Report: Gilead's Experimental Drug Remdesivir Led To 'rapid' Recovery In Coronavirus Patients - Fastivel Imege


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Friday, 17 April 2020

Report: Gilead's Experimental Drug Remdesivir Led To 'rapid' Recovery In Coronavirus Patients

Report: Gilead's Experimental Drug Remdesivir Led To 'rapid' Recovery In Coronavirus Patients

  • In this March 2020 photo provided by Gilead Sciences, rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States.
    In this March 2020 photo provided by Gilead Sciences, rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States.
    Photo: Associated Press

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    In this March 2020 photo provided by Gilead Sciences, rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States.
    In this March 2020 photo provided by Gilead Sciences, rubber stoppers are placed onto filled vials of the investigational drug remdesivir at a Gilead manufacturing site in the United States.
    Photo: Associated Press
    Report: Gilead's experimental drug Remdesivir led to 'rapid' recovery in coronavirus patients
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    Remdesivir, an experimental antiviral drug made by the Bay Area's Gilead Sciences, reportedly had a successful clinical trial in Chicago.
    The Boston Globe's STAT News reported Thursday that Dr. Kathleen Mullane, an infectious disease specialist at University of Chicago Medicine overseeing the hospital's remdesivir studies, informed other faculty members that the results of the trials were encouraging.
    Gilead's two Phase 3 clinical trials involved 125 people with the coronavirus, with 113 of those cases classified as "severe." All the patients were treated with daily infusions of remdesivir.
    “The best news is that most of our patients have already been discharged, which is great," Mullane reportedly said on a video call. "We’ve only had two patients perish."
    Mullane stated that most of the patients were discharged after six days, something STAT News deemed a "rapid" recovery when compared to the typical length of hospitalization required for severe COVID-19 cases.
    However, the Chicago trial did not include a placebo group for comparison, and Mullane warned not to jump to conclusions — yet. Still, Mullane believes that the results are quite encouraging.
    "Certainly, when we start [the] drug, we see fever curves falling,” she said. “Fever is now not a requirement for people to go on trial. We do see when patients do come in with high fevers, they do [reduce] quite quickly. We have seen people come off ventilators a day after starting therapy. So, in that realm, overall our patients have done very well.”
    Similar clinical trials are under way at other hospitals across the country, but no other results have been released to this point.
    Sign up for 'The Daily' newsletter for the latest on coronavirus here.
    Eric Ting is an SFGATE digital reporter. Email: eric.Ting@sfgate.Com | Twitter:@_ericting

    Gilead’s Coronavirus Wonder-Drug Remdesivir Is Masking A Board Contagion

    Medics are inundated in the US epicenter of the coronavirus (COVID-19) pandemic in NY (Photo by ... [+] John Moore/Getty Images)
    Getty Images
    When Gilead Sciences, Inc.’s (GILD) CEO Daniel O’Day pushed the button on his March 28 open letter stating the firm’s new wonder-drug (the antiviral Remdesivir) could work against COVID-19, he had every hope the company's share price would soar - and he was right. Gilead's  shares surged by more than 11% in after-hours trading Thursday after details leaked of a closely watched clinical trial of the company’s antiviral drug Remdesivir, showing what appears to be promising results in treating COVID-19. Gilead have yet to comment.
    The fact that Gilead donated around 140,000 treatment courses to expedite its possible emergence into America’s emergency response offered a much needed boost, and the company is now going full-steam ahead with the experimental drug’s pandemic PR strategy, thanks to a previous report in the New England Medical Journal.
    The report revealed that 36 of 53 patients hospitalized for severe COVID-19 who were treated with compassionate-use Remdesivir had clinical improvement.
    Daniel O'Day, CEO of Gilead Sciences, testifies before the House Committee on Oversight and Reform ... [+] during a hearing on why its HIV prevention drug, Truvada, is so expensive on May, 16, 2019 in Washington, DC.
    The Washington Post via Getty Images
    However, O’Day had other reasons to get ahead of the news agenda. Robin Washington, Gilead’s CFO of 11 years, left only 27 days earlier to join Google parent Alphabet’s board. Meanwhile, 10 other senior executives have departed the business in just two years, leaving O’Day’s existing board in mortal danger.
    Serena Williams poses for a photo with Robin Washington, Executive Vice President and Chief ... [+] Financial Officer of Gilead, and guests during the 2019 Watermark Conference for Women Silicon Valley.
    That’s why The Edge (the leading source for under-performing companies for activist involvement, Special Situations and Spinoffs) believes Gilead Sciences (first listed at $0.70 on January 24, 1992) is ripe for a Spinoff into two units to maximize return for shareholders.
    Fresh CFO Andy Dickinson, who was promoted from Executive Vice President, Corporate Development and Strategy, should present a plan that can potentially revolutionize the research-based biopharmaceutical company he’s worked for since 2016. Alongside O’Day, Dickinson could become a hero in the new dawn of Gilead Sciences, Inc.
    Bizarrely, China has just suspended one trial of the drug Remdesivir in Jin Yin-tan hospital in the outbreak capital of Wuhan and terminated another in Bin Cao Beijing, and the government report says, “The epidemic of COVID-19 has been controlled well at present, no eligible patients can be recruited.”
    Medical staff transfer patients to Jin Yin-Tan hospital on January 17, 2020, in Wuhan, Hubei, China. ... [+] Local authorities have confirmed that a second person in the city has died of a pneumonia-like virus since the outbreak started in December.
    Getty Images
    It is possible the Chinese government are worried Remdesivir is too effective and have moved to shut down the trials over fears the US drug could corner the global market. However, further tests are underway on the US west coast, including hundreds of hospitals and care homes.
    Studies are currently being conducted at universities like University of Alabama at Birmingham School of Medicine - Infectious Disease, University of California, San Diego Health Jacobs Medical Center, and University of California Los Angeles Medical Center - Westwood Clinic.
    Worldwide testing has begun in France, including studies in Paris, Nantes and Lille, there is testing underway in Oslo, Norway, and also in The Democratic Republic of the Congo in Africa.
    Value in Splitting Performing and Struggling Franchises
    The Edge originally examined GILD for potential break-up in November 2019, and all of the following metrics are represented as written in that report (available on request). Once their main cash-generating portfolio, the HCV franchise is now struggling due to increased competition, pricing pressure and declining marketplace. 
    The declining HCV business has had an impact on GILD’s share performance since 2015, underperforming the market as HCV sales dropped by close to -35% Y-o-Y in 2017 and by 57% Y-o-Y in 2018. 
    Even though the HCV business continues to be a high-margin and cash-generating business (as is the case with its peers), the shrinking marketplace and pricing competition is clawing at the franchise’s top-line. 
    On the other hand, GILD’s HIV drugs franchise, which was once anticipated to be a declining business on the verge of a patent cliff (its major blockbuster HIV drugs, Atripla and Truvada, were set to expire in 2017 in the EU and 2018-2021 in the US), has now propelled GILD to be a leader in HIV treatment.
    It has seen its sales grow by 11.2% and 12.4% in FY17 and FY18, respectively, boosted by new drug launches of Genvoya (launched in 2015), Descovy (2016), Odefsy (2016) & Biktarvy (2018).
    These newly launched drugs contribute around 55.3% (or ~$11.9bn) out of the total $14.6bn HIV sales registered by GILD for FY18. Even for 9MFY19, the HIV drugs contributed around 74% of total revenues, rising 12% Y-o-Y for the period.
    Mature Product Concerns Overstated
    Even with concerns over HCV’s sliding revenues, it continues to be highly profitable. Its mature products will continue to sustain current levels, which shows its ability to continue to be a cash generating franchise. 
    The Edge believes investors are ignoring this part of the story and are punishing the stock for the declining mature products’ sales. 
    Additionally, with GILD releasing a generic version (Epclusa) of their previous blockbuster HCV drugs, this new offering has the potential to gain traction in the market and help regain lost market share. 
    The Edge also believes the separation of the distinct franchises can help the HCV business emphasize its effectiveness and liquidity, whereas the HIV business can concentrate on research, development and innovation. 
    Why Break-Up Now Versus 2-3 Years Ago
    It would have been difficult to find value in a split two or three years ago, since GILD’s HCV business was still contributing around 50% of its revenues (FY16) but was on the cusp of declining sales. 
    Likewise, there was limited clarity with its HIV franchise prospects due to the scheduled patent cliff. However, since 2017, GILD’s HIV business has taken off with new drug launches that have turned into blockbuster drugs and bringing billions in cash for GILD. 
    Therefore, with a performing HIV franchise and an expectation of a flattening performance of the HCV franchise, investors will be more willing to see a profitable split of the company compared to the case in late 2016 or early 2017. 
    GILD Franchise Revenues Over the Years ($m) as of November 2019.
    The Edge Consulting Group
    The Edge believes the separation of the HCV franchise via a Spinoff will not only help to discover value for the high cash-generating HCV business, but also help unlock value for the HIV business, which seems currently under-appreciated by the market. 
    The HCV business can be rated based on GILD’s dividend yield, and the performing HIV business can therefore be valued based on its high-growth peer multiple, accounting for its lucrative upcoming pipeline. 
    GILD Will Benefit from Its Current CEO’s Impressive Resume
    After the resignation of ex-CEO John Milligan, GILD announced the appointment of industry veteran, Roche’s (ROG) Daniel O’Day, as the new CEO in March 2019. He was brought in to stabilize the legacy businesses, mobilize the balance sheet (currently GILD boasts $22.8bn in cash on its balance sheet as of Q3FY19) and enter into as-yet-untouched markets where GILD has been lagging, like oncology, inflammation, etc. 
    During his time at ROG, Mr. O’Day was part of a functioning team tasked with acquisition/licensing tactics. Some of the recent noted acquisitions during his tenure at ROG include Tensha Therapeutics (2016, $115m, oncology), MySugr (2017, undisclosed value, diabetes management), Viewics (2017, undisclosed value, laboratory business solutions), Ignyta, Inc. (2017, $1.7bn, oncology), Flatiron Health (2018, $1.9bn, oncology) and Tusk Therapeutics (2018, $759m, immuno-oncology, T regulatory cells), among many others undertaken over his 26 years at the company. 
    With ample ammunition (~$23bn cash on GILD’s balance sheet) for major acquisitions, Mr. O’Day can undertake major transactions with a proactive board’s support, which will drive top-line growth for GILD. 
    Clearly Undervalued
    At the most basic level, GILD is clearly undervalued in comparison to its other biotech peers. Where its peers are trading at an average one-year forward EV/EBITDA multiple of 11.2x and one- year forward P/E multiple of 13.9x, GILD is trading at 7.1x one year forward EV/EBITDA multiple (discount of ~37%) and 9.4x one-year forward P/E multiple (discount of ~32%). 
    Under-Performed Its Peers and the Broader Index
    Over the past three years, GILD has not been able to beat the index’s performance and has under-performed its closest peers.
    GILD 3-Year TSR Vs. Peers & Index as of November 2019.
    The Edge Consulting Group
    Where the S&P 500’s annualized total shareholder returns for last 1, 2 and 3 years have been 20.5%, 12.2% & 14.6%, GILD was just able to manage around 3.4%, -0.1% & -0.4%, respectively, for the same comparable periods. 
    GILD last hit its all-time high in 2015 when it peaked at $108.45 (June 23, 2015) as its HCV franchise’s blockbuster drugs were performing exceedingly well. In FY15, the HCV franchise registered $19.1bn in total sales, representing around 60% of GILD’s total FY15 sales (now dropped to $3.7bn in reported sales in FY18). 
    Gilead’s Pipeline has Promise
    GILD’s formerly major-performing HCV franchise has been losing its market share since the launch of AbbVie’s Mavyret in August 2017. As a result of rising competition, GILD’s HCV sales dropped sharply to ~$3.7bn in 2018 from $19.1bn in 2015 and is expected to drop to around $2bn+ globally in 2020. 
    However, GILD’s HIV franchise continues to offset lost revenues from HCV sales boosted by its robust Biktarvy launch. Furthermore, GILD’s Descovy is likely to receive a favorable FDA review. Filgotinib, which is partnered with Galapagos, is also one of the high-profile assets in GILD’s pipeline. 
    The consensus forecast for Filgotinib sales expects to surpass $1bn by 2024. The Edge feels the market is not accounting for these HIV franchise drivers and the stock will warrant a higher rerating once the drivers are clarified. 
    Given all of the above points, GILD’s management should explore strategic alternatives for its businesses as separate companies, which will unlock value for shareholders.

    Coronavirus Treatment: Gilead's Remdesivir Caused 'Rapid Recoveries' In Patients Treated With Drug


  • Remdesivir, an antiviral drug from Gilead Sciences, Inc., will likely become the first drug approved for the treatment of COVID-19
  • “The best news is that most of our patients have already been discharged, which is great," said the doctor in charge of a clinical trial in Chicago
  • “Remdesivir was a miracle,” said a formerly severely ill patient who was treated with remdesivir and discharged from hospital after only three days

  • Remdesivir, an antiviral nucleotide analog drug developed by Gilead Sciences, Inc., now stands on the brink of becoming the first drug to be approved as a cure for COVID-19, after encouraging news from clinical trials being conducted at a Chicago hospital.
    The phase three clinical trial by the University of Chicago Medical Center (UChicago Medicine) saw rapid recoveries from fever and respiratory symptoms among nearly all patients severely ill from COVID-19 after treatment with remdesivir. Most of these severely ill patients were discharged in less than a week from the hospital.
    The phase three trial involved 125 patients infected with COVID-19. Of this number, 113 were severely ill from SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), the virus that causes COVID-19. All the patients were treated with daily infusions of remdesivir.
    “The best news is that most of our patients have already been discharged, which is great," said Kathleen Mullane, the UChicago Medicine infectious disease specialist overseeing the remdesivir studies for the hospital. "We’ve only had two patients perish."
    One of the patients involved in the trial who fully recovered was a factory worker from Chicago, who was infected by his daughter. He was given his first intravenous infusion of remdesivir on April 4.
    “My fever dropped almost immediately and I started to feel better,” he told STAT, the American medical news website. STAT cited a video it obtained where the remdesivir phase three results were discussed.
    The patient said by the time of his second dose the next day, he was being weaned off oxygen. He received two more daily remdesivir infusions and was well enough to be discharged from the hospital on April 7.
    “Remdesivir was a miracle,” he said.
    The positive results from the Chicago clinical trials support findings in a study published April 10 in The New England Journal of Medicine (NEJM). This study revealed significant clinical improvements in 36 of 53 patients given remdesivir.
    The study showed doctors were able to reduce the amount of oxygen support needed in 68% of these patients (36 out of 53) over a median follow-up of 18 days from the first dose of remdesivir. More importantly, 17 of 30 patients on ventilators were able to come off the machines. Nearly two thirds of patients (64% or 34 out of 53) were on ventilators.
    This finding was important because COVID-19 patients on ventilators were more likely to suffer long-term health consequences. New York governor Andrew Cuomo last month revealed an 80% death rate for patients on ventilators in New York hospitals.
    Gilead Sciences

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