Merck says it has overcome production shortages in vaccine materials

* CEO cites shortages in filtration products

* Also had to clear backlog in bioreactors, diagnostic chems

* Life Science unit has invested more than 425 mln eur since 2017

Germany’s Merck KGaA , one of the world’s largest suppliers of materials and equipment for the production of biotech drugs, is boosting output capacity to keep up with a surge in demand from companies fighting the COVID-19 pandemic.

Diversified Merck makes chemicals for the electronic industry as well as speciality drugs, while its Life Science division supplies lab equipment and plays a role in more than 50 global projects aiming to develop a vaccine against COVID-19.

“We are a very important partner for diagnostic firms, vaccine companies and companies that want to manufacture antibodies,” Merck Chief Executive Stefan Oschmann told Reuters, referring to a new class of potential treatments for people infected with the new coronavirus.

Merck’s Life Science division, as well as its competitors, have been expanding to meet the increase in demand and to support the global effort to mass-produce vaccines, he said.

Competitors of the business include Thermo Fisher and Sartorius. The COVID-19 pandemic, which has claimed more than 900,000 lives globally, has triggered a race to develop an effective vaccine with 35 projects already testing their candidates on humans.

Areas hampered by temporary shortages included filtration products, where Merck has rushed to clear order backlogs, said Oschmann.

Single-use plastic bioreactors, which are replacing traditional metal tanks for the fermentation of therapeutic proteins, were also temporarily out of stock in some places, requiring teams “to work day and night, so far quite successfully”, he added.

The company has also overcome shortages in its supply of speciality chemicals that help extract viral material from samples for the diagnostics industry.

The Life Science unit has invested more than 425 million euros ($503 million) to meet growing market demand since 2017, but the CEO declined to give detailed figures for this year.

The company said earlier on Wednesday at its capital markets day that it now expected 6-9% revenue growth at Life Science over the next five years, versus 5-8% previously.

https://www.marketscreener.com/quote/stock/MERCK-KGAA-436395/news/Merck-says-it-has-overcome-production-shortages-in-vaccine-materials-31307846/

Italy could have AstraZeneca COVID-19 shots by end November: biotech partner

Italy could have its first shots of British drugmaker AstraZeneca’s potential COVID-19 vaccine by the end of November, the managing director of IRBM told Reuters.

Biotech firm IRBM, whose lab is based south of Rome, is cooperating with AstraZeneca in developing a vaccine for the disease which has caused more than 35,600 deaths in Italy.

“It is possible to have the first shots in Italy by the end of November, provided the trial continues as planned and the vaccine is validated,” Matteo Liguori said on Wednesday.

Italy’s Health Minister had already said the vaccine could be available by the end of 2020.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Italy-could-have-AstraZeneca-COVID-19-shots-by-end-November-IRBM-biotech-says-31308212/

Moderna expands cystic fibrosis partnership with Vertex

Moderna (NASDAQ:MRNA) inks a research collaboration and licensing agreement with Vertex Pharmaceuticals (NASDAQ:VRTX) aimed at the discovery and development of lipid nanoparticles (LNPs) and mRNAs for the delivery of gene-editing therapies for cystic fibrosis (CF).

The initial focus of the three-year partnership will be on the discovery and optimization of novel LNPs and mRNAs that can deliver gene-editing therapies to cells in the lungs where cystic fibrosis transmembrane conductance regulator (CFTR) protein can be produced.

Under the terms of the agreement, Moderna will conduct research to discover and optimize novel LNPs for the delivery of gene-editing therapies to lung cells for the treatment of CF. It will also be responsible for the discovery and manufacturing of LNPs and mRNA constructs encoding gene-editing endonucleases.

Vertex will be responsible for providing other components of the gene-editing therapies to be formulated into LNPs as well as subsequent preclinical and clinical development and potential commercialization efforts.

Moderna will receive $75M upfront, up to $380M in milestones and tiered royalties on net sales.

This agreement builds on the companies’ first partnership deal, inked in July 2016, aimed at the discovery and development of mRNAs for CF.

https://seekingalpha.com/news/3614776-moderna-expands-cystic-fibrosis-partnership-vertex-pharma

Moderna teams up with Chiesi Group in pulmonary arterial hypertension

Moderna (NASDAQ:MRNA) will collaborate with Italian healthcare research group Chiesi Farmaceutici S.p.A. to discover and develop mRNA therapeutics for the treatment of pulmonary arterial hypertension (PAH), a rare disorder characterized by high blood pressure in the arteries of the lungs with concomitant right heart failure.

Under the terms of the agreement, Moderna will lead discovery while Chiesi Group will lead development and global commercialization. It will fund all expenses related to the partnership.

Moderna will receive $25M upfront, up to $400M in milestones and tiered double-digit royalties on net sales.

https://seekingalpha.com/news/3614752-moderna-teams-up-chiesi-group-in-pulmonary-arterial-hypertension

Inovio adds to corporate update-stoked rally

Inovio Pharmaceuticals (INO +27.0%) is up on over 80% higher volume. Shares have rallied 73% since Monday’s corporate overview virtually presented by CEO Joseph Kim at H.C. Wainwright’s Global Investment Conference. COVID-related highlights:

DNA medicines, made via a process called SynCon, deliver optimized plasmids into cells with its handheld Cellectra device which employs a brief electrical pulse to reversibly open small pores in the cells to allow the plasmids to enter (intramuscular or intradermal administration).

DNA vaccine has thermal stability with a five-year shelf life at refrigeration conditions (characteristic of point-of-care locations) and a one-year shelf life at stabilized room temperature.

Phase 1 data on COVID-19 vaccine candidate INO-4800 showed both neutralizing antibodies and T cell responses in all 40 participants. Results have been submitted for publication, hopefully in the next few weeks.

Results from a challenge study in non-human primates 13 weeks after the last shot showed faster clearance of the coronavirus in both the lower lung and in the nasal passages. Strong neutralizing antibody and T cell responses were observed.

Phase 2/3 studies on tap in the U.S. this month. Confident that external funding will be sufficient.

Study in South Korea ongoing. Chinese regulators signed off on a study there. Recruitment should commence shortly.

Certain other COVID-19 vaccine developers are also enjoying a spike in buying: Novavax (NVAX +10.9%), Vaxart (VXRT +9.5%), iBio (IBIO +7.2%), Altimmune (ALT +13.8%), Moderna (MRNA +3.5%), Heat Biologics (HTBX +15.2%)

https://seekingalpha.com/news/3614685-inovioplus-27-adds-to-corporate-update-stoked-rally

Chinese virologist: China’s government ‘intentionally’ released COVID-19

The Chinese government intentionally manufactured and released the COVID-19 virus that led to mass shutdowns and deaths across the world, a top virologist and whistleblower told Fox News host Tucker Carlson on Tuesday.

Carlson specifically asked Dr. Li-Meng Yan whether she believed the Chinese Communist Party released the virus “on purpose.” “Yes, of course, it’s intentionally,” she responded on “Tucker Carlson Tonight.”

Yan said more evidence would be released but pointed to her own high-ranking position at a World Health Organization reference lab as a reason to trust her allegation.

“I work[ed] in the WHO reference lab, which is the top coronavirus lab in the world, in the University of Hong Kong. And the thing is I get deeply into such investigation in secret from the early beginning of this outbreak. I had my intelligence because I also get my own unit network in China, involved [in] the hospital … also I work with the top corona[virus] virologist in the world,” she said.

“So, together with my experience, I can tell you, this is created in the lab … and also, it is spread to the world to make such damage.”

Yan’s comments conflicted with the opinion of Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and White House coronavirus adviser, who previously cast doubt on the idea the virus was artificially created. In May, he told National Geographic: “If you look at the evolution of the virus in bats, and what’s out there now is very, very strongly leaning toward this [virus] could not have been artificially or deliberately manipulated — the way the mutations have naturally evolved.”

Other scientists have panned the idea that COVID-19 served as a sort of bioweapon or was released by a lab.

Fox News previously reported on Yan back in July, when she blew the whistle on China’s alleged attempts to suppress information about its handling of the virus. With a vast network of contacts in Chinese medical facilities, Yan attempted to gather more information about the virus as China blocked overseas experts from conducting research in the country.

Her revelations fueled ongoing complaints that the Chinese government failed to tell the world early on about the virus’ threat. Specifically, she believes the Chinese government ignored research that could have saved lives. The State Department did not immediately respond to Fox News’ request for comment.

In response, her former employer, the University of Hong Kong, criticized her account. A press release noted “that the content of the said news report does not accord with the key facts as we understand them.”

“Specifically, Dr Yan never conducted any research on human-to-human transmission of the novel coronavirus at [the University of Hong Kong] during December 2019 and January 2020, her central assertion of the said interview.”

Yan, who said she was one of the first scientists in the world to study the novel coronavirus, fled China and currently fears retaliation. She was allegedly asked by her supervisor at the University/WHO reference lab, Dr. Leo Poon, in 2019 to look into the odd cluster of SARS-like cases coming out of mainland China at the end of December 2019.

https://www.foxnews.com/media/chinese-virologist-government-intentionally-coronavirus

Kodak soars as independent review says no laws were broken

While several governance problems stemmed from Eastman Kodak’s (NYSE:KODK) July announcement of a planned $765M loan from the U.S. government, a special committee hired by the board said none of those issues violated the law.

The stock soared before, and after, the announcement – which vaulted the onetime photography giant into drug manufacturing – but quickly turned into a roller coaster ride as shares fell precipitously.

Specifics: The special committee blamed disclosure issues on a junior employee, who was able to modify the media advisory in a way that made it appear as if the information wasn’t embargoed. On concerns surrounding the options grants, the special committee said there was no intent to manipulate their timing, and a well-timed gift made by Kodak board member George Karfunkel doesn’t appear to have violated federal securities laws.

Instead the committee recommended Kodak’s legal department to undertake additional hires, noting a lack of resources could be the root cause for the existence of some outdated policies. Policies should also be updated in regards to insider trading, the options-grant process and the process for managing contact with the media and other third parties.

https://seekingalpha.com/news/3614436-kodak-soars-25-independent-review-says-no-laws-broken