2010 DDP Awards Nominee: Technology Innovation Nominee: Elan Drug Technologies

Elan Drug Technologies’ NanoCrystal® technology is truly one of the most successful drug delivery technology innovations in the past ten years. Designed to overcome issues associated with poor water solubility, ten years since its first filing with the FDA, it has gone on to achieve product in-market sales for clients in excess of $7.8B.

Five products are now launched in over 100 territories worldwide incorporating this technology. Rapamune® (Wyeth) immunosuppressant, which was launched in 2001, eliminated need for refrigeration of tablet product and provided a 23% improvement in bioavailability. Emend® (Merck) was launched in 2003 for the treatment of nausea and vomiting with a 600% improvement in bioavailability, the product was successfully launched in Japan at end of 2009. TriCor® 145, which provided improved bioavailability and minimal food effect, was launched by Abbott in 2004. Megace ES®,, for cachexia in AIDS patients, was launched in 2005 with a 28% improvement in bioavailability, with a free from food effect. In August 2009, the first once- monthly schizophrenic injectable depot formulation, INVEGA® Sustenna™, was launched by Janssen using this technology.

Since 2001, 11 products using our technologies have been launched for our clients in over 100 countries worldwide, making us the most successful drug delivery company in the past decade. We believe more than any other drug delivery company we have developed superior, commercially successful technologies for our clients.

The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.

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Pfizer and Wyeth merger changes vaccine R&D structure

With the take over of Wyeth, vaccine research and development will be spread to other areas of the Pfizer and Wyeth facilities. There will be five major facilities looking to capture the research and development for the company including: Pearl River, NY, Cambridge, MA, La Jolla, CA, Groton, CT and Sandwich in the UK. Wyeth has been key in the vaccine development industry, which was appealing to Pfizer, as it's viewed as a steady revenue stream as developments allow scientists to find more way to prevent illnesses. Read more here.

This is the global drug delivery partnerships meeting place, focusing on bringing together professionals seeking the latest strategies, industry updates, and networking opportunities to help position your company for a successful partnership/collaboration. Join us today on LinkedIn or Follow us on Twitter!

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Mark McClellan, Carolyn Clancy, and Jim Greenwood to Keynote

Impending legislation coupled with new FDA initiatives, leave many companies wondering what to expect as we head into 2010. Join the Biopharm Regulatory Reform Summit as Steven Kozlowski, MD, Director, Office of Biotechnology Products, FDA discusses the challenges in establishing a regulatory pathway for biosimilars. Quality, patient safety, and efficacy are all primary issues the FDA must focus upon in the review and approvals for these complex biologics. Dr. Kozlowski addresses these issues in addition to comparative effectiveness and factors to consider for drug development plans for products in the pipeline. Bring home regulatory insights to challenges with defining “biosimilars” and their scope, biosimilars’ regulatory pathway, and the latest on comparative effectiveness.

Don’t miss the keynote presentations from Mark McClellan, Senior Fellow, Director of the Engleberg Center for Healthcare Reform, Carolyn Clancy, MD, Director, AHRQ, and Jim Greenwood, CEO, BIO.

Join the Meet and Greet session with Jacquelyn White, Director, Office of Strategic Operations and Regulatory Affairs, CMS

In an era of personalized medicine, IIR’s Biopharm Regulatory Reform Summit provides a unique opportunity to interact with industry thought leaders focusing exclusively on the true downstream effects of reform on how biopharm does business. Join senior leadership for two days to create actionable strategies to respond to reform, protect profitability, and deliver patient driven care for pharmaceutical, biotech and medical device executives.

2009 Faculty Highlights
• Dr. Mark B. McClellan, Senior Fellow, Director of the ENGELBERG CENTER FOR HEALTHCARE REFORM
• Carolyn Clancy, MD, Director, AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)
• Jim Greenwood, CEO, BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO)
• Joseph Antos, Health Adviser to the Congressional Budget Office, AMERICAN ENTERPRISE INSTITUTE FOR PUBLIC POLICY RESEARCH
• D. Bruce Burlington, MD, Pharmaceutical Product Development and Regulatory Affairs, Independent Consultant, former Executive Vice President Business Practices and Compliance, WYETH
• Jane Galvin, Managing Director, Regulatory Affairs, BLUE CROSS BLUE SHIELD (BCBS)
• Julie K. Letwat, JD, MPH, Government and External Affairs, TAKEDA PHARMACEUTICALS AMERICA
• Amy Miller, PhD, Director, Public Policy, PERSONALIZED MEDICINE COALITION
• Les Paul, MD, Vice President, Clinical and Scientific Affairs, NATIONAL PHARMACEUTICAL COUNCIL (NPC)
• Ian D. Spatz, Principal, ROCK CREEK POLICY GROUP and Senior Advisor, MANNATT HEALTH SOLUTIONS, formerly, Vice President, Global Health Policy, MERCK
• Dan Todd, Executive Director, Health Policy, EMD SERONO
• Myrl Weinberg, President, NATIONAL HEALTH COUNCIL
• Jacquelyn White, Director, OFFICE OF STRATEGIC OPERATIONS AND REGULATORY AFFAIRS, CMS

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MDRP Summit coming to Chicago this September!

Join us at Wyeth, Procter & Gamble and others at the MDRP Summit! Register by September 4 to Save $100!

The event has had a great response! Take a look at all the great companies who have already signed on to attend: Amgen, AstraZeneca Pharmaceuticals, Baxter International Inc, Eli Lilly & Co, Bayer Healthcare Pharmaceuticals, Sanofi Aventis and many others.

The MDRP Summit provides participants face to face access to CMS representatives who clarify your most pressing operational rebate compliance and policy questions, USDOJ officials who describe lessons learned from current Medicaid fraud litigations, NACDS staff who detail the AMP and AWP litigation, DoD representatives who share the new TriCare pricing schedule, as well as organized dispute resolution meetings facilitated by CMS, and much, much more.


Click below to join us!
Visit the Event webpage: http://bit.ly/kFe5m
Registration: http://bit.ly/ZH8ca

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Wyeth and the Medical Ghostwriters

The New York Times takes a look at the recent news out of Wyeth. According to the article, hidden industry influence on medical journals may be greater than previously expected. From 1998-2005, a journal article stated that taking hormones would increase the benefits and reduce the risks of skin cancer, heart disease and dementia. However, a federal study was stopped when the results were the opposite. There was a detailed paper train found that showed that Wyeth contracted with a medical publication company and wrote the information then had doctors sign their names with little or no contribution to the article. This is particular dangerous because these medical articles could change the way doctors persrcibe the medication. For a full look at the current ghostwriter claim against Wyeth, read the New York Times article here.

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Delivery of Biologics & Beyond

According to forecasting firm EvaluatePharma, six of the top ten drugs and half of the top 100 drugs in 2014 will be biologics. Predictions for biologic blockbusters include products from Roche, Wyeth, Amgen, Abbott, J&J and Schering Plough, with the top selling product being Roche’s anti-cancer antibody drug Avastin at $9.2 billion in annual sales. This analysis shows overwhelming evidence on how important biological drug development is to pharma pipelines. Pharmaceutical companies need faster and more efficient ways to formulate biologics and to further expand pipelines and competitive advantages with needle-free delivery.

Delivery of Biologics & Beyond, taking place September 23-25th in Boston, brings together senior-level scientists and technology/product developers to share the newest advances and address your most pressing challenges in formulating and delivering biologics and nucleic acids. Explore the latest case studies, discover the drug delivery technology advances for needle-free delivery of large molecules, and establish what technologies hold the most promise for advancing your biologics and RNAi pipelines.

If you'd like to network with other individuals in the space of Biologics, join our LinkedIn group here.

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Wyeth seeks FDA approval to market Prevnar 13

Wyeth created the world's first blockbuster, billion dollar vaccine when it launched Prevnar-7 in 2002, a testament to vaccine profitability in the current market. Prevnar 7 has been credited in massive worldwide reduction of pneumoccal disease, including meningitis and blood infections. Currently, they are filing for Prevnar 13 approval. Prevnar 13 guards against the same seven common strains of strep bacteria that the currently used vaccine protects against. And it adds six new strains that also are appearing regularly around the world. One of those strains is 19A, a growing threat that can often be resistant to antibiotics. Prevnar 13 also expands its patient base to protect adults, as Prevnar 7 is limited to use in children.

Wyeth will be giving a case study about their development strategy at the Vaccines Development Forum, May 6-8, in Boston. Wyeth, along with 20 other leading vaccine developing companies, will be giving case studies on their successful development strategies at the event. Don’t miss out- register today at www.iirusa.com/vaccines to unlock the most efficient ways to bring your vaccines to market. Interested in networking? Join the Linked in group today http://www.linkedin.com/groups?gid=57105

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