Update on Pharmaceutical Pipeline

Minneapolis—The number of products in the pharmaceutical pipeline is less than it was from 2007 through 2009. Although research and development (R&D) spending is still strong for most companies, the US Food and Drug Administration (FDA) has recently approved fewer drugs, which has resulted in changes to how companies conduct research, according to Brian W. Kolling, PharmD, MBA, senior director of pipeline and trend forecasting at Prescription Solutions in Minneapolis.

Dr. Kolling discussed recent pharmaceutical trends and instructed attendees on what to look for in the coming years during a contemporary issues session at the AMCP meeting titled Scanning the Pharmaceutical Pipeline: What’s on the Horizon? Cancer is the disease state with the most drugs in the pipeline, according to Dr. Kolling. There are currently >300 oncology drugs in development, an increase of nearly 100 since 2006. The central nervous system is the second most popular disease state with >150 drugs in development, followed by diabetes, infectious diseases, respiratory, cardiovascular, vaccines, and arthritis. Pfizer, Inc has the greatest number of drugs in development, followed by GlaxoSmithKline plc, AstraZeneca plc, Novartis AG, Eli Lilly and Company, the Roche Group, Merck & Co, Inc, sanofi-aventis US, Astellas Pharma US, Inc, and Takeda Pharmaceuticals.

Dr. Kolling said there are more barriers to entry in drug development, which means pharmaceutical companies need to invest more money to be successful. However, he said most of the money is spent on phase 2 or earlier trials, which have higher failure rates. Still, some companies have decided to cut spending. For instance, Dr. Kolling cited a February New York Times article that said Pfizer would decrease its R&D budget by as much as $2.9 billion in the next 2 years. He also discussed a New York Times article from January that said President Barack Obama’s administration would start a $1-billion drug development center to help create medicines.

Dr. Kolling was skeptical of the project considering it typically costs ≥$1 billion to develop a new drug. Dr. Kolling also spoke about major industry developments to look for in 2011. As of late April, the FDA had approved 11 new molecular entities, including belimumab, the first drug approved in 50 years to treat lupus. Dr. Kolling estimated belimumab would cost approximately $35,000 per year. In the next few months, Dr. Kolling said the FDA would likely approve 2 hepatitis C medications (telaprevir and boceprevir). “You’ll hear a lot about these drugs,” Dr. Kolling said. “This is going to be a big deal.”

In addition, he said he would track the clinical development of vorapaxar, a thrombin receptor intended to treat patients with acute coronary syndrome chest pain. Dr. Kolling is also interested in examining more phase 3 study results for tofacitinib, an oral agent indicated to treat patients with rheumatoid arthritis. Later this year, 2 of the major brand drugs lose exclusivity: olanzapine (to treat schizophrenia) and atorvastatin (to treat high cholesterol). Overall, Dr. Kolling’s analysis said $20.4 billion worth of branded products (measured in annual sales) will become generics in 2011. That figure will increase to $35.6 billion in 2012.