Pharma News Update: January 16, 2008

Fortune scolds Merck for "risky" programs
Fortune writer John Simons is taking Merck to task for two development programs he finds particularly risky. "The riskiest of Merck's current projects is taranabant," writes Simons, "a treatment that until recently was hailed as an elegant solution for attacking excess weight. Rather than working in the gut, taranabant manipulates the brain to suppress appetite. More specifically, the drug acts on the same receptors in the brain that cause marijuana-smokers to experience hunger. Taranabant, in essence, causes a patient to experience the reverse-munchies."
Psychiatric side effects could derail that program, says Fortune. The there's the cholesterol medicine, anacetripib, which bears far too close a resemblance for Simons to Pfizer's infamous torcetrapib. Towards the end of the piece there's at least one analyst willing to agree that Merck is taking big risks, but stands to gain enormous rewards. Sounds like the kind of bet the Big Pharma developers should make more often if they want to find a way to a brighter, richer future. The last thing biopharma needs now is an even more cautious approach to drug development
AstraZeneca launches head-to-head trial comparing Crestor and Lipitor
AstraZeneca on Tuesday announced the launch of a clinical trial to compare Crestor with Pfizer’s Lipitor for the treatment of atherosclerosis in patients with coronary artery disease.
The SATURN study will compare the 40-milligram dose of Crestor with the 80-milligram dose of Lipitor in about 1300 high-risk patients and is designed to measure the ability of the statins to decrease progression or induce regression of atherosclerosis, following two years of treatment.
The trial is expected to be completed in 2011, AstraZeneca noted
Forest's third-quarter profit up 21 percent on drug sales

Forest reported Tuesday that its profit in the third quarter rose 21 percent to $301.8 million over the prior-year quarter, on strong sales of Lexapro and Namenda. The drugmaker also raised its earnings forecast for its fiscal year ending March 31.

In the quarter, sales of Lexapro grew 11 percent to $603.5 million, while sales of Namenda jumped 26 percent to $218.7 million. Overall, third-quarter revenue was $998.2 million, a 12-percent increase over the same quarter in 2006, and higher than analysts' expectations of $947 million.

Regarding its pipeline, the drugmaker anticipates launching its recently approved hypertension drug, Bystolic, this month

HRT increases risk of lobular breast cancer, study
Study results suggest that combination hormone replacement therapy may raise the risk of lobular breast cancer after just three years. The findings are published in the January edition of Cancer Epidemiology, Biomarkers and Prevention.
"Previous research indicated that five or more years of combined hormone-therapy use was necessary to increase overall breast-cancer risk," noted lead researcher Christopher Li. However, Li added that "our study...suggests that a significantly shorter exposure may confer an increased risk."
In the trial, the researchers examined the histories of 1044 postmenopausal women with breast cancer and 469 postmenopausal women without the disease. The results showed that those who took combined HRT for as few as three years were about three times more likely to develop lobular breast tumours compared with those who did not take combined HRT.
Experts have indicated that the incidence of lobular cancer is increasing, and Li noted that "our research suggests that the use of postmenopausal HRT, specifically combined preparations, may be contributing to this
European regulators approve GlaxoSmithKline's Avamys

The European Commission granted marketing authorisation to GlaxoSmithKline’s allergic rhinitis drug, Avamys, the drugmaker announced Tuesday. The treatment is the first intranasal corticosteroid to show "consistently significant improvements" in both nose and eye allergy symptoms, the drugmaker noted.

In the EU, the once-daily nasal spray is indicated for use in adults, adolescents and children aged six to 11 years. The drug was approved by the FDA in April 2007 and is marketed as Veramyst in the US