Gilead Science - Timeline

(January 03, 1997) Donald H. Rumsfeld Named Chairman of Gilead Sciences
[link to www.gilead.com (secure)]

In 1997, Donald Rumsfeld was appointed Chairman of the Board of Gilead Sciences,
a company which a year earlier had developed ‘Tamiflu’(oseltamivir), originally a drug for AIDS
and later marketed as a vaccine for H5N1 avian flu. Upon becoming US Defence Secretary in 2001,
he ordered $1 billion worth of Tamiflu to be bought and injected into US soldiers as a ‘precaution’.
At the time, Rumsfeld was the principal stockholder of Gilead Sciences.
Worse still, it later emerged that Tamiflu was not even effective as a H5N1 vaccine.

(January 23, 2001) Rumsfeld's 94-page financial disclosure form shows
that his holdings include between $6 million and $30 million in Gilead Sciences,
a pharmaceutical company, plus $1 million to $5 million invested stock options.
He served as chairman of the board of Gilead from January 1997 until he joined the Bush administration.
[link to www.washingtonpost.com (secure)]

(March 12, 2006) Donald Rumsfeld makes $5m killing on bird flu drug
[link to www.independent.co.uk (secure)]

(Aug 7, 2013) China revokes patent on Gilead's Viread
"It is a fairly groundbreaking decision," Robert McTiernan of IHS Healthcare told BioWorld.
He sees it as another move by China to gain negotiating power over drug prices in the face of a burgeoning healthcare budget.
"The big trend is that they want pharma companies to be more flexible on pricing.
They will likely be able to use this decision to negotiate lower prices on more drugs."
[link to www.fiercepharma.com (secure)]

(May 19, 2015) High Cost of Sovaldi Hepatitis C Drug Prompts a Call to Void Its Patents
Activists in several countries are seeking to void patents on the blockbuster hepatitis C drug Sovaldi,
saying that the price being sought by the manufacturer, Gilead Sciences, was prohibitive.

The Initiative for Medicines, Access and Knowledge, a legal group in New York,
is expected to announce Wednesday that it has filed challenges in Argentina, Brazil, China, Russia and Ukraine.
In all those countries except China, the organization is being joined by local patient advocacy groups.
[link to www.nytimes.com (secure)]

(October 9, 2015) Antiviral compound effectively treated Ebola in monkeys (GS-5374 - later named Remdesivir)
A clinical trial of the compound, GS-5374, is currently being conducted by the company Gilead Sciences,
which worked with the United States Army Medical Research Institute of Infectious Diseases, or USAMRIID, to develop it.
[link to www.upi.com (secure)]

(March 15, 2016) UNC Epidemiology Study: New SARS-Like Virus May Be Nearly Ready to Infect Humans
A study led by researchers at the University of North Carolina at Chapel Hill found that a SARS-like virus
known as WIV1-CoV, which is found in horseshoe bats, could bind to the same receptors as SARS-CoV and replicate in human cells without the need for adaptation.
Thought to be a critical barrier, the results indicate that bat populations maintain SARS-like viruses poised to reemerge in humans.
The research team worked with both full length and chimeric versions of WIV1-CoV. The virus readily and efficiently replicated in cultured human airway tissues, suggesting and ability to potentially jump directly to humans.
While other adaptations may be required to produce an epidemic,
several viral strains circulating in bat populations have already overcome
the barrier of replication in human cells and suggest reemergence as a distinct possibility.
[link to global.unc.edu (secure)]

(June 28, 2017) New drug holds potential to defeat coronaviruses
Scientists at the UNC Gillings School of Global Public Health have confirmed that an experimental antiviral treatment
prevents the development of SARS coronavirus (SARS-CoV) disease in mice. The drug, GS-5734(Remdesivir), also inhibits MERS-CoV
and multiple other coronaviruses (CoV), suggesting that the treatment may inhibit all CoV.

To date, there are no approved therapies to treat any kind of CoV infection.
GS-5734(Remdesivir) is being developed through a unique public-private partnership between
investigators at the University of North Carolina, Vanderbilt University’s School of Medicine and Gilead Sciences, Inc.
[link to sph.unc.edu (secure)]

(August 31, 2017) Gillings School researchers receive $6M+ grant to fight infectious diseases
The partnership grant awarded to Baric and Sheahan establishes a collaboration between the Gillings School and
Gilead Sciences Inc., Vanderbilt University Medical Center and the University of Texas Medical Branch.
The collaboration builds upon an earlier partnership between the Gillings School and Gilead Sciences Inc.,
and will focus specifically on GS-5734(Remdesivir), an experimental antiviral treatment.
[link to sph.unc.edu (secure)]

(February 5, 2020) China Applies for Patent for Drug That Could Fight Coronavirus
While Gilead’s experimental drug isn’t licensed or approved anywhere in the world,
it is being rushed into human trials in China on coronavirus patients after showing early signs of being highly effective.
The patent application was made on Jan. 21, according to a statement posted on the website of the virology institute in Wuhan,
the central Chinese city at the epicenter of the epidemic. Scientists there have found Gilead’s remdesivir, and chloroquine,
an 80-year-old malaria drug, “highly effective” in laboratory studies at thwarting the novel coronavirus,
[link to time.com (secure)]

(February 12, 2020) Chinese Firm Makes Gilead Drug in Virus Fight, Raising IP Fears
Suzhou-based BrightGene Bio-Medical Technology Co. said it has developed technology to synthesize
the active pharmaceutical ingredients of Gilead’s remdesivir. A leading candidate to treat the virus
that’s killed more than 1,000 people, the drug isn’t licensed or approved anywhere in the world.

Despite the steps by BrightGene and Wuhan researchers, the central government has so far stopped short
of seeking a “compulsory license,” which lets nations override drug patents in national emergencies.
The hesitation to invoke that clause may be part of its continued efforts to demonstrate greater respect for companies’ rights.
[link to www.bloomberg.com (secure)]

(February 25, 2020) Gilead’s Drug Leads Global Race for Coronavirus Treatment
China will release results at the end of April from clinical trials of a Gilead Sciences Inc.
drug that is emerging as a frontrunner in the race to find an effective treatment for the novel coronavirus.

The outcome of trials of the experimental medication remdesivir on 761 patients in Wuhan,
the city where the virus originated, will be made public on April 27,
China’s National Intellectual Property Administration said Tuesday.
[link to www.bloomberg.com (secure)]

(March 23, 2020) Gilead Outrageously Seeks Super-Monopoly Protections for Covid-19 Drug
The U.S. Food and Drug Administration today granted experimental COVID-19 treatment remdesivir
a special orphan status intended for drugs that treat rare diseases. The status sets up
remdesivir’s manufacturer Gilead Sciences to receive additional federal tax credits
in the United States and a bonus lucrative seven-year market exclusivity, allowing Gilead
to exclude generic and more affordable competition while charging high monopoly prices, if the drug is approved.
[link to www.citizen.org (secure)]

(March 24, 2020) Gilead’s potential coronavirus treatment gets FDA’s orphan drug label
Gilead Sciences’ experimental drug remdesivir, seen as one of the more promising potential treatments for the coronavirus,
on Monday received the orphan drug designation from the U.S. Food and Drug Administration.
The orphan drug status provides a seven-year market exclusivity period, as well as tax and other incentives
for drug companies developing treatments for rare diseases that affect fewer than 200,000 people.
[link to www.cnbc.com (secure)]

(April 10, 2020) RdRp, also named nsp12 is the central component of coronaviral replication/transcription machinery
The RNA-dependent RNA polymerase (RdRp, also named nsp12) is the central component of coronaviral replication/transcription machinery
and appears to be a primary target for the antiviral drug, remdesivir.
[link to science.sciencemag.org (secure)]

(April 17, 2020) Coronavirus Drug Results Send Gilead Sciences Stock Flying; JPMorgan Weighs In
New data from a University of Chicago Hospital Phase 3 clinical trial of Gilead's remdesivir antiviral drug, also known as "GS-5734"
shows promising results for the drug's efficacy in treating the novel coronavirus. And no sooner had the data come out, than Gilead's
stock price began marching higher again, rising 12% in pre-market trading on Friday.
[link to www.nasdaq.com (secure)]

(April 23, 2020) WHO mistakenly posted study results that appeared to show that a leading potential coronavirus treatment failed to help patients
A leading coronavirus treatment candidate did not help patients with severe coronavirus cases in a trial survive better than a placebo group,
according to a summary of preliminary study results reported by STAT News and the Financial Times.
The World Health Organization accidentally posted a summary of the study results on its website on Thursday,
a representative confirmed. That post was removed, but not before several news outlets noticed it.
Gilead's stock fell more than 6% on Thursday afternoon.
[link to www.businessinsider.com (secure)]

(April 23, 2020) A preliminary study on the reproductive toxicity of GS-5734 on male mice
The results indicated that after treated with GS-5734, the total sperm count and motile sperm rate showed downward trends,
the abnormal sperm rate showed an increasing trend. As compared with the control group, GS-5734 at a daily dose of 150 μg/mouse caused
a significant decrease in sperm concentration and motility, and a significant increased of abnormal sperm rate; the 50 μg/mouse drug treatment
lead to a significant decrease in sperm motility and an increase in abnormal sperm rate. The HE staining of testicular and epididymal tissues
showed that the spermatogenesis of mice was significantly deteriorated with the increasing dosage of GS-5734, especially in the 150 μg/mouse group.
[link to www.biorxiv.org (secure)]
[link to www.researchgate.net (secure)]

(April 29, 2020) Trump, Fauci tout 'good news' from remdesivir drug trial in treating COVID-19
"What it has proven is that a drug can block this virus," Fauci said, calling the development "very optimistic."
It had not yet been peer-reviewed but was being submitted to a journal for review, Fauci said as he previewed the results.
Experts interviewed by ABC News urged caution until the full data was released.
[link to abcnews.go.com (secure)]

(May 1, 2020) FDA authorizes emergency use of coronavirus drug remdesivir
The authorization comes days after data suggested the experimental drug
can help patients recover faster. The Food and Drug Administration on Friday issued
an emergency-use authorization for remdesivir in a bid to help patients
get quicker access to the first antiviral to show promise against Covid-19 infection.
[link to www.politico.com (secure)]

(May 06, 2020) Gilead Outlines Efforts to Expand Global Supply of Remdesivir for COVID-19
Gilead Sciences’ antiviral drug remdesivir is, to date, the only approved drug treatment for COVID-19.
Shortly after announcing positive results in two clinical trials on April 30, one a small trial run by the company,
the other a larger trial conducted by the National Institutes of Allergy & Infectious Diseases (NIAID),
the U.S. Food and Drug Administration (FDA) approved the drug under Emergency Use Authorization (EUA) for COVID-19.
Gilead is in talks with chemical and pharmaceutical manufacturing companies around the world to work out voluntary licenses
to produce remdesivir for Europe, Asia and the developing world through at least 2022.
[link to www.biospace.com (secure)]

(May 07, 2020) Gilead Announces Approval of Veklury® (remdesivir) in Japan for Patients With Severe COVID-19
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted
regulatory approval of Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19,
under an exceptional approval pathway. The exceptional approval was granted due to the COVID-19 pandemic
and references the Emergency Use Authorization of remdesivir in the United States.
[link to www.businesswire.com (secure)]

(May 11, 2020) Coronavirus tracker: Gilead's remdesivir supply constrained in the U.S.; Ex-NIH head as COVID-19 czar?
Of all the remdesivir Gilead Sciences has committed to donate, only about half of the supply will be allocated to the U.S. over the next six weeks,
according to the Department of Health and Human Services. That news comes after early mistakes shipping out supplies.
Elias Zerhouni, who served as National Institutes of Health director before a seven-year stint at Sanofi’s research operations,
is said to be the Trump administration's top candidate for COVID-19 czar.
The U.S. intelligence agencies are reportedly prepared to accuse hackers linked to the Chinese government
for attempting to steal U.S. research information on coronavirus vaccines and treatments.
[link to www.fiercepharma.com (secure)]

(May 19, 2020) Coronavirus tracker: Gilead ramps up U.S. remdesivir donation; AstraZeneca hunts for new vaccine production deals
Gilead Sciences is increasing its remdesivir donation to the U.S. government to about 940,000 doses by June, up from the previous 607,000.
AstraZeneca, already in a vaccine deal with the University of Oxford and U.K. health officials, is now looking for similar vaccine production pacts with organizations and governments.
Meanwhile, Moderna is hoping to raise $1.34 billion through a public stock offering to fund manufacturing and distribution of its mRNA vaccine candidate.
Before the donated supply runs out in June or early July, Gilead is preparing to pivot to a commercial model and start charging for remdesivir
in the second half of the year, SVB Leerink analyst Geoffrey Porges wrote to clients after talking to senior management.
The company also envisages remdesivir becoming a "multi-year commercial opportunity," he said.
[link to www.fiercepharma.com (secure)]

(May 27, 2020) UK authorises anti-viral drug remdesivir
UK regulators say there is enough evidence to approve its use in selected Covid-19 hospital patients.
The US and Japan have already made similar urgent arrangements to provide early access to the medicine before they have a marketing agreement.
The drug is currently undergoing clinical trials around the world, including in the UK.Early data suggests it can cut recovery time by about four days,
but there is no evidence yet that it will save more lives.
[link to www.bbc.com (secure)]

(May 30, 2020) Taiwan approves remdesivir as COVID-19 medication
Taiwan's health authorities have approved the potential new coronavirus COVID-19 medication remdesivir
for treatment of the disease in the country, the Central Epidemic Command Center said Saturday.
At a daily press briefing, Wu Shou-mei, Director-General of Taiwan's Food and Drug Administration (FDA),
said that a panel of experts which met on Friday found that the drug was needed in Taiwan and agreed
that it should be used to treat severe patients infected with COVID-19.
Taiwan plans to order doses for 1,000 patients, with the order expected to arrive late July,
Wu said, adding that the move is to ensure there is enough medication for severely ill
patients if a second wave of infection occurs.
Due to the emergency of the situation, Taiwan needs to quickly approve the drug for its patients, Wu said.
Remdesivir was given an emergency use authorization in the United States on May 1 and was also given a special approval
for emergencies in Japan on May 7, Wu said.
[link to focustaiwan.tw (secure)]