Supply of Veklury Is Meeting Real-Time Demand in the U.S. -- -- Clinical Benefits of Veklury Consistently Demonstrated Across Three Randomized, Clinical Trials Are Now Available to All Clinically Appropriate Hospitalized COVID-19 Patients in the U.S. -- -- Veklury Distribution Has Transitioned from the U.S. Government to Gilead -- Since the COVID-19 pandemic began, Gilead has worked diligently to ramp up production ...

-- Supply of Veklury Is Meeting Real-Time Demand in the U.S. --

-- Clinical Benefits of Veklury Consistently Demonstrated Across Three Randomized, Clinical Trials Are Now Available to All Clinically Appropriate Hospitalized COVID-19 Patients in the U.S. --

-- Veklury Distribution Has Transitioned from the U.S. Government to Gilead --

Since the COVID-19 pandemic began, Gilead has worked diligently to ramp up production and rapidly expand the supply of our investigational antiviral drug Veklury ® (remdesivir) by making significant investments to increase internal manufacturing capacity, expand our contract manufacturing network and implement process improvements. While working to increase our manufacturing capacity over these past months, the company also donated 1.5 million vials of Veklury and provided clinical drug supply at no cost for evaluation as an investigational agent in clinical trials around the world. As a result of the decision to make early investments to increase Veklury manufacturing efforts, Gilead is now meeting real-time demand for Veklury in the United States and anticipates meeting global demand for Veklury in October, even in the event of potential future surges of COVID-19.

Starting on October 1, Gilead will be responsible for distributing Veklury in the United States upon conclusion of the previous distribution agreement with the U.S. Federal government. To ensure stable management of drug supply in the near term, AmerisourceBergen will continue to serve as the sole U.S. distributor of Veklury through the end of this year and will sell the product directly to hospitals. This distribution model closely reflects the traditional model hospitals use to procure medicines. Hospitals will control the quantity of Veklury that they order, enabling them to have ample, predictable supply of Veklury in advance of any anticipated increase in COVID-19 incidence.

Results from three randomized, controlled clinical trials have consistently demonstrated the clinical benefits of Veklury. These data support the use of Veklury as a standard of care in hospitalized COVID-19 patients. The increased supply of Veklury will expand access to the medicine to additional appropriate patients with COVID-19, offering the potential for patients to recover faster and, in turn, increase healthcare provider capacity and reduce healthcare system costs.

Contact Information for U.S. Veklury Orders

Hospitals interested in ordering Veklury beginning in October may contact AmerisourceBergen Specialty Division directly at 800-746-6273.

About Veklury (remdesivir)

Veklury (remdesivir) is a nucleotide analog invented by Gilead, building on more than a decade of the company's antiviral research. Veklury has broad-spectrum antiviral activity both in vitro and in vivo in animal models against multiple emerging viral pathogens, including Ebola, SARS, Marburg, MERS and SARS-CoV-2, the virus that causes COVID-19. Data from three randomized, controlled clinical trials in hospitalized patients with COVID-19 have consistently demonstrated the clinical benefits of treatment with Veklury. In the placebo-controlled ACTT-1 study, Veklury significantly improved time to recovery and also reduced the likelihood of disease progression. Additional ongoing international Phase 3 clinical trials continue to evaluate the safety and efficacy of Veklury for the treatment of COVID-19, in different patient populations and formulations, and in combination with other therapies.

In recognition of the current public health emergency and based on available clinical data, the approval status of Veklury varies by country. To date, Veklury has been approved or authorized for temporary use as a COVID-19 treatment in approximately 50 countries worldwide.

Veklury has not been approved by the U.S. Food and Drug Administration (FDA) for any use, and its safety and efficacy have not been established. Gilead submitted a new drug application for Veklury on August 7, 2020; the NDA is currently under FDA review. Veklury is currently authorized for temporary use under an Emergency Use Authorization (EUA) for the treatment of hospitalized patients with COVID-19, including patients with moderate to severe disease, regardless of the need for supplemental oxygen. This authorization is temporary and may be revoked, and does not take the place of the formal new drug application submission, review and approval process. For information about the authorized use of Veklury and mandatory requirements of the EUA in the U.S., please review the Fact Sheets and FDA Letter of Authorization available at www.gilead.com/remdesivir .

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

For more information on Gilead's response to the coronavirus outbreak please visit the company's dedicated page: https://www.gilead.com/purpose/advancing-global-health/covid-19 .

Forward-Looking Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors. Veklury is an investigational drug that has not been approved by the FDA for any use, and it is not yet known if Veklury is safe or effective for the treatment of COVID-19. There is the possibility of unfavorable results from ongoing and additional clinical trials involving Veklury and the possibility that Gilead and other parties may be unable to complete one or more of such trials in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of Veklury or that FDA and other regulatory agencies may not approve Veklury, and any marketing approvals, if granted, may have significant limitations on its use. As a result, Veklury may never be successfully commercialized. In addition, there is also the risk that Gilead may be unable to effectively manage the global supply and distribution of Veklury. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Media Contact:
Sonia Choi
(650) 425-5483

News Provided by Business Wire via QuoteMedia

AbbVie Submits Application for Risankizumab in Moderate to Severe Crohn's Disease to European Medicines Agency

ABBVie (NYSE:ABBV) today announced it has submitted an application to the European Medicines Agency (EMA) seeking approval for risankizumab (SKYRIZI ® 600 mg intravenous (IV) induction and 360 mg subcutaneous (SC) maintenance therapy), an interleukin-23 (IL-23) inhibitor, for the treatment of patients 16 years and older with moderate to severe active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy. The submission is supported by three pivotal Phase 3 studies, ADVANCE, MOTIVATE and FORTIFY. 1,2

"Patients with moderate to severe Crohn's disease live with challenging symptoms, such as persistent diarrhea and abdominal pain, impacting their quality of life," said Tom Hudson, senior vice president of research and development, chief scientific officer, AbbVie. "We look forward to working with the regulatory authorities and hope to offer risankizumab as a potential first-in-class treatment option for patients living with this disease."

Keep reading... Show less

SHAREHOLDER ALERT: CLAIMSFILER REMINDS BMY, OWLT, PTON, ZG INVESTORS of Lead Plaintiff Deadline in Class Action Lawsuits

ClaimsFiler, a FREE shareholder information service, reminds investors of pending deadlines in the following securities class action lawsuits:

Bristol-Myers Squibb Company (BMY)
Class: Investors who received Contingent Value Rights ("CVRs") (BMY.RT) in exchange for their shares of Celgene Corporation (CELG) pursuant to Bristol-Myers' acquisition of Celgene on November 20, 2019
Lead Plaintiff Motion Deadline: December 6, 2021
MISLEADING PROSPECTUS
To learn more, visit https://claimsfiler.com/cases/nyse-bmy-3/

Keep reading... Show less
Naturally Splendid Reports Third Quarter Results for 2021

Naturally Splendid Reports Third Quarter Results for 2021

Naturally Splendid Enterprises Ltd. ("Naturally Splendid", "NSE" or "the Company") (FSE:50N)(TSXV:NSP)(OTC PINK:NSPDF) announces its unaudited financial results for the nine months ended September 30, 2021. All amounts are in Canadian dollars and are prepared in accordance with International Financial Reporting Standards

Naturally Splendid CEO Mr. Craig Goodwin reports, "The Company continues to execute on our strategic plan developing, manufacturing and distributing plant-based, meat alternative entrees. Having identified plant-based entrees as our priority, work has already begun retrofitting our existing food manufacturing facility located in British Columbia. This includes installation of a state-of-the-art packaging line which has already been initiated. This line is expected to be operational in the next 30 - 45 days. Once fully operational, this new packaging line creates significant opportunities in the retail market by providing a wide range of packaging formats that can then be placed in both chiller and freezer sections of grocery stores. The versatility of this packaging line creates opportunities for sales in multiple formats for different placement in stores across a wide range of potential clients, ultimately resulting in increased sales.

Keep reading... Show less

Amgen Named To Dow Jones Sustainability World Index For Eighth Consecutive Year

Amgen (NASDAQ:AMGN) today announced that it has been named to the Dow Jones Sustainability World Index for the eighth consecutive year, reflecting the company's enduring commitment to environmental, social, and governance (ESG) issues. Amgen also was named to the DJSI North America Index for the ninth straight year.

The DJSI Indices are among the best indicators of a company's ESG performance due to the breadth of companies evaluated – nearly 11,000 this year – and the rigorous nature of the annual assessment process. The DJSI World Index recognizes the top 10% of companies in the S&P Global Broad Market Index for performance on ESG issues, which S&P Global considers critical to generating long-term stakeholder value.

Keep reading... Show less

Gilead's Bold Ambition of Transforming Triple-Negative Breast Cancer Treatment to Be Highlighted With New Data at SABCS

ASCENT Subgroup Analysis Provides Insights on Treatment Outcomes for Black Patients with Metastatic TNBC –

Separate ASCENT Post Hoc Analysis Examines Outcomes in Patients Who Discontinue Treatment Due to Progressive Disease

Keep reading... Show less

Aptose to Hold Corporate Update Monday, December 13th

HM43239 clinical update in AML after oral presentation at 2021 ASH Annual Meeting
Luxeptinib clinical update in AML and B-cell cancers

Aptose Biosciences Inc. ("Aptose") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, today announced that the company management team will provide a corporate update on Monday, December 13, 2021 at 5:30 PM ET, in conjunction with participation at the 2021 ASH Annual Meeting. The event will include a review of HM43239 data highlighted in an oral presentation at ASH, as well as the up-to-date clinical status of luxeptinib. HM43239 is an oral, myeloid kinome inhibitor in an international Phase 12 trial in patients with relapsed or refractory acute myeloid leukemia (AML). Luxeptinib is an oral, dual lymphoid and myeloid kinome inhibitor in a Phase 1 ab trial in patients with relapsed or refractory B cell malignancies who have failed or are intolerant to standard therapies, and in a separate Phase 1 ab trial in patients with relapsed or refractory AML or high risk myelodysplastic syndrome (MDS)

Keep reading... Show less

Top News

Related News