Pharmaceutical News, July 2009 Sponsored by Kimberly Vaughn, Executive Strategies - Excellence in Executive Search • Despite cutting thousands of jobs in recent years, Eli Lilly continues to swing a mighty bat in Indiana's economy, including its $1.5 billion annual statewide payroll and billions in purchases, employee spending and taxes. Those are numbers that could help the drug maker sell its story that what's good for Lilly is good for Indiana. And as the national healthcare debate heats up this summer, that message could resonate with politicians and consumers. A study commissioned by Lilly and issued by Indiana University (Bloomington, IN) offers the latest look at the company's economic footprint. It concludes that Lilly contributed $8.03 billion, or approximately 3.3%, to Indiana's gross state product in 2007. The report comes out as big pharmaceutical companies find themselves on the defensive. Some critics have painted them as profit-mongers and more interested in promoting expensive lifestyle drugs than developing critical new medicines. The report is the first such examination of Lilly since 1999, when it also contributed about 3% of the state's economic output. • Eurand (Italy) said US health regulators extended the review period of its new drug application for its experimental pancreatic enzyme product, Zenpep, by three months. The FDA, which was to complete the review this month, attributed the delay to the need for additional time to review the current submission. Eurand is developing Zenpep for the treatment for exocrine pancreatic insufficiency, a relatively rare condition marked by a lack of enzymes needed to digest food. • GlaxoSmithKline's chief executive, Andrew Witty, acknowledged that overhauling its drug discovery machine had been traumatic but said turning back the clock on R&D was now delivering results. The upheaval involved job losses in the company's core R&D organization, angering some staff. GSK is now synthesizing more molecules against more disease targets than ever before and there are qualitative signs of improvement, with teams taking a more lateral approach to problem solving. It has been a radical shift. Over that time, the drugs industry was a big commercial success but it took a wrong turn by deciding that drug discovery was an industrial process based on large-scale application of technologies like genomics, proteomics and combinatorial chemistry. Pharmaceutical companies around the world are struggling to find a new business model as blockbuster drugs brought to market in the 1990’s face patent expiry at a time when new ones prove harder and harder to develop. • A combination of two drugs from Novartis cut the size of pancreatic neuroendocrine tumors in more than 80% of patients in a Phase II study. Patients who received a once-daily pill Afinitor in combination with Sandostatin LAR had no progression in their disease for a median of 16.7 months, according to results from the so-called RADIANT-1 study of 160 patients. Afinitor is one of Novartis's most important new drugs and is being tested for use against several different types of cancer, which could help it achieve sales of more than $1 billion annually. It works by blocking a protein known as mTOR and disrupting the growth, division and metabolism of cancer cells and is a key plank of Novartis's strategy to expand in cancer drugs. A Phase III trial evaluating Afinitor as a potential treatment option for patients with pancreatic neuroendocrine tumors is already underway. Pancreatic neuroendocrine tumors are an uncommon form of the disease, a cancer formed from cells that have roles in both the endocrine and nervous systems. At the time of diagnosis, nearly 60% of all patients have advanced disease, meaning the cancer has spread to other parts of the body and has become more difficult to treat. • Pfizer reports the first positive Phase III results in a long time for its anticancer agent Sutent. Patients with advanced pancreatic islet cell tumors treated with the compound had a median progression-free survival of 11.1 months compared to those on placebo who had a PFS of 5.5 months. This trial was stopped earlier this year, Pfizer says, after the Data Monitoring Committee recommended doing so, because they found that Sutent showed significant benefit and the study met its primary endpoint. Sutent is an oral multikinase inhibitor currently approved for advanced renal cell carcinoma and second-line gastrointestinal stromal tumor. Pfizer is studying the compound in a slew of solid tumor settings in the hopes of expanding the label. Evaluations of Sutent in two advanced breast cancer settings, however, failed to show improvements and have been stopped. These Phase III studies looked at Sutent in combination with paclitaxel as a first-line treatment of advanced breast cancer and Sutent alone in patients with advanced breast cancer who had failed standard treatment. The success in the late-stage advanced pancreatic islet cell tumor study thus marks a departure from the trend of Sutent failures.
• Sanofi-Aventis is preparing a big push in generic drugs and a cut in research spending as it girds for the looming loss of patent protection on one of its biggest sellers. Sanofi in coming weeks will disclose that it is cutting R&D spending in some areas where it has been unsuccessful in recent years. Sanofi and partner Bristol-Myers Squibb sell Plavix jointly and divide the profits. Sanofi recently bought two generic-drug companies in Latin America and is planning to start selling their products in more emerging markets.
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