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WHO Now Officially Recommends to Avoid Taking Ibuprofen For COVID-19 Symptoms
The World Health Organization recommended Tuesday that people suffering COVID-19 symptoms avoid taking ibuprofen, after French officials warned that anti-inflammatory drugs could worsen effects of the virus.
The warning by French Health Minister Veran followed a recent study in The Lancet medical journal that hypothesised that an enzyme boosted by anti-inflammatory drugs such as ibuprofen could facilitate and worsen COVID-19 infections.
Asked about the study, WHO spokesman Christian Lindmeier told reporters in Geneva the UN health agency’s experts were “looking into this to give further guidance.”
“In the meantime, we recommend using rather paracetamol, and do not use ibuprofen as a self-medication. That’s important,” he said.
He added that if ibuprofen had been “prescribed by the healthcare professionals, then, of course, that’s up to them.”
His comments came after Veran sent a tweet cautioning that the use of ibuprofen and similar anti-inflammatory drugs could be “an aggravating factor” in COVID-19 infections.
“In the case of fever, take paracetamol,” he wrote.
The French minister stressed that patients already being treated with anti-inflammatory drugs should ask advice from their doctor.
Paracetamol must be taken strictly according to the recommended dose, because too much of it can damage the liver.
The COVID-19 pandemic, which has infected around 190,000 people worldwide and killed more than 7,800, causes mild symptoms in most people, but can result in pneumonia and in some cases severe illness that can lead to multiple organ failure.
Even before the pandemic, French authorities sounded the alarm over serious “infectious complications” linked to the use of ibuprofen, which is sold under various brands like Nurofen and Advil, and other anti-inflammatory drugs.
A spokesperson for British pharmaceutical company Reckitt Benckiser, which makes Nurofen, said in an email statement that the company was aware of concerns raised about “the use of steroids and non-steroidal anti-inflammatory (NSAIDs) products, including ibuprofen, for the alleviation of COVID-19 symptoms.”
“Consumer safety is our number one priority,” the spokesperson said, stressing that “ibuprofen is a well-established medicine that has been used safely as a self-care fever and pain reducer, including in viral illnesses, for more than 30 years.”
“We do not currently believe there is any proven scientific evidence linking over-the-counter use of ibuprofen to the aggravation of COVID-19,” the statement said.
The spokesperson said Reckitt Benckiser was “engaging with the WHO, EMA (the European Medicines Agency) and other local health authorities” on the issue and would provide “any additional information or guidance necessary for the safe use of our products following any such evaluation.”
Coronavirus Live Updates: W.H.O. Chief Warns It’s ‘Time to Act’
As Europe and the United States struggle to contain the virus and the markets stagger, the Chinese province at the center of the outbreak reported no new infections outside its capital, Wuhan. New York State confirmed 11 new cases of the coronavirus, the authorities said Friday, all of them linked to a Westchester man who was the state’s second case to test positive for the virus. That brings the state’s total to 33 cases.
The first large U.S. university has closed classrooms, with more making plans to follow.
The University of Washington said on Friday that it would cancel in-person classes and have students take classes and final exams remotely while the Seattle area grapples with a growing coronavirus outbreak, in a move that other colleges around the country are preparing to follow if the virus becomes more widespread.
A growing number of universities have mobilized emergency planning teams to envision what a shutdown would look like, especially if students were to bring the virus back with them from spring break, which starts Friday on many campuses. Some students have already been warned that they should be prepared to learn online, as many students in Europe and Asia have been forced to do.
The level of concern rose on Thursday with the announcement that a junior at Vanderbilt University in Tennessee who had been studying in Italy had tested positive for the virus after he returned to Chicago when his classes were canceled. The University of California Los Angeles said that three of its students were self-isolating off campus as they awaited test results.
The University of Washington, which has 50,000 students on three campuses across the Seattle region, was apparently the first large college in the United States to shift to online classes amid virus concerns. It said the change would begin on Monday and continue through the rest of the winter quarter, which ends March 20. The university’s president, Ana Mari Cauce, said she was hopeful that normal classes would resume during the spring quarter.
The announcement was the most sweeping decision yet for leaders in the Seattle area rushing to contain the spread of coronavirus, which has been linked to at least 13 deaths and 75 infections in the state — all but one announced over the past week.
“Our goal is to complete this academic quarter with as little disruption to our students and their educational progress as possible,” Ms. Cauce said.
The world’s leading health official implored international leaders to unleash the full power of their governments to combat the new coronavirus outbreak.
“This is not a drill,” said Dr. Tedros Adhanom Ghebreyesus, director general of the World Health Organization. “This is not a time for excuses. This is a time for pulling out all the stops.”
But around the world, as the number of cases passed 100,000, governments have displayed signs of paralysis, obfuscation and a desire to protect their own interests, even as death tolls passed 3,200 and global capitals were so threatened by infection that politicians and health officials tested positive for the illness.
In the United States, the number of cases passed 245 as public health labs anxiously awaited diagnostic kits, which will allow for a fuller sense of the scale of the crisis. As of Friday, New York State had 33 confirmed cases of coronavirus.
President Trump signed an $8.3 billion emergency spending bill Friday morning and decided to visit the Centers for Disease Control and Prevention in Atlanta, reversing his decision hours earlier to skip touring the nerve center of the government’s response to the health crisis.
Americans struggled to make sense of conflicting information from Mr. Trump and members of his own cabinet. Vice President Mike Pence, who previously vowed that “any American could be tested,” conceded on Thursday that “we don’t have enough tests today to meet what we anticipate will be the demand going forward.”
Dr. Tedros warned that time to contain the virus was running out. “Now is the time to act,” he said. China’s draconian measures to stem the outbreak showed more signs of success on Friday, when Hubei province — the place were the coronavirus first emerged — reported that it had no new cases of infection outside its capital, Wuhan, for the first time.
Still, some political leaders around the world seemed more interested in pointing fingers at one another and complaining about tit-for-tat travel restrictions. Japanese citizens have been outraged by the hands-off approach of Prime Minister Shinzo Abe as cases have continued to climb. Lending more outrage, testing has proceeded slowly, leaving many fearful that many infections are going undetected.
In the center of the outbreak in China, residents of Wuhan who have been confined to their homes for weeks heckled the visiting vice prime minister Thursday, with some shouting from their windows: “Fake! Everything is fake!”
At least 45 people on the cruise ship idling off San Francisco who were showing symptoms of the coronavirus could learn the results of their diagnostic tests on Friday.
The panic on the ship, the Grand Princess, began after a 71-year-old man who had traveled on a previous leg of the cruise, a round trip from San Francisco to Mexico, died after leaving the ship. It was the first death from the coronavirus in California. Another passenger from that leg of the trip also tested positive for the virus.
There are 3,533 people currently onboard Grand Princess, including 1,111 crew members. Passengers onboard said they had been confined to their rooms while crew members have canceled large gatherings and were cleaning surfaces more often, among other precautionary measures.
As the coronavirus, which broke out in China last year, has spread across the globe, the West Coast has taken the brunt of the caseload in the United States.
In Washington State, 13 people have died from the virus, most from a Seattle-area nursing home. Also in the Seattle area, two Microsoft employees were being treated for the coronavirus, the first from the company to get the diagnosis, a company spokesman said overnight Thursday. And in California, 56 people have been treated for the coronavirus, the most of any state.
In Southern California, three students at the University of California, Los Angeles are being tested for the virus by the Los Angeles County Department of Public Health, the school’s chancellor said on Thursday night. The students were self-isolating off campus. While the public health department has expedited the test results, university officials decided to keep the campus on its normal schedule of classes and activities.
President Trump signs an $8.3 billion emergency aid bill.
President Trump on Friday signed an $8.3 billion emergency spending bill to confront the coronavirus outbreak and decided to visit the Centers for Disease Control and Prevention in Atlanta, reversing his decision hours earlier to skip touring the nerve center of the government’s response to the health crisis.
As late as 9 p.m. Thursday, Vice President Mike Pence publicly indicated that the trip was still on, telling reporters traveling with him to Washington State that the president would formally approve the spending measure while in Atlanta. “President Trump is expected to sign the legislation tomorrow as he visits the C.D.C. in Atlanta,” Mr. Pence said.
But by 11:30 p.m., when the White House issued the president’s public schedule, the visit was no longer on the calendar. A White House official initially said the president had canceled the visit because he did not want to interfere with the work there. But then Mr. Trump told reporters it was called off because of a suspected case of coronavirus at the C.D.C. itself.
As he signed the spending bill at the White House on Friday, Mr. Trump said the report of an infection at C.D.C. turned out to be negative. “So I may be going,” he told reporters. “We’re going to see if they can turn it around.”
En route to Nashville on Friday to visit the site of a deadly tornado, the White House press secretary, Stephanie Grisham, told reporters that the C.D.C. visit was back on.
“What the president said is true,” Ms. Grisham said when asked about the last-minute reversal. She added that test results from the woman at the C.D.C. who was suspected to have the coronavirus came back negative.
The president is to travel to Atlanta after his visit in Nashville and then head to Florida, where he is to headline campaign fund-raising events. He is expected to spend the weekend at his Mar-a-Lago estate.
How to Conquer Coronavirus: Top 35 Treatments in Development
As the world scrambles to monitor and contain the COVID-19 outbreak, drug companies are racing to develop or repurpose treatments to combat the potential pandemic. The death toll continues to climb. The first U.S. death associated with the SARS-CoV-2 virus was reported in Washington state February 29. As of March 2, according to the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University, 3,048 people in 11 countries had died worldwide, nearly all of them (96% or 2,914) in China.
CSSE also reported 89,198 confirmed cases in 67 countries, including 80,026 (90%) in China and 86 in the U.S. Of those confirmed cases, just over half (45,175) have recovered.
A new survey by Genetic Engineering & Biotechnology News (GEN) reveals 35 active drug development programs in North America, Europe, and China. Those 35 include treatments that have received the greatest public attention in recent days, being developed by companies that range from pharma giants like GlaxoSmithKline and Sanofi, to small and large biotechs such as Moderna and Gilead Sciences. Gilead has begun clinical trials in China after peer-reviewed journals showed its antiviral candidate, remdesivir, having positive results in a case involving an American patient and Chinese in vitro tests.
China’s status as the center of the SARS-CoV-2 outbreak is reinforced by a statistic tucked at the bottom of a report published February 28 by the state-run Xinhua news agency: Of 234 clinical trials registered with the Chinese Clinical Trial Registry, nearly half (105) focus on treatments for COVID-19.
Many of those trials are included in the 60 studies listed in ClinicalTrials.gov whose descriptions include the term COVID-19, as well as the seven studies whose descriptions include SARS-CoV-2. The U.S. website lists 331,715 trials in 209 countries.
In the Xinhua report, Wu Yuanbin, director-general of Science and Technology for social Development with China’s Ministry of Science and Technology (MOST), announced the publication of guidelines for clinical studies of drugs and vaccines intended to combat the deadly viral outbreak. The guideline gives priority to drugs that are already marketed, and whose efficacy has been proven in animal and in vitro studies.
Yet repurposing existing drugs is just one proverbial arrow in the quiver of drug developers and health agencies worldwide, as seen in GEN’s A-List of top 35 treatments under development and/or clinical study for COVID-19, as disclosed by drug developers and/or authorities in recent weeks. Because some of the experimental treatments have yet to be named, or identified, each prospective treatment is listed by its developer, followed by the treatment name or description, the type of treatment including its mechanism, and a brief status update summarizing recent developments.
Where applicable, the status updates include links to recent news reports in GEN, as well as to clinical trials pages maintained by U.S. authorities via ClinicalTrials.gov, and by Chinese authorities as the Chinese Clinical Trial Registry.
In many cases, Chinese authorities, hospitals, and companies are studying potential treatments outside the auspices of their original developers. The First Hospital of Changsha and the Second Xiangya Hospital of Central South University are primary sponsors partnering with Hu’nan Haiyao hongxingtang Pharmaceutical Co. on a clinical trial assessing the combination of Beijing Genova Biotech’s Novaferon, a recombinant interferon alpha (IFN-α) like viral protein launched in 2018 to treat hepatitis B, and AbbVie’s Kaletra® (See above) in eliminating SARS-CoV-2 in patients with COVID-19. The trial has been prospectively registered with Chinese authorities. (ChiCTR2000029496).
Another example: Pirfenidone—an idiopathic pulmonary fibrosis drug marketed by Roche and its Genentech subsidiary as Esbriet®—will be studied in patients with severe and critical COVID-19, under a planned randomized, open-label clinical trial that has been prospectively registered by Tongji Hospital of Tongji Medical College, part of Huazhong Science and Technology University (ChiCTR2000030333).
Two other recent coronavirus-related collaborations focus on potential targets. The Israeli Institute for Biological Research, a government research institute, said February 25 it will explore the potential of Dyadic International’s C1 gene expression platform to express gene sequences and targets developed by the Institute into an rVaccine candidate and monoclonal antibodies for treating COVID-19. A day earlier, Cocrystal Pharma agreed to license proprietary broad-spectrum antiviral compounds for COVID-19 and norovirus from Kansas State University Research Foundation. Cocrystal’s technology is designed to generate a 3D structure of inhibitor complexes at near-atomic resolution, enabling the company to identify novel binding sites.
And at least one collaboration announced January 28 focuses on a platform with the promise of future treatments: AbCellera said it and partners will apply its pandemic response platform to develop field-ready medical countermeasures within 60 days of isolation of an unknown viral pathogen. Those partners include researchers at the Vaccine Research Center at the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
This list is certain to multiply in coming weeks as global health agencies, governments, and drug developers step up efforts against the SARS-CoV-2 virus.
AbbVie
Treatment: Kaletra® (also marketed as Aluvia; lopinavir/ritonavir)
Type: HIV-1 protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children 14 days old and older.
Status: China’s National Health Commission authorized Kaletra to treat pneumonia caused by SARS-CoV-2, AbbVie announced on January 27. AbbVie has donated RMB 10 million ($1.4 million) of Kaletra to Chinese authorities “as an experimental option to support this growing public health crisis.”
The Health Commission of Henan Province announced January 31 that three confirmed cases of patients diagnosed with new coronavirus infections recovered after taking Kaletra, a combination of ritonavir and lopinavir. As of that date, nucleic acid testing of more than 20 confirmed cases of patients infected with new coronavirus, admitted to hospitals in Zhejiang Province turned negative after taking Kaletra, according to Ascletis Pharma, which is evaluating a combination therapy of its own candidates ASC09 and ritonavir (See below).
AIM ImmunoTech
Treatment: Ampligen® (rintatolimod)
Type: Immune modulator indicated for severe chronic fatigue syndrome
Status: AIM ImmunoTech said February 27 it is partnering with ChinaGoAbroad, a matchmaking and advisory service for cross-border deals involving China, to facilitate talks with China’s government to allow entry of AIM’s drug candidate Ampligen into China for use as a prophylactic/early-onset therapeutic against COVID-19. The companies are pursuing approval for trials in China, and FDA authorization under regulations allowing the export of investigational drugs for use in a sudden and immediate national emergency. Through those rules, AIM won FDA authorization to import Ampligen into Argentina in 2019 as a treatment for severe chronic fatigue syndrome.
Altimmune
Treatment: Single-dose, intranasal vaccine designed to provide systemic immunity
Type: Vaccine based on Altimmune’s proprietary platform vaccine technology, which the company applied in developing NasoVAX, the company’s influenza vaccine candidate that showed positive Phase IIa results.
Status: Altimmune said February 28 that it completed the design and synthesis of the vaccine, and was advancing it toward animal testing and manufacturing. Clinical testing of the vaccine could start as early as August. The company also said it was “actively engaged in discussions with a number of potential partners.”
APEIRON Biologics
Treatment: APN01
Type: Recombinant human angiotensin-converting enzyme 2 (rhACE2) developed for the treatment of acute lung injury, acute respiratory distress syndrome, and pulmonary arterial hypertension.
Status: Vienna-based APEIRON on February 26 launched a pilot investigator-initiated clinical trial in China designed to assess APN01 as a treatment for patients with severe SARS-CoV-2 infection. The randomized, unblinded trial will treat 24 patients for seven days to obtain preliminary data on the impact of rhACE2 on biological, physiologic, and clinical outcomes, as well as safety. Suzhou-based Angalpharma is coordinating the Chinese clinical trial, with support from dMed Pharmaceutical, a CRO based in Shanghai.
Ascletis Pharma
Treatments: Ganovo® (danoprevir) plus ritonavir; ASC09 and ritonavir; ASC09 and oseltamivir; ritonavir and oseltamivir;
Types: HIV protease inhibitors
Status: Ascletis stated February 26 that three COVID-19 patients treated with its combination therapy Ganovo® (danoprevir) plus ritonavir were discharged from the Ninth Hospital of Nanchang following treatment. On February 2, Ascletis said it is actively assisting “relevant medical institutions and medical researchers” in clinical trials assessing the combination of Ascletis’ ASC09 and ritonavir for COVID-19, following a request they made to the company. On January 25, Ascletis applied to the National Medical Products Administration and its Drug Evaluation Center to include ritonavir and ASC09 fixed-dose combination into the national emergency channel.
China’s Tongji Hospital is also testing combinations of ASC09 and Tamiflu (oseltamivir), ritonavir and Tamiflu (oseltamivir), and Tamiflu alone in one trial listed on ClinicalTrials.gov (NCT04261270). Tamiflu is distributed in the U.S. by Genentech, a member of the Roche Group, under license from Gilead Sciences. Also, a trial prospectively registered by The First Affiliated Hospital of Zhejiang University School of Medicine is assessing combinations of ASC09 and ritonavir, and lopinavir and ritonavir (ChiCTR2000029603).
Bayer and numerous Chinese manufacturers
Treatment: Chloroquine phosphate (marketed by Bayer as Resochin®)
Type: Phosphate salt of chloroquine, a quinoline compound with antimalarial and anti-inflammatory properties. Resochin was discovered by Bayer and introduced into clinical practice in 1947 to treat malaria.
Status: Evaluated in clinical trials in over 10 hospitals in Beijing, as well as in south China’s Guangdong Province and central China’s Hunan Province, where it has “shown fairly good efficacy” according to Sun Yanrong, deputy head of the China National Center for Biotechnology Development under the Ministry of Science and Technology (MOST), the state-owned Xinhua news agency reported on February 17. Chloroquine and remdesivir were “highly effective in the control of 2019-nCoV infection in vitro,” a team of Chinese researchers reported in a study published February 4 in Cell Research. After China’s National Health Commission included chloroquine phosphate in its latest treatment guidelines for COVID-19 pneumonia, eight Chinese companies sped up manufacturing and supply of the drug, Shanghai Daily reported February 20.
Beijing Staidson Biopharma and InflaRx
Treatment: IFX-1
Type: Anti-C5a monoclonal antibody in development for COVID-19 as well as hidradenitis suppurativa
Status: Chinese authorities approved clinical trials of IFX-1 as a COVID-19 treatment in February.
Biocryst
Treatment: Galidesivir (BCX4430)
Type: Nucleoside RNA polymerase inhibitor designed to disrupt the viral replication process
Status: Shown broad-spectrum activity in vitro against more than 20 RNA viruses in coronaviruses and viral disease families that include filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, and flaviviruses.
BioXyTran
Treatment: BXT-25
Type: Anti-necrosis drug whose glyco-polymer structure consists of hybrid molecules integrating the Hemoglobin molecule and a proprietary polymer chemical structure. BXT-25 is company’s lead product candidate, designed to carry oxygen to tissues when the flow of blood is blocked.
Status: Boston-based Bioxytran said February 5 that it is exploring partnering with “international drug companies” to develop BXT-25 as a treatment for Acute Respiratory Distress Syndrome (ARDS) in end-stage patients with SARS-CoV-2. Since BXT-25 is 5,000 times smaller than red blood cells, the company will use MDX Life Sciences’ MDX Viewer to assess the safety and efficacy of the drug.
Celularity and Sorrento Therapeutics
Treatment: CYNK-001
Type: Allogeneic, off-the-shelf, placental-derived Natural Killer (NK) cell therapy
Status: The companies on January 30 launched a clinical and manufacturing collaboration designed to expand the therapeutic use of Celularity’s CYNK-001 to COVID-19. Sorrento and Celularity agreed to assess CYNK-001 as a potential novel therapy for coronaviruses, specifically SARS-CoV-2. Sorrento—which owns 25% of Celularity—agreed to use current existing capacity in its cGMP cell therapy manufacturing facilities in San Diego to supplement Celularity’s new cGMP facility in Florham Park, NJ. Sorrento said it is already in contact with “leading” scientists and local Chinese experts to discuss clinical validation and logistics requirements for fast-tracking CYNK-001 in China.
Chugai Pharmaceutical and Zhejiang Hisun Pharmaceutical
Treatment: Tocilizumab
Type: Humanized mAb targeting interleukin-6
Status: A 94-patient trial assessing Tocilizumab has been registered with Chinese authorities by The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital) (ChiCTR2000029765).
CSL and The University of Queensland
Treatment: Vaccine
Type: Unspecified vaccine based on subsidiary Seqirus’ proprietary adjuvant technology, MF59®
Status: On February 12, CSL said it will provide technical expertise and a donation of MF59 to the University of Queensland’s preclinical development program. The University will use the adjuvant to test the viral protein it is developing with its molecular clamp technology, CSL said. The company also committed a donation of RMB 1 million ($143,000) to the China Red Cross toward efforts to combat the epidemic.
CureVac
Treatment: mRNA-based vaccine
Type: Vaccine applying CureVac’s mRNA vaccine development platform
Status: CureVac and the public-private Coalition for Epidemic Preparedness Innovations (CEPI) are collaborating to develop a vaccine against SARS-CoV-2, the partners said January 31, extending their existing partnership to develop a rapid-response vaccine platform. CEPI has committed up to $8.3 million in additional funding for accelerated development, manufacturing, and clinical tests. CEPI CEO Richard Hatchett said the Coalition and CureVac aspire to bring the pathogen’s gene sequence to a vaccine candidate for clinical testing “within a few months.”
CytoDyn
Treatment: Leronlimab (PRO 140)
Type: Humanized IgG4 monoclonal antibody. Leronlimab is CytoDyn’s lead candidate, and is a CCR5 antagonist with potential for multiple therapeutic indications.
Status: CytoDyn plans to offer an update during a March 5 conference call with analysts about its planned filing of an IND and its Phase II clinical trial protocol with the FDA, as the company seeks to evaluate the leronlimab as a coronavirus treatment. CytoDyn and Longen China Group said February 12 they will begin exploring leronlimab as a potential treatment for coronavirus as well as cancer.
Leronlimab has successfully completed nine clinical trials in over 800 people, according to CytoDyn, including meeting its primary endpoints in a pivotal Phase III trial in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn has said it plans to file a BLA with the FDA in HIV during Q1 2020. Leronlimab has the FDA’s Fast Track designation as a combination therapy with highly active antiretroviral therapy (HAART) for HIV-infected patients, and for metastatic triple-negative breast cancer.
Fujifilm Holdings and Zhejiang Hisun Pharmaceutical
Treatment: Favipiravir (marketed by Fujifilm as Avigan and by Hisun in China as Favilavir)
Type: Broad spectrum anti-viral agent that is designed to selectively and potently inhibit the RNA-dependent RNA polymerase (RdRp) of RNA viruses. Japan has approved Avigan for novel or re-emergent influenza and was previously used to treat Ebola patients in Guinea.
Status: Japan’s Health Minister Katsunobu Kato said February 22 that his ministry would recommend Avigan, developed by Fujifilm-owned Toyama Chemical, for use as a coronavirus treatment after test dosages appeared effective in mild and asymptomatic cases at least two medical institutions. In China, the National Health Commission on February 17 approved Hisun’s version of the drug as an investigational treatment for SARS-CoV-2 in an upcoming clinical trial being conducted in Shenzhen.
Generex Biotechnology
Treatment: Ii-Key peptide vaccine
Type: Vaccine based on Generex’s Ii-Key immune system activation technology platform
Status: Generex said February 27 it has received a contract from the China Technology Exchange, Beijing Zhonghua Investment Fund Management Co. Ltd., Biology Institute of Shandong Academy of Sciences, and Sinotek-Advocates International Industry Development (Shenzhen) Co. Ltd. to develop a Ii-key vaccine. Generex said it would receive $1 million upfront to initiate project work in the U.S., a $5 million licensing fee for the Ii-Key technology, payment by the Chinese consortium for all costs and expenses related to the development of a COVID-19 vaccine, and a 20% royalty on each dose of vaccine produced.
Gilead Sciences
Treatment: Remdesivir (GS-5734)
Type: Nucleotide prodrug
Status: The NIH announced February 25 it will run the first U.S. clinical trial evaluating an experimental treatment for COVID-19, by assessing remdesivir in patients at the University of Nebraska Medical Center in Omaha, where some Americans with the disease are being cared for or are under quarantine. Remdesivir showed “no adverse events” when administered to the first American confirmed to be infected with SARS-CoV-2, members of the Washington State 2019-nCoV Case Investigation Team reported in a case study published January 31 in The New England Journal of Medicine.
In China, clinical trials of Gilead Sciences’ remdesivir have begun after China’s National Medical Products Administration approved applications by the China-Japan Friendship Hospital and the Chinese Academy of Medical Sciences to conduct the studies. Remdesivir and chloroquine phosphate were “highly effective in the control of 2019-nCoV infection in vitro,” a team of Chinese researchers reported in a study published February 4 in Cell Research.
GlaxoSmithKline and Clover Biopharmaceuticals
Treatment: COVID-19 S-Trimer
Type: Protein-based coronavirus vaccine
Status: GSK agreed to provide Clover with its pandemic adjuvant system for further evaluation of S-Trimer in preclinical studies, the companies said February 24, under a research collaboration whose value was not disclosed. GSK reasons that Clover could rapidly scale-up and produce large-quantities of a new coronavirus vaccine since it has one of the largest in-house, commercial-scale cGMP biomanufacturing capabilities in China.
“GSK is the world leader in vaccines, and partnering with them significantly boosts our hopes of both the timely development of a vaccine, and the capability to produce it in large enough quantities necessary to curb the coronavirus outbreak,” said Michael Breen, director, Infectious Diseases, Pharma at GlobalData.
iBio and Beijing CC-Pharming
Treatment: Vaccine
Type: Plant-derived vaccine to be manufactured using iBio’s FastPharmingSystem™
Status: The companies on February 3 disclosed plans to develop and test a COVID-19 vaccine, combining the vaccine R&D experience—including work on the MERS-coronavirus—by CC-Pharming Chairman and chief scientific officer Kevin Wang, PhD, and iBio VP Upstream Bioprocessing Sylvain Marcel, PhD, in rapid design of manufacturing processes for biopharmaceutical production in plant-based expression systems. If successful, the research will deliver product candidates for production at iBio’s FastPharmingManufacturing Facility, built in 2010 with funding from the Defense Advanced Research Projects Agency (DARPA), to establish facilities capable of rapid delivery of medical countermeasures in response to a disease pandemic.
ImmunoPrecise Antibodies
Treatments: Vaccines and coronavirus-neutralizing antibodies
Types: Prophylactic and therapeutic compounds using ImmunoPrecise’s proprietary discovery platforms (including B Cell Select™ and DeepDisplay™) and ImmunoPrecise subsidiary Talem Therapeutics’ access to the transgenic animal platform OmniAb® for direct generation of human antibodies.
Status: ImmunoPrecise announced its commitment to finding COVID-19 treatments on February 20, saying it had designated Ilse Roodink, PhD, chairwoman of Talem’s scientific committee, as its Coronavirus Global Project Leader.
Incyte, Shanghai Hengrui Pharmaceutical
Treatment: Camrelizumab and thymosin
Types: Humanized monoclonal antibody targeting PD-1 (Camrelizumab); 5-Da polypeptide hormone secreted by the thymus gland (thymosin)
Status: Chinese clinical trials assessing the combination treatment have been registered by Wuhan Jinyintan Hospital (Wuhan Infectious Diseases Hospital) (ChiCTR2000029806) and Southeast University (NCT04268537).
Innovation Pharmaceuticals
Treatment: Brilacidin
Type: Defensin mimetic in Phase II development in oral muscositis in Head and Neck Cancer patients
Status: Innovation said February 24 that it submitted a Material Transfer Agreement with an unidentified “leading U.S.-based virology laboratory” to study Brilacidin as a potential novel treatment for SARS-CoV-2. If lab tests prove successful, Innovation said, it will expedite research and clinical development of Brilacidin “via pharmaceutical partnerships, academic collaborations and government grants.” Innovation has also submitted a preliminary summary of Brilacidin’s potential for treating coronavirus to the Biomedical Advanced Research and Development Authority (BARDA).
Inovio Pharmaceuticals and Beijing Advaccine Biotechnology
Treatment: INO-4800
Type: Vaccine
Status: Inovio said January 30 it will leverage Beijing Advaccine Biotechnology’s expertise to run a Phase I trial in China in parallel with the company’s clinical development efforts in the U.S. to develop INO-4800 as a coronavirus treatment. The company has said it will develop INO-4800 through Phase I testing in the U.S., and has launched preclinical testing for clinical product manufacturing. Development of INO-4800 is supported by $9 million grant from the Coalition for Epidemic Preparedness Innovations (CEPI).
Janssen Pharmaceutical Cos. (Johnson & Johnson)
Treatments: Prezcobix™ (darunavir and cobicistat); Vaccine to be developed with BARDA
Types: HIV protease inhibitors (Prezcobix); vaccine type to be developed
Status: Janssen said January 29 it has donated 300 boxes of Prezcobix to the Shanghai Public Health Clinical Center and Zhongnan Hospital of Wuhan University for use in research to support efforts in finding a solution against SARS-CoV-2. Another 50 boxes have been provided to the Chinese Center for Disease Control and Prevention for laboratory-based investigations. Prezcobix is under study in a trial sponsored by Shanghai Public Health Clinical Center (NCT04252274), while a Chinese trial is assessing Precobix or the lopinavir-ritonavir combination combined with thymosin a1 (ChiCTR2000029541).
Separately, Janssen said February 11 it has expanded an existing collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine candidate for SARS-CoV-2. The partners agreed to share R&D costs and expertise to help accelerate Janssen’s investigational COVID-19 vaccine into clinical trials. Janssen said it is also working closely with global partners to screen its library of antiviral molecules to accelerate discovery of potential COVID-19 treatments.
LineaRx (Applied DNA Sciences) and Takis Biotech
Treatment: Linear DNA vaccine
Type: To be based on PCR-produced linear DNA designed to induce antibodies that can neutralize SARS-CoV-2
Status: LineaRx, a majority-owned subsidiary of Applied DNA Sciences of Stony Brook, NY, and Rome-based Takis Biotech said February 7 they have formed a joint venture to develop the preclinical vaccine using PCR-based DNA manufacturing technology. No commercial partner to take the coronavirus vaccine to market has been identified, the companies said.
The companies said advantages of their technology include the speed of production, the absence of antibiotics and their resistance genes, the purity of the DNA, the simplicity of design, the powerful immunogenicity proved in a prior linear DNA vaccine, the absence of any bacterial contaminants and the effectiveness of the vaccine gene without insertion into the patient’s genome.
Moderna
Treatment: mRNA-1273
Type: Novel lipid nanoparticle (LNP)-encapsulated mRNA vaccine against the COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein.
Status: Moderna said February 24 that it shipped the first batch of mRNA-1273 to the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) for use in a planned Phase I study in the U.S. The primary aim of the Phase I open-label, dose-ranging trial study (NCT04283461), which had yet to recruit patients at deadline, is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 3 dosages in healthy adults. Moderna designed the vaccine in collaboration with investigators at the NIAID Vaccine Research Center (VRC).
NanoViricides
Treatment: Antiviral therapy based on company’s novel nanomedicines platform.
Type: Broad-spectrum virus-binding ligand: “It is like a ‘Venus-Fly-Trap’ for the virus,” says Anil R. Diwan, PhD, President and Executive Chairman.
Status: NanoViricides confirmed January 30 that it was developing a COVID-19 treatment, stating that it “already found some lead candidate ligands in its chemical library” that can bind to the SARS-CoV spike protein just as it binds to cognate receptor ACE2.
NanoViricides’ technology relies on copying the human cell-surface receptor to which the virus binds, and making ligands that chemically attach to a nanomicelle, to create a nanoviricide®. When a virus comes in contact with the nanoviricide, the nanomicelle polymer is designed to fuse with the virus lipid envelope.
The company said it has started preparing for testing of potential candidates in cell cultures against “low-threat” coronaviruses, including ones that use the ACE2 receptor, in its own BSL-2 virology laboratory at its Shelton, CT, campus. NanoViricides added that it is working on developing collaborations to advance its COVID-19 program should an effective drug candidate be identified.
Novavax
Treatment: Vaccine candidate to be selected
Types: Vaccines designed to apply company’s proprietary recombinant protein nanoparticle technology platform to generate antigens derived from the coronavirus spike (S) protein. Novavax said it expects to utilize its proprietary saponin-based Matrix-M™ adjuvant with COVID-19 vaccine candidates to enhance immune responses.
Status: “We are now well-positioned to advance the COVID-19 vaccine candidate to Phase I clinical testing in May or June,” President and CEO Stanley C. Erck said February 26 in a statement. Novavax cited progress in its development saying it has produced and is currently assessing multiple nanoparticle vaccine candidates in animal models prior to identifying an optimal candidate for human testing.
Pharmstandard
Treatment: Arbidol (umifenovir)
Type: Membrane fusion inhibitor developed as a treatment for influenza
Status: Pharmstandard is assessing Arbidol in clinical trials as monotherapy and in combinations that include AbbVie’s Kaletra (See above), Ascletis Pharma’s ASC09 (See above), lopinavir, ritonavir, carrimycin, and Bromhexine Hydrochloride (enrolling by invitation). Five trials including Arbidol were listed on ClinicalTrials.gov. China’s Ruijin Hospital is conducting the monotherapy trial (NCT04260594), while various Chinese hospitals are investigating the combination therapies (NCT04252885, NCT04273763, NCT04261907, NCT04286503).
Q Biomed and Mannin Research
Treatment: Drug to treat vascular diseases in people with COVID-19
Type: Adjunct treatment for vascular leakage and endothelial dysfunction seen in COVID-19 and other infectious diseases, to be developed based on the lead platform of research partner Mannin Research, which is designed to target the activation of the Angiopoietin-Tie2 signaling pathway.
Status: Q Biomed and Mannin Research announced their collaboration on February 4. In September 2019, the German state of Saxony awarded Mannin approximately a US $7.7 million grant to advance its novel therapeutics, including drugs and biologics that reduce endothelial dysfunction and loss of endothelial barrier integrity. Mannin recently submitted a funding application to the NIH’s Small Business Technology Transfer Grant to investigate specific applications of Mannin’s therapeutic platform.
Regeneron Pharmaceuticals
Treatments: REGN3048 and REGN 3051
Types: Combination of neutralizing monoclonal antibodies leveraging Regeneron’s monoclonal antibody discovery platform called VelocImmune®, part of the company’s VelociSuite™ technologies.
Status: On February 4, The Biomedical Advanced Research and Development Authority (BARDA) said it was expanding upon an earlier partnership agreement with Regeneron to develop “multiple monoclonal antibodies that, individually or in combination, could be used to treat new treatments.” The combination completed a Phase I trial in MERS-CoV last year (NCT03301090).
Sanofi
Treatment: Unnamed vaccine
Type: Vaccine based on Sanofi’s recombinant DNA platform, designed to produce an exact genetic match to proteins found on the surface of the virus. Sanofi said the DNA sequence encoding the antigen will be combined into the DNA of the baculovirus expression platform and used for rapidly producing large quantities of the coronavirus antigen, which will be formulated to stimulate the immune system to protect against the virus.
Status: Sanofi said February 18 that its Sanofi Pasteur vaccines global business unit will apply previous development work for a SARS vaccine with the aim of accelerating development of a COVID-19 vaccine through a collaboration with the Biomedical Advanced Research and Development Authority (BARDA). In non-clinical studies, the SARS vaccine candidate was immunogenic and afforded partial protection as assessed in animal challenge models, Sanofi said. That earlier work by Protein Sciences, acquired by Sanofi in 2017, “provides a head start in expediting a COVID-19 vaccine,” Sanofi stated.
Tonix Pharmaceuticals Holding
Treatment: TNX-1800
Type: Live modified horsepox virus vaccine for percutaneous administration
Status: Tonix said February 26 it has partnered with Southern Research to develop TNX-1800 as a vaccine treatment for COVID-19. TNX-1800 is under development as a potential smallpox preventing vaccine for the U.S. strategic national stockpile and as a monkeypox preventing vaccine.
Vaxart
Treatment: Vaccine based on proprietary VAAST™ Platform
Type: Oral recombinant vaccine administered by tablet
Status: Vaxart said January 31 that it plans to generate vaccine candidates based on the published genome of the 2019 COVID-19 (SARS-nCoV-2) and evaluate them in preclinical models based on their ability to generate both mucosal and systemic immune responses.
Vir Biotechnology and WuXi Biologics
Treatment: As-yet undisclosed human monoclonal antibodies
Type: Human monoclonal antibodies shown to bind to SARS-CoV-2, isolated from individuals who had survived a Severe Acute Respiratory Syndrome (SARS) infection.
Status: Vir Biotechnology on February 25 announced a development and manufacturing collaboration With WuXi Biologics to advance and produce human monoclonal antibodies as potential treatments for COVID-19. The antibodies were discovered through the company’s antibody platform, which has been used to identify and develop antibodies for pathogens that include Ebola (mAb114, currently in use in the Democratic Republic of Congo), hepatitis B virus, influenza A, malaria, and others. Should the antibodies receive regulatory approvals, WuXi Biologics has rights to commercialize therapies in Greater China and Vir, in all other markets worldwide. Olive Oil The New Viagra? New Study Shows It Might Be
Olive oil is the staple of the healthy Mediterranean diet – and one that countless studies have credited with being the healthiest in the world, due to its ability to prevent a number of chronic diseases by lowering high blood pressure, high blood sugar, as well as bad cholesterol.
Interestingly, a recent study, printed in The Telegraph, has highlighted a number of bedroom benefits associated with the oil. The study linked olive oil to improved male sexual health and with erectile dysfunction affecting about 5% percent of men in their 40s, with the number increasing to about 15% of men at age 70, proving that the men in our lives might want to start adding this oil to their salads.
The Study
Researchers at the University of Athens School of Medicine in Greece conducted a study focusing on the the benefits of a Mediterranean diet, more so on sexual health.
For the study, the researchers recruited 660 men who had an average age of 67. Some of them were then encouraged to adopt the Mediterranean diet – eating a diet rich in nuts, fruits, vegetables and legumes, low in red meat and refined foods while also moderately high in dairy and fish. They also replaced all butter with olive oil – nine daily tablespoons of olive oil to be exact.
The Results
The study revealed that those who consumed the Mediterranean diet had improved sexual health.
Specifically, the study saw that the nine tablespoons of olive oil actually reduced impotence by around 40%. In fact, olive oil also elevated testosterone levels and this then helped the men not only get an erection, but also maintain it. The oil also encouraged the dilation of the arteries- which translates to improved blood flow which also boosted sexual function.
“What we found here is that the Med diet has a positive effect on aortic dilatation.” explained lead researcher Dr. Christina Chrysohoou. “It keeps your blood vessels healthy and helps men maintain sexual function, and in all of all of the med diet components, it is the olive oil that has a specific effect on aortic dilatation and sexual function as well.” Moreover, unlike viagra, olive oil’s benefits lasted way beyond the three hours commonly associated with the blue pill.
The Verdict On Olive Oil
While erectile dysfunction can be both embarrassing and potentially fatal for your relationship, it can also be a precursor to heart disease. Thankfully, the Mediterranean diet provides a natural remedy that, unlike viagra, is free from uncomfortable side effects.
“This is a drug free solution that allows men to keep their sexual function. But also a long-term answer to protecting a man’s ability to perform in the bedroom,” added Dr. Chrysohoou, “Viagra does not improve something long-term, it can only give some short effect in order to have sexual capacity.”
However, while adopting the Mediterranean diet can be great for your sexual health, it is important to consult your doctor so that they can check if your erectile dysfunction is part of an underlying medical problem.
Read more about the study here
Viagra: the little blue pill that revolutionised our sex lives
The virility drug, soon to be available over the counter in the UK, is a phenomenal success story, despite being the butt of many jokes. In 25 years, it’s also changed how we talk about male impotence
It all began 25 years ago in Britain. The UK division of the American pharmaceutical giant Pfizer was running trials on a new drug for the treatment of angina. It was called UK-92480 and it wasn’t pulling up any trees.
But if UK-92480 failed with the heart, the symbolic home of love, it made a big impact on another organ, one with a rather more prosaic association with romance. Male participants in the trials reported a pronounced side-effect: erections. A lot of trees, and other things, were about to be pulled up.
Six years later, on 27 March 1998, the American Food and Drug Administration approved the sale of Viagra and the rest is hysteria. Or at least it was at first. The drug was a phenomenon. It registered sales of $1bn in its first year. And it seemed to drive some people just a little mad.
A chef was arrested in France after serving his customers a dish entitled “beef piccata in Viagra sauce with fig vinegar and fine herbs”. In Taiwan, a prostitute was arrested for killing a 74-year-old client who forced himself on her having already had sex once. And in Israel it was said that four Viagra pills had gone missing during a meeting of a five-member science committee in the Knesset.
Until the arrival of Viagra, the treatment for erectile dysfunction (ED) involved penile pumps or injections, neither of which, perhaps unsurprisingly, ever captured the male imagination. And probably did little for the female imagination either.
Now, suddenly, here was a drug for the problem-solving era, a drug that fitted the impatient acceleration of time in the personal computer age, a drug that, as the joke went, turned your floppy disc into a hard drive.
The research that underpinned the creation of Viagra itself stemmed from the work by three American scientists who would go on to win the Nobel prize for medicine in, coincidentally enough, 1998, the year of Viagra’s birth. The scientists discovered that the body uses nitric oxide to make blood vessels widen. Sildenafil citrate, the compound of which Viagra is the trademark, helps bind nitric oxide to receptors that enable relaxation of the helicine arteries, which, in turn, increases blood flow into the soft tissue of the penis, and results – as long as no one spoils the mood – in an erection.
Last week, it was announced that Britain would become the first country to make Viagra available over the counter. The move was initiated by the Medicines & Healthcare Products Regulatory Agency (MHRA) in the hope that it would prevent men using unregulated websites, where drugs for ED form a large and lucrative black market.
The legitimate market is already, as it were, huge and growing. Prescriptions have trebled over the past decade to almost 3m. But the sales of unlicensed ED drugs remain a profitable and unscrupulous business: among the £50m worth of counterfeit Viagra and other similar drugs seized over the past five years in Britain, some have been found to contain plaster of Paris, printer ink and even arsenic.
Two reasons have accounted for the illegal market. First, the high price Viagra was originally sold at. That dropped significantly in 2013, when Pfizer’s 15-year exclusive patent ran out. The other reason why men have preferred the sometimes dubious anonymity of the internet to the prescriptive dependability of a GP is that if Viagra increases blood flow to the very core of male identity, it’s also a matter that brings blood to the facial cheeks.
Despite the apparent ubiquity of the small blue, diamond-shaped pill, the issue it addresses – impotency – remains a subject of no little embarrassment.
And where there is embarrassment, humour is seldom far behind. When Viagra launched almost 20 years ago, some of the first beneficiaries of the drug were comedians and chatshow hosts. Not necessarily because they were users of it, but because it formed the punchline to so many of their jokes: “Did you hear about the first Viagra overdose? A guy took 12 pills and his wife died.”
By all accounts, Pfizer was a little downhearted that its star turn had become a laughing matter. After all, it had used the conservative figure of Bob Dole, former Republican leader of the Senate, to front its very sober advertising campaign.
But the truth is that while ED is undoubtedly a serious issue, the vulnerability of the penis remains an inescapably comic idea – manhood reduced to the unreliable dimensions of a fickle extremity.
Even celebrity endorsements could not shift the image of Viagra. Hugh Hefner referred to the drug as “God’s little helper”, but then, given that the dressing-gowned one was dating young Barbie-style twins at the time, his approval was never likely to normalise the drug or render it as unnoteworthy as, say, aspirin or indigestion tablets.
David Bailey (79) recently said that he had no problem getting old because Jack Nicholson had introduced him to Viagra. Michael Douglas has also lent his support, calling Viagra a “wonderful enhancement… that can make us all feel younger”. Disinterested observers might note that his wife Catherine Zeta-Jones is 25 years his junior, just as Bailey’s spouse, Catherine Dyer, is 23 years younger than the photographer.
For all their promotional benefits, such testaments ultimately serve to highlight an imbalance: namely that a much younger female partner necessitates a certain chemical help. And yet there are reports of young men taking Viagra to improve sexual performance or to counteract the effects of overexposure to pornography. In both cases, it seems that the effects are perhaps more psychological than physiological. Pfizer has long insisted that the drug has no effect on those who don’t suffer from ED, just as taking an aspirin will have no noticeable effect on someone without a headache.
Anecdotal evidence contradicts this view, but Pfizer points out the increased placebo effect of ED drugs. One executive said that in studies 20% of the men taking a sugar pill placebo reported “rip-snorting erections”. The mind can play tricks, especially on the penis, arguably the most gullible part of a man.
Another aspect of Viagra’s pulsating success story is its name. Rhyming – almost – with Niagara, it manages to conjure up an image of something vital and potent. But originally the brand name, which came out of Pfizer’s “name bank” (made up of invented words that have no meaning in any major language) was assigned to a drug for shrinking swollen prostate glands. It was only because the marketing people didn’t like it for that product that it was returned to the name bank ready for its adoption by sildenafil citrate.
Apparently, another option was “Alond”. A rose by any other name may smell as sweet, but it’s fair to say that that rule does not apply to erectile dysfunction pharmaceutical treatments. Alond is just, well, limp. However, some names you can’t make up, and one of them is Ringaskiddy, the village in County Cork, where Viagra is produced at the chemical plant. Nicknamed Viagra Falls, the village is rumoured to have love, or at least sex, in the air.
Across the water in Britain, the quality of aphrodisiacal air is open to debate, but the distribution of Viagra users is not. Figures show that men in Bradford are more likely to be prescribed the drug, or similar alternatives, than are those from anywhere else in the country. Blackpool comes second. The lowest prescription rates are in Richmond and Kingston upon Thames.
One explanation is a north-south class divide – that health accompanies wealth and the southern middle classes are in a better physical shape and therefore less susceptible to the various complaints that cause ED.
Another is that there is a higher premium on having a good time in the north and that, as the Royal College of General Practitioners has found, an ageing population still expects an active sex life – and just possibly the citizens of Bradford and Backpool are a little less inhibited about asking for it than their countrymen down south.
As they say in the pharmaceutical business, more research is needed. Until then, the only way for the drug formerly known as UK-92480 is up.
THE VIAGRA FILE
Born April 1998 in the US, although conceived six years earlier in the UK.
Best of times It’s been an almost unrelenting success story, although the first year stands out for its billion-dollar arrival – almost unheralded in a new drug.
Worst of times In the early days, 130 people in the US were reported to have died after taking Viagra. Eventually, no causal link was found, but the scare threatened to derail a stunning campaign.
What they say “People are strange when it comes to sex.” David Brinkley, former head of Pfizer’s Team Viagra.
What others say “I like to date a nice range of women each year, but I only use Viagra when I am with more than one.” Jack Nicholson
As 2020 begins…
… we’re asking readers, like you, to make a new year contribution in support of the Guardian’s open, independent journalism. This has been a turbulent decade across the world – protest, populism, mass migration and the escalating climate crisis. The Guardian has been in every corner of the globe, reporting with tenacity, rigour and authority on the most critical events of our lifetimes. At a time when factual information is both scarcer and more essential than ever, we believe that each of us deserves access to accurate reporting with integrity at its heart.
More people than ever before are reading and supporting our journalism, in more than 180 countries around the world. And this is only possible because we made a different choice: to keep our reporting open for all, regardless of where they live or what they can afford to pay.
We have upheld our editorial independence in the face of the disintegration of traditional media – with social platforms giving rise to misinformation, the seemingly unstoppable rise of big tech and independent voices being squashed by commercial ownership. The Guardian’s independence means we can set our own agenda and voice our own opinions. Our journalism is free from commercial and political bias – never influenced by billionaire owners or shareholders. This makes us different. It means we can challenge the powerful without fear and give a voice to those less heard.
None of this would have been attainable without our readers’ generosity – your financial support has meant we can keep investigating, disentangling and interrogating. It has protected our independence, which has never been so critical. We are so grateful.
As we enter a new decade, we need your support so we can keep delivering quality journalism that’s open and independent. And that is here for the long term. Every reader contribution, however big or small, is so valuable.
The race to replace Viagra
As the last patents on the erectile dysfunction drug run out, interest in finding new treatments has been renewed
Are we witnessing the end of an era for Viagra and Pfizer? Since the famous “little blue pill” exploded on to the market in 1998, becoming the fastest selling drug in history, the American pharmaceutical giant has made vast sums marketing it to erectile dysfunction sufferers all over the world. Within three months of its launch, Viagra had already earned Pfizer $400m, and over the past two decades, it has consistently generated annual sales to the tune of $1.8bn.
However, this will soon come to an end, as in 2020, Pfizer’s remaining patents on Viagra expire for good. A whole host of generic versions have emerged in the past six years, often in quirky forms such as mint strips or breath sprays, as Pfizer’s grip on the rights to the drug has slowly loosened. Soon, these are expected to flood the market, as manufacturers jostle for a slice of the pie.
This will make Viagra more accessible and cheaper, but for the millions of men worldwide with erectile dysfunction, it could also spell good news in the form of much needed treatment innovations. Since Viagra was launched, few genuinely novel therapies have been developed, and while Viagra and similar drugs like Cialis and Levitra – which all increase blood flow to the penis by blocking an enzyme known as PDE5 – are effective in around 70% of patients, they come with significant downsides.
To start with, there are often prominent side-effects ranging from headaches to stomach pain. In addition, with Viagra taking more than an hour to work, there’s the need to pre-plan intercourse, and in the case of older patients, the drugs can often be unsuitable due to potentially dangerous interactions with medications for high blood pressure, or hypertension. For patients with the most severe forms of erectile dysfunction, often resulting from nerve damage due to diabetes or prostate cancer surgery, Viagra typically doesn’t work at all.
The need for better treatments is particularly pressing as erectile dysfunction appears to be getting more common, with the global prevalence set to pass 300 million by the middle of the next decade. Scientists have long argued about whether this is simply due to men becoming more open in reporting their problems, or a by-product of other health problems. One thing is clear: the market is growing.
“There’s a huge need for new treatments which work in the widest patient population possible while having a longer-acting effect to improve spontaneity and reduce the stress of having to take them on a planned basis,” says Dr Samit Soni, a urologist at the Baylor College of Medicine in Houston, Texas. “Many patients would like to be able to take something and then not have to worry about it for 30 days.”
But right now, there are few options. The only alternatives to Viagra consist of medications which need to be injected directly into the shaft of the penis in order to improve blood flow, or complex surgery to fit penis pumps or prosthetic implants. Neither are particularly palatable.
So why is this? While a handful of pharma companies have attempted and failed to get rival drugs into the clinic, the sheer scale of the Viagra profit machine created a monopoly, with most companies shying away from the challenge, perceiving it as too much of a risk. But experts believe this could be about to change.
“For many years after Viagra was developed, little changed in our understanding of erectile dysfunction and how to correct it,” says Soni. “But with the patent expiration there’s definitely a renewed interest in alternative pathways for treating erectile dysfunction, and using them to develop new ideas that can be patented, and provide a sustainable profit to the industry.”
Technicians put Viagra into blister packs at the Pfizer laboratory in Amboise, France, 1999. Photograph: Raphael Gaillarde/Gamma-Rapho via Getty Images Viagra 2.0
In the early 2000s, scientists at Futura Medical, a pharmaceutical company in Surrey, came across stories of a heart disease medication that appeared to accidentally induce erections.
“There were some anecdotal reports of people deliberately spraying this product on to their penises,” says Ken James, head of research and development at Futura. “These observations had been reported in the scientific literature, and the company thought there might be a commercial opportunity.”
The reported effects were due to a particular molecule known as glyceryl trinitrate or GTN, which causes the dilation of blood vessels in the penis, increasing blood flow. But the reason why Futura were so intrigued was because, while Viagra, Cialis and other drugs have to be taken orally – meaning they reach the target area via the bloodstream and so interact with other systems in the body – GTN could be rapidly absorbed into erectile tissue through the skin. This meant that it could potentially be applied directly as part of a gel or cream, with almost instantaneous results and none of the troublesome side effects associated with Viagra.
“Viagra and Cialis are quite effective drugs but 50% of people stop using them within a year,” says James. “60-70% of people have some degree of dissatisfaction with them. This shows there’s an opportunity if we can come to market with something that addresses many of those concerns.”
Over the past decade, Futura have developed a GTN-based gel called Eroxon which appears to be capable of inducing an erection in patients with mild to moderate erectile dysfunction in five to 10 minutes. Already dubbed the new Viagra by some, it seems to have the potential to be the first genuinely novel treatment for erectile dysfunction in two decades, and Futura have even tentatively placed its potential commercial value at $1bn.
After investors showed a renewed interest in backing novel treatments for erectile dysfunction, Futura completed a clinical trial of 232 patients last year, and have now embarked on a final phase III trial of 1,000 patients to be completed by the end of 2019. If this succeeds, Eroxon could become available clinically within the next couple of years, although urologists remain cautious.
“The biggest question from that phase III trial will be how they compare in clinical efficacy to Viagra,” says Soni. “In the past, we’ve seen that it’s difficult to get similar efficacy with topical administration, but at the same time, our understanding of how drugs can be absorbed through the skin into the bloodstream has massively improved.”
Tackling the most severe cases
But even Futura’s scientists admit that Eroxon is unlikely to help the severest cases of erectile dysfunction, which affect around 20-30% of patients, typically due to nerve damage in the lower abdomen.
In the past there have been few options for these people, but over the past five years, the renewed interest in erectile dysfunction has seen research programmes dedicating more time and money to clinical trials of a technology known as shockwave therapy. Unlike Viagra or Eroxon, this attempts to reverse the problems which cause the dysfunction by passing low-intensity sound waves through erectile tissue.
Scientists are still not entirely sure how or why it works, but so far they think it leads to a form of regeneration of the erectile tissue, promoting the growth of new blood vessels and clearing plaque from existing vessels. “Improving the function of these vessels leads to improved blood flow and erections in those patients,” explains Georgios Hatzichristodoulou, who researches shockwave therapy at the University of Würzburg in Germany.
However, because there is such a wide spectrum of causes of erectile dysfunction, shockwave therapy is currently only known to work in a subset of these patients, particularly those where the damage has resulted from diabetes or hypertension.
Hatzichristodoulou points out that there remains a need for further data, with a series of trials of shockwave therapy currently going on in Europe and the US. But compared to Viagra or Eroxon, one of the great promises of the treatment is that it would not be needed on a regular basis. Instead, patients could simply undergo maintenance therapy at half-yearly or annual intervals.
Most tantalisingly, in attempting to restore the natural function of the penis, it points towards an eventual cure, a hope which may yet be realised in years to come.
The search for an all-out cure
Even when Viagra works, one of the problems for people who need to take it indefinitely is that it becomes less effective over the course of months or years.
“This is quite common. Most patients will experience a worsening of their erections after they’ve been on Viagra for a while,” says Hatzichristodoulou. “They take Viagra for five, six, 10 years, and some days they feel that there is little improvement in function.”
Desperation has pushed many patients towards unscrupulous private clinics around the world, who promise an ultimate cure, offering treatments like shockwaves, stem cell infusions and injections of platelet-rich plasma on an unregulated basis. But all of these therapies are highly experimental – as an example, shockwave therapy is currently only approved by the US Food and Drug Administration to stimulate wound healing, as scientists are still working on establishing the best doses for efficacy and investigating long-term safety.
“There’s some particularly compelling data on shockwave therapy, especially in certain patients,” says Soni. “But it is still in an early phase.”
While scientists hope that shockwave therapy may be ready for primetime within the next five to 10 years, progress is also being made on longer-term treatments such as gene therapy which could offer a complete cure. At the Kaiser Permanente Division of Research in northern California, a group of scientists have identified a genetic switch which is thought to be unique to sexual function. They believe that this switch plays a crucial role in controlling the brain signals which initiate an erection, and new genome editing technologies such as Crispr-Cas9 could one day allow scientists to reactivate this switch in patients.
“This genetic location is part of a pathway which is involved in a number of different systems in the body, from pigmentation to weight to sexual function,” explains project leader Eric Jorgenson. “But what is exciting about this, is that it seems to be very specific to sexual function, which would make it possible to target this location and not disturb anything else in the body. But there’s a long way to get there. We need to understand the exact part of the brain where this switch is active, and then try targeting it in mice.”
Because genome editing is still such an experimental concept, Jorgenson says it will take time for regulators to become confident that it could be safe. “The first uses of Crispr-like technology will probably be in patients where there’s more of a direct medical need for experimental therapies,” he says. “You’d need to have a very safe treatment before people will allow it for erectile dysfunction.”
While gene therapy may be a little way off, there are still new treatments on the horizon for erectile dysfunction for the first time in decades. With the Viagra era coming to a close, and increasing amounts of research funding available, the field is in its healthiest state for years.
“There hasn’t been any real innovation in erectile dysfunction for many years now,” says Soni. “These new breakthroughs and treatments are offering excitement to an area of healthcare that has really been lulled for a long time.”
As 2020 begins…
… we’re asking readers, like you, to make a new year contribution in support of the Guardian’s open, independent journalism. This has been a turbulent decade across the world – protest, populism, mass migration and the escalating climate crisis. The Guardian has been in every corner of the globe, reporting with tenacity, rigour and authority on the most critical events of our lifetimes. At a time when factual information is both scarcer and more essential than ever, we believe that each of us deserves access to accurate reporting with integrity at its heart.
More people than ever before are reading and supporting our journalism, in more than 180 countries around the world. And this is only possible because we made a different choice: to keep our reporting open for all, regardless of where they live or what they can afford to pay.
We have upheld our editorial independence in the face of the disintegration of traditional media – with social platforms giving rise to misinformation, the seemingly unstoppable rise of big tech and independent voices being squashed by commercial ownership. The Guardian’s independence means we can set our own agenda and voice our own opinions. Our journalism is free from commercial and political bias – never influenced by billionaire owners or shareholders. This makes us different. It means we can challenge the powerful without fear and give a voice to those less heard.
None of this would have been attainable without our readers’ generosity – your financial support has meant we can keep investigating, disentangling and interrogating. It has protected our independence, which has never been so critical. We are so grateful.
As we enter a new decade, we need your support so we can keep delivering quality journalism that’s open and independent. And that is here for the long term. Every reader contribution, however big or small, is so valuable.
Which Drug for Erectile Dysfunction Is Better: Viagra or Cialis?
Four drugs have been approved for erectile dysfunction. Which is best depends on your individual needs and desires.
Credit…Stuart Bradford Q. Which is better: Viagra or Cialis?
A. The Food and Drug Administration has approved four similar drugs for erectile dysfunction, sold under such names as Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil) and Stendra (avanafil). They all work the same way, producing an erection by increasing blood flow to the penis. Which drug is best may depend on your preference for quick onset versus long duration and your individual medical needs.
The discovery of Viagra is one of the classic stories of serendipity in drug development. In the 1980s, the pharmaceutical company Pfizer began studying sildenafil, the generic name for Viagra, as a treatment for heart disease. It didn’t work, but the men in the study developed unusually strong, long-lasting erections. The rest is history.
All four of the currently approved drugs seem to be equally good at producing erections. But it is difficult to be more definitive in evaluating their efficacy, because few studies directly comparing them have been conducted, a common problem with many drugs.
Since all four drugs are similarly effective, the answer to which drug is best will depend on other attributes, such as side effects, drug interactions, speed of onset and duration of action.
Side effects are similar among the four drugs. Headache, flushing and upset stomach are the most common side effects. And, in rare cases, all can cause a persistent and sometimes painful erection that will not go down, a condition called priapism that can result in permanent damage if not treated promptly.
Drug interactions are largely similar, with the most important interaction being a contraindication to nitrate-containing drugs, such as nitroglycerin, commonly used to treat angina.
Time of onset is an important difference between the drugs. While all take effect within an hour, Stendra is the fastest acting, often taking effect within 15 minutes.
Duration of action is another important difference between the drugs. Cialis is the longest acting, with a duration of up to 36 hours. Cialis’s long duration means that it can be taken once a day, eliminating the need to take a pill before each sexual encounter. Such once-a-day dosing has been reported to increase sexual self-confidence and spontaneity.
Which drug is better depends on your personal situation. For speed of onset, Stendra may be best. For long duration, and perhaps for spontaneity, Cialis may be best. As always, the answer must come from your doctor, who can assess patient-specific factors and help determine which is right for you.