![]() "Obtaining worldwide rights for interferon gamma-1b solidifies our continued investment in the medicine, and pending the outcome of clinical studies investigating it in Friedreich's ataxia and advanced solid tumors, such as kidney and bladder cancer, strengthens our ability to expand its potential global use," noted Timothy Walbert, chairman, president and chief executive of Horizon. The therapy is currently not approved for this indication top line results from a Phase III trials assessing its safety and efficacy in this patient population are expected by the end of the year. In a separate agreement, Horizon has also snapped up US, European and Canadian intellectual property rights for interferon gamma-1b for the treatment of Friedreich's ataxia from an undisclosed their party. The transaction is expected to close by year-end 2016, subject to the satisfaction of closing conditions. Under the terms of the deal, Horizon has paid Boehringer 5 million euros upon signing and will pay 20 million euros upon closing for the rights for interferon gamma-1b in all territories outside of the US, Canada and Japan. ACTIMMUNE ® (Interferon gamma-1b) is approved by the FDA to delay time to disease progression in patients with severe malignant osteopetrosis (SMO). In the US the drug is marketed under the trade name Actimmune, and is approved for reducing the frequency and severity of serious infections linked to chronic granulomatous disease and for extending progression free survival in patients with severe, malignant osteopetrosis. interferon gamma-1b: inter-fr´on any of a family of glycoprotein biological response modifiers used as antineoplastic agents and immunoregulators they inhibit cellular growth, alter the state of cellular differentiation, have effects on the cell cycle, interfere with oncogene expression, alter cell surface antigen expression, have. The move will leave the firm with global rights to the drug - a biologically manufactured protein similar to one the body makes naturally to help prevent infection - as it already owns those for the rest of the world. Do not discontinue study medication on your own, it will be important to follow a plan related to discontinuation with observation and continue to collect data.įARA's mission is to drive research to develop therapies that will treat and cure Friedreich's ataxia and we remain passionately committed to that mission so that, one day soon, patients and caregivers impacted by this devastating disease will have effective treatment options.Dublin-Ireland based biopharma Horizon Pharma has bagged rights to Boehringer Ingelheim's interferon gamma-1b in an around 30 countries primarily in Europe and the Middle East for 25 million euros. Of note, subjects participating in the ongoing extension studies should contact their study site coordinator for further information and next steps. Go Get information about CGD and ACTIMMUNE At, you can learn more about the signs and symptoms of chronic granulomatous disease (CGD). Call 1-833-3-4MYCGD Find a CGD Specialist Find a healthcare provider in your area who has treated CGD. Additional information can be obtained in the below press release from Horizon. Reach out to us Monday Friday from 8 AM to 8 PM ET at 1-83. FARA will continue to work with Horizon and the principal investigator to continue to analyze the data to help inform future research efforts as well as future data presentation or publication. While these are not the results we hoped for, FARA is grateful to everyone involved in this study for their efforts- the investigators, study coordinators, the patients and families, and Horizon Pharma. The products dosage form is injection, solution and is administered via subcutaneous form. 5 ml in 1 vial, single-use (75987-111-10) of Actimmune, a human prescription drug labeled by Horizon Therapeutics Usa, Inc. In addition, the secondary endpoints did not meet statistical significance. The NDC Packaged Code 75987-111-11 is assigned to a package of 12 vial, single-use in 1 carton /. ![]() Horizon Pharma plc today announced that the Phase 3 trial, STEADFAST (Safety, Tolerability and Efficacy of ACTIMMUNE Dose Escalation in Friedreich's Ataxia study), evaluating ACTIMMUNE® (interferon gamma-1b) for the treatment of Friedreich's ataxia (FA) did not meet its primary endpoint of a statistically significant change from baseline in the modified Friedreich's Ataxia Rating Scale (FARS‐mNeuro) at 26 weeks versus treatment with placebo.
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