COVID-19 vaccine vial maker Stevanato preps IPO valuing it at up to $5B

 Italy’s Stevanato Group, manufacturer of glass vials for COVID-19 vaccines and other healthcare products, is making plans for an initial public offering this year that could value the company at between $4 billion-$5 billion, three sources with knowledge of the situation told Reuters.

Bank of America and Morgan Stanley are among the banks appointed for the stock market listing which is expected to take place in New York, two of the sources added.

Spokespersons for Bank of America and Morgan Stanley declined to comment.

One of the sources said the healthcare packaging company would look to raise around $500 million from the IPO.

The company wants to capitalize on strong investor demand for healthcare assets but a final decision on whether to list in New York or possibly Milan has yet to be made, the sources said.

A spokesman for the company declined to comment.

The Padua-based firm, which is owned by Italy’s Stevanato family, makes glass tube containers for the pharmaceutical and healthcare sectors and glass cartridges for insulin pen injectors.

It reported core earnings of 111.1 million euros ($135.88 million) in 2019 and a turnover of 570.3 million euros, the company said.

Its estimated valuation is based on how major peers such as U.S. drug packaging company West Pharma is trading, said one of the sources. West Pharma has a market capitalisation of $20.7 billion.

Last year, Stevanato signed an agreement with the global Coalition for Epidemic Preparedness Innovations - which is a co-leader of the World Health Organization’s global vaccine-sharing scheme COVAX - for the supply of 100 million glass vials to hold up to 2 billion doses of a vaccine against the COVID-19 virus.

Stocks in the healthcare sector have soared since the start of the COVID-19 pandemic, particularly of those companies making products to combat the spread of the novel coronavirus.

New York’s Nasdaq exchange is the world’s biggest investment hub for biotechnology companies and its biotech index has a market cap of $1.3 trillion dollars.

https://www.reuters.com/article/us-stevanato-ipo/covid-19-vaccine-vial-maker-stevanato-preps-ipo-valuing-it-at-up-to-5-billion-sources-idUSKBN2AP1LP

Atossa Has Final Results from Phase 1 of AT-301 Nasal Spray for COVID-19

Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical-stage biopharmaceutical company seeking to discover and develop innovative medicines in areas of significant unmet medical need in oncology and infectious diseases, with a current focus on breast cancer and COVID-19, today announced final results from its Phase 1 double-blinded, randomized, placebo-controlled clinical study using Atossa’s proprietary drug candidate AT-301 administered by nasal spray. AT-301 was considered to be safe and well tolerated in healthy male and female participants in this study at two different dose levels over 14 days. AT-301 is being developed for at home use for patients recently diagnosed with COVID-19. There are currently no FDA-approved therapies to treat COVID-19 at home.

Final analysis of the data from the study indicates that there were no serious adverse events, no discontinuations, no bronchospasms, and only one subject of the 32 subjects in the study experienced adverse events that were considered moderate in severity and all other adverse events were considered mild. Atossa’s assessment is that AT-301 nasal spray was safe and well tolerated in this study. The most common treatment-related adverse events observed with AT-301 treatment with either single or multiple doses were nasal discomfort and sneezing.

Atossa also plans to develop its nasal spray to potentially help prevent COVID-19 infection -- particularly for people in high-risk environments, such as people living with an infected patient, people living and working in healthcare facilities, emergency responders or teachers.

Atossa believes that AT-301 nasal spray will play an important role alongside the traditional vaccines now being deployed, particularly as it becomes clear that it will take months or years for vaccines to be administered around the world. New deadlier and/or more infective variants of COVID-19 are being reported in the U.S. and in many other countries and it is not clear that current vaccines will be completely effective against these and future variants. Additionally, none of the currently available vaccines are 100% effective, they may have more significant side effects in older people, and effectiveness is expected to diminish over time. The intended mechanism of action of AT-301 is to prevent virus entry into human cells by inhibiting the obligatory Spike Protein activation. The activation is performed by three human cell surface enzymes, ACE2, furin, and TMPRSS2, and is therefore unaffected by mutations and variants in SARS-CoV-2.

https://www.globenewswire.com/news-release/2021/02/25/2182576/0/en/Atossa-Therapeutics-Announces-Final-Results-from-Phase-1-Clinical-Study-Showing-Safety-and-Tolerability-of-AT-301-Nasal-Spray-Being-Developed-for-COVID-19.html

Exelixis Gets Breakthrough Tag for Cabozantinib for Thyroid Cancer

 Exelixis, Inc. (NASDAQ: EXEL) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to cabozantinib (CABOMETYX®) as a potential treatment for patients with differentiated thyroid cancer (DTC) that has progressed following prior therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). The FDA’s Breakthrough Therapy Designation aims to expedite the development and review of drugs that are intended to treat serious or life-threatening diseases. To qualify for this designation, preliminary clinical evidence must indicate that the drug may demonstrate substantial improvement on at least one clinically significant endpoint over existing therapies.

https://www.biospace.com/article/releases/exelixis-announces-breakthrough-therapy-designation-granted-to-cabozantinib-for-the-treatment-of-patients-with-previously-treated-radioactive-iodine-refractory-differentiated-thyroid-cancer/

Healthcare innovation SPAC Isleworth Healthcare Acquisition prices upsized $180M IPO

 Isleworth Healthcare Acquisition, a blank check company targeting healthcare innovation, raised $180 million by offering 18 million units at $10. The company offered 3 million more units than anticipated. Each unit consists of one share of common stock and one-half of a warrant, exercisable at $11.50.

The company is led by Chairman Allen Weiss, who has been a Partner at Apollo Capital Management since 2011 and previously served as President of World Wide Operations for Walt Disney Parks and Resorts. He is joined by CEO and Director Robert Whitehead, who previously co-founded and helmed Sprout Pharmaceuticals and Slate Pharmaceuticals, and CFO and Director Dan Halvorson, who previously served as CFO of Brain Corporation and Ingenu prior to that. 

Isleworth Healthcare Acquisition intends to pursue prospective targets that are focused on healthcare innovation, with a particular focus on companies domiciled in North America, Europe, and Asia that are developing assets in the biopharmaceutical and, medical technology/medical device space, which aligns with the management team’s experience in operating healthcare companies and in drug and device/technology development.

Isleworth Healthcare Acquisition plans to list on the Nasdaq under the symbol ISLEU. I-Bankers Securities acted as a lead manager on the deal.

https://www.nasdaq.com/articles/healthcare-innovation-spac-isleworth-healthcare-acquisition-prices-upsized-%24180-million

Brookdale to sell $400M majority stake in home health, hospice, therapy business to HCA

 Brookdale Senior Living has agreed to sell its majority stake in Brookdale Health Care Services (BHS) — provider of home health, hospice and therapy services — to HCA Healthcare, the country’s largest senior living company announced Wednesday. The purchase price is $400 million.

The move is designed in part to position Brookdale’s core senior housing operations for sustained growth, the company said.

Brookdale will maintain a 20% equity interest in BHS, and Brookdale senior living residents still will have access to the services it provides, Brookdale said. In fact, Brookdale said that the new partnership will provide opportunities to improve healthcare service offerings within Brookdale’s communities to enhance residents’ experience and health outcomes.  

“The health and wellbeing of our residents is at the core of Brookdale’s mission,” Brookdale President and CEO Lucinda “Cindy” Baier said in a statement. “Today’s partnership with HCA Healthcare, a leading healthcare organization, will continue the high quality services delivered to our residents and patients, strengthen our liquidity position and provide meaningful opportunities for growth through better integration of services across the entire care continuum.”

The venture also will help enhance the growth prospects for BHS, given the complementary nature of services of both organizations, Brookdale said.

BHS operates 57 home health agencies and 22 hospice agencies across 26 states, along with 84 outpatient therapy locations. Ninety-eight percent of its home health agencies earned a 4 or better Quality Star Rating from the Centers for Medicare & Medicaid Services in December, according to the company. 

HCA Healthcare has more than 2,000 sites of care at which more than 32 million patient encounters occur annually. Brookdale will join HCA Healthcare’s network of care through the new venture.

“HCA Healthcare’s objective is to be the healthcare system of choice in the communities we serve through the development of comprehensive services and by delivering high quality, convenient care to our patients,” HCA Healthcare CEO Sam Hazen said in a statement. “We believe this opportunity to partner with Brookdale will expand the services we offer and enhance our ability to deliver a better experience for our patients as well as for Brookdale residents.”

Brookdale said the transaction represents the latest material announcement in the company’s ongoing efforts to drive meaningful shareholder value, following its July 2020 lease renegotiation with real estate investment trust Ventas and the January 2020 sale of its entry fee continuing care retirement community venture interest to Healthpeak Properties.

https://www.mcknightsseniorliving.com/home/news/brookdale-announces-400-million-sale-of-majority-stake-in-home-health-hospice-therapy-business-to-hca-healthcare/

Pfizer-BioNTech testing booster of their Covid vax in new trial

 Pfizer and BioNTech said on Thursday they are testing a third dose of their Covid-19 vaccine to better understand the immune response against new variants of the virus.

They are also in talks with regulatory authorities about testing a vaccine modified to protect specifically against the highly transmissible new variant found in South Africa and elsewhere, known as B.1.351, as a second arm of the same study.

The companies believe their current two-dose vaccine will work against the South African variant as well as one found in the United Kingdom and elsewhere. But the studies will allow the vaccine makers to be prepared if and when more protection is necessary, they said.

“The rate of mutations in the current virus is higher than expected,” Pfizer Chief Scientific Officer Mikael Dolsten said in an interview.

“It’s a reasonable probability that we would end up with regular boosts. And for potent vaccines, it may be that you need to do a strain change every few years, but not necessarily every year.”

In the first stage of the first arm of the study, a third 30 microgram dose will be given to as many as 144 people who received the vaccine 6 to 12 months ago in the original Phase I safety trial.

Assuming regulatory approval, a redesigned vaccine would also be tested, both as a booster dose in people who have been vaccinated and in people who had not yet received the vaccine, Dolsten said.

The trial would not seek to measure the efficacy of the vaccine like their large Phase III trial last year. Instead, it would measure the antibody response and study whether blood from recipients can neutralize the new coronavirus variants, as well as the safety of a third dose.

The United States discovered its first case of the South African variant in January and it has since turned up in 14 states, according to U.S. government data. Several studies suggest it is more resistant to existing vaccines than other variants of the coronavirus.

Pfizer’s Dolsten said that mRNA vaccines like Pfizer and BioNTech’s vaccine create a potent response. But the immune response may wane over time.

He believes that a third dose of their vaccine will create a similar or better response than the second dose, and could be the logical next step for staying ahead of circulating variants.

“We think our vaccine is robustly active against all strains,” Dolsten said, noting that the companies “want to be prepared for all options and be data-driven — led by science.”

Dolsten said the new trial would likely be predominantly conducted in the United States.

Moderna said on Wednesday it is also working with U.S. government scientists to study an experimental booster shot that targets the variant first found in South Africa.

https://www.cnbc.com/2021/02/25/pfizer-biontech-are-testing-a-booster-shot-of-their-covid-vaccine-in-a-new-trial.html

Altimmune Commences Enrollment in Phase 1 Clinical Trial of Intranasal Covid Vax

 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has commenced enrollment in a Phase 1 clinical trial of AdCOVID, a single-dose intranasal COVID-19 vaccine candidate. AdCOVID is an adenovirus-vector vaccine designed to stimulate a broad immune response including both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA and resident memory T cells) in the nasal cavity and respiratory tract.

The Phase 1 clinical trial will evaluate the safety and immunogenicity of AdCOVID in up to 180 healthy adult volunteers between the ages of 18 and 55. Subjects will receive AdCOVID at one of three dose levels administered as a nasal spray. In addition to the primary study endpoint of safety and tolerability, the immunogenicity of AdCOVID will be evaluated by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody from nasal samples, and T cell responses. Altimmune anticipates having a full data readout from this Phase 1 study in Q2 2021.

https://www.globenewswire.com/news-release/2021/02/25/2182311/0/en/Altimmune-Commences-Enrollment-in-Phase-1-Clinical-Trial-of-AdCOVID-a-Needle-Free-Single-Dose-Intranasal-COVID-19-Vaccine-Candidate.html