Biopharma's success at developing effective treatment regimens for HIV has significantly raised the bar on experimental pipeline projects, making it more difficult to gain new approvals even as the risk of a viral mutation that would pose a deadly new health challenge grows as well.
In an in-depth article, Bloomberg reviews the rise of blockbuster therapies from Gilead, Bristol-Myers Squibb, Pfizer and Merck which have transformed the once-lethal disease into a manageable chronic ailment. But with virtually all the patients in developed countries being treated, it's becoming increasingly difficult to register a response in treatment-experienced populations. Regulators, meanwhile, are demanding more data over longer periods of time to show that the new drugs are better than the ones now in use. And as a result, the number of new HIV drugs in the pipeline has dwindled from around 100 programs five years ago to about 60 today. The last new HIV therapy that was approved for use was J&J's Intelence, which earned a green flag three years ago.
"It's the greatest success of western medicine in our lifetime," says Jacob Lalezari, who runs a clinical trial site in San Francisco. "And the success of HIV drugs is leading to its own demise."
"The bar for bringing on a drug in HIV has gotten higher," said George Hanna, vice president of virology for U.S. medical and HIV early development at Bristol-Myers, based in New York. "You can no longer bring to market a drug you're going to have to take three times a day. All of a sudden, we're seeing a lot less in the pipeline."
- here's the story from Bloomberg