FDA chief: Hydroxychloroquine use a decision between doctor and patient

Stephen Hahn, the commissioner of the Food and Drug Administration (FDA), on Thursday declined to take a definitive stance on whether people should take hydroxychloroquine as a treatment for the coronavirus, instead saying that decision should be made between a doctor and a patient.

“We had data that when this drug was combined with others, there was some risk associated with that. But the question you’re asking me is a decision between a doctor and a patient,” Hahn said on NBC’s “Today” show.

“A doctor and a patient need to assess the data that’s out there, FDA does not regulate the practice of medicine, and that in the privacy of the doctor-patient relationship is where that decision should be made.”

Hydroxychloroquine was thrust back into the news this week after President Trump doubled down on his support for the drug in spite of medical evidence questioning its efficacy as a treatment for COVID-19 and raising concerns over possible side effects.

“It’s safe. It doesn’t cause problems. I had no problem. I had absolutely no problem,” Trump told reporters Tuesday at the White House, referencing his own use of the drug for 14 days earlier this year. “It didn’t get me, and it’s not going to, hopefully, hurt anybody.”

“Many doctors think it’s extremely good, and some people don’t,” he added. “I think it’s become very political.”

The president also praised a doctor who appeared in a video he retweeted this week that praised the controversial drug as a COVID-19 treatment and said people don’t need the wear masks. The video has since been removed from several platforms for violating misinformation policies.

The president’s remarks flew in the face of warnings from health officials. The FDA withdrew an emergency authorization last month over growing evidence from several trials showing the drug is not effective at treating COVID-19 and can possibly harmful side effects, including heart rhythm irregularities.

“The overwhelming prevailing clinical trials that have looked at the efficacy of hydroxychloroquine have indicated that it is not effective in coronavirus disease,” Anthony Fauci, the nation’s leading infectious disease expert, said on “Good Morning America” Tuesday.

https://thehill.com/policy/healthcare/509733-fda-chief-hydroxychloroquine-use-a-decision-between-doctor-and-patient

Teva, Takeda shed generics, plant in Japanese venture reshuffle

Israeli drugmaker Teva and Japan’s Takeda have undergone separate, yearslong cutback sprees, looking to slice away a range of underperforming assets. Now, the two drugmakers will take a scalpel to their joint venture in Japan as they continue to hunt for savings.

Teva and Takeda’s Japanese venture will offload most of its generics portfolio and a manufacturing site to Nichi-Iko Pharmaceutical as the partners “shift focus” to a smaller core of specialty drugs and targeted generics, Teva said Thursday.

The strategic shift follows an “in-depth review of market opportunities” five years after the joint venture’s launch, Teva said. The partners plan to close the sale by early 2021.

Teva didn’t specify how much of the venture’s portfolio would be sold off but did say the partners would retain around 20 small-molecule generic drugs and “several” pipeline assets. The two companies will also market a range of specialty drugs and authorized generics.

The joint venture downsizing comes months after Teva wrapped up a multiyear restructuring that closed down facilities around the globe and cut around 13,000 jobs.

By December, Teva had not only sliced away those employees. It had also either shut down, sold or earmarked for disposal 23 manufacturing sites and shuttered 40 offices and laboratories.

That $3 billion scale-back plan was the centerpiece of Teva’s new strategy under CEO Kåre Schultz, enticed away from Lundbeck in November 2017 to help steer the ship after years of disastrous financial leadership.

Meanwhile, Takeda has also been shedding assets in recent years, selling off whole swaths of commercial medicines to hit its goal of cutting annual operating costs and retiring debt it took on to buy Shire in January 2019.

Most recently, Takeda said in June it would sell 18 over-the-counter and prescription drugs marketed in the Asia-Pacific region to South Korea’s Celltrion for $278 million.

The portfolio generated sales of about $140 million in the fiscal year ended in March 2019, mainly driven by DPP-4 diabetes drug Nesina and hypertension med Edarbi, Takeda said at the time.

Previously, Takeda sold noncore assets in the Russia-CIS region to Germany’s Stada and in the Middle East and Africa region to Swiss firm Acino. It also penned deals to offload products in Latin America to Hypera Pharma and in Europe to Orifarm Group. Plus, it handed Shire’s eye drug Xiidra to Novartis in exchange for up to $5.3 billion.

The money raised goes toward Takeda’s $10 billion selloff goal, aimed at reducing the debt load from the $59 billion Shire takeover. Takeda was said to be working on selling its own consumer health unit in Japan, Nikkei Asia Review reported in April, which the drugmaker had pegged at a value of $3.72 billion.

https://www.fiercepharma.com/pharma/teva-takeda-offload-generics-manufacturing-plant-japanese-joint-venture-reshuffle

COVID-19 gear sales helps HanesBrands smash past revenue consensus

HanesBrands (NYSE:HBI) is up 8.27% premarket after posting a massive Q2 revenue beat of $570M on revenue of $1.74B.

Sale of face masks and medical gowns contributed $752M in the revenue during the quarter, establishing a new protective garments business line. Online channel posted 68% sales growth.

Adj Net income increased 41% to $305M or $0.60 per share; net cash from operations of $65M; year-to-date operating cash flow $40M better than a year ago

2020 Guidance: The company expects to sell over $150M of protective garments in 2H20, excluding potential for additional government contracts. Further expects to generate positive cash flow in H2.

https://seekingalpha.com/news/3597694-covidminus-19-gear-sales-helps-hanesbrands-smash-past-revenue-consensus

AstraZeneca to be exempt from Covid vaccine liability claims in most countries

AstraZeneca has been granted protection from future product liability claims related to its COVID-19 vaccine hopeful by most of the countries with which it has struck supply agreements, a senior executive told Reuters.

With 25 companies testing their vaccine candidates on humans and getting ready to immunise hundred millions of people once the products are shown to work, the question of who pays for any claims for damages in case of side effects has been a tricky point in supply negotiations.

“This is a unique situation where we as a company simply cannot take the risk if in … four years the vaccine is showing side effects,” Ruud Dobber, a member of Astra’s senior executive team, told Reuters.

“In the contracts we have in place, we are asking for indemnification. For most countries it is acceptable to take that risk on their shoulders because it is in their national interest,” he said, adding that Astra and regulators were making safety and tolerability a top priority.

Dobber would not name the countries.

EU officials told Reuters this week product liability was among contentious points in European efforts to secure supply deals for potential COVID-19 vaccines from Pfizer, Sanofi and Johnson & Johnson.

The United States, however, already has a law to exclude tort claims from products that help control a public-health crises in the form of the 2005 Public Readiness and Emergency Preparedness, or PREP Act.

AstraZeneca, Britain’s second-largest drugmaker, has pledged to supply a total of more than 2 billion doses at no profit in agreements with the United States, Britain and European countries, among other nations and organisations.

Astra’s deals differ from most rivals because it has secured government backing for production and development efforts, while competitors such as GlaxoSmithKline are looking to negotiate a price for a finished product, contingent on approval.

To back its claim to forgo profits from the $1.2 billion collaboration in the United States, Astra has even granted the government access to financial accounts related to the venture, according to Dobber.

“There are very clear milestones before they are going to pay. Because we made the promise to manufacture the vaccine at no profit, auditors of the U.S. administration will get free access to our accounting books,” he said.

https://www.reuters.com/article/us-astrazeneca-results-vaccine-liability/astrazeneca-to-be-exempt-from-coronavirus-vaccine-liability-claims-in-most-countries-idUSKCN24V2EN

Obstacle: Where can CanSino test its vaccine abroad?

CanSino Biologics Inc (6185.HK), one of many companies worldwide trying to develop a coronavirus vaccine, needs to conduct late-stage trials overseas if it is to stay in the race, experts say, but it has yet to announce another country willing to help.

Mid-stage trials showed that its vaccine did not work as well in people with immunity to a particular strain of the common cold virus and experts say it needs to broaden its pool of testing in Phase III trials to see if that outcome, described by the company as “the biggest obstacle”, is replicated abroad.

With other countries pushing ahead with their own tests and deepening tensions with the United States posing a challenge to international collaboration, time is not on its side.

A Phase II trial on 508 participants from Wuhan, where the coronavirus outbreak was first identified late last year, was promising and safe, inducing an immune response in most of the volunteers who got one dose, the company said.

But the study showed signs that people who had previously been exposed to a particular adenovirus in the shot had a reduced immune response.

The vaccine uses a harmless cold virus known as adenovirus type-5 (Ad5) to carry genetic material from the coronavirus into the body.

“There is a large fraction of people both in the Western world and particularly in the developing world that have the baseline Ad5 neutralizing antibody,” said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston.

“And how will that impact the vaccine? It will reduce it… They (CanSino) will need to show that it’s immunogenic in the areas of the world with the highest baseline Ad5 titers (levels) if they want to make it a global solution,” he said.

CanSino’s co-founder said this month that it was in talks with Russia, Brazil, Chile and Saudi Arabia to launch a Phase III trial.

Chilean Science Minister Andres Couve told Reuters that its committee has had meetings to discuss various vaccine candidates, including CanSino’s, for “analysis”.

A CanSino representative said the company has not made any announcement on the location of its Phase 3 trial and declined to comment on progress in looking for an overseas location.

“The ideal solution would be to make the Phase III trial large and multinational, so involving as many people as they can so that any impact of different previous exposure is sufficiently diluted,” said Paul Griffin, a professor at the University of Queensland.

TRUMP AND THE ‘CHINA VIRUS’

Research data show that people in the United States have a lower pre-existing immunity to Ad5.

But growing political tension between Washington and Beijing has dimmed prospects for the vaccine being widely used or even tested there as the United States and other countries move ahead with their own research.

U.S. President Donald Trump has expressed a willingness to work with China, but he also blames Beijing for covering up what he calls the “China virus” and faces widespread criticism at home for his mixed messages on the disease.

Anthony Fauci, the leading U.S. expert on infectious diseases, told Reuters this month he hoped China succeeds in finding a vaccine.

“I don’t worry about anybody getting there first,” he said.

The high prevalence of pre-existing antibodies to Ad5 has prompted some researchers to move away to other types of adenovirus, Barouch said.

Both Johnson & Johnson (JNJ.N) and the University of Oxford, which is working with AstraZeneca (AZN.L), for example, use different adenoviruses, called Ad26 and Chimp adenovirus respectively, for their vaccine research.

CanSino’s candidate became the first in China to move into human testing in March but is running behind other potential vaccines. Two vaccines developed by Sinovac Biotech (SVA.O) and a unit of China National Pharmaceutical Group (Sinopharm) have already been approved for Phase III trials overseas. They do not use Ad5.

CanSino’s vaccine, being developed with China’s military-backed research unit, has been approved for use by the military.

If history is any guide, domestic use-only could be a path for China: An Ebola vaccine, also jointly developed by CanSino and the military research unit and based on Ad5, was approved by Beijing in 2017, but it never made it to the global market.

A China-only inoculation, however, might be a hollow victory.

“There would be no point having one country very well vaccinated if the country next door wasn’t,” said Danny Altmann, an Immunology professor at Imperial College in London.

“We really want global solutions and global cooperation.”

https://www.reuters.com/article/us-health-coronavirus-cansino-analysis/a-big-obstacle-where-can-cansino-test-its-vaccine-abroad-idUSKCN24V1NF

Takeda’s pevonedistat nabs accelerated review in U.S. for bone marrow cancer

The FDA has designated Takeda Pharmaceutical Company Limited’s (NYSE:TAK) pevonedistat a Breakthrough Therapy for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS), a type of bone marrow cancer with a poor prognosis.

Phase 3-stage pevonedistat is an NEDD8-activating enzyme (NAE) inhibitor. The company says its kills cancer cells by blocking the modification of certain proteins which disrupts cell cycle progression and survival.

Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

https://seekingalpha.com/news/3597567-takedas-pevonedistat-nabs-accelerated-review-in-u-s-for-bone-marrow-cancer

Edesa Bio +66% on launch of COVID-19 study in U.S.

Edesa Biotech (NASDAQ:EDSA) soars 66% premarket after filing an IND application with the FDA to initiate a Phase 2/3 clinical study of EB05, for the treatment of hospitalized COVID-19 patients.

The company plans to enroll up to 450 patients in the first phase. Patients will be infused with a single dose of EB05 or placebo.

EDSA also received expedited approval in Canada to begin the Phase 2/3 study and is seeking government grants to initiate patient enrollment.

https://seekingalpha.com/news/3597572-edesa-bioplus-66-on-launch-of-covidminus-19-study-in-u-s