Moderna COVID-19 Vaccine Value Largely Reflected In Stock: Morgan Stanley

 A day ahead of an FDA panel meeting for Moderna Inc's 

MRNA 6.92% coronavirus vaccine candidate, an analyst at Morgan Stanley stepped to the sidelines on the stock. 

The Moderna Analyst: Matthew Harrison downgraded Moderna from Outperform to Equal-weight and raised the price target from $100 to $150.

The Moderna Thesis: Moderna is likely to be a more valuable company over a multiyear period, Harrison said in a Wednesday downgrade note.

The vaccine developer is one of the most innovative and is capable of outperforming most biotech companies in the long-term, the analyst said.

The near-term stock movement is likely to be largely dictated by COVID-19 vaccine revenue realization, vaccine competition and long-term COVID-19 revenue sustainability, he said. 

Moderna's vaccine pipeline is estimated at about $100 per share, or two-thirds of its valuation, Harrison said.

The rest of the company's vaccine candidates — including those for cytomegalovirus, respiratory syncytial virus, human metapneumovirus and parainfluenza type 3 — are similar in value to the COVID-19 opportunity, the analyst said. 

While vaccines represent the majority of Moderna's valuation, significant upside exists in both rare diseases and oncology, he said. 

"And with investor expectations closer to the bull case than the bear case on COVID-19, we think its appropriate to step to the sidelines for now and look for entry points to better realize the potential long-term value," Harrison said. 

Morgan Stanley sees COVID-19 revenue as providing the company with a war chest of $10 billion to $20 billion in cash, which the sell-side firm said could come in handy to dramatically accelerate its pipeline and provide the scale needed to realize the broad opportunity of mRNA. 

"This will further distance the company from its mRNA competition and should not be overlooked," Harrison said. 

https://www.benzinga.com/analyst-ratings/analyst-color/20/12/18817841/moderna-analyst-covid-19-vaccine-value-largely-reflected-in-stock

Amgen submits NDA for Sotorasib in non-small cell lung cancer

 

• Amgen (NASDAQ:AMGN)  announced the submission of a New Drug Application with the FDA for sotorasib in the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer.
• Backed by positive Phase 2 results from Amgen’s CodeBreaK 100 clinical study, the NDA submission for sotorasib, the first KRASG12C inhibitor to enter the clinic, is reviewed under FDA’s Real-Time Oncology Review pilot program to accelerate the review process.
• Involving 126 patients, 123 of whom had centrally evaluable lesions by RECIST at baseline, the Phase 2 study was the first-in-human, open-label multicenter study. It was part of CodeBreaK, the KRAS G12C clinical development program of Amgen, which has enrolled than 600 patients across 13 tumor types.
• A global Phase 3 randomized active-controlled study is currently recruiting patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) to evaluate Sotorasib against docetaxel.
• In the U.S., about 13% of patients with NSCLC have the KRAS G12C mutation and face a significant unmet need," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
• "Sotorasib was the first KRASG12C inhibitor to enter the clinic and now is on track to potentially be the first approved targeted therapy for patients with advanced NSCLC harboring the KRAS G12C mutation,” he further added.
• https://seekingalpha.com/news/3645142-amgen-submits-nda-for-sotorasib-in-non-small-cell-lung-cancer

Big differences found between top symptom checker apps

 Apps that patients can use to report symptoms and seek advice on treatment are highly variable in their accuracy, but some come close to matching GPs, says a new study.

The peer-reviewed study – published in the journal BMJ Open – compared eight of the most popular symptom assessment apps to a control group of seven GPs against a series of 200 primary care scenarios or “vignettes” designed to mimic real-world patient experiences and gleaned from the NHS 111 telephone triage service.

The apps – Ada, Babylon, Buoy, K Health, Mediktor, Symptomate, WebMD, and Your.MD – were put through their paces against three criteria, namely the breadth of content covered, and the accuracy and safety of advice given compared to a GP consultation.

The researchers from Brown University in the US and German digital health company Ada Health – which developed the Ada app – suggests there are wide differences between the apps on all these measures which raise questions about whether some are fit for purpose in clinical settings.

The paper found that coverage of the conditions in the vignettes ranged from 51.5% with Babylon to 99% with Ada, with an average overall of 69.5%, while GPs provided 100% coverage.

Those at the bottom of the coverage list were not able to suggest conditions for significant numbers of cases, including scenarios involving children, patients with a mental health condition, or pregnancy, according to the German company.

Ada was also rated as the most accurate for accuracy, suggesting the right condition in its top three suggestions 71% of the time while the average across all the other apps was just 38%, indicating that they didn’t identify the correct condition in the majority of cases. Once again, GPs were top with 82% accuracy.

On the final measure, most apps gave safe advice most of the time, but only three approached the 97% rating for doctors. Among these, Ada came top again at 97%, followed by Babylon at 95% and Buoy at 80%.

It’s worth pointing out that some of the apps that fared less well – including Buoy, K Health and WebMD – were designed for the US market, so may have been penalised by the use of NHS-derived vignettes.

Noting that symptom assessment apps are now used by tens of millions of patients annually in the US and UK alone, Dr Hamish Fraser of Brown’s Centre for Biomedical Informatic said the study is an important indicator of how valuable they are.

“Compared to a similar study from five years ago, this larger and more rigorous study shows improved performance with results closer to those of physicians,” according to Fraser. “It also demonstrates the importance of knowing when apps cannot handle certain conditions.”

The results could also be used to determine which of the apps are ready for clinical testing in observational studies and then randomised controlled trials, he added.

https://pharmaphorum.com/news/study-finds-big-differences-between-top-symptom-spotting-apps/

AbbVie begins trials of COVID-19 antibody therapy

 AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University.

In a joint statement, the biotech and the university said that the antibody, dubbed ABBV-47D11, will be developed for prevention and treatment of COVID-19 and related coronaviruses.

AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

The antibody has been developed by Harbour using transgenic mice, which enabled the quick discovery and development of several candidates.

From these ABBV-47D11 was selected because of its cross-reactive neutralising nature.

The antibody targets a conserved region of the SARS-CoV-2 spike protein and has been developed through a collaboration between Harbour (HBM) and Utrecht University (UU).

The license agreement will help advance the development of ABBV-47D11, which in pre-clinical research demonstrated potential against SARS-CoV-2, as well as the related SARS-CoV-1 virus that caused an outbreak in Asia in 2003.

AbbVie will conduct clinical development of ABBV-47D11, and if successful, will manufacture and market the product worldwide.

AbbVie will pay HBM and UU an undisclosed one-time license fee and will also make payments upon achievement of certain development, regulatory and sales-based milestones.

The pharma will also pay tiered royalties on commercial net sales of the antibody.

Erasmus University Medical Center, based in Rotterdam, Netherlands, was involved in the fundamental science but is not involved in the license agreement.

The phase 1 trial will be a randomised, double-blind, placebo-controlled, study to evaluate the safety, pharmacokinetics, and pharmacodynamics of single ascending doses of ABBV-47D11 in adults hospitalized with COVID-19.

The antibody will be tested in three different doses on 24 patients across global study sites to evaluate study-drug related adverse events as primary endpoints, and several other secondary outcomes.

Regeneron and Eli Lilly have been leading the charge to develop antibody-based therapies against the coronavirus.

Regeneron’s cocktail, REGN-COV2 and Eli Lilly’s bamlanivimab have emergency approvals from the FDA and AstraZeneca has begun clinical development of its rival antibody cocktail last month.

Harbour BioMed is a clinical-stage biotech specialising in antibody therapeutics with operations in Cambridge, Massachusetts; Rotterdam, The Netherlands; and Suzhou and Shanghai, China.

https://pharmaphorum.com/news/abbvie-licenses-in-covid-19-antibody-therapy-from-harbour-utrecht-uni/

Gottlieb pushes for antibody manufacturing scale up as 2021 pandemic 'insurance policy'

 Even as COVID-19 vaccines start to creep across the regulatory finish line, supplies will be limited for months at least. Meanwhile, antibody drugs, hailed as a crucial stopgap treatment since the pandemic's early days, are scarce, thanks to federal manufacturing missteps earlier this year. 

But the U.S. government has the power to ratchet up production of COVID-19 antibody therapies—a move it should pursue if it hopes to snare an “insurance policy” against the pandemic in 2021, former FDA Commissioner Scott Gottlieb, M.D., wrote in The Wall Street Journal.

The two antibodies sporting an emergency nod in the U.S.—Regeneron’s cocktail REGN-COV2 and Eli Lilly’s bamlanivimab—aren’t that difficult to make, but supplies are tight because the government failed to lock down sufficient manufacturing space in the spring, Gottlieb said.

While the companies have taken it upon themselves to boost production—freeing up domestic manufacturing space by shifting other drugs to places like Europe and inking deals with large manufacturers—Regeneron and Lilly together are expected to produce a slim 6 million to 7 million doses next year.

That’s not nearly enough for a drug that many have touted as a necessary backup treatment before vaccines are widely available, Gottlieb said.

All is not lost, though. The government could pay companies for access to their manufacturing space, and it could step in to assuage the risks for companies willing to become contract manufacturers for the COVID-19 treatments, Gottlieb argued.

Further, the government could agree to buy the antibodies and stockpile them at a “worthwhile” price. Plus, Regeneron and Lilly could be paid to license their drugs, he said.

A manufacturer can’t suddenly start pumping out antibodies overnight, Gottlieb conceded. It takes about six months to convert a facility to produce the COVID-19 treatments and another six months to convert it back to its original purpose, he said. A big facility moving at full speed for about eight months could churn out some 2.5 million doses—more than a third of the volume Lilly and Regeneron have planned for 2021.

And many drugmakers already safeguard against disruption by manufacturing their most profitable drugs ahead of time and freezing them, Gottlieb said. The government could pursue this strategy by freezing some of the active pharmaceutical ingredient (API) for Lilly and Regeneron’s drugs, storing it away ahead of next winter.

The API would remain stable at freezer temperatures for at least three years and the process of thawing the drug and turning it into a finished product would take less than a month, he said.

Antibody therapies “were always the best bet for reducing the death and suffering from COVID-19 this fall,” Gottlieb wrote. “Yet supply is severely constrained, and the two available drugs must be rationed, somewhat arbitrarily, because the government didn’t do everything possible last spring to ramp up manufacturing.”

Regeneron in August teamed up with Swiss pharma juggernaut Roche to triple production of its antibody cocktail, REGN-COV2—a combination of the monoclonal antibodies casirivimab and imdevimab.

Under the seven-year licensing deal, both companies agreed to reserve manufacturing capacity for the therapy, with Regeneron tackling the U.S. rollout and Roche on deck to handle distribution elsewhere. In late November, the FDA cleared the drug for emergency use in non-hospitalized patients at least 12 years of age who are at high risk for progressing to severe COVID-19.

Lilly, for its part, has enlisted Amgen to assist with production of bamlanivimab, which snared an emergency OK about a week before Regeneron's cocktail. 

https://www.fiercepharma.com/manufacturing/ex-fda-chief-gottlieb-pushes-for-antibody-manufacturing-scale-up-as-2021-pandemic

Feds field Pfizer's pleas to speed up supplies of COVID-19 vaccine raw materials

 Ever since Pfizer was pegged to participate in the U.S. government’s Warp Speed effort to get COVID-19 vaccines to market, the company has made it quite clear it did not need to take any federal money to develop the vaccine.

But did that refusal of R&D funding contribute to Pfizer’s inability to manufacture more doses of its mRNA vaccine for the U.S. market?

Pfizer could provide more than the 100 million doses it promised in its original contract with the U.S. government in the first half of next year—but only if Trump administration officials demand that suppliers of raw materials quickly fulfill the company’s orders. And CEO Albert Bourla, Ph.D., is calling on the government to use the Defense Production Act to do just that.

The Trump administration hasn't done so yet because they’ve focused on providing those materials to vaccine makers that did take federal R&D funding, like Moderna, according to unnamed sources who spoke to The New York Times.

A spokesperson for Pfizer declined to comment, citing the confidentiality of discussions with the U.S. government. But Bourla said during a CNBC interview that the company is in negotiations to sell an additional 100 million doses of Pfizer’s COVID-19 vaccine to the U.S. government.

“We can provide a lot of that in the third quarter. The U.S. government wants it in the second quarter,” Bourla said in the Monday interview. “We are working very collaboratively to try to find a solution and be able to allocate those 100 million [doses] in the second quarter if possible, or a lot of them.”

Pfizer requested early on that the government award it “favored status” with suppliers of raw materials, but officials were afraid that would damage competing vaccine programs that did take federal R&D money, according to the Times report. Among those companies is Moderna, which is expected to win emergency use authorization from the FDA for its mRNA vaccine this week—and last Friday, inked a deal to add 100 million more doses to its initial U.S. order.

One option to speed up Pfizer’s vaccine output now would be for the government to deploy the Defense Production Act to expand the supply of raw materials needed to make COVID-19 vaccines. In fact, Department of Health and Human Services (HHS) Secretary Alex Azar said earlier this week he had suggested that solution after the government restarted negotiations with Pfizer in October.

Bourla said during the CNBC interview that he hopes the feds invoke the Defense Production Act “very soon” because “we are running at critical supply limitations.”

A rather public tiff between Pfizer and the U.S. government broke out last week, when Pfizer board member and former FDA Commissioner Scott Gottlieb, M.D., told CNBC that Pfizer has made multiple offers to provide additional doses of its COVID-19 vaccine. Gottlieb said earlier this week that the government even turned down an offer for more doses in November after the company released interim data from a phase 3 trial showing the vaccine was 95% effective.

HHS was none too happy about Gottlieb’s remarks, posting a five-part response on Twitter. “At no time did [Warp Speed] turn down an offer from Pfizer for any number of millions of doses having a firm delivery date and quantity, and it's a shame that someone is misinforming the American public,” HHS said. The agency added that it continues to negotiate with Pfizer for additional doses.

Moderna, meanwhile, snagged an expansion of its original supply contract with the U.S. government last Friday. The government said it would pay the company $1.68 billion for 100 million additional doses to be delivered in the second quarter of next year. Moderna expects to ship its first 20 million doses this month, and 80 million in the first quarter, for which the U.S. has vowed $1.525 billion.

All in all, the U.S. government has invested $4.1 billion to develop and purchase Moderna’s mRNA COVID-19 vaccine, HHS estimated.

https://www.fiercepharma.com/pharma/feds-rebuff-pfizer-s-requests-for-speedier-supplies-covid-vaccine-raw-materials-reports

Fosun Pharma to buy 100M doses of BioNTech's COVID-19 vaccine for mainland China

 

Shanghai Fosun Pharmaceutical Group Co Ltd on Wednesday said it will buy at least 100 million doses of a COVID-19 vaccine from Germany's BioNTech SE for use in mainland China next year, if the vaccine receives approval.

The Chinese government has not announced supply deals with Western drugmakers, which instead have partnered local firms.

Fosun said it will be entitled to 60% of annual gross profit from sales of doses that it will make from imported bulk ingredients, and 65% of profit from sales of doses imported ready for use.

For the initial supply of 50 million doses, Fosun will make an advance payment to BioNTech of 250 million euros ($303.80 million) - half by Dec. 30 and the remainder after regulatory approval - the firm said in a Hong Kong stock exchange filing.

The vaccine developed by BioNTech and U.S. partner Pfizer Inc has been administered to the public in Britain and the United States, and has received emergency-use approval in several other countries.

China has granted emergency-use status to two candidate vaccines from state-backed Sinopharm and one from Sinovac Biotech Ltd. It has approved a fourth, from CanSino Biologics Inc, for military use.

Separately, Shenzhen Kangtai Biological Products Co Ltd aims to have enough capacity to produce at least 100 million doses of a vaccine candidate from British partner AstraZeneca PLC by year-end.

Late on Tuesday, Tibet Rhodiola Pharmaceutical Holding Co said it has agreed to double the supply of the Sputnik-V vaccine to its Russian home. It now aims to make enough doses for at least 40 million Russians next year.

Fosun Pharma has brought two BioNTech candidate COVID-19 vaccines into clinical trials in China and is yet to receive regulatory approval for either.

https://www.marketscreener.com/quote/stock/SHANGHAI-FOSUN-PHARMACEUT-6548924/news/Fosun-Pharma-to-buy-100-million-doses-of-BioNTech-s-COVID-19-vaccine-for-mainland-China-32021484/