This week, the FDA and Centers for Disease Control (“CDC”) jointly recommended pausing immunization with
J&J’s ( JNJ Quick Quote JNJ - Free Report) COVID-19 vaccine. Merck ( MRK Quick Quote MRK - Free Report) announced that it is ending the development of its COVID-19 biological therapeutic, MK-7110, while COVID-19 oral antiviral drug molnupiravir will proceed to late-stage development in outpatient setting. Glaxo ( GSK Quick Quote GSK - Free Report) and AstraZeneca ( AZN Quick Quote AZN - Free Report) announced study failures. Recap of the Week’s Most Important Stories The FDA and CDC FDA & CDC Recommend Pausing of J&J’s COVID-19 Vaccine Use: jointly issued a statement to recommend a temporary pause in the use of J&J’s vaccine in the United States as they review six reports of “rare and severe” blood clots accompanied by low levels of blood platelets in people who had taken the J&J one-shot COVID-19 vaccine. All the cases occurred in women between 18 and 48 years of age. While CDC will conduct a meeting of the Advisory Committee on Immunization Practices, the FDA is reviewing these cases. Until the review process is complete, the pause has been recommended as a measure of caution, the statement said. : Merck announced that it is discontinuing the development of its investigational biological therapeutic, MK-7110 (formerly known as CD24Fc), for treating hospitalized patients with COVID-19 as the drug is not expected to be available before the first half of 2022. The FDA asked Merck that additional data would be needed to support filing of an Emergency Use Authorization (EUA) application. A new clinical study will be required to be conducted, which together with manufacturing preparations, would take time. This, coupled with the launch of a number of medicines to treat hospitalized COVID-19 patients, prompted Merck’s decision. Merck Discontinues Development of COVID-19 Drug
Instead, the company will focus on developing molnupiravir, its investigational oral antiviral for COVID-19, which it is developing in partnership with Ridgeback Biotherapeutics. Merck said that it is moving forward with the phase III MOVe-OUT study of molnupiravir (800 mg dose twice a day for five days) in outpatients (non-hospitalized patients) while the phase II/III MOVe-IN study in hospitalized patients will not proceed. Merck said the data from the MOVe-IN study showed that molnupiravir is unlikely to demonstrate a clinical benefit in hospitalized patients, which led to the decision not to continue with the study. Data from the phase III outpatient study is expected by September or October. Merck plans to file for EUA in the second half of 2021. The company also said it plans to initiate a clinical study on molnupiravir for post- exposure prophylaxis in the second half of 2021.
In January, Merck ended the development of its two COVID-19 vaccine candidates, V590 and V591, which were in early-stage studies.
AstraZeneca announced data from the primary analysis of DARE-19 phase III study on Farxiga (dapagliflozin) to treat patients hospitalized with COVID-19 who are at risk of developing serious complications. The study AstraZeneca’s Farxiga COVID-19 Study Fails to Meet Goal: failed to show statistical significance for the primary endpoint of prevention measuring organ dysfunction and all-cause mortality, and the primary endpoint of recovery measuring a change in clinical status (from early recovery to death), at 30 days.
AstraZeneca’s blockbuster medicine, Tagrisso, was approved in China for adjuvant early-stage EGFR-mutated non-small cell lung cancer based on data from the ADAURA phase III study
Glaxo announced its decision to stop enrolling patients and discontinuing treatment in a phase II study (INDUCE-3) evaluating feladilimab, its ICOS agonist plus Merck’s Keytruda to treat PD-L1 positive recurrent locally advanced or metastatic head and neck squamous cell carcinoma. The decision was taken on the recommendation of the Independent Data Monitoring Committee. Glaxo also decided to stop another study (INDUCE-4), which was evaluating feladilimab in combination with Keytruda and chemotherapy. Glaxo Stops Studies on ICOS Agonist:
Separately, Glaxo and partner Vir Biotech announced that European Medicines Agency has begun a review of their dual-action monoclonal antibody VIR-7831 for the early treatment of COVID-19
Sanofi Buys mRNA Research Based Private Biotech: Sanofi ( SNY Quick Quote SNY - Free Report) acquired private biotech Tidal Therapeutics, which added innovative mRNA-based research platform. This will expand Sanofi’s research capabilities in oncology, immunology and other disease areas. For the acquisition, Sanofi made an upfront payment of $160 million while being entitled to make potential milestone payments of up to $310 million. Pfizer/Myovant Begin Dosing in New Study on Relugolix Combo: Pfizer ( PFE Quick Quote PFE - Free Report) and partner Myovant Sciences announced that the first participant has been dosed in the phase III SERENE study evaluating the contraceptive efficacy of the relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg). Please note that relugolix combination tablet is under review by the FDA for the treatment of women with uterine fibroids. The agency has set a target action date of Jun 1, 2021. It is also under review in Europe for this indication. Lilly Modifies COVID-19 Antibody Supply Deal With U.S. Government: Lilly ( LLY Quick Quote LLY - Free Report) modified COVID-19 purchase agreement for its antibody drug, bamlanivimab, along with the U.S. government. Lilly will now focus only on supplying its antibody cocktail, bamlanivimab and etesevimab together, which were granted emergency approval by the FDA in February. In February, Lilly signed an agreement with the U.S. government to supply a minimum of 100,000 doses of bamlanivimab/etesevimab cocktail. This agreement has been modified to enable the supply of etesevimab to complement doses of bamlanivimab the U.S. government has already purchased. With this, the purchase agreement for bamlanivimab alone is terminated, cancelling the remaining 350,856 doses that were scheduled to be delivered by the end of March 2021.
The NYSE ARCA Pharmaceutical Index rose 1.6% in the last five trading sessions.
Here’s how the eight major stocks performed in the last five trading sessions.
In the last five trading sessions, while Pfizer recorded the maximum gain (4.5%), J&J declined the most (1.6%).
In the past six months, Lilly recorded the maximum gain (30.3%) while AstraZeneca declined the most (3.2%).
(See the last pharma stock roundup here
: FDA Decision Delays for PFE, LLY, ABBV, AZN Vaccine Woes) What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates and J&J’s first-quarter results next week.
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