Novavax Has Covid-19 Vaccine News Coming Out Soon

 Covid-19 vaccine makers Moderna and Pfizer are rushing to supply enough vaccine doses to staunch the pandemic’s still-climbing global death toll. Biotech company Novavax may be able to provide a glimmer of hope early this quarter, when data from its first Phase 3 trial of its Covid-19 vaccine is expected to be released.

Unlike the Moderna (ticker: MRNA) and Pfizer (PFE) vaccines, the Novavax (NVAX) vaccine is not based on cutting-edge messenger RNA technology, but on a more established approach. An effective Covid-19 vaccine that works differently from the currently authorized vaccines could help relieve supply chain pressures, and get more people vaccinated faster.

Yet the emergence of a new Covid-19 variant in the United Kingdom, where Novavax is running its first Phase 3 trial, is spreading worries about the current crop of Covid-19 vaccines, even as Moderna says it is confident its current vaccine will work against the new variant.

In a note out Wednesday morning, Cantor Fitzgerald analyst Charles Duncan says that he remains optimistic about the Novavax vaccine, despite the risk posed by the new variant of the virus.

“We have reinforced conviction on Novavax’s prophylactic vaccine candidate... to generate differentiating and viable efficacy/safety data,” Duncan wrote.

There are a few different ways the U.K. trials could turn out, he wrote. Duncan estimated there is a 60% probability that the study will find the Novavax vaccine 90% effective, which would put it in the same league as the Pfizer and Moderna vaccines. He says such a result could drive Novavax shares up 30%.

He sees a 30% probability of Novavax’s vaccine falling slightly short, and clocking an efficacy of 80% to 90%. In such a case, he expects the stock could climb by up to 10%.

Duncan said there is a 10% chance that the efficacy of the vaccine comes in below 80%. In that case, he expects the stock to fall by up to 20%.

Novavax says it expects its U.K. study, which includes 15,000 participants, to produce data early in the first quarter of this year. In late December it announced it had begun a 30,000-participant Phase 3 trial of the vaccine in the U.S. and Mexico.

Shares of Novavax are up more than 2,600% over the past 12 months. The stock had a market value of $7.4 billion as of Tuesday’s close. Of the seven analysts who cover Novavax tracked by FactSet, five rate it at Buy, one rates it at Hold, and one rates it at Sell.

Duncan writes that the vaccine should work on the new strain of the virus circulating in the U.K. But he raised the possibility that the presence of the new strain in the population in which the vaccine is being tested could raise complications in interpreting the results.

“In our view the UK study provides an opportunity to assess [the Novavax vaccine] against the original strain and the UK variant, which may result in a data-driven differentiated profile,” he wrote. “We believe the study has a high [probability of success] as it will be a composite efficacy endpoint against the two strains.”

https://www.barrons.com/articles/novavax-has-covid-19-vaccine-news-coming-out-soon-that-could-be-good-for-the-stock-51609942530

Alnylam's next-gen ATTR amyloidosis drug hits goals in phase 3

 A phase 3 clinical trial of Alnylam’s subcutaneous, long-acting treatment for transthyretin-mediated (ATTR) amyloidosis has met its primary endpoint. The success sets the RNAi specialist up to file for FDA approval early this year, although a lack of data comparing the experimental vutrisiran to Alnylam’s own ATTR incumbent Onpattro make it impossible to tell just how good the results are.

The clinical trial, HELIOS-A, randomized 164 patients with hATTR amyloidosis with polyneuropathy to receive vutrisiran or Onpattro. Three-quarters of participants received vutrisiran. While Alnylam used Onpattro as the comparator, primary and key secondary endpoints compared the vutrisiran results to historical placebo data from a previous clinical trial.

Vutrisiran outperformed the historical placebo control in terms of change in modified Neuropathy Impairment Score at nine months, causing the clinical trial to hit its primary endpoint. The trial also met secondary endpoints that compared the effect of vutrisiran on quality of life and gait speed to the historical control. The p-values for all three endpoints were less than 0.001.

Alnylam plans to file for FDA approval soon. Filings in countries including Brazil and Japan will follow, but the EU will need to wait longer. Alnylam has agreed to hold off on seeking European Medicines Agency approval until it has the 18-month data due late this year.

Critical details that will dictate whether Alnylam can win approval for vutrisiran and make the drug a commercial success are absent from the press release. Alnylam is yet to reveal how vutrisiran fared against the active control Onpattro or to share safety and tolerability data, saying only that the profile is “encouraging.” The availability of Onpattro means beating merely placebo is unlikely to be enough to establish vutrisiran as a major commercial product.  

Onpattro became the first FDA-approved treatment for ATTR when it came to market in 2018. Armed with evidence Onpattro curbs otherwise inevitable declines in the condition of patients, Alnylam has grown the RNAi drug into a product expected to generate sales of around $300 million in 2020.  

There is scope to improve on Onpattro, though. Patients treated with Onpattro undergo an infusion lasting around 80 minutes every three weeks. Vutrisiran has a far more convenient dosing schedule. Patients on the experimental therapy receive a subcutaneous injection every three months. 

If vutrisiran can match or beat the safety and efficacy of Onpattro, the drug will enable Alnylam to tighten its hold on the ATTR market. Alnylam plans to share the full nine-month data early this year. 

Akshay Vaishnaw, M.D., Ph.D., president of R&D at Alnylam, highlighted the fact vutrisiran drove improvements as soon as nine months as positive finding of the phase 3 trial. The pivotal Onpattro clinical trial tracked patients for 18 months, although clear divergence from placebo was evident after nine months. 

https://www.fiercebiotech.com/biotech/alnylam-s-next-gen-attr-amyloidosis-drug-hits-goals-phase-3-teeing-up-approval-filing

AbbVie Risankizumab Shows Improvements in 2 Phase 3 Induction Studies in Crohn's

 AbbVie (NYSE: ABBV) today announced positive results from two Phase 3 induction studies, ADVANCE and MOTIVATE, showing both doses of risankizumab (600 mg and 1200 mg) met both primary endpoints of clinical remission and endoscopic response at week 12 in adult patients with moderate to severe Crohn's disease.1,2 The ADVANCE study enrolled patients who had an inadequate response or were intolerant to conventional and/or biologic therapy.1 The MOTIVATE study evaluated patients who had responded inadequately or were intolerant to biologic therapy.2

https://www.streetinsider.com/Corporate+News/AbbVie+%28ABBV%29+Risankizumab+Demonstrates+Significant+Improvements+in+Clinical+Remission+and+Endoscopic+Response+in+Two+Phase+3+Induction+Studies+in+Patients+with+Crohns+Disease/17795520.html

Biohaven Acquires Kleo Pharma, Licenses Platform Tech From Yale

 - Acquires full ownership of Kleo Pharmaceuticals with two novel immune modulating platforms: the Multi-targeted Antibody Therapy Enhancer (MATE™) conjugation platform and Antibody Recruiting Molecule (ARM™) platform

- Enters into exclusive license agreement with Yale University for the development and commercialization of Yale's extracellular target degrader platform based on intellectual property derived from ground-breaking research in the laboratory of Professor David Spiegel

- Establishes Biohaven Labs at Science Park in New Haven to advance these three novel discovery platforms and several existing discovery partnerships to serve as an integrated chemistry and discovery research engine to complement Biohaven's late-stage clinical development and commercial expertise

https://www.prnewswire.com/news-releases/biohaven-acquires-kleo-pharmaceuticals-and-licenses-platform-technology-from-yale-university-to-form-biohaven-labs-301202462.html

Walgreens earnings top estimates, fueled by higher drug sales

 Walgreens Boots Alliance reported Thursday fiscal first-quarter earnings that exceeded Wall Street’s expectations, helped by stronger-than-expected pharmacy sales.

Walgreens shares were up about 3% in premarket trading.

Here’s what Walgreens reported compared with what analysts were expecting for the first quarter ended Nov. 30, based on Refinitiv data:

• Earnings per share: $1.22 cents, adjusted vs. $1.03 expected
• Revenue: $36.31 billion vs. $34.95 billion expected

In the first quarter, Walgreens posted net loss of $308 million, or 36 cents per share, compared with a net income of $845 million, or 95 cents per share, a year earlier.

Excluding a charge from its AmerisourceBergen investment, it earned $1.22 per share, higher than the $1.03 expected by analysts surveyed by Refinitiv.

Sales rose to $36.31 billion from $34.34 billion a year earlier, outpacing the $34.95 billion that analysts expected.

Walgreens said its pharmacy sales picked up in the U.S. as it filled more prescriptions. Comparable pharmacy sales rose 5% compared with a year earlier. The higher sales came despite less foot traffic, lower sales of cough, cold and flu medications and fewer new prescriptions as people skipped the doctor’s office and socially distanced during the pandemic.

In the United Kingdom, Walgreen’s comparable pharmacy sales rose 2.5% percent compared with a year ago, largely due to a reimbursement from the National Health System. Boots UK stores have been particularly hard-hit by restrictions during the pandemic. The NHS payment helped offset a drop in prescription volume.

Walgreens reiterated its outlook for low single-digit growth in adjusted earnings per share this year. Yet the company cautioned it will face headwinds as the U.K. has another lockdown and customers continue to limit trips to the store.

The company has sought growth opportunities as the drugstore industry faces disruption and the pandemic changes shopping patterns. It’s responded by adding more health-care services and expanding its digital offerings. It unveiled a new mobile app and added curbside pickup at its U.S. stores, which can have online purchases ready for customers in as little as 30 minutes.

It announced plans in July to open hundreds of primary care clinics at its stores staffed and operated by VillageMD. It said Wednesday it would accelerate the timetable for that and expects to have 600 to 700 clinics open within the next four years.

On Wednesday, it also said it would divest its drug distribution business in Europe by selling it to U.S. drug wholesaler AmerisourceBergen for $6.5 billion. The sale will allow Walgreens to focus on its pharmacy and retail businesses.

Walgreens started administering Covid vaccines in mid-December to staff and residents at nursing homes and other long-term care facilities. It plans to offer the shots to the general public at its drugstores, once they’re available.

Walgreens shares have fallen about 28% over the past one year, bring its market value to $37.2 billion.

Read the full press release here.

https://www.cnbc.com/2021/01/07/walgreens-wba-q1-2021-earnings-beat.html

Twist Supplies CDC with Custom SARS-CoV-2 Synthetic RNA Controls

 Twist Bioscience Corporation (Nasdaq: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced it will supply the U.S. Centers for Disease Control and Prevention (CDC) with a customized version of Twist SARS-CoV-2 Synthetic RNA Controls for use in the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay. The CDC SARS-CoV-2 (Flu SC2) Multiplex Assay tests for influenza A, B and SARS-CoV-2 simultaneously.

Positive controls provide quality control measures for the development, verification, and ongoing validation of both next-generation sequencing (NGS) and reverse transcription-polymerase chain reaction (RT-PCR) assays. In addition to using the assay at its primary site, CDC intends to distribute this multiplex assay to additional public health laboratories for testing across the United States.

“We have partnered with the CDC over the last several months to optimize these controls to be stable at room temperature for ease of shipping and storage,” said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. “Integrating our SARS-CoV-2 control into the Flu SC2 Multiplex Assay supports the accurate detection of SARS-CoV-2 in specimens from patients exhibiting symptoms that could result from either COVID-19 or the flu. We remain committed to using our robust synthesis platform to work with industry and government agencies to improve health globally and expect to make these optimized controls widely available to customers later this month.”

https://www.businesswire.com/news/home/20210107005078/en/Twist-Bioscience-Supplies-Centers-for-Disease-Control-and-Prevention-with-Custom-SARS-CoV-2-Synthetic-RNA-Controls

CureVac strikes COVID-19 vaccine alliance deal with Bayer

 

German biotech firm CureVac has agreed to an alliance with drugmaker Bayer to get global support in seeking approval for its experimental COVID-19 vaccine and for distribution, the daily Bild reported.

Under the deal, Germany's Bayer will provide access to international pharmaceutical markets, as well as its global supply chain and distribution network, the tabloid newspaper reported in an excerpt made available to Reuters ahead of publication.

The report did not specify its sources and did not disclose financial terms.

Bayer and CureVac were not immediately available for comment outside regular business hours.

CureVac, which has said it was looking for a larger partner, last month started a late-stage clinical trial of its COVID-19 vaccine candidate, banking on the same technology that has allowed rivals BioNTech and Moderna to lead the development race.

The Nasdaq-listed biotech firm, which is backed by investors Dietmar Hopp, the Gates Foundation, GlaxoSmithKline and the German government, has said it aimed to produce up to 300 million doses of the vaccine in 2021 and up to 600 million in 2022.

In March last year, CureVac was at the centre of a row over alleged attempts by U.S. President Donald Trump to gain access to the vaccine but the company denied at the time having received any U.S. offers for the company or its assets.

Ahead of any regulatory approval, the European Union has secure up to 405 million doses of the immunisation, among a slew of supply deals agreed between the bloc and other vaccine developers.

Bayer's pharma unit, which is trying to build a new cell and gene therapy business, has expertise in cancer, haemophilia, multiple sclerosis, cardiovascular diseases and women's health but not in vaccines.

The group's stock has been battered by billions of euros in writedowns at its agriculture division, litigation woes and a bleaker profit outlook, in large part related to the $63 billion takeover of seed maker Monsanto.

https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/CureVac-strikes-COVID-19-vaccine-alliance-deal-with-Bayer-Bild-32135365/