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To kick off the New Year, I have something for everyone, including a can't-miss biotech event, an earnings report that could tell us more than you think, and a once-a-year massive health-care conference.
On the biotech front, Johnson & Johnson (NYSE: JNJ ) subsidiary Janssen Pharmaceuticals is once again going to take center stage when it goes before the Food and Drug Administration's advisory panel on Thursday for Invokana, its Type 2 diabetes drug. Invokana, previously known as Canagliflozin, was studied in multiple late-stage trials in patients with Type 2 diabetes who were at an elevated risk for cardiovascular disease. The results indicated that after 18 weeks it was more effective in reducing A1C levels than the placebo with similar adverse events and good tolerability. Invokana also met its secondary endpoints, which included modest weight loss and lower systolic blood pressure, and, as Foolish biotech guru Brian Orelli noted, it performed markedly better in trials than Merck's (NYSE: MRK ) billion-dollar drug, Januvia.
This will be a key year for SGLT-2 inhibiting drugs like Invokana, which allow excess glucose to escape through the body's urine. In November, the European Union approved AstraZeneca (NYSE: AZN ) and Bristol-Myers Squibb's (NYSE: BMY ) Forxiga, an SGLT-2 inhibitor, and the first of its kind to be approved, period. In studies, Forxiga reduced A1C levels by 0.8% to 1%, slightly higher than Invokana's 0.75%. Needless to say, this panel meeting could set the tone for the year on Type 2 diabetes, so keep your eyes peeled.
In the earnings department, we can expect to hear from Raptor Pharmaceuticals (NASDAQ: RPTP ) this week. The company's quarterly projected loss, however, won't be the big talk. Instead, look for investors to queue up for what management has to say, if anything, about Procysbi (previously RP103) for the treatment of nephropathic cystinosis. Procysbi was set to receive an a decision from the FDA in late January before the FDA announced it was going to need an additional 90 days, pushing its decision back to late April. Despite the decision extension, JMP Securities continues to pound the table on Raptor and expects an eventual approval of the drug. Considering that Procysbi was proved to be non-inferior to Mylan's (NASDAQ: MYL ) Cystagon in late-stage trials, and actually was used in lower and less-frequent doses, I can't help agreeing with JMP Securities.
Last, but in no way least, we have the JPMorgan Healthcare Conference in San Francisco, Jan. 7-10. It would be impossible to list all of the presenting companies at this conference, but let me state that this is probably the most important or second most important health-care conference of the year, rivaled only by ASCO. With this being another big year for patent expirations, keep your eyes peeled for possible drug combination talks as industry bigwigs mingle with smaller biotech companies to forge drug development pacts.
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