Pharma News Updates: Jan 15, 2008

Genentech's Avastin sales miss expectations in fourth quarter
Genentech reported Monday that its fourth-quarter net income rose 6 percent to $632 million over the year-ago period. Avastin's quarterly sales climbed 23 percent to $603 million, but fell short of analysts' expectations of $616 million.
Rituxan's fourth-quarter sales rose 6 percent to $596 million, while Herceptin's revenue climbed 2 percent to $327 million. Lucentis' quarterly sales were $197 million, a 9-percent decrease compared with the year-ago quarter. Commenting on the results, Robert W. Baird's Christopher Raymond, stated: "It's not much to write home about -- they were light on product revenues." The analyst noted that "Avastin was light, and it's a key number," adding that both Rituxan and Herceptin's quarterly sales were also lower than Wall Street estimates. Total revenue for the quarter was in line with analysts' forecasts at $2.97 billion, compared with $2.71 billion in the year-ago quarter.
The company also reported full-year results, stating that net income rose 31 percent to $2.8 billion on revenue of $11.7 billion. Avastin's full-year sales rose 32 percent to $2.3 billion while Rituxan recorded a 10-percent increase in revenue to $2.3 billion for 2007. Sales of Herceptin were up 4 percent to $1.3 billion for the year.
Additionally, the drugmaker specified that it decided not to continue development of its topical VEGF product, telbermin, for diabetic foot ulcers, following negative Phase II results. Looking forward, CEO Arthur Levinson stated that in 2008, the company "will continue to invest in the 20 new molecular entities in clinical development and look forward to new data from a number of potentially important line extensions, including Rituxan for multiple sclerosis and lupus and Avastin in combination with Tarceva for advanced non-small-cell lung cancer."
FDA approves Tysabri for use in Crohn's disease
The FDA granted expanded approval to Elan and Biogen’s Tysabri for the treatment of Crohn’s disease, Elan announced Monday. The company indicated that the drug should be made available for patients with the disease by the end of February.
The product is now indicated in the US for adults with moderately-to-severely active Crohn's disease with evidence of inflammation and who have had an inadequate response to conventional therapies and TNF-alpha inhibitors. The drug will have a specific risk management plan for patients with Crohn's, Elan noted.
Tysabri, which is approved to treat multiple sclerosis in the US and EU, received a negative opinion in the EU for Crohn's disease last year.
France backs cervical cancer vaccination with Gardasil
France's High Council for Public Health on Monday announced that girls 14 years of age should be vaccinated with cervical cancer vaccine Gardasil. The vaccine, which is sold in Europe by Sanofi Pasteur MSD, a joint venture between Merck & Co. and sanofi-aventis, protects against four strains of human papillomavirus.
The agency, which said the vaccine should protect against four HPV strains, also suggested that vaccination should be offered to women aged 15 to 23 years either before, or within a year, of their first sexual contact. Gardasil competes against GlaxoSmithKline's Cervarix, which protects against two strains of HPV.
Novo Nordisk discontinues development of inhaled insulin, AERx
Novo Nordisk will discontinue development of its AERx inhalable insulin product and plans to eliminate jobs as a result, the company reported Monday. The drugmaker said the move follows an analysis of future medical and commercial prospects for inhaled insulin.
Mads Krogsgaard Thomsen, Novo Nordisk's chief scientific officer, stated that Pfizer's recent move to end sales of its inhalable insulin product, Exubera, prompted Novo Nordisk's decision. Meanwhile, company spokesperson Lori Moore stated that a "significant number" of the 360 workers at the drugmaker's plant in Hayward, California will lose their jobs as a result of the decision.
Novo Nordisk said it will take a charge of 1.3 billion Danish kroner ($260 million) in the fourth quarter related to AERx.