With the SPDR S&P Biotech Index up 41% 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 always, let's have a look at some of the more upbeat stories for the week to begin with. The approval story of the week that investors should take note of belongs to Gilead Sciences (GILD 0.82%), which had Tybost approved by the European Commission. Tybost is a pharmacokinetic enhancer that boosts blood levels for HIV therapies atazanavir and darunavir. This once-daily pill is also one of the four components of Gilead's HIV-fighting four-in-one pill, Stribild, in the United States. In trials it proved non-inferior to the current standard of treatment with a similar safety profile. The big question now is whether or not Tybost will differentiate itself enough from other existing treatments, including Gilead's older EU-approved medications such as Truvada.
Once again, antisense drug developer Isis Pharmaceuticals (IONS 1.52%) makes some noise with positive clinical-stage headlines. This time, Isis reported (on a Saturday, no less) mid-stage results on ISIS-APOCIIIrx as a monotherapy treatment for familial chylomicronemia syndrome, or FCS. According to the study, all patients with this rare disease characterized by extremely high triglyceride levels demonstrated a reduction in triglyceride levels below the 500 mg/DL mark. This drop, as the press release notes, would "significantly reduce the risk of an acute pancreatic event." ISIS-APOCIIIrx also achieved a reduction in APOC-III and APOC-III-asscoiated very low-density lipoprotein cholesterol. With 31 ongoing studies the hits just keep on coming for Isis.
Another shoulder shrug
Middling in neither good nor bad territory this week was struggling big pharmaceutical company Eli Lilly (LLY 2.63%), which reported mixed data on experimental cancer therapy ramucirumab. On the plus side, in a late-stage advanced gastric cancer trial ramucirumab met both its primary endpoint of improved overall survival and its secondary endpoint of improved progression-free survival. Stomach cancer is a difficult disease to treat, so having two positive trials for ramucirumab for gastric cancer certainly looks like a good sign for an approval. On the other hand, in a late-stage metastatic HER2-negative breast cancer study ramucirumab demonstrated a benefit, but not a statistically significant one from the placebo, causing it to not meet its primary endpoint. All things considered, one out of two isn't bad these days for Eli Lilly, whose pipeline has struggled mightily between trial disappointments and patent expirations.
Not everything went shareholders' way this week in the biotech sector, though. Ask shareholders in AMAG Pharmaceuticals (AMAG) or Nektar Therapeutics (NKTR 3.84%), and they'll tell you this week couldn't have ended soon enough.
For AMAG, everything fell apart on Wednesday after it filed an 8-K with the Securities and Exchange Commission to inform shareholders that it had received a notification from the Food and Drug Administration with regard to its supplemental new drug application for its Feraheme injection. According to the 8-K, the FDA identified "deficiencies that preclude discussion of labeling and postmarketing requirements/commitments." This wording could be completely benign and simply mean that AMAG and the FDA need to discuss labeling of the product. Then again, this could mean something totally different, such as the need to conduct a post-approval safety study which would cost quite a lot. Until we have more certainty with regard to the FDA's concerns, AMAG shareholders are sort of left out in the cold. Shares fell 18% this week.
But the worst weekly performance went to Nektar Therapeutics, which dove 24.5% this week after reporting disappointing preliminary top-line mid-stage data for NKTR-181. This completely in-house drug was developed as a chronic pain reliever for osteoarthritis of the knee. Of the 295 patients in the trial, 213 achieved an average pain reduction of 40%, with just 3% achieving no pain reduction whatsoever. The problem was the placebo, which Nektar assumed would cause an increase in pain, actually caused a pain reduction as well, making NKTR-181 miss its primary endpoint of statistical significance. Although Nektar is down, I think NKTR-181 showed decisive clinical benefits and I doubt this is the last time we hear from this experimental therapy. In addition, with nine FDA-approved therapies, 19 ongoing trials, and a slew of partnerships, I'd make sure you keep Nektar high up on your Watchlist.