PM360 AUGUST 2010

Hot Topics / Healthcare Highlights

Tale of the Telemarketers
Traditionally, companies increase sales resources for brands as they approach patent expiration, but AstraZeneca’s new strategy suggests the exact opposite could work just as well. Bernstein Research analyst Tim Anderson told BNet Pharma that by the end of 2009 AstraZeneca essentially eliminated all detailing of Nexium, despite the fact the blockbuster drug does not lose market exclusivity until 2014. Nearly all of the door-to-door sales reps that worked on Nexium were fired with the remaining reps reassigned to other brands, as AstraZeneca replaced them with a 300-person call center. Doctors can use this call center or a website to request samples, reimbursement information, patient materials, or even a visit. “By having a call center and an internet site where doctors can order materials and samples, AstraZeneca says it can adequately meet the needs of many prescribers at a lower cost,” Anderson told BNet Pharma. “Such a sales model could be used for other mature brands.”

The strategy is already showing signs of paying off, as a report from the AARP Public Policy Institute found that the price of Nexium rose 7.4% from April 30, 2009, to March 31, 2010. The question is now whether this experiment will lead other companies to implement similar strategies.

AstraZeneca has already reduced its salesforce by 50%, cutting 430 full-timers, and, according to Anderson, that may just be the beginning. “AstraZeneca concurred with our assessment that there are more costs to come out of the system,” he noted. “They are probably less than halfway through such cost-cutting activities.” —Andrew Matthius

Internet Info
The Internet is now many patients’ go-to resource for medical information, but a new study suggests the Web does not give them the whole picture. The study’s authors examined the quality of online sports medicine information by using Google and Yahoo to research ten of the most common sports medicine diagnoses and then evaluated the top 10 search results for completeness, correctness, and clarity. In terms of content, nonprofit sites received the highest score, followed by academic sites (including medical journal sites), and then certain non-sales-oriented commercial sites (such as WebMD and eMedicine), according to results published in the Journal of Bone and Joint Surgery. The least accurate sources were newspaper articles and personal websites, while commercial sites with a financial interest in the diagnosis, such as sites sponsored by pharmaceutical companies, were common but frequently incomplete. In fact, about 20% of the sites in the top 10 search results were sponsored sites, according to Madhav A. Karunakar, MD, an orthopedic surgeon at Carolinas Medical Center in Charlotte, NC, and one of the study’s authors.

Nearly half the US population with Internet access goes online for health-related information at least once a month, but quality controls of online health information has not grown at the same rate as Internet use. The study’s authors suggest patients should look for the seal of compliance for transparency and accountability from the Health On the Net Foundation and to avoid commercial sites except for the more reputable ones such as WebMD and eMedicine. “Despite its shortcomings, the Internet is the future of how patients will obtain information to make their healthcare decisions,” Karunakar said. “Therefore, patients and physicians need to make sure they are getting that information from reputable, accurate sources.” —A.M.

Pharma Insight
These days, pharmaceutical executives have plenty to keep them up nights. According to the Cegedim Dendrite 2010 Pharma Insights Survey, their No. 1 pain point is the rapidly evolving business model. This came as no surprise to Angela Miccoli, President of Cegedim Dendrite Americas. “Life sciences companies need a way to respond to a rapidly evolving industry that is presented with market access challenges, extreme competitive pressures, and stiffer regulatory requirements,” she said. Four in ten executives named an increased focus on market access strategies as the biggest change to the current business model, followed by primary sales force realignment (20%) and increased focus on managed care (17%). According to the survey’s authors, market access is already a critical issue for success in the European Union, but now it appears to be becoming an important issue for the Americas, which may look to the EU as a guide.

Three in ten respondents named China as the most important BRIC country, while 27% claimed they don’t yet know which country is the most strategically important. Currently, 43% of companies are executing their emerging market strategy from headquarters, with 30% using a mix of locations and only 17% handling it locally. However, only 38% of respondents named growth in emerging markets as one of their top three objectives for 2010. The top three objectives were new product innovation and successful launch (67%), profitability growth (51%), and operations excellence (44%). —A.M.

FDA UPDATE
An FDA panel voted 12-1 recommending the withdrawal of Roche’s Avastin (bevacizumab) as a breast cancer treatment. The panel said post-approval studies failed to prove the use of Avastin with chemotherapies worked better than other medicines alone. Analysts believe Avastin’s annual sales could drop by $1 billion if the FDA follows the panel’s recommendation.

The FDA approved Abbott’s Architect HIV Ag/Ab Combo assay to detect both antigen and antibodies to Human Immunodeficiency Virus (HIV). This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women and children as young as 2 years old.

Pfizer has voluntarily withdrawn Mylotarg (gemtuzumab ozogamicin) from the U.S. market at the request of the FDA after results from a recent clinical trial raised new concerns about the product’s safety, and the drug failed to demonstrate clinical benefit to patients enrolled in trials. Mylotarg was approved in May 2000 to treat patients with acute myeloid leukemia, a bone marrow
cancer.

The first generic version of Effexor XR capsules (venlafaxine hydrochloride) has been approved by the FDA to treat major depressive disorder. It is manufactured by TEVA Pharmaceuticals.

The FDA is requiring Baxter Healthcare to take specific steps to carry out the April 2010 recall of all Colleague Volumetric Infusion Pumps and to provide customers with a refund, a replacement pump, or lease termination.

The FDA warned that certain Advair Diskus inhalers stolen from a GlaxoSmithKline warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used. —A.M.