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Tuesday, April 13, 2021

PhRMA’s new message to Washington: Don’t take us for granted

 Pharmaceutical companies have a frank new message for Washington: Don’t take us for granted.

The industry’s lobbying group, PhRMA, launched a new, seven-figure ad campaign Tuesday with that sentiment prominently laid out across the top, just above a clear reminder of the industry’s role in developing medicines and vaccines for Covid-19.

The group is, at the same time, unveiling a new policy agenda that includes several unprecedented endorsements for drug pricing reforms that will actually ding industry profits, unlike past support for policies that focused on competitors or tiny tweaks.

The policies are much smaller than the drug pricing proposals being considered by Democratic lawmakers, but the group hopes the new plank, which includes a new way to help pay for pricey injectable drugs, will show policymakers that the industry is open to compromise.

The campaign, which will focus on print and digital advertising, is a clear response to lawmakers’ plan to use drug pricing reforms to help pay for expensive new public policies this year. PhRMA is ready to “work with every fiber of our being” against certain changes it considers draconian, according to PhRMA President and CEO Steve Ubl. But, as he put it, “we understand there’s going to be some pain involved.”

“It’s important for us to say, we get it, we’re willing to engage, have these conversations, and be pragmatic,” said Ubl. “What we won’t accept is [a] radical, hyper-partisan proposal that’s going to devastate the industry.”

The new campaign also foreshadows the delicate balance the drug industry will try to strike as it negotiates with a Democratic-controlled Congress and White House, both of which seem intent on taking a hefty financial chunk out of its coffers.

“If policymakers want to punish the industry or if they want to impose meat-axe cuts on the industry for unrelated priorities, they will face opposition,” said Ubl. “If on the other hand — and we hope this is the case — policymakers want to engage on real affordability reforms that lower drug costs for consumers, they’ll find a constructive partner. We’ve got lots of ideas.”

The stakes for PhRMA couldn’t be higher: House Speaker Nancy Pelosi has publicly said that she hopes portions of Democrats’ signature drug pricing bill, H.R. 3, will be included in an infrastructure bill expected to be voted on this summer. That bill would tie what the U.S. pays for certain drugs to the prices paid in other countries and threatens massive fines for drug makers that refuse to lower their prices.

Ubl repeatedly slammed H.R. 3 in an interview with STAT, calling it “a hyper-partisan draconian piece of legislation,” “a job killer,” “an innovation killer,” and “a hope killer.” He also cited predictions the bill could lead to financial collapse for small biotechs. Ubl pledged that PhRMA will “try to push this debate into a more pragmatic center.”

H.R. 3 would also save Medicare $345 billion, according to the Congressional Budget Office.

The policies PhRMA is now endorsing, in contrast, are far smaller. There is an explicit endorsement of the idea, at least, of ending “product hopping,” a tactic drug makers use whereby they introduce a new patented version of a drug to prevent it from going generic.

PhRMA also formally backed a new policy that would see pharmaceutical companies paying Medicare an extra sum for certain expensive injectable drugs to make up for situations where drug makers offer private purchasers a better deal than the price typically paid by the government. The lobbying group has been weighing a version of that proposal for months, and had privately endorsed the policy in negotiations with the Trump White House, but had not previously publicly endorsed it. The group claims the change will save older adults “hundreds or even thousands of dollars a year.”

There is also new language endorsing “addressing patent settlements at the federal level,” though PhRMA is clear that it does not support any changes that would apply retroactively to previous agreements or stop companies from entering into “pro-competitive agreements.”

If its newfound openness to reforms isn’t enough, the drug industry has one other new advantage in the debate over drug pricing: a drastically improved reputation.

Prior to the pandemic, the drug industry was one of the nation’s most hated industries, but that appears to be changing. A February survey from Harris Poll found that 62% of those surveyed gave the pharmaceutical industry a positive rating, versus just 32% in January 2020. A recent poll from Data For Progress, a liberal polling firm, also found that 56% of those surveyed had a positive view of pharma, although 77% of those surveyed still wanted the government to regulate drug prices.

PhRMA’s new ad piggybacks on the industry’s newfound likability. It calls the drug industry’s work on Covid-19, “an American success story we should never take for granted.”

The bulk of the text, however, plugs the group’s new policy agenda, which also touches on racial equity and pandemic preparedness.

PhRMA endorses modernizing the U.S. public health data infrastructure and developing a “clear vision” for the Strategic National Stockpile, among other issues.

On racial equity, PhRMA plugs its recent guidelines on clinical trial diversity and also notes the industry must focus on “improving recruitment and hiring a qualified workforce that is more diverse” and creating “better pathways to biopharmaceutical industry jobs for people of color.” Ubl noted too that PhRMA is “looking at best practices for how our companies can better invest in Black and brown businesses.”

Ubl says he’s under no illusions that the new agenda might be criticized. He insists, however, that it’s an important place to start.

“It’s never going to be enough for some,”  Ubl said. “People might quibble within our membership about certain elements. Policymakers may argue that we should do more, but it’s a good place to start. It shows, in my view, credible engagement on the part of industry to try to solve these issues.”

https://www.statnews.com/2021/04/13/phrmas-campaign-dont-take-us-for-granted/

Pfizer to deliver 10% more covid vax doses to U.S. by end of May

 Pfizer Inc has ramped up production of its COVID-19 vaccine and can deliver 10% more doses to the United States by the end of May, Chief Executive Officer Albert Bourla said in a tweet on Tuesday.

Pfizer will supply the full 300 mln doses two weeks earlier than expected, Bourla said.

https://www.reuters.com/article/us-health-coronavirus-pfizer/pfizer-to-deliver-10-more-doses-to-u-s-by-end-of-may-idUSKBN2C02U4

FDA to scrutinize vaccine design behind COVID-19 shots linked to blood clots

 With two COVID-19 vaccines now under scrutiny for possible links to very rare cases of blood clots in the brain, U.S. government scientists are focusing on whether the specific technology behind the shots may be contributing to the risk.

In Europe, health regulators said last week there was a possible link between the AstraZeneca Plc vaccine and 169 cases of a rare brain blood clot known as cerebral venous sinus thrombosis (CVST), accompanied by a low blood platelet count, out of 34 million shots administered in the European Economic Area.

The U.S. Food and Drug Administration on Tuesday recommended temporarily halting use of the Johnson & Johnson vaccine after reports of six cases of CVST in women under age 50 among some 7 million people who received the shot in the United States.

Both vaccines are based on a new technology using adenoviruses, which cause the common cold, that have been modified to essentially render them harmless. The viruses are employed as vectors to ferry instructions for human cells to make proteins found on the surface of the coronavirus, priming the immune system to make antibodies that fight off the actual virus.

Scientists are working to find the potential mechanism that would explain the blood clots. A leading hypothesis appears to be that the vaccines are triggering a rare immune response that could be related to these viral vectors, FDA officials said at a briefing on Tuesday.

The U.S. agency will analyze data from clinical trials of several vaccines using these viral vectors, including J&J’s Ebola vaccine, to look for clues.

None of the previous vaccines using viral vectors have been administered at close to the scale of the AstraZeneca and J&J COVID-19 shots, which may explain why a potential link to blood clots only materialized during these massive vaccination programs.

The technology has also been used in coronavirus vaccines developed in China and Russia.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, was reluctant to declare the blood clot issues a “class effect” shared by all adenovirus vector vaccines, but he sees marked similarity in the cases.

“It’s plainly obvious to us already that what we’re seeing with the Janssen (J&J) vaccine looks very similar to what was being seen with the AstraZeneca vaccine,” Marks said. “We can’t make some broad statement yet, but obviously, they are from the same general class of viral vectors.”

‘AT THE BEGINNING’

In Europe, scientists are exploring a number of hypotheses, including looking more broadly at the way the SARS-CoV-2 virus itself affects blood coagulation.

One team in the Netherlands plans to conduct lab studies that expose specific types of cells and tissues to the vaccines and monitor how they react. They will also explore whether any risks could be limited further by reducing the vaccine dose.

“There are many hypotheses, and some of them may play a role,” said Eric van Gorp, a virologist at Erasmus Medical Centre in Rotterdam. “We are at the beginning, and - as it goes in research - it may be that we can find the clue at once, or it may be that it goes step by step.”

Other scientists were struck by the parallel between the J&J and AstraZeneca shots.

Danny Altmann, a professor of immunology at Imperial College London, said the similar blood clotting incidents associated with both “is clearly noteworthy for defining mechanism.” There has been no sign of such problems with the vaccines made by BioNTech SE with Pfizer Inc or Moderna Inc using a different technology.

“It would be interesting to know more about Sputnik V - also a similar adenovirus vaccine,” Altmann said. The Russian vaccine developed by the Gamaleya Institute in Moscow uses two different human cold viruses - including the Ad26 virus in the J&J shot.

The issue might also affect the adenovirus vector vaccine from China’s CanSino Biological, experts said.

Examining whether there is some common link to adenoviruses is “a reasonable speculation, and it’s a line of research and investigation. But that doesn’t mean it’s proven,” said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College in New York.

Moore, who took part in an informal White House briefing with other scientists on Tuesday, said the FDA and U.S. Centers for Disease Control and Prevention are working closely with health officials in Europe to determine whether the syndromes linked to the AstraZeneca and J&J vaccines are the same.

An important clue may lie in the fact that the reported events typically appear around 13 days after the shot, which is the period in which antibodies might be expected to appear.

“This is speculation, but the timing of something happening after about 13 days on average is suggestive of an immune response to a component to the vaccine,” Moore said.

Investigations of this sort could take years. But like the vaccines themselves that were produced in record time, Moore believes there will be so much effort put into the research that it will more likely be resolved within weeks.

“It’s so clearly important,” he said.

https://www.reuters.com/article/us-health-coronavirus-johnson-johnson-in/u-s-fda-to-scrutinize-vaccine-design-behind-covid-19-shots-linked-to-blood-clots-idUSKBN2C02UI

PerkinElmer prelim 1Q update

 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, today announced that it anticipates reported and organic revenue growth of 98% and 90%, respectively, for the first quarter ended April 4, 2021.

PerkinElmer’s strong revenue performance was driven by broad-based momentum across the portfolio. In total, non-COVID-19, or core, demand increased approximately 10% organically year-over-year, and COVID-19 related solutions contributed approximately $535 million of revenue in the first quarter.

PerkinElmer will release its first quarter 2021 financial results after market close on Tuesday, May 4, 2021. The Company will host a conference call the same day at 5:00 p.m. ET to discuss these results. Prahlad Singh, president and chief executive officer, and Jamey Mock, senior vice president and chief financial officer, will host the conference call.

To access the call, please dial (720) 405-2250 prior to the scheduled conference call time and provide the access code 7294952. A live audio webcast of the call will also be available on the Investors section of the Company's Web site at www.perkinelmer.com.

A replay of the webcast will be available beginning at 7:00 p.m. ET, Tuesday, May 4, 2021 through the Investors section of the Company’s website at www.perkinelmer.com.

https://finance.yahoo.com/news/perkinelmer-provides-first-quarter-schedules-201500806.html

Bristol-Myers Squibb upped to Buy by Truist

 From Hold

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

Supernus upped to Buy from Hold by Jefferies

 Target to $40 from $25

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

Flexion 1Q prelim revenue, guidance

 

  • First-quarter ZILRETTA® net sales estimated to be approximately $24.6 million

  • 2021 full-year ZILRETTA net sales anticipated to be in the range of $120 million to $130 million and total operating expenses expected between $195 million to $205 million

  • Company to hold conference call today at 4:30 p.m. ET

 Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced preliminary ZILRETTA (triamcinolone acetonide extended-release injectable suspension) net sales of approximately $24.6 million for the quarter ended March 31, 2021.

“Overall, we were pleased with our commercial performance in the first quarter. ZILRETTA net sales were broadly in line with our expectations, in spite of facing some unexpected delays in intra-articular procedures associated with the rollout of the COVID-19 vaccines and the extended power outages that affected Texas and other key markets in February,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion Therapeutics. “While the impacts of the COVID-19 pandemic continue to affect patient flows, barring any unforeseen resurgence or outbreaks of more virulent strains, we anticipate 2021 ZILRETTA net sales in the range of $120 to $130 million, reflecting year-over-year growth of approximately 40 to 50 percent. The opportunity ahead of us is tremendous, and we remain tireless in our commitment to make ZILRETTA a leading intra-articular treatment for the millions of patients confronting osteoarthritis knee pain.”

https://finance.yahoo.com/news/flexion-therapeutics-announces-preliminary-first-200100015.html