Movers and Shakers, Jul. - Sep. 2010 -- Pharma Matters Report


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In this quarterly report, we look at a few of the companies beginning to make their marks on the US generics market either with their fi nished dose products or active ingredients, and analyze trends and statistics relating to the market as a whole.

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Movers and Shakers, Jul. - Sep. 2010 -- Pharma Matters Report

  1. 1. Image CopyrIght: iStOCKpHOtOMOVERS AND SHAKERSA PHARMA MATTERS REPORTJuly-September 2010 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. 2. 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. For more information on Thomson Reuters API Intelligence solutions, including Newport Premium, visit MATTERS | MOVERS AND SHAKERS
  3. 3. SeCtiOn i: intrODuCtiOn WHat iS an anDa?Industry pressures are continuing to mount for innovators as anumber of blockbusters are losing exclusivity with few new launches An Abbreviated New Drug Applicationto fill the gap. In light of that, it is not surprising that in the third (ANDA) is the firstquarter, Big Pharma continued its foray into the generics sector step for a genericand into emerging markets. In September, Abbott completed the drug in the U.S. Itacquisition of Piramal Healthcare’s formulation business in India, is submitted to themaking Abbott the number one pharmaceutical company in India FDA to prove that the generic versionand giving it access to Piramal’s large portfolio of branded generic is bioequivalent todrugs. AstraZeneca’s deal with Aurobindo also gave AstraZeneca the innovator drugaccess to both the generics and emerging markets. (See Section IV). in question. On approval, the genericMeanwhile, the generic industry, faced with its own challenges, version is addedcontinued to consolidate. In August, Teva, the world’s leading to the Approvedgeneric pharmaceutical company, announced that it had completed Drug Products Listthe acquisition of Ratiopharm for $4.78B. This made Teva the (“Orange Book”) andnumber one generics company in Europe. Ratiopharm commanded the company may manufacture anda top position in the German market, where Teva was not a leading market it. An ANDAplayer prior to the acquisition. The acquisition also boosted Teva’s may be submittedsales in Canada. In March, Teva won the bidding for Ratiopharm, before the patent onbeating Pfizer. the innovator drug expires. However,Generic companies also continued their pursuit of patent in that case, thechallenges, geographic and portfolio diversification, and positioning ANDA must include afor biosimilars. certification indicating that the filer doesNow, let’s take a closer look at Abbreviated New Drug Applications not seek to market(ANDA) approvals and Paragraph IV patent challenges, as well as the product beforenotable deals that took place in the third quarter. the expiry of the Orange Book-listed patents (“paragraph III certification”) orSeCtiOn ii: anDa apprOvalS that the filer believes that its producttOtal a-rateD anDaS by COuntry Of Origin Of does not infringe theappliCant fOr July tO September 2010 Orange Book-listed patents or that the 41 Orange Book-listed patents are invalid (“paragraph IV certification”). 29 WHat are “a” rateD DrugS? “A” rated drugs are considered 7 therapeutically 5 4 equivalent and can 3 3 3 2 1 be substituted for each other. “A” rated drugs are designated as AA, AB, AN, AO, AP, and AT in the A A D GE ND Y CA N DA AN FR L JO E E AN CUS DI AN PA RA AN Orange Book. NA RD A IN JA RM RL EL IS IC ZE IT SW PHARMA MATTERS | MOVERS AND SHAKERS
  4. 4. During the third quarter of 2010, U.S.-based companies again WHat iS a u.S. Dmf? received the most ANDA approvals, with 41 approvals going to 24 different corporate groups. During the previous quarter, A DMF (Drug Master File) is a confidential U.S.-based companies had received 62 approvals. document Indian groups were again in second place, with 29 final approvals covering a specific going to nine groups. The quarter before, 19 Indian groups had manufacturing facility, process, or received a total of 44 approvals. article used in the During the third quarter, companies from Switzerland, Iceland, manufacturing, Germany, Japan, Canada, Israel, France, and Jordan also processing, packaging, or storing received final approvals. of a bulk drug. A DMF is reviewed by the FDA only if an ANDA grOupS WitH tHe mOSt a-rateD anDa apprOvalS fOr or NDA referencing July tO September 2010 that particular DMF is filed. An ANDA 9 or NDA will not be 8 7 7 approved until any 5 issues with the DMF 4 3 3 3 3 3 are resolved. 2 DA A AN L IA IA Y ND D IA IA SA AE US AN AN ND ND ND ND NA AP /U LA SR M s/ RL /I /I /I /I /J CA CE ER /I nc er ZE td d d td d /I sI /G rtn c/ Lt d Lt Lt sL IT sL Lt rie Hf b In a Pa W Co al KG La al m es to /S ex p tic tic ax ar tri co ou yo ra im ot eu Ph eu Ap us G Ar bo nk Gr Ap he sA ac ac nd Sa La o es vis el nd m rm rti sI rid ng n hi ta ar bi va yla al ha iic St Ac rI Ph ro tic No Da kP M ge Au eu n rin Su ar ac m eh m en Bo ar Gl Ph va Te 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.PHARMA MATTERS | MOVERS AND SHAKERS
  5. 5. SeCtiOn iii: paragrapH iv CHallengeS WHat iS a biOSimilarIn the third quarter of 2010, we learned of the first Paragraph IV aCCOrDingpatent challenges on eight active ingredients or combinations, tO u.S.up from six during the previous quarter. regulatiOnS? A biosimilar product is definedgrOupS WitH tHe mOSt patent CHallengeS On reCOrD in the Act to meanaS Of September 2010 a biological product that is both “highly similar to the reference product 157 notwithstanding minor differences in clinically inactive components” and for which “there are no clinically 86 meaningful 84 differences between 65 the biological 61 product and the 49 reference product in 43 terms of the safety, 37 34 33 purity, and potency 29 28 of the product.” Interchangeability is defined as a biological product Im Pa td Lu San Da Gro p Ac Dr Su Inc Ap W No ab M Te that “may be yla at va pi ta pa rP n ot iic va Re so n Ph vis ex n hi Ph x L eut rti ha substituted for the dd L n L ar s A orie dus ar rm ab Ph ys tica m m G or or reference product ac ar ac ky up Gr ac at at m o eu ou Indu eu Hf or omp ac Co without the ica tic ie eu sI Lt sI al lC l tic d nc ries nc intervention of the In al sI st healthcare provider nc an t rie ie sL sI who prescribed the Lt td nc d reference product.”Teva continued to be by far the most prolific filer of ANDAs withpatent challenges. At the time of writing this report, we werelinking the company to challenges on 157 products, up from 152products the quarter before.Mylan claimed the second spot with challenges on 86 products,up from 81 the quarter before, while Novartis (Sandoz) droppedto third place with links to 84 challenges, up from 83 thequarter before. PHARMA MATTERS | MOVERS AND SHAKERS
  6. 6. prODuCtS firSt expOSeD tO paragrapH iv CHallengeS, aS repOrteD by WHat iS a paragrapH iv tHe fDa betWeen July anD September 2010 CHallenge? aCtive ingreDient: • SigmaPharm Laboratories has submitted an ANDA with Bioequivalent adefovir dipivoxil Paragraph IV certification for a generic version of Hepsera generic versions of pOSteD by u.S. (adefovir dipivoxil) tablets. drugs that are not fOOD anD Drug protected by patents • The Orange Book lists two patents covering Hepsera tablets. aDminiStratiOn can be produced - U.S. Patent 5,663,159 will expire on September 2, 2014. (fDa): and marketed in the august 23, 2010 - U.S. Patent 6,451,340 will expire on July 23, 2018. U.S. by any company, subject to FDA branD name: In its notice letter to Gilead, Sigmapharm asserted the approval. However, a Hepsera® generic company may invalidity of certain claims of U.S. Patent 5,663,159 and nDa HOlDer: obtain FDA approval gilead noninfringement of other claims. Sigmapharm also claimed before patent expiry if it certifies its product that its proposed product would not infringe U.S. Patent does not infringe 6,451,340, but did not allege that the patent is invalid or the listed patents unenforceable. or the patents are invalid (paragraph IV • Cipla has held an active drug master file (DMF) for adefovir certification). Patent dipivoxil since March 2007. In June 2010, Sigmapharm holders may then sue submitted a DMF for amorphous adefovir dipivoxil (11.6% the ANDA filer for copovidone dispersion). patent infringement. If the patent holder sues aCtive ingreDient: • Tolmar has filed an ANDA with Paragraph IV certification for the ANDA filer within calcipotriene, a generic version of Taclonex (calcipotriene/betamethasone 45 days of notification, betamethasone the FDA may not dipropionate dipropionate) ointment, 0.005%/0.064% approve the ANDA for • The Orange Book lists three patents covering Taclonex 30 months from the pOSteD by fDa: date of notification. If July 7, 2010 ointment. no suit is filed within branD name: - U.S. Patent 5,763,426 and U.S. Patent RE39,706 concern 45 days, the FDA may taclonex® a new crystalline form of calcipotriene. The reissued patent approve the ANDA at any time. nDa HOlDer: claims, among other things, calcipotriene monohydrate. leo pharma 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.PHARMA MATTERS | MOVERS AND SHAKERS
  7. 7. aCtive ingreDient: • Teva has submitted an ANDA with Paragraph IV certificationentecavir for a generic version of Baraclude (entecavir) tabletspOSteD by fDa: • The Orange Book lists only one patent covering Baracludeaugust 9,2010 tablets.branD name: - U.S. Patent 5,206,244 claims entecavir specifically and willbaraclude® expire on February 21, 2015.nDa HOlDer:bristol-myers Squibb 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: • Glenmark Generics has submitted an ANDA with Paragraphhydrocortisone IV certification for a generic version of Locoid Lipocreambutyrate (hydrocortisone butyrate) cream, 0.1%.pOSteD by fDa: • The Orange Book lists only one patent covering LocoidSeptember 20, 2010 Lipocream.branD name:locoid lipocream ® - U.S. Patent 5,635,497 concerns topical applicationnDa HOlDer: compositions and will expire on June 3, 2014. Astellastriax Pharma Europe is the owner of U.S. Patent 5,635,497.pharmaceuticals • 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: • Natco has submitted an ANDA with Paragraph IV certification for alenalidomide generic version of Revlimid (lenalidomide) capsules.pOSteD by fDa: • The Orange Book lists 12 patents covering Revlimid capsules,august 23, 2010 expiring between July 24, 2016 and April 22, 2026. The listedbranD name: patents cover the composition of matter, method of use,revlimid® polymorphs, and Celgene’s restricted distribution program asnDa HOlDer: approved by the FDA.Celgene 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. PHARMA MATTERS | MOVERS AND SHAKERS
  8. 8. aCtive ingreDient: • The companies that have submitted ANDAs with Paragraph rasagiline mesylate IV certification for generic versions of Azilect (rasagiline pOSteD by fDa: mesylate) tablets include Mylan, Orchid, and Watson. august 23, 2010 • The Orange Book lists seven patents covering Azilect tablets, branD name: expiring between February 7, 2012 and December 5, 2026. azilect® In suits against Mylan, Orchid, and Watson, Teva has alleged nDa HOlDer: infringement of U.S. Patent 5,453,446. That patent is directed teva 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: • Nycomed has submitted an ANDA with Paragraph IV tacrolimus certification for a generic version of Protopic (tacrolimus) pOSteD by fDa: ointment, 0.1%. September 20, 2010 • The Orange Book lists two patents covering Protopic branD name: ointment, 0.1%. protopic® - U.S. Patent 5,385,907 includes formulation claims and will nDa HOlDer: astellas 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: • Mylan has submitted an ANDA with Paragraph IV certification varenicline tartrate for a generic version of Chantix (varenicline tartrate) tablets. pOSteD by fDa: • The Orange Book lists three patents covering Chantix tablets. July 23, 2010 - U.S. Patent 6,410,550 will expire on May 10, 2020. branD name: Chantix® - U.S. Patent 6,890,927 will expire on May 6, 2022. nDa HOlDer: - U.S. Patent 7,265,119 will expire on August 3, 2022. pfizer 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.PHARMA MATTERS | MOVERS AND SHAKERS
  9. 9. SeCtiOn iv: nOtable DealSPortfolio DiversificationA number of the deals in the third quarter in the generics sector focused ondiversifying companies’ portfolios and positioning them to become players in thebiosimilars arena.mylanIn September, Mylan announced the acquisition of privately held Bioniche PharmaHoldings for $550 million. Previously, a private equity group, RoundTable HealthcarePartners, 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 fromGeneraMedix. In the past, it has also acquired ANDAs and NDAs from BaxterHealthcare, Nabi Biopharmaceuticals, Xanodyne, Merck, and PharmaForce. Thecompany claims to have 15 ANDAs pending approval, with more than 25 currently inpre-filing state.The acquisition gives Mylan immediate entry into the U.S. injectables market andhelps it build a commercial platform for biogenerics. Mylan plans to combineBioniche’s injectable business with its existing UDL Laboratories unit-dose operation.WatSOnIn 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 ispart of Watson’s plan to build a pipeline of biosimilar products and capitalizes onthe biologics capabilities of the Eden Biodesign business that Watson gained afteracquiring Arrow.enDOIn August, Endo Pharmaceuticals, based in Pennsylvania, announced that it will pay$168M for Penwest Pharmaceuticals, a drug delivery technology and formulationscompany. The deal allows Endo to retain a larger part of the revenue from OpanaER (oxymorphone HCl), an opioid painkiller that uses Penwest’s Timerx extended-release technology. The contract between Endo and Penwest for Opana ER wasoriginally signed in 1997. The acquisition will allow Endo to apply Penwest’s deliverytechnologies 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 acquisitiongives Endo a broad range of products and formulation capabilities, includingcontrolled substances, which make up approximately 40 percent of Qualitest’sproduct portfolio, and liquids, which contribute about 17 percent.Sun pHarmaCeutiCalSIn September, Sun Pharmaceuticals of India announced that it had completed theacquisition of a controlling stake in Taro Pharmaceutical of Israel. Sun holds 48.7percent of economic equity interest and 65.8 percent of the voting rights. Taro has PHARMA MATTERS | MOVERS AND SHAKERS
  10. 10. 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 mOveS Based 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.PHARMA MATTERS | MOVERS AND SHAKERS
  11. 11. SigmaPharm filed its first ANDA in June 2007. It received itsfirst approval, for amiloride HCl tablets, in January 2009. Theproduct was launched for commercial marketing, in partnershipwith Rising Pharmaceuticals, in April 2009. SigmaPharm alsomarkets two other products, ergocalciferol and protriptyline HCl,through Rising.In August 2010, Gilead Science received a Paragraph IVnotification letter informing them that SigmaPharm hadsubmitted an ANDA for adefovir dipivoxil, a generic versionof Hepsera, used to treat hepatitis-B. For additional detailsregarding the challenge, please see the ‘Paragraph IV patentchallenges’ section of this quarter’s Movers and Shakers.epiC pHarma, llCEpic Pharma, based in Laurelton, New York, is a privately heldgeneric company that came to life only two years ago. Thecompany has an FDA-approved manufacturing facility, which itbought from Sandoz (Novartis); Sandoz had planned to closethe facility and outsource the operations.Epic has continued as a contract manufacturer to Sandoz. Thefacility is used for making a number of oral drugs, includingcontrolled drugs, in immediate, sustained, and delayed releaseforms.Epic currently holds 10 ANDAs, which it has acquired this yearfrom various companies such as Mylan, Glenmark, Actavis,Amneal, and others. In March 2009, Epic signed a strategicalliance agreement with Elite Pharmaceuticals. Under theagreement, at least eight generic drugs will be developed byEpic at Elite’s facility. At that time, Epic also invested in Elitethrough the purchase of shares of Elite’s stock.muStafa nevzat ilaC Sanayii aSMustafa Nevzat, established in 1923, is one of the oldestpharmaceutical companies in Turkey and among the first tomanufacture injectable drugs in the country. The companyhas four dedicated finished dosage form production plants inYenibosna, Istanbul, where it manufactures a wide range ofinjectables and oral solids. The company primarily uses activepharmaceutical ingredients (APIs) produced by Unifar, its sistercompany, which manufactures a number of products from itsfacilities in Izmit. Both its API and finished dose facilities havebeen inspected by the U.S. FDA.In 2005, Mustafa Nevzat filed its first ANDA. The companystarted 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 PHARMA MATTERS | MOVERS AND SHAKERS
  12. 12. 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.PHARMA MATTERS | MOVERS AND SHAKERS
  13. 13. Image CopyrIght: reuterS/David grayNeWport U.S. marKet Share moDULeDeeper INSIght INto the WorLD’S LargeStpharmaCeUtICaL marKet OUR LATEST OPTIONAL CONTENT MODULES, NEWPORT MARKET SHARE We have launched the Newport U.S. Market Share Module which covers 10 years of product market share history that can be analyzed by dose form, strength, marketer, and brand vs. generic, providing additional insight into the U.S. market. This module integrates seamlessly with Newport Premium and Newport Global base systems. For more than 2,000 products, current information concerning the most frequent diagnosis and co-prescribed drugs, plus demographics including total population, male/female ratio, number of days supplied, and average annual payments are available. Current market share data for each product can be viewed by the number of dispensed units or prescriptions and as percentages or base figures by dose form, strength, marketer, and generic vs. brand split. History is available for 10 years and may be compared with up to five drugs competing in the same diagnosis code. HOW TO SUBSCRIBE The Newport U.S. Market Share Module is an optional subscription module that may be added to your Newport Premium or Newport Global subscription for an additional annual charge. For more information, contact your account manager or visit©2010 Thomson Reuters. All rights reserved. Thomson Reuters and theKinesis logo are trademarks of Thomson Reuters.
  14. 14. To sign up to our Pharma Matters range of publications visit: THE ONES TO WATCH Focuses on the latest phase changes in the pharmaceutical pipeline. MOVERS AND SHAKERS Unravels the most significant game-play in the U.S. generics market. THE CUTTING EDGE OF CHEMISTRY Insights into the chemistry advances transforming drug discovery and development. ABOUT NEWPORT PREMIUM Newport Premium is the critical product targeting and global business development system from Thomson Reuters, the industry authority on the global generics market. Created specifically for generic pharmaceutical companies and strategic API manufacturers, it can help you to identify and evaluate product opportunities worldwide, ensuring you’ll be first to find the generic product and niche opportunity, first to make the deal, and first to get to market. ABOUT THOMSON REUTERS Thomson Reuters is the leading source of intelligent information for professionals around the world. Our customers are knowledge workers in key sectors of the global economy. We supply them with the intelligent information they need to succeed in fields that are vital to developed and emerging economies such as law, financial services, tax and accounting, healthcare, science, and media. Our knowledge and information is essential for drug companies to discover new drugs and get them to market faster, for researchers to find relevant papers and know what’s newly published in their subject, and for businesses to optimize their intellectual property and find competitive intelligence. NOTE TO PRESS: To request information or permission to reproduce content from this report, please contact: Paul Sandell Phone: + 44 (0)20 7433 4704 Email: For more information on Thomson Reuters API Intelligence solutions, including Newport Premium, please visit or email scientific.lifesciences@thomsonreuters.comheaLthCare & SCIeNCeregIoNaL offICeSNorth Americaphiladelphia +1 800 336 4474 +1 215 386 0100Latin Americabrazil +55 11 8370 9845Other countries +1 215 823 5674Europe, Middle East and Africalondon +44 20 7433 4000Asia PacificSingapore +65 6775 5088tokyo +81 3 5218 6500for a complete office list © 2010 thomson reuterslS-9117 1110 Da