Track the companies that matter to you. It's FREE! Click one of these fan favorites to get started: Apple; Google; Ford.

Tuesday’s Top Biotech Stories: Vanda Pharmaceuticals, Prosensa, and Clovis Oncology

Let's take a quick look at three stocks -- Vanda Pharmaceuticals (NASDAQ: VNDA  ) , Prosensa Holding (NASDAQ: RNA  ) , and Clovis Oncology (NASDAQ: CLVS  ) -- which could all make waves across the health care sector this Tuesday morning.

The European Medicines Agency accepts Vanda's MAA for Hetlioz
The European Medicines Agency (EMA) just accepted Vanda Pharmaceuticals' Marketing Authorization Application (MAA) for Hetlioz (tasimelteon), a treatment for non-24-hour sleep-wake disorder (non-24). Non-24 is a rare disorder which affects blind people who have trouble adjusting their sleep cycles to natural circadian rhythms. Vanda stated that as many as 95,000 people in the U.S. and 130,000 people in Europe suffer from non-24.

The FDA approved Hetlioz in January, and Vanda launched the drug in the U.S. on April 21, 2014. Analysts polled by Thomson Reuters expect the drug to achieve peak sales of $295 million by 2018.

Hetlioz is Vanda's second approved product. Its other marketed product is the schizophrenia drug Fanapt, which is commercialized in the U.S. and Canada by Novartis under a licensing agreement. Vanda reported revenues of $33.9 million in fiscal 2013, including $7.1 million in royalties from Fanapt. It finished last year with a net loss of $0.67 per share, or $20.3 million.

Prosensa surges after the FDA outlines an accelerated approval pathway for drisapersen
Meanwhile, shares of Prosensa Holdings are up modestly in pre-market trading this morning, after the FDA outlined an accelerated approval pathway for drisapersen, its experimental treatment for Duchenne Muscular Dystrophy (DMD), based on its existing trial data.

DMD is a rare and fatal genetic disease which causes muscular atrophy in approximately one out of 3,500 boys worldwide. The disease confines most patients to a wheelchair by age 12 and dramatically decreases life expectancy. There are no approved treatments for DMD. Two experimental drugs -- Prosensa's drisapersen and Sarepta's (NASDAQ: SRPT  ) eteplirsen -- are the most closely watched potential treatments for DMD.

The key takeaway from this morning's announcement is that the FDA now has enough faith in drisapersen to put it on an accelerated path toward a market approval. It's also a much needed vote of confidence for Prosensa, which has fallen out of favor after former partner GlaxoSmithKline ended their marketing partnership for drisapersen in January.

Based on the positive development with the FDA, Prosensa now plans to file an new drug application (NDA) for drisapersen later this year, committing to two confirmatory post-approval studies. The company has also expressed its intention for a filing in Europe as well. If approved, Kepler Capital Markets believes that Prosensa's drisapersen could generate peak sales of £500 million ($838 million), which is roughly the same as estimates for Sarepta's eteplirsen. Sarepta also plans to file an NDA for eteplirsen by the end of the year.

Clovis continues falling on hyperglycemia fears
Last but not least, Clovis Oncology is down 10% in pre-market trading this morning, due to fears that one of its two lead drug candidates, the lung cancer drug CO-1686, could be causing difficult-to-control hyperglycemia, with many patients on metformin and potentially a few on insulin.

Clovis CEO Pat Mahaffay noted in an interview on CNBC yesterday that some lung cancer patients in the ongoing phase I/II study of CO-1686 were now taking metformin to control high blood sugar levels caused by the experimental drug, and that a few patients had "briefly" gone on insulin when they had initially discovered the high blood sugar. However, Mahaffay reiterated that the drug does not cause diabetes.

Analysts at Mizuho Securities stated that the high blood sugar level found in some patients "appears manageable", and still believes that the drug is superior to its closest competitor, AstraZeneca's AZD9291, in terms of progression-free survival. Both Clovis and AstraZeneca's drugs target mutated, drug-resistant cancer cells which are resistant to traditional treatments like Roche's Tarceva and AstraZeneca/Teva's Iressa.

Clovis' two most advanced pipeline products are CO-1686 and rucaparib, a potential treatment for ovarian cancers with specific mutations. Analysts at Goldman Sachs believe that CO-1686 could generate peak sales of $1.9 billion if approved. Clovis does not have any marketed products.

Will this stock be your next multi-bagger?
Give us five minutes and we'll show how you could own the best stock for 2014. Every year, The Motley Fool's chief investment officer hand-picks one stock with outstanding potential. But it's not just any run-of-the-mill company. It's a stock perfectly positioned to cash in on one of the upcoming year's most lucrative trends. Last year his pick skyrocketed 134%. And previous top picks have gained upwards of 908%, 1,252% and 1,303% over the subsequent years! Believe me, you don't want to miss what could be his biggest winner yet! Just click here to download your free copy of "The Motley Fool's Top Stock for 2014" today.


Read/Post Comments (0) | Recommend This Article (0)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

Be the first one to comment on this article.

Sponsored Links

Leaked: Apple's Next Smart Device
(Warning, it may shock you)
The secret is out... experts are predicting 458 million of these types of devices will be sold per year. 1 hyper-growth company stands to rake in maximum profit - and it's NOT Apple. Show me Apple's new smart gizmo!

DocumentId: 2980304, ~/Articles/ArticleHandler.aspx, 3/26/2015 10:05:03 PM

Report This Comment

Use this area to report a comment that you believe is in violation of the community guidelines. Our team will review the entry and take any appropriate action.

Sending report...