Nepal | June 03, 2020

Potential coronavirus treatment granted rare disease status

ASSOCIATED PRESS
Share Now:

WASHINGTON: The pharmaceutical giant that makes a promising coronavirus drug has registered it as a rare disease treatment with US regulators, a status that can potentially be worth millions in tax breaks and competition-free sales.

What that speciality status will actually mean for the marketing or profitability of Gilead Science’s experimental drug remdesivir isn’t clear. The drugmaker did not immediately respond Tuesday to requests for comment.

Experts who have studied the so-called “orphan drug” program say the company’s request — and the Food and Drug Administration’s decision to grant it — seem inappropriate given the rapidly expanding threat of the viral outbreak.

A financial analyst, though, called Gilead’s request “pretty standard.”

The FDA granted the status on Monday, according to the agency’s website. If approved for coronavirus, Gilead Sciences would receive seven years of exclusive US marketing for the drug and tax credits on its research and development costs.

Congress created the orphan drug program more than 35 years ago to encourage companies to develop drugs for niche diseases and conditions that might not otherwise be profitable. But since then, filing for orphan status has become a standard pharmaceutical industry tactic to extend the profitability of drugs and block competitors. Orphan drugs are also typically eligible for other special programs that speed up FDA reviews for approval.

The FDA defines a rare disease as one with fewer than 200,000 patients in the US In a statement Tuesday, the agency said COVID-19 fit that criteria when the request was made. There are more than 50,000 cases in US but many more expected in the coming weeks and months.

“It seems like a misuse of the Orphan Drug Act, even though technically it’s within the bounds of the law,” said Dr Aaron Kesselheim, a Harvard Medical School health policy expert. “There’s no expectation here that this drug wouldn’t be able to generate appropriate revenue for the manufacturer.”

Kesselheim said a number of the early AIDS drugs also received orphan drug status in the 1980s and 1990s, but then went on to generate billions in sales.

But Tyler Van Buren, a senior research analyst at the financial services firm Piper Sandler, called Gilead’s filing “pretty standard.”

“It says nothing about profiting off of the pandemic, but it does provide protection if remdesivir turns into a business in subsequent years,” he said.

In recent years the orphan drug program has come under scrutiny from the media, Congress and government inspectors amid concerns that it is being misused to protect six-figure prices on speciality drugs. Roughly half of the 48 new drugs approved by the agency last year received orphan drug designation. Many were priced well above $100,000 for a year’s supply, including drugs for cancer, muscular dystrophy and other genetic disorders.

The nonprofit Public Citizen group said in a statement that the US government should be “urgently concerned” with the affordability of remdesivir.

Gilead’s chairman and CEO, Daniel O’Day has previously said the company hasn’t discussed with any governments how much remdesivir will cost.

“The topic of pricing comes up once you know the medicine works,” he said.

Remdesivir, given through an IV, is being tested in at least five separate experiments, and Gilead also has provided it to several hundred severely ill COVID-19 patients in the U.S, Europe and Japan under “compassionate use” provisions. The company said Sunday it was halting that program due to an unmanageable number of requests.

The drug interferes with virus reproduction and has shown some promise in lab and animal studies against other coronaviruses that cause similar diseases, MERS and SARS. It was also used briefly in some Ebola patients in Congo.

For most people, the new coronavirus causes only mild or moderate symptoms, such as fever and cough. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia. The vast majority of people recover.

Day said earlier this month at a press conference with other drug industry executives that his company has been working on the drug’s development for a decade. He said Gilead has spent “really billions of dollars” developing the drug and plans to spend even more to scale up manufacturing facilities at Gilead and its partners.

Gilead didn’t respond to questions seeking more details about the company’s spending on remdesivir, including whether the figures used by O’Day included the US government money spent on research by federal scientists and grants to universities.


Follow The Himalayan Times on Twitter and Facebook

Recommended Stories:

More from The Himalayan Times:

Fear-triggered attack on healthcare worker in Doti

DHANGADHI: A healthcare worker carrying medical supplies to a health post has been attacked amid the fear of coronavirus transmission in Doti. According to health coordinator at Shikhar Municipality-9 Harish Shah, Auxiliary Health Worker (AHW) Ramesh Kunwar, stationed at Dankot Health Post in the Read More...

Quarantine facilities in Sudurpaschim crammed as returnees from India surge

DHANGADHI: The quarantine facilities across Sudurpaschim Province have become over-crowded due to the influx of incoming Nepali migrant workers from India. As recorded at the Administration Office in Kailali, approximately 2,000 to 5,000 migrant workers have been regularly entering the provin Read More...

18 discharged after recovering from coronavirus infection in Dharan

DHARAN: As many as eighteen persons have been discharged from Dharan-based BP Koirala Institute of Health Sciences (BPKIHS) after recovering from COVID-19, on Tuesday. Following two back to back negative results, 17 men from Jhapa and one Dharan native woman were allowed to return home owing Read More...

Highlights: Nepal witnesses highest single-day spike in coronavirus cases

KATHMANDU: Nepal's Health Ministry, in its regular press briefing, shared the latest updates on coronavirus contagion from across the country, and the government’s response to the health crisis. As of today, 75,343 tests through Polymerase Chain Reaction (PCR) method and 116,345 Rapid Diagn Read More...

Anupam Kher reminisces Naam Shabana memories with throwback picture

KATHMANDU: Bollywood actor Anupam Kher has reminisced memories from Naam Shabana by sharing a throwback picture of the film's cast on his Instagram on June 2. In the photograph one can see the cast of the 2017 action-thriller — Kher along with Neeraj Pandey, Taapsee Pannu, Manoj Bajpayee, Read More...

45 patients discharged, Nepal's coronavirus recovery tally progresses to 266

KATHMANDU: Forty-five persons earlier diagnosed with coronavirus infection, admitted across various health care facilities have been discharged following recovery, confirmed The Ministry of Health and Population. A 54-year-old woman of Makwanpur, undergoing treatment at the Maharjgunj-based Tribh Read More...

India approves emergency use of remdesivir to treat COVID-19 patients

BENGALURU: India's government said on Tuesday it has approved Gilead Sciences Inc's antiviral drug remdesivir for emergency use for five doses in treating COVID-19 patients. Remdesivir, which is administered intravenously in hospital, is the first drug to show improvement in COVID-19 patients in Read More...

Person in quarantine reported missing after being swept away by river

POKHARA: A person kept in a quarantine facility in Malika Rural Municipality of Myagdi district has gone missing as he was swept away by a river, on Tuesday. The missing 19-year-old was a resident of Dhaulagiri Rural Municipality-7. It has been learnt that he had recently returned from India a Read More...