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Venebio leads medication adherence study for MeadWestvaco Healthcare

RICHMOND, VA, August 2, 2011 – Venebio Group, LLC recently completed a study for the Healthcare Division of MeadWestvaco Corporation (NYSE: MWV) to evaluate the real-world effectiveness of MWV’s Shellpak® brand reminder packaging in improving long-term medication adherence.

MeadWestvaco Healthcare develops and produces innovative pharmaceutical packaging designed to help patients follow their drug regimen as prescribed. Shellpak®, a protective plastic outer shell containing a 30-day, calendar day-stamped medication blister card, is intended to overcome the leading barrier to medication adherence reported by patients: forgetfulness. Walmart pharmacies in the US have been using Shellpak® since 2007, as adherence-promoting packaging for medications dispensed in its discount generics program.

Venebio provided scientific leadership to MeadWestvaco in its ground-breaking efforts to substantiate the adherence benefit of its innovative medication packaging technology. Venebio designed and conducted a retrospective analysis of anonymized prescription dispensing data for more than 3 million adult Walmart pharmacy patients. The results of the study were compelling: use of calendar blister packaging alone, unaccompanied by any instructions to patients or pharmacists about how to use it or its purpose, was associated with significant improvement in both refill adherence and persistence compared with loose pills in vials.

The benefits of Shellpak® on refill behavior were particularly pronounced among certain subgroups, including patients with the poorest levels of medication adherence at baseline while using vials. The results appear in the June issue of Clinical Therapeutics, a peer-reviewed scientific journal, and add to the scientific evidence base that Venebio has contributed to over the past year for the adherence-enhancing potential of innovative pharmaceutical packaging.

“Medication non-adherence is a complex global problem with staggering public health costs,” commented Venebio’s Chief Medical Officer, Barbara K. Zedler, MD. “The World Health Organization estimates that 50% of patients prescribed long-term medications for numerous chronic illnesses are non-adherent. The resultant poor health outcomes contribute to an avoidable cost burden of nearly $300 billion per year in the US alone, or 13% of total US healthcare spending.”

Dr. Zedler added, “Venebio’s work provides evidence that part of the solution to the multidimensional problem of non-adherence is as simple as what medications are packaged in. It is exciting that a simple, low-cost adherence intervention may have significant public health benefit,”

Venebio also defined and successfully executed a strategy to engage regulatory authorities and policy-making entities to facilitate acceptance of the adherence-promoting packaging design. Dr. Zedler said, “Venebio offers custom solutions to a wide variety of life science problems. Our work with MWV Healthcare on this project is an excellent example of how Venebio’s in-depth statistical analysis capabilities, FDA regulatory experience and scientific knowledge can lead to improved quality of life and positive commercial results.”

According to T.D. Lithgow, PhD, President and Chief Science Officer of MeadWestvaco Healthcare, “We couldn’t be more enthusiastic about the great job Venebio did in a short time to build a robust, objective scientific dossier which we believe will help us significantly in our marketing efforts for Shellpak®. Venebio’s white paper, scientific manuscripts and talking points provided the basis for successful engagements with regulatory authorities as well as commercial customers regarding the role of adherence packaging for medications.”

MeadWestvaco’s VP of Regulatory Affairs, Elizabeth Whalley Buono, added, “Venebio provided impressive and timely scientific leadership and regulatory guidance for a major initiative at MeadWestvaco Healthcare. Venebio and its team of experts planned and spearheaded a remarkable research effort to establish the scientific evidence behind our regulatory approach. Their strategy culminated in the publication of two papers in a leading scientific journal and a successful, ongoing engagement with officials at the highest levels of the FDA regarding the exciting role of innovative pharmaceutical packaging in addressing the huge public health problems of medication non-adherence and medication errors.”

About Venebio: Venebio (www.venebio.com ) is a privately held contract research organization (CRO) that provides cost-effective, custom solutions for complex life sciences problems. Venebio integrates the expertise of a global network of scientists in a broad range of biomedical fields to deliver comprehensive project management with single-point accountability in the following areas: Epidemiologic literature review and analysis, Pharmacogenomics (PGx) and personalized medicine; Bioinformatics, systems biology, and statistical genetics; Molecular and genetic epidemiology; Pharmacoepidemiology; and, Biomarker discovery, development and validation. Venebio offers comprehensive services to pharmaceutical companies, biotechnology and medical device companies, healthcare organizations, academic research centers, law firms, government entities and NGOs. Venebio is a member of the Virginia BioTechnology Research Park in Richmond, Virginia and was selected as a 2010 Greater Richmond Area Company to Watch. For more information about Venebio, email us at info@venebio.com or call 877-344-4347.

About MeadWestvaco: MeadWestvaco Corporation (NYSE: MWV), provides packaging solutions to many of the world’s most- admired brands in the healthcare, beauty and personal care, food, beverage, home and garden, and tobacco industries. The company's businesses also include Consumer & Office Products, Specialty Chemicals, and the Community Development and Land Management Group, which sustainably manages the company’s land holdings to support its operations, and to provide for conservation, recreation and development opportunities. With 19,000 employees worldwide, MWV operates in 30 countries and serves customers in more than 100 nations. MWV manages all of its forestlands in accordance with internationally recognized forest certification standards, and has been named to the Dow Jones Sustainability World Index for seven consecutive years. For more information, please visit www.mwv.com.