The Burrill Report


The United Kingdom’s healthcare watchdog, which decides what medicines should be used in the U.K.’s publicly funded National Health Service, has declined to recommend Roche’s Avastin as a first-line treatment of metastatic breast cancer in combination with chemotherapy. The National Institute for Health and Clinical Excellence, or NICE, said the drug didn’t represent value for the money. “We can’t recommend a drug that has not been shown to work as well as, or better than, current treatments and costs much more,” NICE Chief Executive Andrew Dillon said. For its part, Roche believes Avastin is still an important treatment option for women with breast cancer and in a statement cited how a subgroup of women treated with the a combination of Avastin and chemotherapy saw their survival rates more than double from 4.2 months to 8.7 months. NICE also expressed concern about a lack of data showing patients would have a better quality of life using an Avastin as a reason for the not recommending the use of the therapy.

Merck KGaA’s CEO said that the company would refrain from any major takeovers until the end of 2013 and instead focus on cost cutting measures including job reductions. The action comes after a number of setbacks in its drug development pipeline. The cost cutting measures are expected to run through 2018 with the first phase expected to run through the end of 2013. “We do not plan to make any major acquisitions during this first phase of the program. However, we will continue to strengthen our business through in-licensing or targeted acquisitions if the opportunities arise,” says CEO Karl-Ludwig Kley.

Novartis announced that the U.S. Food and Drug Administration put on clinical hold development of an experimental drug for the treatment of Hepatitis C after the death of a patient, which may have been linked to the use of the drug. A small portion of patients treated with the experimental Hepatitis C drug, DEB025 or alisporivir, developed pancreatitis, believed to have been the cause of the patient’s death. Novartis says that the death was the only case in the overall DEB025 program, which has been involved in nearly 1,800 patients to date.

Forest Laboratories saw its quarterly profit plunge more than 40 percent as the company lost patent protection on its blockbuster antidepressant drug, Lexapro. Forest also lowered its fiscal-year forecast due to increased spending on the marketing and development of new products designed to replace Lexapro. Net income in first quarter of 2012 was also down substantially, falling to $192.7 percent from $322.5 million from the year ago quarter. Despite the financial hit Forest took in the first quarter, its shares actually rose on the day of the announcement as investors had braced for a poor quarter with Lexapro’s patent expiring in March.

Despite unveiling positive trial data from a study examining its drug candidate for the treatment of Parkinson’s disease, Addex has announced that it plans to ax 28 jobs at its Geneva, offices. “We are implementing these strategic initiatives from a position of strength following our recent positive results in Parkinson’s disease Phase II clinical trials,” says CEO Bharatt Showrira. The goal of the cuts is to ensure the most efficient use of the company’s capital and resources as it pursues further development of its pipeline and new product opportunities, says the company.



April 20, 2012
http://www.burrillreport.com/article-nice_rejects_avastin_for_breast_cancer.html