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Monday, July 6, 2020

WHO reviewing report urging new guidance on airborne covid spread

The World Health Organization (WHO) is reviewing a report urging it to update guidance on the novel coronavirus after more than 200 scientists, in a letter to the health agency, outlined evidence the virus can spread in tiny airborne particles.
The WHO says SARS-CoV-2, the virus that causes COVID-19, spreads primarily through small droplets expelled from the nose and mouth of an infected person that quickly sink to the ground.
But in an open letter to the Geneva-based agency, published on Monday in the Clinical Infectious Diseases journal, 239 scientists in 32 countries outlined evidence that they say shows floating virus particles can infect people who breathe them in.
Because those smaller particles can linger in the air, the scientists are urging WHO to update its guidance.
“We are aware of the article and are reviewing its contents with our technical experts,” WHO spokesman Tarik Jasarevic said on Monday in an email.
How frequently the coronavirus can spread by the airborne or aerosol route – as opposed to by larger droplets in coughs and sneezes – is not clear.
Any change in the WHO’s assessment of risk of transmission could affect its current advice on keeping 1-metre (3.3 feet) of physical distancing. Governments, which rely on the agency for guidance policy, may also have to adjust public health measures aimed at curbing the spread of the virus.
Although the WHO has said it is considering aerosols as a possible route of transmission, it has yet to be convinced that the evidence warrants a change in guidance.
Dr. Michael Osterholm, an infectious disease expert at the University of Minnesota, said the WHO has long been reluctant to acknowledge aerosol transmission of influenza, “in spite of compelling data,” and sees the current controversy as part of that simmering debate.
“I think the frustration level has finally boiled over with regard to the role that airborne transmission plays in diseases like influenza and SARS-CoV-2,” Osterholm said.
Professor Babak Javid, an infectious disease consultant at Cambridge University Hospitals, said airborne transmission of the virus is possible and even likely, but said evidence over how long the virus stays airborne is lacking.
If it can hang in the air for long periods of time, even after an infected person leaves that space, that could affect the measures healthcare workers and others take to protect themselves.
WHO guidance to health workers, dated June 29, says SARS-CoV-2 is primarily transmitted through respiratory droplets and on surfaces.
But airborne transmission is possible in some circumstances, such as when performing intubation and aerosol-generating procedures, the WHO says. They advise medical workers performing such procedures to wear heavy duty N95 respiratory masks and other protective equipment in an adequately ventilated room.
Dr. William Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health, said the report under review at the WHO “makes many reasonable points about the evidence that this mode of transmission can happen, and they should be taken seriously.”
But how often airborne transmission happens, which is unknown, also matters.
“If airborne transmission is possible but rare, then eliminating it wouldn’t have a huge impact,” he said in emailed comments.
Officials at South Korea’s Centers for Disease Control said on Monday they were continuing to discuss various issues about COVID-19, including the possibility of airborne transmission. They said more investigations and evidence were needed.

AlloVir on deck for IPO

AlloVir (ALVR) has filed a preliminary prospectus for a $100M IPO.
The Cambridge, MA-based biotech develops allogeneic off-the-shelf T cell therapies to designed to restore immunity in patients with T cell deficiencies who are at risk of life-threatening consequences of viral diseases.
Lead candidate is Viralym-M, a multi-VST (virus-specific T cell) therapy targeting five viruses (BK, CMV, AdV, EBV and HHV-6) for immunocompromised patients who have undergone allogeneic hematopoietic stem cell transplant or solid organ transplant at risk of infection from the five viruses. A Phase 3 clinical trial in patients with virus-associated hemorrhagic cystitis is next up.
2019 Financials: Revenue: $0.2M; Operating Expenses: $2.9M (-70%); Net Loss: ($2.5M) (+73%); Cash Consumption: ($2.0M) (+81%).

Otonomy reports positive data on tinnitus candidate and Otividex

Otonomy (NASDAQ:OTIC) announces a positive development related to the statistical analysis plan for its ongoing Phase 3 clinical trial evaluating Otividex in patients with Ménière’s disease, a disorder of the inner ear that can lead to vertigo and hearing loss.
In response to FDA questions, the company has changed its statistical approach to a Negative Binomial model that, it says, provides the best fit for clinical data and will enable it to drop the enrollment target to 142 from 160. Enrollment should be competed this quarter with topline data available in Q1 2021.
OTIVIDEX (formerly OTO-104), a sustained-exposure formulation of the steroid dexamethasone, was being developed to treat a range of balance and hearing disorders. It is administered directly into the middle ear via injection through the eardrum.
On another note, topline results from a Phase 1/2 clinical trial evaluating OTO-313, a sustained-exposure formulation of the NMDA receptor antagonist gacyclidine, in patients with persistent tinnitus showed a “positive clinical signal.” Specifically, 43% of treated patients responded at day 29 and day 57, defined as at least a 13-point drop in Tinnitus Functional Index (TFI) score from baseline, well head of 13% in the control arm.
Management hosted a conference call today at 4:30 pm to discuss both candidates.

Sanofi reiterates expected drop in sales in Q2

In a statement, Sanofi (NASDAQ:SNY) continues to expect a “low single-digit” drop in Q2 revenues from a year ago and lower sequentially due to COVID-19-related product stocking.
It expectations assume a reduction in pharmaceutical in-channel inventory build, a negative impact in travel vaccines and immunization, continuation in flu demand, China recovery, unwinding in consumer stocking, lower pharmacy traffic and continued delivery on efficiencies.
Citing its $11.7B sale of most of its stake in Regeneron, Q2 non-GAAP net income will exclude the effect of the equity method of accounting related to its Regeneron investment in the share of profit/loss of associates and joint ventures line. The effect will be presented as a reconciling item between IFRS net income and business net income.

Pacira BioSciences under pressure on preliminary Q2 results

Pacira BioSciences (NASDAQ:PCRX) reports preliminary 2Q20 revenue of $75.5M, down from $102.6M in 2Q19, driven by the negatively impacted EXPAREL sales due to COVID-19 disruptions.
Average daily sales of EXPAREL were 30% and 81% of the prior year in April and May, respectively, while June rebounded to 107%.
EXPAREL net Q2 sales were $73.0M, down 26% from $98.9M a year ago.
Sales of iovera° were $1.4M vs. $2M last year and royalty revenue was $0.3M compared to $0.8M a year ago.
On another note, the company has proposed a direct offering of $300M convertible senior notes due 2025 with initial purchasers’ over-allotment option of additional $45M worth notes. Interest rate and others terms are yet to be determined.
It intends to use net proceeds to repurchase part of its 2.375% convertible senior notes and for general corporate purposes.

Cellectis under pressure on safety signal in multiple myeloma study

Cellectis (NASDAQ:CLLS) is down 8% after hours after its Phase 1 MELANI-01 trial in multiple myeloma patients was placed on clinical hold by the FDA.
The agency suspended the study after one participant who received candidate UCARTCS1A experienced a fatal heart attack.
Clinical evaluation of the incident is ongoing. The company is working to address the required changes to the MELANI-01 clinical protocol aimed at enhancing patient safety.
UCARTCS1A is an allogeneic, off-the-shelf, gene-edited T-cell product candidate designed for CS1/SLAMF7-expressing blood cancers.

Quidel sees Q2 revenue above consensus

Quidel (OTC:QDEL) up 4.4% as the company expects Q2 revenues to increase more than 80% to ~$201M – $202M, compared to consensus of $172.6M, driven by demand for COVID-19 diagnostic products.
During the quarter, Quidel manufactured over 3M Lyra SARS-CoV-2 and Lyra Direct SARS-CoV-2 assays. Later in the quarter, completed the development of Sofia SARS Antigen, gained emergency use authorization clearance, and manufactured almost 4M Sofia SARS Antigen cassettes. In June shipped ~1,500 Sofia instruments.
The company expects to issue full Q2 results in late July.