The weekly round-up of failed trials, missed targets, and other business mishaps.
Pharmacy benefits manager Express Scripts has agreed to pay $2.75 million to settle allegations that it violated the Controlled Substances Act by failing to put in place buffers that prevent the theft of drugs that are subject to abuse. The U.S. Attorney’s office alleged that between 2002 and 2006, the company experienced multiple counts of employee theft of controlled substances, had discrepancies in its inventories, and failed to report in-transit losses to the U.S. Drug Enforcement Administration. Employees at the company were also accused of using invalid DEA numbers to fill some prescriptions at all of its mail order facilities, increasing the risk that they were filling orders for drugs that weren’t legitimately prescribed by doctors. Express Scripts has said it has created a plan to enhance inventory controls, employee background checks, and mandatory training for employees who work with controlled substances.
A new major study has found that some patients in the EU wait up to nine years for cancer and Alzheimer’s drugs to be available through the health service because the National Institute for Health and Clinical Excellence is bogged down in other tasks. On average, it takes five years from a treatment’s launch by a manufacturer to approval by NICE.
The report by the Office for Health Economics looked at all drugs approved by NICE since 2000, covering a total of nearly 300 treatments. NICE classifies drugs into two groups: drugs used on their own, and those which are taken with another drug. Combination drugs on average take several years longer to receive a decision from NICE. Doctors reacting to the report called the dynamics uncovered by the study unfair for patients because they were being denied potentially life-saving drugs due to backlogs at NICE.
AstraZeneca has begun making the first of its planned 1,100 job cuts, originally announced in February. Some 400 jobs will be cut from AstraZeneca’s R&D hub just south of Stockholm. The first 50 cuts occurred two weeks ago with the rest soon to follow. “Those who are affected in this cut are economists, lawyers, the personnel department, IT technicians, lab technicians, and those types of broad competencies,” said an AstraZeneca spokeswoman to the Swedish news agency Tidningarnas Telegrambyrå. AstraZeneca has attempted to make the restructuring as easy as possible for those affected by providing labor market days where 100 companies have been invited to meet and interview those who have been or will be laid-off. The company has also provided start-up days to offer coaching and seminars for those choosing to pursue entrepreneurial endeavors. The new layoffs add to the more than 20,000 cuts AstraZeneca has completed in the last five years.
Pfizer revealed poor data from a late-stage trial of its experimental kidney cancer drug Torisel, which it was testing in comparison with Bayer’s Nexavar. Top-line results from the late-stage study found that Torisel failed to meet the trial’s primary endpoint of prolonging progression-free survival of patients when compared to Bayer’s Nexavar. The secondary endpoint (overall survival) also showed statistical significance in favor of Nexavar. Despite the unfortunate data, Mace Rothenber, head of clinical development and medical affairs at Pfizer’s oncology unit said that the trial advanced the company’s understanding of renal cell carcinoma. He also added that Torisel would remain an important treatment of advanced kidney cancer based on the company’s previously completed pivotal study of the drug in first-line patients with poor prognostic risks for the disease.
A new study finds that the commonly used antibiotic developed by Pfizer, Zithromax, as well as generic competitors increase the likelihood of sudden death in adults, especially those who have heart disease or a higher prognosis of heart disease. Though the pills caused only a “small absolute increase in cardiovascular deaths” it is considered significant enough to prompt doctors to consider prescribing different antibiotics, such as amoxicillin. The U.S. Food and Drug Administration said it is reviewing the results from the study and will soon provide any new information the review.