Previously we took a look at the late-stage pipeline for diseases that are already vaccine-preventable. Now, we're examining the drugs in development for diseases that are not yet available for treatment--vaccines that, if approved, could put an end to some of today's most challenging diseases and end up as blockbusters a decade from now.
The list of vaccine-preventable diseases stands at 26, representing a major advancement in the quality of human health. Diseases like smallpox, polio, diphtheria and rubella have been defeated, while other widespread diseases have been reduced to just a few cases a year. And there are many more vaccines in drugmakers' pipelines that may be on course to eradicate some of today's most difficult-to-treat illnesses. In Kalorama Information's report on the future of emerging vaccines, the group estimates that by 2020, emerging vaccines could account for $24.7 billion in new sales. Though sales of vaccines totaled less than two percent of the $800 million pharmaceutical market, the group thinks that slice of the pie will increase as technology advances bring about safer, more effective vaccines for a broader range of diseases.
The near-term, Phase III vaccine pipeline features potential treatments for addiction, allergy, diabetes and a number of infectious diseases. This list does not include cancer vaccines in development, as they will be covered in a separate report.
Phase III vaccines in development
Disease Company Drug Name Priority Smoking Addiction Nabi Biopharmaceuticals NicVAX High Grass Allergy ALK Abello GRAZAX Moderate Grass Allergy Allergy Therapeutics Pollinex Quattro Grasses Moderate Ragweed Allergy Allergy Therapeutics Pollinex Quattro Ragweed Moderate Grass Allergy Fornix Biosciences Oralgen Grass Pollen Moderate Grass Allergy Greer Labs Sublingual-oral immuno-therapy Moderate Grass Allergy Paladin Labs Oralair Grasses Moderate Pollen Allergy Schering-Plough/Merck Allergy Immunotherapy Tablet Moderate Dengue fever Sanofi Pasteur ChimeriVax High Diabetes Diamyd Medical Diamyd High ETEC infection Intercell Travelers' Diarrhea vaccine patch Moderate Herpes virus GlaxoSmithKline Simplirix Moderate Leishmaniasis Tehran University of Medical Sciences Alum-ALM High Malaria GlaxoSmithKline Mosqurix High Shigellosis Eunice Kennedy Shriver National Institute of Child Health and Human Development N/A High
But this is a look at just the late-stage pipeline. There are many more products in Phase I and II being developed for a wide range of conditions. Using the information provided by Kalorama, we've selected some of the most intriguing vaccine programs in the pipeline--programs that treat unmet medical need and, if approved, stand to become bestselling vaccines by 2020.
Alzheimer's is caused by the irreversible loss of nerve cells in brain areas, leading to losses in thought, memory and language. Though a number of companies are working on an Alzheimer's vaccine, Cytos Biotechnology's Phase II CAD106 is the most advanced. AFFiRiS, Merck, Oklahoma Medical Research Foundation and United Biomedical are all pursuing an Alzheimer's vaccine, which could have a potential market of $1.15 billion by 2020.
A lethal hemorrhagic fever found in Africa, Ebola can kill 50 to 89 percent of the people who contract it. NIAID has a Phase II program for the disease in the works; National Microbiology Laboratory (Canada) and the Southwest Foundation for Biomedical Research have Phase I research projects underway. A preventative Ebola vaccine could be worth $400M a year by 2010
Hepatitis C and E
All strains of hepatitis attack and destroy the liver, leading to infection, cirrhosis and possibly cancer. Intercell and GlaxoSmithkline have Phase II programs for hepatitis C and E, respectively. The combined market for a preventative hepatitis vaccine is projected to hit $2.3 billion.
Hypertension, or high blood pressure, would represent a $2.4 billion vaccine market by 2020. Cytos Biotechnology's CYT006-AngQb and an unnamed drug from Protherics are both in Phase II for the disease.
An HIV/AIDS vaccine has been one of the most sough-after preventative treatments since the disease was first identified in the 1980s. Sadly, the development field has been littered with failure. Crucell, GSK, Mymetics and Novartis are all working on Phase I programs, but Bavarian Nordic's Phase II MVA-BN HIV is the most advanced.
Methicillin-resistant Staphylococcus aureus is a bacterium responsible for several difficult-to-treat infections in humans. It is often contracted in hospital or community settings and is extremely hard to treat, even with powerful antibiotics. Kalorama notes that more people in the U.S. die from MRSA infections than HIV/AIDS, emphysema or homicide. Merck has a Phase II product in the works for MRSA, while GSK's PentaStaph vaccine is in Phase I testing. 2020 sales are estimated to hit $650 million.
MS is an autoimmune diseases in which the immune system attacks the brain and spinal cord. Approximately 5 million people worldwide suffer from the disease, which causes muscle problems and a wide range of neurological issues. Bayhill Therapeutics' BHT-3009 and Opexa Therapeutics' Tovaxin and both in Phase II trials. The 2020 MS vaccine market could hit $1.1 billion.
Obesity is a growing epidemic in America. Braasch Biotech is currently conducting preclinical research on an unnamed vaccine for the disease, and Kalorama estimates the 2020 market could be worth $900 million.
Like Alzheimer's research, drug companies have been largely unsuccessful at creating a drug to treat Parkinson's--a neurological condition caused by the the degeneration of nerve cells in the brain (neurons) that produce the neurotransmitter dopamine. AFFiRiS is developing a Phase I vaccine for the condition, which affects up to 30 million people worldwide.
A stroke occurs when a blood vessel bursts or is clogged, depriving the brain of essential blood flow. It's a leading cause of long-term disability, and in the U.S., 160,000 die of strokes each year. JN International Medical Corp. has an unnamed vaccine for stroke prevention in its Phase I pipeline.