With the SPDR S&P Biotech Index up 39% year-to-date, it's very 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.
Eli Lilly (LLY -1.81%) shot out of the gate like a cannon earlier in the week after announcing that its experimental Alzheimer's drug, solanezumab, reduced memory decline in patients with a mild form of the disease over an 18-month period by 34%. With many Alzheimer's drug hopeful's being written off for dead-Johnson & Johnson and Pfizer's bapineuzumab for example – further studies may prove that solanezumab is effective in earlier stages of the disease. As announced earlier this week, scientists selected solanezumab and two other experimental drugs to be used in a two-year study in preventing Alzheimer's.
As summed up by my colleague Keith Speights on Tuesday, Novartis (NVS 1.10%) also received some good fortune from a decision reversal. The U.K.'s National Institute for Health and Clinical Excellence announced its decision to recommend Lucentis as a treatment for diabetic macular edema. Previously, the agency had come out against Lucentis as a treatment for DME. With approximately 50,000 people suffering from DME in the U.K., Lucentis should provide a nice boost for Novartis.
Celgene (CELG) ended the week on a high note by announcing that it won new marketing approval for Abraxane as a primary treatment for non-small cell lung cancer in combination with chemotherapy agent carboplatin for those patients who are not eligible for surgery or radiation therapy. Celgene's focus is on broadening Abraxane's indications, and a late-stage trial earlier this month indicating positive results in slowing the progression of skin cancer melanoma, along with this new indication for primary NSCLC, signal it's well on its way.
Shareholders of NPS Pharmaceuticals (NASDAQ: NPSP) also got their piñatas out on Friday following the release of briefing documents by the FDA regarding recommendation from the Gastrointestinal Drug Advisory Committee. The committee, despite noting three issues with NPS' short bowel syndrome drug, Gattex, recommended no restrictions be placed on the drug. With safety unlikely a concern, and Gattex demonstrating statistically positive late-stage results, next week's FDA panel advisory meeting should hopefully be a breeze. .
Filed under the "it can't always be sunny" column, Amarin (AMRN -0.53%) was the one true downside surprise this week. Amarin can't seem to win for trying as it released word in an 8-K that the FDA still hasn't decided whether to award Vascepa, its FDA-approved triglyceride reducing drug, new chemical entity, or NCE, status. Clearly, Amarin has made its case for why its drug deserves NCE status and the five-year marketing exclusivity period that goes along with it, but the length of time the FDA is taking to make its decision is making investors skittish .
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