This Week in Biotech
May 18th 2013 1:45PM
Updated May 18th 2013 5:00PM
With the SPDR S&P Biotech Index up 38% over the trailing-12-month period, it's evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let's have a look at some of the rulings, studies, and companies that made waves in the sector last week.
With the American Society of Clinical Oncology's annual meeting right around the corner, we were privy to plenty of clinical data (both good and bad), a three-month early drug approval from the Food and Drug Administration, and a head-scratcher of a deal in the biotech sector.
Starting in reverse, Elan surprised investors on Monday by coming out of the bleachers and entering into a $1 billion royalty deal with Theravance . If you recall, Theravance and development partner GlaxoSmithKline received FDA approval for their long-acting COPD maintenance inhaled treatment Breo Ellipta last week. The companies are also working on Breo Anoro which is also under FDA review and two additional compounds. The deal by Elan entitles it to receive 21% of Theravance's royalties and assumes that the remainder of respiratory treatments will be quite successful. While a fantastic deal for Theravance shareholders, it's a hefty price to pay for Elan, which appears to be wildly reaching for growth ideas.
On the clinical data front, Sanofi delivered positive news to investors on Friday with its JAK2 inhibitor SAR302503. The drug, which is meant to treat myelofibrosis, met its primary endpoint in late-stage trials of reducing spleen volume by greater than 35% after 24 weeks in both dosage groups. The side effects of SAR302503 were consistent with phase 1 trials, and Sanofi could file for regulatory approval relatively soon.
Roche also reported positive initial data for its chronic lymphocytic leukemia drug, GA-101 (also known as obinutuzumab), on Thursday. When combined with chlorambucil, GA-101 demonstrated a statistically significant 86% reduction in disease progression, relapse, or death. Median progression-free survival also more than doubled to 23 months from just the 10.9 months associated with taking chlorambucil by itself. Roche noted that it will present its full data set on GA-101 at ASCO.
Things didn't go nearly as well for Oncothyreon , which announced the full, and disappointing, results from its unresectable, locally advanced non-small-cell lung cancer drug, L-BLP25. While delivering a median overall survival of 25.6 months, it wasn't statistically significant next to the median OS of 22.3 months for the placebo group. Oncothyreon also revealed initial results from two mid-stage studies of PX-866 in patients with glioblastoma and castration-resistant prostate cancer. Both results proved decent, but not enough to excite investors would were disappointed by L-BLP25's failure.
Finally, Bayer and Algeta received a once-in-a-blue-moon FDA approval for Xofigo (previously Radium-223 dichloride) to treat metastatic castration-resistant prostate cancer that's spread to bones but no other organs because of surgical therapies aimed at lowering testosterone. The FDA approved Xofigo three months early and, in trials, extended PFS to 14 months, as compared with 11.2 months for the placebo.
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