinoin prescriptions were denied due to failures to meet iPLEDGE^™ requirements. To help support patients, Promius Pharma, marketers of Zenatane^™ (Isotretinoin Capsules USP), a generic form of isotretinoin, has created the Promius Promise App designed to help educate and guide patients through the various treatment requirements.

The Promius Promise App can be downloaded free of charge by anyone who has received a prescription for Zenatane^™ through the Promius Promise program. It provides answers to frequently asked questions and makes it easy for the patient to find important information, which may make sticking with treatment requirements easier. The App, which acknowledges that there are many steps involved in the treatment process, and outlines them with an easy-to-follow roadmap. The idea for the App came from market research that suggested it may be especially beneficial for young adults and teenagers. It can serve as a tool for parents as well, who may want easy access to Promius Promise information and phone numbers in the event a question arises, so they can support the isotretinoin patient in their life. Providers can also use the App to access the new secure web portal if they desire current information on prescriptions of Zenatane^™ for their patients.

Novartis announced the FDA has approved Cosentyx™ (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy (a drug that is absorbed into the bloodstream and distributed to all parts of the body) or phototherapy (light therapy). Cosentyx is the first approved psoriasis medication to selectively bind to IL-17A and inhibit interaction with the IL-17 receptor. The approval is based on the efficacy and safety outcomes from 10 Phase II and Phase III studies, including over 3,990 adult patients with moderate-to-severe plaque psoriasis, which demonstrated that Cosentyx resulted in clear or almost clear skin in the majority of patients and had an acceptable safety profile.

Valeant introduced the NEW AMBI^® EVEN & CLEAR CC+ CREAM Even Tone Environmental Shield – the first color product in the AMBI^® Skincare Line. Specially formulated to match the rich tones of women of color, this CC+ Cream contains argan oil, shea butter, and antioxidants to moisturize the skin.

AMBI^® CC+ Cream provides broad-spectrum SPF 30 sunscreen protection from UV sun rays that can accelerate the formation of fine lines and wrinkles. This sunscreen is formulated not to leave the skin looking ashy or gray.

Galderma Laboratories, L.P. has announced that the FDA has approved Galderma’s Soolantra^® (ivermectin) Cream, 1% for the once-daily topical treatment of inflammatory lesions of rosacea.

The approval of Soolantra Cream was based on two pivotal phase 3, multicenter, randomized, doubleblind, 12-week, vehicle-controlled, parallel-group studies where Soolantra Cream met each of its coprimary efficacy endpoints. The onset of treatment effect was observed as early as week two with continuous improvement. In long-term extensions to the 12-week studies, Soolantra Cream was also safe and well-tolerated for an additional 40 weeks. Some study subjects experienced skin burning sensation and skin irritation while using Soolantra Cream.

Galderma also reports that in a separate head to head study with metronidazole 0.75% cream Soolantra Cream was shown to be more efficacious from as early as week three onwards.

The FDA has approved Dr. Reddy’s and Endo’s AB-rated generic versions of Roche’s Valcyte (valganciclovir) 450 mg tablets. Valcyte is indicated for adult patients in the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome and prevention of CMV disease in kidney, heart, or kidney; pancreas transplant patients at high