Wyeth vs. GSK: A Vaccine Showdown?

tim — Sun, 11 Jan 2009 23:41:02 +0000

Today Biohorizon will take its first look at two new vaccines that promise to make the prevention of pneumococcal disease far more interesting and complex. Both Wyeth and GSK have advanced emerging pneumococcal conjugate vaccine candidates to the filing stage in either the United States, European Union or both. In an effort to understand and scope out some of the questions and controversies surrounding these biologics we need to review a little bit of history…

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.

Wyeth’s Enbrel for treatment of Psoriasis

admin — Fri, 30 Jul 2004 18:30:23 +0000

On July 30, 2004 Wyeth reported that a European Commission panel had recommended that regulators approve Enbrel as a treatment for psoriasis after other treatments were found inadequate or inappropriate. The Committee for Medicinal Products for Human Use will report its findings to the European Commission for endorsement before Enbrel can receive marketing approval. Wyeth is responsible for marketing Enbrel outside North America and co-promotes the drug with Amgen Inc. in North America. The company is recommending the approval of Enbrel, also a treatment for rheumatoid arthritis, for the treatment of adults with moderate to severe psoriasis when phototherapy or systemic treatments have been inadequate or are inappropriate. According to Wyeth, a study of more than 1,200 plaque psoriasis patients showed that the drug lead to a rapid and significant clearing of skin lesions and improvement in quality-of-life scores compared with placebo. This most recent approval adds to Enbrel’s previously FDA approved indications of Psoriasis, Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis.

Enbrel is a protein that is thought to exert its action through the binding and subsequent inactivation of a naturally produced cytokine known as Tumor Necrosis Factor (TNF). TNF is produced by the body’s immune system. In patients with psoriasis and other autoimmune diseases, certain immune cells increase production of TNF. This increased TNF activity is thought to be critical in mediating the overactive immune response that causes the tissue damage that is a hallmark of psoriasis and rheumatoid arthritis. Amgen has indicated that approximately 234,000 patients have already been treated with Enbrel worldwide. Amgen reports total sales of Enbrel for 2003 in the 1.3 billion dollar range.

The true incidence of psoriasis in the United States is difficult to determine. Estimates of prevalence suggest that approximately 4.5 million people are affected by psoriasis with approximately one third of these suffering from the ‘plaque’ type of the disease. Psoriasis is characterized by the development of red, itchy skin plaques that are often painful and disfiguring.

Enbrel satisfies all BioHorizon criteria for High Impact Technologies: it is an innovative therapy, it has diffused rapidly, it has demonstrated efficacy in clinical trials, and with this most recent approval, it is indicated for more prevalent conditions. In light of the psoriasis indication, clients should begin or revisit assessment activities at this time.

Technology Details
Target Disease / Indication: Psoriasis
Technology Classification: Drug
Body System: Dermatologic
Program Area: Medicine/Infectious Disease
Regulatory Status: Phase III
BioHorizon Impact Score: 63/100-Moderate/High Impact

BioHorizon » Wyeth

Wyeth vs. GSK: A Vaccine Showdown?

Wyeth’s Enbrel for treatment of Psoriasis