1. Image CopyrIght: iSTOCKPHOTO
MOVERS AND SHAKERS
A PHARMA MATTERS REPORT
A REVIEW OF OCTOBER – DECEMBER 2010. PUBLISHED FEBRUARY 2011.
The Thomson Reuters quarterly report on the U.S. generics
industry uses strategic intelligence and competitive analysis
information from Newport Premium™, the critical product
targeting and global business development system from the
industry authority on the global generics market.

2. The Thomson Reuters quarterly report on the US generics
industry using strategic intelligence and competitive analysis
information from Newport Premium™, the critical product
targeting and global business development system from the
industry authority on the global generics market.
In this quarterly report, we look at a few of the companies
beginning to make their marks on the US generics market with
their finished dose products or active ingredients, and analyze
trends and statistics relating to the market as a whole.
For more information on Thomson Reuters
API Intelligence solutions, including Newport Premium,
visit go.thomsonreuters.com/newport
PHARMA MATTERS | MOVERS AND SHAKERS

3. SECTIOn I: InTRODUCTIOn WHAT IS
An AnDA?
In 2010, the generics industry continued to thrive in the United
States. Despite challenges, such as long approval timelines, An Abbreviated New
Drug Application
companies from 18 countries received a total of 412 final ANDA
(ANDA) is the first
approvals, down from 2009 when companies from 15 countries step for a generic
received a total of 448 ANDA approvals. As in 2009, US-based drug in the U.S. It
companies received more approvals than any other country (159 is submitted to the
approvals going to 46 groups). Indian companies continued to FDA to prove that
the generic version
make inroads into the US generic market with 23 companies
is bioequivalent to
receiving 132 approvals. the innovator drug
It is worth noting that at the end of 2010, the first Chinese in question. On
approval, the generic
company – Novast Laboratories – received a final ANDA version is added
approval. An additional three Chinese companies have acquired to the Approved
final ANDAs from existing players in the US market and other Drug Products List
companies are awaiting approvals for their filings. Huahai of (“Orange Book”) and
China is already manufacturing benazepril for the US market. the company may
manufacture and
We anticipate that, over time, manufacturing for a number market it. An ANDA
of Chinese owned ANDAs will move to China and regulated may be submitted
market players may move manufacturing to China to take before the patent on
advantage of lower costs. However, the backlog at the FDA will the innovator drug
likely slow this transfer significantly. expires. However,
in that case, the
In 2010, companies launched generic versions of several ANDA must include a
blockbusters, among them sanofi’s anti-thrombotic Lovenox™ certification indicating
that the filer does
(enoxaparin sodium), Merck’s antihypertensive Cozaar™ (losartan
not seek to market
potassium), and Boehringer Ingelheim’s benign prostatic the product before
hyperplasia treatment Flomax™ (tamsulosin HCl). Additional the expiry of the
blockbusters were exposed to Paragraph IV patent challenges, Orange Book-listed
among them Viread (tenofovir disoproxil fumarate), Gilead’s patents (“paragraph
III certification”) or
antiviral drug. During 2010, 33 molecules or combinations were
that the filer believes
first exposed to patent challenges, down from the previous year, that its product
when more than 60 molecules or combinations received their first does not infringe the
Paragraph IV patent challenges. We believe that the decline in Orange Book-listed
the number of products first exposed to challenges is the result of patents or that the
Orange Book-listed
a diminishing number of products open to challenge and not an
patents are invalid
indication that generics companies are becoming less aggressive. (“paragraph IV
One of the key topics in the US generics market in 2010 was certification”).
follow-on biologics. At long last, in 2010 the US market got WHAT ARE “A”
the abbreviated pathway for approving biosimilar products. RATED DRUgS?
However, it will be a while before we know how many
“A” rated drugs
companies will use the new abbreviated pathway rather than are considered
continue to use the BLA route. therapeutically
equivalent and can
be substituted for
each other. “A” rated
drugs are designated
as AA, AB, AN, AO,
AP, and AT in the
Orange Book.
PHARMA MATTERS | MOVERS AND SHAKERS

4. Positioning for the follow-on biologics era was the driving force
WHAT IS A
U.S. DMF? behind several acquisitions and deals in 2010, such as Mylan’s
acquisition of Bioniche Pharma. However, in 2010, M&A activity
A DMF (Drug Master
File) is a confidential
wasn’t limited to biologics. The generics industry continued
document to consolidate in pursuit of scale and diversification, both in
covering a specific terms of geographic reach and product portfolios. Big Pharma
manufacturing continued its interest in generics, both in established and
facility, process, or emerging generics markets. Among others, Pfizer announced
article used in the
manufacturing,
collaboration agreements with Strides Arcolab of India, sanofi-
processing, aventis announced a joint venture (JV) with Japan’s Nichi-Iko,
packaging, or storing GlaxoSmithKline expanded its business in Latin America by
of a bulk drug. A DMF acquiring Laboratorios Phoenix in Argentina, Abbott acquired
is reviewed by the Piramal’s Healthcare Solutions Business, and AstraZeneca
FDA only if an ANDA
or NDA referencing
signed a deal for a portfolio of branded generic products to be
that particular DMF supplied by India’s Torrent Pharmaceuticals. To subscribe to our
is filed. An ANDA white papers covering deal making in the generics industry and
or NDA will not be the US follow-on biologic market, click here.
approved until any
issues with the DMF That was a brief recap of happenings on the generics stage
are resolved. in 2010. Now, let’s take a closer look at developments in the
fourth quarter.
SECTIOn II: AnDA APPROVALS
TOTAL ‘A’-RATED AnDAS BY COUnTRY OF ORIgIn
OF APPLICAnT FOR OCTOBER TO DECEMBER 2010
38
34
7 6 5 5 5
3 2 1 1 1 1
n
nd
s
A
a
l
d
n
na
n
le
da
y
ae
nd
an
di
a
pa
ai
n
US
i
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i
na
la
la
Isr
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rm
rla
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er
Ice
Jo
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e
Ge
itz
th
Sw
Ne
PHARMA MATTERS | MOVERS AND SHAKERS

5. In the fourth quarter, 48 companies from 13 countries received
WHAT IS A
a total of 109 approvals. US-based companies again received BIOSIMILAR
the most final ANDA approvals, with 38 approvals going to ACCORDIng
21 different corporate groups. The numbers were slightly TO U.S.
down from the previous quarter, when 24 different US-based REgULATIOnS?
companies received a total of 41 approvals. A biosimilar
product is defined
As during the third quarter, Indian groups were in second place in the Act to mean
during the last quarter of 2010 with 34 approvals going to 15 a biological product
groups. Both the number of Indian groups with approvals and that is both “highly
the number of approvals were up from the third quarter when similar to the
reference product
29 final approvals went to nine Indian groups.
notwithstanding
gROUPS WITH THE MOST ‘A’-RATED AnDA APPROVALS minor differences
FOR OCTOBER TO DECEMBER 2010 in clinically inactive
components” and
7 for which “there
are no clinically
6 meaningful
differences between
5 5 5 5 5 5 5 the biological
product and the
reference product in
terms of the safety,
3 3 3 3 purity, and potency
of the product.”
Interchangeability
is defined as a
biological product
that “may be
substituted for the
reference product
without the
intervention of the
No
W
Ac
Al
Gl
Te
Hi
Ap
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yla ners
at
es
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healthcare provider
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ot
ax
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ex
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rin
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ar
iu
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who prescribed the
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rt
s A heim
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ar
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rI
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ar
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ra
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ra
ng
reference product.”
ite
p
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to
ac
to
eu
rm
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ac
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sI
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al
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td
In the fourth quarter of 2010, Novartis of Switzerland (parent
of Sandoz) topped the list with seven final ANDA approvals,
followed by Watson (US) with six approvals. A number of
companies received five ANDA approvals.
In the third quarter, Novartis also received seven final
approvals. However, during that quarter, seven was enough to
earn only the third spot. During the third quarter of 2010, Mylan
(US) was on top of the list with nine ANDA approvals, followed
by Glenmark of India, with eight approvals.
PHARMA MATTERS | MOVERS AND SHAKERS

6. WHAT IS A SECTIOn III: PARAgRAPH IV CHALLEngES
PARAgRAPH IV
CHALLEngE?
In the fourth quarter of 2010, we learned of first Paragraph
IV patent challenges on five new active ingredients or
Bioequivalent
combinations, down from eight during the previous quarter.
generic versions of
drugs that are not gROUPS WITH THE MOST PATEnT CHALLEngES On RECORD
protected by patents AS OF DECEMBER 2010
can be produced
and marketed in the
157
U.S. by any company,
subject to FDA
approval. However, a
generic company may 95
obtain FDA approval 87
before patent expiry if 72
66
it certifies its product 51
44
does not infringe 40 36 35 31 30
the listed patents
or the patents are
invalid (paragraph IV
certification). Patent
p
Hf
td
nc
G
nc
td
d
d
c
c
c
holders may then sue
In
In
In
ou
Lt
Lt
sA
sL
sL
sI
sI
p
es
s
ex
Gr
n
Co
ou
rie
ie
al
rti
rie
rie
pi
ni
ot
or
the ANDA filer for
tic
Gr
va
y's
Lu
to
yo
st
st
pa
Ap
at
eu
No
ra
du
du
dd
nk
vis
m
or
bo
ac
Sa
In
In
Re
Co
ta
ab
patent infringement. If
m
La
Ac
al
al
hi
xL
Dr
al
ar
tic
tic
n
iic
tic
Ph
pa
yla
eu
eu
the patent holder sues
Da
eu
Im
n
M
ac
ac
ac
so
m
m
m
at
the ANDA filer within
ar
ar
ar
W
Ph
Ph
Ph
va
n
45 days of notification,
r
Su
Pa
Te
the FDA may not
approve the ANDA for
30 months from the
date of notification. If Teva continues to be associated with more patent challenges
no suit is filed within than any other company. At the time of this writing, we
45 days, the FDA may continued to link the company to challenges on 157 products.
approve the ANDA at Mylan, with associations to 95 products with patent challenges,
any time.
stayed in the second spot and increased the lead over Novartis,
with whom we associated 87 challenged products.
160, pat n
PHARMA MATTERS | MOVERS AND SHAKERS

7. PRODUCTS FIRST ExPOSED TO PARAgRAPH IV CHALLEngES, AS REPORTED
BY THE FDA BETWEEn OCTOBER AnD DECEMBER 2010
ACTIVE IngREDIEnT: • Lupin and Mylan have submitted ANDAs with Paragraph
darunavir ethanolate IV certification for generic versions of Prezista (darunavir
POSTED BY FDA: ethanolate) tablets.
04 October 2010
• The Orange Book lists several patents covering Prezista tablets,
BRAnD nAME: expiring between August 25, 2012 and December 26, 2026.
Prezista®
Tibotec’s suit against Lupin and Mylan alleges infringement
nDA HOLDER: of US Patent 7,700,645, which claims a novel ethanolate form
Tibotec
of darunavir useful for the treatment of HIV infections. That
patent will expire on December 26, 2026.
In another suit against Lupin and Mylan, The United States of
America and the University of Illinois have alleged infringement
of US Patent 7,470,506. That patent is directed to the
treatment of HIV infection in adults and pediatric patients over
the age of 6 years and will expire on June 23, 2019. Tibotec
holds a non-exclusive license to US Patent 7,470,506 through
an agreement with the University of Illinois.
• At the time the first ANDA with Paragraph IV certification
was submitted for a generic version of Prezista tablets, Cipla,
Hetero, and Matrix held DMFs for darunavir.
ACTIVE IngREDIEnT: • Apotex has submitted an ANDA with Paragraph IV certification
dastinib for a generic version of Sprycel (dasatinib) tablets.
POSTED BY FDA: • The Orange Book lists four patents covering Sprycel tablets.
04 October 2010
US Patent 6,596,746 claims dasatinib specifically as well as
BRAnD nAME:
its uses for the treatment of cancer and a protein tyrosine
Sprycel®
kinase-associated disorder. It will expire on June 28, 2020.
nDA HOLDER:
Bristol-Myers Squibb US Patent 7,125,875 concerns cyclic protein tyrosine kinase
inhibitors and includes claims to their use in the treatment of
chronic myelogenous leukemia. It will expire on April 13, 2020.
US Patent 7,153,856 also concerns the use of cyclic protein
tyrosine kinase inhibitors for the treatment of cancer. It will
expire on April 28, 2020.
US Patent 7,491,725 includes both drug substance and drug
product claims directed to Sprycel and will expire on October
12, 2025.
In its suit against Apotex, BMS has alleged infringement of all
four patents.
• At the time the first ANDA with Paragraph IV certification
was submitted for a generic version of Sprycel tablets, Hubei
Haosun held the only DMF for dasatinib reported by the FDA.
PHARMA MATTERS | MOVERS AND SHAKERS

8. ACTIVE IngREDIEnT: • Actavis, Mylan, and Par are among the filers of ANDAs with
doxepin HCl Paragraph IV certification for generic versions of Silenor
POSTED BY FDA: (doxepin HCl) tablets.
18 October 2010
• The Orange Book lists eight patents covering the method of
BRAnD nAME: use and formulation of Silenor tablets.
Silenor®
According to the Orange Book, the six patents directed to
nDA HOLDER: the drug product will expire on January 9, 2015. Two patents
Somaxon
concerning the treatment of insomnia will expire on March
26, 2013 and February 17, 2020.
Although the Actavis, Mylan, and Par ANDAs included
Paragraph IV certification to seven of the eight patents,
Somaxon has alleged infringement of only US Patent 6,211,229.
That patent concerns the treatment of transient and short-term
insomnia and will expire on February 17, 2020.
• At the time the first ANDA with Paragraph IV certification was
submitted for a generic version of Silenor tablets, Dipharma
Francis, Sifavitor, and Teva held the only active DMFs for
doxepin HCl reported by the FDA.
ACTIVE IngREDIEnT: • Watson has submitted an ANDA with Paragraph IV
hydromorphone HCl certification for a generic version of Exalgo (hydromorphone
POSTED BY FDA: HCl) extended-release tablets.
18 november 2010
• The Orange Book lists two patents covering Exalgo extended-
BRAnD nAME: release tablets.
Exalgo®
US Patent 5,702,725 and US Patent 5,914,131 include
nDA HOLDER: claims directed to the Exalgo formulation and its use in the
Mallinckrodt
management of pain. Both patents will expire on July 7, 2014.
Mallinckrodt’s suit against Watson alleges infringement of
only US Patent 5,914,131.
• Several companies hold active DMFs for hydromorphone HCl.
PHARMA MATTERS | MOVERS AND SHAKERS

9. ACTIVE IngREDIEnT: • Roxane Laboratories has submitted an ANDA with Paragraph
sodium oxybate IV certification for a generic version of Xyrem (sodium
POSTED BY FDA: oxybate) oral solution.
04 October 2010
• In a suit against Roxane, Jazz alleged infringement of all five
BRAnD nAME: patents listed for Xyrem oral solution in the Orange Book at
xyrem®
the time the ANDA was submitted.
nDA HOLDER: US Patent 6,780,889 and US Patent 7,262,219 include drug
Jazz Pharmaceuticals
product claims directed to Xyrem oral solution and will expire
on July 4, 2020.
US Patent 7,668,730 concerns a method for distributing
sodium oxybate under the control of a central pharmacy. It
will expire on March 7, 2024.
US Patent 7,765,106 and US Patent 7,765,107 concern
methods of controlling the distribution of prescription drugs
using a computer database. They will expire on June 16, 2024.
In December 2010, Jazz announced that a newly issued
patent related to Xyrem had been added to the Orange
Book. US Patent 7,851,506 includes claims directed to the
treatment of cataplexy in patients with narcolepsy. It will
expire on December 22, 2019. Jazz later sued Roxane alleging
infringement of that patent along with US Patent 6,472,431,
which does not appear in the Orange Book listing for Xyrem.
• Johnson Matthey submitted a DMF for sodium oxybate in
August 2010.
PHARMA MATTERS | MOVERS AND SHAKERS

10. SECTIOn IV: nOTABLE DEALS
In the fourth quarter, both generics and innovators alike
continued their expansion into emerging markets, including
Latin America. Watson, for example, expanded its presence
in Brazil by agreeing to pay $30 million for Moksha8, which
supplies both original drugs and branded generics. Under the
agreement, Moksha8 will market and distribute in Brazil and
Mexico products manufactured by Watson. Pfizer, meanwhile,
acquired a 40-percent stake in Brazil’s Laboratorio Teuto.
At the same time, emerging market players made acquisitions
in the United States. Hikma Pharmaceuticals (Jordan) has
agreed to acquire Baxter’s injectables business and through
it will gain a manufacturing facility and significant foothold
in the US injectables market. Dr Reddy’s Laboratories of
India, meanwhile, entered into a deal with GlaxoSmithKline
to acquire the latter’s US penicillin business and a penicillin
manufacturing facility in Bristol, Tennessee. According to
Dr Reddy’s spokesperson, the company has aspirations to
significantly increase its North American generics business.
In the fourth quarter, we continued to see examples of
companies expanding their presence in the value chain.
Cambrex, a US-based API manufacturer and drug delivery
company, paid $20 million in Q4 for a 51-percent stake in
Zenara Pharma in India to gain access to Zenara’s formulation
and finished dosage capabilities. And Aceto, a company that
only a few years ago was primarily known as a distributor of
APIs and chemicals, announced that it was paying $80M for
Rising Pharmaceuticals, based in New Jersey.
There continued to be considerable interest in niche products
in the last quarter of 2010. For example, Zentiva, now part
of sanofi-aventis, announced its acquisition of an inhaler
franchise from Siegfried, allowing Zentiva to become a player
in a market that is expected to develop rapidly after 2013 when
a number of respiratory products will lose patent protection.
Meanwhile, Teva acquired Théramex, a player focused on
the gynaecological market, from Merck KGaA, and Amneal
expanded into the dermatology market by taking control of
Quinnova Pharmaceuticals. The latter markets a number of
products for dermatitis and eczema treatments.
PHARMA MATTERS | MOVERS AND SHAKERS

11. We also continued to see deal-making in the biologics arena.
Actavis, which has aspirations to become a major player in the
biologics arena, is planning to acquire Bioton, based in Poland.
Not to be outdone by generics, Big Pharma kept the pressure
on with their own generics industry-focused deals involving
both large and small molecules. In October, Pfizer signed
a deal with Biocon under which Pfizer will have the right to
commercialize several recombinant insulins developed by
Biocon. And right before New Year’s, Pfizer entered into an
agreement with Akorn-Strides, a JV between US-based Akorn
and Indian Strides Arcolab, to purchase 16 approved and six
pending ANDAs from the joint venture.
SECTIOn V: OPEnIng MOVES
Based on our research of ANDA filings and Paragraph IV
challenges, we highlight some of the companies making
significant game plays in the US generics industry.
ALKEM LABORATORIES, LTD.
Alkem Laboratories, based in Mumbai, India, was founded
in 1974. The US FDA, UK MHRA, Brazil’s ANVISA, and other
authorities approved the company’s dose manufacturing
facilities, and the company claims to export its products to
more than 40 countries.
Alkem’s formulations have been in the US market since 2009.
The company currently holds final approvals for three products
and a tentative approval for one, lamivudine. This tentatively-
approved product was reviewed under expedited review
provisions for the President’s Emergency Plan for AIDS Relief
(PEPFAR). The tentative approval made the product eligible for
purchase outside the United States even before US patent expiry.
At around December 1, 2010, Alkem informed Shire that it had
filed an ANDA with Paragraph IV certification for a generic
version of Fosrenol (lanthanum carbonate) chewable tablets.
We believe that this is the first Paragraph IV filing by Alkem.
Alkem is also acting as a contract manufacturer and is making
amlodipine besylate finished dose product for a number of
companies, including Breckenridge and Ascend.
PHARMA MATTERS | MOVERS AND SHAKERS

12. STASOn PHARMACEUTICALS, InC.
Stason Pharmaceuticals, based in Irvine, California, is a
privately held pharmaceutical company involved in developing,
manufacturing, and marketing both generic and branded
products. Its primary area of development is oncology.
The company was founded by Harry Fan and has a strategic
alliance with Standard Chemical and Pharmaceutical
Company of Taiwan, which was founded by his father and is
today managed by his brother. While in the beginning the two
companies worked separately, today Stason and Standard are
closely collaborating and have a joint pipeline in the United
States. Stason currently holds five ANDAs, but is geared to
file four to five or more ANDAs per year, mostly in the areas of
oncology and CNS.
The two companies also have their eyes set on
biopharmaceuticals. They jointly created Stonsa Biopharm,
Inc., a new spin-off biopharmaceutical company, based in
Southern California. In December 2010, Stason and Lonza
announced that they had signed an agreement granting Stason
a worldwide license to use Lonza’s GS (glutamine synthetase)
Gene Expression System.
Stason is also a player in the contract manufacturing arena and
provides both non-high containment and high containment
manufacturing services to a number of companies, including
Par, Cypress, and Heritage. Stason is capable of manufacturing
both solid and semi-solid dosage forms, including immediate
and delayed-release tablets and capsules, fast-disintegrating
tablets, creams, and lotions.
HAnDA PHARMACEUTICALS, LLC.
Handa Pharmaceuticals, based in Fremont, California, is a
specialty pharmaceutical company founded by Dr. Fangyu “Bill”
Liu in 2005. Liu previously served as Chief Operating Officer
and Vice President of Product Development and Operations
at Anchen Pharmaceuticals. Handa is focusing on difficult-to-
formulate, controlled-release formulations. In July 2009, Fosun
Pharmaceutical of China invested in Handa; today they own about
10 percent of the company. Handa and Fosun have announced
that they will cooperate to jointly develop generic drugs and
challenge patents both in the United States and in Europe.
In July 2008, Handa announced that it had filed an ANDA for
AstraZeneca’s Seroquel XR (quetiapine fumarate extended-
release tablets). The company claimed that it was the first
to file an ANDA with Paragraph IV certification for several
strengths and should be entitled to 180 days of marketing
exclusivity. In December 2010, Handa received tentative
approval of its ANDA. According to the Chinese media, this was
the first time that a company with Chinese ties has received a
tentative approval for a patent challenge product and could be
entitled to the 180-day generic exclusivity.
PHARMA MATTERS | MOVERS AND SHAKERS

13. Image CopyrIght: REUTERS/Petr Josek
BIologICs
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