Like most of the drug/biotech companies, Novo Nordisk NVO and Bristol-Myers BMY announced strong first-quarter results, beating estimates on both counts. The FDA granted Emergency Use Authorization (EUA) to Roche’s RHHBY COVID-19 diagnostic test while Pfizer PFE and its German-based partner began dosing in a U.S. COVID-19 vaccine study.
Recap of the Week’s Most Important Stories:
Novo Nordisk & Bristol-Myers Q1 Results: Bristol Myers beat estimates for both earnings and sales in the first quarter. While earnings rose 56%, total revenues increased 82%, mainly driven by the addition of Celgene’s products and 37% increase in sales of its blood thinner drug, Eliquis. The company maintained its earnings guidance for 2020 but slightly lowered its sales expectations. The company expects earnings of $6.00-$6.20 per share. Revenues are expected in the range of $40-$42 billion compared with the previous guidance of $40.5-$42.5 billion
Novo Nordisk’s earnings and sales beat estimates. Sales in the Diabetes and Obesity Care segment increased 14% at CER while that in the Biopharmaceuticals segment increased 16%. Novo Nordisk maintained its guidance for 2020. The company expects 3-6% sales growth at CER for 2020.
Pfizer/ BioNTech Begin U.S. Studies on Coronavirus Vaccine: Pfizer and its Germany-based partner BioNTech announced that the first patients have been dosed in the United States in the phase I/II clinical study for BioNTech’s mRNA-based vaccine program, BNT162 to prevent COVID-19. Pfizer and BioNTech announced plans to co-develop a vaccine to prevent COVID-19 in March. Four vaccine candidates, each representing different mRNA formats and target antigens, will be evaluated in a single, continuous study in the United States. Last month Germany’s regulatory authority granted approval to begin a phase I/II clinical study in Germany. The dosing of the first cohort in Germany was completed last week.
FDA Grants Emergency Use to Roche’s New COVID-19 Antibody Test: The FDA granted Emergency Use Authorization to Roche’s new serology test, Elecsys, for detecting antibodies in people who have been exposed to SARS-CoV-2, the virus that causes COVID-19 disease. Elecsys is now available in countries that accept the CE mark. Roche has started shipping the test to global laboratories and has plans to increase production capacity to high double-digit millions per month. In March, the FDA had issued an EUA for Roche’s cobas SARS-CoV-2 test developed for qualitative detection in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing.
Lilly to Make COVID-19 Antibodies With China-based Biotech: Lilly LLY signed a collaboration with China-based Junshi Biosciences to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19. Junshi Biosciences has identified multiple neutralizing antibodies and the lead asset is expected to enter clinical studies in the second quarter. While Junshi Biosciences will have all rights to products under the deal in Greater China, Lilly will receive exclusive development, manufacturing and distribution rights of products outside Greater China.
FDA Approves Novartis’ Capmatinib and AstraZeneca’s Farxiga for Heart Risk: The FDA granted accelerated approval to Novartis’ NVS capmatinib, an oral selective MET inhibitor, for first-line and previously treated patients with metastatic MET exon14 skipping-mutated non-small cell lung cancer (NSCLC) — a type of lung cancer with a particularly poor prognosis. Capmatinib will be marketed by the trade name of Tabrecta and is the first therapy approved in the United States to specifically target METex14 mutated advanced lung cancer. Novartis acquired rights to Tabrecta from Incyte in 2009 and the approval triggers a $70 million-milestone payment to Incyte.
AstraZeneca’s AZN SGLT2 inhibitor, Farxiga was also approved by the FDA to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in patients with reduced ejection fraction, with and without type-II diabetes. The sNDA was based on positive results from the DAPA-HF study on Farxiga.
FTC Clears AbbVie-Allergan Merger: AbbVie and Allergan announced that the U.S. Federal Trade Commission (FTC) cleared AbbVie’s pending acquisition of Allergan. The companies had announced the cash-and-stock deal worth nearly $63 billion in June last year. The closing of the acquisition still remains subject to other customary closing conditions. In connection with the pending merger, Allergan agreed to divest its mid-stage immunology candidate brazikumab and marketed medicine, Zenpep to AstraZeneca and Nestle, respectively. In March, the European Commission (EC) approved the divestiture of brazikumab to AstraZeneca. The EC had approved the merger in January, conditional on the divestiture of brazikumab. EC’s final approval cleared the path in Europe for the pending merger.
Sanofi/Regeneron’s Libtayo Shows Response in Difficult Skin Cancer: Sanofi and Regeneron announced that their PD-1 inhibitor Libtayo demonstrated clinically meaningful and durable response in a phase II study in patients with locally advanced basal cell carcinoma, a difficult to treat skin cancer. In the study, the objective response rate in patients treated with Libtayo was 29%. Meanwhile approximately 85% of patients who responded to Libtayo maintained their response for at least one year. Libtayo is presently approved to treat metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC.
FDA Delays Decision on Bristol-Myers’ CAR-T Therapy: The FDA delayed its PDUFA date for Bristol-Myers’ biologics license application (BLA) seeking approval for its CAR-T-cell immunotherapy, lisocabtagene maraleucel (liso-cel) for the treatment of relapsed or refractory large B-cell lymphoma by three months. The FDA will now give its decision on Nov 16 instead of theprior date of Aug 17. The BLA filing was based on results from the TRANSCEND NHL 001 study. The candidate was added to Bristol-Myers’ portfolio with the $74 billion-acquisition of Celgene. After Bristol-Myers filed the BLA, it submitted additional information to the FDA, which the latter classified at a major amendment to the BLA and hence delayed its decision.
The NYSE ARCA Pharmaceutical Index declined 0.7% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last five trading sessions.
Last week, AstraZeneca rose the most (0.9%) while Merck declined the most (4.7%).
In the past six months, Lilly has risen the most (35.7%) while Merck declined the most (9.2%).
(See the last pharma stock roundup here: Q1 Earnings of LLY, Coronavirus Update from PFE, NVS, AZN)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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Novo Nordisk AS (NVO) : Free Stock Analysis Report
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