The rising number of the research and development activities for the pipeline drugs acts as drivers for the cytomegalovirus infection therapeutics pipeline. The prophylaxis treatment of cytomegalovirus is also increasing due to its effective and safe treatment. The U.S. Food and Drug Administration (USFDA) and European Medicines Agency (EMA) are supporting the cytomegalovirus infection therapeutics pipeline by encouraging the drug development process through different types of designations. The pipeline is being driven by different factors such as increasing awareness regarding the cytomegalovirus infection treatment, high demand for safe and effective medications, technological advancements and increasing prevalence of the cytomegalovirus.
According to Centers for Disease Control and Prevention, cytomegalovirus, is a common virus that infects people of all ages. Over half of adults by age 40 have been infected with cytomegalovirus. Once cytomegalovirus is in a person's body, it stays there for life and can reactivate., with a major number of people infected with cytomegalovirus showing no signs or symptoms of the disease. However, cytomegalovirus infection can cause serious health problems for people with weakened immune systems, as well as babies infected with the virus before they are born. When a baby is born with cytomegalovirus infection, it is called congenital cytomegalovirus infection. About one out of every 150 babies are born with congenital cytomegalovirus infection. However, only about one in five babies with congenital cytomegalovirus infection will be sick from the virus or will have long-term health problems. In some cases, infection in healthy people can cause mild illness that may include fever, sore throat, fatigue and swollen glands.
In pipeline drugs, Chimerix Inc., is developing brincidofovir, a Phase III product of a nucleotide analog lipid conjugate. Brincidofovir is an oral and intravenous formulation which blocks replication of double-stranded DNA viruses. Chimerix is developing the compound for dual use as a medical countermeasure in the event of a smallpox release and as a broad-spectrum antiviral for the treatment of diseases in immunocompromised transplant and cancer patients. In April 2016, the European Commission granted orphan drug designation to brincidofovir for the prevention of cytomegalovirus infections. The U.S. FDA also granted a fast track designation to brincidofovir for the prevention of cytomegalovirus infections in March 2013.
In December 2015, the NIH has awarded grants of $3.6 million to the researchers from Louisiana State University to support two studies of human cytomegalovirus. Half of the funding was allotted to research that aims to analyze the movement of the virus, while the rest was designated for studying the mechanism of the virus in altering white blood cells. Therefore, grant and other funding has been driving the pipeline growth. However, complex mechanism of action of the disease, high cost of treatment and the side effects associated with the treatment act as key barriers hindering the growth of the pipeline.
Some of the companies having a pipeline of cytomegalovirus infection therapeutics include Biotest AG, Merck & Co., Inc., Chimerix Inc., Astellas Pharma, Inc., CSL Behring, Cell Medica Ltd., GlaxoSmithKline plc, Pfizer, Inc., F. Hoffmann-La Roche and AstraZeneca plc.