Osteoporosis Treatment Now Approved in Europe & US for Men

Paris, France (ots/PRNewswire) -

- Male Osteoporosis: Neglected and Under Treated

PARIS, France, August 17 /PRNewswire/ --

The US Food and Drug Administration (FDA) this week approved
Actonel(R) 35mg (risedronate sodium tablets) for 'treatment to
increase bone mass in men with osteoporosis'. This follows the
positive outcome in July 2006 of the European application for the
additional indication of 'treatment of osteoporosis in men at high
risk of fracture.' National approvals will now follow in all
twenty-five EU member states. This new indication now opens the door
for more men with osteoporosis to benefit from Actonel treatment.

'Male osteoporosis is neglected and under-treated,' said Pierre
Delmas, Professor of Medicine and Rheumatology at the Université
Claude Bernard, in Lyon, France. 'We have to ask ourselves why other
conditions such as prostate cancer receive more attention than
osteoporosis, when in reality men over 50 are at far greater risk of
osteoporosis than they are of prostate cancer. We cannot accept the
low levels of awareness that exist among patients and physicians
because osteoporosis is such a devastating and debilitating disease
for men.'

Approximately half of male osteoporosis cases are associated with
aging. Men with age-related osteoporosis usually develop the disease
later in life than do women. With an aging population and increasing
life expectancy, age-related cases of male osteoporosis are expected
to increase. The other half of all male osteoporosis cases are due to
secondary causes such as oral steroid use, low testosterone
(hypogonadism), and heavy alcohol use (1).

The approval of Actonel for men with osteoporosis is based on a
two-year, placebo-controlled, double-blind multi-centre clinical
trial of 284 male patients with osteoporosis (2). In the trial,
patients treated with once-a-week Actonel 35mg experienced
statistically significant improvements in lumbar spine bone mineral
density at all time points measured, 6, 12 and 24 months. Likewise,
statistically significant reductions in bone turnover markers were
achieved at all time points measured, 3, 6, 12 and 24 months.
Actonel was well-tolerated and adverse events were generally similar
between patients receiving Actonel and patients receiving placebo.
The most commonly reported adverse events were constipation, back
pain, arthralgia, influenza and nasopharyngitis.

'This approval builds upon the efficacy of Actonel seen in women,'
said David Cahall, International Medical Director, sanofi-aventis.
'With this new indication we hope many men, a group of patients that
are often overlooked, will now be able to benefit from treatment with
Actonel'.

About Actonel(R) (risedronate sodium tablets)

In Europe, Actonel 5 mg daily and 35 mg once-a-week are indicated
for the treatment of postmenopausal osteoporosis to reduce the risk
of vertebral fractures and the treatment of established
postmenopausal osteoporosis to reduce the risk of hip fractures.
Actonel 5mg daily is indicated for the prevention of osteoporosis in
postmenopausal women with increased risk of osteoporosis and to
maintain or increase bone mass in post menopausal women undergoing
long-term (more than 3 months) systemic corticosteroid treatment at
doses greater than or equal to 7.5mg/day prednisone or equivalent.
Actonel 35mg is indicated for the treatment of osteoporosis in men at
high risk of fractures. The 5 mg dose is not approved for males
receiving systemic corticosteroid treatment and is not approved for
male osteoporosis. The 35 mg dose is not approved in men or women
receiving long-term systemic corticosteroids and is not approved for
the prevention of osteoporosis in postmenopausal women. Please see
the Summary of Product Characteristics for Actonel(R) 5mg and 35mg
(risedronate sodium tablets) for more information.

In the USA, Actonel 5 mg daily and 35 mg once-a-week are indicated
for the prevention and treatment of postmenopausal osteoporosis in
women. Actonel 35 mg once-a-week is indicated to increase bone mass
in men with osteoporosis. Actonel 5mg daily is indicated for the
prevention and treatment of glucocorticoid-induced osteoporosis in
men and women who are either initiating or continuing systemic
glucocorticoid treatment (greater than or equal to 7.5 mg/d
prednisone or equivalent) for chronic diseases. Please see full
prescribing information for Actonel(R) (risedronate sodium tablets)
for more information. For a copy of the full prescribing information
for Actonel visit the Actonel website at www.actonel.com.

About The Alliance for Better Bone Health

The Alliance for Better Bone Health was formed in May 1997 to
promote bone health and disease awareness through numerous activities
to support physicians and patients around the globe. It is a
collaboration between Procter & Gamble Pharmaceuticals and
sanofi-aventis U.S.

About Procter & Gamble (NYSE:PG)

Three billion times a day, P&G brands touch the lives of people
around the world. The company has one of the strongest portfolios of
trusted, quality, leadership brands, including Pampers(R), Tide(R),
Ariel(R), Always(R), Whisper(R), Pantene(R), Mach3(R). Bounty(R),
Dawn(R), Pringles(R), Folgers(R), Charmin(R), Downy(R), Lenor(R),
Iams(R), Crest(R), Oral-B(R), Actonel(R), Duracell(R), Olay(R), Head
& Shoulders(R), Wella, Gillette(R), and Braun. The P&G community
consists of almost 140,000 employees working in over 80 countries
worldwide. Please visit http://www.pg.com for the latest news and
in-depth information about P&G and its brands.

About sanofi-aventis

Sanofi-aventis is the world's third largest pharmaceutical
company, ranking number one in Europe. Backed by a world-class R&D
organization, sanofi-aventis is developing leading positions in seven
major therapeutic areas: cardiovascular, thrombosis, oncology,
metabolic diseases, central nervous system, internal medicine, and
vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in
New York (NYSE: SNY)

For P&G: All statements, other than statements of historical fact
included in this release, are forward-looking statements, as that
term is defined in the Private Securities Litigation Reform Act of
1995. In addition to the risks and uncertainties noted in this
release, there are certain factors that could cause actual results to
differ materially from those anticipated by some of the statements
made. These include: (1) the ability to achieve business plans,
including with respect to lower income consumers and growing existing
sales and volume profitably despite high levels of competitive
activity, especially with respect to the product categories and
geographical markets (including developing markets) in which the
company has chosen to focus; (2) successfully executing, managing and
integrating key acquisitions (including the Domination and Profit
Transfer Agreement with Wella); (3) the ability to manage and
maintain key customer relationships; (4) the ability to maintain key
manufacturing and supply sources (including sole supplier and plant
manufacturing sources); (5) the ability to successfully manage
regulatory, tax and legal matters (including product liability
matters), and to resolve pending matters within current estimates; 6)
the ability to successfully implement, achieve and sustain cost
improvement plans in manufacturing and overhead areas, including the
success of the company's outsourcing projects; (7) the ability to
successfully manage currency (including currency issues in volatile
countries), interest rate and certain commodity cost exposures; (8)
the ability to manage the continued global political and/or economic
uncertainty and disruptions, especially in the company's significant
geographical markets, as well as any political and/or economic
uncertainty and disruptions due to terrorist activities; (9) the
ability to successfully manage increases in the prices of raw
materials used to make the company's products; (10) the ability to
stay close to consumers in an era of increased media fragmentation;
and (11) the ability to stay on the leading edge of innovation. For
additional information concerning factors that could cause actual
results to materially differ from those projected herein, please
refer to our most recent 10-K, 10-Q and 8-K reports

References

1) Kamel HK. Male Osteoporosis: New trends in diagnosis and
therapy. Drugs Aging 2005; 22 (9): 741-748
2) Boonen S et al. Oral Risedronate Treatment in Men with
Osteoporosis: Study Design and Baseline Characteristics. Poster presented
at ASBMR 2005 (number SU404)

ots Originaltext: The Alliance for Better Bone Health
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Salah Mahyaoui, sanofi-aventis, Tel: +33(0)153-774-031, Email:
Salah.mahyaoui@sanofi-aventis.com