COVID-19 anti-viral drug remdesivir effective on monkeys and people

AsiaNews | April 18, 2020

COVID-19 anti-viral drug remdesivir effective on monkeys and people
Washington (AsiaNews/Agencies) – The anti-viral drug remdesivir has proven effective in treating monkeys and people with COVID-19. Trial results have not yet been fully vetted by the scientific community, but they present good prospects for coronavirus patients. In a US study published yesterday by the National Institute of Infectious Diseases, two groups of six macaques were infected with the SARS-CoV-2, the coronavirus that causes COVID-19. One was treated with the antiviral drug remdesivir; the other was not. After a week, only one of the treated macaques had slight breathing difficulties; the other group, untreated, had severe breathing difficulties. Another study, published on Thursday in the online medical journal Stat, shows that the most severe COVID-19 patients in a Chicago hospital, when treated with remdesivir, were able to go home in few days, and only two patients died. Official results from the trial are not expected until later this month, with further data to come in May.

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BUSINESS INSIGHTS

Zenas BioPharma Acquires Exclusive Worldwide Rights to Obexelimab from Xencor

Xencor, Zenas BioPharma | November 22, 2021

Xencor, Inc. a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, and Zenas BioPharma (“Zenas”), a global biopharmaceutical company based in the USA and China committed to the development and delivery of immune-based therapies, today announced that Zenas has acquired from Xencor exclusive worldwide rights to develop, manufacture and commercialize the investigational antibody obexelimab. Obexelimab is a potential first-in-class bifunctional antibody that targets CD19 with its variable domain and uses Xencor's XmAb® Immune Inhibitor Fc Domain to target FcγRIIb, a receptor that inhibits the function of B-cells, which are important components in the immune system. Xencor demonstrated through early-stage clinical studies that obexelimab effectively inhibits B-cell function without depleting the cells and generates an encouraging treatment effect in patients with multiple autoimmune diseases. “Zenas is advancing a broad pipeline of differentiated drug candidates that are intended to bring best-in-class innovation to patients with underserved medical needs. Today, we are pleased to add obexelimab to our portfolio, and based on its clinical profile, we believe it is positioned as a first-in-class candidate with the potential to treat numerous autoimmune diseases.” Hua Mu, Ph.D., MD, president and chief executive officer at Zenas “Obexelimab’s highly potent and broad blockade of B-cell activation—without depleting B cells—differentiates it from other B-cell targeting therapies, and it has demonstrated disease-modifying activity in settings where B-cell inhibition is a proven strategy,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “In Zenas BioPharma, we have found a partner committed to broadly and aggressively developing therapeutics like obexelimab for patients with autoimmune diseases, enabling Xencor’s continued focus on the growing opportunities provided by our XmAb bispecific antibody and cytokine pipeline.” Under the terms of the new agreement, Zenas will issue to Xencor a warrant giving Xencor the right to acquire additional Zenas equity, such that Xencor’s total equity in Zenas would be 15% of its fully diluted capitalization following the closing of Zenas’ next round of equity financing, subject to certain requirements. Xencor previously received equity in Zenas under a separate license agreement. Xencor is also eligible to receive up to $480 million based on the achievement of certain clinical development, regulatory and commercialization milestones and is eligible to receive tiered, mid-single digit to mid-teen percent royalties upon commercialization of obexelimab, dependent on geography. Zenas will have sole responsibility for advancing the research, development, regulatory and commercial activities of obexelimab worldwide. About Xencor, Inc. Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases. Currently, 22 candidates engineered with Xencor's XmAb® technology are in clinical development internally and with partners. Xencor's XmAb antibody engineering technology enables small changes to the structure of proteins resulting in new mechanisms of therapeutic action. About Zenas BioPharma Zenas BioPharma is a global biopharmaceutical company based in the USA and China committed to becoming a leader in the development and delivery of immune-based therapies for patients in the US, China and around the world. Zenas is rapidly advancing a deep pipeline of innovative therapeutics that continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those facing autoimmune and rare diseases. Xencor Forward-Looking Statements Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by our use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to the development of obexelimab as a potential treatment for patients with autoimmune diseases; the commercial potential of obexelimab; the safety, tolerability, efficacy and pharmacokinetics of obexelimab; the quotations from Xencor’s president and chief executive officer; and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2020 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended to date. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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PHARMACY MARKET

H.I.G. Capital Acquires Aspire Pharma

Aspire | September 24, 2021

H.I.G. Capital, LLC, a leading global alternative investment firm with $45 billion of equity capital under management, is pleased to announce that one of its affiliates has acquired Aspire Pharma Limited, a leading UK provider of niche generic and branded specialty pharmaceuticals, alongside its founder Graham Fraser-Pye. The financial terms of the transaction have not been disclosed. Aspire licenses and develops niche generic and specialty pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets that are often underserved. The business holds leadership positions in urology, ophthalmology, CNS and dermatology, with a highly diversified portfolio of more than 250 products across multiple categories, including branded specialty products and unbranded niche generics. H.I.G., together with the management team, aims to continue Aspire’s strong track record of organic growth and to support new initiatives, such as M&A and international expansion. The existing management team of Aspire Pharma will remain in place, with Graham Fraser-Pye taking the role of Chairman. I am very pleased to welcome H.I.G. as a key investor in the future of Aspire Pharma. Since our foundation in 2009, we have grown rapidly and consistently through our astute strategic choices and extensive development know-how. H.I.G., with its significant financial and geographic reach, will help us maintain our impressive growth trajectory and take Aspire into another exciting phase for its people and customers. We remain committed to the development and supply of innovative products and medicines that offer value to our customers and make a difference to the lives of patients. - Graham Fraser-Pye We are delighted to be supporting Graham and his team to further build upon Aspire’s success. The Company’s track record of identifying, developing and launching niche pharmaceutical products, coupled with H.I.G.’s international presence and history of supporting organic and acquisitive growth in its portfolio companies, underpins an exciting next chapter for Aspire. - John Harper, Managing Director and Head of the H.I.G. Europe Lower Middle Market LBO team in London About Aspire Aspire was founded in 2009. Aspire has an asset-light business model that focuses on R&D, business development and sales and marketing, while outsourcing manufacturing and distribution to specialist third parties. About H.I.G. Capital H.I.G. is a leading global private equity and alternative assets investment firm with $45 billion of equity capital under management.* Based in Miami, and with European offices in London, Hamburg, Madrid, Milan, Paris, and U.S. and Latin American offices in New York, Boston, Chicago, Dallas, Los Angeles, San Francisco, Atlanta, Bogotá, Rio de Janeiro and São Paulo, H.I.G. specializes in providing both debt and equity capital to small and mid-sized companies, utilizing a flexible and operationally focused/ value-added approach

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PHARMACY MARKET

Sanofi's hopes for rare blood disease candidate sutimlimab on hold after FDA blasts 3rd-party manufacturer

Sanofi | November 17, 2020

When a new drug goes in front of the FDA for consideration, a lot of moving pieces must be in place for a successful review—manufacturing standards included. That didn't happen for Sanofi, which is pressing pause on a rare disease candidate after the FDA found issues at a contract manufacturer's plant. The FDA blasted a third-party manufacturer of Sanofi's rare blood disease drug sutimlimab in a complete response letter, citing "certain deficiencies" at the contractor's site, the French drugmaker said Friday. A Sanofi spokeswoman declined to specify who the manufacturer cited in the FDA's letter was or what the nature of the deficiencies were. With its application on hold, Sanofi said it would work with its manufacturer and the FDA to resolve the issues in a "timely manner." The drugmaker didn't say how quickly it expected to turn around a new application. The untimely feedback from the FDA dims C1 inhibitor sutimlimab's chances in cold agglutinin disease (CAD), a rare blood disease characterized by anemia, fatigue and other symptoms.

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Spotlight

Pharmaceutical Contract Manufacturing history at Norwich, New York. Take a look at more than 100 years of history for Norwich Pharmaceutical.