RESEARCH TRIANGLE PARK, N.C., June 15 Talecris Biotherapeutics announced today that it has agreed to a co-promotion arrangement with Novartis Vaccines to jointly market and sell their respective post-exposure rabies products.
Talecris provides HyperRAB® S/D (Rabies Immune Globulin [Human]), an essential component of rabies post-exposure prophylaxis for previously unvaccinated individuals, that is administered in combination with rabies vaccines. Novartis provides RabAvert® Rabies Vaccine for both pre-exposure and post-exposure prophylaxis.
"Through our agreement with Novartis, we are seeking to improve access to this critical-care therapy by ensuring that patients receive the immune protection provided by HyperRAB S/D and RabAvert," said John Perkins, executive vice president, global commercial operations at Talecris. "By co-promoting the two products, we will also enhance awareness of the recommended CDC guidelines for preventing rabies following an exposure."
Rabies is a preventable viral disease of mammals most often transmitted through the bite of a rabid animal. Rabies has the highest case fatality rate of any known infectious disease and is virtually 100% fatal following onset of clinical symptoms. The rabies virus infects the central nervous system, ultimately causing disease in the brain followed by death. For people who have not been vaccinated against rabies previously, post-exposure anti-rabies vaccination should always include administration of both passive antibodies and a series of rabies vaccines. Concurrent administration of a human rabies immune globulin (HRIG), such as Talecris' HyperRAB S/D, and a rabies vaccine, such as RabAvert, is recommended for both bite and non-bite exposures, regardless of the interval between exposure and initiation of treatment. Together, these therapies provide optimum immune protection against rabies.
In the coming months, both RabAvert and HyperRAB S/D will be made available from novartisvaccinesdirect.com and through a network of preferred wholesalers and distributors. Both companies' sales teams will promote HyperRAB S/D and RabAvert. Financial terms of the deal were not disclosed.
The early symptoms of rabies in people are similar to that of many illnesses, including fever, headache, and general weakness or discomfort. As the disease progresses, more specific symptoms appear and may include insomnia, anxiety, confusion, slight or partial paralysis, excitation, hallucination, agitation, hyper-salivation, difficulty swallowing and hydrophobia. Death usually occurs within days of the onset of these symptoms. There is no treatment or cure for rabies once symptoms have appeared. The only way to prevent the onset of symptoms is by vaccinating individuals (known as post-exposure prophylaxis) shortly after they have been exposed to rabies. Unless a wild animal is tested and shown not to be rabid, post-exposure prophylaxis should be initiated. For persons who have never been immunized against rabies, the regimen consists of an initial injection of rabies immune globulin, followed by a series of five doses of rabies vaccine.(1)
Important Safety Information for HyperRAB® S/D
Rabies vaccine and HyperRAB® S/D should be given to all persons suspected of exposure to rabies with one exception: persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine.
HyperRAB S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.
The attending physician who wishes to administer HyperRAB S/D to persons with isolated immunoglobulin A (IgA) deficiency must weigh the benefits of immunization against the potential risks of hypersensitivity reactions. Such persons have increased potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.
As with all preparations administered by the intramuscular route, bleeding complications may be encountered in patients with thrombocytopenia or other bleeding disorders.
Soreness at the site of injection and mild temperature elevations may be observed at times. Sensitization to repeated injections has occurred occasionally in immunoglobulin-deficient patients. Angioneurotic edema, skin rash, nephrotic syndrome, and anaphylactic shock have rarely been reported after intramuscular injection so that a causal relationship between immunoglobulin and these reactions is not clear.
Administration of live vaccines (e.g., MMR) should be deferred for approximately 3 months after rabies immune globulin (human) administration.
HyperRAB S/D is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.
Important Safety Information for RabAvert
RabAvert is indicated for pre-exposure vaccination, in both primary series and booster dose, and for post-exposure prophylaxis against rabies in all age groups.
Anaphylaxis, encephalitis including death, meningitis, neuroparalytic events such as encephalitis, transient paralysis, Guillain-Barre Syndrome, myelitis, and retrobulbar neuritis; and multiple sclerosis have been reported to be temporally associated with the use of RabAvert.
The most commonly occurring adverse reactions are injection site reactions, such as injection site erythema, induration and pain; flu-like symptoms; arthralgia; dizziness; lymphadenopathy; nausea; and rash.
History of anaphylaxis to the vaccine or any of the vaccine components constitutes a contraindication to pre-exposure vaccination with this vaccine. In the case of post-exposure prophylaxis, if an alternative product is not available, vaccination should proceed with caution and close observation. A patient's risk of acquiring rabies must be carefully considered before discontinuing vaccination.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, neurology and hemostasis. For more information, please visit: www.talecris.com.
Cautionary statement regarding forward-looking statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, quotations from management in this press release, statements regarding strategic and operation plans, and statements regarding the development or commercialization of therapies. Forward-looking statements are based on current beliefs and expectations and are subject to inherent risks and uncertainties. You are cautioned not to place undue reliance on forward-looking statements. Although Talecris believes that the forward-looking statements contained in this press release are reasonable, there is no assurance that expectations will be fulfilled.
The following factors, among others, could cause actual results to differ materially from those expressed or implied in forward-looking statements: possible U.S. legislation or regulatory action affecting, among other things, the U.S. healthcare system, pharmaceutical pricing and reimbursement, including Medicaid and Medicare; our ability to procure adequate quantities of plasma and other materials which are acceptable for use in our manufacturing processes from our own plasma collection centers or from third-party vendors; our ability to maintain compliance with government regulations and licenses, including those related to plasma collection, production and marketing; our ability to identify growth opportunities for existing products and our ability to identify and develop new product candidates through our research and development activities; and the timing of, and our ability to, obtain and/or maintain regulatory approvals for new product candidates, the rate and degree of market acceptance, and the clinical utility of our products. Additional information about factors that could affect the business and financial results of Talecris is contained in its final Prospectus filed pursuant to Rule 424(b) (1) with the Securities and Exchange Commission on October 1, 2009. Talecris undertakes no duty to update any forward-looking statement.
(1). RabAvert Rabies Vaccine Prescribing Information
SOURCE Talecris Biotherapeutics