Biden team renews focus on Covid therapies — J&J and Merck set for Biden meeting — Six million tests a day

From: POLITICO's Prescription Pulse - Tuesday Mar 09,2021 05:03 pm
Presented by the Pharmaceutical Care Management Association: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
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By Sarah Owermohle and David Lim

Presented by the Pharmaceutical Care Management Association

With Emily Martin and Brianna Ehley

On Tap

— Biden team renews focus on Covid therapies with a targeted strategy based on HIV lessons.

— Johnson & Johnson and Merck set for Biden meeting on Wednesday to discuss Covid-19 vaccines.

— Six million tests are being administered a day according to federal officials.

It’s Tuesday, welcome back to Prescription Pulse. Brits reacting to American pharmaceutical ads during the Meghan Markle/CBS interview is a story in itself (there’s always a health care connection). As always, send tips to Sarah Owermohle (sowermohle@politico.com or @owermohle) and David Lim (dlim@politico.com or @davidalim).

 

A message from The Pharmaceutical Care Management Association:

Medicare beneficiaries appreciate the Biden Administration’s decision to delay the prescription drug rebate rule which would increase Medicare Part D premiums 25% and cost taxpayers $170 billion. Congress and the Administration should now permanently repeal the rebate rule and instead advance real solutions that lower the costs of prescription drugs.

 
Coronavirus

BIDEN TEAM RENEWS FOCUS ON COVID THERAPIESWhile national attention has been trained on coronavirus vaccine development this past year, the Biden administration is signaling new effort to develop targeted therapies to treat the virus.

Anthony Fauci, President Joe Biden’s chief medical adviser, on Monday pointed to work underway on developing direct-acting antivirals using similar strategies to those that led to breakthrough treatments for HIV. He said the idea is to design drugs that directly inhibit vulnerable targets, Brianna Ehley reports.

“This is really the beginning of the phase of looking in a strategic way for direct acting antivirals which are going to be used to prevent people from progressing in their disease, namely keeping them out of the need for hospitalization,” Fauci said.

The details: The NIH has been working to encourage public-private partnerships to develop more targeted Covid-19 drugs.

While researchers have studied convalescent plasma, steroids and hydroxychloroquine (since debunked) to treat the virus, this effort is aimed at developing totally new treatments resting on some tried-and-true approaches.

“With the same strategy that was used on with HIV, we will be screening and then proactively designing entry inhibitors, protease inhibitors, polymerase inhibitors and others,” he said.

Gilead’s remdesivir, a polymerase inhibitor, is already approved for Covid-19 treatment and shows effectiveness in shortening hospital stays. Fauci noted another candidate from Ridgeback Biotherapeutics and Merck that is in mid-stage trials, and possible options in early studies from Atea Pharmaceuticals and Pfizer.

J&J AND MERCK SET FOR BIDEN MEETING The president will meet with leaders of Johnson and Johnson and Merck this week after canceling an appearance at Emergent Biosciences — a J&J partner to produce vaccines — on Monday.

J&J has pledged to produce 20 million coronavirus vaccine doses by the end of the month and 100 million by this summer but has enlisted aid from Merck and Emergent. It’s unclear how much those two could help with the current pledges, considering it could take months for both to get rolling on production and fill-finish for shots.

Biden has already moved up the timeline for broad availability of Covid-19 shots, saying most adults can get them in May. Officials say that mostly relies on increased production from Pfizer and Moderna, which have each promised an influx of supply in coming weeks.

“Merck has a long history of vaccine expertise, and we expect this manufacturing arrangement will enhance our production capacity so that we can supply beyond our current commitments,” a J&J spokesperson said, adding that Merck is the ninth manufacturer to join the company’s “global network” to supply shots worldwide.

HHS, DOD ESTIMATE U.S. IS RUNNING 6 MILLION TESTS PER DAY — The country is processing far more Covid-19 tests each day than state and local public health departments are reporting, according to an estimate buried in the federal government’s solicitation for groups to apply to run four testing coordinating centers.

HHS and DOD estimate the country is currently running 2 million daily lab-based tests and 4 million daily point-of-care tests, which would translate to about 180 million tests per month.

“There is potential capacity to conduct over an additional 150 million tests per month if the existing supply was supplemented through increased manufacturing, distribution, and utilization,” the government document states.

The Biden administration plans to further boost testing numbers by opening the first coordinating hub by April to oversee weekly tests in K-8 schools and other settings like homeless shelters. But industry sources appear skeptical it will be smooth sailing to the 25 million monthly tests the administration wants to eventually add through the $650 million effort, in part because schools aren’t required to participate.

Still, HHS Testing & Diagnostic Working Group lead industry officer Steven Santos believes testing and vaccinations will be key to beating down transmission of Covid-19.

"With the vaccine available, there is a real opportunity to get to zero transmission and stay there,” Santos said on a call with industry last week. “But to do so we need to increase testing capacity and to continue to identify and stop spread. Maintaining high levels of testing as vaccination rolls out and transmission decreases is critical to controlling this pandemic and to preventing another wave."

ROCKEFELLER FOUNDATION WANTS GLOBAL SEQUENCING NETWORK — The Rockefeller Foundation is the latest group urging the U.S. to dramatically increase its genomic surveillance of Covid-19 variants. But the group wants the U.S. to do even more: help coordinate a global genomic surveillance network to detect threats before they spread across the globe.

“You have several countries around the world who are doing a great job as sequencing and genomic surveillance,” Rick Bright, the group’s new senior vice president of pandemic prevention and response, told POLITICO. “And the goal that I have in mind with the Rockefeller Foundation is bringing that all together, stitching it all together into one global early warning system.”

PhRMA WANTS BIDEN ADMIN TO OPPOSE GLOBAL IP WAIVER The branded drug lobby is asking President Joe Biden to maintain the U.S.’s opposition to a request by South Africa and India to the World Trade Organization to waive certain intellectual property protections for Covid-19 treatments until widespread global vaccination is achieved.

 

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Coming Up in Pharma

WEDNESDAY: NIH Director Francis Collins, FDA acting Commissioner Janet Woodcock, PHRMA Chief Medical Official Richard Moscicki and Friends of Cancer Research Chair Ellen Sigal discuss “silver linings” of unprecedented Covid-19 research and innovations at the Milken Institute.

In Congress

HOUSE SET FOR $1.9T RELIEF BILL VOTE — The Senate approved Biden’s American Rescue Plan this weekend, sending it back to the House for a vote likely today or Wednesday.

What made it: A move to let Medicaid programs fine drugmakers that raise prices at rates beyond inflation is included in the bill but delayed until 2024—which advocates argue gives too much time for the industry to lobby against it.

Also in the final package are funding boosts for state and local vaccine distribution and Medicaid home and community-based care.

 

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Inside AgencyIQ

Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA.

— A trio of FDA leaders offered ideas for how to apply lessons learned during the pandemic to the development of other medical products, including those intended to treat rare diseases. Directors Patrizia Cavazzoni, Peter Marks and Jeff Shuren — respectively the top drug, biologics and device regulators at FDA — provided details about a pilot program for gene therapies, a coming focus on so-called “platform trials” and an assessment that the current regulatory paradigm for devices intended for rare diseases “doesn’t work.”

Flu season could be complicated this year, members of the FDA’s vaccines advisory committee met Friday to discuss possible flu strains used in vaccines will address this upcoming influenza season. While the process is ordinarily routine, Covid-19 made this year considerably more difficult, panelists said.

“We’re trying to predict which strains will be dominant next year to put into the influenza vaccine, yet the pattern used to make that prediction has basically been broken this year because there’s been very little influenza,” explained Jay Portnoy, Medical Director of Telemedicine at Children’s Mercy Hospital and an industry representative on the committee.

Pharma in the States

DE BLASIO RESERVES J&J SHOTS FOR HOMEBOUND ELDERLY — New York City Mayor Bill de Blasio said the city plans to deliver J&J vaccines to homebound elderly residents in certain neighborhoods, POLITICO’s Amanda Eisenberg reported.

De Blasio said the delivery is possible because the one-shot vaccine does not require a rigorous level of refrigeration. He also revealed that the J&J doses set to arrive in the city will allow vaccine appointment sign-ups to open up for New Yorkers in other neighborhoods.

The city has administered more than 2.15 million doses and expects to ramp up its efforts with the arrival of the J&J vaccine.

 

FIND OUT THE LATEST WHISPERS FROM THE WEST WING: Add Transition Playbook to your daily reads to find out what's really happening inside the West Wing, who really has the president's ear, and get the latest scoop from inside cabinet departments and agencies. Track the people, policies and emerging power centers of the Biden administration. Don’t miss out. Subscribe today.

 
 
Pharma Worldwide

SMALL MODERNA ORDERS FOR EU COUNTRIES — A delivery schedule published by the Hungarian government revealed that more than half of EU countries did not order as many doses of Moderna’s coronavirus vaccine as they could have, POLITICO EU’s Jillian Deutsch and Lili Bayer reported.

The prime minister’s chief of staff published the schedule and the EU’s purchasing agreement with Moderna after opposition parties blamed the government for not buying enough vaccines. Minister Gergely Gulyás then confirmed that Hungary stuck with the initial order for 1.7 million doses and did not purchase as many doses as possible because they would have arrived too late in 2021.

According to the document, 16 other countries also opted out of the vaccine top-up offered in December, including Belgium, Greece, Ireland and more.

AUSTRIA HALTS ASTRAZENECA SHOT FOLLOWING DEATH — Austrian authorities have suspended distribution of the Oxford/AstraZeneca coronavirus vaccine as a "precautionary measure" while they investigate a person's death and another's illness after taking the jab, POLITICO EU’s Leonie Carter reported.

The Federal Office for Safety in Health Care received two reports centered on a 49-year-old woman who "died as a result of severe coagulation disorders" and a 35-year-old woman "who developed a pulmonary embolism is on the way to recovery."

While the office asserted that there is currently “no evidence of a causal relationship with the vaccination," they also noted that remaining stocks of the batch will no longer be distributed.

Pharma Moves

Former deputy director of the National Institute of Allergy and Infectious John McGowan has joined consultancy Guidehouse.

 

A message from The Pharmaceutical Care Management Association:

Medicare beneficiaries appreciate the Biden Administration’s decision to delay the prescription drug rebate rule which would increase Medicare Part D premiums 25% and cost taxpayers $170 billion. Congress and the Administration should now permanently repeal the rebate rule and instead advance real solutions that lower the costs of prescription drugs.

 
Quick Hits

— The head of the World Health Organization called for patent rights to be waived until the end of the pandemic so that vaccine supplies can be dramatically increased, AP reported.

— The EU wants to access coronavirus vaccine doses produced in the U.S. as part of broader cooperation on the coronavirus response, though the U.S. is bound to an executive order from former President Donald Trump to meet domestic demand first, the Financial Times reported.

— Satsuma Pharmaceutical rolled out a new plan to test its migraine treatment that earned $80 million from investors, after a previous Phase III trial failed in September 2020, MedCity News reported.

Document Drawer

FDA announced a March 23 public meeting to discuss expanding drug trials to include more older adults.

Researchers at Martin Luther University Halle-Wittenberg and the University of Greifswald published a study on a new substance that makes drug-resistant tumor cells respond again to chemotherapy.

 

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