Naperville, IL -- (SBWIRE) -- 02/20/2013 -- Cytomegalovirus (CMV) Infections - Analysis and Market Forecasts to 2019, studies cytomegalovirus (CMV), which is generally asymptomatic in healthy children and adults, but can manifest as a mild infection. Following primary CMV infection, the latent virus can reactivate under favorable conditions as a secondary CMV infection. More serious problems develop in congenital CMV infection, which can cause serious disease symptoms and neurological disabilities. Immuno suppressed individuals can also suffer serious diseases from CMV, such as pneumonitis, hepatitis, pancreatitis, gastritis and colitis. HIV positive individuals, organ transplant patients, bone marrow transplant patients and stem cell transplant patients, as well as patients taking immuno suppressants, are at risk of clinically significant CMV disease.

Roche’s Valcyte is currently the only branded product for the treatment of CMV infections, but the impending loss of patent protection will overturn this market dominance. Valcyte is the standard of care for both CMV retinitis treatment and CMV disease prevention in high-risk kidney, heart, or kidney pancreas transplant patients, and its oral administration leads to good compliance rates. However, Valcyte is associated with serious adverse events, and has a black-box warning for blood toxicity in clinical studies, and carcinogenicity, birth defects and impairment of fertility in animal studies. Valcyte’s patent will expire worldwide in 2015, but generic company Ranbaxy challenged Valcyte’s patent in the US in 2010, and after a series of legal battles Ranbaxy is allowed to launch its version of the product in 2013, almost two years before the patent expires.

Aside from Valcyte, the market is completely dominated by generics such as ganciclovir, foscarnet, US biologic CMV-IG, and off-label drugs such as acyclovir and valacyclovir. All have low efficacy and safety profiles, offering little competition to the market leader. However, Valcyte will face strong competition with the launch of the TransVax vaccine.

The CMV development pipeline is strong, with 49 molecules in development, and a big focus on prophylactic products, which account for 40% of all pipeline products. Late-stage pipeline First-In-Class (FIC) vaccine TransVax is expected to have a significant impact on the future market landscape, as the first plasmid DNA vaccine developed for CMV prophylaxis in both the US and Europe. It has received orphan drug designation from the US Food and Drug Administration (FDA), and is expected to enter the market in the US in 2016. Transvax has shown improved clinical safety and efficacy, and is expected to raise market competition

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