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Saturday, January 30, 2021

Enough Covid vaccine for ‘entire U.S. adult population by June,’ J&J director

 Johnson & Johnson board member Dr. Mark McClellan told CNBC Friday that there could be enough vaccinations for the entire U.S. adult population by the summer. 

“Assuming all of the close review of the J&J data all pans out, we’re going to have the capacity between ModernaPfizer, J&J, to have enough vaccines available by June for the entire U.S. adult population,” McClellan, a former FDA commissioner, said on “The News with Shepard Smith.” 

The U.S. plans to buy 200 million Covid vaccine doses from Moderna and Pfizer. The Department of Health and Human Services will boost its vaccine supply to states from 8.6 million to a minimum of 10 million doses per week. So far, states have received more than 49 million doses, but only about half of those have actually ended up in people’s arms, according to the Centers for Disease Control and Prevention. The agency reports that the U.S. is administering a little more than a million shots every day.

McClellan that the U.S. should significantly increase the amount of shots administered per day and “get our capacity for doing vaccinations up closer to 3 million doses per day.”

The United States has ordered 100 million doses of the J&J vaccine, which the company plans to deliver by June. J&J plans to file for emergency use authorization next week. If J&J’s vaccine is authorized by the FDA, it would be the third vaccine approved for emergency use in the U.S. Pfizer’s vaccine was authorized by the FDA on Dec. 11, and Moderna’s was authorized a week later.

The J&J vaccine efficacy numbers were lower than those for Pfizer and Moderna. Pfizer’s vaccine was found to be 95% effective against preventing Covid-19, while Moderna’s was found to be about 94% effective. J&J’s vaccine was found to be 66% effective overall in preventing moderate to severe Covid.

Host Shepard Smith asked McClellan about the lower efficacy numbers compared to Pfizer and Moderna, and he explained to Smith that “we’re fighting a different virus today than we were three months ago when previous trials were done.”

Additionally, J&J ran its trial across three continents and the level of protection varied by region. Its vaccine demonstrated overall, 72% effectiveness in the United States and 66% in Latin America. In South Africa, where the dangerous B.1.351 strain of Covid caused a surge in cases, the J&J  vaccine demonstrated 57% effectiveness.

“Unfortunately, we’re probably going to be fighting a different virus three months from now, so most important in winning this battle, is getting as many people vaccinated as possible,” said McClellan. “The faster we get shots in arms, the more people we get vaccinated here in this country and around the world, the better we’re going to do in containing that further spread and the further damage from Covid.”

https://www.cnbc.com/2021/01/29/there-will-be-enough-covid-vaccines-for-the-entire-us-adult-population-by-june-doctor-says.html

Novavax's Coronavirus Vaccine Data: 2 Analyst Takes

 Novavax, Inc. 

NVAX 64.87% shares were roaring higher Friday after the company reported topline results from the late-stage trial of its coronavirus vaccine candidate in the U.K.

The Novavax Analyst: H.C. Wainwright analyst Vernon Bernardino reiterated a Buy rating and $207 price target for Novavax shares.

Novavax Regulatory News As A Positive Catalyst: Novavax's NVX-CoV2373 is now firmly in line to become the fifth COVID-19 vaccine authorized, and upon a positive outcome from the ongoing PREVENT-19 Phase 3 trial in the U.S. and Mexico, potentially the fourth authorized in the U.S., H.C. Wainwright analyst Bernardino said in a note.

The protein-based vaccine candidate showed 96% efficacy against the SARS-CoV-2 original strain and 86% efficacy against the emergenct U.K. strain, the analyst said.

Data from the Phase 2b study conducted in South Africa against an emergent strain showed a lower efficacy, he said. 

Bernardino shrugged off the lower efficacy data from the South African trial.

"However, we view the South Africa studies as positive, as they point to positive implications regarding the potential for Novavax's vaccines to confer cross-protection, as has been observed with NanoFlu, the company's investigational quadrivalent seasonal influenza vaccine."

With data from Phase 1, 2 and 3 trials that involved over 20,000 participants, Novavax is in a strong position to gain authorization for use of NVX-CoV2373 in the U.K., Bernardino said.

The company has initiated a rolling submission for the vaccine candidate in the U.K., the analyst said. 

Regulatory updates could be positive catalysts in the first quarter of 2021, he said. 

Bernardino expects a potential interim analysis of PREVENT-19 Phase 3 trial being conducted in the U.S. and Mexico in early February and a potential final analysis as early as the end of February 2021.

"NVX-CoV2373, which Novavax expects to ship in ready-to-use liquid formulation, is stable under refrigeration conditions (2°C to 8°C), permitting use of existing vaccine supply chain channels," the analyst said.

The company has manufacturing and supply deals in eight geographies around the world, and annual capacity of over 2 billion doses that the company expects to have in place by mid-2021, he said.

H.C. Wainwright said the scope and robustness of Novavax's strategy to be the leader in COVID-19 vaccines remains underappreciated.


Less Inspiring South African Data A Setback: The vaccine's efficacy against the new variant in South Africa — B1.351 — may have been in the range of 55%-65%, SVB Leerink analyst Geoffrey Porges said.

"Reducing efficacy against the variant virus is a major blow to any plans to the vaccines to achieve herd immunity in the immediate future against the virus," the analyst said.

Yet the vaccine candidate should not be considered as "not clinically useful" against the variant, given a tolerable safety profile and evidence of effective reduction in severe disease, he said.

For Novavax, the data amounts to a tremendous success, despite the alarming implications of B1.351 and similar variants, the analyst said. The company has validated their platform, and confirmed the promise shown by their very high titer of antibodies and robust T cell responses in animals and earlier human trials, Porges said.

"They have a clear path to approval and commercial sale of their first product, and given their favorable product characteristics, should see widespread purchase and adoption." 

Ultimately, Novavax is well-positioned to develop a combined multi-valent influenza/COVID-19 vaccine, and this may be its most compelling commercial opportunity longer term, according to SVB Leerink.

The firm also sees a positive read-across for other protein subunit vaccine developers such as Sanofi SA SNY 0.76%GlaxoSmithKline plc GSK 2.03%, despite the need to use new antigen for their programs.

https://www.benzinga.com/analyst-ratings/analyst-color/21/01/19396279/breaking-down-novavaxs-coronavirus-vaccine-data-2-analyst-takes

Biotech week ahead, Feb. 1

 Biotech stocks alternated between gains and losses in the week ended Jan. 29 before ending lower. Big pharma earnings season kick started, with Novartis AG

NVS 2.56%Johnson & Johnson JNJ 3.46% and Eli Lilly And Co LLY 0.92% all in the mix.

Coronavirus vaccine and treatment news flow abounded in the week. J&J and Novavax, Inc. NVAX 64.87% released top-line results from their respective late-stage vaccine studies. Merck & Co., Inc. MRK 1.1%, meanwhile, dropped out of the vaccine race.

Lilly and Vir Biotechnology Inc VIR 9.89% announced a study combining their COVID-19 antibody treatments.

Biogen Inc BIIB 5.5% reacted with a move to the upside after the Food and Drug Administration extended the review period of its Alzheimer's drug, aducanumab, by three months.

Here are the key catalytic events for the unfolding week:

Conferences

Canaccord Genuity's "New Paradigms & Treatment Approaches in Mental Health" conference: Feb. 3-4

PDUFA Dates

The FDA is scheduled to announce its verdict on Adamas Pharmaceuticals Inc's ADMS 10.06% new drug application for Gocovri as a treatment option for "off episodes" in Parkinson's disease patients receiving levodopa-based therapy. The decision is due Monday, Feb. 1.

The agency will also decide on Mallinckrodt PLC's MNKKQ 2.07% biologics license application for StrataGraft, an engineered tissue designed to mimic natural human skin, with both inner dermis-like and outer epidermis-like layers. StrataGraft is being evaluated as a treatment option for deep partial-thickness thermal burns. The PDUFA goal date is Tuesday, Feb. 2.


Clinical Readouts

Turning Point Therapeutics Inc TPTX 3.99% will present at the IASLC World Conference On Lung Cancer updated data from the TRIDENT-1 study of its lead candidate repotrectinib in TKI-naive patients with ROS1-positive advanced non-small cell lung cancer (Sunday, Jan. 31).

Vaxart Inc VXRT 34.3% is expected to release data from the Phase 1 study of its oral COVID-19 vaccine candidate.

Earnings

Monday

Omnicell, Inc. OMCL 0.99%
Vertex Pharmaceuticals Incorporated VRTX 0.42% (after the market close)

Tuesday

Bio-Techne Corp TECH 0.74% (before the market open)
Catalent Inc CTLT 0.05% (before the market open)
Haemonetics Corporation HAE 0.11% (before the market open)
Pfizer Inc. PFE 0.13% (before the market open)
Amgen, Inc. AMGN 2.55% (after the market close)

Wednesday

AbbVie Inc ABBV 1.59% (before the market open)
Biogen (before the market open)
Ligand Pharmaceuticals Inc. LGND 3.26% (before the market open)
Boston Scientific Corporation BSX 2.39% (before the market open)
Cardiovascular Systems Inc CSII 2.03% (after the market close)

Thursday

Alexion Pharmaceuticals, Inc. ALXN 2.52% (before the market open)
Baxter International Inc BAX 0.39% (before the market open)
Bristol-Myers Squibb Co (NYSE: BMY (before the market open)
Brainstorm Cell Therapeutics Inc BCLI 4.2% (before the market open)
Quest Diagnostics Inc DGX 4.41% (before the market open)
Twist Bioscience Corp TWST 3.06% (after the market close)
Neurocrine Biosciences, Inc. NBIX 1.95% (after the market close)
Misonix Inc MSON 0.22% (after the market close)
Gilead Sciences, Inc. GILD 1.42% (after the market close)

Friday

Meridian Bioscience, Inc. VIVO 1.33% (before the market open)
Zimmer Biomet Holdings Inc ZBH 2.07% (before the market open)
Regeneron Pharmaceuticals Inc REGN 0.48% (before the market open)

IPOs

Blacksburg, Virginia-based Landos Biopharma, Inc. has filed for an initial public offering of 6.25-million shares priced between $15 and $17 each. This clinical-stage biopharma develops oral therapeutics for patients with autoimmune diseases. It is expected to list its shares on the Nasdaq under the ticker symbol LABP.

Danish AI-immunology platform company Evaxion Biotech A/S is offering 2.75 million ADSs in an IPO, with each ADS representing one ordinary share. The company estimates a price range of $10-$12 for the offering. The company has applied for listing its shares on the Nasdaq under the ticker symbol EVAX.

Sana Biotechnology, Inc. is developing in-vivo and ex-vivo cell engineering platforms for developing treatments for a wide range of diseases. The company proposes to offer 15 million shares in an IPO, with an estimated price range of $20-$23. The Seattle-based company has applied for listing its shares on the Nasdaq under the ticker symbol SANA.

IPO Quiet Period Expiries

Gracell Biotechnologies Inc GRCL 1.47%

Other Events

Johnson & Johnson could file for emergency use authorization approval in the U.S. in the coming week. The company said in a release announcing topline results from the Phase 3 study of its vaccine candidate that an EUA filing will be done in early February.

https://www.benzinga.com/general/biotech/21/01/19403826/the-week-ahead-in-biotech-merck-pfizer-in-earnings-mix-plus-adamas-mallinckrodt-fda-decisions-ipo

Older Shoppers Are the Hot New Thing for Consumer Brands

 Demographic changes and the pandemic are propelling consumer-goods companies to take a fresh look at a group of shoppers who are often ignored: the elderly.

As people live longer and have fewer babies, the number of over-65s surpassed those under five globally for the first time in 2018, according to United Nations data, and the trend has accelerated since.

The pandemic has disproportionately harmed older people, which executives say has highlighted the importance of staying healthy later in life.

That shift is prompting companies like Nestle SA, Colgate-Palmolive Co. and Danone SA to launch new products aimed at consumers they say are increasingly interested in aging well.

"We clearly see healthy aging, even more now with the Covid world, as a huge trend," Danone Chief Executive Emmanuel Faber said.

Danone in November said it was setting up a new healthy-aging unit to accelerate research into how nutrition impacts cognition and mobility. The Activia yogurt maker recently launched in Brazil Fortifit Pro, a whey-protein product that claims to aid muscles, joints and bones, and said it plans to develop more products intended to help people age better.

The number of countries with over 20% of the population aged 65 or above is estimated to rise from 15 last year to 44 by 2030, according to the U.N. That number is forecast to reach 61 by 2050, when it will include the U.S., China and Brazil.

Researchers estimate economic uncertainty related to Covid-19 will also accelerate declining birthrates in the U.S. and China.

Nestle last month launched a powdered-milk drink in China under its Yiyang brand, aimed at older adults, which it says enhances mobility during aging.

In recent years the company's health-sciences unit has shifted its focus from making food and drink to aid the recovery of people in hospitals, to helping prevent people from being admitted in the first place, said Greg Behar, who heads the unit.

"There are more and more people who want to proactively manage their health in the aging process," Mr. Behar said. "What is most impacting people is a drop in physical and cognitive functions and then there's the beauty and skin element too."

About 20% of Nestle Health Science's research budget is now dedicated to aging. The company uses tiny nematode worms known as C. elegans, which age quickly with a lifespan of just two days, to test its nutrition hypotheses.

Reckitt Benckiser Group PLC, which makes infant-formula brand Enfamil, has also launched a milk drink aimed at older consumers in China that it says contains ingredients to boost the immune system.

Overall, Reckitt says the market in China for milk with added ingredients to provide specific benefits is worth 500 million British pounds, equivalent to $686 million, and growing at 13% a year. The company is developing several products to capitalize on the self-care trend, and is expecting Covid-19 to accelerate demand.

Other companies are tweaking products to serve older people who they say will spend longer living at home, rather than in assisted-living facilities.

IKEA has begun selling upright armchairs with higher seating to make getting up easier, slanted footstools to promote blood circulation and jar grippers to help unscrew lids, among its products aimed at people with reduced mobility, including the elderly.

The range is part of an effort to imbue design catering to people of different capabilities across IKEA's products, said Britt Monti, a senior designer who worked on the collection. IKEA held off on labeling the range as being specifically for the elderly, she added.

"Especially later in life you don't want to be labeled as older," said Ms. Monti. "We don't want to make a big thing out of it, we just want it to be a natural part of the design process."

Procter & Gamble Co. last year began selling a razor intended for caregivers in Canada, where the company said data show one in four people provides help to someone with aging-related needs, a disability or long-term health condition. The Gillette Treo, which was already available in the U.S., has a safety comb and a wider handle filled with shaving gel that is designed to give caregivers better control while shaving their elderly charges.

In beauty and skin care, older consumers tend to spend more, making them a key demographic for companies like L'Oréal SA. In France, women over-65s spend 184 euros, equivalent to $223, on beauty products each year, compared with EUR120 for 25-to-30-year-olds, said Delphine Viguier, global brand president for L'Oréal Paris.

Last year the company said growth in the skin-care market had accelerated, driven in part by an aging population. It expects the trend to continue longer-term.

Others have found success targeting antiaging products at younger consumers.

When Colgate last year launched an upscale amino acid toothpaste in China intended to reverse visible signs of gum aging, the company focused its marketing on a young audience using celebrity bloggers and social-media apps. Colgate took the approach after Filorga, its antiaging facial-care brand, proved popular online with women between 25 and 35. The company said 80% of shoppers buying Colgate Miracle Repair were under the age of 30.

"In China aging is for the young consumer," Colgate CEO Noel Wallace said last year. "They are taking antiaging products -- across whether its skin health or otherwise -- and very, very much looking to provide benefits to themselves at an early age."

https://www.marketscreener.com/quote/stock/COLGATE-PALMOLIVE-COMPANY-12089/news/Older-Shoppers-Are-the-Hot-New-Thing-for-Consumer-Brands-32314754/