French drugmaker Sanofi
said it plans to enroll thousands of subjects globally for trials of an
experimental vaccine for the coronavirus it is developing with GlaxoSmithKline Plc, and that it has started to discuss advanced purchases with several countries.
Sanofi is working on two vaccine projects to prevent COVID-19 – the
illness caused by the new coronavirus – and said it is exploring several
manufacturing options, including fresh collaborations to ensure it can
meet demand, if either program is successful.
Drugmakers are rushing to develop treatments and vaccines for the
highly contagious coronavirus that has killed over 255,000 people
worldwide, infected more than 3.6 million and ravaged economies
globally.
Of more than 100 vaccine candidates in development, 10 have reached
the clinical testing stage so far, according to California-based think
tank Milken Institute.
Sanofi, whose Pasteur division has an established track record in
influenza vaccines, teamed with British rival GSK last month to come up
with a candidate it hopes will be ready next year.
Sanofi will bring in a protein antigen – a molecule designed to
trigger an immune response in the body – based on a platform it uses for
its influenza vaccine Flublok.
GSK will contribute one of its approved adjuvants, which work by
boosting the immune response to produce more antibodies and
longer-lasting immunity.
Sanofi Pasteur executives told Reuters the company hopes to start
early-stage trials in September, with hundreds of subjects enrolled.
While Phase I vaccine trials typically involves a small number of
healthy volunteers to test for safety, Sanofi said it had opted for
higher numbers to secure stronger data sooner.
“We envisioned Phase I to actually have several hundreds of subjects,
so it is really a phase I/II trial,” said John Shiver, head of Sanofi
vaccine research.
Beyond finding the right vaccine, a key challenge lies in
manufacturing on an enormous scale and distributing the product
globally.
“We will be comparing different doses of the vaccine and that is very
critical. It will tell us about the factory capacity and what we need
to do to produce the number of doses that we projected,” Shiver said.
Sanofi previously said it will be able to produce over a billion
doses. Its project with GSK has received financial support from the
Biomedical Advanced Research and Development Authority (BARDA) of the
U.S. Health Department.
Late-stage trials with thousands of subjects comparing the vaccine to
placebo are expected to take place by year-end or early 2021, Shiver
said, adding that some previous Sanofi influenza trials had enrolled up
to 30,000 participants.
A BIT ‘TRICKY’
David Loew, executive vice president for vaccines, said Sanofi has
begun preliminary discussions with countries over mechanisms for
pre-ordering the vaccine, if it works, although legal details must still
be worked out with GSK.
“It is a bit of a tricky thing when you partner with another
company,” he said, adding that talks were taking place with U.S.
officials as well as with some European countries.
Given the support from BARDA, doses produced at its U.S.
manufacturing facility are expected to go to U.S. patients first, a
prospect that has raised concern in Europe.
Asked if Sanofi would consider new collaborations to ensure it can
deliver on its manufacturing pledges, Loew said, “yes, if we come to the
conclusion that we do not have enough capacity.”
Sanofi Chief Executive Paul Hudson on April 24 urged stronger
European coordination in the hunt for a vaccine against the new
coronavirus, criticising Europe for being too slow. [L5N2CC67J]
Sanofi is also working with U.S.-based Translate Bio Inc on another
vaccine candidate based on messenger RNA technology (mRNA), similar to
experimental vaccines being developed by Pfizer Inc in partnership with
BioNTech SE and another Moderna Inc is developing in partnership with
the U.S. government.
The mRNA technology instructs cells in the body to make specific
coronavirus proteins that then produce an immune response. Trials of
that vaccine are expected to start in the fourth quarter.
https://www.marketscreener.com/GLAXOSMITHKLINE-9590199/news/Exclusive-Sanofi-to-enroll-thousands-for-its-coronavirus-vaccine-trials-30545089/
Tuesday, May 5, 2020
EssilorLuxottica Warns of Coronavirus Hit in 2Q After Tough 1Q
EssilorLuxottica SA said Tuesday that first-quarter revenue fell 10%
due to the coronavirus pandemic and that the impact of the crisis will
likely be stronger in the second quarter.
Revenue for the quarter was 3.78 billion euros ($4.13 billion), the Franco-Italian optical giant said. At constant currencies, revenue shrank 11%.
The company–which was created in October 2018 from the combination of optical-lens manufacturer Essilor and luxury-eyewear maker Luxottica–reported lower revenue across its business divisions, with its lenses and optical instruments category posting a 5.1% decline, while the sunglasses and readers business saw revenue decline 19%.
The company said it can’t assess the full impact of the pandemic at the moment. However, the health crisis is likely to hit revenue and profitability even harder in the current quarter.
In March, the company scrapped its guidance for the year due to the impact of the coronavirus.
EssilorLuxottica won’t propose a dividend at the June 25 shareholders’ meeting. However, it may propose a special dividend before the end of the year “if the recovery is solid enough,” it said.
https://www.marketscreener.com/ESSILORLUXOTTICA-4641/news/EssilorLuxottica-Warns-of-Coronavirus-Hit-in-2Q-After-Tough-1Q-30538453/
Revenue for the quarter was 3.78 billion euros ($4.13 billion), the Franco-Italian optical giant said. At constant currencies, revenue shrank 11%.
The company–which was created in October 2018 from the combination of optical-lens manufacturer Essilor and luxury-eyewear maker Luxottica–reported lower revenue across its business divisions, with its lenses and optical instruments category posting a 5.1% decline, while the sunglasses and readers business saw revenue decline 19%.
The company said it can’t assess the full impact of the pandemic at the moment. However, the health crisis is likely to hit revenue and profitability even harder in the current quarter.
In March, the company scrapped its guidance for the year due to the impact of the coronavirus.
EssilorLuxottica won’t propose a dividend at the June 25 shareholders’ meeting. However, it may propose a special dividend before the end of the year “if the recovery is solid enough,” it said.
https://www.marketscreener.com/ESSILORLUXOTTICA-4641/news/EssilorLuxottica-Warns-of-Coronavirus-Hit-in-2Q-After-Tough-1Q-30538453/
Pfizer Coronavirus Vaccine Enters Human Testing in U.S.
Researchers have begun giving healthy volunteers in the U.S. an
experimental coronavirus vaccine developed by Pfizer Inc. and partner
BioNTech SE, the latest study exploring a potential defense against the
respiratory disease.
Researchers at the New York University Grossman School of Medicine in Manhattan and the University of Maryland School of Medicine in Baltimore said Tuesday they began injecting people with the first of four vaccine candidates from Pfizer and Germany’s BioNTech.
The clinical trial will help the researchers evaluate whether the candidates are safe, which produces the strongest immune response that could fend off the coronavirus and what the dose should be. Pfizer plans to advance the candidate that proves most promising. Testing of the vaccine candidates in Germany began last month.
Results from the 360-person study in the U.S. could come as early as next month, but the vaccine will still need to undergo additional testing in more patients, said Kathrin Jansen, Pfizer’s head of vaccine research and development.
Pfizer will track the progress of the study to pick the most promising vaccine candidate, Dr. Jansen said.
The plan is to “weed out, weed out, weed out, focus on what’s good and move on,” Dr. Jansen said. “It’s a quick elimination.”
A vaccine could be ready for emergency use as early as the fall if testing indicates it works safely, Pfizer Chief Executive Albert Bourla told The Wall Street Journal last week, though the company would keep studying it in clinical trials.
The U.S. government has the authority to grant limited use of a vaccine or drug during a health emergency, before testing is complete.
Several potential coronavirus vaccines have entered human testing, including candidates from Moderna Inc. and Oxford University.
The vaccine efforts have advanced quickly compared with typical vaccine R&D timelines, though some experts have expressed concern over whether testing will be rigorous enough to adequately assess if the shots can safely protect people from contracting the coronavirus.
“The question is, what steps are you skipping?” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, who developed a vaccine for a common disease in young children called rotavirus that causes diarrhea and vomiting.
Adding to the challenges of deciphering whether a coronavirus vaccine works, researchers say, is uncertainty about how immunity develops against the virus.
Without that knowledge, researchers are relying on their understanding of previous coronaviruses and antibodies that neutralize viruses, said Kirsten Lyke, a professor of medicine at the University of Maryland School of Medicine, who is helping lead the Pfizer trial.
The Pfizer and BioNTech vaccine will initially be studied in adults 18 to 55 years old, and eventually will enroll older volunteers, Pfizer said.
After receiving the first dose, patients will receive a second dose three weeks later. Pfizer will test other doses later on, including a single shot, Dr. Jansen said.
Four out of every five study subjects will get the vaccine, while the remaining subjects will take a placebo.
The vaccine uses a gene-based technology known as messenger RNA. Messenger RNA, or mRNA, carries instructions from DNA to the body’s cells to make certain proteins. An mRNA vaccine has never been approved to prevent any infectious disease.
Mark Mulligan, director of the Vaccine Center at NYU Langone Health, said he doesn’t expect challenges enrolling patients.
“People, frankly, are sick of this virus and they want to do whatever they can to fight back,” he said. “The public recognizes that in order to start returning to normalcy, we’ve got to get people protected, and vaccines hold the greatest hope for that.”
Melissa Honkanen, 42 years old, of New York City, enrolled in the study after hearing about it from her husband, a pediatrician at NYU Langone, because she wanted to be helpful.
“It’s really hard to see all of this happening,” said Ms. Honkanen, a yoga instructor. “We’re in a world where we can’t hug each other or be social and active.”
Aside from working on a vaccine, Pfizer is also trying to develop an antiviral treatment that could begin testing this summer, and it is testing whether rheumatoid-arthritis drug Xeljanz helps fight Covid-19, the disease caused by the coronavirus.
Pfizer plans to soon manufacture the vaccines at its facilities in Massachusetts, Michigan and Missouri, as well as Puurs, Belgium, with additional locations to come.
https://www.marketscreener.com/PFIZER-INC-23365019/news/Pfizer-Coronavirus-Vaccine-Enters-Human-Testing-in-U-S-30540276/
Researchers at the New York University Grossman School of Medicine in Manhattan and the University of Maryland School of Medicine in Baltimore said Tuesday they began injecting people with the first of four vaccine candidates from Pfizer and Germany’s BioNTech.
The clinical trial will help the researchers evaluate whether the candidates are safe, which produces the strongest immune response that could fend off the coronavirus and what the dose should be. Pfizer plans to advance the candidate that proves most promising. Testing of the vaccine candidates in Germany began last month.
Results from the 360-person study in the U.S. could come as early as next month, but the vaccine will still need to undergo additional testing in more patients, said Kathrin Jansen, Pfizer’s head of vaccine research and development.
Pfizer will track the progress of the study to pick the most promising vaccine candidate, Dr. Jansen said.
The plan is to “weed out, weed out, weed out, focus on what’s good and move on,” Dr. Jansen said. “It’s a quick elimination.”
A vaccine could be ready for emergency use as early as the fall if testing indicates it works safely, Pfizer Chief Executive Albert Bourla told The Wall Street Journal last week, though the company would keep studying it in clinical trials.
The U.S. government has the authority to grant limited use of a vaccine or drug during a health emergency, before testing is complete.
Several potential coronavirus vaccines have entered human testing, including candidates from Moderna Inc. and Oxford University.
The vaccine efforts have advanced quickly compared with typical vaccine R&D timelines, though some experts have expressed concern over whether testing will be rigorous enough to adequately assess if the shots can safely protect people from contracting the coronavirus.
“The question is, what steps are you skipping?” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, who developed a vaccine for a common disease in young children called rotavirus that causes diarrhea and vomiting.
Adding to the challenges of deciphering whether a coronavirus vaccine works, researchers say, is uncertainty about how immunity develops against the virus.
Without that knowledge, researchers are relying on their understanding of previous coronaviruses and antibodies that neutralize viruses, said Kirsten Lyke, a professor of medicine at the University of Maryland School of Medicine, who is helping lead the Pfizer trial.
The Pfizer and BioNTech vaccine will initially be studied in adults 18 to 55 years old, and eventually will enroll older volunteers, Pfizer said.
After receiving the first dose, patients will receive a second dose three weeks later. Pfizer will test other doses later on, including a single shot, Dr. Jansen said.
Four out of every five study subjects will get the vaccine, while the remaining subjects will take a placebo.
The vaccine uses a gene-based technology known as messenger RNA. Messenger RNA, or mRNA, carries instructions from DNA to the body’s cells to make certain proteins. An mRNA vaccine has never been approved to prevent any infectious disease.
Mark Mulligan, director of the Vaccine Center at NYU Langone Health, said he doesn’t expect challenges enrolling patients.
“People, frankly, are sick of this virus and they want to do whatever they can to fight back,” he said. “The public recognizes that in order to start returning to normalcy, we’ve got to get people protected, and vaccines hold the greatest hope for that.”
Melissa Honkanen, 42 years old, of New York City, enrolled in the study after hearing about it from her husband, a pediatrician at NYU Langone, because she wanted to be helpful.
“It’s really hard to see all of this happening,” said Ms. Honkanen, a yoga instructor. “We’re in a world where we can’t hug each other or be social and active.”
Aside from working on a vaccine, Pfizer is also trying to develop an antiviral treatment that could begin testing this summer, and it is testing whether rheumatoid-arthritis drug Xeljanz helps fight Covid-19, the disease caused by the coronavirus.
Pfizer plans to soon manufacture the vaccines at its facilities in Massachusetts, Michigan and Missouri, as well as Puurs, Belgium, with additional locations to come.
https://www.marketscreener.com/PFIZER-INC-23365019/news/Pfizer-Coronavirus-Vaccine-Enters-Human-Testing-in-U-S-30540276/
Supernus Pharmaceuticals EPS beats by $0.13, beats on revenue
Supernus Pharmaceuticals (NASDAQ:SUPN): Q1 GAAP EPS of $0.40 beats by $0.13.
Revenue of $94.97M (+11.1% Y/Y) beats by $10.96M.
Shares +22.7% AH.
https://seekingalpha.com/news/3569738-supernus-pharmaceuticals-eps-beats-0_13-beats-on-revenueFDA OKs Emergency Use for Muscle Stimulator to Reduce Vent Usage
The Food and Drug Administration has issued an Emergency Use
Authorization (EUA) for the VentFree Respiratory Muscle Stimulator in
order to potentially reduce the number of days adult patients, including
those with COVID-19, require mechanical ventilation, according to a press release from Liberate Medical.
In comparison with mechanical ventilation, which is invasive and commonly weakens the breathing muscles, the VentFree system uses noninvasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation, according to the press release. This allows patients to begin treatment during the early stages of ventilation while they are sedated and to continue until they are weaned off of ventilation.
A pair of pilot randomized, controlled studies, completed in Europe and Australia, showed that VentFree helped to reduce ventilation duration and ICU length of stay, compared with placebo stimulation. The FDA granted VentFree Breakthrough Device status in 2019.
VentFree has been authorized for use only for the duration of the current COVID-19 emergency, as it has not yet been approved or cleared for usage by primary care providers.
https://www.medscape.com/viewarticle/930006
In comparison with mechanical ventilation, which is invasive and commonly weakens the breathing muscles, the VentFree system uses noninvasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation, according to the press release. This allows patients to begin treatment during the early stages of ventilation while they are sedated and to continue until they are weaned off of ventilation.
A pair of pilot randomized, controlled studies, completed in Europe and Australia, showed that VentFree helped to reduce ventilation duration and ICU length of stay, compared with placebo stimulation. The FDA granted VentFree Breakthrough Device status in 2019.
VentFree has been authorized for use only for the duration of the current COVID-19 emergency, as it has not yet been approved or cleared for usage by primary care providers.
https://www.medscape.com/viewarticle/930006
State data show coronavirus cases as early as January in Florida
Florida Health Department data shows that 171 people had coronavirus
symptoms or had tested positive for COVID-19 in the months before cases
were publicly announced, according to a Palm Beach Post report.
The Post analyzed state data, which was removed from the health department’s website May 4 without explanation. The newspaper had previously downloaded and retained the data.
The data showed that 171 people were either showing symptoms or had tested positive for the new virus in January and February. Florida officially announced its first presumed cases of coronavirus March 1.
It is unclear whether the patients reported their coronavirus symptoms to the state later or if the health department’s local offices were actively investigating COVID-19 at the time, or both, according to the Post.
Of the 171 people, 105 were women and 66 were men. Most of these early patients hadn’t traveled, and none reported going to China, the Post reports.
https://www.beckershospitalreview.com/public-health/state-data-shows-coronavirus-cases-as-early-as-january-in-florida.html
The Post analyzed state data, which was removed from the health department’s website May 4 without explanation. The newspaper had previously downloaded and retained the data.
The data showed that 171 people were either showing symptoms or had tested positive for the new virus in January and February. Florida officially announced its first presumed cases of coronavirus March 1.
It is unclear whether the patients reported their coronavirus symptoms to the state later or if the health department’s local offices were actively investigating COVID-19 at the time, or both, according to the Post.
Of the 171 people, 105 were women and 66 were men. Most of these early patients hadn’t traveled, and none reported going to China, the Post reports.
https://www.beckershospitalreview.com/public-health/state-data-shows-coronavirus-cases-as-early-as-january-in-florida.html
Seattle Genetics’ bladder cancer med Padcev blows early expectations away
Even a pandemic can’t slow Seattle Genetics’ new bladder cancer
treatment Padcev down—and analysts are jacking up their sales estimates
for the drug as a result.
In its first quarter on the market after a mid-December FDA approval, the therapy “blew out expectations … exceeding consensus estimates” by four- to fivefold with $34.5 million in sales, J.P. Morgan analyst Cory Kasimov wrote in a note to clients.
Even SVB Leerink’s Andrew Berens, whose Padcev sales projection was twice as high as Kasimov’s, noted that the drug “handily beat our estimate of $10 million for the quarter, even in the midst of the pandemic.”
And the performance was no fluke, either. While other drugmakers have seen their Q1 sales boosted by some stockpiling early in the pandemic, that’s likely not what happened to Padcev, which “follows a ‘just in time’ delivery model” that sees the drug delivered as-needed, Kasimov wrote.
Berens also cited assurances from SeaGen’s leaders that many of the patients who received Padcev in Q1 are still alive and receiving therapy. Management said it “had no reason to believe this early adoption was driven primarily by a warehouse of end-stage patients which might have truncated duration of usage as has been seen with several other oncology drug launches.”
If that’s the case, “many of these Q1 patients are likely to be on the drug in Q2 given the expected duration of treatment of about 4.5 months in this setting,” Berens wrote, upping his 2020 target for the drug to $221 million and peak sales prediction in relapsed or refractory bladder cancer to $2 billion.
The thing is, SeaGen isn’t stopping there. It’s currently trying for a nod in previously untreated patients, an opportunity Berens pegs at $5.8 billion. And those SVB Leerink estimates don’t even factor in potential revenue from earlier stages of the disease, such as muscle-invasive bladder cancer (MIBC), a “sizable” market the company is pursuing with a phase 3 trial testing Padcev alongside Merck immuno-oncology powerhouse Keytruda.
“We estimate there are about 10,000 MIBC patients in the U.S., and the expected duration of therapy could be significant in these less advanced patients,” Berens wrote.
But it wasn’t all rosy news for Seattle Genetics in Q1, with Adcetris—until December its only approved drug, and a powerhouse with several indications—narrowly missing consensus estimates at $164.1 million.
https://www.fiercepharma.com/marketing/seattle-genetics-padcev-blows-early-sales-expectations-out-water
In its first quarter on the market after a mid-December FDA approval, the therapy “blew out expectations … exceeding consensus estimates” by four- to fivefold with $34.5 million in sales, J.P. Morgan analyst Cory Kasimov wrote in a note to clients.
Even SVB Leerink’s Andrew Berens, whose Padcev sales projection was twice as high as Kasimov’s, noted that the drug “handily beat our estimate of $10 million for the quarter, even in the midst of the pandemic.”
And the performance was no fluke, either. While other drugmakers have seen their Q1 sales boosted by some stockpiling early in the pandemic, that’s likely not what happened to Padcev, which “follows a ‘just in time’ delivery model” that sees the drug delivered as-needed, Kasimov wrote.
Berens also cited assurances from SeaGen’s leaders that many of the patients who received Padcev in Q1 are still alive and receiving therapy. Management said it “had no reason to believe this early adoption was driven primarily by a warehouse of end-stage patients which might have truncated duration of usage as has been seen with several other oncology drug launches.”
If that’s the case, “many of these Q1 patients are likely to be on the drug in Q2 given the expected duration of treatment of about 4.5 months in this setting,” Berens wrote, upping his 2020 target for the drug to $221 million and peak sales prediction in relapsed or refractory bladder cancer to $2 billion.
The thing is, SeaGen isn’t stopping there. It’s currently trying for a nod in previously untreated patients, an opportunity Berens pegs at $5.8 billion. And those SVB Leerink estimates don’t even factor in potential revenue from earlier stages of the disease, such as muscle-invasive bladder cancer (MIBC), a “sizable” market the company is pursuing with a phase 3 trial testing Padcev alongside Merck immuno-oncology powerhouse Keytruda.
“We estimate there are about 10,000 MIBC patients in the U.S., and the expected duration of therapy could be significant in these less advanced patients,” Berens wrote.
But it wasn’t all rosy news for Seattle Genetics in Q1, with Adcetris—until December its only approved drug, and a powerhouse with several indications—narrowly missing consensus estimates at $164.1 million.
https://www.fiercepharma.com/marketing/seattle-genetics-padcev-blows-early-sales-expectations-out-water
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