Court Rules for Latisse on Patent Infringement
A US appeals court last month sided with Allergan in its suit alleging patent infringement of Latisse (bimatoprost). The court overturned a previous lower-court ruling that dismissed a case brought by Allergan in 2009. In the original lawsuit Allergan alleged that a number of companies either infringed the patent for the eyelash growth product or induced others to infringe it.
New Kit Available for Melanoma Research
The Celltracks Circulating Melanoma Cell (CMC) kit is now available from Veridex, providing research scientists a convenient and reliable way to capture CMCs for research studies. The Celltracks CMC kit is an enabling technology for using biomarkers to identify and enumerate CMCs, melanoma cells that have detached from tumors and entered the blood stream. Research continues to uncover new insight into the value and use of CMC assays in the study of metastatic melanoma, most recently in a study published in the International Journal of Oncology correlating CMCs and metastatic spread.
Global Skin Initiative Launches
The International League of Dermatological Societies (ILDS) and Stiefel, a GSK company, have launched “Hats On For Skin Health,” a global initiative on sun protection for albinos in sub-Saharan Africa. The program aims to raise funds to purchase hats and other sun-protective items for albinos living in Tanzania, a country with one of the highest rates of albinism in the world. Tanzania is home to tens of thousands of albinos, and unless measures are taken to protect their skin from the sun's rays, there is a high likelihood that they will develop skin cancer at a very early age.
To learn more about the campaign or to make a donation that will be used to purchase hats or other sun-protective items, visit Hatsonforskinhealth.org and follow on Facebook (facebook.com/StiefelGSK) and Twitter (twitter.com/stiefelagskco).
Worldwide Pharma Growth Slowing
Global spending for medicines will reach nearly $1.1 trillion by 2015, which actually reflects a slowing compound annual growth rate of three to six percent over the next five years, according to a new report. Lower levels of spending growth for medicines in the US, the ongoing impact of patent expiries in developed markets, continuing strong demand in “pharmerging” markets, and policy-driven changes in several countries are among key factors that will influence growth.
Positive Results for Cream/Light Compound
Positive preliminary results from Photocure's consumer trial of Allumera demonstrate that the product can improve the appearance of skin. The RevitAll study was designed to determine the ability of Allumera cream to improve the appearance of skin compared to illumination by light alone. The fivemonth study included 120 women; half received three applications of Allumera one month apart. The remaining 60 received light alone. Results showed that individuals who received Allumera for one hour followed by illumination showed a time-dependent and significant reduction in the appearance of pores, significant improvement in appearance of skin suppleness, and a significant increase in apparent firmness compared to both baseline and light alone. In addition, there was a significant improvement in the appearance of even skin tone compared to baseline, but improvement in the appearance of even skin tone did not reach statistical significance compared to light alone. The majority of women receiving Allumera reported substantial benefits across important personal cosmetic evaluation measurements. Allumera followed by illumination was well tolerated with few side effects and minimal downtime.
Vemurafenib Submitted for Approval
Genentech has submitted a New Drug Application for vemurafenib to the FDA for people with BRAF V600 mutation-positive metastatic melanoma, while Roche submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for vemurafenib for the same indication. Vemurafenib is designed to selectively target and inhibit a mutated form of the BRAF protein found in about half of all cases of melanoma. 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, as determined by the investigational companion diagnostic test also being developed by Roche. Roche submitted a Premarket Approval Application (PMA) for the cobas 4800 BRAF V600 Mutation Test in the US.
Patient AK Resource Launched
A new online patient resource, “AK Connect” (www.solaraze.com/akconnect) was developed to help clinicians better inform patients about diagnosis of AK, symptoms, and treatment options. Launched by PharmaDerm, a division of Nycomed US Inc., the site is intended to help physicians better inform patients about the skin condition, the importance of staying on therapy if diagnosed with AK, and helpful information on protecting the skin from AK lesions.
Test For MRSA/MSSA Now Available
FDA recently cleared the first test for Staphylococcus aureus infections that quickly identifies whether bacteria are methicillin resistant (MRSA) or methicillin susceptible (MSSA). The KeyPath MRSA/MSSA Blood Culture Test makes the determination within about five hours after any bacterial growth is first detected in the sample. Aside from the blood culture equipment, the test does not require any specific instruments to acquire results.
Briakinumab Surpasses Etanercept
In a recent 12-week phase 2 study the anti-IL-12/23 monoclonal antibody briakinumab demonstrated superior efficacy to etanercept (Br J Dermatol. May 17). Researchers randomized 347 patients in a 2:2:1 ratio to receive 200mg briakinumab at weeks zero and four, followed by 100mg briakinumab at eight week; 50mg etanercept twice weekly three to four days apart at weeks zero through 11; or placebo injections matching active treatment. In all, 71 percent of briakinumabtreated patients achieved a PGA of 0/1 at 12 weeks, compared with 39.7 percent of etanercept-treated patients and 2.9 percent of placebo-treated patients. PASI 75 response at week 12 was seen in 81.9 percent of briakinumab-treated patients, 56 percent of etanercept- treated subjects, and 7.4 percent of controls. Serious adverse event rates were reported in 2.9 percent of briakinumab patients, 0.7 percent of etanercept patients, and 1.5 percent of placebo-treated patients.