Teva Canada Innovation Announces Approval of CINQAIR™ by Health Canada
Jul 25, 2016, 07:59 ET
Company Launches Respiratory Franchise in Canada with a New Biologic for Add-On Maintenance Treatment of Adult Patients with Severe Eosinophilic Asthma
MONTREAL, July 25, 2016 /CNW/ - Teva Canada Innovation, a subsidiary of Teva Pharmaceutical Industries Ltd., announced today that Health Canada has approved CINQAIRTM (reslizumab), a humanized interleukin-5 (IL-5) antagonist monoclonal antibody (IgG4 kappa), for the add-on maintenance treatment of adult patients with severe eosinophilic asthma who are inadequately controlled with medium-to-high-dose inhaled corticosteroids and an additional asthma controller(s) (e.g. LABA), and have a blood eosinophil count of ≥400 cells/μL at initiation of the treatment1.
Upon commercial availability of CINQAIRTM, Teva Canada Innovation will launch Teva Support SolutionsTM in Canada. Teva Support SolutionsTM is a comprehensive program that will provide personalized support, training and education to healthcare providers and patients who have been prescribed CINQAIRTM. CINQAIRTM is administered by intravenous infusion at a weight-based dose of 3 mg/kg once every four weeks. The treatment is expected to become commercially available to patients, by prescription, in late fall 2016.
The clinical trial program consisted of five placebo-controlled studies in a population of 1,028 adults and adolescent asthma patients treated with CINQAIRTM 3 mg/kg. Two of these studies constituted the Phase III program (the late-stage of the drug development process) in patients with asthma and elevated blood eosinophils. The data demonstrated that treatment with CINQAIRTM was associated with reduction in asthma exacerbations as well as significant improvement in lung function, symptoms, and asthma-related quality of life3,4,5,6. The incidence of the most common adverse events in the placebo-controlled asthma studies, in CINQAIRTM-treated patients, was lower than or similar to the placebo-treated patients.
A new innovative player in respiratory disease
"Teva Canada Innovation is committed to developing therapies that address the unmet needs of patients, healthcare providers, caregivers, and payers in our key therapeutic areas of focus," said John C. Jacobs, General Manager of Teva Canada Innovation. "We are proud to demonstrate that commitment with the development of CINQAIRTM, for those suffering from respiratory disease, by advancing the treatments available. It is a targeted therapy for a specific subset of patients with a persistent, inadequately controlled, severe eosinophilic asthma—a disease and patient population that is very difficult to treat."
About CINQAIRTM (reslizumab)
CINQAIRTM (reslizumab) is a humanized interleukin-5 (IL-5) antagonist monoclonal antibody (IgG4 kappa), approved by Health Canada for the add-on maintenance treatment of adult patients with severe eosinophilic asthma who are inadequately controlled with medium-to-high-dose inhaled corticosteroids and an additional asthma controller(s) (e.g. LABA), and have a blood eosinophil count of ≥400 cells/μL at initiation of the treatment.
IL-5 plays a major role in the maturation, activation and survival of eosinophils. In asthma patients, the eosinophilic phenotype is associated with compromised lung function, more frequent symptoms, and increased risk of exacerbations7. Reslizumab binds to human IL-5 and prevents it from binding to the IL-5 receptor, thereby reducing eosinophilic inflammation8.
About Teva Canada Innovation
Teva Canada Innovation (TCI) is a branded, specialty medicines company, with operations in Canada since 1997. TCI's mission is to introduce new, innovative health care solutions for Canadians in the central nervous system (CNS), respiratory and pain care therapeutic areas. The company also markets brands in women's health and oncology, and has established partnerships with other Canadians pharmaceutical companies in these areas. Throughout 2017, TCI will introduce a portfolio of new respiratory medicines and technologies to Canada ranging from intuitive rescue and maintenance inhalers to a new targeted biologic option for patients with severe asthma. TCI is a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. For more information, visit www.tevacanadainnovation.ca.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world's largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2015 amounted to $19.7 billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our specialty products, especially Copaxone® (which faces competition from orally-administered alternatives and a generic version); our ability to consummate the acquisition of Allergan plc's worldwide generic pharmaceuticals business ("Actavis Generics") and to realize the anticipated benefits of such acquisition (and the timing of realizing such benefits); the fact that following the consummation of the Actavis Generics acquisition, we will be dependent to a much larger extent than previously on our generic pharmaceutical business; potential restrictions on our ability to engage in additional transactions or incur additional indebtedness as a result of the substantial amount of debt we will incur to finance the Actavis Generics acquisition; the fact that for a period of time following the consummation of the Actavis Generics acquisition, we will have significantly less cash on hand than previously, which could adversely affect our ability to grow; the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from investments in our pipeline of specialty and other products; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; adverse effects of political or economic instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; the impact of continuing consolidation of our distributors and customers; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; our potential exposure to product liability claims that are not covered by insurance; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; significant impairment charges relating to intangible assets, goodwill and property, plant and equipment; the effects of increased leverage and our resulting reliance on access to the capital markets; potentially significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2015 and in our other filings with the U.S. Securities and Exchange Commission (the "SEC"). Forward-looking statements speak only as of the date on which they are made and we assume no obligation to update or revise any forward-looking statements or other information, whether as a result of new information, future events or otherwise.
1CINQAIRTM (reslizumab injection) Product Monograph. Teva Canada Innovation, July 19th, 2016.
2Severe Asthma, The Canadian Patient Journey, A study of the personal, social, medical and economic burden of Severe Asthma in Canada, Asthma Society of Canada, 2014 Accessed June 20, 2016, available at: http://www.asthma.ca/pdfs/SAstudy.pdf
3Kips JC et al. Am J Respir Crit Care Med. 2003;167:1655-1659.
4Castro M et al. Am J Respir Crit Care Med. 2011;184:1125–1132
5Bjermer L et al. Eur Respir J. 2014;44(suppl):58.
6Castro M et al. Lancet Respir Med. 2015;3(5):355-66
7Takatsu K et al. Curr Opin Immunol. 2008;20(3):288-294.
8Egan et al. Arzneimittelforschung. 1999;49(9):779-790.
SOURCE Teva Canada Innovation
For further information: IR Contacts: Kevin C. Mannix, United States, (215) 591-8912; Ran Meir, United States, (215) 591-3033; Tomer Amitai, Israel, 972 (3) 926-7656; PR Contacts: Nancy Leone, Teva Pharmaceuticals, (215) 284-0213; Michelle Larkin, Teva Pharmaceuticals, (610) 786-7335; Michael Kohn, Weber Shandwick Toronto, (416) 642-7914; Yannick Gayama, Weber Shandwick Montreal, (514) 447-3943
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