U.S. Risks Missing Out on New Covid Pill As Funds Run Out

(Bloomberg) -- In its quest to build up its stockpile of Covid-19 drugs, the U.S. government has held talks with Japanese drugmaker Shionogi & Co. about buying its experimental antiviral pill, people familiar with the matter said. Finding the money to pay for it could be a problem. 

Two years into the pandemic and after nearly a million deaths in the U.S., a standoff in Congress has left those in charge of building up the country’s drug supplies without the resources to do so. The implications are far-reaching. The government needs more funding to pay for existing orders with companies like Pfizer Inc. and could end up unable to invest in new therapies like Shionogi’s.

The talks to buy Shionogi’s drug have been preliminary, the people said, speaking on condition of anonymity because of the confidential nature of the discussions. The Japanese company’s treatment is currently in late-stage clinical trials and hasn’t yet been authorized. In earlier studies, the drug reduced viral loads in patients within the first few days of use.

It’s seen as a promising option given it will likely require fewer pills than Pfizer’s coronavirus treatment, which involves taking 30 tablets over five days. It’s not unusual for the U.S. to put orders in for drugs before authorization. 

Shionogi shares rose as much as 2.7% in Tokyo on Friday, before paring gains to trade 0.2% higher. A company spokesman confirmed Shionogi is in talks with the U.S. government regarding the supply and manufacturing of its Covid pill.

Governments around the world have been racing to lock up supplies of Covid treatments to protect their populations. Successful drugs often generate early demand and countries that order first are typically first in line to receive them -- meaning the U.S. could find itself waiting for shipments behind other countries.

President Joe Biden’s administration has said having a “medicine cabinet” of treatments will stem the virus’ worst outcomes, while raising the alarm about the lack of funding for more drugs.

Cash Crunch

At the moment, the government needs more funding from Congress just to pay for existing orders of treatments as well as to place new orders. A Senate deal on a potential $10 billion funding package collapsed earlier this month over a dispute about a border measure. Talks are likely to resume with the Senate’s return next week, but it isn’t clear a deal will be reached.

If new funding is authorized, roughly half it will go to finalizing an order of 20 million courses of Pfizer’s Paxlovid. The U.S. has only paid for about 11 million of the courses, officials have said, and the rest will cost nearly $5 billion. The remainder of the money is supposed to be used for testing, the purchase of vaccines, drugs and other measures.

The cash crunch is growing urgent. If the U.S. doesn’t get new financing from Congress within the next few weeks, it risks falling well back in line for purchases of new treatments, potentially including Shionogi’s, an administration official said, speaking on condition of anonymity.

“We just want to be very clear: if we don’t purchase these vaccines and therapies for the American people, other countries will step in to purchase them for their citizens,” Karine Jean-Pierre, the White House’s principal deputy press secretary, told reporters Thursday, without addressing Shionogi specifically. 

Without new funding, “we can’t buy any more treatments,” Jean-Pierre said.

And even if a deal is reached, the White House has signaled it will continue to need more money -- at home and abroad. Buying Shionogi’s drug would likely come from future funding deals, as there’s no funds for a sizable purchase otherwise.

Antiviral Needs

“We have a collective amnesia in this country when it comes to pandemic preparedness, and, in a way, that’s playing out right now,” said Carl Dieffenbach, director of the division of AIDS at the National Institute of Allergy and Infectious Diseases, or NIAID, who was tapped by Anthony Fauci last year to lead the Biden administration’s multibillion effort to develop antivirals for Covid and future pandemic threats. Dieffenbach wasn’t commenting specifically on Shionogi’s talks with the U.S. government but rather on the broader state of antiviral development and stockpiling. 

Since the Antiviral Program for Pandemics began in June, the U.S. government has worked closely with companies like Pfizer and Shionogi to bring new Covid drugs to market. A NIAID-supported study of Shionogi’s drug will launch globally at the end of the month, according to ClinicalTrials.gov.

The U.S. has focused on new candidates that offer a clear edge over existing therapies. Shionogi’s drug fits that description, Dieffenbach said, because it’s easier for patients to take.

Paxlovid is intended for high-risk patients within five days of symptom onset. Patients must take three pills, a combination of the drug and a booster pill, twice a day over five days. Shionogi’s therapy employs the same mechanism as Paxlovid, but will require fewer pills. On the first day of treatment, patients are given a higher dose and then over the next four days they’re given one pill per day, without the need for a boosting agent, a spokesperson for the Osaka-based drug company said.

Results from the NIAID-supported study and a late-stage trial in Asia will help determine the dose Shionogi ultimately brings to market, the company spokesperson said. 

Multiple antivirals are needed because viruses tend to mutate to render drugs ineffective. The ideal coronavirus treatment would combine drugs to target the coronavirus spike protein in different ways, he said. 

“I hope we can maintain momentum and that Congress will recognize the value of this and keep it going,” Dieffenbach said. “Basically all progress is kind of frozen.”

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