Cowen's CEO sees gains in biotech, helped by easier access to cash

 U.S. regulations enacted after the financial crisis helped biotechnology companies raise the funds they needed to fight COVID-19 and will pave the way for further growth in the sector next year, the chief executive officer of investment bank Cowen Inc. said.

Dozens of biotechs including two leading the race for a coronavirus vaccine, are flourishing because the Jump-start Our Business Start-ups or JOBS Act has made it easier for small companies to raise financing.

Over the last 10 years, 415 biotechnology companies have listed their shares publicly, raising $200 billion through IPOs and follow-on fund raising, Cowen data show. Their continuing research allowed the companies to get 420 drugs approved during that time, the data show.

BioNtech, which listed its stock last year, and Moderna Therapeutics, which went public in 2018, have both asked U.S. and European regulators to approve their COVID-19 vaccines.

“Individuals and small businesses now have a smoother pathway to the capital markets thanks to more inclusionary rules and that has had a huge impact on many sectors but most prominently the biotech sector,” Jeffrey Solomon, Cowen’s CEO and chairman said at the Reuters Global Investment Outlook Summit. “Are we going to see more growth in the biotech sector next year? Yes.”

Cowen has helped a number of companies raise funds for researching therapeutics and creating tools and diagnostics.

Solomon said the companies Cowen has worked with have researchers working on therapies for cancer, aging, heart disease and mental health among others while also applying big data analytics and cloud computing.

Biotech investing has been lucrative for institutional investors and retail investors alike with health-care oriented hedge funds gaining an average 13% in the first 10 months of 2020 and retail funds like the Fidelity Select Biotechnology Portfolio gaining 31% in the first 11 months of 2020.

Solomon, who serves on the Securities and Exchange Commission’s Small Business Capital Formation Advisory Committee, said easier access to capital is just one theme of a handful he called instrumental.

He said he has been urging corporate chiefs to be more diverse in boardrooms and on the factory floors and embrace more sustainable production methods.

“CEOs are getting the message that your business model is predicated on embracing the changing demographics of the country. If you don’t do this, your business will be less relevant,” he said.

On Tuesday Nasadaq made a big push for diversity by saying it will require its listed companies to include women, racial minorities and LGBTQ individuals on their boards.

The pandemic has helped executives understand that what worked for decades might have to be thrown out the window. “Why wait, it is better to get out in front of new trends and adopt the mindset of stakeholder capitalism,” Solomon said.

https://www.reuters.com/article/us-investment-summit-solomon/cowens-solomon-sees-gains-in-biotech-helped-by-easier-access-to-cash-idUSKBN28C2ZE

U.S. employers 'could mandate COVID-19 vaccine, but unlikely to do so'

 Private U.S. companies have the right under the law to require employees to get vaccinated against COVID-19, but are unlikely to do so because of the risks of legal and cultural backlash, experts said.

Companies are still in the early stages of navigating access and distribution of vaccines against the disease caused by the novel coronavirus, but inoculation is considered the key to safely resume operations at crowded warehouses, factory lines and on sales floors.

“Companies have every good reason to get all of their employees vaccinated and also have an obligation to keep all employees and customers safe,” said Lawrence Gostin, a global health law professor at Georgetown University.

Gostin and five other health law experts said private companies in the United States have broad liberties to set health and safety standards, which would allow them to mandate vaccinations as a condition of employment with some exceptions.

The Equal Employment Opportunity Commission in May said employers were allowed to compel employees to get a coronavirus test before allowing them to return to work, a decision that some experts said might be extended to vaccine mandates.

But Robert Field, a law and public health professor at Drexel University, said companies considering mandates should wait for vaccines to undergo a full-fledged regulatory review process.

“Employers are on shakier grounds because of the emergency use authorization,” Field said, adding there was no precedent for vaccine mandates during that phase.

U.S. courts that have ruled on lawsuits by healthcare workers opposing employer-mandated flu vaccines have largely sided with hospitals as long as they provided reasonable exemption policies, court records showed.

REGULATORY PATCHWORK

In Europe, companies face a patchwork of national vaccine regulation, with some countries mandating childhood vaccines, but European employers overall are unlikely to be able to mandate vaccination for staff, experts said.

In France, which in 2018 began mandating some childhood vaccines, some vaccinations are obligatory for professionals in the social and healthcare industry. President Emmanuel Macron has said a coronavirus vaccine will not be mandatory.

In Germany currently, only measles vaccines are mandatory for some employees and companies have no sufficient legal basis to order COVID-19 vaccination, said Pauline Moritz, a Frankfurt-based employment law attorney.

And in the UK, the government has no legal power to compel vaccination and employers attempting to mandate vaccines would likely confront human rights concerns, employment lawyers at Morgan Lewis wrote in a blog post. bit.ly/3lDbG9W

U.S. agencies to date have not weighed in on COVID-19 vaccine mandates, but the Occupational Safety and Health Administration (OSHA) in the past has said employers have the right to mandate vaccines.

OSHA referred a request for comment to the U.S. Department of Health and Human Services, which did not respond.

VACCINE MANDATES UNLIKELY

U.S. companies so far are shying away from discussing vaccine mandates, ahead of formal approval for a vaccine by the U.S. Food and Drug Administration.

Ford Motor Co, which has ordered a dozen ultra-cold freezers to distribute vaccines to employees, said they would be made available on a voluntary basis.

A spokeswoman for Kellogg Co said the company was working with a medical expert and industry trade associations to make vaccines available to employees on a voluntary basis, in compliance with local and regional regulations.

“Companies could theoretically issue a mandate, but in the current political climate it is very unlikely they will do so,” said Peter Meyers, a law professor at George Washington University Law School. “Americans tend to shy away from mandates.”

Surveys have shown many Americans have safety concerns about a COVID vaccine, with nearly half of the 10,000 respondents polled in a September Pew research survey saying they would definitely or probably not get the vaccine.

Some experts said any vaccine mandates would prompt litigation. Cases alleging infringement on religious freedom could make it to a more conservative U.S. Supreme Court.

Vaccine mandates are common in the U.S. healthcare industry, where many hospitals require staff to take annual flu shots and all U.S. states mandate vaccines for school children.

Employees and parents can object to vaccines largely on two grounds: medical conditions that contraindicate vaccination or - depending on the U.S. state - religious or personal believes.

Some union contracts with individual employers, particularly in the healthcare industry, also prevent mandatory vaccines.

If an employee rejects vaccination on religious grounds, an employer has to make a reasonable effort to accommodate the worker, such as offering a transfer to a different department with fewer personal interactions or mandating masks, said Dorit Rubinstein Reiss, a law professor at UC Hastings.

So far two companies, Pfizer Inc and Moderna Inc, have asked the U.S. Food and Drug Administration for emergency use authorization of their vaccine candidates.

The chief adviser of the U.S. government’s COVID-19 vaccine program said on Tuesday that 20 million people could be vaccinated by the end of 2020, and that by the middle of 2021 most Americans will have access to highly effective vaccines.

https://www.reuters.com/article/idUSKBN28C2LL

EU criticises 'hasty' UK approval of COVID-19 vaccine

The European Union criticised Britain’s rapid approval of Pfizer and BioNTech’s COVID-19 vaccine on Wednesday, saying its own procedure was more thorough, after Britain became the first western country to endorse a COVID-19 shot.

The move to grant emergency authorisation to the Pfizer/BioNTech vaccine has been seen by many as a political coup for UK Prime Minister Boris Johnson, who has led his country out of the EU and faced criticism for his handling of the pandemic.

The decision was made under an ultra-fast, emergency approval process, which allowed the British drugs regulator to temporarily authorise the vaccine only 10 days after it began examining data from large-scale trials.

In an unusually blunt statement, the European Medicines Agency (EMA), which is in charge of approving COVID-19 vaccines for the EU, said its longer approval procedure was more appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by Britain.

The agency said on Tuesday it would decide by Dec. 29 whether to provisionally authorise the vaccine from U.S. drugmaker Pfizer Inc and its German partner BioNTech SE .

A spokesman for the European Commission, the EU executive, said the EMA’s procedure was “the most effective regulatory mechanism to grant all EU citizens’ access to a safe and effective vaccine,” as it was based on more evidence.

Pfizer UK Country Manager Ben Osborn said, “We have provided complete data packages, the unblinded data, to both regulators. I think what you’re seeing is just the difference in the underlying process and timelines, as opposed to any difference in data submission.”

June Raine, the head of Britain’s Medicines and Healthcare products Regulatory Agency (MHRA), said, “The way in which the MHRA has worked is equivalent to all international standards. 

“Our progress has been totally dependent on the availability of data in our rolling review and our rigorous assessment and independent advice we have received,” she added.

The EMA started a rolling review of preliminary data from Pfizer trials on Oct. 6, an emergency procedure aimed at speeding up possible approval, which usually takes at least seven months from reception of full data.

The UK regulator launched its own rolling review on Oct. 30, and analysed less data than made available to the EMA.

“The idea is not to be first but to have a safe and effective vaccine,” Germany’s Health Minister Jens Spahn told a news conference.

Asked about the emergency procedure used by Britain, he said EU countries had opted for a more thorough procedure to boost confidence in vaccines.

“If you evaluate only the partial data as they are doing they also take a minimum of risk,” the EMA’s former head Guido Rasi told an Italian radio.

“Personally I would have expected a robust review of all available data, which the British government has not done to be able to say that without Europe you come first,” he added.

‘PROBLEMATIC’

EU lawmakers were even more explicit in their criticism of Britain’s move.

“I consider this decision to be problematic and recommend that EU Member States do not repeat the process in the same way,” said Peter Liese, an EU lawmaker who is a member of German Chancellor Angela Merkel’s party.

“A few weeks of thorough examination by the European Medicines Agency is better than a hasty emergency marketing authorisation of a vaccine,” said Liese, who represents the centre right grouping, the largest in the EU Parliament.

Under EU rules, the Pfizer vaccine must be authorised by the EMA, but EU countries can use an emergency procedure that allows them to distribute a vaccine at home for temporary use.

Britain is still subject to EU rules until it fully leaves the bloc at the end of the year.

“There is an obvious global race to get the vaccine on the market as fast as possible,” said Tiemo Wolken, an EU lawmaker from the socialist grouping, the second largest in the Parliament.

“However, I do believe that it is better to take the time and make sure that the quality, effectiveness and safety is guaranteed and matches our EU standards.”

https://www.reuters.com/article/us-health-coronavirus-britain-eu/eu-criticises-hasty-uk-approval-of-covid-19-vaccine-idUSKBN28C1B9

Oramed launches late-stage NASH study with oral insulin

 

• Oramed Pharmaceuticals (ORMP +2.7%) has screened the first patients in Phase 2 trial evaluating oral insulin capsule ORMD-0801 for the treatment of Nonalcoholic steatohepatitis (NASH).
• The trial will measure efficacy endpoints via MRI-PDFF (Non-invasive, quantitative assessment of liver fat), for 12-weeks dosing.
• Last week, the company initiated Phase 3 trials of its oral insulin for the treatment of type 2 diabetes.
• https://seekingalpha.com/news/3640914-oramed-launches-late-stage-nash-study-oral-insulin

Mesoblast cell therapy Fast Track'd for COVID-19-related acute respiratory distress syndrome

 

• The FDA designates Mesoblast Limited's (NASDAQ:MESO) Phase 3-stage Ryoncil (remestemcel-L) for Fast Track review for the treatment of acute respiratory distress syndrome (ARDS) due to COVID-19.
• Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
• Remestemcel-L is an allogeneic mesenchymal stem cell product. It consists of culture-expanded mesenchymal stromal cells derived from the bone marrow of an unrelated donor. It is thought to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by downregulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.
• https://seekingalpha.com/news/3640734-mesoblast-cell-therapy-fast-trackd-for-covidminus-19-related-acute-respiratory-distress

CytoDyn launches mid-stage study of leronlimab in nonalcoholic fatty liver disease

 

• The first patient has been enrolled in a Phase 2 clinical trial evaluating CytoDyn' (OTCQB:CYDY) leronlimab, for the treatment of non-alcoholic steatohepatitis (NASH) and/or Nonalcoholic Fatty Liver Disease (NAFLD).
• As previously reported, the Company’s preclinical study demonstrated strong positive data highlighting the potential of leronlimab in treating nonalcoholic fatty liver disease (NAFLD), a common precursor to NASH. Inhibition of CCR5 has been shown to be effective in reducing fibrosis in animal models of NASH liver fibrosis.
• Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.
• https://seekingalpha.com/news/3640733-cytodyn-launches-mid-stage-study-of-leronlimab-in-nonalcoholic-fatty-liver-disease

Appili Therapeutics advances late-stage study of favipiravir for COVID-19

 

• Dosing is underway in a Phase 3 clinical trial, PRESECO, evaluating Appili Therapeutics' (OTCQX:APLIF) Avigen tablets (favipiravir) for the treatment of COVID-19 patients with mild-to-moderate symptoms. The goal is to alleviate the symptoms and prevent disease progression.
• Enrollment target is ~826 subjects. The primary endpoint is time to sustained recovery from day 0 to day 21 compared to placebo.
• Preliminary data should be available in H1 2021.
• Favipiravir is a broad-spectrum antiviral developed by FUJIFILM Toyama Chemical Co., Ltd. (OTCPK:FUJIF). It is approved in Japan for the treatment of influenza. Based on encouraging clinical data, Russia and India recently approved its emergency use for COVID-19. FUJIFILM recently announced positive results from a Phase 3 study in hospitalized COVID-19 patients.
• Appili is part of a consortium that includes Dr. Reddy's Laboratories (NYSE:RDY), Global Response Aid and FUJIFILM backing global development and distribution (ex. Japan, China and Russia) of Avigan tablets for the potential treatment and prevention of COVID-19.
• https://seekingalpha.com/news/3640768-appili-therapeutics-advances-late-stage-study-of-favipiravir-for-covidminus-19