Infinata’s BioPharm Insight™ Investigative Journalists to Release Informative Articles on Trial Design, Drug Development and Biosimilars

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Findings to be presented at DIA Annual Meeting and BIO International Convention

Infinata, the exclusive provider of BioPharm Insight™ and BioPharm Clinical™ business development tools and market intelligence, today announced that BioPharm Insight investigative journalists will release informative articles on trial design, drug development and biosimilars at prominent industry conferences this month.

Led by Global Editor Kimberly Ha, the team uncovers and reports on breaking news pertinent to the biopharma industry. Access to these proprietary forward-looking articles is typically limited to BioPharm Insight subscribers, though attendees of the DIA and BIO conferences will be able to receive complementary copies. Individuals who will not be attending the shows may also sign up to receive electronic versions at http://www.zoomerang.com/Survey/WEB22CJGFZ6GAM.

DIA Annual Meeting (June 19-21, Chicago, IL):
“Current Trends in Trial Design and Drug Development”

  •     Pulmonary arterial hypertension drug development future faces patient recruitment challenges
  •     Pfizer, Eli Lilly, Boehringer discuss current state of molecular testing in lung cancer and clinical trial design
  •     Roche/Plexxikon's vemurafenib: Likely to be used in combination with MEK inhibitors and Yervoy melanoma to overcome resistance
  •     United Therapeutics: Oral Remodulin an attractive drug though position in PAH treatment paradigm debated
  •     Raptor's DR Cysteamine (RP-103): Phase IIb design and MOA make sense for NASH indication but questions remain on juvenile population, secondary outcomes
  •     Roche/Genentech faces significant hurdles retaining Avastin's label in breast cancer, as proposed study with paclitaxel faces enrollment issues

BIO International Convention (June 27-30, Washington, D.C.):
“Biosimilar Developers Likely to Have to Conduct Head-to-Head Clinical and PK/PD Trials”

  •     CMS guidance on ASP payment system for biosimilars could spur product development, affect payer strategies
  •     South Korean biosimilar manufacturers expected to follow Celltrion, Samsung’s lead and form industry partnerships to enter US market
  •     Amgen, Pfizer, Abbott: Enbrel, Humira and Remicade biosimilars still years away because of drug development, regulatory challenges
  •     Teva, Sandoz, Mylan: Expected biosimilar licensing/collaboration deals to have more milestones, risk-sharing pacts, higher payouts
  •     Sandoz: Biosimilar manufacturing focused on facilities in Austria, Slovenia; continued focus on MAbs development
  •     Specialist device and biosimilar manufacturers may team up to meet interchangeability requirements
  •     Sanofi-Aventis' Lantus: vultures circling key biosimilar insulin opportunity
  •     FDA's first draft guidance on biosimilars likely to address overarching issues before delving into specific product categories
  •     Sandoz, Teva, Dr Reddy’s likely to pursue parallel BRIC/US biosimilars approval strategy

About BioPharm Insight™
BioPharm Insight™ is a comprehensive online system providing real-time intelligence into global biopharmaceutical companies, key R&D and management contacts, drug pipelines, drug sales forecasts, licensing deals, M&A activity and more. A cornerstone product within Infinata’s comprehensive portfolio of BioPharm business development tools and market intelligence solutions, BioPharm Insight is used by hundreds of service providers and financial markets firms, 8 of the top 10 CROs, and 9 of the top 10 biopharmaceutical companies. To learn why, visit http://www.biopharminsight.com.

About Infinata
Infinata provides business development tools and market intelligence solutions for the biopharmaceutical and financial services communities. Infinata is a wholly owned subsidiary of Pearson PLC and the Financial Times Group. To learn more, visit http://www.infinata.com.

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Holly Burke
Infinata
(781) 619-0131
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