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Good morning, fellow Foolish investors! Let's take a look at three biotech stocks that could make waves this morning -- BioCryst Pharmaceuticals (NASDAQ: BCRX ) , Verastem (NASDAQ: VSTM ) , and InterMune (NASDAQ: ITMN ) .
BioCryst's NDA for intravenous peramivir is accepted by the FDA
BioCryst Pharmaceuticals just announced that the FDA has accepted its new drug application (NDA) for intravenous peramivir, which was originally submitted last December. The drug was assigned a standard review time, which means it will be up for a PDUFA (Prescription Drug User Fee Act) review on December 23, 2014.
Peramivir is an intravenous antiviral treatment that has been tested against multiple strains of influenza, including H7N9 (avian flu) and H1N1 (swine flu), and is intended to treat patients who cannot tolerate oral or inhaled drugs. The peramivir NDA submission included results from 27 clinical trials that tested the drug on 2,700 subjects. Peramivir has already been approved in Japan and Korea, where it has been used to treat over a million patients to date. Sales could provide a considerable boost for BioCryst, which reported revenue of $26.3 million in fiscal 2012 and $6.8 million in revenue in the first three quarters of 2013.
Verastem acquires the license for VS-4718 from Poniard
Meanwhile, Verastem just announced that it acquired the license to VS-4718, an oral drug which targets cancer stem cells, from Poniard Pharmaceuticals. The acquisition gives Verastem access to all future developmental, regulatory, and commercial royalty milestones and payments associated with the drug.
Verastem does not have any marketed products, and its main pipeline focuses on drugs that kill cancer stem cells. Its most advanced treatment candidate is VS-6063, which is in phase 2 trials for mesothelioma (cancer in the protective lining of the organs) and a mutated form of lung cancer.
VS-4718 is currently in a phase 1 clinical trial for patients with advanced solid tumors. If approved, analysts at Edison Investment Research believe that VS-4178 and VS-6063 could generate peak sales of $346 million and $829 million, respectively -- not bad for a company with a market cap of $379 million.
InterMune reports positive late-stage clinical results for pirfenidone
Last but not least, InterMune just announced that its experimental lung drug, pirfenidone, showed a significant reduction of the progression of idiopathic pulmonary fibrosis (IPF), an irreversible disease that causes progressive scarring of the lungs, when compared to a placebo.
InterMune's late-stage trial showed that 16.5% of its pirfenidone group experienced disease progression, compared to 31.8% in the placebo group. Pirfenidone, which is also known by its proposed trade name Esbriet, is expected to hit peak U.S. sales of $900 million, according to analysts at Stifel Nicolaus. InterMune intends to submit a marketing application to the FDA by the third quarter of this year.
In March 2011, the European Commission granted InterMune marketing authorization for Esbriet as an orphan drug for mild to moderate IPF cases in adults. In October 2012, Esbriet was approved for the treatment of mild to moderate IPF in adult patients in Canada. The FDA has already granted Esbriet with Orphan Drug and Fast Track designations.
As a result of those approvals, sales of Esbriet have rapidly risen. According to InterMune's preliminary fourth-quarter earnings announcement, unaudited Esbriet revenue is expected to rise 212% year over year to $25.6 million. Total sales of Esbriet for fiscal 2013 are expected to rise 168% year over year to $70.2 million.
One more stock to watch this morning...
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