Teva CEO Kare Schultz On Drugmaker’s Outlook, Coronavirus Response

Generic drugmaker Teva Pharmaceutical Industries Ltd TEVA 10.36% reported a first-quarter earnings beat as the company managed to maintain business continuity, CEO Kare Schultz said on CNBC’s “Squawk on the Street.”

Teva’s ‘Very Good’ Quarter

Teva is dedicated to supplying therapies to the 200 million people who use its generic drugs and this resulted in a “very good” quarter, the CEO said.
Looking forward, the company expects to see “some reversal” of the strong demand seen in March, but Schultz said full-year revenue should fall within its guidance.

Teva Supply Chain Update

One of Teva’s drugs, propofol, experienced shipping delays due to the COVID-19 pandemic. Part of the problem stems from a reduction in air traffic, less air cargo availability and some countries placing new restrictions on imported goods.
While air cargo issues remain a problem, Teva is seeing improving conditions, as it has been able to increase volume outputs, but with higher transportation costs.
In the meantime, all of Teva’s facilities are operating at “full capacity,” Schultz said, and the “majority” of logistical problems have been overcome.

Teva And The Hydroxychloroquine Controversy

Teva is one of the few makers of the anti-malaria drug hydroxychloroquine, which has come under its fair share of controversy.
The CEO said he can’t at this time offer a “clarifying answer” on the efficacy of the drug in treating COVID-19. The ultimate responsibility rests with the health care professionals, he said.
Nevertheless, Teva was able to respond to the growing demand for the drug and was “quite successful” in shipping the product, Schultz said.

Teva CEO On Coronavirus Second Wave Concerns

The coronavirus could return for a “second wave” in the fall season, but it is “too early to say” what, if any, actions hospitals are taking now to prepare themselves, Schultz said.
It is nevertheless important for all companies to increase the production of products to better prepare in the event of a second wave outbreak, he said.
https://www.benzinga.com/news/earnings/20/05/15981383/teva-ceo-kare-schultz-on-drugmakers-outlook-coronavirus-response

FDA approves new heart failure use for AstraZeneca’s Farxiga

The FDA has approved a new use for AstraZeneca’s Farxiga (dapagliflozin) to reduce risk of cardiovascular death and hospitalisation with heart failure, in adults with reduced ejection fraction heart failure, with or without type 2 diabetes. 
AZ is building a metabolic and cardiovascular franchise around Farxiga, which was first approved in type 2 diabetes and was added to the company’s portfolio of drugs after the company bought out Bristol-Myers Squibb’s share of a diabetes joint venture in 2013.
An SGLT-2 class drug, Farxiga has become one of the company’s most important products in terms of sales, generating $407 million in Q1 this year, up 16%. 
With this new indication Farxiga has become the first drug in the class to be approved by the FDA to treat patients with heart failure with reduced ejection fraction (HFrEF). 
AZ’s big rivals Eli Lilly and Boehringer Ingelheim are also attempting to develop their class competitor Jardiance (empagliflozin) to prevent heart failure, but suffered a setback in December when the drug failed to improve exercise ability in two phase 3 studies. 
Approval for Farxiga was based on positive results from the phase 3 DAPA-HF trial, which showed Farxiga achieved a statistically significant and clinically meaningful reduction of death or hospitalisation for heart failure compared with placebo. 
DAPA-HF trial showed that Farxiga, in addition to standard of care, reduced the risk of the composite outcome of CV death or the worsening of HF versus placebo by 26% in patients with HFrEF. 
During the trial duration, one CV death or hospitalisation for HF or an urgent visit associated with HF could be avoided for every 21 patients treated with Farxiga. 
The FDA had granted a faster priority review in January, where the regulator committed to making a decision within six months. 
In October the FDA approved Farxiga to reduce risk of hospitalisation for heart failure in adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. 
The FDA is also evaluating data from the phase 3 DAPA-CKD trial, which tested the drug in chronic kidney disease and was stopped early because of efficacy. 
AZ is also developing Farxiga in heart failure patients with reduced ejection fraction.  
There is a potential threat of generic competition for Farxiga in the US – the FDA has tentatively approved a cheaper copy but it is unable to launch until a patent dispute is resolved in courts.

FDA approves new heart failure use for AZ’s Farxiga

Concerns over Bristol-Celgene merger payout as FDA extends drug review

Bristol-Myers Squibb’s risky three-drug bet with former shareholders in Celgene is still on – but it could be a close-run thing after the FDA extended the review of a cancer cell therapy close to key deadline.
Shareholders in Celgene accepted a “contingent value right” (CVR) to sweeten the $74 billion merger with BMS in November. 
Each Celgene share entitled the holder to one CVR that can be publicly traded and pays out $9 if three big drugs from Celgene’s pipeline are approved by the FDA in time for certain deadlines. 
The first of the three drugs – Celgene’s multiple sclerosis drug Zeposia (ozanimod) – was approved in March. 
That leaves two complex cancer CAR-T cell therapies outstanding, and the FDA just extended the review period for one of them after BMS had to submit further data to support the filing. 
The three-month extension of the review for lisocabtagene maraleucel (liso-cel) gives a new FDA action date of 16th November this year, around six weeks before the deadline of 31st December mandated by the CVR. 
Liso-cel is a CAR-T (chimeric antigen receptor T-cell) therapy designed to target the protein CD19, a protein expressed during the formation of B-cells and maintained following their transformation into cancer cells. 
Formerly known as JCAR017 it was originally developed by Celgene’s Juno unit, and is under review by the FDA for relapsed or refractory large B-cell lymphoma after at least two prior therapies. 
The value of the CVR slipped following the announcement, as investors got spooked by the tightness of the deadline. 
While the FDA seems to be approving drugs on time at the moment, there are concerns that the ongoing COVID-19 pandemic could cause further delays as staffers at the regulator turn their attention to drugs and vaccines to fight the coronavirus. 
The final drug in the CVR “bet” is bb2121, another CAR-T that Celgene developed in partnership with bluebird bio, which must get approved before 31st March next year.

Concerns over BMS and Celgene merger payout as FDA extends drug review

Don’t expect return to pre-COVID-19 business before vaccine, herd immunity

While hospitals around the country are carefully moving forward offering elective surgeries again, don’t expect them to get back to pre-COVID-19 volumes anytime soon.
In fact, healthcare leaders from health systems such as Kettering Health Network as well as Vituity Healthcare and Medical Staffing Services said they don’t expect hospitals to get close to normal business until a vaccine is developed.
“It will vary from community to community but I think chances are good we won’t see normal again until after a vaccine or sufficient herd immunity,” said Gregg Miller, M.D., Vituity’s chief medical officer, during a webinar hosted by FierceHealthcare.

That will almost certainly be the case in Ohio, said Jodie Cremeans, who manages Kettering Health Network’s Operations Command Center there.
“For us and our community, it’s probably going to be 12 to 18 months before we’re even that close to what our baseline was just because [there is] a lot of hesitation,” Cremeans said during the Coronavirus Virtual Roundtable series.
“With flu season—especially in Ohio, we see a huge flu surge in flu season because of where we are geographically and everyone being inside and touching each other all the time—we really do think it’s going to be quite a while before we’re back to that new norm,” she said. “It’s going to take a long time and probably not until we have a vaccine, or a mixture of a vaccine and herd immunity.”
Miller pointed to the precipitous drops in non-COVID-related care for patients in hospitals around the country as the pandemic raised fears among patients of catching the virus in a healthcare setting.
Health systems have a communications battle to fight in convincing them about their safety, he said, even as they prepare for a surge in the fall that could require a redoubling of shelter in place efforts. Health systems in markets around the country, including Los Angeles, are banding together to put out public announcements to remind patients they are still open for business.
That’s the case at Cedars-Sinai as the hospital begins reaching out to patients about scheduling their procedures. “We’re starting with what we’ve postponed first,” said Bryan Croft, senior vice president of operations for Cedars-Sinai.
Simultaneously, they are doing a campaign about the importance of community members feeling comfortable seeking necessary medical care as they consider the best way to open up access more broadly through its health system.
“We haven’t yet established a firm timeline on the reopening of our clinics,” Croft said. “We see about 800,000 visits a year within the whole system and we recognize that, in order to do that, we have to be aware of the issues associated with the stay-at-home guidance that still exists in this state until the 15 of May.” That includes understanding the potential impact on personal protective equipment, the impact of social distancing and how the health system may need to physically reorient spaces such as parking garages or waiting rooms to assure patients they are safe, he said.

“There are still so many unknown elements,” Croft said. “If we’re planning the way everyone else is, and everyone else should be, about the fact this could surge with the easing of certain social distancing or stay at home orders that are going on across the country, we need to be aware of what’s going on around us so we can quickly flex back to be able to think in terms of surge again.”
Bottom line: All eyes will be on the health systems, and they need to get this right, Melanie Morris, senior director of the Roanoke, Virginia-based Carilion Clinic’s transfer and communications center.
“It’s huge how we do it when we first start to open back up because people are going to be watching closely and we can still lose the trust and faith of the community if we backtrack,” Morris said. Health systems will have to focus on variables they can control such as how well they are screening patients and get quick turnaround results.
“I think we need to be very careful about how we open back up and gain that trust back with the public,” Morris said. “We can’t predict how quickly it will happen. It will be a phased approach. But all eyes upon us and we have to do it quickly and correctly.”
https://www.fiercehealthcare.com/hospitals-health-systems/health-system-experts-don-t-expect-to-return-pre-covid-levels-before

Why COVID-19 will ‘fundamentally’ change care delivery

As the country begins to emerge from the COVID-19 pandemic, what will the “new normal” look like?
Health insurance industry experts say to expect a continued focus on telehealth and a significant acceleration of the move to bring more care into the home.
“Care delivery will be fundamentally reorganized in addition to telehealth,” said Sree Chaguturu, M.D., chief medical officer at CVS Caremark, during a webinar hosted by FierceHealthcare.

Brett Lotito, vice president of insurance strategy and operations at Oscar Health, said the growing demand for virtual care options due to the pandemic “pretty much changed the landscape immediately.”

Oscar is built on technology, so its membership was already comfortable with digital health tools, with about 30% to 40% utilizing its telehealth tools—quite high for the industry overall. Overnight with COVID-19, Lotito said, that changed to interest from all providers and many patients seeking out these tools.
In March, Oscar Medical Group saw 62% higher telehealth visits per 1,000 members than in March 2019. At the time, about 20% of those visits were related directly to COVID-19.
Chaguturu emphasized that the pandemic is making the use case for other home health solutions beyond telemedicine. CVS, for example, offers home infusion and dialysis, both of which are attractive options as members are urged to shelter in place.

As providers begin to offer elective procedures when the pandemic wanes, there are several concerns for health plans: namely, that members have been putting off care that was necessary, as well as tracking what’s likely to be a crush in demand for elective services.
Glen Stettin, M.D., senior vice president and chief innovation officer at Express Scripts, said he and his team have been tracking data on members deferring care and have found significant numbers of people avoiding trips to the emergency room for potentially high-risk needs such as heart conditions due to COVID-19 fears.
He said releasing the data has helped people understand they’re putting themselves at greater risk in an emergency by not seeking care and has also led some providers to make it clearer to patients that it is safe to come to the ER if they need to.
“We saw that as a need to help reeducate the public,” Stettin said.
David Weathington, senior vice president of health plan operations at Clover Health, said that as a Medicare Advantage insurer they’re focused on tracking data on members with chronic conditions now to avoid potentially negative outcomes in the future.
The means working with members individually and crafting care plans for their specific needs so they can get necessary care during the pandemic, he said.
Clover’s team is “beginning to proactively work with those folks on treatment plans, both with the members directly and with their supervising physicians, to make sure as things begin to open up those folks who are not acute but at risk of suffering as a result of deferring care get treatment sort of quickly as things start to open up,” Weathington said.
https://www.fiercehealthcare.com/payer/payer-experts-why-covid-19-will-fundementally-change-care-delivery

Pfizer tags 3 U.S. manufacturing sites for possible COVID-19 vaccine launch

Global coronavirus vaccine makers have been rolling out details about their manufacturing and launch plans—even ahead of any clinical data. Now, Pfizer says it will draw on three sites in the U.S., plus one in Belgium, for the early stages of a launch, provided its BioNTech-partnered shot wins a green light.
Pfizer plans to draw on sites in Kalamazoo, Michigan, and Andover, Massachusetts, as well as St. Louis for the early stages of its mRNA vaccine ramp-up. The company is in human testing with four candidates alongside partner BioNTech, which will supply doses for clinical testing.
The company plans raw material manufacturing in St. Louis and drug substance manufacturing in Andover. The Kalamazoo site is slated to handle formulation and filling.

Aside from Pfizer’s U.S. sites, the drugmaker has identified a plant in Puurs, Belgium, as a COVID-19 vaccine manufacturing center. The company plans to select other sites as well. For its part, BioNTech intends to add capacity at two of its facilities in Germany.
Pfizer believes it can deliver millions of doses by the end of 2020—which would be a remarkable accomplishment—and then deliver hundreds of millions in 2021.
Even though the partners just entered human testing and haven’t reported any data, Pfizer employees are taking steps to prepare for the possible rollout now.
Those include exchanging technology to plan the manufacturing process, ordering materials, preparing “parallel” supply chains and hiring new staff. Like other companies, Pfizer is doing the work “at risk,” or before the vaccine demonstrates efficacy, to cut crucial time it would take to launch if the data turn out positive.

In response to the news, Michigan Gov. Gretchen Whitmer said in a statement that she’s “so proud that one of the largest pharmaceutical manufacturing facilities in the world is the Pfizer site right here in Kalamazoo,” citing how global supply chains have hindered the U.S. COVID-19 response.

Pfizer isn’t alone in planning for a massive COVID-19 vaccine ramp-up. Part of the reason Sanofi and GlaxoSmithKline entered their unprecedented tie-up was to combine scale for a massive rollout in 2021. Those companies, plus Pfizer and Merck & Co., are the largest vaccine players in the world.

Johnson & Johnson, meanwhile, has struck multiple manufacturing deals for its own COVID-19 vaccine program with plans to produce more than 1 billion doses. The New Jersey drugmaker’s deal with Emergent BioSolutions was intended to ensure U.S. production for early batches, The New York Times reported. J&J has also signed a deal with Catalent.

Meanwhile, AstraZeneca has signed on to produce and distribute vaccines for the University of Oxford’s promising program, which is speeding ahead.

And Moderna, which has one of the most advanced COVID-19 vaccine projects, has signed a manufacturing deal with Lonza for up to a billion doses per year. Moderna on Thursday said it has received FDA approval to enter phase 2 testing and is planning phase 3 testing in the “early summer.”

https://www.fiercepharma.com/manufacturing/pfizer-to-incorporate-3-u-s-sites-for-possible-covid-19-vaccine-launch

Guardant Health EPS beats by $0.11, beats on revenue

Guardant Health (NASDAQ:GH): Q1 GAAP EPS of -$0.29 beats by $0.11.

Revenue of $67.51M (+84.2% Y/Y) beats by $12.06M.

Press Release

https://seekingalpha.com/news/3571465-guardant-health-eps-beats-0_11-beats-on-revenue