With the SPDR S&P Biotech Index up 29% 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.
As we do at the conclusion of every week, let's lead off with some of the most positive stories within the sector. Perhaps none stands out as more intriguing than Gilead Sciences (NASDAQ: GILD) late-stage study of idelalisib in previously treated chronic lymphocytic leukemia patients who aren't fit for chemotherapy. According to Gilead's press release on Wednesday, an independent data monitoring committee stopped the trial early because of, "highly statistically significant efficacy for the primary endpoint of progression-free survival in patients receiving idelalisib plus rituximab compared to those receiving rituximab alone." It's looking as if we can chalk up another successful late-stage study for Gilead.
Alkermes (NASDAQ: ALKS) also joined the party by announcing on Thursday that its experimental major depressive disorder therapy ALKS-5461 had received a fast track designation from the Food and Drug Administration. A fast track designation helps a biotechnology company by expediting its review process once it files for a new drug application so this is great news for Alkermes shareholders and MDD patients. In mid-stage trials ALKS-5461 met its primary endpoint of a change from the baseline in depressive symptoms according to the Hamilton Depression Rating Scale when tested in a group of 142 patients. ALKS-5461 holds unique promise since most MDD drugs are really a one-size-fits-all type medication.
Pfizer's shoulder shrug
For others it was more of a mixed week. On Wednesday, Pfizer (NYSE: PFE) reported top-line results from two of its five late-stage studies for its FDA-approved drug Xeljanz (known chemically as tofacitinib) for the treatment of moderate-to-severe chronic plaque psoriasis. As you may have inferred from the subhead, the results were so-so at best. The 5mg dose didn't demonstrate non-inferiority to Enbrel in one study, but Xeljanz did show a demonstrable benefit in patients relative to Enbrel once they stopped taking the drug. There's still plenty of data left to play out and we won't get that data until next year, but Pfizer is probably going to need stronger data than this if it hopes to add psoriasis as an indication for Xeljanz.
Teva brings out the ax
Becoming the latest large biopharmaceutical company to dramatically trim its workforce, on Thursday Teva Pharmaceutical (NYSE: TEVA) announced that it'd be shedding 5,000 of its 46,000 global employees in an effort to save $2 billion annually by 2017. Teva plans to use its saved cash to reinvest in its R&D pipeline with a specific focus on complex generic drugs and specialty branded pharmaceutical products. In addition, it also plans to focus on emerging markets which should help it cope with the upcoming loss of Copaxone to generic competition. Copaxone, a multiple sclerosis blockbuster, currently accounts for close to one-fifth of Teva's revenue. This looks like a necessary move for the company, but it could lead to shaky growth over the next couple of quarters as it transitions.
This week's duck-and-cover
This week's disaster du jour 00 and what a disaster it was -- is Ariad Pharmaceuticals (NASDAQ: ARIA) which plummeted as much as 77% at one point after updating investors to new developments with its only FDA-approved drug and primary pipeline candidate, Iclusig. According to Ariad's press release, follow-up studies of patients taking Iclusig demonstrated a higher risk for arterial thrombosis, causing Ariad and the FDA to place a clinical hold on all new clinical trial patients and cut the dosing in half for all remaining trial patients. Investors have been expecting Iclusig to gain considerably more indications in treating chronic myeloid leukemia, the most common type of blood cancer in adults, but toxicity issues are certainly going to make that difficult to achieve now.
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