This week, AstraZeneca AZN resumed the late-stage study on its coronavirus vaccine candidate in the United Kingdom, which it had halted last week. Also, Lilly LLY announced promising interim data for COVID-19 antibody treatment. Moreover, Merck MRK announced two cancer deals with Seattle Genetics SGEN.
Recap of the Week’s Most Important Stories
AstraZeneca Resumes COVID-19 Vaccine Study: AstraZeneca resumed late-stage clinical studies on its COVID-19 vaccine candidate AZD1222 in the United Kingdom after British regulatory authorities confirmed that it was safe to do so. Last week, AstraZeneca temporarily paused all its global late-stage studies on AZD1222, which it is developing in partnership with Oxford University, as a patient in the U.K. suffered an unspecified illness. Management said that the company is in talks with other health authorities as to when they can resume the other studies on AZD1222.
Meanwhile, AstraZeneca announced an agreement to acquire a preclinical oral PCSK9 inhibitor program from Dogma Therapeutics. It plans to conduct clinical studies on the program in dyslipidaemia and familial hypercholesterolemia, which are expected to begin in 2021.
Lilly’s COVID-19 Studies Meet Primary Endpoints: Lilly’s phase II study (BLAZE-1) evaluating LY-CoV555 ,for the treatment of mild-to-moderate recently diagnosed COVID-19 patients, met the primary endpoint. LY-CoV555, a SARS-CoV-2 neutralizing antibody, is Lilly’s lead COVID-19 antibody therapy candidate in collaboration with private biotech AbCellera.
Interim data from the study showed that treatment with LY-CoV555 led to a reduced rate of hospitalization for patients while consistent effects of viral reduction were seen at earlier time points. The primary endpoint of viral load change from baseline at day 11 was met for the 2800 mg dose but not for the other two doses of 700 mg and 7000 mg. Most patients demonstrated near-complete viral clearance by day 11. The study is ongoing with additional treatment arms.
Meanwhile, Lilly’s phase III study evaluating its rheumatoid arthritis drug Olumiant (baricitinib) in combination with Gilead’s remdesivir for hospitalized patients with COVID-19 infections met the primary endpoint of reduction of time to recovery in comparison with remdesivir. The ACTT-2 study is being conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and included more than 1,000 patients. Lilly is conducting a separate phase III study to evaluate Olumiant as a potential treatment for hospitalized patients diagnosed with COVID-19. Based on data from the ACTT-2 study, Lilly will consider seeking emergency use authorization (EUA) from the FDA.
The FDA granted a Fast Track status to Lilly’s Jardiance to prevent heart failure and reduce the risk of mortality in adults with and without diabetes who have had an acute myocardial infarction, commonly known as heart attack. The designation to the SGLT-2 inhibitor was based on data from the EMPACT-MI study.
Pfizer Seeking to Increase the Size of COVID-19 Vaccine Study: Pfizer PFE and its German partner BioNTech announced that they filed an amended protocol to the FDA seeking an approval to expand the size of the late-stage studies on their potential coronavirus vaccine from 30,000 subjects to approximately 44,000. This increase in study size will allow enrollment of new patient populations. The companies expect to meet the initial target of 30,000 participants next week.
Merck’s Dual Cancer Deals With Seattle Genetics: Merck announced an agreement to co-develop and co-commercialize Seattle Genetics’ antibody-drug conjugate ladiratuzumab vedotin, which is in mid-stage development for breast cancer and other solid tumors. The companies plan to study ladiratuzumab vedotin as a monotherapy and in combination with Merck’s Keytruda for triple-negative breast cancer, hormone receptor-positive breast cancer and other LIV-1-expressing solid tumors. For the deal, Merck will make an upfront payment of $600 million to Seattle Genetics and also invest $1 billion (5 million shares) in its stock. Seattle Genetics will also be entitled to potential milestone fees of up to $2.6 billion.
In another oncology collaboration, Merck acquired an exclusive license to commercialize Seattle Genetics’ newly-approved breast cancer drug Tukysa in Asia, the Middle East and Latin America besides other regions outside the United States, Canada and Europe. For this deal, Seattle Genetics will receive $125 million as upfront payment besides being eligible for milestones of up to $65 million.
FDA’s Breakthrough Therapy Tag to Sanofi’s Dupixent for Eosinophilic Esophagitis: The FDA granted a Breakthrough Therapy designation to Sanofi SNY/Regeneron’s REGN blockbuster immunology drug Dupixent for treating eosinophilic esophagitis. The designation is based on positive data from Part A of a phase III study for EoE, a chronic type II inflammatory disease that damages the esophagus and impacts patients’ ability to swallow and eat. Dupixent is now approved for three type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma and moderate-to-severe atopic dermatitis.
The NYSE ARCA Pharmaceutical Index rose 2.5% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the eight major stocks performed in the last five trading sessions.
Last week, AstraZeneca recorded the highest increase (5.4%) while AbbVie was flat.
In the past six months, AstraZeneca has risen the most (39.4%) while Lilly has recorded the minimum increase (14.6%).
(See the last pharma stock roundup here: AZN & PFE’s Coronavirus Vaccine Updates & FDA Approvals)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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