Pandemic Slashes Donations of Lifesaving Plasma

Collections of blood plasma have fallen sharply in recent months because of the coronavirus pandemic, raising worries about the supply of important medicines that rely on it.

CSL Ltd., which runs one of the biggest collection-center networks in the U.S., said plasma donations fell by more than 25% in the three months through June. Grifols SA, which is based in Spain but has facilities in the U.S., has said it expects plasma availability this year to drop by 10% compared with a year ago.

The decline is worrying for patients with illnesses ranging from immune disorders to cancer for whom plasma-derived therapies can be lifesaving. Many need immunoglobulin, which contains antibodies harvested from plasma, and is manufactured by pharmaceutical companies that supply hospitals and clinics.

“Across the globe, there’s going to be a lot of tightness in the market and there will be some shortages in various countries,” CSL Chief Executive Paul Perreault said of immunoglobulin. “Whether the U.S. sees all of that or not, really depends on how quickly plasma collections come back.”

Immunoglobulin’s role in health care has gained a bigger profile during the pandemic. Researchers are studying whether blood-plasma transfusions from recovered Covid-19 patients are safe and improve outcomes for severely ill patients. Data are so far promising, adding urgency to discussions about building a plasma stockpile from recovered Covid-19 patients in the U.S.

However, the pandemic has also disrupted companies’ ability to secure enough plasma, despite U.S. authorities relaxing certain rules to help process donations faster.

While CSL’s collection centers in the U.S. have been allowed to remain open throughout the pandemic, Mr. Perreault said the patchwork of different lockdown measures across the country made it confusing for would-be donors to know if their local center was accepting donations. In some cases, local authorities placed limits on how many people could be in the centers, creating long wait times and dissuading some donors, he said.

It takes months for raw plasma to be made into the immunoglobulin that is given to patients, so any shortage likely wouldn’t appear until next year.

If the coronavirus crisis eases, it could be easier for people to donate plasma, and donors might be more comfortable going to a collection center. However, donors in the U.S. get paid, and another round of stimulus could dissuade people from donating if they don’t need cash.

“The situation is still uncertain and difficult to predict in the long run,” Grifols said in July.

Companies that run collection centers have already made changes to make donors more comfortable during the pandemic, including putting up barriers between beds, increasing the distance between the beds and checking temperatures of all donors who came through the door.

Mr. Perreault said CSL has a modest inventory of finished plasma products, while noting that collections have improved in recent weeks compared with the peak period of lockdowns. Goldman Sachs estimated that CSL’s plasma collections would need to decline by 30% this year for the company’s supply of plasma therapies to be affected materially.

There have been plasma shortages in the past, even without a pandemic. Last year, some U.S. hospitals had to suspend immunoglobulin treatments for many patients because of supply issues. At the time, some immunoglobulin manufacturers said there was increased demand for the product because of higher rates of diagnosis of conditions that it has long treated, plus new uses for the drug.

Periodic plasma shortages have led pharmaceutical companies to invest more in collection centers in recent years to increase supply of the raw material. Morgan Stanley estimated that U.S. plasma collection increased by 10% in 2019. CSL, which has its headquarters in Australia, opened 40 new collection centers in the U.S. in the 2020 fiscal year that ended in June. It plans to open another 20 to 30 in the current fiscal year.

“CSL is in the business to take care of patients,” Mr. Perreault said on Wednesday, shortly after CSL reported a 10% rise in profit for fiscal 2020. “We’re going to do everything in our power to make sure that they’re supplied.”

https://www.marketscreener.com/quote/stock/CSL-LIMITED-6492492/news/Coronavirus-Pandemic-Slashes-Donations-of-Lifesaving-Plasma-31142560/

U.S. to let pharmacists vaccinate kids as lockdowns slash immunization levels

The U.S. government said on Wednesday pharmacists would be allowed to administer routine vaccines to children, calling a drop in immunization from lockdowns aimed at curbing the spread of the coronavirus a “public health threat.”

The Department of Health and Human Services (HHS) announced the plan on Wednesday, as children across the country return to daycare, schools and colleges.

The U.S. Centers for Disease Control and Prevention, in a report in May, documented a drop in child vaccination rates since lockdowns were imposed, raising concern about outbreaks of other diseases such as measles.

“This decrease in childhood vaccination rates is a public health threat and a collateral harm caused by the COVID-19 pandemic,” HHS said in a statement.

The United States has more than 5.5 million cases of confirmed coronavirus infections, the highest in the world, according to a Reuters tally.

The amendment under the Public Readiness and Emergency Preparedness Act allows pharmacists to order and administer vaccines to children aged three to 18 years.

https://www.reuters.com/article/us-health-coronavirus-children-vaccinati/u-s-to-let-pharmacists-vaccinate-kids-as-lockdowns-slash-immunization-levels-idUSKCN25F2BD

BioMarin selloff pressures other AAV gene therapy developers

UniQure (QURE -4.6%) and REGENXBIO (RGNX -4.1%) are feeling BioMarin Pharmaceutical’s (BMRN -35.0%) pain after the FDA rejected its marketing application for hemophilia A treatment valoctogene roxaparvovec, a gene therapy based on a vector called adeno-associated virus type 5 (AAV5).

QURE is also developing AA5 gene therapies while RGNX is involved with AAV types 7,8, 9 and 10.

Recombinant replication-defective adenoviruses are popular vectors for delivering gene therapies since they infect most cell types, are very efficient with no requirements for cell division and are relatively inexpensive to engineer.

https://seekingalpha.com/news/3607165-biomarin-selloff-pressures-aav-gene-therapy-developers

Hemophilia A players in the green on BioMarin gene therapy delay in U.S.

On script, BioMarin Pharmaceutical’s (BMRN -36.2%) stumble with hemophilia A gene therapy candidate valoctogene roxaparvovec has stoked modest buying in other players in the space as investors perceive improved prospects from the sidelining of a key competitor.

Earlier today, it announced that it received a CRL citing the need for more data to prove the duration of the treatment effect, extending the timeline for possible approval into 2022.

Selected tickers: Regeneron Pharmaceuticals (REGN +3.2%), Intellia Therapeutics (NTLA +1.9%), Bayer (OTCPK:BAYRYBAYRY 17.16 0.13 0.76% Bayer Aktiengesellschaft Bayer Aktiengesellschaft operates as a life science company worldwide. More » (10,508 followers) +0.6%), Sangamo Therapeutics (SGMO +2.8%), Novo Nordisk (NVO +0.7%), Catalyst Biosciences (CBIO +0.6%), Roche (OTCQX:RHHBY +1.1%)

https://seekingalpha.com/news/3607153-hemophilia-players-in-green-on-biomarin-gene-therapy-delay-in-u-s

Alkermes initiates phase 2 study on ALKS 4230 clinical, immunologic activity

Alkermes (ALKS -0.4%) announced the initiation of ARTISTRY-3, a new phase 2 study to evaluate the clinical and immunologic effects of ALKS 4230 monotherapy on the tumor microenvironment in patients with advanced solid tumors.

Data from the ARTISTRY-3 clinical trial will provide a deeper understanding of the effects of ALKS 4230 on immunologic activity in the tumor microenvironment across a variety of tumor types.

“Early clinical data from our ARTISTRY program showed that ALKS 4230 selectively expanded cancer-fighting immune cells in the periphery, with negligible effects on regulatory T cells.” said Craig Hopkinson, M.D., Chief Medical Officer and Executive VP of R&D.

https://seekingalpha.com/news/3607136-alkermes-initiates-phase-2-study-to-evaluate-clinical-and-immunologic-activity-of-alks-4230

More on Supernus Pharmaceuticals Q2 earnings

For Q2, Supernus Pharmaceuticals (SUPN -4.6%) reported revenue of $126.73M (+21.0% Y/Y) missed consensus by $5.27M.

GAAP EPS of $0.65 (vs. $0.61 in year ago quarter) beats consensus by $0.16.

As of June 30, 2020, cash and equivalents stood at $210.98M compared to $181.38M as of December 31, 2019.

In early April, the company entered into a development and option agreement with Navitor Pharmaceuticals for conducting a Phase II clinical program for NV-5138 (SPN-820) in treatment-resistant depression.

In early June, Supernus completed  its acquisition of all of the outstanding equity of privately-held biopharmaceutical company, USWM Enterprises for $297.2M in cash thereby acquiring the right to further develop and commercialize APOKYN, XADAGO and the Apomorphine Infusion Pump in the U.S. and MYOBLOC worldwide for treating Parkinson’s disease.

Previously: Supernus Pharmaceuticals EPS beats by $0.16, misses on revenue (Aug 18)

https://seekingalpha.com/news/3607125-on-supernus-pharmaceuticals-q2-earnings

Side effects of COVID-19 suggest way it gains foothold in the body

It’s an odd side effect. But could it provide clues as to how coronavirus attacks the body?

Why do some people with COVID-19 lose their sense of smell? And what can be learned from that? Scientists studying tissue removed from patients’ noses during surgery believe they may have discovered the reason why so many people with COVID-19 lose their sense of smell, even when they have no other symptoms and, as a result, one way the virus enters the body.

In a study published in the European Respiratory Journal on Wednesday, the researchers found extremely high levels of “angiotensin converting enzyme II,” or ACE-2, only in the area of the nose responsible for smelling. The ACE-2 enzyme is thought to be the gateway that allows coronavirus to enter the cells of the body and cause an infection. Advertisement

Researchers at the Johns Hopkins University School of Medicine in Baltimore conducted the study, led by Professor Andrew Lane, director of the division of rhinology and skull base surgery, and Dr. Mengfei Chen, a research associate. They used fluorescent dyes on the tissue samples to detect and visualize the presence of ACE-2 in the nose cells.

The study used these samples from the back of the nose of 23 patients, removed during endoscopic surgical procedures for conditions such as tumors or “chronic rhinosinusitis,” an inflammatory disease of the nose and sinus. They also studied biopsies from the trachea (windpipe) of seven patients. None of the patients had been diagnosed with coronavirus.

“This technique allowed us to see that the levels of ACE-2 — the COVID-19 ‘entry point’ protein were highest in the part of the nose that enables us to smell,” Chen said. “These results suggest that this area of the nose could be where the coronavirus is gaining entry to the body.” They found the most ACE-2 on the lining cells of the “olfactory epithelium” at the back of the nose where we detect smells.

In fact, the levels of ACE-2 in these cells was between 200 and 700 times higher than other tissue in the nose and trachea, Chen said, and they found similarly high levels in all the samples of olfactory epithelium. The ACE-2 enzyme was not detected on olfactory neurons, the nerve cells that pass information about smells to the brain.

“The olfactory epithelium is quite an easy part of the body for a virus to reach, it’s not buried away deep in our body, and the very high levels of ACE-2 that we found there might explain why it’s so easy to catch COVID-19,” Chen said. Lane added that this research may enable doctors to tackle the infection with antiviral therapies delivered directly through the nose.

Many common respiratory infections, such as coughs and colds, can make us temporarily lose our sense of smell, said Tobias Welte, professor of pulmonary medicine and director of the Department of Pulmonary and Infectious Diseases at Hannover University School of Medicine, Germany. Welte, who was not involved in this study, said this study may reveal why that happens in so many patients.

It could also be one reason why COVID-19 is so infectious and, he added, this theory could potentially offer more effective treatments. “It suggests that the part of our nose responsible for smelling could also be the place where the coronavirus gains a foothold in the body. This finding will need to be confirmed, but it offers possible new avenues for treating the infection.”

“ Another study found evidence of direct viral damage to the olfactory system in two patients who died from COVID-19. ”

A separate study released earlier this month and published in JAMA Otolaryngology — Head & Neck Surgery, a peer-reviewed journal, looked at the nasal cells of two patients who had died of SARS-CoV-2, the virus that causes the disease COVID-19, and found evidence of direct viral damage to the sensory system used for smelling in patients testing positive for SARS-CoV-2.

As of Wednesday, the U.S. still had the world’s highest number of COVID-19 cases (5,486,232) and deaths (171,877). Worldwide, there had been 22,179,934 confirmed cases and 781,932 deaths. COVID-19 attacks the respiratory system, but doctors say it also affects the cardiovascular system, affecting organs and causing blood clots among some patients, even young ones.

Some younger COVID-19 patients who were otherwise healthy are suffering loss of taste and/or smell, blood clots and strokes. Many “long-haulers” — COVID-19 patients who have continued showing symptoms for months after the initial infection passed — report neurological problems including confusion, difficulty concentrating, headaches, extreme fatigue, mood changes and insomnia.

https://www.marketwatch.com/story/johns-hopkins-scientists-examining-weird-side-effects-of-covid-19-say-this-could-be-how-virus-gains-a-foothold-in-the-body-2020-08-19