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Wednesday, October 27, 2021

Glaxo Q3 results beat expectations as it gears up to sell consumer healthcare unit

 Pharma giant GSK (GSK.L) delivered better-than-expected third quarter results thanks to double-digit sales growth in its pharmaceuticals and vaccines divisions as well as continued cost-cutting.

The company also announced it had raised its annual profit outlook.

Group turnover was up by 5% to £9.07bn ($12.5bn) for the three months to 30 September. Analysts had expected slightly lower Q3 earnings of of £8.73bn, as per a consensus compiled by the company.

Pharmaceuticals sales rose by 5.5% to £4.4bn, and its vaccines unit saw sales growth of 7% to £2.2bn.

The company now expects 2021 adjusted earnings per share to decline by between 2% and 4% at constant exchange rates, excluding any boost from its COVID-19 offerings. It had previously expected profit to fall by mid-to-high single digit percentages.

Shares in the company ticked up 3.2% on Wednesday afternoon.

CEO Emma Walmsley said: “GSK has delivered another quarter of strong business performance. This has allowed us to improve our full-year guidance and, alongside the progress in strengthening our R&D pipeline, reinforces our confidence in the outlook for a step-change in growth and performance in 2022 and beyond.”

“We also continue to make excellent progress towards unlocking the value of consumer healthcare through a successful demerger in mid-2022.”

GSK's stock was up on Wednesday afternoon. Chart: Yahoo Finance UK
GSK's stock was up on Wednesday afternoon. Chart: Yahoo Finance UK

Last month activist hedge fund Bluebell Capital Partners had turned up the pressure on Walmsley after it followed in the footsteps of Elliott Investment Management and bought a stake in the pharma firm. Both parties have called for a sale of the consumer healthcare unit.

The CEO has also been under pressure for lagging behind in the coronavirus vaccines race compared with rivals such as AstraZeneca (AZN.L).

Earlier this month GSK had signed a deal to supply 10,000 doses of its COVID-19 monoclonal antibody therapy to the Canadian government.

Two weeks ago, CureVac (CVAC) said it will give up on its first-generation COVID-19 vaccine candidate and instead focus on working with GSK to develop improved mRNA vaccine technology.

In its latest results GSK said its vaccines business faced significant disruption during 2021, given the governments’ prioritisation of COVID-19 vaccinations.

This impacted GSK's immunisations, including shingles vaccine Shingrix, particularly in the US. 

GSK said in Q3 2021, the surge in the COVID Delta variant delayed the expected second half recovery in Shingrix prescriptions but "this was more than offset by beneficial year-on-year wholesaler inventory comparisons and by growth in the US non-retail channel as well as encouraging sales outside the US from existing and new launch markets."

It now expects vaccines revenue for 2021 to decline by mid-single digits but it remains "confident in the underlying demand and medium term prospects for Shingrix and our vaccines portfolio."

https://finance.yahoo.com/news/gsk-q-3-results-beat-expectations-as-it-gears-up-to-spin-off-consumer-healthcare-business-133420182.html

Amneal Launches Generic Dexamethasone Following ANDA Approval by FDA

 Amneal Pharmaceuticals, Inc. (NYSE: AMRX) ("Amneal" or the "Company") today announced that it is launching dexamethasone, 4mg and 6 mg, following Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA).

Dexamethasone, the generic version of Decadron®, is a well-established anti-inflammatory glucocorticoid steroid used to treat several medical conditions, including respiratory complications associated with COVID-19.

"Today’s approval and launch of dexamethasone reflects the continued execution of our innovation agenda. Expanding access to essential therapies, particularly in the treatment of COVID-19, is core to our mission at Amneal and we are pleased to play our part," said Chirag and Chintu Patel, Co-Chief Executive Officers.

https://finance.yahoo.com/news/amneal-launches-generic-dexamethasone-following-120000986.html

Novavax files for its first COVID-19 vaccine authorization in UK

 Novavax (NVAX) submitted its first authorization filing for its COVID-19 vaccine in the U.K. Wednesday, and expects to follow suit in several other global markets in the coming week.

The U.S. and its Food and Drug Administration (FDA) is not among those, but CEO Stanley Erck said the company intends to have its U.S. package ready for filing by the end of 2021.

Erck told Yahoo Finance in an exclusive interview Tuesday that he hopes the filings will allay concerns about the company's ability to reach the finish line with its vaccine.

"We've reached a very big milestone for the company, and hopefully for global health," Erck said.

"It allows us to prepare for not only this filing, but also for global filings with various regulatory agencies in Europe and Australia and Canada," he added.

The company has faced several setbacks in the past year, including running into supply chain constraints and building out its manufacturing.

recent Politico report revealed concerns within the FDA about the quality of the vaccine, which tanked the company's stock. Erck said he hopes the slew of filings this week is a strong enough signal to clear any doubts.

"You don't file for emergency use approval if you haven't solved all of your manufacturing issues. So we feel that the filing today, and the other regulatory agencies this week, should largely put to bed any of those concerns," Erck said.

Novavax's clinical trials showed the vaccine to be 90% effective.

The news comes amid an ongoing global shortage of vaccines, which Erck also said Novavax is ready to tackle. The company has partnered with the Serum Institute of India in order to supply the global COVAX distribution channel as well as for bilateral agreements.

Novavax and the Serum Institute pledged 1.1 billion doses to COVAX earlier this year. "Much of our early production is going to go to low- and middle-income countries through COVAX," Erck said.

The Serum Institute was supposed to produce and ship AstraZeneca's (AZN) vaccine through COVAX, but the Indian government halted exports of the vaccine and forced the company to redirect doses to the sub-continent amid its Delta surge earlier this year. 

That severely hampered the availability of doses in low- and middle-income countries which continue to struggle to gain access.

Erck hopes that will soon change and is confident the Serum Institute will be able to meet demand, as it recently announced delivering its one-billionth dose, doubling its monthly output to 200 million doses.

Novavax has also built up manufacturing capacity in the U.S. and abroad to help with its global distribution.

https://finance.yahoo.com/news/novavax-files-for-covid-19-vaccine-authorization-in-uk-124809823.html

Fulgent Genetics Launches At-Home Neutralizing Antibody Test for COVID-19

 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health, today announced that it has launched an antibody test for COVID-19 which will specifically target neutralizing antibodies. The test will be available through the Company’s consumer initiated platform, Picture Genetics.

Fulgent aims to empower individuals with better data on their potential resistance levels to COVID-19 by making antibody testing readily available to consumers through its Picture Genetics platform. This lab developed test is performed with a finger prick in the comfort of a patient’s home, with no need for a physician visit and venipuncture. By expanding access to this antibody data, we hope to better understand the long-term effectiveness of vaccines and potential herd immunity to COVID-19.

Unlike typical antibody tests that detect all antibodies in patients, Fulgent’s antibody test will specifically detect the level of neutralizing antibodies in patients from a recent COVID-19 infection, or those who have been vaccinated against the virus. Neutralizing antibodies are unique in that they bind to a specific part of a pathogen and have been observed to decrease SARS-CoV-2 viral infection of cells, thus targeting these specific antibodies gives us better insight into the level of immunity of a patient. The detection of neutralizing antibodies in patients requires a higher level of specificity and sensitivity given antibodies can rapidly decrease within the months following a COVID-19 infection or vaccination. Immunity to SARS-CoV-2 and its variants is not yet well understood as research on the topic is ongoing.

"With the launch of our neutralizing antibody test, we hope to provide patients and healthcare providers with better data on immunity to COVID-19, whether from the vaccine or a previous infection," said Dr. Harry Gao, Chief Scientific Officer of Fulgent. "While we cannot yet conclude whether the presence of neutralizing antibodies guarantees immunity against a COVID-19 infection, we hope that this test can help determine immunity levels and the need for vaccine boosters across the population and help to improve our country’s overall response to the virus."

Merck signs pact to broaden generic manufacturing of COVID-19 pill

 Merck & Co has signed a licensing agreement with the United Nations-backed Medicines Patent Pool (MPP) that will allow more companies to manufacture generic versions of its experimental oral antiviral COVID-19 treatment, the U.S. drugmaker and the organization announced on Wednesday.

Merck said the royalty-free license would apply to 105 low- and middle-income countries. It allows manufacturers selected by MPP to make generic versions of molnupiravir, the antiviral pill Merck has developed with Ridgeback Biotherapeutics.

The U.S. Food and Drug Administration is considering emergency use authorization of the medicine, which was shown in a clinical trial https://www.reuters.com/business/healthcare-pharmaceuticals/mercks-covid-19-pill-cuts-risk-death-hospitalization-by-50-study-2021-10-01 to halve the risk of serious disease and death when given early for COVID-19.

"This is the first transparent, public health-driven voluntary license for a COVID-19 medical technology," Merck and MPP said in a joint statement.

Companies will be able to apply for a sub-license from MPP and the license, which also includes technology transfer, will remain royalty-free so long as the World Health Organization classifies the pandemic as a "Public Health Emergency of International Concern," the statement said.

Merck earlier this year signed bilateral licensing deals with eight Indian generic drugmakers, including Aurobindo Pharma , Cipla Ltd, Dr. Reddy's Labs, Emcure Pharmaceuticals, Hetero Labs, Sun Pharmaceuticals , and Torrent Pharmaceuticals.

The agreement with MPP broadens the manufacturing base beyond those companies. MPP told Reuters recently https://www.reuters.com/business/healthcare-pharmaceuticals/merck-covid-19-pill-sparks-calls-access-lower-income-countries-2021-10-17 that it had 24 companies that had expressed interest in making the drug.

"We all along knew that we would want to diversify the geographic footprint of our generic partners, so that we did not only have generic suppliers in India, but in other geographies as well," Paul Schaper, Merck's executive director of global public policy, said in an interview.

The Bill & Melinda Gates Foundation said last week it will spend up to $120 million to kick-start development of generic versions of molnupiravir to help ensure lower-income countries have equal access to the drug.

https://finance.yahoo.com/news/merck-signs-pact-broaden-generic-100000105.html

Business lobby calls for admin to 'pump the brakes' on vaccine mandate

 The Biden administration’s looming vaccine-or-test mandate has unsettled several business groups, who are calling for the rule to be postponed until after the holidays.  

These business groups, representing sectors ranging from retail to trucking, scheduled meetings with the Office of Management and Budget (OMB) this week to discuss their concerns about the federal requirements. 

Groups worry that the mandate will lead to bulk resignations and add to industries’ struggles. Businesses are already experiencing a shortage of workers in the lead-up to the holiday season. 

But many public health officials have supported vaccine mandates, saying they might be the country’s best bet to end the pandemic.  

The Occupational Safety and Health Administration (OSHA) was tasked with drafting the rule announced by President Biden last month that requires employers with at least 100 employees to mandate vaccines or weekly testing. Employers could face penalties up to $14,000 per violation.  

OSHA issued a written rule to the OMB earlier this month for review, and the office booked meetings with dozens of interest groups and individuals over the past two weeks, including the National Retail Federation.  

The National Retail Federation, which has dedicated millions of dollars to vaccine incentives, has “serious questions” about the forthcoming rule, particularly its “one size fits all” approach, Edwin Egee, vice president of government relations and workforce development, said.  

“We’re really concerned how that’s going to impact us,” Egee said. “There’re already over a million vacant positions in the retail industry, and this is not going to help that, especially as we’re going to try to hire up more as we move into the holiday season.” 

Egee said he is urging the White House to “pump the brakes a little” with an at least 90-day implementation period. The longer timeline would allow officials to see how COVID-19 trends go and to address “the complexities” of the requirements, including mapping out the logistics of weekly testing for unvaccinated employees, he said.

“Simply imposing this mandate on all employers, regardless of their facilities, regardless of the style of their operations, it could be really problematic potentially ... as retailers move into the holiday season,” he said. 

The American Trucking Associations also called for the implementation period to extend at least 90 days in a letter sent to the OMB last week, citing that the industry could lose up to 37 percent of drivers with retirements, resignations and job changes.

“Even if the ultimate goal is something we all agree on — increasing vaccination protections and defeating the COVID-19 Pandemic — it is vital that public health measures first do no harm,” Chris Spear, the association’s president and CEO, wrote in the letter obtained by The Hill. 

American Apparel and Footwear Association President and CEO Steve Lamar said his organization has called for a “realistic implementation period,” including a potential delay if the administration does not answer their questions on topics such as testing “satisfactorily.”  

“A lot of confusion has created and fueled concerns during the course of a pandemic,” Lamar said. “And a brand new vaccine mandate, testing mandate that adds to that confusion, adds to that concern is not what we need right now.” 

The labor market has already been affected by shortages as the quits rate reached a record high of 2.9 percent in August when millions of Americans left their jobs voluntarily.

White House officials have consistently defended the federal vaccine requirements as effective and key to exiting the pandemic, touting an at least 20 percent increase in vaccination rates in companies and institutions requiring the shots.

Biden had also previously announced a vaccine mandate for federal employers and contractors. White House coronavirus coordinator Jeff Zients said last week these rules would not cause disruptions to government services, including holiday travel, because the “small number” of those who don’t comply are first given education and counseling. 

“Agencies will not be removing employees from federal service until after they’ve gone through a process of education and counseling,” he said.

Biden has not filled the role of OMB director in the nine months of his presidency after withdrawing Neera Tanden’s nomination for the position. In the meantime, acting Director Shalanda Young has served in the role.  

A Goldman Sachs analysis from last month predicted the Biden requirement, expected to apply to almost 80 million workers, could boost the vaccination rate by 12 million people by March 2022 but warned the labor market could take a hit.

Two of the biggest lobbying groups in corporate America — the U.S. Chamber of Commerce and the Business Roundtable — previously said they were not against the federal mandate.  

A recent statement from Business Roundtable, however, additionally called for OMB to “provide the flexibility for companies to comply, taking into account” workforce shortages and supply chain issues ahead of the holiday season. 

Twelve percent of unvaccinated workers said they’d get the vaccine if presented with a vaccine-or-test mandate, while 30 percent said they’d leave their job, a Kaiser Family Foundation poll from last month concluded. 

But Georges Benjamin, the executive director of the American Public Health Association, said the requirement will overall help businesses keep functioning amid any local outbreaks in the upcoming months. 

Although a small number of employees may quit due to the mandate, Benjamin said businesses could lose even more staff if a COVID-19 outbreak strikes, potentially forcing the business to shut down for a few weeks during the holiday season. 

“This is not a barrier to getting good business done,” he said. “This was actually ... a business friendly proposition.”

https://thehill.com/policy/healthcare/578628-business-lobby-calls-for-administration-to-pump-the-brakes-on-vaccine

Relief Therapeutics Unit: Positive Interim Trial Data on Covid Nasal Spray

 RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) ("Relief"), a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, today announced that its wholly owned subsidiary, APR Applied Pharma Research SA ("APR"), reported positive interim results from its clinical trial of nasal spray Sentinox in SARS-CoV-2 infected patients, confirming its safety and tolerability. Relief also reported that data from the study suggest that Sentinox could be effective in reducing the SARS-CoV-2 viral load at the level of the nasal mucosa.

The post-market, confirmatory, interventional, randomized, placebo controlled clinical study is expected to enroll a total of 57 patients. The study is designed to assess the efficacy and safety of Sentinox spray in reducing viral load in the upper respiratory airways of recently infected SARS-CoV-2 individuals and is being conducted by the Hygiene Unit of IRCCS Policlinico San Martino Hospital in Genoa, Italy and coordinated by Prof. Giancarlo Icardi as lead investigator.

The interim analysis, based on 30 patients who have completed the study -- 10 patients for each treatment group (0.5 ml into each nostril, 3x/day, 5x/day or control group, for five days) -- showed that all patients treated with Sentinox tested negative for SARS-CoV-2 by the end of the study period (Day 21). By contrast, one out of 10 patients in the control group was still positive by Day 21. All subjects using Sentinox 3 times a day had already tested negative by visit number 7 (V7; Day 10) vs. 70% of subjects in the control group over the same study period. At visit 4, 5 and 6, a trend in favor of the 3 times a day treated group vs. control group was observed (10% of patients using Sentinox tested negative at V4 vs 0% of patients in the control arm; 40% of patients using Sentinox tested negative vs 20% in the control arm at V5; 70% of patients using Sentinox tested negative vs 40% at V6). For the purpose of this study, subjects are considered negative when their COVID-19 test becomes negative and remains negative throughout the study period.

https://www.marketscreener.com/quote/stock/RELIEF-THERAPEUTICS-HOLDI-5527488/news/Relief-Therapeutics-Wholly-Owned-Subsidiary-APR-Applied-Pharma-Research-Reports-Positive-Interim-36792354/