The key headlines in the biotech sector this week include Regeneron Pharmaceuticals’ (REGN - Free Report) strong Q2 results and its $100 million investment in bluebird bio (BLUE - Free Report) . Meanwhile, among regular pipeline and regulatory updates, Gilead (GILD - Free Report) is making further inroads into China with its HIV franchise.
Recap of the Week’s Most Important Stories:
Regeneron Reports Strong Results for the Second Quarter: Like most of its other biotech peers, bigwig Regeneron’s second-quarter results were impressive. The company comfortably beat both earnings and sales estimates on the back of growth in Dupixent’s sales, which came in at $209 million. Flagship drug Eylea sales maintained the momentum as well. Net product sales increased to $996 million in the quarter, up 8% year over year. The majority of sales came from Eylea in the United States ($992 million, up 8%). Regeneron’s efforts to expand the label of its approved drugs and concurrently develop its pipeline are encouraging as well. The potential label expansion of Eylea in patients with wet age-related macular degeneration will further boost sales. The company is also working to expand Dupixent’s label, which should diversify the company’s revenue base and reduce dependence on Eylea. Cemiplimab’s progress looks promising as well.
Gilead’s HIV Regimen Gets Approval in China: Gilead announced today that the China National Drug Administration (CNDA) has approved its HIV regimen Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. Genvoya is the first TAF-based single tablet regimen for the treatment of HIV to be approved in China. The regimen is approved in China as a complete regimen for the treatment of adults and adolescents (aged 12 years and older with body weight of at least 35 kg) infected with HIV-1 without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir. Genvoya carries a boxed warning in its product label regarding the risks of post treatment acute exacerbation of hepatitis B in the United States. Gilead was the first to bring to market a single-tablet regimen (STR) for the treatment of HIV – Atripla. Additional STRs for HIV in the market include Complera/Eviplera and Stribild among others. The TAF-based products Genvoya, Odefsey and Descovy are performing well with strong adoption in both the United States and Europe. Approval in China should further boost sales.
Gilead currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
bluebird bio Surges on Collaboration with Regeneron: Shares of bluebird bio (BLUE - Free Report) surged following news that Regeneron will make a $100 million investment in the company’s common stock at a price of $238.10 per share. The share price represents a 59% premium over the $150 closing price on Aug 3, 2018. Both companies have collaborated on applying their respective technology platforms to the discovery, development and commercialization of novel immune cell therapies for cancer. Regeneron will leverage its VelociSuite platform technologies for the discovery and characterization of fully human antibodies as well as T cell receptors (TCRs) directed against tumor-specific proteins and peptides while bluebird bio will contribute its field-leading expertise in gene transfer and cell therapy. Regeneron and bluebird have jointly selected six initial targets and will equally share the costs of research and development up to the point of submitting an Investigational New Drug (IND) application. Both companies might select additional targets over the five-year research collaboration term. When an IND is submitted for a potential cell therapy product, Regeneron will have the right to opt-in to a co-development/co-commercialization arrangement for certain collaboration targets, with 50/50 cost and profit sharing. If Regeneron decides not to opt-in, it will be entitled to receive payments and royalties from bluebird bio on any potential resulting products.
Vertex Gets FDA Approval For Label Expansion of Orkambi: Vertex Pharmaceuticals (VRTX - Free Report) announced that the FDA has approved a label expansion of Orkambi (lumacaftor/ivacaftor) for use in children 2 through 5 years of age with cystic fibrosis (CF), who have two copies of the F508del-CFTR mutation. Orkambi is already approved for the treatment of CF in patients ages 6 and older. The company’s application for the same is under review in Europe and a decision is expected in the first half of 2019.
Spark Plunges on Data From Hemophilia A Trial: Shares of Spark Therapeutics (ONCE - Free Report) crashed 27.8% as the company’s second-quarter results were overshadowed by the results of phase I/II trial for experimental hemophilia A candidate, SPK-8011. Per the company, 12 participants in the trial received a single administration of SPK-8011, including two at a dose of 5x1011 vector genomes (vg)/kg body weight, three at a dose of 1x1012 vg/kg and seven at a dose of 2x1012 vg/kg. A 97% reduction in annualized bleeding rate (ABR) and a 97% reduction in annualized infusion rate (AIR) was observed across all participants, at all three doses, beginning four weeks after vector infusion. The results showed that five of the participants in the 2x1012 vg/kg cohort have FVIII activity levels between 16% and 49% with the mean FVIII activity for these five participants being 30% based on average FVIII levels post-12 weeks after vector infusion. However, the other two participants in the 2x1012 vg/kg cohort had an immune response that caused their FVIII levels to decline to less than 5%. Consequently, both of these participants were moved from prophylactic to on-demand treatment. Moreover, one of these participants did not rapidly respond to oral steroids and was hospitalized to receive two intravenous (IV) methylprednisolone infusions. While the event was subsequently resolved, the admission to hospital for these infusions met the criteria for a serious adverse event (SAE). Investors were not too impressed with this data and shares of the company plummeted on the same.
The NASDAQ Biotechnology Index gained 1.63% over the last five trading sessions. Among the major biotech stocks, Regeneron has gained 6.36%. Over the past six months, Celgene has lost 5.10% while Regeneron has gained 16.9%. (See the last biotech stock roundup here: Biotech Stock Roundup: Celgene, Amgen, Vertex Impress in Q2, Gilead's CEO to Exit)
What's Next in Biotech?
Stay tuned for regulatory updates and pipeline development news.
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