Xtandi has reached a key milestone: success in a Phase III trial eyeing the drug from Medivation and Astellas as a prechemo treatment for advanced prostate cancer.
Soon after Xtandi hit the market last year, analysts were figuring that the prostate cancer drug would help pump up that market to $9.1 billion by 2021. And now, the drug has shown success in a Phase III trial eyeing Xtandi as a prechemo treatment for advanced prostate cancer.
Xtandi, the prostate cancer drug from Astellas, is a pill, and that is a benefit to patients in the eyes of an independent committee for the U.K.'s price watchdog, NICE. But then, so is Johnson & Johnson's competitor Zytiga, which NICE has already approved. The difference is that Xtandi can be taken after eating, an advantage the makes it more convenient in the eyes of NICE evaluators who have favored its use in the U.K.
Herewith we bring you our Top 15 Drug Launch Superstars. Some of them will be obvious to anyone who follows the pharma business. They certainly were obvious to us. But choosing the rest was a challenge--one we weren't exactly expecting, based on previous experience. Read the full report >>
Japan's drugmakers aren't any more immune from generic competition than U.S. pharma companies are. Still the country's second- and third-largest drugmakers are predicting sales growth this year, even as low-cost copies drain away sales of their key products. New drugs are coming in to pick up the slack, the companies said.
Drug names starting with an X or a Z may be hard to pronounce but that is really the last thing that drugmakers consider when coming up with new names. They want something that is memorable.
The market for prostate cancer drugs is expected to double by 2021 to $9.1 billion, thanks in part to the debut of new, more expensive drugs. According to Decision Resources, Johnson & Johnson's ($JNJ) Zytiga, along with Medivation ($MDVN) and Astellas Pharma's new Xtandi, will help drive sales growth in 7 major drug markets.
More than two years ago Oxford BioMedica put out the word that the FDA had cleared a Phase II study for its troubled program for TroVax, an immunotherapy to be tested in 80 patients suffering from hormone resistant prostate cancer. For Oxford, the mid-stage study was a key part of its comeback strategy for TroVax, which had already failed a study for renal cancer in 2008.
Astellas Pharma and Medivation won FDA approval for their prostate cancer treatment Xtandi three months ahead of schedule. That's welcome news for them--but perhaps not so welcome for competitors, especially Johnson & Johnson, whose Zytiga pill will be Xtandi's closest rival.
Medivation won FDA approval for MDV3100 today, setting up the quick commercialization of another prostate cancer drug that will further change an already roiled cancer market. The drug, later dubbed enzalutamide and now called Xtandi, won an OK a full three months ahead of the agency's PDUFA date. Astellas is partnered on the program.