Regeneron REGN got a bit of a boost with the company and its partner being allowed to continue marketing their PCSK9 inhibitor, Praluent, pending their appeal in a patent infringement lawsuit. Meanwhile, Gilead GILD , which saw its shares being punished for a not-so-rosy outlook for 2017, presented promising data on its HIV franchise.
Recap of the Week's Most Important Stories
Regeneron, Sanofi PCSK9 Inhibitor to Remain in Market During Appeal Process: Regeneron and partner Sanofi got a reprieve in their PCSK9 inhibitor patent infringement case with the United States Court of Appeals for the Federal Circuit suspending the permanent injunction for Praluent pending the companies' appeal. This means that Sanofi and Regeneron will continue marketing, selling and manufacturing Praluent in the U.S. while the appeal process against Amgen is ongoing. The companies are challenging the injunction ruling as well as the validity judgment. Although both PCSK9 inhibitor sales are yet to ramp up significantly, the market represents huge commercial potential.
Gilead Presents Promising HIV Data: Gilead was present with data on its HIV treatments at the 2017 Conference on Retroviruses and Opportunistic Infections. The company presented promising mid-stage data on bictegravir plus emtricitabine/tenofovir alafenamide (FTC/TAF) compared to GlaxoSmithKline's Tivicay (dolutegravir) plus FTC/TAF in treatment naïve, HIV-1 infected adults. High virologic response rates were observed in the study. The bictegravir combination is currently in phase III studies with data expected later this year (Read more: Gilead Announces Data on Combination Therapy for HIV ). Gilead also presented data on Genvoya which showed higher rates of virologic suppression and favorable renal and bone laboratory parameters compared to Stribild through three years of treatment. Findings from a preclinical study evaluating HIV capsid inhibitors (CAIs) for potential use as a long-acting antiretroviral (ARV) treatment were also presented.
Gilead's been under pressure for quite a while now with the company providing a disappointing outlook for 2017. The company has underperformed the Zacks-categorized Medical-Biomedical/Genetics industry year to date (YTD) with shares declining 5.7% compared to the industry gain of 4.5%. The company's hepatitis C virus (HCV) franchise, which was a major revenue generator, is expected to post a steep decline in sales in 2017.
EU Nod for Incyte's Olumiant: Incyte INCY , which reported fourth quarter results this week, also gained EU approval for its rheumatoid arthritis (RA) treatment, Olumiant. Olumiant can be used for the treatment of moderate-to-severe active RA in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs). This makes Olumiant the first JAK inhibitor approved to treat RA in the EU which may be used as monotherapy or in combination with methotrexate. The EU approval triggers a $65 million milestone payment from partner Lilly that will be recorded by Incyte in the first quarter of 2017 (Read more: Lilly's Olumiant Gets Marketing Authorization in Europe ).
Olumiant is currently under review in the U.S. with the FDA extending the review period by three months in January. Incyte is a Zacks Rank #3 (Hold) stock. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .
Seattle-Immunomedics in ADC Deal Worth $2B: Seattle Genetics SGEN , which reported fourth quarter results last week (Read more: Seattle Genetics Loss Wider than Expected in Q4, Revenues Miss ), announced a development and license agreement with Immunomedics for sacituzumab govitecan (IMMU-132), an antibody-drug conjugate (ADC). Sacituzumab govitecan has breakthrough therapy status in the U.S. for triple negative breast cancer (TNBC) in patients who have failed prior therapies for metastatic disease. A phase I/II study for this indication is ongoing -- a BLA will be filed based on data from this study. With this deal, Seattle Genetics is looking to strengthen its ADC pipeline and possibly benefit from a near-term opportunity to commercialize a second drug in the U.S.
Immunomedics' shares were up on the deal which will see the company getting an upfront payment of $250 million. Immunomedics will also be entitled to payments of up to about $1.7 billion on the achievement of development, regulatory and sales milestones across multiple indications and geographic regions, as well as tiered double-digit royalties. Seattle Genetics will also acquire a stake in Immunomedics.
Acorda Shoots Up on Parkinson's Study Data: Acorda's ACOR shares soared on positive data from a late-stage study on CVT-301, which showed a statistically significant improvement in motor function in people with Parkinson's disease experiencing OFF periods. Acorda expects to seek FDA approval for the drug in the second quarter while data from a couple of long-term safety studies is expected this quarter. EU regulatory submission is being targeted by year end.
According to information provided by the company, about one million people in the U.S. and 1.2 million in Europe suffer from Parkinson's disease with OFF periods being experienced by about 350,000 in the U.S. and 420,000 in Europe. CVT-301 became a part of Acorda's pipeline following its $525 million acquisition of Civitas.
Medical - Biomedical and Genetics Industry 5YR % Return
The NASDAQ Biotechnology Index was up 2.6% over the last five trading sessions. Among major biotech stocks, Biogen BIIB was up 7.2% while Gilead declined 7.6%. Over the last six months, Gilead was down 15.2%, while Celgene CELG was up 2.1% (See the last biotech stock roundup here: Amgen, Gilead Report 4Q Results, ARIAD Seeks EU Nod for Brigatinib ).
What's Next in the Biotech World?
Watch out for the usual pipeline and regulatory updates. Meanwhile, will Tesaro be the next biotech acquisition target?
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