AstraZeneca UK vaccine trial drops sub-group with children - U.S. trial register

 Drugmaker AstraZeneca has removed a study group comprising children from a trial of its COVID-19 vaccine candidate in Britain, clinical trial registers in the United States showed on Monday.

The mid-to-late stage trial of more than 12,000 participants previously included children above the age of five years with the consent of their parents. However, the page was updated on Dec. 10 to reflect the changes. (bit.ly/34EOHVj)

AstraZeneca, which is developing the vaccine along with the University of Oxford, did not immediately respond to a request for comment.

https://www.reuters.com/article/health-coronavirus-astrazeneca-study-gro/astrazeneca-uk-vaccine-trial-drops-sub-group-with-children-u-s-trial-register-idUSKBN28O1JS

Pfizer CEO says in talks with U.S. on more COVID-19 shots

 Pfizer’s chief executive Albert Bourla said on Monday that the drugmaker has not yet signed an agreement with the United States on providing 100 million more coronavirus vaccine doses in 2021.

Bourla said in an interview that Pfizer is still negotiating with the U.S. on whether it will be able to deliver the vaccine in the second or third quarter of the year.

“The U.S. government is asking (for) more. They have asked now for an additional 100 million doses from us,” Bourla said, adding that these were wanted in the second quarter of 2021.

“We can provide them the additional 100 million doses, but right now most of that we can provide in the third quarter.”

“The U.S. government wants them in the second quarter so are working very collaboratively with them to make sure that we can find ways to produce more or allocate the doses in the second quarter,” Bourla said.

https://www.blogger.com/blog/post/edit/3207539574676545063/181275873156707256

AstraZeneca shares fall on "hefty" $39-billion Alexion deal

 AstraZeneca shares fell as much as 9% on Monday, as investors moved to price in the costs of a $39 billion deal for U.S. biotech company Alexion Pharmaceuticals that would be the British drugmaker’s biggest ever corporate acquisition.

The deal, announced over the weekend, is also one of the biggest in an already bumper year for mergers and acquisitions and at current market prices will be almost two-thirds funded with AstraZeneca shares.

The terms of the deal give Alexion shareholders $60 in cash and about $115 worth of equity per share, working out at a premium of more than $50 per share according to Reuters calculations.

Analysts from two brokerages, Cowen and Liberum, called the price respectively “considerable” and “hefty”, while praising the quality of the assets AstraZeneca was buying.

AstraZeneca shares were down 5.9% at 7,676 pence by 1048 GMT, wiping roughly 7 billion pounds ($9.4 billion) off its market value of 107.1 billion pounds, as of its last close.

The deal is a bet on rare-disease and immunology drugs that will aid Chief Executive Pascal Soriot in his bid to broaden AstraZeneca’s drug portfolio further after a successful push into cancer treatments.

Some analysts wondered if the $175 per share price tag left room for a competing bid but Soriot said on Saturday that the deal was the result of exclusive talks and that no competitive bidder had been involved.

Shares in Alexion surged to more than $163 a share, enough to suggest investors believed the deal would succeed but stopping well short of pricing in a bidding war. The company would also have to pay AstraZeneca up to $1.2 billion to walk away from the deal.

Alexion shares in 2015 traded as high as $200 a share and the deal follows pressure from hedge fund Elliott Management to complete a sale.

In eight years at the helm, Soriot has made AstraZeneca one of the pharmaceutical world's success stories, raising profits and broadening its portfolio.

https://www.reuters.com/article/us-alexion-pharms-m-a-astrazeneca-stocks/astrazeneca-shares-fall-on-hefty-39-billion-alexion-deal-idUSKBN28O0RZ

Pfizer, BioNTech report additional data from German COVID-19 vaccine study

 

• Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) announce additional data on neutralizing antibody and T cell responses from the Phase 1/2 trial with BNT162b2 conducted in Germany.
• Analysis of 37 participants immunized with BNT162b2 showed a broad immune response with SARS-CoV-2-specific neutralizing antibodies, TH1 type CD4+ T cells, and almost 92% of participants demonstrated strong expansion of CD8+ T cells of the early effector memory phenotype.
• All vaccinated participants demonstrated neutralizing antibody as well as T cell responses. CD8+ T cell responses were directed against multiple regions of the spike protein, and several of the multiple epitopes recognized by BNT162b2-induced CD8+ T cells were molecularly identified.
• Overall, these results mirror previous findings from the U.S. trial demonstrating a favorable safety profile and robust induction of antibody responses with a longer follow-up period of 85 days.
• Antibodies generated efficiently neutralized 19 pseudo-viruses, indicating the potential for broad BNT162b2-elicited protection against reported mutations.
• As of today, BNT162b2 has been authorized or approved for emergency use for individuals 16 years of age and older in the U.S., U.K., Bahrain, Canada, Saudi Arabia, and Mexico.
• The companies have submitted a final Conditional Marketing Authorization Application following rolling submissions with the EMA and several other regulatory agencies.
• Vaccines are rolling out for delivery in the United States today.
• https://seekingalpha.com/news/3643978-pfizer-biontech-report-additional-data-from-german-covidminus-19-vaccine-study

Incyte/Novartis' Jakafi study in COVID-19 misses endpoints

 

• Incyte's (NASDAQ:INCY) Phase 3 RUXCOVID study evaluating the safety and efficacy of ruxolitinib (Jakafi) plus standard-of-care (SoC) as a treatment for patients 12 years and older with COVID-19 associated cytokine storm did not meet its primary endpoint. RUXCOVID study was sponsored by Incyte in U.S. and Novartis (NYSE:NVS) outside of U.S.
• Initial data show that there was no reduction in the proportion of patients receiving ruxolitinib plus SoC who experienced severe complications including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) care by Day 29, compared to SoC treatment alone (12.0% vs. 11.8% [OR: 0.91 [95% CI: 0.48-1.73], P=0.769, respectively).
• In addition, there was no clinically relevant benefit observed among secondary and exploratory endpoints, including mortality rate by Day 29 and time to recovery.
• Ruxolitinib was generally well tolerated and no significant safety concerns were identified. A comprehensive analysis including safety data is ongoing.
• The data will be further analyzed to determine any potential impact on other studies of ruxolitinib in patients with COVID-19, and will be submitted for publication.
• Incyte launched study of Jakafi for COVID-19 complication in April 2020.
• https://seekingalpha.com/news/3643920-incyte-novartis-jakafi-study-in-covidminus-19-fails-to-meet-endpoints

CureVac commences global mid-stage trial for COVID-19 vaccine candidate

 

• CureVac (NASDAQ:CVAC) has enrolled the first participant in the pivotal Phase 2b/3 study of its mRNA vaccine candidate, CVnCoV, against COVID-19.
• The trial called HERALD will assess the safety and efficacy of CVnCoV in adults at a dose of 12 µg and is expected to include more than 35,000 participants at sites in Europe and Latin America. Subjects 18 years of age or older will receive a two-dose schedule of either SARS-CoV-2 or placebo.
• Besides the primary safety objective, the study design includes two primary efficacy objectives: the demonstration of the efficacy of CVnCoV in preventing first episodes of confirmed cases of COVID-19 of any severity, as well as preventing moderate to severe confirmed cases of COVID-19 in participants who have never been infected.
• The data will be reviewed by an independent Data Safety Monitoring Board on a regular basis.
• The subjects will continue to be monitored in a 1-year extension study to evaluate long-term safety, persistence of antibodies to SARS-CoV-2 and the occurrence of COVID-19 cases to assess the duration of vaccine efficacy.
• https://seekingalpha.com/news/3643919-curevac-commences-global-mid-stage-trial-for-covidminus-19-vaccine-candidate

Bahrain OK's Chinese COVID-19 vaccine for use

 

• Bahrain has approved the use of a China's coronavirus vaccine, developed by Sinopharm (OTCPK:SHTDF), following earlier vaccine approval made by Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ:BNTX).
• Bahrain's news agency said the Chinese vaccine would be available in the island kingdom off the coast of Saudi Arabia in the Persian Gulf.
• It offered few details though on study results of the vaccine, in line with the UAE, which last week announced vaccine efficacy of 86%.
• Morocco is gearing up for an ambitious COVID-19 vaccination program, aiming to vaccinate 80% of its adults this month, relying initially on the Sinopharm vaccine.
• Separately, Kuwait has granted emergency use for the Pfizer vaccine. The ministry has already offered citizens the option to pre-register to receive the vaccine on its website.
• https://seekingalpha.com/news/3643921-bahrain-oks-chinese-covidminus-19-vaccine-for-use