The health care sector is showing no signs of slowing down in 2014, and the rapid-fire pace of novel therapies coming to market appears to be speeding. With that in mind, here's a Foolish look at three companies that could see their drugs get approved in the New Year.
Dynavax Technologies (NASDAQ: DVAX ) had a rough year in 2013 after its hepatitis B vaccine candidate, Heplisav, was rejected by the Food and Drug Administration. As a refresher, Heplisav was deemed superior to currently available vaccines, but the FDA wanted more data on the drug's safety profile. As a result, Dynavax spent most of 2013 designing a new clinical trial and raising cash to fund it. This final late-stage trial is set to get under way in early 2014, with results expected by mid-2015.
Why is Dynavax worth watching? Simply put, Heplisav's approval would be a game-changer for this mid-cap biotech. Because Heplisav is more effective in a broader range of patients and requires fewer doses than currently available vaccines, experts believe it will help grow the already $700 million hepatitis B market. Heplisav is also currently under regulatory review in Europe, with a possible approval coming in the second half of 2014. Although sales projections in Europe aren't exactly eye-popping, it is another potential catalyst for this stock in the New Year.
While I'm not usually a fan of developmental biotechs, Dynavax does have a compelling bull case on its hands. With funding issues resolved, for the time being, and a potential approval in Europe coming soon, I think Dynavax shares will rebound in 2014. As such, you may want to dig deeper into this one.
Orexigen Therapeutics (NASDAQ: OREX ) seems to think that its obesity medication Contrave will be approved in both the U.S. and Europe next year. In fact, Orexigen's marketing partner Takeda Pharmaceutical is already into the planning process for the drug's commercial launch.
Sound confident? Well, they should be. Based upon conversations with the FDA, Orexigen believes that the interim results for its cardiovascular outcomes trial called the LIGHT study are the final piece of the regulatory puzzle. Last month, Orexigen reported that the interim analysis shows that Contrave is exhibiting an acceptable risk profile according to the FDA's pre-defined guidelines. The company also believes that the LIGHT study will provide clarity on any safety issues the European Medicines Agency, or EMA, brings up in its review of the drug.
If approved, Contrave would be the third anti-obesity drug to hit the market in two years. Yet I view that as a good thing. Contrave will benefit from Arena Pharmaceuticals' and VIVUS' efforts to develop the obesity drug market, and the potential market size is so big that competition may not be a problem. So you might want to keep tabs on this obesity drugmaker in 2014.
MannKind (NASDAQ: MNKD ) is hoping for a big year in 2014. The company's entire future pretty much hinges on the approval of its inhaled insulin product Afrezza and its delivery apparatus dubbed 'Dreamboat' next year. To recap, Mannkind reported positive late-stage trial data for its Afrezza/Dreamboat combo this year, and subsequently filed a NDA with the FDA. An approval could come as early as next April.
Why is MannKind worth watching? The diabetes market is ridiculously big and is expected to grow to a mind-boggling $100 billion by 2018. It's so big that both Eli Lilly and Novo Nordisk's fast-acting insulin products have reached megablockbuster status, and sales are still growing.
What's important to keep in mind, however, is that the Afrezza/Dreamboat combo is actually superior to these products in terms of delivering insulin. Specifically, Afrezza is an ultra-fast acting insulin that reaches peak levels within 14 minutes. As such, it is much better at mimicking the natural function of the pancreas than the fast-acting insulin analogues that take up to 30 minutes.
In a nutshell, Afrezza/Dreamboat may be the product of choice, if approved, because it is inhalable and provides faster peak insulin levels. Even though MannKind does have a high market cap for a developmental stage biotech, this is definitely a company to watch in the New Year.
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