Novartis receives Health Canada approval of Menveo* to prevent meningococcal
disease

    
    -   Menveo* licensed in 11 to 55 year olds to help protect against
        potentially deadly meningitis and sepsis caused by four common
        vaccine-preventable serogroups(1)

    -   Meningococcal disease causes approximately 50,000 deaths globally
        each year, many of which could be prevented through vaccines(2)

    -   Novartis plans to seek licensure of Menveo* in infants and children
        two to 10 years of age
    

DORVAL, QC, June 8 /CNW/ - Novartis Pharmaceutical Canada Inc. announced that Menveo* (Meningococcal (Groups A, C, Y and W-135) Oligosaccharide CRM197 Conjugate Vaccine), a quadrivalent meningococcal conjugate vaccine was approved by Health Canada for active immunization of adolescents (11 to 18 years of age) and adults (19 to 55 years of age) to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135(1).

"Meningococcal disease is particularly distressing because it can rapidly kill or debilitate previously healthy adolescents. Even with early and appropriate treatments, patients can die from meningococcal disease, often within 24 to 48 hours of onset of symptoms. This is why we welcome this new vaccinethat can prevent meningococcal disease caused by all four vaccine-preventable serogroups." says Kathryn Blain, founder and chair of the Meningitis Research Foundation of Canada (www.meningitis.ca).

"Menveo* is a welcome addition to our armamentarium in preventing this deadly disease. In the head-to-head study versus Menactra comparing the rate of protection for both vaccines that studied adolescents and adults. Menveo* demonstrated superiority for A, Y and W-135 serotypes. These results are theoretically significant given we know that circulating antibodies are necessary for protection. However, the clinical significance is not yet known" says Jay Keystone, MD, FRCPC, Professor, Department of Medicine, University of Toronto and Senior Staff Physician, Toronto General Hospital.

The National Advisory Committee on Immunization is now recommending that a dose of meningococcal conjugate vaccine be given in early adolescence, ideally around 12 years of age, even if the adolescent was previously vaccinated as part of a routine infant or toddler vaccination program. This adolescent dose is to ensure that circulating antibodies are present as adolescents enter the peak years for invasive meningococcal disease beyond infancy, which are between 15 and 24 years of age(3).

In Canada, the incidence of meningococcal disease varies, ranging between 200 and 250 cases per year(3). As many as one in 7 patients who contract meningococcal disease die from it(9). Approximately one in 5 meningococcal disease survivors suffer serious, permanent and devastating side effects, including limb amputations, seizures, paralysis, hearing loss and learning disabilities(4). Meningococcal disease is a leading cause of bacterial meningitis, which is an infection of the membrane around the brain and spinal cord, and sepsis, an often life-threatening bloodstream infection(4)(5).

Approval of Menveo* is the result of 10 years of dedicated effort by Novartis Vaccines to provide a vaccine that can help protect people against meningococcal disease. The Menveo* development program for other age groups continues in multiple Phase III clinical trials.

The Health Canada approval of Menveo* was based on a Phase III head-to-head clinical trial that compared Menveo* to the other licensed ACWY meningococcal conjugate vaccine among subjects 11 to 55 years of age. The trial, which was broken into two subsets - adolescents, age 11 to 18, and adults, age 19 to 55 - measured for each of the four serogroups both the percentage of subjects who achieved an immune response as measured by seroresponse and proportions achieving human serum bactericidal antibody (hSBA) titers greater than or equal to 1:8. Additionally the study examined antibody level as measured by geometric mean titers (GMT)(1)

In study participants aged 11 to 18 years, Menveo* met its primary endpoint for all four serogroups using hSBA seroresponse. The percentages of subjects who demonstrated an immune response (i.e., achieved an hSBA titer greater than or equal to 1:8) for each serogroup for Menveo* and its comparator (the other licensed ACWY meningococcal conjugate vaccine) respectively, were: Serogroup A - 75: 67; serogroup C - 84: 84; serogroup Y - 88: 69; and serogroup W-135 - 96: 88(1).

The seroresponse with Menveo* for serogroups A, Y and W-135, was statistically higher. However, the clinical relevance of higher post-vaccination immune responses is not known.

In the same group, the levels of circulating antibodies (i.e., GMT) in those who received Menveo* vs. those who received the comparator, respectively, were: Serogroup A - 29: 18; serogroup C - 59: 47; serogroup Y - 51: 18; and serogroup W-135 - 87: 44(1).

Menveo* will be available in Canada in the coming months.

About meningococcal disease, a leading cause of bacterial meningitis

Because invasive meningococcal disease can progress so rapidly, high levels of circulating antibodies are critical for protection. Immune memory typically takes up to five days to develop, so there often is not enough time for immune memory to mount a protective response once the disease has started(7). Five serogroups cause the majority of meningococcal disease worldwide: A, B, C, Y and W-135(8). Distribution of serogroups varies widely from geographic region to region and changes over time(9).

Currently, in Canada, most disease is caused by serogroups B, C, and Y(3). The prevalence of serogroup C is 20% followed by Y at 13% with serogroups B being the dominant serogroups at 55%. Epidemiology of meningococcal disease is constantly changing(9), so it is impossible to determine which serogroups will result in the majority of disease cases year over year. For more information, please visit www.meningitis.com.

About Novartis Vaccines' global meningococcal franchise

Novartis Vaccines is a global leader in providing vaccines to protect against deadly meningococcal disease. Through industry-leading scientific expertise, the company is focused on extending critical meningococcal vaccines research. In addition to developing Menveo* vaccine, Novartis Vaccines is developing a recombinant vaccine for its potential to provide broad coverage against multiple strains of serogroup B, for which no vaccine is currently available.

Menveo* vaccine is based on the same proprietary technology Novartis Vaccines pioneered to produce Menjugate*, a meningococcal serogroup C conjugate vaccine approved for use in Canada since 2001. The company has already distributed more than 41 million doses of Menjugate* around the world and produced MenZB(R), a vaccine against a strain of meningococcus B specific to a recent outbreak in New Zealand.

About Novartis Vaccines and Diagnostics Canada

Novartis Vaccines and Diagnostics is a division of Novartis Pharmaceuticals Canada Inc. focused on the development of preventive treatments.

About Novartis Pharmaceuticals Canada Inc.

Novartis Pharmaceuticals Canada Inc. (Novartis Pharmaceuticals), a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. Novartis Canada conducts hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, oncology, diabetes, cancer, ophthalmology. In 2009, the Company invested close to $100 million in research and development. Novartis Pharmaceuticals employs more than 750 people in Canada and its headquarters are located in Dorval, Québec. In addition to Novartis Pharmaceuticals, the Novartis Group in Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., CIBA Vision Canada Inc. and Sandoz Canada Inc. For further information about Novartis Pharmaceuticals, please consult www.novartis.ca.

Important Safety Information

Menveo* is contraindicated in individuals who have experienced a severe allergic reaction after a previous dose of Menveo*, any component of this vaccine, or any other CRM197, diphtheria toxoid or meningococcal-containing vaccine. Appropriate medical treatment must be available should an acute allergic reaction, including an anaphylactic reaction, occur following administration of Menveo*. Vaccinees may develop syncope, sometimes resulting in falling with injury. Observation for 15 minutes after vaccination is recommended. Patients who are immunocompromised or receiving immunosuppressive therapy may have an inadequate response to vaccination. Following vaccination with a licensed meningococcal quadrivalent polysaccharide conjugate vaccine, an evaluation of post marketing adverse events suggested a potential for an increased risk of Guillain-Barré syndrome (GBS). Data are not available to evaluate the potential risk of GBS following administration of Menveo*. In clinical trials, the most frequently occurring adverse events in all subjects who received Menveo* were pain at the injection site, headache, myalgia, malaise, and nausea. Some events were severe. Safety has not been established in pregnant women. Vaccination with Menveo* may not protect all individuals.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as potentially, could, plans, may, risk, dedicated, can, potential, plans, expected, expects, will, or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Menveo*, potential future approvals of additional Novartis vaccines, or the timing of any such approvals or regarding potential future revenues from such vaccines. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Menveo* will be approved for any additional indications or labeling in any market. Nor can there be any guarantee that any additional vaccines will be approved for sale in any markets. Neither can there be any guarantee that any such approvals will be obtained at any particular time. Nor can there be any guarantee that Menveo* or any additional vaccines will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Menveo* or any additional vaccines could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

    
    References

    1.  Menveo* Product Monograph. May 2010.
    2.  World Health Organization. Meningococcal Position Paper. Weekly
        Epidemiological Record No. 44, 2002, 77, 329-340.
    3.  National Advisory Committee on Immunization. Update on the Invasive
        Meningococcal disease and Meningococcal Vaccine Conjugate
        Recommendations. CcDR April 2009, Volume 36, ACS - 3
    4.  Centers for Disease Control and Prevention. Epidemiology and
        Prevention of Vaccine-Preventable Diseases (The Pink Book: Course
        Textbook). 10th Edition, 2nd printing. February 2008 update.
    5.  Centers for Disease Control and Prevention. Meningococcal Disease:
        Frequently Asked Questions. May 2008.
    6.  World Health Organization. Meningococcal Meningitis Fact sheet. May
        2003.
    7.  Novartis Vaccines and Diagnostics, Scientific Platform: Meningococcal
        Vaccines, Revised December 11, 2008.
    8.  Schaffner, W. et al. The Changing Epidemiology of Meningococcal
        Disease Among US Children, Adolescents, and Young Adults. National
        Foundation for Infectious Diseases. November 2004.
    9.  Centers for Disease Control and Prevention. Prevention and Control of
        Meningococcal Disease - Recommendations of the Advisory Committee on
        Immunization Practices. MMWR 2005; 54 (RR07): 1-21.
    

* Menveo and Menjugate are registered trademarks.

Menactra(R) is a trademark of Sanofi Pasteur Limited

For further information: Lise Huneault, Novartis Pharmaceuticals Canada Inc., [phone] ext. 1203, [email protected]; Andrea Herman, Cohn & Wolfe, [phone] ext. 4020, [email protected]