Aclasta* receives Health Canada approval as first and only once-yearly treatment for women with postmenopausal osteoporosis



    
    -   Shown to be effective in strengthening bones and protecting against
        osteoporosis-related fractures, including spine and hip

    -   Aclasta(*) reduced spine fractures by 70 percent and hip fractures by
        41 percent compared to placebo in study published in New England
        Journal of Medicine

    -   Unique once-yearly dosing provides potential for significant
        treatment adherence benefits

    -   One in four women over the age of 50 has osteoporosis. The cost of
        treating osteoporosis and the fractures it causes is estimated to be
        $1.9 billion each year in Canada alone(1).
    

    DORVAL, QC, Nov. 6 /CNW/ - Aclasta(*) (zoledronic acid) Injection has been
approved by Health Canada as the first and only once-yearly medicine for
postmenopausal osteoporosis, offering an important new approach to the
treatment of a bone disease affecting 1.4 million Canadians(1).
    Unlike oral bisphosphonate therapies that have to be taken regularly on a
daily, weekly or monthly dosing regimen, Aclasta(*) is given as a once-yearly
15-minute intravenous (IV) infusion. This means with a single dosing a patient
can benefit from a full year's protection against the effects of osteoporosis
- a disorder that causes bones to break easily.
    "The fact that Aclasta(*) is highly effective and can be administered
once-yearly represents a major milestone in the treatment of postmenopausal
osteoporosis," said Jonathan D. Adachi, MD, Professor of Medicine,
St. Joseph's Healthcare - McMaster University in Hamilton, Ontario.
    "For the first time we can ensure women receive a full year of the
treatment they need to protect their bones," said Dr. Adachi.
    The regulatory approval was based on efficacy and safety data from a
three-year pivotal fracture trial published in The New England Journal of
Medicine, showing that 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. hip, wrist, arm, leg, rib). Aclasta(*) is the
only treatment proven to prevent fractures across all of these key sites.
    In this study involving more than 7,700 women, Aclasta(*) reduced the risk
of spine fractures by 70 percent and hip fractures by 41 percent(2). The
reduction in spine fractures was sustained over three years (60 percent in
year one, 71 percent in year two, and 70 percent in year three). Bone mineral
density increased significantly in the spine by 6.7 percent and the hip by
6 percent in women on Aclasta(*) compared to placebo(2).
    "Aclasta(*) has shown significant efficacy in protecting women against
fractures in all the common osteoporotic fracture sites, while demonstrating a
favorable safety profile," said Dr. Adachi. "It is our hope that this
innovative once-yearly dosing regimen will have a positive impact on the
management of this potentially devastating condition."
    The need for effective treatments is pressing, with one in four women and
more than 1 in 8 men over the age of 50 suffering from osteoporosis. In
Canada, almost 30,000 hip fractures occur each year(3). 70 to 90 percent of
these hip fractures are caused by osteoporosis(4). These fractures result in
death in up to 20 percent of cases, and disability in 50 percent of those who
survive(5).
    "The approval of a new medication is welcome news for the millions of
Canadians who have osteoporosis," says Julie Foley, President and CEO,
Osteoporosis Canada. "Osteoporosis is a debilitating disease that can take a
huge toll on those who suffer from it, their families, and our healthcare
system. It is very important that a wide range of treatment options is
available so patients can discuss with their physician the option that suits
them best."
    About 60 percent of patients on daily bisphosphonate treatment regimens
and about 40 to 50 percent on weekly bisphosphonate treatment regimens are not
persistent with their prescribed medication after 1 year(6)(7).
    The cost of treating osteoporosis and the fractures it causes is
estimated to be $1.9 billion each year in Canada alone. Long term, hospital
and chronic care account for the majority of these costs. Given the increasing
proportion of older people in the population, these costs will likely rise(1).

    About Aclasta(*)

    Aclasta(*) is approved in more than 60 countries, including Canada, the US
and the EU for the treatment of Paget's disease, the second most common
metabolic bone disorder and has been recently approved in the US and in the EU
for the treatment of PMO. The product is known as Reclast(*) in the US.
Additional studies have been recently completed/published (to examine the use
of Aclasta(*) to prevent fractures following a hip fracture in men and women) or
are ongoing to examine the use of Aclasta(*) in the treatment of
corticosteroid-induced osteoporosis, and male osteoporosis.
    The active ingredient in Aclasta(*) is zoledronic acid, which is also
available in a different dosage under the brand name Zometa(R) (zoledronic
acid 4 mg) Injection for use in certain oncology indications.
    Aclasta(*) is contraindicated in patients with hypocalcemia (low blood
calcium) and those who are allergic to zoledronic acid. Aclasta(*) contains the
same active ingredient (zoledronic acid) found in Zometa(*), though at a
different dose. Patients already being treated with Zometa(*) should not be
treated with Aclasta(*). Aclasta(*) should not be used during pregnancy because of
potential harm to the fetus. Aclasta(*) is not recommended for use in patients
with severe renal impairment (creatinine clearance less than 35 mL/min) and
infusion time should not be less than 15 minutes.
    The most common side effects associated with Aclasta(*) are fever, pain in
the muscles, bones or joints, flu-like symptoms, and headache. These symptoms
usually occur within the first three days following Aclasta(*) administration
and usually resolve within 3 to 4 days of onset but resolution could take up
to 7 to 14 days. Patients have reported severe bone, joint and/or muscle pain
after using bisphosphonates. Osteonecrosis of the jaw (ONJ) has been reported
rarely in postmenopausal osteoporosis patients treated with bisphosphonates. A
routine oral examination should be performed by the prescriber prior to
initiation of bisphosphonate treatment. Hypocalcemia may occur with Aclasta(*)
therapy. In the Pivotal Fracture Trial an increased number of cases of serious
atrial fibrillation were observed in women given Aclasta(*) compared to those on
placebo (1.3 percent vs. 0.4 percent respectively)(2). The timing of these
events suggests that they were not related to the acute infusion. This finding
has not been observed in other zoledronic acid clinical studies and in
post-marketing experience from more than 1.5 million patients treated with
Zometa(*).
    It is recommended that all patients with postmenopausal osteoporosis
should receive 1000-1500 mg of supplemental calcium (elemental) daily, in
divided doses and 400-1200 IU of Vitamin D daily, if dietary intake is not
sufficient (for additional information please refer to the Aclasta(*) Product
Monograph).
    For more information about Aclasta(*), visit www.aclasta.ca.

    Disclaimer

    The foregoing press release contains forward-looking statements that can
be identified by the use of forward-looking terminology such as "highly
effective", "significant", "provides potential", "major milestone",
"benefits", similar expressions or express or implied discussions regarding
potential future regulatory submissions or approvals with respect to, or
future sales of, of Aclasta(*), Reclast(*) or Zometa(*). Such forward-looking
statements reflect the current views of Novartis 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
Aclasta(*) or Reclast(*) will be approved for any additional indications in the
EU, US or any additional markets or that Aclasta(*), Reclast(*) or Zometa(*) will
reach any particular level of sales. In particular, management's expectations
regarding Aclasta(*), Reclast(*) and Zometa(*) could be affected by, among other
things, unexpected regulatory actions or delays or government regulation
generally; unexpected clinical trial results, including additional analysis of
existing clinical data, and new clinical data; 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; as well as the additional factors discussed in Novartis
AG's Form 20-F filed 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
described herein as anticipated, believed, estimated or expected. Novartis is
providing this information as of this date and does not undertake any
obligation to update any forward-looking statements contained in this document
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 conducts hundreds of clinical trials across the country seeking new
treatments for cardiovascular disease, diabetes, cancer, organ
transplantation, musculoskeletal diseases and ophthalmic diseases. In 2006,
the Company invested over $69 million in research and development. Novartis
Pharmaceuticals Canada Inc. employs approximately 850 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 and Gerber (Canada) Inc.) Sandoz Canada and
CIBA Vision Canada Inc. For further information about Novartis Canada, please
consult http://www.novartis.ca.

    About Novartis

    Novartis AG (NYSE:   NVS) is a world leader in offering medicines to
protect health, cure disease and improve well-being. Our goal is to discover,
develop and successfully market innovative products to treat patients, ease
suffering and enhance the quality of life. We are strengthening our
medicine-based portfolio, which is focused on strategic growth platforms in
innovation-driven pharmaceuticals, high-quality and low-cost generics, human
vaccines and leading self-medication OTC brands. Novartis is the only company
with leadership positions in these areas. In 2006, the Group's businesses
achieved net sales of USD 37.0 billion and net income of USD 7.2 billion.
Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel,
Switzerland, Novartis Group companies employ approximately 100,000 associates
and operate in over 140 countries around the world. For more information,
please visit http://www.novartis.com.

    
    (*) Aclasta, Reclast and Zometa are registered trademarks.

    -----------------------------

    (1) Osteoporosis Canada. Prevalence of osteoporosis in Canada. Available
        at:
www.osteoporosis.ca/english/about%20osteoporosis/what-is/default.asp?s(equal s
ign)1
    (2) Black, DM, Delmas PD, Eastell MD et al. Once-yearly zoledronic acid
        for treatment of postmenopausal osteoporosis. NEJM 2007; 356:1809-22.
    (3) Goeree R, O'Brien B, Pettitt D, et al. (1996) An assessment of the
        burden of illness due to osteoporosis in Canada. J. Soc. Obstet.
        Gynaecol. Can. 18:15.
    (4) Melton LJ, Thamer M, Ray NF, et al. (1997) Fractures attributable to
        osteoporosis: report from the national osteoporosis foundation. J
        Bone Min Research. 112: 16 - 23.
    (5) Osteoporosis Canada. Costs of osteoporosis in Canada. Available at:
www.osteoporosis.ca/english/about%20osteoporosis/what-is/default.asp?s(equal s
ign)1
    (6) Ettinger MP et al. Endocr Pract 2006;12(5):522-8.
    (7) Omar M, Gause D. ACOG 2006 (107; suppl 4.)
    





For further information:

For further information: or to arrange an interview with a physician or
patient, please contact: Jason Jacobs, Novartis Pharmaceuticals Canada Inc.,
(514) 633-7872 (direct), jason.jacobs@novartis.com; Sarah Rutka,
Fleishman-Hillard Canada Inc., (416) 645-8191 (direct), (905) 782-1247
(mobile), sarah.rutka@fleishman.ca


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