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Sunday, August 16, 2020

CureVac aims to make reasonable profit on COVID-19 vaccine

Ruling out selling its mRNA-based COVID-19 vaccine at cost, if approved, fresh IPO CureVac (NASDAQ:CVAC) says it plans on earning an “ethical” profit margin based on a competitive price.

CFO Pierre Kemula declined to disclose what the expected margin will be but said the unit price will be dose-dependent not cost-related.

Rival COVID-19 vaccine developers AstraZeneca (NYSE:AZN) and the University of Oxford have floated $3 – 4 per dose for their offering while Johnson & Johnson’s (NYSE:JNJ) will be $10 per dose, reflecting their previously stated commitment not to profit from their respective vaccines during the pandemic. Fellow mRNA vaccine developer Moderna (NASDAQ:MRNA) has priced some of its shots at $74 per course.

Talks between the EU and company for a committed supply of product are in process.

Earlier this year, the German government invested €300M in the company, representing a 23% stake, aimed at blocking any foreign takeover attempt.

The company is working with Tesla Grohmann Automation, a subsidiary of the electric car maker, to develop RNA printers to help manufacture the vaccine. At present, there are eight prototypes, each capable of making 0.5 gm per week.


UAE, Israeli companies in ‘strategic commercial agreement’ on covid R&D

The Emirati APEX National Investment company signed a “strategic commercial agreement” with Israel’s Tera Group to cooperate on research and development related to COVID-19, including a testing device, the UAE’s state news agency WAM said late on Saturday.

The deal “is considered the first business to inaugurate trade, economy and effective partnerships between the Emirati and Israeli business sectors, for the benefit of serving humanity by strengthening research and studies on the novel Coronavirus,” WAM quoted APEX’s chairman Khalifa Yousef Khoury as saying.

The agreement was signed at a press conference in Abu Dhabi, coming soon after Israel and the UAE announced an agreement on Thursday that will lead to a full normalization of diplomatic relations between the two states.

“The United Arab Emirates and Israel will immediately expand and accelerate cooperation regarding the treatment of and the development of a vaccine for the coronavirus,” the two countries said on Thursday in a joint statement.

U.S. President Donald Trump helped broker the deal, under which Israel agreed to suspend its planned annexation of areas of the occupied West Bank.

Delegations from Israel and the United Arab Emirates will meet in the coming weeks to sign agreements regarding investment, tourism, direct flights, security, telecommunications and other issues, the joint statement said.

“TeraGroup’s BioSafety testing is conducted in selected countries around the world, including the Emirates Field Hospital in Abu Dhabi, with plans to expand the testing to cover the entire UAE,” WAM said.

In June, the UAE had said two private companies from the United Arab Emirates and two Israeli companies would work together on medical projects, including ones to combat the new coronavirus.

Two state-owned Israeli defense contractors in July announced partnerships with Abu Dhabi-based technology company Group 42 to develop technologies to help fight the new coronavirus.


Interest in homeschooling has ‘exploded’ amid pandemic

“We just saw that with her wearing a mask for the entire day, that would make learning more difficult for her,” she said. “It was going to be such a different environment. We didn’t think it would be as beneficial for her.”

Homeschooling applications are surging in states including Nebraska, where they are up 21%, and Vermont, where they are up 75%. In North Carolina, a rush of parents filing notices that they planned to homeschool overwhelmed a government website last month, leaving it temporarily unable to accept applications.

There were about 2.5 million homeschool students last year in grades K-12 in the U.S., making up about 3% to 4% of school-age children, according to the National Home Educators Research Institute. Brian Ray, the group’s president, is anticipating that their numbers will increase by at least 10%.

“One day the school district says X and four days later they say Y,” Ray said. “And then the governor says another thing and then that changes what the school district can do. And parents and teachers are tired of what appear to be arbitrary and capricious decisions. They are tired of it and saying we are out of here.”

Interest in homeschooling materials also has been surging, driven in part by parents who are keeping their children enrolled in schools but looking for ways to supplement distance learning.

The National Home School Association received more than 3,400 requests for information on a single day last month, up from between five and 20 inquiries per day before the coronavirus. The group had to increase the size of its email inbox to keep up.

“Clearly the interest we have been getting has exploded,” said J. Allen Weston, the executive director of the suburban Denver-based group. “That is really the only way to describe it.”

Some parents in rural parts of Nebraska are turning to homeschooling because staffing and limited access to home internet leave districts unable to offer a virtual learning option, said Kathryn Dillow, president and executive director of Nebraska Home Schools, a support and advocacy group.

Homeschooling applications continue arriving in Nebraska, where the number of homeschoolers already had risen to 3,400 as of July 14, up from 2,800 at the same time a year ago, said David Jespersen, a spokesman for the Nebraska Department of Education.

Jespersen said there is “a lot of confusion” and that “parents are delayed in making their decision” because so much is changing.

Regardless of the final number, Jespersen doesn’t expect that the increase will bust districts’ budgets because homeschoolers will still remain a small fraction of about 326,000 students spread over the state’s 244 school systems.

Most other states don’t have homeschooling numbers, either because they aren’t collected at the state level or it’s too early. But all indications point to increases across the country.

“Now is when the reality sets in,” said John Edelson, president of Time4Learning, an online curriculum provider, which has seen business explode. “People have postponed the decision, but we are at this great inflection point. And it is hard to see what the angle is going to be, but it is definitely up.”

In Missouri, calls and emails pour into the homeschool advocacy group Families For Home Education each time a district releases its reopening plan, said Charyti Jackson, the group’s executive director. She said families are in a “panic” about virtual starts to the year and hybrid plans in which students attend classes parttime and study at home the rest.

“They are asking, ’What am I supposed to be doing with my children when I am working full time?’” she said.

For the families who only plan to homeschool for a semester or two, some in small groups or pods, her advice is focused on how to make sure students can transition back to public schooling smoothly when the pandemic ends. That’s trickier for students who receive special education services and high schoolers who need to meet their district’s graduation requirements.

There also are some indications the exodus to homeschooling could continue well into fall. Christina Rothermel-Branham, a psychology and counseling professor at Northeastern State University in Tahlequah, Oklahoma, said she is going to attempt remote learning through her local school district for her 6-year-old son. But she said the virtual learning she oversaw in the spring was “very monotonous” and that she plans to switch to homeschooling if the first month goes poorly.

“If there is a lot of stress between the two of us it is probably going to get him pulled out,” she said.

Rothermel-Branham, 39, already has scouted out curriculum as a backup and has signed up for art and music classes through Outschool, an online learning platform that is reporting 30 times year-over-year growth since March.

“It is such a big mess,” said Outschool CEO Amir Nathoo. “A lot of schools spent all summer preparing for a social distanced reopening and now it looks like that isn’t going to happen because of the virus.”

He said the demand for classes has been particularly strong in states that moved aggressively to reopen, including Texas, Florida, Georgia and Arizona.

Chris Perrin, the CEO of Camp Hill, Pennsylvania-based Classical Academic Press, said curriculum sales to homeschoolers are up by 50% and that enrollment in its online Scholé Academy has increased by 100% amid the pandemic. He said some there was “understandably a lot of bad online learning” in the spring and that some parents were “appalled” as they oversaw it.

“They are saying I can’t stand by and do nothing,” Perrin said. “So they are becoming homeschoolers.”


Recurrence of SARS‐CoV‐2 infection with a more severe case after mild COVID‐19


First published: 14 August 2020



Abstract


In general, SARS‐CoV‐2 replication in the host reaches its peak in the first week of infection, decreasing rapidly afterwards, while some level of immunity is build up. Yet, the infection seems to follow a distinctive course in some individuals, reactivating after the apparent resolution of symptoms1‐3. We report here the first case to be disclosed of a more vigorous COVID‐19 recurrence with SARS‐CoV‐2 RNA redetection and late antibody response, and also the first to address COVID‐19 recurrence in Brazil.


Biotech week ahead, Aug. 17

Biotech stocks came under pressure in the week ended Aug. 14 amid mixed earnings news flow from the sector. FDA decisions scheduled for the week also produced adverse outcomes. Eagle Pharmaceuticals Inc EGRX 0.15% and Fennec Pharmaceuticals Inc FENC received complete response letters for their respective regulatory applications, while a decision on Eton Pharmaceuticals Inc’s ETON 5.67% eye inflammation drug hadn’t come by the Aug. 10 decision date.

The week, however, saw a signing spree by coronavirus vaccine developers, which stitched up manufacturing as well as supply deals.

Here are the key catalysts for the unfolding week.

Conferences

Virtual Keystone Symposia: Advances in Cancer Immunotherapy: Aug. 17-19

PDUFA Dates

Gilead Sciences, Inc. GILD 0.47% and licensing partner GALAPAGOS NV/S ADR GLPG 3.59% await FDA decision on the NDA for filgotinib in moderate-to-severe rheumatoid arthritis. (estimated date of Wednesday, Aug. 19, assuming priority review)

The FDA is set to rule on BioMarin Pharmaceutical Inc.’s BMRN 1.1% BLA for valoctocogene roxaparvovec, its investigational AAV5 gene therapy for treating adults with hemophilia A. (Friday)

Tricida Inc TCDA 0.42% has a Aug. 22 PDUFA date for the NDA for its TRC 101, a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease. With FDA’s communication to the company in mid-July, stating that it has identified deficiencies in the application, it is less likely the investigational drug is approved by the D-day. (Saturday)

Earnings

Monday

Milestone Scientific Inc. MLSS 3.63% (before the market open)
China Biologic Products Holdings Inc CBPO 0.97% (after the close)
Precipio Inc PRPO 0.94% (after the close)

Tuesday

ADC Therapeutics SA ADCT 6.02% (before the market open)
PAVmed Inc PAVM (after the close)
Supernus Pharmaceuticals Inc SUPN 3.43% (after the close)

IPOs

La Jolla, California-based InhibRx, a clinical-stage biotechnology company with a pipeline of novel biologic therapeutic candidates, with particular focus on oncology, has filed with the SEC to offer 6 million shares of its common stock at an estimated price range of $16-$18. The company said in the filing it has applied to list its shares on the Nasdaq under the ticker symbol INBX.

Harmony Biosciences Holdings Inc, a Plymouth, Pennsylvania-based commercial-stage pharmaceutical company focused on innovative therapies for patients living with rare neurological disorders, has filed with the SEC to offer 4.651 million shares of its common stock. The estimated price range for the offering is $20-$23. The company has applied for listing its shares on the Nasdaq under the ticker symbol HRMY.

IPO Quiet Period Expiry

Nurix Therapeutics Inc NRIX 4.37%
iTeos Therapeutics Inc ITOS 1.65%
Inozyme Pharma Inc INZY 1.5%
Annexon Inc ANNX 5.22%


CureVac doesn’t rule out accelerated approval for COVID-19 vaccine August 16, 2020

German biotechnology firm CureVac does not rule out a speedy approval process for its prospective vaccine against COVID-19, its chief executive was quoted as saying on Sunday.

The company said on Friday that it expects to put its vaccine on the market by mid-2021. Obtaining speedy approval suggests the company is pushing for an earlier release date although CEO Franz-Werner Haas did not give any details on how likely this was.

“We are not ruling out accelerated approval, but this can only be achieved in close cooperation with the authorities,” Haas told the Boerse Online financial website.

CureVac, backed by Microsoft founder and billionaire Bill Gates, listed on the Nasdaq stock market on Friday, raising $213 million.

The results of the recently started clinical trials of the company’s prospective vaccine are to be published in autumn, Haas said, reiterating that at the moment approval was expected in the first half of next year.

CureVac is researching how to use molecules carryinga specific genetic code called messenger RNA (mRNA) to treat aseries of diseases, including COVID-19.

By using messenger RNA, researchers hope they can compel apatient’s own body to create proteins that can play an importantrole in combating disease.

“We see a deeper and broader understanding in the United States that the mRNA technology we use has the potential to quickly develop an effective and efficient vaccine,” Haas said.


UnitedHealthcare spurns Gilead’s newer PrEP drug Descovy as Truvada generic looms

UnitedHealthcare has a history of limiting HIV drug costs, including offering cash incentives to patients who opt for low-priced regimens. Now, in a potentially major blow to HIV giant Gilead Sciences, the insurer has set its eyes on one of the California drugmaker’s new therapies.

Gilead’s new HIV PrEP option, Descovy, will no longer be covered by UnitedHealthcare starting next month, as the company’s old stalwart Truvada is slated to go generic, MedCity News reported, citing a notice the insurance supplier sent to its plan members.

Those who still wish to get Descovy as a PrEP med will have to seek prior authorization, a process through which the insurer will review whether the drug is indeed necessary for a patient. By contrast, generic Truvada will be offered at no out-of-pocket cost once it becomes available on Sept. 30, according to MedCity.

The decision, from such a big insurer as UnitedHealthcare, could be a blow to Gilead’s booming PrEP business, which the Big Biotech’s been busy securing by switching existing Truvada takers to Descovy ahead of the generic entry.

The FDA approved Descovy to prevent HIV last October. The drug, which combines a different version of tenofovir with emtricitabine, boasts a better kidney and bone toxicity profile than Truvada does, though studies showed no efficacy difference between the two drugs.

That better safety profile is Descovy’s main selling point, and Gilead has priced the two drugs with the same $1,758-per-month list tag. But SVB Leerink analyst Geoffrey Porges, calling the two products’ differences “modest,” previously noted that winning payer coverage for Descovy in PrEP could be challenging and warned that patients might transition back to Truvada upon generic arrival.

So far, the newer therapy has attracted new patients as Gilead planned. In the first half of 2020, Descovy sales in the U.S. jumped 46% year-over-year to $700 million, driven by increased use in PrEP. Meanwhile, Truvada’s U.S. sales dropped 38% to $753 million during the same period. The company has converted 43% of PrEP takers to Descovy, Gilead Chief Commercial Officer Johanna Mercier said on a conference call last month. Both Truvada and Descovy can also be paired with another drug in the HIV treatment setting.

Now UnitedHealthcare’s decision to favor low-cost generic Truvada could blunt Descovy’s growth trajectory. Through a patent deal with Gilead, Teva is set to launch its copycat in the U.S. on Sept. 30.

This is not the first time Gilead has felt the burn from a new policy by UnitedHealthcare. In 2018, the insurer rolled out the My ScriptRewards program, which offered patients up to $500 in prepaid debit cards to use toward other medical expenses if they choose a recommended lower-cost HIV regimen, which they could get at a pharmacy for no out-of-pocket cost. Select HIV antivirals by GlaxoSmithKline and Merck & Co. were the first medications included in that cost-savings program, whereas Gilead’s offerings were left out.

Generic Truvada and a Descovy rejection from UnitedHealthcare are not the only problems Gilead’s PrEP business could be facing. GSK recently showed its long-acting injectable cabotegravir, given every two months, cut HIV acquisition by 66% over daily oral Truvada in a phase 3 trial. The British pharma, through its HIV-focused subsidiary ViiV Healthcare, plans to file for FDA approval in early 2021.