The loss of marketing exclusivity for its bestseller, blood thinner Lovenox, prompted Sanofi-Aventis to trim its earnings outlook. Novartis' generic division, Sandoz, and Momenta plan to launch their copycat version in the US, where FDA approval was received Friday. Sanofi-Aventis said earnings may fall by as much as 4%, Bloomberg reported. Sandoz began taking pre-orders for generic Lovenox in January, and Sanford Bernstein analyst Tim Anderson predicted a US launch by 2012. As Anderson pointed out, Lovenox is not a biologic per se, but its manufacturing process is just as complex. Making generic Lovenox fully substitutable may be an indication of what FDA may do when it comes to true biologics that other firms are seeking to market. The news is likely to be viewed as a negative for biotech firms as well as branded pharma companies that also have biologic drugs, Anderson added, while it probably will be perceived as a positive for payers, distributors and generic companies. Sanofi-Aventis filed suit in federal court to enjoin Momenta from selling the copycat version and, as first reported by The Wall Street Journal, made a takeover bid for Genzyme in anticipation of sales erosion for Lovenox, a $3 billion (wholesale) a year seller.
Pfizer launched a social media channel on SlideShare, becoming the first company in a regulated industry to do so. SlideShare bills itself as "the world's largest community for sharing presentations" such as Powerpoint decks and other documents or videos. Other companies with SlideShare channels include Symantec, Cisco, Dell and HP. Roche's
top seller Avastin may shed as much as $1 billion in sales if the FDA decides to follow an advisory panel's overwhelming recommendation to withdraw the Genentech
drug's breast cancer indication, an analyst said. The panel, which voted last week, also rejected Roche's application to broaden the Avastin label. Genentech is a member of the Roche group. There is a good chance that the FDA, whose final ruling on the breast cancer indication is due September 17, may follow the committee's advice, “given the overwhelming majority against Avastin on every question,” wrote Bernstein's Tim Anderson after the vote. Anderson estimated that $1.2 billion of Avastin sales comes from use in breast cancer, adding that, “perhaps $1 billion of 2015 sales could go,” assuming a “savage and pessimistic” scenario in which European regulators also rescind the indication. Avastin, cleared for breast cancer in 2008 under the FDA's accelerated-review program, is also approved for brain, lung and colon tumors.