First of all, on behalf of  the entire BioHorizon staff, let me welcome you to the BioHorizon Health Technology Surveillance Update.  Long time clients  and readers will remember that Surveillance Updates last graced these pages in 2005-2006 and based on your feedback we have changed the focus of this feature to better meet your needs -  we hope you  agree!

Lets start by turning our attention to  FDA approvals of note in January and February 2010.  On January 11th, Genentech Inc.’s rheumatoid arthritis therapy, Actemra (tocilizumab),  was approved for treatment of adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes  for this disease.  Serious safety concerns associated with this interleukin-6 blocker were cited as the basis for the FDA’s requirement for a post-marketing clinical trial to evaluate long term safety as well as a Risk Evaluation and Mitigation Strategy that directs Genentech to implement a communication plan for prescribing physicians detailing the appropriate approach to obtaining informed consent and side effect monitoring.

Acorda Therapeutics’ Ampyra (dalfampridine) extended release tablets were approved on January 22nd, to improve walking in multiple sclerosis patients representing the first drug approved for this use.  The FDA cautioned that Ampyra can cause seizures when given at greater than recommended doses. 

Turning to medical devices for a moment, Thoratec Corp.’s HeartMate II Left Ventricular Assist System was approved on January 20th for severe heart failure patients who are not acceptable transplant candidates.  The HeartMate II was already approved for certain patients waiting for complex medical treatments including transplants.   The FDA directed Thoratec to conduct a post-approval study to further characterize the device’s performance.

 On January 25th,  Novo Nordisk Inc got the nod for Victoza (liraglutide (rDNA) injection) the company’s once daily GLP-1 receptor agonist which is indicated for treatment of type 2 diabetes in adults and joins Eli Lilly’s twice daily Byetta in the injectable GLP-1 agonist class.

GlaxoSmithKline’s Tykerb (lapatinib) got an expanded indication from the FDA on January 29, and can now be used in combination with the Novarits product Femara (letrozole) in the treatment of hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

And finally, on February 2nd the FDA approved Auxillium Pharmaceuticals’  injectable Dupuytren’s contracture therapy, Xiaflex (collagenase clostridium histolyticum) – this is the first FDA approved non-surgical therapy inidicated for this progressive hand disease. 

We encourage our readers to visit www.fda.gov as well a company or product specific website for more details, in subsequent weekly updates we will begin to include some discussion of interesting clinical trial results from the week that was in additon to setting the table for the next week in emerging health technology.  Thanks for reading.

Since its approval in the United States in 2000 Wyeth’s Prevnar vaccine against pneumococcal disease has helped to transform what was thought of as a mature, marginally profitable segment of the pharmaceutical business into a much more dynamic and profitable one. Prevnar has proven to be both effective and innovative while filling an unmet need in the prevention of serious pediatric infections caused by the pneumococcal bacteria. According to CNN Money.com, Prevnar sales surged 24% in 2007 to $2.4 billion, making it the first vaccine to exceed $2 billion in annual sales.

Prevnar has been the only conjugate pneumococcal vaccine available to immunization programs and clinicians throughout North America and European Union looking to prevent pneumococcal disease. However, GSK’s new 10-valent conjugate pneumococcal vaccine (Synflorix) could soon start changing this.

There are two significant differences between Synflorix and Prevnar that our readers should be aware of. First, Prevnar contains antigen from seven different serotypes of pneumococcal bacteria while Synflorix contains antigen from ten different types. The second difference is in the carrier protein that these polysaccharide antigens are attached to. In Prevnar the protein is called CRM-197 and it has been critical in the success of Wyeth’s product. The carrier protein is more than a passive molecule, it greatly enhances the immunogenicity of the vaccine and makes it more effective. In Synflorix, the carrier protein (NTHi) not only does this, but because it is derived from non-typable Haemophilus Influenza bacteria, provides protection against infections with this pathogen as well. GSK has filed for Synflorix approval in the EU and the vaccine has recently been approved for sale in Canada but we have no word on when or even if approval will be sought in the United States.

The story does not end here as Wyeth is countering with an enhanced version of Prevnar that contains protection against thirteen different serotypes of the pneumococcal bacteria and has filed for approval in both the United States and the European Union.

There are some fundamental questions that need to be explored further concerning the safety and effectiveness of these new vaccines, the changing epidemiology of pneumococcal disease, and of course the cost-effectiveness data that is all important to vaccine program planners. Readers should stay tuned as we plan to explore these crtical areas in the coming days. Thanks for joining us today on the BioHorizon.