J&J
JNJ
announced the start of a pivotal late-stage study on its potential coronavirus vaccine. Meanwhile, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency gave positive recommendations, granting marketing approval to several drugs this week.
Recap of the Week’s Most Important Stories
J&J Launches Late-Stage Studies on Coronavirus Vaccine:
J&J initiated a pivotal phase III study (ENSEMBLE) on its potential COVID-19 vaccine candidate, JNJ-78436735. The study will enroll 60,000 adult participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States. The large pivotal phase III study will evaluate the safety and efficacy of a single dose of JNJ-78436735 in contrast to two doses being tested for rival vaccines of Pfizer
PFE
/BioNTech, AstraZeneca
AZN
/Oxford University and Moderna that are also in late-stage development. J&J expects to file for emergency use authorization of its vaccine candidate in early 2021. J&J initiated the ENSEMBLE study in collaboration with BARDA and NIAID.
FDA Grants Priority Review to Pfizer’s Xalkori sNDA:
The FDA accepted Pfizer’s supplemental new drug (sNDA) seeking approval of its oncology medicine Xalkori for a new indication. The sNDA is seeking approval of Xalkori for the treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. With the FDA granting a priority review to the sNDA, a decision is expected in January 2021. Xalkori is presently approved to treat ALK-positive metastatic NSCLC.
Sanofi/Glaxo to Supply 300M Doses of Coronavirus Vaccine in Europe:
Sanofi
SNY
and GlaxoSmithKline
GSK
announced an
advanced purchase agreement
with the European Union to supply up to 300 million doses of the COVID-19 vaccine, if approved. The vaccine is being developed by combining Sanofi’s recombinant protein-based technology with Glaxo’s pandemic adjuvant technology.
The companies also signed an agreement to supply up to 72 million doses of the vaccine to Canada, if approved.
CHMP Recommends Approving Some Drugs in EU:
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of AstraZeneca/Merck’s
MRK
Lynparza for the treatment
of BRCA1/2 mutated metastatic castration-resistant prostate cancer
. The agency also recommended approving Lynparza in combination with Roche’s Avastin as a maintenance treatment for first-line advanced ovarian cancer in women who have an HRD-positive tumor.
The European agency also adopted a positive opinion recommending approval of Lilly’s
LLY
rheumatoid arthritis drug
Olumiant (baricitinib) for a new indication
i.e. treating atopic dermatitis. Meanwhile, Glaxo’s
Zejula was recommended as a monotherapy
for the first-line maintenance treatment of women with platinum-responsive ovarian cancer regardless of the BRCA mutational status based on data from the phase III PRIMA study. Zejula was approved in the first-line setting in United States in April this year.
The CHMP recommended granting marketing authorization to Roche’s immuno-oncology combo,
Tecentriq plus Avastin
for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) or liver cancer. The combination is already approved in the United States for the same patient population.
The CHMP recommended approving Sanofi’s two vaccines, quadrivalent recombinant influenza vaccine, Supemtek and its meningococcal vaccine, MenQuadfi. Both vaccines are already marketed in the United States.
The final decision by the European Union on these products is expected in the coming months.
The NYSE ARCA Pharmaceutical Index declined 2.9% in the last five trading sessions.
Here is how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, all the stocks declined with Novartis recording the maximum decrease (3.9%)
In the past six months, AstraZeneca has risen the most (37.8%) while Novartis has recorded the minimum increase (13.7%).
(See the last pharma stock roundup here:
AZN, LLY & PFE’s Coronavirus Updates, MRK’s New Cancer Deals
What’s Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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