IDIS Opens New American Office in Response to Industry's Growing Need for Pre-Launch Named Patient Programs

August 27, 2008

Company News Release

IDIS, a leader in the development and implementation of pre-launch Named Patient Programs (NPPs), announces the opening of a new regional office in Iselin, New Jersey, USA.

IDIS Opens New American Office in Response to Industry's Growing Need for Pre-Launch Named Patient Programs


LONDON, Aug. 26 /PRNewswire/ -- IDIS, the world leader in the development and implementation of pre-launch Named Patient Programs (NPPs), announces the opening of a new regional office in Iselin, New Jersey, USA. This office places IDIS in a stronger position to support US based pharmaceutical companies in the implementation of programs to support early access of their medicines.

NPPs provide drug developers across the world with a legal and ethical way to make medicines available where appropriate, in response to requests made by physicians, when those medicines are not yet approved in their country or in late-stage clinical trials. The programs that IDIS establishes in partnership with pharmaceutical and biotechnology companies must adhere to the strict regulatory guidelines of the country from which the request originates to allow patients, who have a genuine unmet medical need, with access to potentially life-saving medicines.

The Iselin office will be headed by John Lagus, Vice President of Business & Corporate Development, IDIS, who is leading the expansion of IDIS in the US.

John Lagus said: "This expansion is critical for building our presence in the US for all our global partners, as well as providing proximity to the pharmaceutical and biotechnology companies based in the US. This new office demonstrates IDIS' commitment to our clients, who requested we establish a US presence, and helps the business to further deliver global market access for the pharmaceutical and biotechnology industry through named patient programs, as well as comparator drug sourcing."

In support of companies sponsoring comparative effectiveness clinical trials, IDIS has built expertise in the strategy for and the procurement of comparator drugs. IDIS has a dedicated procurement team that is focused exclusively on identifying reputable sources for comparator drugs from around the world, achieved as a result of extensive and long-running relationships with drug manufacturers.

 About IDIS


Founded in the UK in 1987, IDIS expanded into Europe six years later, with US pharmaceutical and biotechnology strategic partners established in the last 10 years. IDIS is the world leader in the development and implementation of NPPs.

 IDIS is headquartered near central London.

Visit the IDIS website at

http://www.idispharma.com

<

http://www.idispharma.com

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Contact

: Lynn Blenkhorn of Feinstein Kean Healthcare, +1-508-851-0930

ADDITIONAL NOTES



Named Patient Programs (NPPs)


The status of drug development is increasingly in the public eye both within and outside the US. As a result, pharmaceutical and biotechnology companies are faced with growing international demand from physicians and patients for drugs tha are not yet approved in their home country. Such pre-approval demand is typically seen when a drug is nearing approval or has been approved in the US or another major market but not in other countries.  US-based companies can respond to this demand via a Named Patient Program.

Within the US, pre-approval demand can be met through treatment investigational new drug applications (INDs) or single-patient INDs. These mechanisms, often called compassionate use programs or expanded access programs, provide access to drugs for groups of patients or individuals residing in the US.  

When the demand originates from overseas, companies can employ Named Patient Programs (NPPs) NPPs provide controlled, pre-approval access to drugs in response to requests by physicians in foreign markets on behalf of specific, or "named" patients with unmet medical needs, before those medicines are licensed in particular geographies.  

Through Named Patient Programs, patients can access drugs in late-stage clinical trials or drugs that are approved in the US, before those drugs have been licensed in the patient's home country.

Clinical Trial Procurement & IDIS:



Clinical Trial Procurement  (CTP) services enable pharmaceutical companies to obtain comparator drugs for clinical trials. As a company seeks to bring a new drug to market, demonstrating its value increasingly hinges on how it compares in safety, efficacy, and cost to currently available standard therapies. Healthcare professionals, regulators, and consumers alike are more and more calling for such evidence in an effort to reign in healthcare costs and improve patient outcomes. IDIS’ is an expert in supplying comparator drugs from reputable sources that offer the optimal combination of requirements including:  scheduling, lot size, documentation needs and price. Locating in the US will facilitate IDIS’ interaction with US pharmaceutical and biotech firms to source comparator drugs they need for clinical trials.  As comparative effectiveness is increasingly introduced, having a company that can supply comparator drugs when you need them, with the proper lot size,  with the proper pedigree documentation, at the right price, will become important.  

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