Hoth Therapeutics Expands IP with Novel Alzheimer's Treatment

 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced it has filed a provisional patent application with the United States Patent and Trademark Office for the use of one of its current portfolio therapeutics to treat and prevent Alzheimer's disease.  Hoth also secured an exclusive license agreement with respect to the use of this drug for other indications.

Alzheimer's disease (AD) is a progressive neurodegenerative disorder that is associated with the destruction of higher brain structures, such as those involved in memory and cognition. The disease leads to deficits in cognitive function and declines in memory, learning, language, and in the ability to perform intentional and purposeful movements. The disease is predicted to increase at least threefold between 2000 and 2050, rendering AD a world-wide public health problem.

https://www.prnewswire.com/news-releases/hoth-therapeutics-expands-intellectual-property-portfolio-with-novel-alzheimers-treatment-301234718.html

Allakos started at Overweight by Cantor

 Target $218

https://finviz.com/quote.ashx?t=ALLK

Pfizer eyes higher prices for COVID-19 vaccine after the pandemic wanes

 Amid the high-stakes fight against COVID-19, a company at the forefront of the vaccine effort is laying plans to hike prices after the crisis. A top Pfizer exec said the drugmaker aims to charge more after the "pandemic pricing environment," and an influential analyst says the company could be eying prices 3 to 4 times higher.

On an earnings call earlier this month, CFO Frank D’Amelio said that “obviously,” the company is “going to get more on price” after the “pandemic pricing environment." He was speaking in response to Bank of America Merrill Lynch analyst Jason Zemansky, who asked the management team about how profit margins for the program could change over time.

In short, D’Amelio explained that Pfizer expects its COVID vaccine margins to improve. Under one pandemic supply deal, Pfizer is charging the U.S. $19.50 per dose, D'Amelio said, which is “not a normal price like we typically get for a vaccine—$150, $175 per dose. So, pandemic pricing.”

As a specific for-instance, a dose of Pfizer's pneumococcal vaccine Prevnar 13 costs more than $200 on the private market in the U.S., according to CDC data.

Pfizer has said it expects $15 billion from its COVID-19 vaccine this year, but if the company charges higher prices after the pandemic, it could continue to reap significant sales from the product in the years to come, particularly if routine boosters are needed as variants arise. 

Even as Pfizer uses “pandemic pricing" during the crisis, the company is also paying for materials, labor, factory overhead, shipping, distribution costs and more to deliver doses, D'Amelio said. With all of its costs, "you come out with the high 20s in terms of that as a percentage of revenue," the CFO said.

Moving into the future, after the pandemic period, Pfizer is “going to get more on price,” and will increase output at its factories, driving production costs per unit lower, the CFO said. In all, D’Amelio said there’s a “significant opportunity for those margins to improve once we get beyond the pandemic environment that we're in.” 

Bernstein analyst Ronny Gal picked up on the comments and highlighted a recent report in Germany’s Sueddeutsche Zeitung in a Monday note to clients. The publication reports that Pfizer and BioNTech approached European officials seeking €54 per dose, or €27 billion for 500 million doses, last summer.

While officials negotiated the price down to €15.50 per dose, Gal suspects that all of the developments indicate a “first hint" of Pfizer's thoughts on "post-epidemic pricing." The deal, in addition to other European supply pacts, was large enough to be "at least partially ... for post-pandemic use," Gal figured.

A Pfizer representative said in a statement these are "extraordinary times, and our pricing reflects that."

"During the pandemic, we priced our vaccine consistent with the urgent global health emergency we are facing to ensure widespread vaccination for all countries," he added. During government supply negotiations, the company considers volume and equitable distribution aims, he said, and has a "tiered pricing approach that enables poorer countries to pay less."

"Moving forward, we will continue to take a thoughtful approach to pricing, balancing a number of factors—including the value of the vaccine based on the growing evidence base, and access, affordability, and sustainability considerations," he added.

In initial deals with the U.S. government, Pfizer and BioNTech's vaccine costs $19.50 per dose, compared with $15 for Moderna's shot, $16 for Novavax's program, $10 for Johnson & Johnson's vaccine and $4 for AstraZeneca's. Pfizer didn’t take any government development funds for its shot, while other players received various amounts of assistance, and Pfizer was the first to reach the market. 

The drugmaker isn’t alone in viewing vaccine pricing differently during the pandemic and afterward. Johnson & Johnson and AstraZeneca have each pledged to sell their vaccines on not-for-profit basis during the pandemic.

https://www.fiercepharma.com/pharma/pfizer-eyes-higher-covid-19-vaccine-prices-after-pandemic-exec-analyst

Germany approves COVID home tests to ease way out of lockdown

 Germany approved three COVID-19 tests for home use as part Health Minister Jens Spahn’s strategy to help Europe’s biggest economy emerge from a lockdown that has been in place since mid-December.

The infection rate in Germany fell steadily in the first weeks of the year but has stagnated in recent days, making it more difficult for leaders to ease restrictions when they meet next week to consider lockdown rules that run to March 7.

Chancellor Angela Merkel has told lawmakers in her conservative party that making rapid tests more available and boosting testing capacity could make a return to normality more durable, two sources at the meeting told Reuters on Tuesday.

The government expects such tests will cost it up to 810 million euros ($985 million) a month for 30 million to 45 million tests, according to documents obtained by Reuters.

The Federal Institute for Drugs and Medical Devices, Germany’s pharmaceutical regulator, on Wednesday approved antigen tests made by Healgen Scientific, Xiamen Boson Biotech and Hangzhou Laihe Biotech for use by people who are not medical professionals, according to its website.

Spahn told broadcaster ZDF earlier that further home test kits would be approved next week.

Other countries are also banking on home tests to help limit the spread of the virus. In Austria, self-tests are already being used in schools, and they will be available to the public for free at pharmacies from next week.

In England, volunteers and police have handed out COVID-19 testing kits to try to halt the spread of a highly infectious variant that originated in South Africa.

In Germany, the number of confirmed coronavirus cases rose by 8,007 to 2,402,818, an increase of 451 compared with a week ago. The infection rate rose to 59.3 cases per 100,000 people over the past seven days, from 57 a week earlier.

https://www.reuters.com/article/us-health-coronavirus-germany/germany-approves-covid-home-tests-to-ease-way-out-of-lockdown-idUSKBN2AO0ZW

Johnson & Johnson's one-shot COVID-19 vaccine effective, safe: FDA staff

 Johnson & Johnson’s one-shot COVID-19 vaccine appeared safe and effective in trials, U.S. Food and Drug Administration (FDA) staff said in documents published on Wednesday, paving the way for its approval for emergency use.

The FDA’s panel of independent experts meets on Friday to decide whether to approve the shot. While it is not bound to follow the advice of its experts, the FDA did so when authorizing the Pfizer Inc and Moderna Inc vaccines.

J&J’s vaccine was 66% effective in preventing COVID-19 against multiple variants in a global trial involving nearly 44,000 people, the company said last month.

Its effectiveness varied from 72% in the United States to 66% in Latin America and 57% in South Africa, where a new variant has spread, though the vaccine was 85% effective overall in stopping severe cases of the disease.

The vaccine was effective in reducing the risk of COVID-19 and preventing PCR-test confirmed COVID-19 at least 14 days after vaccination, the FDA said in its briefing documents.

Three vaccine recipients had severe side effects in the trial, but the FDA said that its analysis did not raise any specific safety concerns that would preclude issuance of an emergency use authorization.

J&J had not previously released details of its clinical trial data beyond efficacy rates.

https://www.reuters.com/article/us-health-coronavirus-vaccines-johnson-j/johnson-johnsons-one-shot-covid-19-vaccine-effective-safe-fda-staff-idUSKBN2AO1LS

CRO megamerger is back as Icon snaps up PRA Health for $12B

 After a flurry of CRO takeovers a few years back, the megamerger market went quiet. But, today, as the industry hauls itself out of the pandemic funk of 2020, Icon is getting out its checkbook in a massive $12 billion buyout of PRA Health.

The deal sees Icon stump up that sum in a cash and stock transaction, and it's around a 30% premium to PRA’s closing price as of Feb. 23. This comes after a tough year for Icon, which, in the spring last year, amid the height of the first pandemic wave, was forced to slash costs due to the COVID-19 disruptions to its business, while around a third of trial sites were hit.

It has slowly but surely got back on track, though only just: Today, alongside the buyout, it also announced its fourth-quarter and full-year financials. The former were healthy, seeing sales up 4.8% year on year to $760.2 million, and also up 8.3% on the third quarter. For the whole year, however, revenue dipped by 0.3% to $2.78 billion, with the second quarter being the biggest culprit for its losses.

But it is hoping to start 2021 on a brighter note with the PRA deal. This CRO has also struggled amid the pandemic, yanking its guidance last year, but it has also been ramping up its siteless trial offering and also launched a new mobile app aimed at tracking patients’ physical and psychological symptoms from COVID-19 as part of its response to the pandemic.

PRA also has deep ties with Takeda, and, back in 2016, 2016, the CRO and the Japanese Big Pharma said PRA would manage “an entire pipeline of studies” across all phases of clinical development for Takeda. It also agreed to provide regulatory, pharmacovigilance and other services for drugs in development as well as those already on the market. At the time, the partners expected to move about 300 Takeda employees over to PRA, which then took over pipeline development activities for Takeda in the U.S. and European markets.

But three years down the line, PRA bought out its joint venture with the Japanese pharma. Previously known as the Takeda PRA Development Center, the unit was in 2019 renamed PRA Health Sciences K.K. and is now operating in Japan as a subsidiary of PRA.

Icon sees the buyout as being “highly accretive,” delivering double-digit accretion in the first full year and growing to 20% plus thereafter “driven by growth momentum, estimated annual run-rate cost synergies of $150 million, and the combined effective tax rate decreasing to 14%, both to be realised in approximately 4 years,” it said in a statement.

“The combined company will create a new paradigm for accelerating clinical research and bringing new medicines and devices to market,” said Steve Cutler, Ph.D., CEO at Icon.

“Both ICON and PRA have track records of robust growth and performance and we are ready to build on this unrivalled position of strength, utilising the outstanding talent in both organisations. With broader and deeper operational scale combined with innovative technology and real world data solutions, we will enable all customers to reduce their development time and cost. 

“We will be the leading provider of de-centralised and hybrid trial solutions through the integration of our data capabilities, health platforms and Accellacare site network. The transaction will be highly accretive from full year 1 post-close.”

The combined company will be headquartered in Dublin, Icon’s current base. Cutler becomes chief of both companies under one umbrella, with Brendan Brennan, chief financial officer of Icon, becoming CFO for the combined CRO.

PRA’s chief and chair, Colin Shannon, will no longer run the company, moving into a board post “along with one additional board member from PRA.”

“I joined PRA 13 years ago to help build a company that would make a difference in the world and transform the way we developed new medicines,” Shannon said. “The way we do it now takes far too long and costs far too much. Critically ill patients can’t wait for cures. Underserved populations can’t wait for access.

“Every day counts. COVID-19 created a platform for change that we cannot ignore. The pandemic accelerated the adoption of mobile health technologies and healthcare intelligence tools—tools that PRA helped develop—at an unprecedented rate. The union of PRA and ICON will create an organization that has the people, data and technology to bring those cures to patients faster and more efficiently than ever before.”

https://www.fiercebiotech.com/cro/cro-mega-merger-back-as-icon-snaps-up-pra-health-for-12-billion

Bausch Health to add two directors from Icahn Group

 Bausch Health Companies Inc BHC.TO said on Wednesday it will add two directors from Icahn Group to its board, including Carl Icahn's son Brett, weeks after the activist investor disclosed a nearly 8% stake in the Canadian drugmaker.

With the latest appointment of Bret Icahn and Steve Miller, both portfolio managers at Icahn Capital LP, the size of Bausch Health's board will increase to 13 members.

The new members will be appointed to board committees - the finance and transactions committee and the committee assisting with evaluating strategic alternatives, including the potential spin of Bausch's eye health business.

https://www.nasdaq.com/articles/bausch-health-to-add-two-directors-from-icahn-group-to-board-2021-02-24