movers and shakers, jul. - sep. 2010 -- pharma matters report

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.

MOVERS AND SHAKERSA PHARMA MATTERS REPORTJuly-September 2010

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PHARMA MATTERS | MOVERS AND SHAKERS

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In this quarter’s report, we look at the companies beginning to make their mark on the U.S. generics market with their finished dose products or active ingredients, and analyze trends and statistics relating to the market as a whole.



WHat iS an anDa?

An Abbreviated New Drug Application (ANDA) is the first step for a generic drug in the U.S. It is submitted to the FDA to prove that the generic version is bioequivalent to the innovator drug in question. On approval, the generic version is added to the Approved Drug Products List (“Orange Book”) and the company may manufacture and market it. An ANDA may be submitted before the patent on the innovator drug expires. However, in that case, the ANDA must include a certification indicating that the filer does not seek to market the product before the expiry of the Orange Book-listed patents (“paragraph III certification”) or that the filer believes that its product does not infringe the Orange Book-listed patents or that the Orange Book-listed patents are invalid (“paragraph IV certification”).

WHat are “a” rateD DrugS?

“A” rated drugs are considered 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.

SeCtiOn i: intrODuCtiOnIndustry pressures are continuing to mount for innovators as a number of blockbusters are losing exclusivity with few new launches to fill the gap. In light of that, it is not surprising that in the third quarter, Big Pharma continued its foray into the generics sector and into emerging markets. In September, Abbott completed the acquisition of Piramal Healthcare’s formulation business in India, making Abbott the number one pharmaceutical company in India and giving it access to Piramal’s large portfolio of branded generic drugs. AstraZeneca’s deal with Aurobindo also gave AstraZeneca access to both the generics and emerging markets. (See Section IV).

Meanwhile, the generic industry, faced with its own challenges, continued to consolidate. In August, Teva, the world’s leading generic pharmaceutical company, announced that it had completed the acquisition of Ratiopharm for $4.78B. This made Teva the number one generics company in Europe. Ratiopharm commanded a top position in the German market, where Teva was not a leading player prior to the acquisition. The acquisition also boosted Teva’s sales in Canada. In March, Teva won the bidding for Ratiopharm, beating Pfizer.

Generic companies also continued their pursuit of patent challenges, geographic and portfolio diversification, and positioning for biosimilars.

Now, let’s take a closer look at Abbreviated New Drug Applications (ANDA) approvals and Paragraph IV patent challenges, as well as notable deals that took place in the third quarter.

SeCtiOn ii: anDa apprOvalStOtal a-rateD anDaS by COuntry Of Origin Of appliCant fOr July tO September 2010

5 4 3 3 37

29

41

USAIN

DIA

SWITZERLAND

ICELAND

GERMANY

JAPAN

CANADA

ISRAEL

FRANCE

JORDAN

2 1


During the third quarter of 2010, U.S.-based companies again received the most ANDA approvals, with 41 approvals going to 24 different corporate groups. During the previous quarter, U.S.-based companies had received 62 approvals.

Indian groups were again in second place, with 29 final approvals going to nine groups. The quarter before, 19 Indian groups had received a total of 44 approvals.

During the third quarter, companies from Switzerland, Iceland, Germany, Japan, Canada, Israel, France, and Jordan also received final approvals.

grOupS WitH tHe mOSt a-rateD anDa apprOvalS fOr July tO September 2010

During the third quarter of 2010, Mylan (U.S.) was again on top of the list with nine ANDA approvals, down from 18 approvals the previous quarter, followed by Glenmark of India, with eight approvals. Aurobindo (India) and Novartis (Switzerland) each received seven final approvals. Teva, which had been in the top three during quarters one and two, was only in 7th place this time with three approvals.

WHat iS a u.S. Dmf?

A DMF (Drug Master File) is a confidential document covering a specific manufacturing facility, process, or article used in the manufacturing, processing, packaging, or storing of a bulk drug. A DMF is reviewed by the FDA only if an ANDA or NDA referencing that particular DMF is filed. An ANDA or NDA will not be approved until any issues with the DMF are resolved.

7

5

3

78

9

Mylan Labora

tories I

nc / U

SA

Glenmark Pharmace

uticals

Ltd /

INDIA

Aurobindo Pharm

a Ltd /

INDIA

Novarti

s AG /

SWITZERLAND

Actavis

Gro

up Hf /

ICELAND

Boehringer In

gelheim KG /

GERMANY

Strides A

rcoLab Ltd

/ IN

DIA

Sun Pharmace

uticals

Ltd /

INDIA

Teva

Pharmace

uticals

Industries L

td /

ISRAEL

Daiichi S

ankyo Co Ltd

/ JA

PAN

Apax Partn

ers / U

SA

Apotex Inc /

CANADA

34

3 3 32


SeCtiOn iii: paragrapH iv CHallengeSIn the third quarter of 2010, we learned of the first Paragraph IV patent challenges on eight active ingredients or combinations, up from six during the previous quarter.

grOupS WitH tHe mOSt patent CHallengeS On reCOrD aS Of September 2010

86

157

84

6561

4943

37

Impax Laboratories Inc

Par Pharmaceutical Companies Inc

Lupin Ltd

Daiichi Sankyo Co Ltd

Actavis Group Hf

Dr Reddy's Group

Sun Pharmaceutical Industries Ltd

Apotex Inc

Watson Pharmaceuticals Inc

Novartis AG

Mylan Laboratories Inc

Teva Pharmaceutical Industries Ltd

34 33 29 28

Teva continued to be by far the most prolific filer of ANDAs with patent challenges. At the time of writing this report, we were linking the company to challenges on 157 products, up from 152 products the quarter before.

Mylan claimed the second spot with challenges on 86 products, up from 81 the quarter before, while Novartis (Sandoz) dropped to third place with links to 84 challenges, up from 83 the quarter before.

WHat iS a biOSimilar aCCOrDing tO u.S. regulatiOnS?

A biosimilar product is defined in the Act to mean a biological product that is both “highly similar to the reference product notwithstanding minor differences in clinically inactive components” and for which “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, 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 healthcare provider who prescribed the reference product.”


prODuCtS firSt expOSeD tO paragrapH iv CHallengeS, aS repOrteD by tHe fDa betWeen July anD September 2010

aCtive ingreDient: adefovir dipivoxil

pOSteD by u.S. fOOD anD Drug aDminiStratiOn (fDa): august 23, 2010

branD name: Hepsera®

nDa HOlDer: gilead

• SigmaPharm Laboratories has submitted an ANDA with Paragraph IV certification for a generic version of Hepsera (adefovir dipivoxil) tablets.

• The Orange Book lists two patents covering Hepsera tablets. - U.S. Patent 5,663,159 will expire on September 2, 2014. - U.S. Patent 6,451,340 will expire on July 23, 2018. In its notice letter to Gilead, Sigmapharm asserted the invalidity of certain claims of U.S. Patent 5,663,159 and noninfringement of other claims. Sigmapharm also claimed that its proposed product would not infringe U.S. Patent 6,451,340, but did not allege that the patent is invalid or unenforceable.• Cipla has held an active drug master file (DMF) for adefovir

dipivoxil since March 2007. In June 2010, Sigmapharm submitted a DMF for amorphous adefovir dipivoxil (11.6% copovidone dispersion).

aCtive ingreDient: calcipotriene, betamethasone dipropionate

pOSteD by fDa: July 7, 2010

branD name: taclonex®

nDa HOlDer: leo pharma

• Tolmar has filed an ANDA with Paragraph IV certification for a generic version of Taclonex (calcipotriene/betamethasone dipropionate) ointment, 0.005%/0.064%

• The Orange Book lists three patents covering Taclonex ointment.

- U.S. Patent 5,763,426 and U.S. Patent RE39,706 concern a new crystalline form of calcipotriene. The reissued patent claims, among other things, calcipotriene monohydrate. Both patents will expire on June 9, 2015. - U.S. Patent 6,753,013 includes drug product claims as well as claims directed to the treatment of psoriasis. That patent will expire on January 27, 2020. Leo Pharma has alleged infringement of U.S. Patent

RE39,706 in suits against Tolmar concerning proposed generic versions of both Taclonex ointment and Dovonex (calcipotriene) topical cream.

• At the time of the first ANDA submission for a generic version of Taclonex ointment, there were multiple active DMFs for each component of the combination on file with the FDA.

WHat iS a paragrapH iv CHallenge?

Bioequivalent generic versions of drugs that are not protected by patents can be produced and marketed in the U.S. by any company, subject to FDA approval. However, a generic company may obtain FDA approval before patent expiry if it certifies its product does not infringe the listed patents or the patents are invalid (paragraph IV certification). Patent holders may then sue the ANDA filer for patent infringement. If the patent holder sues the ANDA filer within 45 days of notification, the FDA may not approve the ANDA for 30 months from the date of notification. If no suit is filed within 45 days, the FDA may approve the ANDA at any time.


aCtive ingreDient: entecavir

pOSteD by fDa: august 9,2010

branD name: baraclude®

nDa HOlDer: bristol-myers Squibb

• Teva has submitted an ANDA with Paragraph IV certification for a generic version of Baraclude (entecavir) tablets

• The Orange Book lists only one patent covering Baraclude tablets.

- U.S. Patent 5,206,244 claims entecavir specifically and will expire on February 21, 2015. In its notice letter to BMS, Teva asserted the invalidity of

certain claims of the patent and that its proposed product would not infringe the patent’s other claims.

• Cipla submitted a DMF for entecavir monohydrate on May 21, 2010.

aCtive ingreDient: hydrocortisone butyrate

pOSteD by fDa: September 20, 2010

branD name: locoid lipocream ®

nDa HOlDer: triax pharmaceuticals

• Glenmark Generics has submitted an ANDA with Paragraph IV certification for a generic version of Locoid Lipocream (hydrocortisone butyrate) cream, 0.1%.

• The Orange Book lists only one patent covering Locoid Lipocream.

- U.S. Patent 5,635,497 concerns topical application compositions and will expire on June 3, 2014. Astellas Pharma Europe is the owner of U.S. Patent 5,635,497.• At the time the first ANDA with Paragraph IV certification was

submitted for a generic version of Locoid Lipocream, Crystal Pharma, Pfizer, Sicor de Mexico, and Taro held active DMFs for hydrocortisone butyrate.

aCtive ingreDient: lenalidomide

pOSteD by fDa: august 23, 2010

branD name: revlimid®

nDa HOlDer: Celgene

• Natco has submitted an ANDA with Paragraph IV certification for a generic version of Revlimid (lenalidomide) capsules.

• The Orange Book lists 12 patents covering Revlimid capsules, expiring between July 24, 2016 and April 22, 2026. The listed patents cover the composition of matter, method of use, polymorphs, and Celgene’s restricted distribution program as approved by the FDA.

Celgene has filed a suit against Natco alleging infringement of 10 of those patents.

• At the time of the first ANDA submission for a generic version of Revlimid capsules, Mylan held the only DMF for lenalidomide reported by the FDA. Celgene’s infringement complaint included the allegation that Natco had entered into an agreement with an unknown partner under which that partner would market and distribute Natco’s proposed lenalidomide product upon FDA approval. Mylan and Natco have cooperated in the past. For example, in June 2008, Mylan announced a license and supply agreement for Natco’s glatiramer acetate pre-filled syringes.


aCtive ingreDient: rasagiline mesylate

pOSteD by fDa: august 23, 2010

branD name: azilect®

nDa HOlDer: teva

• The companies that have submitted ANDAs with Paragraph IV certification for generic versions of Azilect (rasagiline mesylate) tablets include Mylan, Orchid, and Watson.

• The Orange Book lists seven patents covering Azilect tablets, expiring between February 7, 2012 and December 5, 2026.

In suits against Mylan, Orchid, and Watson, Teva has alleged infringement of U.S. Patent 5,453,446. That patent is directed to the use of the R-enantiomers of N-propargyl 1-aminoindan compounds for the treatment of Parkinson’s disease. It has been granted an extension of five years under 35 USC § 155 and will now expire on February 7, 2017.

• At the time of the first ANDA submission for a generic version of Azilect tablets, Actavis, Alkem, Amino, Apotex, Dr. Reddy’s Laboratories, Mylan, Orchid, Sun, and Teva held active DMFs for rasagiline mesylate.

aCtive ingreDient: tacrolimus

pOSteD by fDa: September 20, 2010

branD name: protopic®

nDa HOlDer: astellas

• Nycomed has submitted an ANDA with Paragraph IV certification for a generic version of Protopic (tacrolimus) ointment, 0.1%.

• The Orange Book lists two patents covering Protopic ointment, 0.1%.

- U.S. Patent 5,385,907 includes formulation claims and will expire on January 31, 2012. - U.S. Patent 5,665,727 concerns the treatment of dermatitis and will expire on September 9, 2014.• At the time the first ANDA with Paragraph IV certification was

submitted for a generic version of Protopic ointment, 0.1%, several companies held DMFs for tacrolimus.

aCtive ingreDient: varenicline tartrate

pOSteD by fDa: July 23, 2010

branD name: Chantix®

nDa HOlDer: pfizer

• Mylan has submitted an ANDA with Paragraph IV certification for a generic version of Chantix (varenicline tartrate) tablets.

• The Orange Book lists three patents covering Chantix tablets. - U.S. Patent 6,410,550 will expire on May 10, 2020. - U.S. Patent 6,890,927 will expire on May 6, 2022. - U.S. Patent 7,265,119 will expire on August 3, 2022. According to the Orange Book, all three patents include

claims directed to the drug substance, drug product, and their use as an aid to smoking cessation. In a suit against Mylan, Pfizer has alleged infringement of U.S. Patent 6,890,927 and U.S. Patent 7,265,119.

• At the time the first ANDA for a generic version of Chantix tablets was submitted, Mylan’s Matrix subsidiary held an active DMF for varenicline tartrate, as did Actavis, ALP Pharm Beijing Company, Apotex, and Teva.


SeCtiOn iv: nOtable DealSPortfolio Diversification

A number of the deals in the third quarter in the generics sector focused on diversifying companies’ portfolios and positioning them to become players in the biosimilars arena.

mylan

In September, Mylan announced the acquisition of privately held Bioniche Pharma Holdings for $550 million. Previously, a private equity group, RoundTable Healthcare Partners, held a majority stake in the company. Bioniche, based in Galway, Ireland, generates most of its turnover in the U.S.

In February of this year, Bioniche acquired seven injectable products from GeneraMedix. In the past, it has also acquired ANDAs and NDAs from Baxter Healthcare, Nabi Biopharmaceuticals, Xanodyne, Merck, and PharmaForce. The company claims to have 15 ANDAs pending approval, with more than 25 currently in pre-filing state.

The acquisition gives Mylan immediate entry into the U.S. injectables market and helps it build a commercial platform for biogenerics. Mylan plans to combine Bioniche’s injectable business with its existing UDL Laboratories unit-dose operation.

WatSOn

In July, Watson Pharmaceuticals announced that it had entered into an exclusive, global licensing deal with Itero Biopharmaceuticals for a recombinant follicle-stimulating hormone (rFSH) that Itero has in pre-clinical development. The deal is part of Watson’s plan to build a pipeline of biosimilar products and capitalizes on the biologics capabilities of the Eden Biodesign business that Watson gained after acquiring Arrow.

enDO

In August, Endo Pharmaceuticals, based in Pennsylvania, announced that it will pay $168M for Penwest Pharmaceuticals, a drug delivery technology and formulations company. The deal allows Endo to retain a larger part of the revenue from Opana ER (oxymorphone HCl), an opioid painkiller that uses Penwest’s Timerx extended-release technology. The contract between Endo and Penwest for Opana ER was originally signed in 1997. The acquisition will allow Endo to apply Penwest’s delivery technologies across its portfolio of drug products, both branded and generic.

In September, Endo entered into an agreement to acquire Qualitest Pharmaceuticals, a privately held generics company, for approximately $1.2B in cash. The acquisition gives Endo a broad range of products and formulation capabilities, including controlled substances, which make up approximately 40 percent of Qualitest’s product portfolio, and liquids, which contribute about 17 percent.

Sun pHarmaCeutiCalS

In September, Sun Pharmaceuticals of India announced that it had completed the acquisition of a controlling stake in Taro Pharmaceutical of Israel. Sun holds 48.7 percent of economic equity interest and 65.8 percent of the voting rights. Taro has


manufacturing facilities in Canada and Israel focused on topical dose forms, such as creams and ointments, but also for manufacturing liquids and oral solids. Sun is hoping to build on Taro’s Canadian and American market presence and expertise in dermatology.

aCtaviS

Actavis is pursuing an entry into the biosimilars sector through a proposed acquisition of 51 percent of Bioton’s shares in Biopartners. Bioton, a Polish biotechnology company, acquired the Swiss company Biopartners in 2007 for $78M. Biopartners has long-term strategic partnerships with companies such as LG Life Sciences and Rentschler Biotechnologie. Actavis has been reportedly seeking additional deals and partnerships to gain access to monoclonal antibodies.

Big Pharma’s Interest in Generics

In the third quarter, Big Pharma continued its entry into the generic sector. In September, Aurobindo of India announced that it had entered into an agreement with AstraZeneca. The agreement covers licensing and supply of generic drugs, both in solid dose form and injectables, to AstraZeneca for sale in emerging markets. The Aurobindo deal is the second for AstraZeneca with an Indian generic. In March, AstraZeneca entered into an agreement with Torrent. Torrent agreed to supply to AstraZeneca a portfolio of generic medicines that will be manufactured by Torrent and marketed by AstraZeneca in a number of emerging markets.

In September, Abbott completed the acquisition of Piramal Healthcare’s Indian formulations business. In May, Abbott agreed to pay $3.72B for the business. According to Abbott, the deal will give them the number one position in the Indian pharmaceutical market.

SeCtiOn v: Opening mOveSBased on our research of ANDA filings and Paragraph IV challenges, we highlight some of the companies making significant game play in the U.S. generics industry.

SigmapHarm labOratOrieS llC

SigmaPharm, a privately held specialty pharmaceutical company based in Langhorne, Pennsylvania, is involved in the development, manufacturing, and marketing of generic and branded products. The company also provides contract development and manufacturing services and holds a number of patents.

SigmaPharm filed its first ANDA in June 2007. It received its first approval, for amiloride HCl tablets, in January 2009. The product was launched for commercial marketing, in partnership with Rising Pharmaceuticals, in April 2009. SigmaPharm also markets two other products, ergocalciferol and protriptyline HCl, through Rising.

In August 2010, Gilead Science received a Paragraph IV notification letter informing them that SigmaPharm had submitted an ANDA for adefovir dipivoxil, a generic version of Hepsera, used to treat hepatitis-B. For additional details regarding the challenge, please see the ‘Paragraph IV patent challenges’ section of this quarter’s Movers and Shakers.

epiC pHarma, llC

Epic Pharma, based in Laurelton, New York, is a privately held generic company that came to life only two years ago. The company has an FDA-approved manufacturing facility, which it bought from Sandoz (Novartis); Sandoz had planned to close the facility and outsource the operations.

Epic has continued as a contract manufacturer to Sandoz. The facility is used for making a number of oral drugs, including controlled drugs, in immediate, sustained, and delayed release forms.

Epic currently holds 10 ANDAs, which it has acquired this year from various companies such as Mylan, Glenmark, Actavis, Amneal, and others. In March 2009, Epic signed a strategic alliance agreement with Elite Pharmaceuticals. Under the agreement, at least eight generic drugs will be developed by Epic at Elite’s facility. At that time, Epic also invested in Elite through the purchase of shares of Elite’s stock.

muStafa nevzat ilaC Sanayii aS

Mustafa Nevzat, established in 1923, is one of the oldest pharmaceutical companies in Turkey and among the first to manufacture injectable drugs in the country. The company has four dedicated finished dosage form production plants in Yenibosna, Istanbul, where it manufactures a wide range of injectables and oral solids. The company primarily uses active pharmaceutical ingredients (APIs) produced by Unifar, its sister company, which manufactures a number of products from its facilities in Izmit. Both its API and finished dose facilities have been inspected by the U.S. FDA.

In 2005, Mustafa Nevzat filed its first ANDA. The company started exporting finished dose products to the U.S. in 2007. Mustafa Nevzat has strategic partnerships with several U.S. generic companies, including Par Pharmaceutical Companies



Inc. The two companies entered into an agreement to develop and market as many as 10 generic injectable pharmaceuticals. Under the agreement, Mustafa Nevzat would be responsible for the development and manufacture of the product, while Par would submit each ANDA to the U.S. FDA on behalf of Mustafa Nevzat. The agreement stipulated that Par would be responsible for any litigation expenses arising from the ANDA submissions and would have exclusive rights to market, sell, and distribute the products in the U.S.

On May 24, 2007, Mustafa Nevzat and Par sent notice to Sanofi-Aventis of their ANDA with Paragraph IV certification for oxaliplatin. On July 6, 2007, Sanofi-Aventis and Debiopharm sued Mustafa Nevzat and Par in New Jersey District Court in response to their ANDA for oxaliplatin injection 5mg/mL in 10mL and 20mL vials. Currently, Mustafa Nevzat holds a tentative approval for oxaliplatin.

The company holds ANDAs with final approval for pamidronate disodium and vecuronium bromide. The company acquired both ANDAs from Generamedix. Mustafa Nevzat had been manufacturing pamidronate for Generamedix prior to the ANDA transfer. Mustafa Nevzat has also had contract manufacturing arrangements with other companies, such as Bioniche Pharma.

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movers and shakers, jul. - sep. 2010 -- pharma matters report

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