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DORVAL, QC, Oct. 7 /CNW Telbec/ - For the close to 400,000 Quebec women
suffering from postmenopausal osteoporosis (PMO), a new treatment option is
now a reality. As of October 1, 2008, PrAclasta(*) (zoledronic acid 5mg/100mL)
is now reimbursed for the treatment of postmenopausal osteoporosis (PMO) among
women who cannot receive an oral bisphosphonate because of a serious
intolerance or contraindications. Aclasta(*) is the first and only treatment for
women with PMO that is administered once-yearly.
Oral bisphosphonate treatments for osteoporosis have been available to
patients in Canada for a number of years. Taken on a daily, weekly or monthly
dosing regimen, many patients stop taking them because of frequent and
sometimes serious side-effects, leaving those patients at risk of fracture.
Compliance of at least 50% is required for any benefit to be achieved with
bisphosphonate therapy and it has been demonstrated that 50-75% of patients
discontinue their oral bisphosphonate treatment within the first year.
Aclasta (*) provides a genuine alternative. It is given as a 15-minute
intravenous (IV) infusion that can be carried out at a doctor's office,
through a network of infusion centers or at home. Following this brief
procedure, most patients benefit from a year's protection against the effects
"The Quebec government's decision to reimburse Aclasta(*) is a very
welcomed one for women in this province suffering from osteoporosis," said
Dr. Denis Choquette, Rheumatologist, at l'Institut de Rhumatologie de
Montréal. "Compliance is a real issue when it comes to osteoporosis drugs,
since up to half of patients stop taking their treatment within a year
according to recent study. Now, with one yearly infusion, we can really
improve the success rate of osteoporosis treatment and protect women from the
debilitating and sometimes deadly consequences that can result from untreated
Efficacy and safety data from a three-year fracture trial published in
The New England Journal of Medicine, showed that a once-yearly infusion of
Aclasta(*) increases bone strength and reduces fracture risk in areas of the
body typically affected by osteoporosis, including the hip, spine and
non-spine (i.e. wrist, arm, leg, rib). Aclasta(*) is the only treatment proven
to prevent fractures across all of these key sites. It was also shown to
reduce spine fractures by 70 per cent and hip fractures by 41 per cent
compared to placebo.
"Osteoporosis Canada welcomes Quebec's decision to include Aclasta(*) in
its approved formulary, as this expands options for physicians and patients.
It is our hope that patients nation-wide will soon be equipped with access to
a wider range of treatment options for osteoporosis" says Julie M. Foley,
President and CEO, Osteoporosis Canada.
"Aclasta(*) is a new and simple therapy that represents an important
milestone in the treatment of osteoporosis. Compliance to daily or weekly
osteoporosis therapy has long been a challenge. Yearly administration of
Aclasta now offers an efficacious and safe treatment to protect women against
bone loss and fractures" said Dr Jacques Brown, Head of Rheumatology Division,
at Centre hospitalier universitaire de Québec, in Quebec City.
Aclasta(*) was approved in Canada for the treatment of PMO in October 2007.
Aclasta(*) is also approved in more than 60 countries for the treatment of
Paget's disease, the second most common metabolic bone disorder. The product
is known as Reclast(R) in the US.
The active ingredient in Aclasta(*) is zoledronic acid 5mg, which is also
available in a different dosage under the brand name Zometa(R) (zoledronic
acid 4 mg) for certain oncology indications. As with other bisphosphonates,
Aclasta(*) works by attaching to bone, stopping excessive bone breakdown and
rebalancing the body's natural bone remodeling process. For more information
about Aclasta(*), visit www.aclasta.ca.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "unique", "once a year", "first and only",
"genuine alternative", or similar expressions, or by express or implied
discussions regarding potential new indications or labelling for Aclasta(*) or
regarding potential future revenues from Aclasta(*). Such forward-looking
statements reflect the current views of the Company regarding future events,
and involve known and unknown risks, uncertainties and other factors that may
cause actual results with Aclasta(*) to be materially different from any future
results, performance or achievements expressed or implied by such statements.
There can be no guarantee that Aclasta(*) will be approved for any additional
indications or labeling in any market. Nor can there be any guarantee that
Aclasta(*) will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding Aclasta(*) could be affected by,
among other things, unexpected regulatory actions or delays or government
regulation generally; unexpected clinical trial results, including unexpected
new clinical data and unexpected additional analysis of existing clinical
data; the company's ability to obtain or maintain patent or other proprietary
intellectual property protection; competition in general; government, industry
and general public pricing pressures, 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
Pharmaceuticals Canada Inc. 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.
About Novartis Canada
Novartis Pharmaceuticals Canada Inc., 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 Pharmaceuticals
Canada Inc. conducts hundreds of clinical trials across the country seeking
new treatments for cardiovascular disease, diabetes, cancer, ophthalmology and
organ transplantation. In 2007, the Company invested over $86 million in
research and development. Novartis Pharmaceuticals Canada Inc. employs more
than 800 people in Canada and its headquarters are located in Dorval, Quebec.
In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in
Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer
Health Canada Inc., (including Novartis Nutrition Corporation) CIBA Vision
Canada Inc. and Sandoz Canada Inc. For further information about Novartis
Canada, please consult http://www.novartis.ca.
Novartis AG provides healthcare solutions that address the evolving needs
of patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines,
cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions
in these areas. In 2007, the Group's continuing operations (excluding
divestments in 2007) achieved net sales of USD 38.1 billion and net income of
USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities
throughout the Group. Headquartered in Basel, Switzerland, Novartis Group
companies employ approximately 98,000 full-time associates and operate in over
140 countries around the world. For more information, please visit
(*) Aclasta is a registered trademark
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For further information:
For further information: or to arrange an interview, please contact:
Chantal Benoit, Health Group, NATIONAL Public Relations, (514) 843-2306, Cell:
(514) 893-7247, firstname.lastname@example.org; Lise Huneault, Novartis Pharmaceuticals
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