Tis the Season, For the Flu

CenterWatch reported in June that sales for vaccines were projected to double to $39 billion by 2013. A segment of the vaccine market, the influenza vaccine, gets a lot of attention with the onset of winter in the Northern Hemisphere. To prepare, the FDA at the end of July issued its approved vaccines and their manufacturers for the 2010-2011 influenza season in the United States. They are as follows: Afluria, CSL; Agriflu and Fluvirin, Novartis Vaccines and Diagnostics; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical; FluMist, MedImmune Vaccines; and Fluzone and Fluzone High-Dose, Sanofi Pasteur.

According to a VisionGain "Influenza Vaccines Market Outlook 2010-2020" report, 2010 and onward will feature increased sales of influenza vaccines. Novel vaccines are expected to boost the pharmaceutical industry for many reasons. For example, unlike other drugs and biologics in development, influenza vaccines are important in both developed and developing nations. For the developing countries, all infectious diseases remain high on the healthcare agenda.

Influenza by Phase

According to figures based on PhRMAs Medicines in Development report, there are currently 37 vaccines in development for various strains of influenza. Last year, the concern over the H1N1 virus spurred development for a vaccine. In addition, preparing for a global pandemic of influenza has led governments to stockpile antivirals as a core strategy, according to Market Research Media. Specifically, the report stated that since the outbreaks of bird flu in 2005 and the swine flu in 2009, the stockpiling of antirvirals has increased, and "migrated across all branches of the healthcare systems and sub systems." The size of antirviral pandemic stockpiling spending has grown faster than the market overall.

For clinical trials professionals involved in the design of an influenza vaccine or a drug affected by seasonality, there are a number of factors to consider. These were highlighted in a January 2010 article in Applied Clinical Trials and include:

• Recruitment planning: drugs that require enrollment as soon as a disease is diagnosed, such as influenza, require rapid recruitment and enrollment. Site selection would involve sites that could handle larger number of patients in a shorter time frame.

• Regional profiles in global trial planning: peak incidence and peak timing of the indication for these different regions, as well as variations in hemisphere.

• Study start-up: should be carried out in phases, to give priority to the peak area regions/countries and rolled out accordingly.

• Feasibility studies: these should include a review of the incidence of disease in previous season for the sites/regions.

Phase II

• BiondVax Pharmaceuticals, an Israeli biopharmaceutical company has begun to immunize subjects in a Phase IIa clinical trial of its Universal Flu Vaccine candidate Multimeric-001. The Phase IIa study is a randomized, double-blind, placebo-controlled, multi-center, safety and immunogenicity study in 200 healthy volunteers being conducted at two clinical research centers in Israel. The company expects results by mid-2011. The study has a www.clinicaltrials.gov identifier of NCT01146119.

Approved

• Daiichi Sankyo received approval to manufacture and market Inavir® for the treatment of influenza in adults and children in Japan. Inavir is Daiichi Sankyo's brand of laninamivir octanoate, also previously known as CS-8958. This is the first drug of a new class of long acting neuraminidase inhibitors (LANIs) to address the limitation of current products, which require daily or more frequent dosing. Inavir is an antiviral, not a vaccine, and was developed under a co-ownership agreement with Biota Holdings, which will receive royalties on all sales in Japan. It has a clinicaltrials.gov identifier of NCT00803595.