Tr The Pharma Matters

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Tr The Pharma Matters

  1. 1. Image Copyright: REUTERS/Felix Ausin OrdonezMOVERS AND SHAKERSA PHARMA MATTERS REPORT.July – September 2009 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.
  2. 2. 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 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/globalgenericsPHARMA MATTERS | MOVERS AND SHAKERS
  3. 3. Section I: Introduction What is an ANDA?As the northern hemisphere heads toward winter, it fell to the12th annual IGPA annual meeting, held in Montreal at the end An Abbreviated New Drug Applicationof September, to provide cheer and encouragement. Jim Keon, (ANDA) is the firstthe President of CGPA, reminded delegates that the generic step for a genericindustry is greatly benefiting from governments and other payers drug in the US. Itencouraging the use of generic drugs in order to reduce health is submitted to thecare expenditures. FDA to prove that the generic versionThe US pharmaceutical industry, including the generic sector, is bioequivalent tocould see a boost from the reforms that are currently being the innovator drugdiscussed. According to Ben Sasse, Former US Assistant in question. On approval, the genericSecretary of Health & Human Services, the pharmaceutical version is addedindustry has been supportive of the reform since it will likely see to the Approveddemand for its products go up significantly if millions of new Drug Products Listpatients are insured. (“Orange Book”) and the company mayAccording to Alan Sheppard, Principal of Global Generics, IMS manufacture andHealth, the global generic market is now worth $80 billion and is market it. An ANDAexperiencing 8% growth, up from 3% last year, though it is down may be submitted before the patent onfrom the double digit growth rates the industry saw in 2004– the innovator drug2007. In the US and UK, the growth of the generic industry is expires. However,back in positive territory, a welcome finding after 2008, when the in that case, thegeneric industries in these two countries experienced their first ANDA must include aever period of negative growth. The industry is growing at double certification indicating that the filer doesdigit rates in China (25%) and Brazil (12%). not seek to marketFor the first time ever, generics make up over half of the volume the product beforeof total pharmaceutical sales in unit terms, though there the expiry of the Orange Book-listedcontinue to be dramatic differences in terms of market share in patents (“paragraphkey markets—ranging from over 60% in US and UK to less than III certification”) or30% in Italy and Spain. that the filer believes that its productUpcoming patent expiries continue to offer significant does not infringe theopportunities for generics in many major markets. In the US Orange Book-listedalone, over $90 billion in brand sales is at risk from patent patents or that theexpiries taking place between 2009 and 2013. However, as Ken Orange Book-listed patents are invalidCacciatore, Managing Director, Cowen and Company, warned, (“paragraph IVif generic opportunities are in undifferentiated products with no certification”).sourcing, formulation or manufacturing challenges, then thegeneric opportunity from those brand products will be minimal. What are “A” rated drugs?Several speakers raised the hope that biosimilars may be one of “A” rated drugsthe growth opportunities for the generic industry, but seemed are consideredquite skeptical that more than a few generic companies will have therapeuticallyall the necessary capabilities to participate in the generic biologic equivalent and canarena: biologic formulation capabilities, biologic manufacturing be substituted forcapabilities, experience with clinical trials, sales force capable of each other. “A” rated drugs are designatedmarketing the non-substitutable products, and sufficient capital as AA, AB, AN, AO,required for the investments. These capabilities are found within AP, and AT in thelarge pharmaceutical companies and within the biotechnology Orange Book. PHARMA MATTERS | MOVERS AND SHAKERS
  4. 4. industry, and therefore those companies might be more suited What is a US DMF? to participate in the generic biologic arena. Defensive price reductions by originators could serve as additional barriers to A DMF (Drug Master File) is a confidential generic biologics. document As discussion continues, Movers & Shakers continues to show covering a specific significant activity throughout the US generics industry. First, manufacturing facility, process or let’s take an in-depth look at this quarter’s ANDA approvals and article used in the Paragraph IV challenges. manufacturing, processing, Section II: ANDA approvals packaging or storing of a bulk drug. A DMF Total ‘A’-rated ANDAs by country of origin is reviewed by the of applicant for July to September 2009 FDA only if an ANDA or NDA referencing 122 that particular DMF is filed. An ANDA or NDA will not be approved until any issues with the DMF are resolved. What is the 180- 44 39 day exclusivity? In order to encourage generic companies 9 7 5 4 3 3 3 to develop non- 1 1 1 1 1 infringing products and challenge invalid nd s nd UK m an an A a l y n ly l da ae ta nd an di pa US Ita iu rd iw na la la To Isr In rm d, la patents, the Hatch- lg Ja er Ice Jo Ta Ca an d er Be Ge itz an th gl Waxman act provides Sw Gr Ne En the incentive of 180 days of market During the third quarter of 2009, US-based companies were exclusivity for the first again in the first place in terms of final approvals, with 44 company to file an ANDA with paragraph approvals going to 24 different groups, up from 36 approvals IV certification for a going to 22 groups in the second quarter. Just like the second product. The FDA quarter, Indian companies were in second place with 39 may not approve approvals going to 13 groups followed by Israel (9 approvals additional ANDAs for going to 1 group), Germany (7 approvals going to 2 groups) and a period of 180 days commencing from Switzerland (5 approvals going to one group). the first commercial Groups based in Canada, Iceland, Japan, Jordan, England, marketing of the Netherlands, Taiwan, Italy, and Belgium also received final first-to-file product. In cases where more approvals in this quarter. than one ANDA with Paragraph IV certification is filed on the same day, the period of exclusivity may be shared.PHARMA MATTERS | MOVERS AND SHAKERS
  5. 5. Groups with the most ‘A’-rated ANDA approvals What isfor July to September 2009 Corporate API Rating? 9 Corporate API Rating 8 is a proprietary analytic by Thomson Reuters 6 designed to indicate how capable a 5 5 5 5 corporate group 4 4 4 is of supplying bulk materials to 3 3 3 3 3 3 3 3 3 regulated markets, such as North America and Europe. The rating values are: Established An experienced Te Au har Su ind eu Fr M No Lab Or tis A tor Ak Ch W Inc ical W nP UR ard ac Zy har d Ac Ca Ap G He Dr x In Hf care No ddy Hi star oup Ho Ph LLC Im ra In ace source with a history yla s A tica at oc es m km R va du m ch ta dil or pa c n ro ma ot rou alt sp arm va rth s G Re c L so en ac a L str kh Ph Ph cal vis a n n b e id P s- P xL r i a of supplying APIs to iu eu td ar arm Ind ab o ha em t L eu regulated markets. G ies or or G a X rm a at t p r c In or c ti ies sa Less established ut ica h nd lI tic In In A moderate track nd c c al ls Ph sI us u ar Lt record in supplying nc tri m d ies es ac APIs to regulated Lt eu Lt d d tic markets, either in al sL terms of the im number of years, ite d or the number ofDuring the third quarter of 2009, Teva of Israel received 9 ANDA products supplied. They are stillapprovals, putting the group on top of the list. Aurobindo (8 considered capableANDAs) and Sun (6 ANDAs), both of India, were in the second and of supplyingthird places. regulated markets.In comparison, during the second quarter of 2009, Novartis Potential future(through its Sandoz subsidiary) of Switzerland was on top of the list The group has an interest in supplyingwith 8 approvals, followed by Teva of Israel (6 approvals), Zydus- regulated markets,Cadila of India (5 approvals), and Mylan of U.S. (5 approvals). but so far has no known performance.Section III: Paragraph IV challenges LocalIn the third quarter of 2009, we learned of first paragraph IV Locally focusedpatent challenges on ten new active ingredients or combinations, only (non-regulateddown from 14 during the previous quarter. Among the product markets).challenges posted by the FDA in this quarter were docetaxel Big Pharma Large innovator company. PHARMA MATTERS | MOVERS AND SHAKERS
  6. 6. anhydrous—Sanofi Aventis’s blockbuster antineoplastic product What is a paragraph IV marketed in the US as Taxotere®—and efavirenz, a blockbuster challenge? anti-HIV product marketed in the US by Bristol-Myers as Sustiva®. Bioequivalent Groups with the most patent challenges generic versions of on record as of September 2009 drugs that are not protected by patents 140 can be produced and marketed in the US by any company, subject to FDA approval. However, a generic company may obtain FDA approval before patent expiry if it 68 66 certifies its product 53 does not infringe 40 37 the listed patents 32 30 27 or the patents are 25 25 23 22 invalid (paragraph IV 16 14 certification). Patent holders may then sue the ANDA filer for patent infringement. If p nc td nc G c td d c c up d KG ny pa Hf In In In ng n Lt ou Lt sA sL sL pa sI sI the patent holder sues ro p im ex ies es Gr Co ou rie al rti lG m rie rie pi ni ot he or tic va Gr ys Co the ANDA filer within to Lu yo st na st Ap at el eu No ra du du dd nk vis io m go or bo ac 45 days of notification, at Sa In In Re Co ta ab rri rI m La rn al al Ac Pe ge xL hi Dr al ar the FDA may not te tic tic n iic tic rin Ph pa In yla eu eu Da eu eh w Im approve the ANDA for M n ac ac ro ac so Bo m m Ar rm at 30 months from the ar ar W ha Ph Ph date of notification. If rP va n Su Pa Te no suit is filed within 45 days, the FDA may approve the ANDA at Teva continued to be by far the most prolific filer of ANDAs with any time. patent challenges. At the time of writing this report, we are linking them to challenges on 140 products, up from 136 the quarter before. Mylan has remained in second place with links to patent challenges on 68 different products, up from 65 the quarter before, with Novartis closely behind with challenges on 66 products, up from 62 products the quarter before.PHARMA MATTERS | MOVERS AND SHAKERS
  7. 7. Products first exposed to Paragraph IV challenges,as reported by the FDA between July and September 2009Active Ingredient: • At least one company has filed an ANDA with Paragraph IVatovaquone certification for a generic version of Malarone (atovaquone andand proguanilhydrochloride proguanil hydrochloride) tablets, 250mg/100mg: Glenmark Generics.Posted by FDA: • The Orange Book lists three unexpired patents covering1 July 2009 Malarone tablets in the 250mg/100mg strength:Brand name: US Patent 5,998,449, US Patent 6,166,046, and US PatentMalarone® 6,291,488 concern the combination of atovaquone with proguanil for the treatment of protozoal infections. TheNDA Holder: pediatric exclusivities associated with these patents will expireGlaxoSmithKline on May 25, 2014. In its suit against Glenmark, GlaxoSmithKline alleges infringement of all three patents. • At the time of the first ANDA submission for a generic version of Malarone tablets in April 2009, several active DMFs for each component of the combination were on file with the FDA. Glenmark Generics holds an active DMF for atovaquone that it submitted in October 2008.Active Ingredient: • At least one company has filed an ANDA with Paragraphdexmedetomidine IV certification for a generic version of PrecedexPosted by FDA: (dexmedetomidine hydrochloride) injection: Sandoz.3 August 2009 • The Orange Book lists three patents covering Precedex: US Patent 4,910,214 is the US product patent forBrand name:Precedex® dexmedetomidine. It will expire on July 15, 2013. Orion is the assignee and sole owner of the patent and Hospira is theNDA Holder: exclusive licensee in the United States.Hospira US Patent 5,344,840 concerns the sedation of non-intubated patients before or during surgical and other procedures. It will expire on September 6, 2011. US Patent 6,716,867 covers the use of dexmedetomidine for intensive care unit sedation. It will expire on March 31, 2019. Hospira and Orion are co-assignees of that patent and share ownership. In their suit against Sandoz, Hospira and Orion allege infringement of US Patent 4,910,214 and US Patent 6,716,867. • Cambridge Major Laboratories submitted a DMF for dexmedetomidine HCl in March 2009. PHARMA MATTERS | MOVERS AND SHAKERS
  8. 8. Active Ingredient: • At least one company has filed an ANDA with Paragraph docetaxel IV certification for a generic version of Taxotere (docetaxel) Posted by FDA: injection: Sandoz. Apotex, Hospira, and Sun have filed 505(b) 21 September 2009 (2) NDAs with Paragraph IV certification for docetaxel products. • The Orange Book lists five patents covering Taxotere: Brand name: Taxotere® US Patent 4,814,470 claims docetaxel generically and will expire on May 14, 2010. NDA Holder: US Patent 5,438,072 is a formulation patent expiring on Sanofi-Aventis November 22, 2013. US Patent 5,698,582, US Patent 5,714,512, and US Patent 5,750,561 are formulation patents expiring on July 3, 2012. The suit against Sandoz alleges infringement of US Patent 5,714,512, US Patent 5,750,561, and US Patent 5,438,072. The suits against the 505(b)(2) NDA filers allege infringement of US Patent 5,714,512 and US Patent 5,750,561. • At the time the first ANDA with Paragraph IV certification was submitted for a generic version of Taxotere, several companies held active DMFs for docetaxel. Active Ingredient: • At least one company has submitted an ANDA with Paragraph efavirenz IV certification for a generic version of Sustiva (efavirenz) Posted by FDA: tablets: Mylan. 1 July 2009 • The Orange Book lists five patents covering Sustiva tablets. US Patent 5,519,021 is the basic product patent for efavirenz. It Brand name: Sustiva® will expire on May 21, 2013. US Patent 5,663,169 claims methods of inhibiting HIV reverse NDA Holder: transcriptase. It will expire on September 2, 2014. Bristol-Myers Squibb US Patent 5,811,423 also claims methods of treating HIV infection and AIDS. It will expire on August 7, 2012. US Patent 6,639,071 is directed to a process for the crystallization of a reverse transcriptase inhibitor. It will expire on February 14, 2018. US Patent 6,939,964 also concerns crystal forms of efavirenz. It will expire on January 20, 2018. The Mylan notification letter included a detailed statement of the factual and legal basis for Paragraph IV certification to US Patent 6,639,071 and US Patent 6,939,964. The BMS suit against Mylan alleges infringement of only US Patent 6,673,372, which is not listed for Sustiva in the Orange Book. The estimated expiry date for that patent is June 10, 2019. • At the time the first ANDA with Paragraph IV certification for a generic version of Sustiva tablets was submitted, several companies held active DMFs for efavirenz, including Matrix (a Mylan subsidiary).PHARMA MATTERS | MOVERS AND SHAKERS
  9. 9. Active Ingredient: • At least one company has filed an ANDA with Paragraph IVepinephrine certification for a generic version of EpiPen (epinephrine) Auto-Posted by FDA: Injector: Teva.8 September 2009 • The Orange Book lists only one patent covering EpiPen (epinephrine) Auto-Injector:Brand name:EpiPen® US Patent 7,449,012, entitled “Automatic Injector,” was issued by the Patent and Trademark Office on November 11, 2008 andNDA Holder: will expire on September 11, 2025.Meridian Medical • At the time Teva submitted its ANDA for a generic epinephrineTechnologies injection product, Boehringer Ingelheim and Wockhardt held active DMFs for epinephrine.Active Ingredient: • At least two companies have filed ANDAs with Paragraph IVfluvoxamine maleate certification for generic versions of Luvox CR (fluvoxaminePosted by FDA: maleate) extended-release capsules: Actavis and Anchen.17 August 2009 • The Orange Book lists only one patent covering Luvox CR capsules: US Patent 7,465,462 concerns multiparticulate controlledBrand name:Luvox CR® release selective serotonin reuptake inhibitor formulations and will expire on May 10, 2020. Elan is the assignee of the patentNDA Holder: Jazz and Jazz Pharmaceuticals is the exclusive licensee. • At the time the first ANDA for a generic version of Luvox CR capsules was filed in early 2009, several companies held DMFs for fluvoxamine maleate, including Apotex, Medichem, Lonza, TAPI Puerto Rico (Teva), and Sun. This is not surprising since generic fluvoxamine maleate tablets have been approved in the U.S. since 2000.Active Ingredient: • At least one company has filed an ANDA with Paragraph IVminoxidil certification for a generic version of Men’s Rogaine (minoxidil)Posted by FDA: topical aerosol foam: Perrigo.17 August 2009 • The Orange Book lists only one patent covering Men’s Rogaine topical aerosol foam:Brand name:Men’s Rogaine® US Patent 6,946,120 concerns a homogeneous aerosol formulation consisting of approximately 5% or greater byNDA Holder: weight of minoxidil or a pharmaceutically acceptable saltJohnson & Johnson thereof. It will expire on April 20, 2019. Stiefel is the assignee of the listed patent and Johnson & Johnson is the owner of the approved NDA. • At the time the first ANDA a generic version of Men’s Rogaine topical aerosol foam was filed in early 2009, active DMFs for minoxidil were held by Alchymars, Flamma, Kumar Organic Products, and Solmag. PHARMA MATTERS | MOVERS AND SHAKERS
  10. 10. Active Ingredient: • According to Wyeth, at least five companies have filed ANDAs piperacillin sodium with Paragraph IV certification for generic versions of Zosyn and tazobactam sodium (piperacillin sodium/tazobactam sodium) for injection. Orchid’s ANDA for a generic version of Zosyn for injection included Posted by FDA: Paragraph IV certification. Sandoz and Abraxis have also 21 September 2009 filed ANDAs for the piperacillin/tazobactam combination; we assume those ANDAs also included Paragraph IV certification. Brand name: Zosyn® • The Orange Book lists only one patent covering Zosyn for injection: US Patent 6,900,184 concerns compositions containing NDA Holder: piperacillin and tazobactam in the presence of a buffer, Wyeth preferably citrate, and a particulate formation inhibitor, preferably EDTA. It will expire on April 14, 2023. According to the Orange Book, the patent includes both drug substance and drug product claims related to Zosyn for injection. • Aurobindo, Orchid, Sandoz, and Shandong Qilu King-Phar are among the holders of active DMFs for both components of the combination. Active Ingredient: • At least two companies have filed ANDAs with Paragraph IV repaglinide certification for generic versions of PrandiMet (repaglinide/ and metformin hydrochloride metformin HCl) tablets: Actavis and Sandoz. • The Orange Book lists only one unexpired patent for Posted by FDA: PrandiMet tablets: 21 September 2009 US Patent 6,677,358 concerns the fixed combination or Brand name: simultaneous administration of repaglinide with metformin to PrandiMet™ lower blood glucose and includes both use and formulation claims. It will expire on June 12, 2018. NDA Holder: Novo Nordisk Novo Nordisk alleged infringement of US Patent 6,677,358 in suits against Caraco and Mylan concerning ANDAs for generic versions of Prandin (repaglinide) tablets. Active Ingredient: • At least one company has filed an ANDA with Paragraph solifenacin succinate IV certification for a generic version of Vesicare (solifenacin Posted by FDA: 3 succinate) tablets: Teva. August 2009 • The Orange Book lists only one patent covering Vesicare tablets: US Patent 6,017,927 includes both drug substance claims and Brand name: Vesicare® drug product claims. It will expire on November 19, 2018. • At the time of the first ANDA submission for a generic version NDA Holder: of Vesicare tablets, Teva held a DMF for solifenacin and Dr. Astellas Reddy’s Laboratories and Glenmark Generics held DMFs for solifenacin succinate.PHARMA MATTERS | MOVERS AND SHAKERS
  11. 11. Section IV: Notable dealsMuch of the deal-making in the generic industry remains aroundbiologics and emerging markets.Sanofi-Aventis continued its aggressive program of acquisitionsin the third quarter, after gathering the Mexican genericmanufacturer Laboratorios Kendrick and the Brazilian drugcompany Medley during the first half of the year. In July 2009it announced two further deals. Firstly, it will acquire the Indianbiologics and vaccines manufacturer Shantha Biotechnics for$784 million through its vaccine division Sanofi-Pasteur. ShanthaBiotechnics is expected to command sales of $90 million this year.Secondly, it will buy the Swiss generics company Helvepharm,which has an expected turnover of $29 million this year.In July Valeant Pharmaceuticals International acquired the Mexicangeneric manufacturer Tecnofarma S.A. de C.V. The deal givesValeant two new capabilities in Mexico: to exploit Tecnofarma’ssales experience to the Mexican Government and private labels,and to reduce its dependence on third party manufacturers due toTecnofarma’s 160,000 square foot manufacturing plant. Tecnofarmaboasts a portfolio of 80 registered products and commands sales ofapproximately $33 million.Section V: Opening movesBased on our research of ANDA filings and Paragraph IVchallenges, we highlight some of the companies makingsignificant game play in the US generics industry.Alembic LtdAlembic received its first ANDA approval in January 2009.So far this year, Alembic Ltd has received final approvalsfor five drugs (famotidine, fluoxetine hydrochloride, lithiumcarbonate, meprobamate and metronidazole). In the thirdquarter, it received a tentative approval for a sixth, pramipexoledihydrochloride. In 2007, the company reported that it wasexpecting to file new ANDAs at the rate of 12-15 per year for thesubsequent three years.Though a newcomer to the US generic market, the company iscertainly well established as a finished dose and API manufacturerin India, with a 3 million square meter manufacturing facility inBaroda, numerous ISO and WHO certifications, and a historystretching back more than a hundred years. It specializes inantibiotics and other fermentation products, which it exports tomore than 70 countries around the world.Alembic is also investing in new drug delivery systems. In 2007,the company signed a licensing deal with UCB to apply Alembic’snovel drug delivery system for a once-a-day version of UCB’sKeppra® (levetiracetam). PHARMA MATTERS | MOVERS AND SHAKERS
  12. 12. Tris Pharma This New Jersey specialty pharmaceutical delivery company is notable as a new player in the US generic market. It has one new patent challenge (for cough medicine dextromethorphan polistirex, tradename Delsym®) and one ANDA (for ibuprofen suspension/drops) approved on 31 August 2009. It may be new in the generic sphere, but Tris Pharma boasts a pipeline of over 50 products in active development and a number of proprietary technologies including Controlled Release, Enhanced Solubility/Bioavailability, Fast Dissolve/ODT, and Abuse Deterrence. Its OralXR platform pioneered the sustained release delivery of drugs through liquid, chewable tablet, and other forms, suitable for patients who cannot swallow pills. Tris Pharma has also licensed its technology to other companies. Four years ago, it entered into technology licensing and product development agreements with Interpharm Holdings (acquired in 2008 by Amneal) covering the development of 25 liquid products and seven solid oral dosage products. In 2007, Tris Pharma licensed its LiquiXR technology, a novel and propiretyar drug delivery platform for sustained relase products in liquid form, to Alpharma. MDRNA Inc Based in Bothell, Washington state, biotechnology company MDRNA Inc (formerly Nastech Pharmaceutical) holds an approved ANDA for the osteoporosis treatment salcatonin (aka calcitonin- salmon) nasal spray, marketed by Novartis as Miacalcin®. Although the ANDA included Paragraph IV certification, Novartis elected not to sue because the application was based on a different formulation. On April 1, 2009, MDRNA announced an agreement with Par Pharmaceutical, Inc. under which Par would acquire a manufacturing facility and MDRNA’s salcatonin ANDA. In return, MDRNA would receive an upfront payment and double- digit profit sharing on commercial sales of salcatonin. The FDA approved the ANDA on June 8, 2009, and Par announced that it had begun shipping the product the next day. MDRNA hopes the revenue generated from salcatonin will provide it with working capital to advance its core research, the development and commercialization of therapeutic products based on RNA interference (RNAi), primarily for oncology and for hepatocellular carcinoma and other liver diseases.PHARMA MATTERS | MOVERS AND SHAKERS
  13. 13. Image Copyright: Thomson ReutersNEWPORT GENERIC DEALS MODULEINTELLIGENCE AT YOUR FINGERTIPSFOR YOUR NEXT DEAL One of our new optional content modules, Newport Generic Deals Do you have all the background facts at hand when making your next deal, choosing a partner, scouting the competition, or looking for your next acquisition? The Newport Generic Deals Module covers many thousands of merger, acquisition, development, supply, manufacturing, joint venture, patent settlement and authorized generic deals involving generic companies worldwide since 1999. For these deals, you will be able to view the parties involved, transaction date, dollar value, deal type and a short summary description. A new focused search enables comprehensive searching and analysis of global generic deal-making activity. HOW TO SUBSCRIBE The Newport Generic Deals Module is an optional subscription module that may be added on a per-seat basis to Newport Premium™, Newport Global™, and Newport Sourcing™ product configurations for an additional annual charge. A subscription to a base system is required before purchasing this module. To get a quotation, contact your account manager or visit science.thomsonreuters.com/info/newport_deals_module
  14. 14. NOTESPHARMA MATTERS | MOVERS AND SHAKERS
  15. 15. NOTESPHARMA MATTERS | MOVERS AND SHAKERS
  16. 16. To sign up to our Pharma Matters range of publications visit: scientific.thomsonreuters.com/forms/matters/ 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 US generics market. WHO IS MAKING THE BIGGEST SPLASH Reviews the leading sources of information on medical research. 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 further information or permission to reproduce content from this report, please contact: Sue Besaw Phone: + 1 215 823 1840 Email: susan.besaw@thomsonreuters.com For more information on Thomson Reuters API Intelligence solutions, including Newport Premium, please visit go.thomsonreuters.com/globalgenericsScientific Regional Head OfficesAmericasPhiladelphia +1 800 336 4474 +1 215 386 0100Europe, Middle East and AfricaLondon +44 20 7433 4000Asia PacificSingapore +65 6411 6888Tokyo +81 3 5218 6500For a complete listing of Scientific offices, visit:scientific.thomsonreuters.com/contactCopyright © 2009 Thomson Reuters PH0905111a

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