Genmab H1 top line up big on upfront payment from AbbVie

Danish biotech Genmab (GMAB +0.6%) reports H1 results. Highlights:

Revenue: DKK 6,343M (+364.7%). Increase driven primarily by the upfront payment related to the AbbVie collaboration ($750M or about DKK 4,688M) and higher Darzalex royalties.

Net Darzalex sales by Johnson & Johnson: $1,838M (+31.0%).

Operating income: DKK 4,568M (+999%).

2020 guidance (DKK): Revenue: 9,100M – 9,700M from 9,100M – 9,500M; operating income: 5,200M – 5,800M from 5,200M – 5,600M. Current revenue consensus is 9,438M.

https://seekingalpha.com/news/3604670-genmab-h1-top-line-up-big-on-upfront-payment-from-abbvie

Philippines talking to Russian vaccine maker on trials

Philippine scientists were set on Wednesday to meet representatives of the Russian state research facility that developed a coronavirus vaccine, to discuss participation in clinical trials and access to its research data.

Philippine President Rodrigo Duterte has lauded the Russian vaccine and offered to be “injected in public”, to allay public fears about its safety.

Russia on Tuesday became the world’s first country to grant regulatory approval for a COVID-19 vaccine, to be named “Sputnik V” in homage to the Soviet Union’s launch of the world’s first satellite.

Russia’s decision to grant approval before completing trials has raised concerns among some experts, who fear it may be putting national prestige before safety.

Health Undersecretary Rosario Vergeire said Philippine experts would meet representatives of research facility Gamaleya to discuss trials and would request a “complete dossier” on the vaccine.

“We will see if the allegations are true,” she said, referring to concern that it was hastily approved.

“That is why were talking with them to understand this vaccine,” Vergeire said, adding that local regulatory approval for conducting trials was needed.

The Philippines has among Asia’s highest coronavirus case numbers, which rose to 143,749 on Wednesday, two days after hitting a daily record of 6,958 infections. A strict lockdown has been re-imposed in and around the capital.

Duterte is keen to access a vaccine and in July made a plea to China to make the Philippines a priority if it develops one.

The Philippines will conduct nine months of clinical trials of anti-flu drug Avigan, manufactured by a subsidiary of Japan’s Fujifilm Holdings, starting with 100 doses to administer to patients in four Manila hospitals, Vergerie said.

Several drugmakers globally are conducting large-scale, advanced human trials of their potential COVID-19 vaccines, each with tens of thousands of volunteers.

The Russian vaccine’s approval comes before trials that would normally involve thousands of people, commonly known as a Phase III trial, which are usually prerequisites for a vaccine’s approval.

https://www.reuters.com/article/us-health-coronavirus-russia-vaccine-phi/philippines-talking-to-russian-vaccine-maker-on-trials-seeks-complete-dossier-idUSKCN258121

Israel to examine Russia’s COVID-19 vaccine, minister says

Israel will examine Russia’s COVID-19 vaccine and enter negotiations to buy it if it is found to be a “serious product”, Israel’s health minister said.

Russian President Vladimir Putin said on Tuesday his was the first country to grant regulatory approval to a COVID-19 vaccine, after less than two months of human testing. His health minister on Wednesday dismissed allegations that the vaccine was unsafe.

“We are following vigilantly every report, no matter what country,” Israeli Health Minister Yuli Edelstein told reporters. “We have already discussed the reports from the research centre in Russia about the vaccine development.

“If we are convinced it is a serious product, we will also try to enter negotiations. But I don’t want to delude anyone. The ministry’s professional staff is working on this all the time. The vaccine will not come tomorrow,” he said.

Israel is developing its own vaccine candidate and intends to begin human trials as early as October. It has also signed with Moderna and Arcturus Therapeutics for the option to buy their potential vaccines.

https://www.reuters.com/article/us-health-coronavirus-israel-russia/israel-to-examine-russias-covid-19-vaccine-minister-says-idUSKCN258139

Vaping linked to risk of COVID-19 in teens, young adults

Vaping may be associated with a five to seven times increased risk of COVID-19 among U.S. teenagers and young adults, a study published on Tuesday suggests.

Researchers at the Stanford University School of Medicine analyzed nationally representative survey data collected in May from 4,351 participants aged 13–24 years. The findings were published in the Journal of Adolescent Health.

“Young people may believe their age protects them from contracting the virus or that they will not experience symptoms of COVID-19, but the data show this isn’t true among those who vape,” study leader Shivani Mathur Gaiha said in a press statement.

Participants were asked if they had ever used vaping devices or combustible cigarettes, whether they had vaped or smoked in the past 30 days, and if they had experienced COVID-19 symptoms, been tested for COVID-19 or been diagnosed with the infectious disease.

Participants who had used both cigarettes and e-cigarettes in the previous 30 days were 4.7 times more likely to experience COVID-19 symptoms compared with those who never smoked or vaped.

Among people tested for COVID-19, those who used just e-cigarettes were five times more likely to get a positive COVID-19 test result. Those who had ever used both e-cigarettes and cigarettes were seven times more likely to be diagnosed with COVID-19, the study found.

The study cannot prove that vaping causes COVID-19. The researchers note, however, that vaping involves the repeated touching of hands to the mouth and face, which is associated with the spread of COVID-19. Further, exposure to nicotine and other chemicals in e-cigarettes and combustible cigarettes causes lung damage.

The researchers hope their findings will prompt the U.S. Food and Drug Administration to effectively regulate e-cigarettes during the COVID-19 pandemic.

https://www.reuters.com/article/us-health-coronavirus-vaping/vaping-linked-to-risk-of-covid-19-in-teens-young-adults-idUSKCN2581UW

Medtronic snaps up smart insulin pen maker Companion Medical

Medtronic is buying up leading smart insulin pen and connected phone app maker Companion Medical as it looks to shore up its growing weakness in the pump market.

The med tech major gets access to Companion’s InPen, a so-called smart insulin pen that not only delivers insulin, but also tracks insulin on board, provides an meal bolus calculator and shares information with connected systems.

The InPen last for around a year and works with short-acting insulins, although work is being done on long-acting insulins. The company made around $11 million in 2019 sales and was looking to triple that this year, after launching in late 2017, though its market penetration is pretty low.

“This acquisition is an ideal strategic fit for Medtronic as we further simplify diabetes management and improve outcomes by optimizing dosing decisions for the large number of people using multiple daily injection (MDI),” said Sean Salmon, EVP and president of the Diabetes Group at Medtronic.

“We look forward to building upon the success of the InPen by combining it with our intelligent algorithms to deliver proactive dosing advice personalized to each individual. This smart CGM system can help people think less about diabetes and be able to live life with more freedom, on their own terms.

”Our goal is to become a trusted partner that offers consistent support whether an individual wants to stay on MDI, transition to automated insulin delivery or take a break from their pump.”

Analysts at Jefferies said the buyout was a “bold move” and a “source of growth” for Medtronic, and could add $200 million in incremental revenue.

It points out that Medtronic has “been floundering in diabetes,” losing around a point of share a month in the pump market. The Companion deal will help offset this, and allows Medtronic to serve not only the current and future pump market, but also those that chose to stay on pens, Jefferies said in a note the clients.

The plan now is to combine its diabetes tools (from its Nutriono and Klue buyouts) with InPen and integrate its own continuous glucose monitoring (CGM) system.

Jefferies notes however that the future of insulin delivery “remains a debate.” They firm muses whether smart pens “provide enough of a clinical leap for patients such that pumps prove too much of a relative burden for their benefits.”

Financial details of the deal were not made public.

https://www.fiercebiotech.com/medtech/medtronic-snaps-up-smart-insulin-pen-maker-companion-medical-a-bold-move

Alphabet’s Verily opens own lab to speed up COVID testing

The buzzy life sciences company Verily is looking to speed up COVID testing with a new lab based at its native South San Francisco.

In a blog post, Verily, Alphabet’s life sciences research arm and a sister company to Google, has set up its own CLIA-certified lab (i.e., it has clinical laboratory credentials) and used tech from Thermo Fisher Scientific’s‎ TaqPath test kit, which has an emergency use tag (EUA) from the FDA, to test for COVID-19.

It’s also sent off an EUA application for an adaptation of the TaqPath test for use in testing pooled patient specimens, which can further speed up testing. And it’s “verified” the Roche Elecsys Anti-SARS-CoV-2 antibody test, which can assess if you’ve had the disease (rather than currently have it), with plans to “implement additional tests in our lab,” said Deb Hanks, M.D., lead pathologist at Verily, in the blog post.

The reasons for this move are two-fold: To speed up testing, which is still seeing many wait a week or more for results, and to help Verily’s own staff return to work.

“In response to the continued demand for testing, Verily has established a CLIA-certified lab at our South San Francisco headquarters to create additional lab capacity in support of programs in the COVID-19 testing space, including our own return-to-work efforts for our own employees,” it said in the blog post.

“The lab infrastructure is now up and running, and we have created a lab information system that will enable us to implement a strict chain of custody procedure for the specimens in our care.”

This also comes four months after Verily rolled out a COVID-19 screening tool for health systems and hospitals to help automate frontline response to the pandemic.

This follows similar moves from other tech companies, such as Amazon, which is setting up its own labs, although predominately to test its workers to have them return to the warehouses.

Capacity is one issue, but not as big as the shortages of critical ingredients and components for testing, from reagents to basic tubing, which is a global challenge that will not be easily or quickly resolved. Some are looking at creating new tech, such as tapping CRISPR to help create the next-gen of tests, though this is still being trialled.

https://www.fiercebiotech.com/medtech/alphabet-s-verily-opens-own-lab-to-speed-up-covid-testing

Biomerica nabs new patent in U.S.; updates on COVID-19 antibody tests

The USPTO has issued a Notice of Allowance for Biomerica’s (NASDAQ:BMRA) second U.S. patent pertaining to its InFoods diagnostic guided therapy for treatment of patients with Irritable Bowel Syndrome (IBS) and other gastrointestinal diseases.

The new patent claims to cover the method to identify patient-specific foods, that when removed may alleviate or improve an individual’s IBS symptoms and provide broad protection for a test panel.

The Company also provided an update on its COVID-19 antibody tests. A newly published study in Canada reported that Biomerica’s rapid 10-minute test showed 100% sensitivity and 100% specificity.

Unique high-volume COVID-19 IgG ELISA laboratory test:  BMRA is waiting for the FDA response to its submitted emergency use authorization. The data submitted for this test showed 100% specificity and zero percent cross reactivity with many common viruses or diseases.

Biomerica plans to issue its year-end results and 10-K on August 31.

https://seekingalpha.com/news/3604575-biomerica-nabs-new-patent-in-u-s-updates-on-covidminus-19-antibody-tests