This week the COVID-19 vaccine developers pledged to observe high ethical standards and sound scientific principles in conducting clinical studies and manufacturing vaccines. AstraZeneca (AZN - Free Report) paused late-stage studies on its coronavirus vaccine candidate. The FDA granted approval to Roche’s (RHHBY - Free Report) Gavreto (pralsetinib) for treating a lung cancer indication and Glaxo’s (GSK - Free Report) Trelegy Ellipta for asthma.
Recap of the Week’s Most Important Stories
AstraZeneca Pauses COVID-19 Vaccine Study: AstraZeneca said it is voluntarily pausing all late-stage studies on its COVID-19 vaccine candidate, AZD1222, which it is developing in partnership with Oxford University as a patient in U.K. suffered an unspecified illness. The studies were paused to allow an independent data committee to review the safety data. AstraZeneca said the review by the independent data committee is a standard procedure when there is an unexplained illness observed in a study. The review is necessary to maintain the integrity of the studies.
Meanwhile, AstraZeneca’s Fasenra met both co-primary endpoints of a phase III study (OSTRO) evaluating it patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Treatment with Fasenra led to a statistically significant improvement in the size of nasal polyps and in nasal blockage in such patients.
Joint COVID-19 Vaccine Safety Pledge: The chief executive officers of nine leading drug companies working on making a vaccine for COVID-19 signed a pledge to develop their vaccines by observing the highest ethical standards and making the safety and well-being of the vaccinated individuals their top-most priority. The companies vowed not to look out for approval or emergency use authorization (EUA) for their vaccine candidates from the FDA and other regulatory agencies until their respective vaccines are proven to be safe and effective through large phase III studies. The nine companies are AstraZeneca, Pfizer (PFE - Free Report) and its German partner BioNTech, Glaxo, J&J (JNJ - Free Report) , Merck (MRK - Free Report) , Moderna, Novavax, and Sanofi.
FDA Approves Roche’s New Precision Drug for Lung Cancer: The FDA granted approval to Roche and partner Blueprint Medicines’ once-daily, oral precision therapy, pralsetinib for treating metastatic RET-fusion positive non-small cell lung cancer (NSCLC). The approval of pralsetinib, to be marketed as Gavreto, came much ahead of the PDUFA date of Nov 23, 2020. The FDA approval was on an accelerated basis based on data from the phase I/II ARROW study. Additionally, the FDA also granted priority review to Gavreto for treating advanced RET mutant and RET fusion-positive thyroid cancer under the FDA's Oncology Center of Excellence Real-Time Oncology Review (RTOR) pilot program. A FDA decision for these indications is expected on Feb 28. Genentech and Blueprint Medicines will co-commercialize Gavreto in the United States.
Meanwhile, Roche announced the initiation of a phase III study on investigational BTK inhibitor fenebrutinib in multiple sclerosis. Also, two phase IIIb studies were initiated to evaluate a higher dose of its multiple sclerosis medicine, Ocrevus’ impact on reducing disability progression in RMS and PPMS compared with the currently approved 600 mg dose
FDA Approves Glaxo’s Trelegy Ellipta for Asthma: The FDA approved Glaxo’s triple combination once-daily single inhaler Trelegy Ellipta as a maintenance treatment of asthma. With the approval for the asthma indication, Trelegy becomes the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD. The approval was based on data from the CAPTAIN study.
Pfizer May Supply 200M Doses of Coronavirus Vaccine to EU: Pfizer and BioNTech announced that they have concluded exploratory talks with the European Commission to supply 200 million doses of BNT162 mRNA-based vaccine candidate to EU member states. Delivery of the vaccines will begin by end of 2020, subject to regulatory approval. The proposed agreement also includes an option to purchase additional 100 million doses. The companies will begin contract talks with the EC.
The companies also released positive preclinical immunization data on BNT162by vaccine candidate. BNT162b2 is Pfizer’s selected lead coronavirus vaccine candidate, which moved to late-stage development in July. The data showed that immunization of rhesus macaques, a species of monkeys with BNT162b2 resulted in strong anti-viral effects against an infectious SARS-CoV-2 challenge.
Pfizer expects to file regulatory applications for BNT162b2 by October. Eventually, if the vaccine is approved this year, Pfizer plans to manufacture up to 100 million doses by the end of this year and potentially more than 1.3 billion doses by the end of 2021.
AbbVie Buys Rights to Novel Cancer Candidate from I-Mab: AbbVie (ABBV - Free Report) acquired an exclusive global license (excluding greater China) from China-based biotech I-Mab to develop and commercialize the latter’s anti-CD47 monoclonal antibody lemzoparlimab, which is in early-stage studies for treating different cancers. AbbVie will pay I-Mab $180 million in an upfront payment and $20 million in milestone payments based on the results of a phase I study, which were also released. In addition, AbbVie will be entitled to pay up to $1.74 billion in clinical development and regulatory milestone payments. AbbVie plans to explore the combination of lemzoparlimab with its blood cancer drug, Venclexta.
Merck’s Pneumococcal Vaccine Meets Goal in Two Adult Studies: Merck announced that two phase III studies evaluating V114, its investigational 15-valent pneumococcal conjugate vaccine candidate in adults met its primary immunogenicity objectives.
In the pivotal PNEU-AGE study, V114 met the primary endpoint by showing noninferiority to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for 13 serotypes contained in both vaccines. Meanwhile, V114 also demonstrated superiority in immune response for two additional serotypes, 22F and 33F, which are not contained in PCV13.
In the second PNEU-TRUE study, V114 demonstrated equivalent immune response across all 15 serotypes for three different lots of V114. Merck plans to file regulatory applications for V114 before the end of this year.
J&J Seeks Approval of Darzalex Faspro for a Rare Disease: J&J filed a supplemental biologics license application (sBLA) seeking label expansion of Darzalex Faspro for treating patients with newly diagnosed light chain (AL) amyloidosis, a rare life-threatening disorder. The sBLA was based on data from the phase III ANDROMEDA study. Darzalex Faspro is the subcutaneous formulation of J&J’s blockbuster drug, Darzalex, which is approved to treat multiple myeloma.
The NYSE ARCA Pharmaceutical Index declined 1.18% in the last five trading sessions.
Here is how the eight major stocks performed in the last five trading sessions.
Last week, Roche and Novartis recorded the highest increase (1.7%) while AbbVie declined the most (2.4%).
In the past six months, AstraZeneca has risen the most (30.3%) while Merck recorded the minimum increase (12.3%).
(See the last pharma stock roundup here: SNY, GSK, AZN’s Coronavirus Vaccines/Treatments Progress)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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