This week, FDA granted emergency use authorization (EUA) to
Pfizer ( PFE Quick Quote PFE - Free Report) and BioNTech’s COVID-19 vaccine. AstraZeneca ( AZN Quick Quote AZN - Free Report) proposed to buy biotech giant Alexion ( ALXN Quick Quote ALXN - Free Report) and Eli Lilly ( LLY Quick Quote LLY - Free Report) raised its 2020 sales and earnings guidance, and provided upbeat outlook for 2021. Recap of the Week’s Most Important Stories The FDA granted EUA for Pfizer/BioNTech’s mRNA-based coronavirus vaccine candidate, BNT162b2. The FDA Grants Emergency Approval for Pfizer’s COVID-19 Vaccine: FDA’s EUA approval came just a day after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-4, recommending that the FDA grant the EUA. Vaccinations in the United States are expected to begin from Monday. Pfizer and BioNTech have plans to file a biologics license application for possible full regulatory approval in 2021 as it gathers additional data from ongoing studies on BNT162b2.
The EUA was based on data from a phase III study announced last month, which showed that BNT162b2, a two-shot vaccine, was 95% effective in preventing COVID-19 after two doses were given three weeks apart. Pfizer/BioNTech had filed the EUA on Nov 20. BNT162b2 is now approved for emergency use in the United States, United Kingdom, Bahrain, Mexico, Singapore and Canada.
AstraZeneca announced a AstraZeneca to Buy Alexion: definitive agreement to acquire rare disease drugmaker Alexion for $175 per share or $39 billion. The acquisition, if successful, will diversify AstraZeneca’s portfolio from oncology and cardiovascular areas to rare disease. The proposed cash-and-stock acquisition will add Alexion’s blockbuster drug Soliris, approved for treating four ultra-rare disorders and newly launched Ultomiris, second-generation C5 complement inhibitor, to AstraZeneca’s portfolio. Per the deal, holders of each Alexion share will get $60 in cash and 2.1243 of AstraZeneca American depositary shares. Alexion shareholders will own approximately 15% of the combined company, once the acquisition closes. The buyout has been approved by the boards of both the companies.
European Commission approved AstraZeneca’s triple combination therapy, Trixeo Aerosphere, as maintenance treatment for chronic obstructive pulmonary disease (COPD). The triple combination therapy is already approved by the trade name of Breztri Aerosphere in Japan, China and the United States.
Meanwhile, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending conditional marketing authorization of AstraZeneca’s antibody drug conjugate (ADC), trastuzumab deruxtecan in the European Union for third-line HER2-positive metastatic breast cancer
The CHMP also gave nod to a new four-week, fixed-dose regimen of AstraZeneca’s PD-L1 inhibitor, Imfinzi, in the approved indication of unresectable non-small cell lung cancer (NSCLC) after chemoradiation therapy in Europe.
Lilly issued a Lilly Issues 2021 Outlook and Ups 2020 Guidance: better-than-expected financial guidance for 2021 and raised its previously issued 2020 sales and earnings projections.
Lilly expects adjusted earnings in the range of $7.75-$8.40 per share for 2021. Revenues in 2021 are expected in the range of $26.5-$28.0 billion as volumes are expected to grow on continued price decline. Lilly expects its revenue growth to be driven by higher demand for key products including Trulicity, Taltz, Verzenio, Jardiance, Olumiant, Cyramza, Emgality, Tyvyt, as well as the newly launched cancer drug, Retevmo. Importantly, Lilly expects revenues in the range of $1-$2 billion from COVID-19 therapies.
Lilly also raised its previously issued 2020 adjusted earnings and sales outlook. It expects full-year earnings in the range of $7.45- $7.65, up from the prior expectations of $7.20-$7.40. Revenues are expected in the range of $24.2-$24.7 billion, up from the prior expectation of $23.7-$24.2 billion. Expectations for higher bamlanivimab sales due to an additional purchase agreement signed with the U.S. government this month led to the guidance increase.
Lilly also announced a definitive agreement to acquire New York-based gene therapy maker,
Prevail Therapeutics, for $22.50 per share in cash or an aggregate value of $880 million. The acquisition will add Prevail’s promising gene-therapy candidates, targeting neurodegenerative diseases, to Lilly’s portfolio. ( J&J’s COVID-19 Vaccine Study Fully Enrolled: J&J JNJ Quick Quote JNJ - Free Report) said that its ENSEMBLE phase III study on its single-dose COVID-19 vaccine candidate, JNJ-78436735, is now fully enrolled with approximately 45,000 participants. J&J had earlier said it will enroll 60,000 participants globally. However, it clarified that 45,000 participants will be sufficient to generate the data needed to determine the efficacy and safety of the candidate.
The ENSEMBLE study was paused in October due to an unexplained illness observed in a study participant. The study was resumed later in the month. J&J expects to report interim efficacy data from the ENSEMBLE study by end of January 2021. If the data are positive, J&J will file application for EUA from the FDA in February.
Novartis New Acquisition to Boost Neuroscience Pipeline: Novartis ( NVS Quick Quote NVS - Free Report) announced a definitive agreement to acquire Cambridge, Massachusetts-based private neuroscience biotech, Cadent Therapeutics. The acquisition will strengthen Novartis’ neuroscience portfolio by adding two clinical stage programs, CAD-9303 for schizophrenia and CAD-1883for movement disorders. The deal also involves buyout by Novartis of milestones and royalties for an experimental phase II candidate for depression, MIJ821, which was previously in-licensed by the company from Cadent in 2015.
Meanwhile, Novartis’ phase III study evaluating
ruxolitinib for hospitalized patients with COVID-19 failed to meet the primary endpoint. The study failed to show that treatment with ruxolitinib plus standard of care (SOC) medicine led to a statistically significant reduction in the number of hospitalized COVID-19 patients who experienced severe complications (death, mechanical ventilation or ICU care) compared to SOC alone.
Novartis also announced that an
FDA advisory committee voted 12-1 recommending approval for expanded use of Entresto for the treatment of patients with heart failure with preserved ejection fraction (HFpEF). Entresto is already approved heart failure with reduced ejection fraction (HFrEF). The FDA is expected to give its decision on the sNDA seeking approval of Entresto for HFpEF in the first quarter of 2021.
Novartis phase III KESTREL study evaluating its ophthalmology drug, Beovu (brolucizumab 6 mg) for treating diabetic macular edema (DME) met its primary and key secondary endpoints. Beovu achieved its primary endpoint demonstrating non-inferiority to Regenron/Bayer’s Eylea (aflibercept) 2 mg in mean change in best-corrected visual acuity (BCVA) at year one (week 52). KESTREL is the second successful study on Beovu in the DME indication. Positive top-line data from the first phase III study, KITE, were announced in September. Data from both the studies are expected to be filed with regulatory authorities to seek approval for the DME indication in the first half of next year. Beovu is already approved in the United States and the EU for the treatment of wet age-related macular degeneration (AMD).
Meanwhile the FDA granted Breakthrough Therapy Designation to Novartis’s investigational oral therapy iptacopan (LNP023) for paroxysmal nocturnal hemoglobinuria (PNH) and Rare Pediatric Disease Designation for C3 glomerulopathy.
The FDA granted priority review to a supplemental Biologics License Application (sBLA) seeking approval of FDA Grants Priority Review Tag to Merck’s Keytruda sBLA: Merck’s ( MRK Quick Quote MRK - Free Report) Keytruda plus chemotherapy as first-line treatment for locally advanced or metastatic esophageal and gastroesophageal junction cancer. The sBLA was based on positive data from the pivotal phase III KEYNOTE-590 study. The FDA’s decision is expected on Apr 13, 2021.
Merck also announced data from a phase III study (KEYNOTE-775/Study 309) which showed that a combination of Keytruda and Lenvima demonstrated a statistically significant improvement in overall survival, progression-free survival and objective response rate versus chemotherapy in patients with advanced endometrial cancer following at least one prior platinum-based regimen. Please note that the Keytuda+Lenvima combo was approved on an accelerated basis to treat advanced endometrial cancer in 2019 based on tumor response rate and durability of response data from the KEYNOTE-146/Study 111. The KEYNOTE-775 is the confirmatory trial for KEYNOTE-146.
The NYSE ARCA Pharmaceutical Index declined 0.7% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
Last week Lilly recorded the maximum gain (7.2%) while Pfizer declined the most (9.4%).
In the past six months, while Pfizer recorded the maximum rally (13.2%) AstraZeneca declined the most (4.1%).
(See the last pharma stock roundup here:
FDA Panel’s Nod to PFE/BNTX Coronavirus Vaccine, Other Updates) These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking.
Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
See the 5 high-tech stocks now>>