Cangene assumes U.S. commercialization rights for WinRho(R) SDF
Readers are referred to the cautionary notes regarding Forward-looking information at the end of this release
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“This move is in line with our increasing focus on our commercial products, particularly in the important U.S. market,” said Dr.
Cangene had already begun to build its sales force in the U.S. at its Cangene bioPharma, Inc. subsidiary in
“It’s very exciting to see our commercial sales group in the U.S. grow to more than 30 people, said
Cangene manufactures WinRho(R) SDF in its
About WinRho(R) SDF (Rho(D) Immune Globulin Intravenous (Human)) and
Important Risk Information
WinRho(R) SDF is a sterile, lyophilized or liquid gamma globulin (IgG) fraction containing antibodies to the Rho(D) antigen. It is approved in
WinRho(R) SDF is derived from human plasma and is administered intravenously for treating immune thrombocytopenic purpura (“ITP”), which is an autoimmune bleeding disorder caused by an abnormally low level of platelets, which are a necessary component of the body’s blood-clotting mechanism. In ITP, the immune system produces antibodies against platelets causing their premature destruction. Individuals who suffer from ITP may have symptoms such as bruising on skin and gums, nosebleeds, or mucosal bleeding. The most serious risk in patients who develop ITP is intracranial hemorrhage (bleeding into the brain).
WinRho(R) SDF must be administered via the intravenous route when used in clinical situations requiring an increase in platelet count to prevent excessive hemorrhage in the treatment of non-splenectomized, Rho(D)-positive:
- children with chronic or acute ITP, - adults with chronic ITP, or - children and adults with ITP secondary to HIV infection.
The safety and efficacy of WinRho(R) SDF have not been evaluated in clinical trials for patients with non-ITP causes of thrombocytopenia, or in previously splenectomized patients or in patients who are Rho(D) negative.
Intravascular hemolysis (“IVH”) leading to death has been reported in patients treated for ITP with WinRho(R) SDF.
IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome (“ARDS”).
Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation (“DIC”) have also been reported.
Patients treated with WinRho(R) SDF for ITP are to be closely monitored in a healthcare setting for at least eight hours after its administration. A dipstick urinalysis is to be performed at baseline, and then after administration at 2 hours, 4 hours and prior to the end of the monitoring period. Physicians are instructed to alert patients and monitor for the signs and symptoms of IVH including back pain, shaking chills, fever, and discoloured urine or hematuria. Absence of these signs and/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently. If signs and/or symptoms of IVH are present or suspected after WinRho(R) administration, post-treatment laboratory tests should be performed including plasma hemoglobin, haptoglobin, LDH, and plasma bilirubin (direct and indirect).
For use in the treatment of ITP, WinRho(R) SDF is not to be used in: - patients with known anaphylactic or severe hypersensitivity responses to human immune globulin products - patients with autoimmune hemolytic anemia - patients with pre-existing hemolysis or in patients at high risk for hemolysis - patients who are IgA deficient with antibodies against IgA
The liquid formulation of WinRho(R) SDF contains maltose. Maltose in immune globulin intravenous (“IGIV”) products has been shown to give falsely high blood-glucose levels in certain types of blood-glucose testing systems. Due to the potential for falsely elevated glucose readings, only testing systems that are glucose-specific should be used to test or monitor blood-glucose levels in patients receiving WinRho(R) SDF Liquid.
WinRho(R) SDF is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (“CJD”) agent. While testing and manufacturing steps are employed to reduce this risk, the possibility of transmitting infectious agents cannot be totally excluded.
Use of IGIV products, particularly those containing sucrose, has been reported to be associated with renal dysfunction, acute renal failure, osmotic nephropathy, and death. WinRho(R) SDF does not contain sucrose. For patients at risk of renal dysfunction or failure, WinRho(R) SDF is to be administered at the minimum infusion rate practicable.
In Rho(D)-positive patients with ITP, side effects related to the destruction of Rho(D)-positive red blood cells, most notably decreased hemoglobin, can be expected. In most cases, the red blood cell destruction is believed to occur in the spleen.
Thrombotic events may occur following treatment with WinRho(R) SDF and other IGIV products. Non-cardiogenic pulmonary edema (Transfusion-related Acute Lung Injury (“TRALI”)) may occur in patients following IGIV treatment.
General adverse reactions associated with the use of WinRho(R) SDF include body weakness, abdominal or back pain, low blood pressure, paleness, diarrhea, abnormal blood work, joint pain, muscle pain, dizziness, abnormal movement, sleepiness, itchiness, rash, and sweating. In the treatment of ITP, the most common adverse events ((less than or equal to) 2% of infusions) were headache, chills and fever.
About Cangene Corporation
Cangene is one of
Cangene is focused on developing therapeutics for infectious diseases, and the Company uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. Cangene has five FDA and/or Health Canada-approved products. In addition, the Company has several more products in development at various stages. Three of Cangene’s products have been accepted into the U.S. Strategic National Stockpile – botulism antitoxin (investigational product), anthrax immune globulin (investigational product) and vaccinia immune globulin, a product used to counteract certain complications that may arise from smallpox vaccination. Capitalizing on its drug manufacturing expertise, Cangene also operates a significant contract research and manufacturing business using the resources of
“Cangene”, “HepaGam B”, “VariZIG”, “WinRho” and “WinRho SDF” are trademarks belonging to Cangene Corporation.
Forward-looking and risk information
The reader should be aware that Cangene’s businesses are subject to risks and uncertainties that cannot be predicted or quantified; consequently, actual results may differ materially from past results and those expressed or implied by any forward-looking statements. Factors that could cause or contribute to such risks or uncertainties include, but are not limited to: the regulatory environment including the difficulty of predicting regulatory outcomes; changes in the value of the Canadian dollar; the Company’s reliance on a small number of customers including government organizations; the demand for new products and the impact of competitive products, service and pricing; availability and cost of raw materials, especially the cost, availability and antibody concentration in plasma; fluctuations in operating results; government policies or actions; progress and cost of clinical trials; reliance on key strategic relationships; costs and possible development delays resulting from use of legal, regulatory or legislative strategies by the Company’s competitors; uncertainty related to intellectual property protection and potential costs associated with its defence; the Company’s exposure to lawsuits; and other matters beyond control of management. Risks and uncertainties are discussed more extensively in the MD&A section of the Company’s most recent annual report and annual information form, which are available on the Company’s website or on SEDAR at www.sedar.com.
The preceding cautionary statements should be considered in connection with all written or oral statements, especially forward-looking statements, that are made by the Company or by persons acting on its behalf and in conjunction with its periodic filings with Securities Commissions, including those contained in the Company’s news releases and most recently filed annual information form. Forward-looking statements can be identified by the use of words such as “expects”, “plans”, “will”, “believes”, “estimates”, “intends”, “may”, “bodes” and other words of similar meaning (including negative and grammatical variations). Should known or unknown risks or uncertainties materialize, or should management’s assumptions prove inaccurate, actual results could vary materially from those anticipated. The Company undertakes no obligation to publicly make or update any forward-looking statements, except as required by applicable law.
Scientific information that relates to unapproved products or unapproved uses of products is preliminary and investigative. No conclusions can or should be drawn regarding the safety or efficacy of such products. Only regulatory authorities can determine whether products are safe and effective for the uses being investigated. Healthcare professionals are directed to refer to approved labelling for products and not rely on information presented in news releases, which may not contain all relevant safety information. Drug names and prescribing information may differ in various countries.
SOURCE Cangene Corporation