Business briefs: Roche, Vital Art and Science, Gilead, Sanofi
The first FDA-approved mobile vision test has landed. The regulator approved Vital Art and Science's 510(k) conforming app known as myVisionTrack, reported MobiHealth News, which said the approval applies to the prescription app when run on the iPhone 4S. The app is for patients with degenerative eye conditions and age-related macular degeneration, and will allow users to regularly evaluate their vision on their own. It also compares previous data to help identify changes and trends. MobiHealth notes the app isn't yet downloadable, and filling a prescription will most likely mean getting a pre-loaded iPhone.
Gilead's experimental oral hepatitis C treatment sofosbuvir has been sent to the FDA for review, the company announced Monday. The nucleotide analogue was accompanied by data supporting its use with RBV and pegylated interferon for treatment-naïve patients with genotype 1, 4, 5 and 6 HCV. The company said in a statement it expects to file with the EMA later this year.
FDA has revived the once-banned morning sickness medication Bendectin with the same indication, but a new name – Diclegis, reported the New York Times. The medication was pulled off shelves 30 years ago after a slew of lawsuits that claimed to link the medication to birth defects. According to the Times, FDA did not find a cause-and-effect scenario, but manufacturer Merrell Dow found the lawsuits too costly and ended production in 1983. The new iteration, marketed by Canadian firm Duchesnay, was studied in 261 pregnant women who had nausea and vomiting and had been pregnant for between 7 and 14 weeks. FDA says the daily treatment is appropriate after lifestyle changes haven't helped. The drug revival is not a first for the regulator – Thalidomide, which was linked to birth defects, was brought back in 1998 as a leprosy treatment.
Although Booz & Co gave Sanofi and Novartis points for emerging market strategy, a Tuesday research note from Bernstein analyst Tim Anderson shows another way to square the cube: examine the field based on exposure and anticipated rate of growth. By this measure, Anderson notes that Sanofi, whose local efforts have included a recent investment in Vietnam among other efforts, has the highest emerging markets exposure among peers, with 32% of its revenues in the field, outpacing Roche with 29%, and GSK with 26%. On the flip side the three with the lowest emerging market exposure were BMS (12% of total revenues), Eli Lilly (14% of pharma revenues) and Merck (19% of pharma revenues). Just as execs told Booz, Anderson wrote that emerging markets are important, regardless of possible volatile growth and other challenges, because they "are likely to grow sustainably faster than developed markets.” Anderson also notes that establishing an emerging markets foundation will be important as the industry braces for “the longer-term, gradual, yet inevitable shift from older-basic off-patent medications to more lucrative, on-patent medications.”