Medtech's COVID-19 recovery will have to wait for second half of 2021: analysts

 Wall Street expects declines in elective care to continue as coronavirus cases keep rising. However, a more widespread rollout of vaccines could spur a recovery later in the year.

As the year comes to an end and companies look to move on from the volatile economic environment created by the coronavirus pandemic, analysts are warning the challenges for the medtech industry for much of 2020 will not be easily escaped.

For the first half of 2021, the medtech industry will have to manage another likely decline in elective care and lower general hospital admissions due to the ongoing rise of COVID-19 cases, with the risk of another surge after the holidays, J.P. Morgan analysts wrote in a report.

The recent climb in cases will not just impact the first half of 2021, companies will likely miss Street estimates for the fourth quarter of 2020 as well.

However, the second half of next year could provide some relief. The rollout of coronavirus vaccines, easy comps to 2020 performances, and a snapback in procedure volumes from pent up demand could all contribute to somewhat of a return to form for the medtech industry.

Medtech should see organic revenue growth of 10.1% and earnings growth of about 24.8% next year, compared to declines of minus .5% and minus 12.7% expected in 2020, respectively, according to the report.

"While we won't get back all the revenues lost in 2020 ... we remain bullish on this reacceleration as underlying market fundamentals remain healthy and focused innovation into high-growth markets has continued through the pandemic," the analysts wrote.

A delayed recovery for procedures

One of the lessons learned from 2020 is how exposed the medtech industry is to the pandemic, particularly its reliance on elective procedures and emergency care, analysts noted. While some return to normalized volumes is expected throughout the first half of 2021, the analysts "don't expect a meaningful bolus of catch-up volumes."

The industry will also be hit by a decline in emergency care that cannot be easily recovered and hesitancy from patients to return to hospitals.

Some procedures, however, are expected to return more quickly than others, such as orthopaedics, spine and neuromodulation, according to J.P. Morgan.

SVB Leerink analysts outlined a similar near-term environment for the industry — vaccine availability will likely help elective volumes, but procedure comebacks are not expected until the second half of 2021 and even 2022.

Even with recovery delayed to the back half of next year, the SVB Leerink analysts believe that medtech's fundamentals are "relatively stable" and 2021 sales for large-cap companies should beat 2019 levels. The analysts added that while 2020 brought a lot of pressure for the industry, new trends like the boom in telehealth could benefit "all medtech subsectors."

William Blair analysts also pointed to telehealth as a positive for the industry going forward while the traditional procedure decline continues.

https://www.medtechdive.com/news/medtech-pandemic-challenges-remain-recovery-second-half-2021/592524/

S. Korea's Celltrion to launch COVID-19 treatment soon

 Celltrion is expected to launch its COVID-19 treatment as early as this month, raising hopes that it will be able to combat the new coronavirus strain which is causing fear due to its high transmissibility.

The company said it has applied for conditional approval for its CT-P59 treatment from the Ministry of Food and Drug Safety. Conditional approval is given to a new drug that has finished Phase 2 clinical trials, if there is no other treatment for the disease. The drug developer is required to continue with and finish full clinical trials at the same time.

Hours after receiving Celltrion's application, the ministry said it has begun its review.

Earlier this week, the ministry said it will shorten the review period for drugs to treat COVID-19 from 180 days to 40 days. Given this, the treatment is anticipated to become available in late January.

The Phase 2 trials were conducted on 327 patients in Korea, Romania, Spain and the U.S., and final treatment injections took place Nov. 25. Celltrion said it decided to apply for domestic approval immediately after the trials, because "the company believes it has secured enough evidence and data to file for approval."

Since the trials were designed in coordination with the ministry, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, the company is expecting the emergency approval processes to proceed smoothly in those regions. The company plans to apply for emergency use authorization in the U.S. and Europe next month, and will launch contiguous Phase 3 clinical trials in 10 countries soon.

If Celltrion's treatment gets domestic approval, it will be the world's third company to develop a COVID-19 treatment from scratch, following Eli Lilly and Regeneron.

In a conference held Monday, Celltrion Vice Chairman Kee Woo-sung said CT-P59 is designed for the early treatment of mild COVID-19 cases, and the company has confirmed that the drug is effective against all variants of the coronavirus.

The fear over new COVID-19 strains is growing in Korea. The Central Disease Control Headquarters has confirmed that a mutated coronavirus strain that's been spreading in the U.K. infected three Koreans who entered Korea, Dec. 23.

Overseas news outlets are reporting that the variant could be up to 70 percent more infectious than others already in circulation. Though the government said Tuesday there is "slim chance of the U.K. variant circulating in the country," public fear is growing as the U.K. and other variants are spreading rapidly across the globe.

Following Celltrion's announcement, the company's share price rose, closing at 360,500 won, Tuesday, up 10.8 percent from the previous session.

As conditional approval is expected, Celltrion sent text messages to its employees and executives Sunday asking for them to stop trading any shares they held in the company and its two listed affiliates.

"Due to our development of a COVID-19 treatment, public attention is high on employees' and executives' trading of company shares," the message read. "Until the treatment gets approval, employees and their family members are asked not to trade listed Celltrion Group shares."

The message, however, came after eight executives and their family members sold more than 30,000 Celltrion shares. Of them, Celltrion Holdings Vice Chairman Yoo Heon-young sold 10,000 shares, worth about 3.6 billion won, followed by Executive Director Baek Kyung-min who sold 7,078 shares worth 2.5 billion won.

http://www.koreatimes.co.kr/www/nation/2020/12/119_301635.html

India's coronavirus vaccine approved by drug regulator

 India’s drugs regulator on Saturday recommended for emergency use a locally developed coronavirus vaccine called COVAXIN, which is expected to be a backup to the AstraZeneca/Oxford shot.

COVAXIN has been developed by Bharat Biotech, a company based in Hyderabad, with backing from the state-run Indian Council of Medical Research (ICMR).

Not much is known about the safety and efficacy of COVAXIN. The company says it has submitted all data to the drugs regulator.

The head of India’s drugs regulator is expected to share details about it at a news conference on Sunday, when its formal approval is likely to be announced.

Here are some major developments related to COVAXIN:

June 30, 2020 - The Drugs Controller General of India (DGCI) approves COVAXIN for human trials, making it the country's first domestic vaccine candidate. (reut.rs/3hJ1j40)

July 3 - An official at ICMR, India’s top clinical research agency, says in a leaked letter it envisages launching a coronavirus vaccine by Aug. 15, India’s independence day, leading to questions from some health experts about the short timeline.

The same day, Bharat Biotech shares its target of producing up to 300 million doses of the vaccine if its trials succeed.

July 4 - ICMR says its decision to fast-track development of a potential coronavirus vaccine is in line with international standards.

Oct 23 - Bharat Biotech says it is in discussions with more than 10 countries that have shown an interest in its vaccine candidate. It says Phase 1 and 2 trials have found the vaccine to be safe.

Nov 01 - Bharat Biotech says it is planning to launch the vaccine in the second quarter of 2021.

Nov 16 - Bharat Biotech says it is starting phase III trials.

Nov 20 - Bharat Biotech offers Brazil the vaccine and a possible technology-transfer partnership.

Dec 07 - Bharat Biotech seeks emergency use approval for COVAXIN.

Dec 22 - U.S.-based drug developer Ocugen Inc says it has partnered with Bharat Biotech to co-develop the vaccine candidate for the U.S. market.

Jan 2 - Experts at India’s drug regulator approve the vaccine “for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains”.

Bharat Biotech says it has recruited 23,000 volunteers out of its target of 26,000 for an ongoing Phase-3 trial of COVAXIN in India that began in mid-November. It is the largest Phase III efficacy trial conducted for any vaccine in India.

https://www.reuters.com/article/us-health-coronavirus-india-covaxin-time/indias-coronavirus-vaccine-approved-by-drugs-experts-idUSKBN2970KI

Russia ready to trial combined AstraZeneca, Sputnik V vaccine in Ukraine

 MOSCOW (Reuters) - Russia is ready to conduct clinical trials in Ukraine of a COVID-19 vaccine combining its Sputnik V with a vaccine developed by AstraZeneca together with Oxford University, the head of Russian Direct Investment Fund (RDIF) said on Saturday.

Russia’s sovereign RDIF, which is marketing the Sputnik V vaccine abroad, announced in December trials to test a combination of the AstraZeneca vaccine with the Sputnik V shot to see if this can boost the efficacy of the British drugmaker’s vaccine.

https://www.reuters.com/article/us-health-coronavirus-russia-ukraine/russia-ready-to-trial-combined-astrazeneca-sputnik-v-vaccine-in-ukraine-idUSKBN2970JP

Biotech Investors: Mark Your Calendar For January PDUFA Dates

 Year-end reviews by the Food and Drug Administration produced mostly positive outcomes, with most therapies passing the regulatory hurdle without any hiccups.

Despite the problems posed by the pandemic for the conduct of clinical trials and regulatory inspections of facilities, the biopharma sector continued to innovate at a brisk pace this year. New molecular entity approvals, considered a measure of innovation, totaled 53 in 2020 compared to 48 in 2019.

Notable among the NME approvals for December were BioCryst Pharmaceuticals, Inc.'s BCRX 0.67% heredity angioedema treatment Orladeyo, MacroGenics Inc's MGNX 3.89% Margenza for treating breast cancer and Myovant Sciences Ltd's MYOV 0.36% Orgovyx to treat prostate cancer.

The FDA also accorded emergency use authorizations for the investigational vaccines of Pfizer Inc. PFE 0.14%-BioNTech SE – ADR BNTX 2.88% and Moderna Inc MRNA 5.99%.

Here are the key PDUFA goal dates for the unfolding month:

Merck Seeks Approval For Heart Failure Drug

Company: Merck & Co., Inc. MRK 1.48%
Type of Application: NDA
Candidate: vericiguat
Indication: heart failure
Date: Jan. 20

Vericiguat is an orally administered soluble guanylate cyclase stimulator that is being evaluated, in combination with existing heart failure therapies, as a treatment option to reduce the risk of cardiovascular death and heart failure hospitalization in patients with symptomatic chronic heart failure with reduced ejection fraction, or HFrEF.

HFrEF occurs due to the inability of heart to eject blood sufficiently during the contraction phase. About 6.5 million people in the U.S. have heart failure, and approximately 40-50% of these patients have HFrEF, Merck said.

Aurinia's Kidney Inflammation Drug Awaits Nod

Company: Aurinia Pharmaceuticals Inc AUPH 0.93%
Type of Application: NDA
Candidate: voclosporin
Indication: lupus nephritis
Date: Jan. 22

Voclosporin is Aurinia's investigational drug, which is being evaluated for multiple indications. The FDA accepted the company's new drug application for voclosporin as a treatment option for lupus nephritis on July 21.

Lupus nephritis is serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus.

In mid-December, Aurinia announced a licensing agreement with Otsuka Pharma to commercialize voclosporin in Europe and Japan.

Can Pfizer's Cancer Treatment Get Label Expansion?

Company: Pfizer Inc. PFE 0.14%
Type of Application: sNDA
Candidate: Xalkori (crizotinib)
Indication: pediatric lymphoma
Date: Jan. 23

Xalkori is a tyrosine kinase inhibitor, which has already been approved by the FDA for the treatment of patients with metastatic non-small cell lung cancer, whose tumors are ALK-positive or ROS1-positive as detected by an FDA-approved test.

Pfizer has now filed to get approval for the drug to treat pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma that is ALK-positive.

Fourth Approval In The Cards For Amgen's Nplate

Company: Amgen, Inc. AMGN 1.21%
Type of Application: sBLA
Candidate: Nplate
Indication: Hematopoietic Syndrome of Acute Radiation Syndrome.
Date: Jan. 28

Nplate, a peptibody protein, works by raising and sustaining platelet counts. It was initially approved by the FDA in 2008 for the treatment of thrombocytopenia in adults with chronic immune thrombocytopenic purpura.

Chronic ITP is a serious autoimmune disorder characterized by low platelet counts in the blood, which can lead to serious bleeding events.

Subsequently, in Dec. 2018, it was approved to treat pediatric patients, one year of age and older, with ITP. It received another label expansion in Oct. 2019, indicating it can be used to in newly diagnosed and persistent adult ITP patients who have had an insufficient response to corticosteroids.

The company is now seeking approval for Nplate as a treatment option for Hematopoietic Syndrome of Acute Radiation Syndrome.

https://www.benzinga.com/general/biotech/21/01/18957074/attention-biotech-investors-mark-your-calendar-for-january-pdufa-dates

Abbott antigen test gets FDA nod as first at-home, virtually guided COVID-19 diagnostic

 

• Abbott on Wednesday received FDA emergency use authorization for a 15-minute antigen test, making it the first at-home, virtually guided coronavirus diagnostic to get the agency's nod.  
• The BinaxNOW COVID-19 Ag Card Home Test, which requires a prescription, offers a telehealth service to walk users through the sample self-collection process and to help them read and understand their results. Abbott said the $25 cost for the test and service is the "lowest currently available for at-home testing" but warned that it must be performed "only with the supervision of a telehealth proctor."   
• Abbott's EUA comes a day after an antigen test from Australia's Ellume was authorized by FDA as the first COVID-19 diagnostic that can be purchased over the counter and fully performed at home — without a prescription. Some public health experts are questioning why prescriptions are being required for some tests, potentially limiting their availability as U.S. coronavirus cases continue to surge.   

With the authorization of Abbott's and Ellume's rapid antigen tests, there are currently three COVID-19 diagnostics that can be fully used at home by consumers. FDA last month gave the green light for the first completely at-home coronavirus test from Emeryville, California-based biotech Lucira Health.

None of the three at-home tests are yet widely available. Abbott expects to deliver 30 million home tests in the first quarter of 2021 and 90 million in the second quarter. Ellume plans to produce more than 3 million tests in January and deliver 20 million to the U.S. within the first half of 2021, while Lucira said its COVID-19 test kit will be available nationally by early spring 2021 through healthcare providers. 

Lucira's molecular test, which costs about $50, delivers results in 30 minutes or less with self-collected nasal swab samples. With a $25 price tag for its 15-minute antigen test, Abbott easily beats Lucira on those two features. Ellume in that regard sits in between with its $30 antigen test that delivers results in about 20 minutes.

The three at-home tests also differ when it comes to their respective authorizations for certain symptomatic and asymptomatic individuals. While the Lucira kit is authorized for people age 14 and older suspected by their healthcare provider to be infected with the virus, Ellume's diagnostic is OK'd for individuals with or without coronavirus symptoms and for individuals as young as 2 years old. 

Abbott's BinaxNOW home test is authorized for those 15 years or older suspected by their healthcare provider of infection within the first 7 days of symptom onset, as well as adult-collected nasal swab samples from individuals ages 4 years or older who are likewise suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset.

The BinaxNOW COVID-19 Ag Card Home Test is a different product than the company's $5 point-of-care BinaxNOW COVID-19 Ag Card test that was authorized by FDA in August. The previous EUA only allowed for the rapid antigen diagnostic to be used by medical personnel or trained operators in certain non-clinical environments operating through a CLIA certificate.

FDA in Wednesday's Abbott EUA announcement noted that while antigen tests are "very specific for COVID-19" they are not as sensitive as molecular polymerase chain reaction (PCR) tests.

"This means that there is a higher chance of false negatives than with many molecular tests. Positive results from antigen tests, while generally highly accurate, may be subject to false positive results especially in areas where there are fewer infections," according to the agency.

Compared to lab-based molecular PCR tests, Abbott said data collected from four U.S. investigational sites showed that the BinaxNOW COVID-19 Ag Card Home Test delivered 91.7% positive agreement (sensitivity) and 100% negative agreement (specificity) in people 7 days or less post-symptom onset at all cycle threshold (Ct) counts, and 100% positive agreement (sensitivity) in people 7 days or less post-symptom onset with Ct counts of 33 or below.

According to Ellume, its at-home antigen test correctly identified 96% of positive samples and 100% of negative samples in a multi-site U.S. clinical study of both adults and children above 2 years of age. In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples.

Lucira claims its at-home COVID-19 test is comparable to the PCR gold standard for detecting SARS-CoV-2 infections. The company contends its molecular diagnostic, which uses a method called loop mediated amplification reaction (LAMP), was able to accurately detect 94% of infections found by "one of the most reliable FDA authorized" PCR tests, and also correctly identified 98% of the healthy, uninfected people in a clinical trial.  

Both the Abbott BinaxNOW COVID-19 Ag Card Home Test and the Lucira self-testing kit are currently authorized for prescription use only. Ellume's antigen test stands alone as an over-the-counter coronavirus diagnostic that can be used completely at home without a prescription.  

However, Michael Mina, a professor of epidemiology at Harvard's T. H. Chan School of Public Health, has questioned why at this stage in the pandemic the FDA is even requiring prescriptions for some coronavirus tests.   

"FDA has now conceded that COVID testing doesn't require a medical prescription. So the real question now is how can they continue to hold back these tests and require medical prescriptions for some tests, but not others? These are all COVID tests. There’s no reason to have this dichotomy existing now," Mina said during a Friday press conference. 

At the same time, Mina contends that FDA's making the first at-home collection COVID-19 PCR test available with no prescription doesn't make much sense.

FDA last week authorized the first non-prescription test that requires a lab to process a home-collected sample. That nod went to laboratory giant LabCorp, which is selling the PCR test through its Pixel consumer website and may expand into retail channels.

"You can now get a COVID test from LabCorp without a prescription, without anyone telling you that you need it, but it’s going to take a while. You got to get the thing delivered. You have to use it to mail it back the next day and you get a result back three days later. So you’ve already wasted your entire transmission period. It’s never going to work for public health," Mina said.

https://www.medtechdive.com/news/abbott-rapid-antigen-test-gets-fda-nod-as-first-at-home-virtually-guided-c/592352/

SARS-CoV-2 infection induces long-lived bone marrow plasma cells in humans

 Jackson S. Turner1 , Wooseob Kim1 , Elizaveta Kalaidina2 , Charles W. Goss3 2 , Adriana M. Rauseo4 , Aaron J. Schmitz1 , Lena Hansen1,5 , Alem Haile6 , Michael K. Klebert6 3 , Iskra Pusic7 , Jane A. O’Halloran4 , Rachel M. Presti4 , Ali H. Ellebedy1,8#

DOI: https://doi.org/10.21203/rs.3.rs-132821/v1

PDF: https://www.researchsquare.com/article/rs-132821/v1.pdf

Summary 

Infection or vaccination induces a population of long-lived bone marrow plasma cells (BMPCs) that are a persistent and essential source of protective antibodies. Whether this population is induced in patients infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is unknown. Recent reports  have suggested that SARS-CoV-2 convalescent patients experience a rapid decay in their antigen-specific serum antibodies, raising concerns that humoral immunity against this virus may be short-lived 6 . Here we show that in patients  who experienced mild infections (n=73), serum anti-SARS-CoV-2 spike (S) antibodies indeed decline rapidly in the first 3 to 4 months after infection.  However, this is followed by a more stable phase between 4- and 8-months after  infection with a slower serum anti-S antibody decay rate. The level of serum  antibodies correlated with the frequency of S-specific long-lived BMPCs obtained  from 18 SARS-CoV-2 convalescent patients 7 to 8 months after infection. S specific BMPCs were not detected in aspirates from 11 healthy subjects with no  history of SARS-CoV-2 infection. Comparable frequencies of BMPCs specific to  contemporary influenza virus antigens or tetanus and diphtheria vaccine antigens  were present in aspirates in both groups. Circulating memory B cells (MBCs)  directed against the S protein were detected in the SARS-CoV-2 convalescent  patients but not in uninfected controls, whereas both groups had MBCs against6 influenza virus hemagglutinin. Overall, we show that robust antigen specific long lived BMPCs and MBCs are induced after mild SARS-CoV-2 infection of humans.

https://www.researchsquare.com/article/rs-132821/v1