TeaRx, LLC, a company of High Tech Centre ChemRar announced today the successful completion of clinical studies and state contract for the development of new and innovative anticoagulant Tearexaban, a direct inhibitor of blood factor Xa. The contract was awarded and successfully completed within the Federal Targeted Program “Development of Pharmaceutical and Medical Industry in the Russian Federation until 2020” and further perspectives.
Safety and effecacy of Tearexaban has been proven in a multicenter, randomized, open clinical trial in the indication of prevention of venous thromboembolic events after knee arthroplasty compared with enoxaparin. The study has been conducted in 6 centers in Russia with 200 patients enrolled.
TeaRx, a ChemRar group company, starts Phase II clinical trial of its innovative anticoagulant – novel oral direct Factor Xa inhibitor
January 7, 2014 – Moscow, Russia – TeaRx, a ChemRar group company, announces initiation of Phase II clinical trial of its novel anticoagulant TeaRx, an oral Factor Xa inhibitor. This new class of anticoagulant is being introduced and applied across the world addressing highly unmet needs in prevention and treatment of such common cardiovascular disorders as deep venous thrombosis and thromboembolism, and also stroke in patients with atrial fibrillation associated with acute coronary syndrome.
The drug in development, TeaRxaban contains an active pharmaceutical ingredient developed by F.Hoffmann-La Roche, which has conducted a wide range of preclinical studies and Phase I clinical trials. In 2011 Roche granted TeaRx LLC an exclusive license to develop, manufacture and commercialize this novel antithrombotic agent in Russia and the CIS.
The main advantages of the emerging new class of oral anticoagulant over older vitamin K antagonists (i.e. warfarin) are more rapid onset and cessation of action, minimal impact of inter-drug interactions on efficacy and safety, and elimination of the need for laboratory monitoring of clotting speed (INR), which is usually required to adjust dosages of warfarin and other vitamin K antagonists. An equally important advantage of this class of drugs is the high selectivity of their effect on coagulation factors, which makes their effects more predictable and the dosages used more universal. Simple oral administration of a capsule, instead of injection will be a major convenience for patients.
The clinical trial will determine the range of optimal dosages, and evaluate safety and efficacy when administered to prevent venous thromboembolic complications following knee replacement, in comparison with standard Enoxaparin therapy. The trials will be conducted at ten research centers in various regions of Russia.
Kirill Volynchik, MD, PhD, Director of Development at TeaRx LLC: “Preclinical and clinical studies of TeaRxaban demonstrated that the drug has a high therapeutic index and its pharmacological properties and safety may have several advantages over currently approved anticoagulants. Launch of such innovative Russian drug with potentially higher efficacy and safety than drugs in current clinical practice is of strategic significance for better treatment of patients in Russia, and the development of the Russian pharmaceutical industry.”
Mikhail Zamyatin, MD, Professor, Head of Department of Anesthesiology and Intensive Care, FGBI “Pirogov National Medical Surgical Center”, Ministry of Health of Russian Federation: “Millions of people in Russia are prone to diseases caused by thrombosis, and most of them need preventive medication. The high risk group for deep vein thrombosis and life-threatening pulmonary embolism includes patients who have undergone knee joint replacement. Conducting clinical trials of the first Russian drug in the group of oral Factor X inhibitors and proving its efficacy in this patient population will expand the therapeutic arsenal available to Russian physicians and patients.”
About TeaRx LLC
TeaRx LLC is a private specialty pharmaceutical company incorporated in 2011 as an entity of the ChemRar Group. The major focus of the company is development and commercialization of innovative anticoagulants for prophylaxis and treatment of thrombosis and thromboembolism. TeaRx performs full cycle of pre-clinical and clinical trials implicating experience and knowledge of foreign partners and Russian scientists. For more information about TeaRx LLC please visit company`s website: www.tearx.ru
All trademarks used or cited in this press release are protected by law.
Elena Surina, PR- director of HTC ChemRar
tel. +7 (495) 925 30 74 # 132
ChemRar Group Company TeaRx participated and presented a Poster in the competition of France’s biggest Partnering Event between Pharma and BioTech companies in Paris at the Cite International Universitaire from October 7 – 9.
The conference and exhibition, organized for the 4th time, brought together some 250 participants from big European Pharma companies, such as Sanofi, Sanofi Pasteur, Pierre Fabre, Pfizer, Roche, Glaxo Smith Kline, Astra Zeneca, UCB Pharma, Ipsen Innovation, and major Research Institutions such a Institute Pasteur, and the Karolinska Institute, with start-up companies from around Europe. TeaRx presented at a corporate booth about its innovative drugs in development on thrombotic prophylaxis. TeaRx, along with ChemRar group company NewVac, were invited by the International Jury of the Innovation Prize, to be part of a selected Poster Gallery, of 16 Posters, selected from more than 200 applications. Innovation Prize is awarded to a start-up BioTech company since 2009. Prize finalists, and posters, selected by the Jury came from France, Switzerland, Spain, the United Kingdom, Croatia, Canada, and
– for the first time – from Russia.
The Jury included representatives from the European Commission, Institute Pasteur, Karolinka Institute, Astra Zeneca,
GlaxoSmithKline, and the Ipsen Group.
Selection of the Innovation Prize winner, and the Poster
Presentations was based on
– scientific quality of the innovation
– level of intellectual property
– quality of human resources
– project feasibility
– chances of successs on the market/ investor interest
The third day of the conference and exhibition was dedicated to
Emerging Pharma Markets of the BRIC countries, Brazil, Russia,
India, and China.
TeaRx CEO, and ChemRar Board Member Henrik Konarkowski was part of a panel of three experts, presenting to the audience opportunities how to partner with Russian companies, and to participate in the Pharma 2020 programs of the Russian Government. Ludmila Maksimova of the National Center for Health Technology Evaluation of Russia, presented on the State effort in the Russian Federation to improve Healthcare, in particular by improving Diagnostics, and promoting a Healthy Life Style, as well as National Healthcare spending, and the medicine price regulations, and reimbursement system in Russia, Henrik elaborated on partnering and licensing opportunities for foreign Pharma, BioTech, and MedTech companies in Russia, as well as the status of the drug import-replacement program in Russia.
In comparison, the conference showed, that Brazil for example has accomplished the task of import replacement over a 20 years time, with now more than 85% of drugs sold in Brazil, being produced in the country. While Russia is still far away from that number, it can however show a much bigger effect on in-country R&D, with many Russian companies participating in Discovery and Development of drugs, and not only producing and distributing. It became clear at the conference, that every country of the BRIC countries is going a separate, individual way in the developing of a local Pharma Industry, and that Russia has the best chances of integrating its highly developed Research base into the global Research community.
The TeaRx Poster presented:
The TeaRx project will be presented by Henrik Konarkowski, CEO of the company at the Third International Forum “Innovation in Russia: research and development,” which will be held November 21-23, 2012 at the Marriott Grand Hotel.
The event presents a unique platform for the key figures involved in the development of Russian innovative products, where leading industry professionals will be able to discuss how to develop a perfect cycle of innovative therapy, given the specifics of the market and current economic conditions.
Key discussion topics in 2012 will include:
- Review and analysis of the potential growth of the sector of innovative drugs in Russia
- Reforms in the sector. Government policy in the field of innovative pharmaceutical industry. What goals for the Government and regulators in 2013 and beyond are defined?
- Evaluation of innovation, the use of open innovation model
- Where are the most profitable opportunities for international players?
- Opportunities to improve ways of collaboration between academic centers and pharmaceutical companies
- The investment climate and opportunities for attracting investment in the sector
- Strategies for preclinical drug development stage, and more
Detailed information on the Forum website: http://www.adamsmithconferences.com/hr23gmp
May. 24, 2011
Roche and TeaRx, Ltd. sign license agreement for innovative drugs fighting Thrombosis, Stroke, and Embolism
Basel, Switzerland, and Moscow, Russia, May 2010
Roche (SIX: RO, ROG; OTCQX: RHHBY) and TeaRx, LLC, Member of The Center for Innovative Technologies ChemRar, Russia, have signed a licence agreement granting TeaRx development and commercialization rights for a novel treatment for patients at risk of Thrombosis in Russia and 12 other, countries. Royalties from resulting sales in these markets will be paid to Roche, and the company may negotiate rights in further territories.
Under the terms of the agreement, Roche will provide TeaRx with clinical candidates belonging to a new class of oral Factor Xa inhibitors. TeaRx LLC will develop these innovative compounds in Russia, and initiate clinical studies which are expected to begin in 2012. Roche will co-invest into the project by manufacturing the API material (active ingredient) for the early clinical studies in a high tech facility in the USA, TeaRx will produce the final formulation in Russia. TeaRx will conduct clinical studies to prevent deep venous thrombosis (DVT) and pulmo-nary embolism (PE) in patients undergoing orthopedic and general surgery. They will also conduct clinical studies for other potential indications like the prevention of thrombotic events (stroke) in risk patients with atrial fibrillation (AF) Cerebrovascular disease, as stroke is known to Doctors, is actually the second leading cause of death worldwide, counting for about 10% of all deaths worldwide, according to the WHO. Stroke prevention is one of the priorities of the WHO worldwide programs, and the new drug developed by TeaRx can play a major role in this endeavour.“This agreement will finally bring an innovative medicine to patients with stroke and thrombosis in countries with a high disease prevalence, and a high mortality. This new partnership with ChemRar, in line with PHARMA-2020, a significant Government initia-tive aimed at accelerating development of the Russian pharmaceutical industry, is the result of good experience with an earlier partnership in the HIV field”, said Milos Pet-rovic, General Manager of Roche Moscow Ltd. and Head of Roche Representative Office in Russia.
Tuygan Goeker ,Roche Regional Head for CEMAI (Central&Eastern Europe, Middle East, Africa, Indian sub-continent) added: “Our partnership with TeaRx builds on Roche’s innovation strategy in growing markets like Russia. The compounds licensed to TeaRx will help to foster the Russian BioCluster/Incubator, that Roche has worked with successfully in the past, and continues to support. Roche will pursue its search for innovative products and creative partnerships in ther emerging markets that will strengthen our efforts to make differentiated medicines available to the patients in need.
Andrey Ivashenko, Chairman of ChemRar, commented: “We welcome Roche’s pioneering ap-proach and support to developing the innovative Pharma market in Russia. With this TeaRx deal, ChemRar extends its existing partnering with Roche in combating AIDS, by co-investing in a best in class antitrombotic treatment, which will be produced in Russia and exported to many other countries.
Nikolay Savchuk, Chairman of TeaRx, said: “We are honored that Roche extended its partner-ship with ChemRar group and selected TeaRx to license a highly interesting clinical candidate for development of a novel treatment. Trombosis is taking numerous lives in Russia every day. The novel safe treatments are 50 years overdue. This drug, if successfully launched, will help to save lives of stroke patients and in-crease success and post-operational safety in hospitals in Russia and worldwide. We expect the drug to become best in class against exiting and recently developed competitive therapeutics.