1 of 998 DOCUMENTS


                                  US Fed News

                    January 25, 2012 Wednesday 2:06 PM  EST

GRANT WILL FUND STUDY OF COGNITION AND SCHIZOPHRENIA

LENGTH: 927 words


SACRAMENTO, Calif., Jan. 25 -- The University of California issued 
the following
press release:

Michael Minzenberg, a UC Davis psychiatry researcher, has been 
awarded a
prestigious three-year, $200,000 seed grant from the Dana Foundation 
to study
the brains of patients being treated for schizophrenia to determine 
how
additional treatment to improve cognition interacts with antipsychotic
medication.

"Cognition is very important in schizophrenia because it is a strong 
predictor
of outcome. It determines whether a person can be a contributing 
member of a
community, stay out of the hospital and live independently," said 
Minzenberg,
associate professor in the Department of Psychiatry and Behavioral 
Sciences and
a faculty member of the UC Davis Imaging Research Center.

Schizophrenia is a chronic mental disorder characterized by decline 
in thought
processes and loss of emotional responsiveness. It affects 3.2 million
Americans, the majority of whom are not receiving treatment. It can 
lead to
auditory hallucinations, paranoia and delusions.

Despite the importance of cognition in the rehabilitation of those 
with
schizophrenia, there are no U.S. Food and Drug Administration 
(FDA)-approved
drugs for the improvement of cognition in this patient population.

"Dr. Minzenberg is at the forefront of trying to develop therapies 
for impaired
cognition in schizophrenia, using powerful new non-invasive brain 
imaging to
measure the effects of drugs and other treatments on functional 
networks in the
brain," said Cameron Carter, director of the Center for Neuroscience 
and the
Imaging Research Center at UC Davis.

"His work is suggesting that some of the other medications that 
patients are
taking may interfere with the procognitive effects of some of the 
newer more
promising therapies. If this proves to be true then it will be 
important to
'fine tune' patients' medications to optimize cognitive outcomes in 
people with
schizophrenia and other brain disorders."

Modafinil is a drug approved by the FDA for the treatment of 
narcolepsy. It is
also known by the brand name Provigil. Narcolepsy is a chronic 
neurological
disease characterized by sudden urges to sleep, episodes of loss of 
voluntary
muscle tone, vivid dreams while falling asleep or upon awakening, and 
brief
episodes of total paralysis while waking up from sleep. Both genetic 
and
environmental factors appear to contribute to narcolepsy. Although no 
cure
exists, medications can often help restore a patient's quality of 
life.

Like other stimulants, Modafinil's side effects are relatively mild. 
It is used
off-label to combat the effects of sedatives. Currently, it is not 
prescribed on
a long-term basis to schizophrenia patients.

However, Minzenberg and his colleagues conducted a small, unpublished 
pilot
study that showed Modafinil can improve cognition in patients being 
treated for
schizophrenia.

"What we understand about how Modafinil works in the brain leads us 
to believe
that it might be good for improving cognition deficits of our 
patients,"
Minzenberg said.

Because the cause of schizophrenia is unknown, treatment focuses on 
eliminating
symptoms. Antipsychotic drugs are effective at reducing its most 
serious
symptoms: delusions and hallucinations. Any treatment to improve 
cognition
cannot interact with these drugs in a negative way.

"The use of antipsychotic medications is the standard of care in 
patients with
schizophrenia. So, before we can move forward with a large clinical 
trial
involving Modafinil's impact on cognition, we need to know how it 
interacts with
these drugs."

Cognition refers to a range of high-level brain functions, including 
the
abilities to learn, remember information, organize, plan, 
problem-solve and
understand and use language. It is thought to be controlled by an 
area of the
brain called the locus coeruleus, which controls the body's 
physiological
responses to stress and panic, commonly referred to as the "fight or 
flight"
response.

"This area of the brain also serves to coordinate activity in the 
entire brain
as it performs almost any type of task or behavior," Minzenberg said.

Minzenberg and his colleagues will conduct the study at the UC Davis 
Early
Diagnosis and Preventive Treatment of Psychosis (EDAPT) Clinic. 
Researchers will
enroll 60 patients newly diagnosed with schizophrenia. These patients 
will have
a specialized brain scan performed, called functional magnetic 
resonance imaging
or fMRI, and will be randomly assigned to an FDA-approved treatment 
for
schizophrenia.

After eight weeks of treatment, another fMRI scan will be conducted. 
The
patients, who also will have been assigned to either a control or 
study group,
will undergo a third scan while performing a cognitive task.

Functional magnetic resonance imaging allows researchers to see 
changes in blood
flow related to neural activity. Minzenberg and his colleagues will 
examine
whether patients being treated with Modafinil perform better or 
worse, as
measured by the changes in activity in locus coeruleus, depending on 
which
antipsychotic medication they receive.

"We are hoping to find evidence that using Modafinil we can improve 
brain
function in stable schizophrenia patients," Minzenberg said.

The New York-based Dana Foundation is a private philanthropic 
organization that
supports clinical research in neuroscience and neuroimmunology and 
their
interrelationship in human health and disease. For further 
information, visit
www.dana.org. For any query with respect to this article or any other 
content
requirement, please contact Editor at htsyndication@hindustantimes.com

LOAD-DATE: January 26, 2012

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newswire


                          Copyright 2012 HT Media Ltd.
                              All Rights Reserved


                               2 of 998 DOCUMENTS


                                 CNS Drug News

                               November 29, 2011

Modiodal approved for additional indication in Japan

SECTION: NEWS

LENGTH: 154  words


Alfresa Pharma (Alfresa Holdings) has received approval in Japan of a 
partial
change in the indications of Modiodal (modafinil) Tablets 100mg, a 
sleep
disorder treatment that has been jointly developed in the country with
Mitsubishi Tanabe Pharma.

Since March 2007, Modiodal has been jointly marketed by the companies 
as a
treatment for excessive daytime sleepiness associated with 
narcolepsy. The new
indication, approved for the first time in Japan, is "excessive 
diurnal
sleepiness accompanied with obstructive sleep apnoea syndrome under 
treatment
for airway obstruction by continuous positive airway pressure therapy 
and the
like".

Modafinil is a wakefulness-enhancing agent to which Alfresa acquired 
the right
to develop, manufacture and market in Japan from Cephalon in June 
1998. The drug
is currently approved in more than 30 countries, and in seven, 
including the US,
it is marketed with approval for the new indication.

LOAD-DATE: November 29, 2011

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newsletter

JOURNAL-CODE: CNS Drug News


                  Copyright 2011 Espicom Business Intelligence
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                               3 of 998 DOCUMENTS


                                 CNS Drug News

                               November 29, 2011

Modiodal approved for additional indication in Japan

SECTION: NEWS

LENGTH: 154  words


Alfresa Pharma (Alfresa Holdings) has received approval in Japan of a 
partial
change in the indications of Modiodal (modafinil) Tablets 100mg, a 
sleep
disorder treatment that has been jointly developed in the country with
Mitsubishi Tanabe Pharma.

Since March 2007, Modiodal has been jointly marketed by the companies 
as a
treatment for excessive daytime sleepiness associated with 
narcolepsy. The new
indication, approved for the first time in Japan, is "excessive 
diurnal
sleepiness accompanied with obstructive sleep apnoea syndrome under 
treatment
for airway obstruction by continuous positive airway pressure therapy 
and the
like".

Modafinil is a wakefulness-enhancing agent to which Alfresa acquired 
the right
to develop, manufacture and market in Japan from Cephalon in June 
1998. The drug
is currently approved in more than 30 countries, and in seven, 
including the US,
it is marketed with approval for the new indication.

LOAD-DATE: January 6, 2012

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newsletter

JOURNAL-CODE: CNS Drug News


                  Copyright 2011 Espicom Business Intelligence
                              All Rights Reserved


                               4 of 998 DOCUMENTS



                           The Pharmaceutical Journal

                           November 29, 2011 Tuesday

Modafinil indication and dosage error in BNF 62

LENGTH: 80 words



HIGHLIGHT: An error is included under the indications and dosage 
information for
modafinil that are printed in the British National Formulary 62...


An error is included under the indications and dosage information for 
modafinil
that are printed in the British National Formulary 62 (section 4.4, 
pp250-251).

Modafinil is listed as indicated for the treatment of daytime 
sleepiness
associated with narcolepsy, obstructive sleep apnoea syndrome and 
chronic shift
work sleep disorder. The entry should list daytime sleepiness 
associated with
narcolepsy only.

Corrected indication and dosage information is available on the BNF 
website.

LOAD-DATE: November 29, 2011 Tuesday

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Journal


                            Copyright 2011 PJ Online
                              All Rights Reserved


                               5 of 998 DOCUMENTS


                                      IPR

                     November 25, 2011 Friday 3:11 PM  EST

India Tender Notice: South Central Railway Seeks "Modafinil 100 Mg 
Tablets"

LENGTH: 87 words

DATELINE: SECUNDERABAD, Andhra Pradesh


SECUNDERABAD, Andhra Pradesh, Dec. 5 -- South Central Railway has a 
requirement
for "Modafinil 100 Mg Tablets."

Tender Bidding Type: Domestic Competitive Bidding

According to the description: "Tenders are invited for Supply of 
Modafinil 100
Mg Tab - 7500 Nos"

The tender ref. no. is L-883/2011-2012.

Project Location: India

The expression of interest should be received by Dec. 5 till 1:00 
p.m. For any
query with respect to this article or any other content requirement, 
please
contact Editor at htsyndication@hindustantimes.com

LOAD-DATE: November 25, 2011

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newspaper


                          Copyright 2011 HT Media Ltd.
                              All Rights Reserved


                               6 of 998 DOCUMENTS


                             Targeted News Service

                     November 7, 2011 Monday 10:51 PM  EST

Teva Pharmaceutical Industries Assigned Patent

BYLINE: Targeted News Service

LENGTH: 238  words

DATELINE: Alexandria, Va.


ALEXANDRIA, Va., Nov. 7 -- Teva Pharmaceutical Industries, Petah 
Tiqva, Israel,
has been assigned a patent (8,048,222) developed by Arina Ceausu, 
Rishon Lezion,
Israel, Anita Lieberman, Ramat Aviv, Israel, and Judith Aronhime, 
Rechovot,
Israel, for a highly pure modafinil.

The abstract of the patent published by the U.S. Patent and Trademark 
Office
states: "The present invention provides an improved process for 
preparing
modafinil, whereby it may be isolated in high purity by a single
crystallization. The process produces modafinil free of sulphone 
products of
over-oxidation and other byproducts. The invention further provides 
new
crystalline Forms II-VI of modafinil and processes for preparing 
them. Each of
the new forms is differentiated by a unique powder X-ray diffraction 
pattern.
The invention further provides pharmaceutical compositions containing 
novel
modafinil Forms II-IV and VI."

The patent application was filed on Sept. 23, 2004 (10/947,228). The 
full-text
of the patent can be found at
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&
u=%2Fnetah
tml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=8,048,222&
OS=8,048,2
22&RS=8,048,222

Written by Satyaban Rath; edited by Hemanta Panigrahi.

For more information about Targeted News Service federal patent 
awards please
contact: Myron Struck, Editor, Direct: 703/866-4708, Cell: 
703/304-1897,
Myron@targetednews.com

SR1107HP1107-666772

LOAD-DATE: November 7, 2011

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newswire


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                              All Rights Reserved


                               7 of 998 DOCUMENTS


                              Health Daily Digest

                            November 4, 2011 Friday

Modafinil may not affect Operating Skills of Weary Surgeons

LENGTH: 164 words

DATELINE: U.S.


U.S., Nov. 4 -- Weary surgeons may benefit with the intake of 
sleep-fighting
medication modafinil by having an enhanced brain power but it may not 
bring any
changes in their operating skills, according to a new study.

The research was carried out on 39 young surgeons. They were made to 
be awake
throughout the night. As many as 50 percent of doctors were given a 
modafinil
pill and the remaining were provided with a dummy pill. The doctors 
went through
some psychological tests and did a virtual surgery on a simulator as 
early as 6
a.m in the morning.

It was observed that having a sleep-fighting medication modafinil 
improved the
brain power of weary surgeons but it was of no use as far as 
enhancing their
operating skills in a simulator is concerned.

Written by Manishika Miglani Published by HT Syndication with 
permission from
Health Daily Digest. For any query with respect to this article or 
any other
content requirement, please contact Editor at 
htsyndication@hindustantimes.com

LOAD-DATE: November 15, 2011

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newspaper


                          Copyright 2011 HT Media Ltd.
                              All Rights Reserved


                               8 of 998 DOCUMENTS


                              Indian Patents News

                     October 22, 2011 Saturday 6:30 AM EST

Cephalon Inc Receives Patent for a Pharmaceutical Composition

LENGTH: 262  words


New Delhi, Oct. 22 -- Cephalon Inc received patent for a 
pharmaceutical
composition on April 11, 2008. The patent number issued by the Indian 
Patent
Office is 218719.

Cephalon Inc had filed patent application number IN/PCT/2002/128/KOL 
for a
pharmaceutical composition on Jan. 25, 2002. The inventors of the 
patent are
Miller Matthew S and Scammell Thomas E.

The International classification number is A61K31/165.

The PCT International application number of the patent is 
PCT/US00/22338 and the
application was filed on Aug. 16, 2000.

According to the Controller General of Patents, Designs & Trade 
Marks, "
Modafinil is effective in improving symptoms of attention deficit 
hyperactivity
disorder and symptoms of multiple sclerosis fatigue. The 
administration of
modafinil is also shown to activate the tuberomamillary neurons of 
the posterior
hypothalamus, and thus exhibits activity in an area of the brain 
associated with
normal wakefulness functions. A method of identifying a compound that
selectively modulates activity of the tuberomamillary nucleus of the 
posterior
hypothalamus is also disclosed."

About the Company

Cephalon, Inc. (NASDAQ: CEPH) is a U.S. biopharmaceutical company 
co-founded in
1987 by Dr. Frank Baldino, Jr., a pharmacologist and former scientist 
with the
DuPont Company, who served as the company's chairman and chief 
executive officer
until his death in December 2010.[2] The company's name comes from 
the adjective
"cephalic" meaning "related to the head or brain," and it was 
established
primarily to pursue treatments for neurodegenerative diseases.


LOAD-DATE: October 22, 2011

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newswire


         Copyright 2011 Indian Patents News, distributed by 
Contify.com
                              All Rights Reserved


                               9 of 998 DOCUMENTS


                              World Generic Market

                                October 21, 2011

Teva completes Cephalon acquisition

SECTION: NEWS

LENGTH: 967  words


Teva Pharmaceutical Industries announced on 14th October 2011 that it 
had
completed its acquisition of Cephalon.  The firm had initially 
announced it had
acquired all of Cephalon's outstanding shares for US $81.50 per share 
in cash in
May 2011; the deal amounted to a total enterprise value of some US 
$6.8 billion.
With the acquisition of Cephalon now completed, Teva commented that 
the combined
company would have a significant presence in over 60 countries and 
generated
around US $20 billion in revenues on a pro-forma basis for the year 
ended June
2011.

The completion of the deal came after two hurdles were cleared.  On 
7th October
2011, Teva reported that the US Federal Trade Commission had accepted 
a proposed
consent order in connection with the transaction and granted early 
termination
of the Hart-Scott-Rodino waiting period.  The FTC had complained that 
the
acquisition as originally proposed would have violated US antitrust 
law by
reducing competition in three markets: transmucosal fentanyl citrate 
lozenges
used to treat cancer pain; extended-release cyclobenzaprine 
hydrochloride used
as a muscle relaxant; and modafinil tablets used to improve 
wakefulness.

The FTC commented that transmucosal fentanyl citrate lozenges are 
versions of a
cancer pain drug developed by Cephalon and marketed under the brand 
name Actiq.
Three generic versions of the drug, manufactured and marketed by 
Teva, Cephalon
/ Watson Pharmaceuticals and Covidien, currently exist in the US.  
Teva's
acquisition of Cephalon would have reduced this to two, and would 
have given
Teva a more than 80% share of the sales of generic Actiq.  
Extended-release
cyclobenzaprine hydrochloride is the generic form of Amrix.  The FTC 
noted that
Cephalon had acquired the rights to the branded version, which was 
approved by
the FDA in 2007.  Currently, no generic versions of the drug are 
marketed in the
US, but the FTC argued that Teva and Cephalon were two of only a 
limited number
of suppliers that could enter the market quickly with a generic 
version.  As a
result, combining the two firms would reduce competition in the 
future.
Modafinil tablets are generic versions of the brand drug Provigil, 
marketed by
Cephalon and used to treat excessive sleepiness caused by narcolepsy 
or shift
work disorder.  The FTC noted again that no companies currently 
market a generic
version of the product, which had sales worth US $1 billion in 2010.  
Teva,
Ranbaxy Pharmaceuticals, Mylan Pharmaceutical and Barr Laboratories 
(another
Teva company) have all taken steps to enter the market, and are all 
eligible to
seek the 180-days marketing exclusivity allowed under the 
Hatch-Waxman Act for
being the first to file an ANDA.  However, the FTC noted that each 
company had
also signed an agreement with Cephalon to refrain from marketing a 
generic
version until April 2012.  The FTC contended that without the proposed
settlement, Teva and Cephalon would have been two of only a limited 
number of
suppliers of generic Provigil during the 180-day period.

In order to replace the competition potentially lost through the 
acquisition,
the FTC proposed a settlement order which would require Teva to sell 
all of its
rights and assets related to generic Actiq or transmucosal fentanyl 
citrate
lozenges, Actiq or generic extended-release cyclobenzaprine 
hydrochloride
capsules, to Par Pharmaceutical Companies.  With regard to modafinil, 
the FTC's
proposed order required Teva to enter into a supply agreement to 
provide Par
with generic modafinil tablets in the US for one year.  This would 
allow Par to
compete with a generic modafinil product during the 180-day 
exclusivity period.
In addition, Par may extend the agreement for another year.

Across the Atlantic

The second hurdle to the transaction had been in Europe.  In April 
2011, before
Teva had announced its acquisition agreement, the European Commission 
reported
that it had opened a formal antitrust investigation regarding an 
agreement
between Teva and Cephalon that was unconnected with the acquisition.  
The EC had
reported that in December 2005, the two firms had settled patent 
infringement
disputes in the US and UK concerning modafinil, with Teva undertaking 
as part of
the agreement not to sell its generic version in the European 
Economic Area
markets before October 2012.  The EC was investigating whether this 
agreement
may have had the object or effect of hindering generic competition 
for the drug
in the EEA.

On 14th October 2011, the EC formally announced that it had cleared 
the proposed
acquisition of Cephalon under the EU Merger Regulation.  However, the 
decision
was conditional upon the divestment of Cephalon's generic version of 
its
Provigil product.  The Commission commented that it had examined the 
effects of
the proposed transaction on the market for modafinil drugs, having 
had concerns
that the acquisition, as originally proposed, would have 
significantly reduced
generic competition.  The Commission determined that the divestment of
Cephalon's generic pipeline modafinil product, as was offered by the 
company,
would allow a competitor to emerge and compete effectively with the 
Teva /
Cephalon combined company.  The investigation did not reveal any other
significant modification to the competitive situation and dynamics of 
other
relevant markets, as a number of significant and credible competitors 
would
continue to exercise a competitive constraint on the merged entity.
Consequently, the Commission was happy with the modified transaction 
proposal.
Teva noted that it was required to divest Cephalon's marketing 
authorisation of
generic modafinil in France and grant to the purchaser of the 
marketing
authorisation certain additional rights with respect to the entire 
EEA,
including a covenant not to sue effective as of October 2012.

LOAD-DATE: October 21, 2011

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newsletter

JOURNAL-CODE: World Generic Markets


                  Copyright 2011 Espicom Business Intelligence
                              All Rights Reserved


                              10 of 998 DOCUMENTS


                              World Generic Market

                                October 21, 2011

Teva completes Cephalon acquisition

SECTION: NEWS

LENGTH: 967  words


Teva Pharmaceutical Industries announced on 14th October 2011 that it 
had
completed its acquisition of Cephalon.  The firm had initially 
announced it had
acquired all of Cephalon's outstanding shares for US $81.50 per share 
in cash in
May 2011; the deal amounted to a total enterprise value of some US 
$6.8 billion.
With the acquisition of Cephalon now completed, Teva commented that 
the combined
company would have a significant presence in over 60 countries and 
generated
around US $20 billion in revenues on a pro-forma basis for the year 
ended June
2011.

The completion of the deal came after two hurdles were cleared.  On 
7th October
2011, Teva reported that the US Federal Trade Commission had accepted 
a proposed
consent order in connection with the transaction and granted early 
termination
of the Hart-Scott-Rodino waiting period.  The FTC had complained that 
the
acquisition as originally proposed would have violated US antitrust 
law by
reducing competition in three markets: transmucosal fentanyl citrate 
lozenges
used to treat cancer pain; extended-release cyclobenzaprine 
hydrochloride used
as a muscle relaxant; and modafinil tablets used to improve 
wakefulness.

The FTC commented that transmucosal fentanyl citrate lozenges are 
versions of a
cancer pain drug developed by Cephalon and marketed under the brand 
name Actiq.
Three generic versions of the drug, manufactured and marketed by 
Teva, Cephalon
/ Watson Pharmaceuticals and Covidien, currently exist in the US.  
Teva's
acquisition of Cephalon would have reduced this to two, and would 
have given
Teva a more than 80% share of the sales of generic Actiq.  
Extended-release
cyclobenzaprine hydrochloride is the generic form of Amrix.  The FTC 
noted that
Cephalon had acquired the rights to the branded version, which was 
approved by
the FDA in 2007.  Currently, no generic versions of the drug are 
marketed in the
US, but the FTC argued that Teva and Cephalon were two of only a 
limited number
of suppliers that could enter the market quickly with a generic 
version.  As a
result, combining the two firms would reduce competition in the 
future.
Modafinil tablets are generic versions of the brand drug Provigil, 
marketed by
Cephalon and used to treat excessive sleepiness caused by narcolepsy 
or shift
work disorder.  The FTC noted again that no companies currently 
market a generic
version of the product, which had sales worth US $1 billion in 2010.  
Teva,
Ranbaxy Pharmaceuticals, Mylan Pharmaceutical and Barr Laboratories 
(another
Teva company) have all taken steps to enter the market, and are all 
eligible to
seek the 180-days marketing exclusivity allowed under the 
Hatch-Waxman Act for
being the first to file an ANDA.  However, the FTC noted that each 
company had
also signed an agreement with Cephalon to refrain from marketing a 
generic
version until April 2012.  The FTC contended that without the proposed
settlement, Teva and Cephalon would have been two of only a limited 
number of
suppliers of generic Provigil during the 180-day period.

In order to replace the competition potentially lost through the 
acquisition,
the FTC proposed a settlement order which would require Teva to sell 
all of its
rights and assets related to generic Actiq or transmucosal fentanyl 
citrate
lozenges, Actiq or generic extended-release cyclobenzaprine 
hydrochloride
capsules, to Par Pharmaceutical Companies.  With regard to modafinil, 
the FTC's
proposed order required Teva to enter into a supply agreement to 
provide Par
with generic modafinil tablets in the US for one year.  This would 
allow Par to
compete with a generic modafinil product during the 180-day 
exclusivity period.
In addition, Par may extend the agreement for another year.

Across the Atlantic

The second hurdle to the transaction had been in Europe.  In April 
2011, before
Teva had announced its acquisition agreement, the European Commission 
reported
that it had opened a formal antitrust investigation regarding an 
agreement
between Teva and Cephalon that was unconnected with the acquisition.  
The EC had
reported that in December 2005, the two firms had settled patent 
infringement
disputes in the US and UK concerning modafinil, with Teva undertaking 
as part of
the agreement not to sell its generic version in the European 
Economic Area
markets before October 2012.  The EC was investigating whether this 
agreement
may have had the object or effect of hindering generic competition 
for the drug
in the EEA.

On 14th October 2011, the EC formally announced that it had cleared 
the proposed
acquisition of Cephalon under the EU Merger Regulation.  However, the 
decision
was conditional upon the divestment of Cephalon's generic version of 
its
Provigil product.  The Commission commented that it had examined the 
effects of
the proposed transaction on the market for modafinil drugs, having 
had concerns
that the acquisition, as originally proposed, would have 
significantly reduced
generic competition.  The Commission determined that the divestment of
Cephalon's generic pipeline modafinil product, as was offered by the 
company,
would allow a competitor to emerge and compete effectively with the 
Teva /
Cephalon combined company.  The investigation did not reveal any other
significant modification to the competitive situation and dynamics of 
other
relevant markets, as a number of significant and credible competitors 
would
continue to exercise a competitive constraint on the merged entity.
Consequently, the Commission was happy with the modified transaction 
proposal.
Teva noted that it was required to divest Cephalon's marketing 
authorisation of
generic modafinil in France and grant to the purchaser of the 
marketing
authorisation certain additional rights with respect to the entire 
EEA,
including a covenant not to sue effective as of October 2012.

LOAD-DATE: January 6, 2012

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newsletter

JOURNAL-CODE: World Generic Markets


                  Copyright 2011 Espicom Business Intelligence
                              All Rights Reserved


                              11 of 998 DOCUMENTS




                                 Global Insight

                                October 19, 2011

Teva Sells Three Generic Products Rights to Par Pharma

BYLINE: Georgette Calnan

SECTION: In Brief

LENGTH: 242 words


US firm Par Pharmaceutical yesterday (18 October) announced the 
ownership of the
rights to three products from Teva (Israel) as a result of the terms 
attached by
the US Federal Trade Commission (FTC) to the latter's acquisition of 
Cephalon
(US). Under the terms of the agreement, Par will now own the 
Abbreviated New
Drug Applications (ANDAs) of the generic versions of Actiq (fentanyl 
citrate
lozenges), Amriz (cyclobenzaprine extended-release--ER--capsules), as 
well as
the US rights to market the generic version of Provigil (modafinil). 
According
to Par's press release, citing IMS data, Actiq, Provigil and Amrix 
achieved
annual sales in the US of USD173 million, USD1.1 billion and USD125 
million
respectively. Par will begin immediate shipment of all strengths of 
fentanyl
citrate lozenges which were previously available from Teva. 
Cyclobenzaprine ER
capsules and modafinil tablets are not yet available.

Significance:The deal was part of the US Federal Trade Commission 
(FTC)'s
conditional nod of Teva's acquisition of Cephalon. The sale of the 
ANDAs allowed
Teva to complete its acquisition of Cephalon by its targeted deadline 
of 14
October. Par's acquisition of the three products preserves 
competition in all
relevant markets. This will boost the US firm's generic drug 
portfolio which in
turn could result in increased revenues. The acquisition of Amrix and 
Provigil
ANDAs will allow Par to enter the generic market for both products 
next year.

LOAD-DATE: October 19, 2011

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Web Publication


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                              All Rights Reserved


                              12 of 998 DOCUMENTS


                             India Investment News

                      October 18, 2011 Tuesday 6:30 AM EST

Par Pharmaceutical Acquires Three Generic Products from Teva 
Pharmaceuticals

LENGTH: 173  words


New Delhi, Oct. 18 -- Par Pharmaceutical Companies Inc. issued the 
following
news release:

Par Pharmaceutical Companies, Inc. (NYSE: PRX) announced today that 
it acquired
rights to three products from Teva Pharmaceuticals in connection with 
Teva's
acquisition of Cephalon. Under terms of the agreement, Par will own 
the ANDAs of
fentanyl citrate lozenges, a generic version of Actiq, and 
cyclobenzaprine ER
capsules, the generic version of Amrix, as well as the U.S. rights to 
market
modafinil tablets, the generic version of Provigil.



According to IMS Health data, annual sales in the U.S. for Actiq and 
the
equivalent generic products are $173 million. Annual sales in the 
U.S. for
Provigil and Amrix are approximately $1.1 billion and $125 million,
respectively.

Par is currently shipping to the trade all strengths of fentanyl 
citrate
lozenges that were previously available from Teva. Cyclobenzaprine ER 
capsules
and modafinil tablets were not previously marketed by Teva and are 
not yet
available.

Source: Par Pharmaceutical Companies Inc.

LOAD-DATE: January 3, 2012

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Web Publication


                           Copyright 2011 Contify.com
                              All Rights Reserved


                              13 of 998 DOCUMENTS


                                Key Pharma News

                            October 18, 2011 Tuesday

Par acquires three generic products from Teva

SECTION: NEWS

LENGTH: 177  words


Par Pharmaceutical Companies has acquired rights to three products 
from Teva
Pharmaceutical Industries in connection with the latter's acquisition 
of
Cephalon.

Under terms of the agreement, Par will own the ANDAs for fentanyl 
citrate
lozenges, a generic version of Actiq, which is indicated for the 
management of
breakthrough cancer pain in patients aged >=16 years with 
malignancies who are
already receiving and tolerant to around-the-clock opioid therapy for 
their
underlying persistent cancer pain, and cyclobenzaprine 
extended-release (ER)
capsules, a generic version of Amrix, indicated as an adjunct to rest 
and
physical therapy for the relief of muscle spasm associated with 
acute, painful
musculoskeletal conditions, as well as the US rights to market 
modafinil
tablets, a generic version of Provigil, a wakefulness-promoting agent.

Par is currently shipping all strengths of fentanyl citrate lozenges 
that were
previously available from Teva. Cyclobenzaprine ER capsules and 
modafinil
tablets were not previously marketed by Teva, and are not yet 
available.

LOAD-DATE: October 18, 2011

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newsletter

JOURNAL-CODE: Pharma Company Insight


                  Copyright 2011 Espicom Business Intelligence
                              All Rights Reserved


                              14 of 998 DOCUMENTS


                                Key Pharma News

                            October 18, 2011 Tuesday

Par acquires three generic products from Teva

SECTION: NEWS

LENGTH: 177  words


Par Pharmaceutical Companies has acquired rights to three products 
from Teva
Pharmaceutical Industries in connection with the latter's acquisition 
of
Cephalon.

Under terms of the agreement, Par will own the ANDAs for fentanyl 
citrate
lozenges, a generic version of Actiq, which is indicated for the 
management of
breakthrough cancer pain in patients aged >=16 years with 
malignancies who are
already receiving and tolerant to around-the-clock opioid therapy for 
their
underlying persistent cancer pain, and cyclobenzaprine 
extended-release (ER)
capsules, a generic version of Amrix, indicated as an adjunct to rest 
and
physical therapy for the relief of muscle spasm associated with 
acute, painful
musculoskeletal conditions, as well as the US rights to market 
modafinil
tablets, a generic version of Provigil, a wakefulness-promoting agent.

Par is currently shipping all strengths of fentanyl citrate lozenges 
that were
previously available from Teva. Cyclobenzaprine ER capsules and 
modafinil
tablets were not previously marketed by Teva, and are not yet 
available.

LOAD-DATE: January 6, 2012

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newsletter

JOURNAL-CODE: Pharma Company Insight


                  Copyright 2011 Espicom Business Intelligence
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                              15 of 998 DOCUMENTS


                                  PR Newswire

                      October 18, 2011 Tuesday 9:00 AM EST

Par Pharmaceutical Acquires Three Generic Products From Teva 
Pharmaceuticals;
Par Begins Shipping Fentanyl Citrate Lozenges to the Trade Immediately

LENGTH: 453 words

DATELINE: WOODCLIFF LAKE, N.J., Oct. 18, 2011


Par Pharmaceutical Companies, Inc. (NYSE: PRX) announced today that 
it acquired
rights to three products from Teva Pharmaceuticals in connection with 
Teva's
acquisition of Cephalon. Under terms of the agreement, Par will own 
the ANDAs of
fentanyl citrate lozenges, a generic version of Actiq®, and 
cyclobenzaprine ER
capsules, the generic version of Amrix®, as well as the U.S. rights 
to market
modafinil tablets, the generic version of Provigil®.

According to IMS Health data, annual sales in the U.S. for Actiq® 
and the
equivalent generic products are $173 million. Annual sales in the 
U.S. for
Provigil® and Amrix® are approximately $1.1 billion and $125 
million,
respectively.

Par is currently shipping to the trade all strengths of fentanyl 
citrate
lozenges that were previously available from Teva. Cyclobenzaprine ER 
capsules
and modafinil tablets were not previously marketed by Teva and are 
not yet
available.

About Par Pharmaceutical Companies, Inc.

Par Pharmaceutical Companies, Inc. is a US-based specialty 
pharmaceutical
company. Through its wholly-owned subsidiary's two operating 
divisions, Par
Pharmaceutical and Strativa Pharmaceuticals, it develops, 
manufactures and
markets high barrier-to-entry generic drugs and niche, innovative 
proprietary
pharmaceuticals. For press release and other company information, 
visit
www.parpharm.com.

Safe Harbor Statement

Certain statements in this news release constitute "forward-looking 
statements"
within the meaning of the Private Securities Litigation Reform Act of 
1995. To
the extent any statements made in this news release contain 
information that is
not historical, these statements are essentially forward-looking and, 
as such,
are subject to known and unknown risks, uncertainties and 
contingencies, many of
which are beyond the control of the Company, which could cause actual 
results
and outcomes to differ materially from those expressed herein. Risk 
factors that
might affect such forward-looking statements include those set forth 
in Item 1A
of the Company's most recent Annual Report on Form 10-K, in other of 
the
Company's filings with the SEC from time to time, including Quarterly 
Reports on
Form 10-Q and Current Reports on Form 8-K, and on general industry 
and economic
conditions. Any forward-looking statements included in this news 
release are
made as of the date hereof only, based on information available to 
the Company
as of the date hereof, and, subject to any applicable law to the 
contrary, the
Company assumes no obligation to update any forward-looking 
statements.

SOURCE Par Pharmaceutical Companies, Inc.



CONTACT:Allison Wey, Vice President, Investor Relations and Corporate 
Affairs,
Par Pharmaceutical Companies, Inc., +1-201-802-4000

URL: http://www.prnewswire.com

LOAD-DATE: October 19, 2011

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newswire


                   Copyright 2011 PR Newswire Association LLC
                              All Rights Reserved


                              16 of 998 DOCUMENTS



                        Europolitics (daily in English)

                            October 17, 2011 Monday

MERGERS : ISRAEL'S TEVA CLEARED TO BUY CEPHALON, SUBJECT TO CONDITIONS

BYLINE: Sophie Mosca

SECTION: No. 4286

LENGTH: 246 words


The world's number one generic pharmaceutical company, Teva, obtained 
the
European Commission's green light, on 13 October, to buy its American
competitor, Cephalon, which is primarily an originator company. The 
EU executive
nevertheless makes the EUR4.5 billion merger contingent on Cephalon's 
sale of
its generic version of Provigil, a medicine used to treat excessive 
daytime
sleepiness.

The Commission determined that the two groups have a similar generic 
drug based
on the same active ingredient as Provigil, namely modafinil, and that
competition on the generic drug markets where modafinil is sold could 
be
hampered.

The commitment on the "divestment of Cephalon's generic pipeline 
modafinil
product, as offered by the company, will allow a competitor to emerge 
and
compete effectively with the merged entity," explains the EU 
executive. The
investigation did not reveal any other significant modifications to 
the
competitive situation and dynamics of other relevant markets, as a 
number of
credible and significant competitors will continue to exercise a 
competitive
constraint on the merged entity. The Commission concluded that the 
proposed
transaction, as modified by the commitment, would not significantly 
impede
effective competition in the European Economic Area.

The US trade regulator, the Federal Trade Commission, made the merger
conditional on Teva's divestment of its Provigil generic, its Actiq 
generic used
to treat cancer and Amrix, a muscle relaxant.

LOAD-DATE: October 14, 2011

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newspaper

JOURNAL-CODE: EURE


                          Copyright 2011 Europolitique
                              All Rights Reserved


                              17 of 998 DOCUMENTS



                           The Sunday Times (London)

                            October 16, 2011 Sunday
                                   Edition 1;
                                National Edition

Doctors given drug perform better surgery;
Tests of the brain-stimulant modafinil on exhausted surgeons produced 
remarkable
results, says Jonathan Leake

BYLINE: Jonathan Leake

SECTION: NEWS; Pg. 15

LENGTH: 673 words


IS your doctor on drugs? If not, perhaps they should be. A new study 
suggests
that surgeons given "smart drugs" perform better, safer operations.

Researchers gave sleepdeprived surgeons a brain stimulant called 
modafinil,
known to boost memory and brain power, and then tested how good they 
were at
thinking clearly, solving problems and carrying out simulated 
operations.

The results were so convincing that scientists believe the medical 
profession
could even be weaned off its current drug of choice: caffeine.

The study, led by Lord Darzi, professor of surgery at Imperial 
College London
and a junior health minister in the previous Labour government, 
suggests that
doctors whose brains have been sharpened by the drug will perform 
better under
pressure.

What is more, he says, their extra brain power means they would think 
faster and
react more decisively if something went wrong.

"We found that when surgeons had taken modafinil they saw sharp 
improvements in
their ability to solve problems and think flexibly. In fact, their 
performance
was very good," said Barbara Sahakian, professor of psychiatry at 
Cambridge
University.

The sight of bleary-eyed doctors scrubbing up for surgery after 
sleepless nights
in hospital has caused widespread concern over the risk to patients. 
But the
usual remedy of strong coffee, taken orally in large quantities, can 
cause hand
tremors, the last thing a surgeon needs during a tricky procedure.

Sahakian suggests that modafinil could be a superior substitute for 
caffeine.

Sahakian and Charlotte Housden, her research colleague, worked with 
Darzi and
his surgical team in conducting the tests.

Housden said: "Sleep deprivation is like being legally drunk - it 
causes
problems with learning, memory and increased impulsiveness. This is 
particularly
important for people with critical jobs like surgeons, pilots and 
drivers.

"Imaging studies show that the pre-frontal cortex, which is where you 
do your
thinking, undergoes changes in people who lack sleep."

In the study, Housden and her colleagues tested 39 tired doctors who 
had worked
all day and then stayed up all night. They were divided into two 
groups: one was
given 200mg of modafinil while the other took a placebo.

Then, from 6am to 8am, the doctors were subjected to a battery of 
tests to
measure their cognitive skills, including carrying out virtual 
operations using
a surgical training system.

Compared with those who received modafinil, the doctors given a 
placebo achieved
much lower scores on memory tasks, were more impatient, less able to 
solve
problems and to think flexibly.

Housden said: "Doctors who are deprived of sleep lose their ability 
to solve
problems and think flexibly. It means that if they encounter a 
surgical problem
they will find it harder to solve.

"However, when they took modafinil they regained their ability to 
solve problems
and think flexibly."

Modafinil is currently available only on prescription but it has been 
approved
in America for shift workers suffering from sleeping problems while 
at work. It
is, however, widely available from online pharmacies for about 50p a 
tablet. One
key concern is that modafinil has not been subjected to long-term 
safety tests.

Sahakian suggests, however, that, subject to safety approval, 
modafinil could
even be offered over the counter.

In other jobs, the use of modafinil has already become widespread - 
if hidden.

The military in Britain and America use the drug to keep soldiers and 
pilots
awake on long missions and in recent years it has become popular with 
students
and, increasingly, with business executives and other groups.

Darzi says in his paper, published in the Annals of Surgery: "The 
continuing
discourse over work hours, service provisions, graduate education, 
fatigue and
patient safety strongly suggests that novel solutions might 
ultimately be
required."

If modafinil can make even the most exhausted of doctors bright-eyed 
and
cheerful, then that is a problem solved.

Of course, they could just cut the working hours instead.

Additional reporting: Jan Piotrowski

LOAD-DATE: October 16, 2011

LANGUAGE: ENGLISH

GRAPHIC: Smart drugs might have benefited the medics in Carry on 
Doctor
ALLSTAR

PUBLICATION-TYPE: Newspaper

JOURNAL-CODE: STS


                    Copyright 2011 Times Newspapers Limited
                              All Rights Reserved


                              18 of 998 DOCUMENTS


                                Tendersinfo News

                     October 15, 2011 Saturday 6:30 AM EST

BELGIUM : Mergers: Commission approves the acquisition of Cephalon by 
Teva,
subject to conditions

LENGTH: 338  words


The European Commission has cleared under the EU Merger Regulation 
the proposed
acquisition of US-based pharmaceutical company Cephalon by the generic
pharmaceutical company Teva of Israel. The decision is conditional 
upon the
divestment of Cephalon's generic version of its "Provigil" drug. 
Provigil is
indicated for the treatment of excessive daytime sleepiness 
associated with
narcolepsy. Teva has also developed a generic version of the drug. In 
light of
the commitments, the Commission concluded that the transaction does 
not raise
competition concerns.



The Commission examined the effects of the proposed transaction on 
the market
for drugs based on Modafinil, the main active pharmaceutical 
ingredient of
Provigil and the generic version developed by Teva as well as the one 
Cephalon
has in the pipeline. The Commission was concerned that the proposed 
transaction,
as initially notified, would have significantly reduced generic 
competition in
the markets where Modafinil is sold.

The Commission's investigation showed that the divestment of 
Cephalon's generic
pipeline Modafinil product, as offered by the company, will allow a 
competitor
to emerge and compete effectively with the merged entity.

The investigation did not reveal any other significant modification 
to the
competitive situation and dynamics of other relevant markets, as a 
number of
credible and significant competitors will d continue to exercise a 
competitive
constraint on the merged entity.

The Commission therefore concluded that the proposed transaction, as 
modified by
the commitment, would not significantly impede effective competition 
in the
European Economic Area (EEA)1 or a substantial part of it.

Teva is the world  s largest generic pharmaceutical company. Cephalon 
is a
primarily originator company, but also supplies generic 
pharmaceuticals in the
EEA.

The transaction was notified to the Commission on 25 August 2011.

LOAD-DATE: October 15, 2011

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Web Publication


          Copyright 2011 Tendersinfo News, distributed by Contify.com
                              All Rights Reserved


                              19 of 998 DOCUMENTS


                           Globes (Tel Aviv, Israel)

                 Distributed by McClatchy-Tribune Business News

                            October 14, 2011 Friday

Teva receives European approval for Cephalon acquisition

BYLINE: Guy Katsovitch, Globes, Tel Aviv, Israel

SECTION: BUSINESS AND FINANCIAL NEWS

LENGTH: 272 words


Oct. 14--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: 
TEVA) and
Cephalon Inc. (Nasdaq: CEPH ) announced today that they received 
approval from
the European Commission to proceed with Teva's $7 billion acquisition 
of
innovative drugs company Cephalon.

A condition of the approval is that Teva must divest Cephalon's 
marketing
authorization of generic modafinil in France and grant to the 
purchaser of this
marketing authorization certain additional rights with respect to the 
entire
European Economic Area, including a covenant not to sue effective as 
of October
2012.

Teva received approval for the US authorities for the merger at the 
beginning of
the week. Under that approval, Teva is required to divest two ANDAs 
for fentanyl
citrate lozenges, a generic version of Actiq, and cyclobenzaprine ER 
capsules,
the generic version of Amrix. Teva will also grant non-exclusive U.S. 
rights to
an undisclosed company to market modafinil tablets, the generic 
version of
Provigil, which had annual brand sales in the US of approximately 
$1.1 billion.

With the European Commission approval, the parties have now obtained 
all
regulatory approvals required to close the transaction and, 
accordingly, have
scheduled a closing date of October 14, 2011.

Teva projects that the deal will be accretive on a non-GAAP basis as 
soon as it
is completed, and on a GAAP basis within four quarters. Teva also 
expects
synergies of $500 million in the third year after completion.

___ (c)2011 the Globes (Tel Aviv, Israel) Visit the Globes (Tel Aviv, 
Israel) at
www.globes.co.il/serveen/globes/nodeview.asp?fid=942 Distributed by 
MCT
Information Services

LOAD-DATE: October 15, 2011

LANGUAGE: ENGLISH

ACC-NO:
20111014-TL-Teva-receives-European-approval-for-Cephalon-acquisition-1
014-201110
14

PUBLICATION-TYPE: Newspaper

JOURNAL-CODE: TL


                    Copyright 2011 Globes (Tel Aviv, Israel)


                              20 of 998 DOCUMENTS


                              States News Service

                            October 14, 2011 Friday

MERGERS: COMMISSION APPROVES THE ACQUISITION OF CEPHALON BY TEVA, 
SUBJECT TO
CONDITIONS

BYLINE: States News Service

LENGTH: 459 words

DATELINE: BRUSSELS


The following information was released by the European Union:

The European Commission has cleared under the EU Merger Regulation 
the proposed
acquisition of US-based pharmaceutical company Cephalon by the generic
pharmaceutical company Teva of Israel. The decision is conditional 
upon the
divestment of Cephalon's generic version of its "Provigil" drug. 
Provigil is
indicated for the treatment of excessive daytime sleepiness 
associated with
narcolepsy. Teva has also developed a generic version of the drug. In 
light of
the commitments, the Commission concluded that the transaction does 
not raise
competition concerns.

The Commission examined the effects of the proposed transaction on 
the market
for drugs based on Modafinil, the main active pharmaceutical 
ingredient of
Provigil and the generic version developed by Teva as well as the one 
Cephalon
has in the pipeline. The Commission was concerned that the proposed 
transaction,
as initially notified, would have significantly reduced generic 
competition in
the markets where Modafinil is sold.

The Commission's investigation showed that the divestment of 
Cephalon's generic
pipeline Modafinil product, as offered by the company, will allow a 
competitor
to emerge and compete effectively with the merged entity.

The investigation did not reveal any other significant modification 
to the
competitive situation and dynamics of other relevant markets, as a 
number of
credible and significant competitors will d continue to exercise a 
competitive
constraint on the merged entity.

The Commission therefore concluded that the proposed transaction, as 
modified by
the commitment, would not significantly impede effective competition 
in the
European Economic Area (EEA)1 or a substantial part of it.

Teva is the world's largest generic pharmaceutical company. Cephalon 
is a
primarily originator company, but also supplies generic 
pharmaceuticals in the
EEA.

The transaction was notified to the Commission on 25 August 2011.

Merger control rules and procedures

The Commission, in 1989, was given the power to assess mergers and 
acquisitions
involving companies with a turnover above certain thresholds (see 
Article 1 of
the Merger Regulation). Its duty is to prevent concentrations that 
would
significantly impede effective competition in the EEA or any 
substantial part of
it.

The vast majority of mergers do not pose competition problems and are 
cleared
after a routine review. From the moment a transaction is notified, the
Commission generally has a total of 25 working days to decide whether 
to grant
approval (Phase I) or to start an in-depth investigation (Phase II).

A non-confidential version of today's decision will be available at:

http://ec.europa.eu/competition/elojade/isef/case_details.cfm?proc_cod
e=2_M_6258

LOAD-DATE: October 14, 2011

LANGUAGE: ENGLISH

PUBLICATION-TYPE: Newswire


                       Copyright 2011 States News Service


                              21 of 998 DOCUMENTS


                              States News Service

                            October 14, 2011 Friday

PRELIMINARY STUDY EXAMINES EFFECTS OF 'COGNITIVE ENHANCEMENT' DRUG ON
SLEEP-DEPRIVED DOCTORS

BYLINE: States News Service

LENGTH: 919 words

DATELINE: LONDON


The following information was released by Imperial College London:

Researchers have carried out a preliminary study looking at the 
effects of the
'cognitive enhancement' drug modafinil on the performance of doctors 
who had
been deprived of sleep for one night.

Modafinil, discovered in the 1970s, is currently prescribed in the UK 
for the
treatment of sleepiness associated with narcolepsy, sleep apnoea, and 
shift work
sleep disorder, a condition that affects people who frequently have 
to work at
night.

In the new study of 39 people, published today in the Annals of 
Surgery by
researchers from Imperial College London and the University of 
Cambridge,
modafinil improved performance in a series of mental tasks when 
compared with
placebo, but had no effect on the performance of a surgical motor 
skills task.
The doctors did not interact with any patients during the exercise.

See also:

Annals of Surgery

Imperial College London is not responsible for the content of 
external internet
sites

Department of Surgery and Cancer

Faculty of Medicine

Long periods without sleep are known to increase doctors' risk of 
making poor
judgements and committing medical errors. The study was designed as a
preliminary investigation into whether certain drugs might be 
effective at
reversing some of the effects of fatigue.

Colin Sugden, Clinical Lecturer in Surgery, Department of Surgery and 
Cancer at
Imperial College London, who led the study, said: "This study set out 
to explore
whether modafinil, a wakefulness-promoting drug, might help doctors 
to perform
more effectively under conditions of fatigue when their performance 
might
otherwise be compromised."

In this randomised double-blind trial, 20 healthy male doctors took 
modafinil
and 19 took a placebo after one night of sleep deprivation. All were 
asked to
complete both a series of tasks that are commonly used in psychology 
research
and a virtual reality surgical motor skills task.

In the psychological tasks, the group that had taken modafinil 
performed better
in tests of working memory and planning, were less impulsive 
decision-makers,
and were more responsive to changing demands during a task. However, 
there was
no significant difference between the two groups on the surgical 
motor skills
task.

Mr Sugden said: "Participants in the modafinil group were less 
impulsive,
displayed greater flexibility and solved working memory and planning 
problems
more efficiently than those in the placebo group. However, no benefit 
was seen
in the performance of a basic motor skills task. This was a small, 
short-term
study so we have to be very cautious about how the results are 
interpreted. Most
importantly, it is not clear how performance on tests of mental 
function relate
to how someone performs as a doctor."

The researchers stress that these results remain to be confirmed with 
a larger
sample size and ideally in a longer term study.

The research explored the effects of one dose of modafinil over a 
short term and
it was not designed to investigate the effects of repeated use, 
either on a
person's physical and mental health or on their performance.

Mr Sugden said: "Larger studies looking at the performance effects 
and safety of
longer term use of the drug would need to be performed before we 
could draw
conclusions about whether or not sleep-deprived doctors might benefit 
from
taking it. There are also many challenging ethical considerations 
which will
need to be thought through very carefully.

"We should continue to do everything we can to ensure that doctors 
aren't in a
situation where fatigue might impact upon their performance. We don't 
suggest
that anyone should take modafinil to combat sleep deprivation, unless 
it has
been prescribed by a doctor.

The study was funded by Imperial College London.

-ENDS-

For further information please contact:

Simon Levey

Research Media Officer

Imperial College London

e-mail: s.levey@imperial.ac.uk

Telephone: +44 (0)207 594 6702 or ext. 46702

Out of hours duty Press Officer: +44 (0)7803 886 248

Notes to editors:

1. Journal reference: C. Sugden et al. Effect of pharmacological 
enhancement on
the cognitive and clinical psychomotor performance of sleep deprived 
doctors.
Annals of Surgery, 2011 DOI: 10.1097/SLA.0b013e3182306c99

2. About Imperial College London

Consistently rated amongst the world's best universities, Imperial 
College
London is a science-based institution with a reputation for 
excellence in
teaching and research that attracts 14,000 students and 6,000 staff 
of the
highest international quality. Innovative research at the College 
explores the
interface between science, medicine, engineering and business, 
delivering
practical solutions that improve quality of life and the environment -
underpinned by a dynamic enterprise culture.

Since its foundation in 1907, Imperial's contributions to society 
have included
the discovery of penicillin, the development of holography and the 
foundations
of fibre optics. This commitment to the application of research for 
the benefit
of all continues today, with current focuses including 
interdisciplinary
collaborations to improve global health, tackle climate change, 
develop
sustainable sources of energy and address security challenges.

In 2007, Imperial College London and Imperial College Healthcare NHS 
Trust
formed the UK's first Academic Health Science Centre. This unique 
partnership

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