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PRESS RELEASE

May 2023

Radicava® Oral Suspension granted approval for treatment of ALS in Switzerland

ZURICH, May 5^th, 2023 – Mitsubishi Tanabe Pharma GmbH (hereinafter, “MTPD”), a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (hereinafter, “MTPC”) obtained approval for Radicava^® Oral Suspension (generic name: edaravone) from the Swiss Competent Authority, Swissmedic, on May 1 for the indication of treatment of amyotrophic lateral sclerosis (ALS). This important milestone was achieved in cooperation with Mitsubishi Tanabe Pharma Europe, a parent company of Mitsubishi Tanabe Pharma GmbH. This causally oriented therapy will thus soon be available all over Switzerland. Radicava^® Oral Suspension meets a high unmet medical need in Switzerland as only few therapeutic options are available for ALS.

4 years ago, we launched Radicava^® as a new treatment option for patients with ALS in Switzerland. Now, we are very proud to announce another milestone with the Swissmedic approval of Radicava^® (edaravone) Oral Suspension, an orally administered option allowing patients in Switzerland flexibility in how they take their medicine." said Samir Larak, President, MTPD.

MTPC Group has been developing Radicava^® Oral Suspension formulation as a new treatment option for ALS patients in order to address unmet needs of ALS patients, caregivers and the community.

Since the approval of Radicava^® intravenous infusion in January 2019, it is the only intravenous infusion of edaravone approved in Switzerland. Radicava^® Oral Suspension offers the same efficacy as Radicava^® intravenous infusion, a treatment shown in a pivotal trial to help slow the loss of physical function in ALS.

The data from one Phase 3 study demonstrated that, in comparison with placebo, the administration of Radicava^® intravenous infusion over six months for patients with comparatively moderate ALS slowed the decline of physical function by approximately 33% on the ALS Functional Rating Scale-Revised (ALSFRS-R). ALSFRS-R is a validated rating instrument for monitoring the progression of disability in patients with ALS.

The approval of the oral suspension formulation offers an important new oral treatment option for ALS patients in Switzerland. Radicava^® Oral Suspension is specifically formulated for patients with ALS and provides a flexible administration option (taken orally or via feeding tube) with a small, 5 mL dose, a portable bottle, an oral dosing syringe and no need for patients to refrigerate before taking.

ALS is an idiopathic neurodegenerative disease in which preferentially motor neurons degenerate and vanish. Due to muscle atrophy muscle strength declines throughout the entire body, including the limb, facial, and respiratory muscles. The cause for the majority of cases is not well understood but may involve genetic and environmental factors. Initial symptoms of the condition can be subtle, and it can take 12 to 14 months to be accurately diagnosed. It is one of the most well-known neuromuscular diseases, affecting approximately two in 100,000 people worldwide. As many as 500-600 people are estimated to be affected by ALS in Switzerland https://www.als-schweiz.ch/krankheitsbild/.

MTPC group will continue working to contribute to patients suffering from ALS worldwide as a leading company in the treatment of ALS by delivering Radicava^® Oral Suspension in Switzerland, in addition to the U.S., Canada, and Japan where Radicava^® Oral Suspension has been approved and is available on the market.

■ About amyotrophic lateral sclerosis: ALS

ALS is an idiopathic neurodegenerative disease in which motor neurons selectively degenerate and vanish. Muscle strength declines throughout the entire body, including the extremity, facial, and respiratory muscles, and muscular atrophy progresses. While the cause for the majority of cases is not well understood but may involve genetic and environmental factors. It is one of the most well-known neuromuscular diseases and incidence is approximately two in 100,000 people per year worldwide. As many as 500-600 people are estimated to be affected by ALS in Switzerland.

■ About Radicava^® Oral Suspension

Radicava^® Oral Suspension is specifically formulated for patients with ALS and provides a flexible administration option with a 5ml dose taken orally or via feeding tube. One cycle of administration of Radicava^® Oral Suspension is a total of 28 days, including both the dosing period and the drug-free period, and that cycle is repeated. The first cycle has a dosing period of 14 consecutive days of administration followed by a drug-free period of 14 days. In subsequent cycles, patients receive daily dosing for 10 days within a 14-day dosing period, followed by a 14-day drug-free period. Radicava^® Oral Suspension are available in bottles and do not require water or solution to administer. Radicava^® Oral Suspension needs to be refrigerated during the distribution process and in pharmacies, but patients can keep it at room temperature.

■ About edaravone

Edaravone is a free radical scavenger discovered by MTPC. It was approved by the Ministry of Health, Labour and Welfare in April 2001 for the treatment of patients with acute cerebral infarction and is marketed in Japan under the product name of Radicut^®. Edaravone has been approved for ALS in several countries including Japan (Radicut^®) in June 2015, South Korea (Radicut^®) in December 2015, the U.S. (Radicava^®) in May 2017, Canada (Radicava^®) in October 2018, and Switzerland (Radicava^®) in January 2019.

Edaravone (oral suspension) for the treatment of ALS was approved in the U.S. in May 2022, in Canada in November 2022, and in Japan in December 2022.

■ About Mitsubishi Tanabe Pharma GmbH

Headquartered in Dusseldorf, Germany, Mitsubishi Tanabe Pharma GmbH has been founded in 2003 as a subsidiary of Mitsubishi Pharma Europe Ltd. (London/UK). The company in Switzerland, based in Zurich, focuses not only on Radicava^®, but also on marketing the direct thrombin inhibitor, Argatra^® (argatroban monohydrate).

■ About Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678 and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, “Forging the future”. MTPC sets the MISSION of “Creating hope for all facing illness”. To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on “precision medicine” to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is working to develop “around the pill solutions” to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.mt-pharma-ch.com.

PRESS RELEASE

December 2020

Biologix - Mitsubishi Tanabe Pharma GmbH cooperation in the Middle East - North Africa region

Mitsubishi Tanabe Pharma GmbH and Biologix FZ LLC Partner to Distribute Radicava® (edaravone) in the Middle East and North Africa Region.
Düsseldorf December 21st, 2020 -- Mitsubishi Tanabe Pharma GmbH, a Pharmaceutical company built on the promise of providing treatments for patients who have limited or inadequate therapeutic options, has entered into an exclusive agreement with Biologix FZ LLC under which Biologix will distribute Radicava® (edaravone) in certain countries throughout the Middle East and North African (MENA) region. Under the terms of the agreement, Biologix will be responsible for managing named-patient requests through which physicians can legally and ethically prescribe Radicava® for patients prior to commercial availability.

 
About Edaravone
Edaravone is a free-radical scavenger that was discovered by Mitsubishi Tanabe Pharma. It was approved by the Japanese Ministry of Health, Labour and Welfare in April 2001 as a treatment agent for the acute stage of cerebral infarction. In Japan, it is being marketed under the product name RADICUT®. Edaravone has the effect of scavenging free radicals that arise accompanying cerebral ischemia, controlling the lipid peroxidation reaction, and protecting neurons in the region of the ischemia and the surrounding region. Accordingly, it is thought that edaravone has the effect of scavenging free radicals, which increase in ALS, protecting motor neurons from oxidative stress, and delaying the decline in muscle strength and the progress of muscular atrophy.
For use as a treatment for ALS, edaravone was approved in Japan in June 2015, South Korea in December 2015, US in May 2017, Canada in October 2018, Switzerland in January 2019, China in July 2019 and Indonesia in July 2020.

About Biologix
Biologix, a privately owned pharmaceutical company organized and existing under the laws of the United Arab Emirates (UAE), was incorporated in the Dubai Airport Free Zone in September 2002 as a regional distributor and promoter of pharmaceutical specialties in the Middle East & North Africa (MENA) countries. Biologix provides end to end services from the pre-registration phase including named patient supply, medical and disease awareness activities, to registration, promotion, cold chain distribution, tender management, market access programs, pharmacovigilance and product safety, as well as the administration of risk management plans, on behalf of its partners.

About Mitsubishi Tanabe Pharma GmbH (MTPD)
Headquartered in Dusseldorf, Germany, Mitsubishi Tanabe Pharma GmbH has been founded in 2003 as a subsidiary of Mitsubishi Pharma Europe Ltd. (London/UK). The company in Switzerland, based in Zurich, focuses not only on Radicava®, but also on marketing the direct thrombin inhibitor, Argatra® (argatroban monohydrate).
The parent company of MTPD is Mitsubishi Tanabe Pharma Corporation (MTPC) which is headquartered in Osaka, Japan.
Mitsubishi Tanabe Pharma GmbH I Willstätterstrasse 30 I 40549 Düsseldorf I Germany
www.mt-pharma-de.com
info@mt-pharma-de.com

14.08.2020

Mitsubishi Tanabe Pharma GmbH unterstützt die DGAI

Die andauernde COVID-19 Pandemie lässt die „Anästhesietage“ in diesem Jahr leider nicht zu.

Die Absagen von Kongressen und Fortbildungsveranstaltungen führen für alle Veranstalter zu nicht unerheblichen finanziellen Schäden.

Auch die Deutsche Gesellschaft der Anästhesie und Intensivmedizin (DGAI) ist hiervon betroffen. Als enger Partner der DGAI leistet MTPD einen Solidaritätsbeitrag von 2.000,- Euro, verbunden mit der Hoffnung, im Jahr 2021 wieder gemeinsam regionale und überregionale Kongresse und Fortbildungen veranstalten zu können.

Argatra® jetzt auch in der Schweiz verfügbar

Die Mitsubishi Tanabe Pharma GmbH hat am 06.07.2016 das Medikament Argatra^® (Argatrobanmonohydrat) in den Schweizer Gesundheitsmarkt eingeführt.

Argatra^® ist ein synthetischer, monovalenter und reversibler, direkter Thrombininhibitor zur parenteralen Antikoagulation bei erwachsenen Patienten mit einer heparininduzierten Thrombozytopenie Typ II (HIT II) ^[1].

Argatra^® zeichnet sich durch seine vorhersagbare antikoagulatorische Wirkung^[2,3] bei HIT II, sowie eine geringes Nebenwirkungspotential^[2] und ein einfaches Dosierungsschema aus.

Seit 1990 wurden weltweit bereits über 1.080.000 Patienten mit Argatrobanmonohydrat in verschiedenen Indikationen behandelt. Das Präparat ist bereits seit Jahren in mehreren europäischen Ländern im Einsatz - in Deutschland seit 2005 und in Österreich seit 2006.

Argatra^® ist in der Schweiz als Argatra Singledose verfügbar.

Die Mitsubishi Tanabe Pharma GmbH mit Sitz in Düsseldorf wurde 2003 gegründet und ist die erste Landesvertretung der Mitsubishi Tanabe Pharma Cooperation, die außerhalb Asiens Produkte aus der eigenen Forschung in den Markt bringt. Von Deutschland aus werden auch die Niederlassungen in Wien und Zürich betreut, die 2011 bzw. 2012 gegründet wurden.

[1]    Fachinformation Argatra® 100 mg/ml

[2]    Swan SK, St Peter JV, Lambrecht LJ, Hursting MJ. Comparison of anticoagulant effects and safety of argatroban and heparin in healthy subjects. Pharmacotherapy. 2000; 20(7): 756-770.

[3]    Swan SK, Hursting MJ. The pharmacokinetics and pharmacodynamics of argatroban: effects of age, gender, and hepatic or renal dysfunction. Pharmacotherapy. 2000; 20(3): 318-329

Die Mitsubishi Tanabe Pharma GmbH hat am 06.07.2016 das Medikament Argatra^® (Argatrobanmonohydrat) in den Schweizer Gesundheitsmarkt eingeführt.

Argatra^® ist ein synthetischer, monovalenter und reversibler, direkter Thrombininhibitor zur parenteralen Antikoagulation bei erwachsenen Patienten mit einer heparininduzierten Thrombozytopenie Typ II (HIT II) ^[1].

Argatra^® zeichnet sich durch seine vorhersagbare antikoagulatorische Wirkung^[2,3] bei HIT II, sowie eine geringes Nebenwirkungspotential^[2] und ein einfaches Dosierungsschema aus.

Seit 1990 wurden weltweit bereits über 1.080.000 Patienten mit Argatrobanmonohydrat in verschiedenen Indikationen behandelt. Das Präparat ist bereits seit Jahren in mehreren europäischen Ländern im Einsatz - in Deutschland seit 2005 und in Österreich seit 2006.