Phase III study of Novavax’s RSV vaccine fails primary objective: March’s industry headlines


Take a look at this month’s industry headlines including news on Sanofi’s Dengvaxia® vaccine from the USA and the Philippines, clinical trial results for RSV vaccines and HIV injectables and new acquisitions for Merck.

Merck to acquire Immune design, bolstering vaccine development

Merck & Co (NJ, USA) have announced a definitive agreement under which Merck will acquire Immune design (WA, USA) for approximately US $300 million, boosting its capabilities in vaccine development for both infectious diseases and cancer.

Roger Perlmutter, president of Merck Research Laboratories, commented: “Scientists at Immune Design have established a unique portfolio of approaches to cancer immunization and adjuvant systems designed to enhance the ability of a vaccine to protect against infection, which could meaningfully improve vaccine development.”

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Sanofi executives face charges in Philippines over deaths linked to Dengvaxia® vaccine

Regulators in the Philippines plan to file criminal charges against former health officials from the country and executives from Sanofi (Paris, France) over the deaths of children given the company’s dengue vaccine, Dengvaxia. The resolution claims that the 20 charged officials, including six Sanofi employees, “totally disregarded the identified risks and adverse effects of the vaccine.”

Thirty-five deaths are under investigation, ten of which form the basis of these charges, that fault Sanofi for “failing to actively monitor and conduct close surveillance of Dengvaxia recipients.”  In response to the news Sanofi commented: “We strongly disagree with the findings made against Sanofi and some of its employees and we will vigorously defend them.”

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FDA advisory panel recommends against Sanofi’s Dengvaxia in adults

An FDA committee has voted 7–6 that data provided by Sanofi do not support the effectiveness of Dengvaxia in patients aged 9–45 living in endemic areas who were previously diagnosed with dengue. However, the panel voted 13–1 that the vaccine prevented disease cause by serotype 1–4 in children aged 9–17 in endemic areas with prior dengue diagnosis.

The FDA is currently evaluating the marketing application for Dengvaxia under a priority review, with a decision expected May 1.

Read more about Dengvaxia: FDA grants priority review for controversial dengue vaccine >

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Phase III study of Novavax’s RSV vaccine fails primary objective

A Phase III study of Novavax’s respiratory syncytial vaccine (RSV) ResVax® has failed to meet its primary endpoint.

The fusion protein recombinant nanoparticle vaccine was being assessed in 4636 pregnant women for its ability to protect infants. Topline results demonstrated that the efficacy of ResVax for preventing significant RSV infection in the lower respiratory tract was 39% versus the placebo, missing the trials main goal. Although the vaccine did meet it’s secondary objective, preventing hospitalizations by 44%, shares in the company fell nearly 70% at the news.

CEO Stanley Erck commented: “While this study did not meet the pre-specified success criterion for the primary clinical endpoint…the data indicate that ResVax protects infants from some of the most serious consequences of RSV, including RSV lower respiratory tract  infection hospitalizations.”

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FDA accepts Genentech’s supplemental New Drug Application for Xofluza™

Genentech, a member of the Roche Group (Basel, Switzerland) has announced that the US FDA has accepted a supplemental New Drug Application for Xofluza as a single-dose, oral treatment for individuals at a high risk of complications from flu. Xofluza is already approved for individuals aged 12 or older, representing the only single-dose, oral medication for flu and the first new flu medicine with a novel mechanism in nearly 20 years.

This new approval would make Xofluza the first antiviral medicine approved specifically for this population, and a decision is expected by November 4 2019.

Discover more about Xofluza: FDA approves Xofluza™, the first single-dose oral medicine for influenza >

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Phase III studies on long-acting injectable HIV treatment rilpivirine and cabotegravir report positive data

Phase III results from two trails – the ATLAS and FLAIR studies – have demonstrated the one-monthly combination of Johnson & Johnson’s Edurat (rilpivirine) and Viiv Hea;thcare’s experimental integrase inhibitor cabotegravir meet the primary endpoint of maintaining viral suppression in adults with HIV-1.

The results, presented at the Conference on Retroviruses and Opportunistic Infections 2019 (CROI; 4–7 March, Seattle, WA, USA) suggest patients could have the option of managing their virus with just 12 injections a year, rather than daily tablets.

Discover more headlines from CROI 2019 >

Brian Woodfall, Global Head of Development for Infectious Diseases at Johnson & Johnson’s Janssen Pharmaceutica unit, commented: “If approved by regulators, this will be the first monthly dosing solution for people living with HIV and represents a major step for HIV treatment.”

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GARDP and Evotec partner to discover novel antibiotics

The Global Antibiotic Research and Development Partnership (GARDP; Geneva, Switzerland) and Evotec (Hamburg, Germany) have announced a new partnership to discover new antibiotics for drug-resistant infection. The partnership will focus on accelerating the development of first-in-class antibiotic treatments for hard-to-treat bacterial infections by establishing a platform that spans the length of the drug development value chain as well as developing a joint pipeline.

The Global Antibiotic Research & Development Partnership (GARDP) – an interview with Jean-Pierre Paccaud >

“Partnerships are central to GARDP’s model. Working with Evotec will undoubtedly strengthen GARDP’s efforts to develop new antibiotics, while addressing the need for their sustainable access. Evotec’s expertise complements GARDP’s approach, which allows both partners to develop a drug from early exploratory to preclinical and clinical studies all the way to patients.” said Dr Seamus O’Brien, Research and Development Director at GARDP. “Developing treatments to treat drug-resistant bacterial infections is key to achieve universal health coverage.”

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Could nationalized drug companies help mend the antibiotics market?

Economist, Lord Jim O’Neill, has suggested that nationalized or state-run drug companies could be the answer to the lack of investment in antibiotic development. This measure would be intended to ensure the development and production of new antibiotics aren’t linked to market forces.

Funding and finance in antibiotic development – an interview with John Rex >

Lord O’Neill stated that empty words from global policy makers and pharmaceutical companies had lead to thoughts about nationalizing part of the pharmaceutical industry: “It leads me to think that some of the more radical ways of changing the risk-reward incentive and social circumstances of it now need to be explored more.”

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