Search This Blog

Sunday, November 22, 2020

Moderna to charge $25-$37 for COVID-19 vaccine: CEO

 

Moderna will charge governments between $25 and $37 per dose of its COVID-19 vaccine candidate, depending on the amount ordered, Chief Executive Stephane Bancel told German weekly Welt am Sonntag (WamS).

"Our vaccine therefore costs about the same as a flu shot, which is between $10 and $50," he was quoted as saying.

On Monday, an EU official involved in the talks said the European Commission wanted to reach a deal with Moderna for the supply of millions of doses of its vaccine candidate for a price below $25 per dose.

"Nothing is signed yet, but we're close to a deal with the EU Commission. We want to deliver to Europe and are in constructive talks," Bancel told WamS, adding it was just a "matter of days" until a contract would be ready.

Moderna has said its experimental vaccine is 94.5% effective in preventing COVID-19, based on interim data from a late-stage clinical trial, becoming the second developer to report results that far exceeded expectations after Pfizer and its partner BioNTech.

The EU has been in talks with Moderna for its experimental COVID-19 vaccine at least since July.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-to-charge-25-37-for-COVID-19-vaccine-CEO-tells-paper-31842595/

VC firm SR One completes GSK spin-out, raising $500m

 Trans-Atlantic biotech venture capital firm SR One has completed its spin-out from GlaxoSmithKline and closed its first fund with $500m in its coffers.

The VC built itself a considerable reputation after it was founded in 1985 and works with entrepreneurs and scientists to build biotechnology companies.

GSK is the largest investor in the independent fund, which said it is the largest first-time VC fund to close in 2020 focused on US and European biotechs.

CEO Simeon George will lead the company’s investment team, bringing more than a decade’s worth of experience in the sector.

George has been with the fund since 2007 and established its San Francisco office in 2010.

He earned his MD and MBA from the University of Pennsylvania School of Medicine/Wharton and BA from Johns Hopkins University.

Previously, he worked in management consulting (Bain & Co.) and investment banking (Goldman Sachs) and has led some of SR One’s highest profile investment deals.

These include CRISPR Therapeutics and Principia Biopharma, which was recently acquired by Sanofi for $3.7 billion, Turning Point Therapeutics, Progyny and Nkarta Therapeutics, which he co-founded.

David Redfern, chief strategy officer at GSK, said: “Since inception, SR One’s mandate has been to deliver financial returns by investing in innovative biotechnology companies.

“Following SR One’s spin-out from GSK and establishment as an independent fund management business, GSK has remained a committed investor in SR One’s new independent fund, alongside a diversified and top tier investor base.

“The close of the fund at the hard cap and its over-subscription by global investors underscore the team’s abilities and strong track record.”

CEO Simeon George said: “Our spin-out from GSK and successful raise of a new independent fund provide a foundation for SR One’s next chapter, enabling us to scale our investment strategy and build upon our track record of success.”

It’s been a busy time for life sciences VC, with the likes of Canaan Partners, Atlas Venture creating new funds amid the investment boom in life sciences amid the COVID-19 pandemic.

https://pharmaphorum.com/news/vc-sr-one-completes-gsk-spin-out-raising-500m/

Biotech week ahead, Nov. 23

 Biotech stocks came under pressure in the week ended Nov. 20, reversing course from the previous week. The sector started the week on a strong note, thanks to positive vaccine data reported by Moderna Inc 

MRNA 5.22%.

The momentum faltered through the week after the broader market came under pressure amid fresh COVID-19 restrictions.

Earnings news flow slowed considerably. On the regulatory front, Sanofi SA SNY 0.71% was handed a complete response letter for its sutimlimab biologics license application. "The CRL refers to certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing," the company said in a release. Sutimlimab is an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease. Alkermes Plc ALKS 0.39% also faced a rejection, with the FDA turning down the regulatory application for its schizophrenia drug.

Meanwhile, Eli Lilly And Co LLY 1.47% received FDA approval for the emergency use of its in-licensed arthritis drug to treat COVID-19. The FDA also approved the first at-home COVID-19 diagnostic test during the week.

Notable news of the week included the decision by Pfizer Inc. PFE 1.35% and BioNTech SE – ADR BNTX 9.63% to file for emergency use authorization Friday. This increases the possibility of limited approval coming before the year end.

Conferences

Piper Sandler 32nd Annual Virtual Healthcare Conference: scheduled for Dec. 1-3; pre-recorded "fireside chat" by participating companies will be made available from Monday (Nov. 23).

PDUFA Dates

The FDA is scheduled to rule on Roche Holdings AG'RHHBY 0.57% two sNDAs for its next-gen flu medication Xofluza. The company is seeking approval for an additional formulation of Xofluza — oral suspension granules for people with influenza who are age one or older — and another for post-exposure prophylaxis. (Monday)

Liquidia Technologies Inc LQDA 7.65% awaits FDA word on its NDA for LIQ861, an investigational, inhaled dry powder formulation of Treprostinil for the treatment of pulmonary arterial hypertension. (Tuesday)


Revance Therapeutics Inc's RVNC 1.6% regulatory application for Daxi in the treatment of moderate to severe glabellar, or frown, lines has a FDA decision date of Nov. 25. (Wednesday)

The FDA is also expected to announce its verdict on Rhythm Pharmaceuticals Inc's RYTM 2.11% new drug application for setmelanotide in genetically-induced obesity. (Friday)

Earnings

  • Twist Bioscience Corp TWST 0.93% (Monday, before the market open)
  • Arrowhead Pharmaceuticals Inc ARWR 0.17% (Monday, after the close)
  • Enanta Pharmaceuticals Inc ENTA 1.31% (Monday, after the close)
  • Medtronic PLC MDT 0.78% (Tuesday, before the market open)
  • China Biologic Products Holdings Inc CBPO 0.21% (Tuesday, after the close)

Other Events

Moderna could announce final Phase 3 data for its mRNA vaccine candidate mRNA-1273, and then apply for emergency use authorization.

IPO Quiet Period Expiry

Are COVID-19 vaccines developed in record time safe?

 There are now two COVID-19 vaccines that, at least according to preliminary reports, appear to be 94.5% and 95% effective. Both were developed in a record-breaking 11 months or so.

I am an infectious diseases specialist and professor at the University of Virginia. I care for patients with COVID-19 and am conducting the local site for a phase 3 clinical trial of Regeneron's antibody cocktail as a tool to prevent household transmission of COVID-19. I'm also conducting research on how dysregulation of the immune system during SARS-CoV-2 infection causes lung damage.

Despite the vaccines' relatively rapid development, the normal  testing protocols are still in place.

How long does most vaccine development take?

Vaccines typically take at least a decade to develop, test and manufacture. Both the chickenpox vaccine and FluMist, which protects against several strains of the influenza virus, took 28 years to develop. It took 15 years to develop a  for human papilloma virus, which can cause six kinds of cancer. It also took 15 years to develop a vaccine for rotavirus, which commonly causes severe, watery diarrhea. It took Jonas Salk six years to develop and test the first polio vaccine, starting with the isolation of the virus.

The Pfizer-BioNTech and the Moderna COVID-19 messenger RNA vaccines, by contrast, have been developed in less than a year. That's a game-changer.

How was this vaccine developed so quickly?

The mRNA vaccines produced by Pfizer and Moderna are faster to develop as they do not require companies to produce protein or weakened pathogen for the vaccine.

Traditional vaccines typically use a weakened version of the pathogen or a protein piece of it, but because these are grown in eggs or cells, developing and manufacturing vaccines takes a long time. By contrast, by using just the genetic material that makes the Spike glycoprotein—the protein on the surface of the  that is essential for infecting human cells—the design and manufacture of the vaccine is simplified.

The  mRNA is easy to make in a laboratory. Manufacturing an mRNA vaccine rather than a protein vaccine can save months, if not years.

Another factor that accelerated vaccine development was the swift and efficient recruitment of patients for .

How is safety assured when vaccine development is so fast?

Safety is the first and foremost goal for a vaccine.

In my opinion, safety is not compromised by the speed of vaccine development and emergency use authorization. The reason that vaccines may be approved so quickly is that the large clinical trials to assess vaccine efficacy and safety are happening at the same time as the large-scale manufacturing preparation, funded by the federal government's Operation Warp Speed program.

Typically, large-scale manufacturing begins only once the vaccine has been tested in clinical trials. In the case of COVID-19, the U.S. government wanted to be ready to begin distributing the vaccine the moment the results of the phase 3 trials were known and the safety data had been analyzed.

To this end, the pharmaceutical companies launched at-risk manufacturing—which means that the manufactured vaccine doses would be thrown away if the vaccine was ineffective or unsafe – during the FDA-mandated two-month safety waiting period.

The upside is that if the vaccine is safe and effective, it can be distributed immediately, and vaccination can begin.

Are these vaccines riskier than others?

No mRNA vaccines have been approved before because it is relatively new technology.

But these mRNA vaccines appear safe and no riskier than other tried and tested ones, like the childhood measles vaccine. To date, no significant side effects have been reported in the interim phase 3 studies of the Moderna and Pfizer vaccines.

Side effects that have been reported are minor things that one would expect with any vaccine, including soreness at the site of injection and transient fatigue, muscle or joint aches.

How will EUA work?

EUA stands for emergency use authorization.

Under EUA, the FDA is requiring that a COVID-19 vaccine be at least 50% effective at preventing symptomatic illness.

It is also requiring a median of two months of follow-up after completion of the vaccination for half of the vaccine recipients (for most of the vaccines this is two doses). This two-month period is to allow detection of an adverse event from the vaccine.

https://medicalxpress.com/news/2020-11-covid-vaccines-game-changers-safe.html

Saturday, November 21, 2020

Every Sheriff In LA Region Refuses To Enforce Gov's COVID Curfew

 Sheriffs in 5 Southern California counties with a total population of 17.25 million people – equivalent to the fifth most populous state – are defying that state’s governor. They will not arrest people for violating the statewide curfew that Governor Gavin Newsom has imposed starting today, apparently on the belief that the virus wakes up, and goes out at 10 PM.

Bill Melugin of KTTV, Fox 11 in Los Angeles (hat tip: Breitbart) contacted them about enforcing the statewide curfew:

We’ve now heard from every Sheriff in our SoCal viewing area. San Bernardino, Orange, Ventura, & Riverside Counties will not actively enforce the curfew order. LA Sheriff will take a voluntary compliance/education first approach, will not make any arrests related to order @FOXLA


We’ve heard from the Sheriffs, we are now starting to hear from from city police departments about the curfew. Ontario and Laguna Beach PDs say they will NOT actively enforce the order, seeking voluntary compliance. Costa Mesa and Irvine PDs WILL take part in enforcement.


Newsom has lost all credibility for restricting activity in the name of suppressing the spread of Covid.  He was caught and exposed flouting his own ridiculous strictures on eating in restaurants (put your mask back on between bites of food).  Public exposure of his mask-less attendance at a party full of lobbyists at one of the fanciest restaurants in the world with no social distancing was bad enough. But his subsequent lying, smirking  non-apology apology may well be the death knell for his political career.

Other sheriffs in Northern California, including Sacramento County, where the Governor now lives, are also refusing to enforce the curfew.

Newsom is facing an existing recall effort, with a deadline of March 17, 2021 to collect 1,495,709 valid signatures. In practice, because some signatures will be challenged, at least 1,700,000 signatures will be required to get the recall election on the ballot. According to Rescue California, which is sponsoring the recall effort, there is already a running start:

In a telephone conversation with Paul Olson on November 18, whose company, GoCo Consulting, is doing the petition verification for the recall, he confirmed that his firm has already processed 494,000 signed petitions which have either just been turned in or are now being delivered to the county clerks around the state. Olson also confirmed that his firm is currently processing another 230,000 signatures.

When combined with the 55,000 that were turned in earlier in the year, and the ones already signed but still being delivered, conservatively estimated at 60,000, this campaign has already collected over 800,000 signed recall petitions.

Californians may go here and download hard copies of the recall petition and obtain up to 5 signatures for each copy, for submission.

Californians have already recalled one governor, Gray Davis, which ended his political career. Newsom, who long has had his sights on the Oval Office, and who is related by marriage to Nancy Pelosi, is now the focus of public resentment over arbitrary restrictions in the name of Covid. It is a status he has earned.

https://www.zerohedge.com/political/every-sheriff-la-region-refuses-enforce-gavin-newsoms-covid-curfew 

FDA grants emergency use OK to Regeneron COVID-19 antibody given to Trump

 The U.S. Food and Drug Administration on Saturday issued emergency use authorization for Regeneron Pharmaceuticals Inc’s COVID-19 antibody therapy, an experimental treatment given to U.S. President Donald Trump that he said helped cure him of the disease.

The FDA said the monoclonal antibodies, casirivimab and imdevimab, should be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.

This includes those who are 65 years of age or older or who have certain chronic medical conditions.

The agency said the antibodies are not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19. A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalized due to COVID-19.

https://www.reuters.com/article/us-health-coronavirus-regeneron-pharms-f/u-s-fda-grants-emergency-use-authorization-to-regeneron-covid-19-antibody-given-to-trump-idUSKBN28201L

Controlling the Pandemic: Keep It Simple

 Presumptive President-Elect Joe Biden’s transition organization has published an initial plan to “beat” the rapidly worsening Covid-19 pandemic. Though it is essential and not wholly unreasonable, some parts seem to have been highjacked by a political agenda that contains tangentially related issues. The plan’s sole focus should be on the difficult and complex problem of interrupting the runaway pandemic while maintaining a viable economy. It needs a sensible organizational structure to use the available and prodigious federal, state, local, and private resources efficiently.

Some of the plan’s proposals seek to address non-pandemic-specific problems, using Covid-19 as an action-forcing and funding device—for example, the formation of a “Covid-19 Racial and Ethnic Disparities Task Force,” which, post-pandemic, would become “a permanent Infectious Disease Racial Disparities Task Force.” This issue is already on the agenda of various federal agencies and need not be recapitulated in the context of the pandemic.

In other respects, as well, the plan reinvents the proverbial wheel (at significant expense). For example, it proposes a new U.S. Public Health Jobs Corps that would hire 100,000 new employees (nine times the number currently at the Centers for Disease Control and Prevention) to trace contacts of infected persons, so that they could be quarantined. With numbers of infections currently out of control in much of the United States—on November 16, the seven-day moving average of cases was more than 157,000—track, trace, and quarantine is not now feasible. There are already too many cases, too many possible contacts, too little public cooperation, and insufficient numbers of tests with the necessary accuracy and speed. Moreover, with widespread vaccination expected to be in progress by about the middle of 2021, the need for active contact tracing will eventually be substantially reduced.

Instead of this new, massive bureaucracy, we should rely on existing federal, state, and local resources. In this large and diverse country, public health is primarily addressed at the state and local levels, where enhanced capacity to track and trace would build competence for this pandemic and other future needs. This does not mean that there should be no federal role; Department of Health and Human Services agencies, including the CDC, can offer guidance and, perhaps, coordination. In addition, the Biden administration will need to develop a coherent organizational structure that includes the White House and all involved federal departments and agencies and designate qualified personnel to implement the plan.

Biden has announced an ambiguous coronavirus advisory board, with 13 members, including three co-chairs. Its members’ expertise suggests that the group will be focused primarily on public-health issues. It’s unclear to whom it will report, and whether it is advisory or operational; and if operational, which programs and agencies it would oversee. According to the president-elect, “The advisory board will help shape my approach to managing the surge in reported infections; ensuring vaccines are safe, effective, and distributed efficiently, equitably, and free; and protecting at-risk populations.” However, an article in the Washington Post suggests a possible operational role: “The task force will have subgroups that focus on issues related to the response, including testing, vaccine distribution and personal protective equipment.”

Biden also needs to determine whether the interagency Operation Warp Speed initiative, primarily concerned with accelerating the development and distribution of Covid-19 vaccines, will continue, and whether its remit will expand to address more than vaccine development and logistics. Testing to diagnose active infections in individuals and to ascertain the penetrance of Covid-19 in the population has been a significant failure in U.S. prevention and suppression efforts. In order to slow the spread, OWS should refine the various kinds of tests, make them widely available and accurate with results reported rapidly, and establish paradigms for their optimal use. Likewise, OWS or an equivalent should oversee the development and stockpiling of important materiel such as personal protective equipment (PPE), which is inexpensive and highly effective at preventing Covid-19 infection, and which remains in short supply in many places. Even this far into the pandemic, we have not had clear, useful guidance and standards from federal officials or other sources about which masks and other PPE work best.

Now that the distribution of two vaccines appears near, the plan should include an urgent, aggressive public education campaign to promote vaccine use and also to reinforce the continuing need for the basic, low-tech pillars of Covid-19 prevention: masks; physical distancing; frequent hand-washing; and avoidance of crowded venues, especially indoors. Without success on both those fronts, the plague will continue.

Suppressing the pandemic is complicated and will require a multifaceted effort. But at the same time, we would urge the KISS—Keep It Simple, Stupid—approach to implementing the plan, lest the effort become so complex and ponderous that constructing it, rather than controlling the pandemic, becomes the goal.