Common Drug Review refuses to recommend public access of unique once-yearly osteoporosis treatment


    Now up to each province to make things right for patients.

    DORVAL, QC, July 2 /CNW Telbec/ - A recent decision by the Common Drug
Review (CDR) marks a major setback in terms of access to a new and effective
treatment for osteoporosis, a debilitating and potentially deadly disease
affecting 1.4 million Canadians. On June 25, the Common Drug Review, Canada's
national process for making formulary listing recommendations on prescription
drugs, counseled provincial drug plans not to reimburse Aclasta(*).
    Aclasta(*) is the first and only treatment for women with postmenopausal
osteoporosis (PMO) that is administered once-yearly. Aclasta(*) is given as a
15-minute intravenous (IV) infusion that can be done at a doctor's office or
at home. Following this simple procedure, most patients benefit from a year's
protection against the effects of osteoporosis. Osteoporosis, which strikes
one in four women over the age of 50, is a disease that causes bones to break
    As well, compliance is a real issue when it comes to osteoporosis drugs,
as half of patients stop taking their treatment within a year or have
difficulty taking them, meaning that they are still at risk from fractures.
Aclasta(*) offers a convenient, safe and effective alternative to oral
bisphosphonates that are taken daily or weekly.
    "The CDR's recommendation on Aclasta(*) is certainly very disappointing.
This is an effective treatment for postmenopausal osteoporosis that is given
once yearly, representing a major milestone in the treatment of the disease,"
said Alain Boisvert, Vice President, Health Policy and Market Access, Novartis
Pharmaceuticals Canada Inc.
    Novartis Pharmaceuticals Canada Inc., the maker of Aclasta(*), had proposed
that the drug be listed for the treatment of postmenopausal women with
evidence of intolerance, inability to take, or inadequate response to oral
    There is significant data to show that Aclasta(*) provides therapeutic and
economic advantages over raloxifene, a selected estrogen receptor modulator
(SERM) that is the therapeutic option currently reimbursed for PMO patients
who are unable to take or do not respond to an oral bisphosphonate. Novartis
Pharmaceuticals Canada Inc. maintains that not only is raloxifene listed at a
higher price than Aclasta(*), but it has shown poor compliance among PMO
patients, as demonstrated by a one-year probability of discontinuation of 52
per cent in one study, and persistence rates reported at only 16.2 per cent in
another study.
    Efficacy and safety data from a three-year fracture trial published in
The New England Journal of Medicine, showed that an annual 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. hip, 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. Another important trial also published in The New England
Journal of Medicine, showed that an annual infusion of Aclasta(*) administered
within 90 days after repair of a low-trauma hip fracture was associated with a
reduction in the rate of new clinical fractures and improved survival compared
to placebo. This is the first of its kind and only randomized controlled trial
with a bisphosphonate in a post hip fracture population.
    Nevertheless, the committee reviewing the file felt there was
insufficient evidence to recommend listing in this group of patients.
    While the CDR is mandated to provide objective, rigorous reviews, and
evidence-based recommendations to help support and inform drug plan decisions,
each provincial authority has the right to make final benefit-listing and
coverage decisions based on its own priorities and resources.
    Quebec's Conseil du médicament, which carries out a separate review
process from the CDR, is expected to make its recommendation on the listing of
Aclasta(*) in the fall. Ontario will be reviewing the file later this year, with
a decision also expected later this year.
    "Novartis is committed to working in close collaboration with the
individual participating provincial drug plans to ensure that all Canadians
have appropriate access to this important drug," said Alain Boisvert. "We have
developed a comprehensive patient treatment and support program covering all
of Canada and are convinced that Aclasta(*) represents good value to provincial
drug plans."

    About Osteoporosis

    Osteoporosis is a debilitating and potentially deadly disease, affecting
one in four women and more than one in eight men over the age of 50. In
Canada, almost 30,000 hip fractures occur each year and 70 to 90 percent of
these are caused by osteoporosis. These fractures result in death in up to
20 percent of cases, and disability in 50 percent of those who survive.
Currently, the cost of treatment of osteoporosis and related fractures is
estimated to be $1.9 billion each year in Canada alone.

    About Aclasta(*)

    Aclasta(*) was approved in Canada for the treatment of postmenopausal
osteoporosis (PMO) in October 2007 and was recently approved in the US and in
the EU for this condition. Aclasta(*) is also 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. The product is known
as Reclast(TM) in the US.
    The active ingredient in Aclasta(*) is zoledronic acid, which is also
available in a different dosage under the brand name Zometa(TM) (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

    Forward-Looking Statement

    The foregoing press release may contain 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 future
sales of Aclasta(*). Such forward-looking statements reflect the current views
of Novartis Pharmaceuticals Canada Inc. 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(*) will be
approved for any additional indications in Canada, the EU, US or any
additional markets or that Aclasta will reach any particular level of sales.
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 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 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

    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 2007, the Group's businesses
achieved net sales of USD 38 billion. Approximately USD 6.4 billion was
invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies
employ approximately 98,000 associates and operate in over 140 countries
around the world. For more information, please visit

    (*)Aclasta is a registered trademark

For further information:

For further information: or to arrange an interview: Silvie Letendre,
Novartis Pharmaceuticals Canada Inc., (514) 633-7872,

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