SAN RAFAEL, Calif., Sept. 15, 2014 (GLOBE NEWSWIRE) — BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced that CenterWatch, a leading source for global clinical trial information, has named it one of the fastest drug developers in the industry. CenterWatch reviewed 307 therapies approved between 2000 and 2013 and concluded that BioMarin ranked within the top five in all categories. The three assessed categories were clinical duration, NDA approval duration and total duration of approval. BioMarin was also among the fastest companies named in drug development for endocrine disorders.
Analysis showed that BioMarin took a median 61 months to bring a treatment through the entire regulatory process, from IND filing to approval. With regard to clinical duration, the time to take a therapy from IND filing through to NDA submission, the company was able to complete the process in a median 55 months, while needing just six months to complete the NDA approval process. BioMarin was also among the top five fastest companies in endocrine development with a median development time of 2.6 years. This compares to a median clinical phase of 5.3 years for endocrine development for all companies analyzed.
“The analysis by CenterWatch showed that BioMarin develops treatments 12 months faster than the industry median. For the patients we seek to treat, those with ultra-rare conditions, one year can make a lifetime of a difference,” said Hank Fuchs, M.D., Chief Medical Officer of BioMarin. “We thank CenterWatch for conducting this analysis, which truly underscores our continued commitment to developing therapies that address unmet medical needs as quickly and efficiently as possible.”
The results of the analysis were published in the September issue of CenterWatch Monthly, a newsletter providing clinical trial information to patients and professionals. This is the second such analysis conducted by CenterWatch.