Glaxo buys 10% of CureVac in vaccine tech deal

GSK (GSK.L) is to buy a 10% stake in German biotech company CureVac for 130 million pounds ($163.67 million), the two companies said on Monday, in a deal that bets on new technologies already being used in potential COVID-19 vaccines.

GSK and CureVac, backed by Microsoft billionaire Bill Gates, will work on developing up to five so-called mRNA-based vaccines and monoclonal antibodies (mAbs) for infectious diseases, they said.

The deal points to a valuation of more than $1.6 billion for CureVac as it prepares for a stock market launch this year.

For GSK, the world’s biggest vaccine maker, it adds to the company’s raft of investments in technologies that may fight future outbreaks.

mRNA vaccines use ribonucleic acid (RNA), a chemical messenger that evokes an immune response when injected by instructing cells to make proteins that mimic pathogens.

The approach, also being deployed in experimental COVID-19 vaccines by BioNTech and partner Pfizer (PFE.N) and Moderna (MRNA.O), is yet to be approved in any therapy.

“CureVac’s experience complements our own expertise,” said Roger Connor, President of GSK Vaccines.

GSK shares fell 1.6% to 1,633.2 pence by 0743 GMT.

After a 300 million euro ($343.77 million) investment by the German government CureVac had planned to list on Nasdaq this month, a document seen by Reuters in June showed.

It has since received 75 million euros in European funding, in addition to the GSK boost.

CureVac is now planning a stock market listing in September or October, led by Bank of America (BAC.N), Credit Suisse (CSGN.S) and Jefferies (JEF.N), which is likely be able to command a similar valuation to that signalled by GSK’s investment, people familiar with the matter said.

CureVac declined to comment on the IPO but said it remained open to all financing options. The banks declined to comment or were not immediately available for comment.

The GSK deal makes CureVac eligible for milestone payments of up to 606 million pounds and tiered royalties on sales.

The transaction does not include CureVac’s existing COVID-19 and rabies vaccines research programs.

https://www.reuters.com/article/us-gsk-curevac-stake/gsk-buys-10-of-curevac-in-vaccine-tech-deal-idUSKCN24L0JR

BeiGene in-licenses Assembly Bio HBV candidates in China

BeiGene (NASDAQ:BGNE) inks an agreement with Assembly Biosciences (NASDAQ:ASMB) securing exclusive development and commercialization rights in Greater China (Mainland, Macau, Taiwan, Hong Kong) for ABI-H0731, ABI-H2158 and ABI-H3733, three clinical-stage core inhibitor candidates for the treatment of hepatitis B virus (HBV) infection.

Under the terms of the deal, BGNE will pay ASMB $40M upfront, up to ~$500M in milestones and tiered royalties on net sales. BGNE will contribute initial funding for clinical development in China after which costs will be equally shared.

The upfront cash extends ASMB’s runway into H2 2022.

ASMB will host a conference call this morning at 8:30 am ET to discuss the agreement.

https://seekingalpha.com/news/3592503-beigene-in-licenses-assembly-bio-hbv-candidates-in-china

Grifols to acquire plasma facilities in Montreal and U.S. for $460M

Grifols (NASDAQ:GRFS) has executed purchase arrangements with the South Korean-based GC Pharma whereby Grifols will acquire the Montreal-based plasma fractionation facility and two purification facilities, along with 11 U.S.-based plasma collection centers for a total amount of $460M.

No additional financing will be required for the acquisition. Once the facilities are fully licensed, Grifols will become the only large-scale commercial manufacturer of plasma products in Canada, with a fractionation capacity of 1.5M liters annually.

The company plans to be ready to manufacture IVIG and Albumin in the facilities starting in 2023.

As part of the transaction, Grifols has also committed to supply certain output of plasma arising out of the Green Cross Collection Centers to GC Pharma for a 24-month period. The collection centers achieved a collection volume of 350,000 litres of plasma in 2019.

The transaction is expected to close prior to the year end.

https://seekingalpha.com/news/3592489-grifols-to-acquire-plasma-facilities-in-montreal-and-u-s-for-460m

FDA OKs emergency use of Luminex third COVID-19 antibody test

THE FDA has issued Emergency Use Authorization (EUA) for Luminex’s (NASDAQ:LMNX) xMAP SARS-CoV-2 Multi-Antigen IgG Assay to identify the presence of antibodies in COVID-19 infected people.

The xMAP IgG Assay delivers results for up to 96 patient samples in under three hours and helps minimizing the risk of both false positives and false negatives.

The assay demonstrated specificity of 100% in human serum and >99% in human plasma, with sensitivity greater than 96% for both human serum and plasma (>14 days post-symptom onset) in clinical studies.

“More than 17,000 xMAP systems have been sold to laboratories around the world,” said Nachum Shamir, President and CEO of Luminex.

The xMAP-based serology test is the third COVID-19 Luminex test to receive an EUA.

https://seekingalpha.com/news/3592483-fda-oks-emergency-use-of-luminex-third-covidminus-19-antibody-test

Allergan pulls Europe, Japan application for wet macular degeneration drug

AbbVie (NYSE:ABBV) unit Allergan has informed Molecular Partners (OTCPK:MLLCF) of its intent to withdraw application filings with both the European Medicines Agency and the Japanese Regulatory Agency for abicipar pegol, a novel DARPin therapeutic for patients with neovascular (wet) age-related macular degeneration (nAMD).

On June 26, the FDA rejected Allergan’s application for the wet AMD drug, following which AbbVie is working with the regulatory agencies to discuss requirements for potential resubmissions for abicipar pegol.

https://seekingalpha.com/news/3592463-allergan-pulls-back-european-and-japanese-application-for-wet-amd-drug

Pfizer and BioNTech to supply 30M doses of BNT162 vaccine candidate in UK

Pfizer (NYSE:PFE) and collaboration partner BioNTech (NASDAQ:BNTX) announce an agreement with the UK to supply 30M doses of their BNT162 mRNA-based vaccine candidate against SARS-CoV-2.

Financial details were not disclosed.

The companies are on track to begin an anticipated Phase 2b/3 safety and efficacy trial later this month, seek regulatory review as early as October 2020 and manufacture globally up to 100M doses by the end of 2020 and more than 1.3B doses by end of 2021.

https://seekingalpha.com/news/3592461-pfizer-and-biontech-to-supply-30m-doses-of-bnt162-vaccine-candidate-in-uk

Men should limit alcohol to just one drink per day, experts say

Health experts are bringing down the bar: Men should limit themselves not to two drinks per day — the long-standing recommendation — but just one.

So says a report out Wednesday, which is set to be included later this year as part of the first update to the US Dietary Guidelines for Americans in five years. Since 1990, the guidelines had maintained that men could healthily drink two alcoholic beverages daily, while women could only drink one.

Now, though, experts are saying there’s insufficient evidence that either gender is better physically streamlined for alcohol consumption; men and women alike are better off stopping after a single drink. (A single drink is defined as roughly 12 ounces of beer or 5 ounces of wine or liquor, and not drinking on a Thursday does not mean one can healthily have two drinks on Friday.)

“As a nation, our collective health would be better if people generally drank less,” Dr. Timothy Naimi, a member of the committee behind the report, told the Associated Press.

After observing drinking habits’ correlation with all causes of death, the committee determined that having more than one drink marginally increased the risk of dying.

The one-drink advice, however, is somewhat toothless. US health agencies aren’t required to adopt the committee’s recommendations, according to the AP, and the report is used more as general guidance and by lobbyists.

The report comes as many Americans are relying heavily on booze as a coping mechanism during the coronavirus pandemic — even though drinking may heighten drinkers’ risk for developing COVID-19, the World Health Organization stated in April.

A rash of studies have long maintained that even moderate amounts of alcohol can be detrimental to human health. In June, the American Cancer Society changed its guidelines to recommend sobriety over just moderation in the name of cancer reduction and prevention.

https://nypost.com/2020/07/17/men-should-limit-alcohol-to-just-one-drink-per-day-experts-say/