Billy Talent & other: August 2008

Friday, 22 August 2008

Multaq(R) (dronedarone) Granted FDA Priority Review For Patients With Atrial Fibrillation

�Sanofi-aventis
(EURONEXT: SAN and NYSE: SNY) announced that U.S. Food and Drug
Administration (FDA) has assigned priority limited review status for its New Drug
Application (NDA) for Multaq(R) (dronedarone). The priority review time period
begins on July 31, 2008.

The priority review is given to applications in which a new
indication or new drug product, if approved, has the voltage to deliver a
safe and effective therapy where no satisfactory alternative exists
compared to currently useable therapies or marketed products.

A registration dossier is also under regulatory limited review by the European
Medicines Agency (EMEA) for a Marketing Authorization Application.

"We are pleased that the FDA has designated Multaq(R) for precedency
review," said Marc Cluzel, sanofi-aventis Senior Vice President, R&D for
sanofi-aventis. "This follows the exciting results of the landmark ATHENA
study that showed Multaq(R) significantly decreased the risk of
cardiovascular hospitalizations or death from any causal agent in patients with
Atrial Fibrillation."

Atrial fibrillation is a major cause of hospitalization and mortality
and affects about 2.5 million people in the United States, as well as 4.5
million people in the European Union and is rising as a growing public
health concern due to an ripening population. Patients suffering from atrial
fibrillation have double the risk of death, an increased risk of stroke and
cardiovascular complications, including congestive heart failure.
Furthermore atrial fibrillation considerably impairs patients' lives,
mainly because of their inability to execute normal daily activities due to
complaints of palpitations, chest botheration, dyspnoea, fatigue or
light-headedness.

About Multaq(R) (dronedarone)

Dronedarone (brand bring up Multaq(R)) is an investigational new discussion
for patients with atrial fibrillation, which has been discovered and
developed by sanofi-aventis for the bar and discourse of patients
with atrial fibrillation or atrial flutter. Dronedarone is a multi-channel
blocker that affects calcium, potassium and sodium channels and has
anti-adrenergic properties. Dronedarone does not hold the i radical
and did not show any evidence of thyroid or pulmonary toxicity in clinical
trials.

About Sanofi Aventis

Sanofi-aventis, a ahead global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY).

Forward Looking Statements

This press release contains forward-looking statements as outlined in
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include intersection development, product potential projections
and estimates and their underlying assumptions, statements regarding plans,
objectives, intentions and expectations with respect to future events,
operations, products and services, and statements regarding future
performance. Forward-looking statements are generally identified by the
words "expects," "anticipates," "believes," "intends," "estimates," "plans"
and similar expressions. Although sanofi-aventis' management believes that
the expectations reflected in such forward-looking statements are
sane, investors ar cautioned that forward-looking information and
statements are issue to various risks and uncertainties, many of which
are hard to call and loosely beyond the control of
sanofi-aventis, that could causal agency actual results and developments to take issue
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and uncertainties
include among former things, the uncertainties underlying in research and
development, future clinical data and analysis, including post selling,
decisions by regulatory government, such as the FDA or the EMEA, regarding
whether and when to approve whatsoever drug, device or biological application that
may be filed for any such product candidates as well as their decisions
regarding labeling and other matters that could affect the availability or
commercial potential of such products candidates, the absence of guarantee
that the products candidates if approved will be commercially successful,
the future approval and commercial success of therapeutical alternatives as
well as those discussed or identified in the public filings with the SEC
and the AMF made by sanofi-aventis, including those listed under "Risk
Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' yearly report on Form 20-F for the year over December 31,
2007. Other than as required by applicable law of nature, sanofi-aventis does not
undertake any obligation to update or revise any advanced
information or statements.

Sanofi Aventis
http://www.sanofi-aventis.com

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Tuesday, 12 August 2008

New Research Questions Use Of Common Fertility Treatments

�
A raw study promulgated on bmj.com
has found that fertility is not improved in sterile couples wHO have
been treated with long-established medical interventions. The team of
researchers lED by the University of Aberdeen has called for UK and
national guidelines to be reviewed with this new evidence that
challenges current practices.

In the UK, one in seven couples experience infertility. Of these, about
25% of the infertility is unexplained, and the criterion treatment
includes a body of common interventions that have been used for years
and have been issued by the National Institute for Health and Clinical
Excellence (NICE).

The research squad set out to compare two specific interventions with
expectant management (i.e., no intervention). From quatern teaching hospitals
and a district general hospital in Scotland, they recruited a sample of
580 women who own had unexplained infertility for over deuce years. The
women were arbitrarily assigned such that one group had no medical
intervention and tried naturally to become pregnant, a second radical
took oral clomifene citrate (CC) to correct subtle ovulatory
disfunction, and a third group received unstimulated intra-uterine
insemination (IUI) of sperm.

During the course of the study, 101 women became pregnant and had a
alive birth. The birth pace for women with no intervention was 17%, and
the rates for the oral CC group and the IUI group were 14% and 23%,
respectively. According to the researchers, the 6% difference between
the IUI and the non-intervention group is no large enough for the
results to suggest a meaningful and significant advance in the live
parentage rate.

Many women suffered from side effects that included: pain, bloating,
hot flushes, nausea and headaches. These affected approximately 10 to 20% of
women, most of whom were taking oral CC. Also, it is worth noting that
satisfaction was higher in the groups of women being actively treated -
as they were reassured by the treatment process - compared to women who
received no intervention.

"These interventions, which have been in use for many years, ar
unlikely to be more effective than no treatment. These results
challenge stream practice, as endorsed by a national guideline in the
UK," conclude the authors.

Tarek El-Toukhy and Yacoub Khalaf (Assisted Conception Unit at Guy's
and St Thomas' NHS Foundation Trust) write in an incidental editorial
that: "As a direct resolution of the lack of evidence, many couples with
unexplained infertility endure (and even request) expensive,
potentially hazardous, and often unnecessary treatments." There is a
need for high quality clinical trials as well as better information for
patients to determine the best treatments in light of strength and
adverse effects. El-Toukhy and Khalaf also call for the current NICE
guidelines to be reviewed with this inquiry in mind.

Clomifene citrate or unstimulated intrauterine insemination
compared with anticipative management for unexplained sterility:
pragmatic randomized controlled trial

S Bhattacharya, K Harrild, J Mollison, S Wordsworth, C Tay, A Harrold,
D McQueen, H Lyall, L Johnston, J Burrage, S
Grossett, H Walton, J Lynch, A
Johnstone, S Kini, A Raja, A Templeton
BMJ (2008). 337: a716.

doi:10.1136/bmj.a716
Click
Here to View Journal Web Site

Written by: Peter M Crosta

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

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Wednesday, 6 August 2008

'Mummy' dearest at international boxoffice

Sequel takes in $61.2 mile from 27 countries

With 1 month to go before the trek back to school begins, the blockbuster action adventures keep gushing out in assembly-line mode, with the past weekend's new