This week Eli Lilly LLY announced strong first-quarter results but warned that the coronavirus-related uncertainty may hurt financial results in 2020 and beyond. Roche RHHBY also announced strong first-quarter sales. As far as coronavirus research efforts are concerned, Novartis NVS announced plans to study generic malaria drug hydroxychloroquine for COVID-19 while Pfizer PFE and its Germany-based partner gained approval to start the first in-human study on COVID-19 vaccine candidate in Germany. AstraZeneca AZN announced initiation of a late-stage study on its SGLT2 inhibitor, Farxiga for COVID-19 patients who have pre-existing health conditions.
Recap of the Week’s Most Important Stories:
Lilly Q1 Earnings & Sales Top: Lilly reported strong first-quarter results, beating estimates for both earnings and sales. Its earnings grew 32% while sales rose 15%, gaining from strong underlying demand trends for key growth products like Trulicity and Taltz, Demand was boosted by increased buying and patient prescription trends resulting from the COVID-19 pandemic.
Lilly raised the higher end of its earnings guidance from a range of $6.70-$6.80 per share to $6.70 - $6.90 but kept the revenue range intact at $23.7 billion-$24.2 billion as it expects the coronavirus-related benefits seen in the first quarter to reverse over the course of 2020.
New Drugs Drive Roche’s Q1 Sales: Roche recorded sales of CHF 15.1 billion in the first quarter of 2020, up 2% from the year-ago quarter driven by strong performance of new drugs. While sales at the Pharmaceuticals division increased 7% that in the Diagnostics division sales climbed 5%. Sales of older drugs like Rituxan/MabThera, Herceptin and Avastin fell 15%, 24% and 13%, respectively, due to impact of competition from biosimilars. Sales of relatively newer drugs like Ocrevus and Tecentriq rose 38% and 99/% respectively.
Notably, the company confirmed its 2020 outlook of sales growth in low- to mid-single digit range amid the global coronavirus outbreak.
Meanwhile, the FDA and the Europeans Medicines Agency accepted Roche’s supplementary application seeking approval of its multiple sclerosis medicine, Ocrevus for a shorter two-hour infusion time from the current 3.5 hours.
Novartis to Study Hydroxychloroquine for COVID-19: Novartis announced that the FDA gave green signal to proceed with the large phase III study to evaluate the use of malaria drug, hydroxychloroquine in hospitalized patients with COVID-19 disease. The study of approximately 440 patients will be conducted at more than a dozen sites in the United States. Enrolment of patients will begin within the next few weeks. The supply of this generic medicine for the study will be provided by Novartis’ generics arm, Sandoz. Earlier this week, the FDA granted an Emergency Use Authorization to allow the use of hydroxycholoroquine for emergency use to treat COVID-19.
Meanwhile, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Novartis’ CAR-T cell therapy Kymriah for relapsed or refractory (r/r) follicular lymphoma. Please note that Kymriah is being evaluated in a phase II ELARA study for the r/r follicular lymphoma indication with a U.S. regulatory filing anticipated next year. The RMAT designation reflects the unmet need for patients with r/r follicular lymphoma and was based in preliminary data from the ELARA study.
Pfizer Gets Approval to Begin Clinical Study on Coronavirus Vaccine in Germany: Pfizer and its Germany-based partner BioNTech announced that German regulatory authority has granted approval to begin a 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, are expected to enter clinical studies in Germany. The companies will jointly conduct clinical studies on their COVID-19 vaccine candidate in the United States as well upon getting regulatory approvals.
AstraZeneca Begins Phase III Study on Farxiga for COVID-19: A phase III study (DARE-19) has been initiated to evaluate AstraZeneca’s SGLT2 inhibitor, Farxiga as a treatment in patients hospitalized with COVID-19 who have pre-existing health conditions like diabetes or chronic kidney disease and are at risk of developing serious complications, such as organ failure. The study is open for enrolment in the United States and other European countries and is being conducted by AstraZeneca and Saint Luke’s Mid America Heart Institute. AstraZeneca, last week, announced that it will initiate a study (CALAVI) to evaluate the effect of Calquence on the exaggerated immune response (cytokine storm) of patients hospitalized with COVID-19 infection.
Bristol-Myers’ Two Pivotal Studies on Opdivo Meet Main Goal: Bristol-Myers BMY announced positive interim data from a pivotal phase III study (CheckMate -743) evaluating a combination of Opdivo and Yervoy for first-line treatment of malignant pleural mesothelioma (MPM), a rare and aggressive form of cancer. The study met its primary endpoint of overall survival (OS). Data from a pre-specified interim analysis conducted by the independent Data Monitoring Committee showed that the Opdivo+Yervoy combination led to statistically significant and clinically meaningful improvement in OS compared to chemotherapy.
Meanwhile, another pivotal phase III study on Opdivo plus Exelixis’ Cabometyx in previously untreated metastatic renal cell carcinoma met its primary endpoint of significantly improving progression-free survival (PFS). The study also met its secondary endpoints of overall survival and objective response rate versus Pfizer’s Sutent (sunitinib).
FDA Approves AbbVie/J&J’s Imbruvica for 11th Indication: The FDA granted approval to AbbVie ABBV & Johnson & Johnson’s Imbruvica in combination with Roche’s Rituxan for the treatment of previously untreated, younger adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The application was based on data from the phase III E1912 study. With approval for this combination use, Imbruvica is now approved for 11 indications across six distinct disease areas. Imbruvica is already approved as monotherapy for previously untreated CLL/SLL patients. The drug has also been approved for the first-line treatment of CLL/SLL patients in combination with Roche’s another drug, Gazyva last year.
Meanwhile, Merck re-submitted its supplemental biologics license application (sBLA) seeking approval from the FDA for an improved dosing schedule of Keytruda. Merck is looking for approval of a six-week 400 mg dosing option of Keytruda for all adult indications, which will be delivered as an intravenous infusion over 30 minutes and will provide greater flexibility than the currently approved dose of 200 mg every three weeks infused over 30 minutes. In February, the FDA had granted a complete response letter to the sBLA
FDA Approves Sanofi’s Meningococcal Vaccine: The FDA approved Sanofi’s BLA for MenQuadfi, a meningococcal vaccine candidate, developed for the prevention of meningococcal meningitis in persons 2 years of age and older. The vaccine is under review in Europe and other countries.
Sanofi also announced that its investigational brain-penetrant BTK inhibitor, SAR442168 met the primary as well as secondary endpoints in a phase IIb study in relapsing multiple sclerosis. Data from the study showed that SAR442168 significantly reduced disease activity associated with multiple sclerosis as measured by magnetic resonance imaging (MRI). Sanofi plans to initiate four pivotal phase III studies on SAR442168 in relapsing and progressing forms of multiple sclerosis by mid-2020.
The NYSE ARCA Pharmaceutical Index rose 1.5% 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, all the stocks were in the green except Merck, which declined 2.5%. J&J recorded the highest increase (4%).
In the past six months, Lilly has risen the most (45.1%) while Glaxo declined the most (3.7%).
See the last pharma stock roundup here: JNJ's Q1 Earnings, Coronavirus Product Development Efforts
What's Next in the Pharma World?
Watch out for Novartis, Merck, Pfizer and others’ earnings and regular pipeline and regulatory updates next week.
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