EDMONTON, April 26 /PRNewswire/ - Compass Biotechnologies Inc. (OTCBB: COBI) is focused on the development and commercialization of generic, biosimilar and bio-better therapeutic products. In continuation of executing on its business plan, the Company is pleased to announce an agreement to develop a heat stable Hepatitis B vaccine formulation based upon acquiring a worldwide exclusive license from ARECOR Ltd. (Cambridge U.K.), using its proprietary Arestat™ formulation technology.
Globally Hepatitis B virus (HBV) causes about 4 million new infections per year. Of the over 350 million chronic carriers of HBV worldwide, 25% are expected to die within the next 5 to 25 years because of liver disease complications caused by the HBV infection. In the USA more than 620,000 will die from Hepatitis B liver-related disease within this same period.
The market for current prophylactic vaccines against hepatitis B is estimated at $800 million, while the global 2010 travel vaccines market was estimated to be worth $2.7 billion. By 2017, the travel vaccines market is estimated to reach $6.6 billion, indicating a CAGR of 13%. None of these vaccines are heat stable and if improperly stored they can lose their effectiveness in a short period of time.
According to the World Health Organization (WHO), global immunization against Hepatitis B is estimated at only 60%. Areas with high rates of infection such as S.E. Asia have coverage of only 28%, while Africa has 49% and the Americas 89%. One of the main constraints in achieving higher immunization targets is maintaining proper refrigeration of the vaccine product. The use of a heat stable Hepatitis B vaccine has the potential to increase the availability and the immunization coverage. Also this strategy may avoid problems with freezing, noted to be one of the primary cold chain problems threatening vaccine integrity.
Currently most protein based drugs need to be kept refrigerated in order to ensure their stability and effectiveness. Arestat™ is a formulation technology that stabilizes proteins to prevent the loss of their biological activity when stored under non refrigerated conditions. The development of a heat stable Hepatitis B vaccine able to be stored at room temperatures will create a large market opportunity and expand the use of this vaccine not only in the developed markets but in those markets where keeping a vaccine under refrigeration is impossible.
Studies with the Arestat™ heat stable formulation of Hepatitis B vaccine have demonstrated:
- greater than 70% potency being retained after 12 months of storage at 37°C (98.6°F).
- that the Arestat™ heat stable vaccine proved to be just as effective after the 12 months storage at 37°C (98.6° F) when compared to it being stored at refrigeration temperatures.
- In contrast, a commercially available Hepatitis B vaccine completely lost its effectiveness and showed a 100-fold drop in the anti-hepatitis B titer when stored at 37°C. (98.6° F)
"Arecor has successfully applied Arestat™ to a wide number of therapeutic proteins and vaccines to minimize degradation in storage. Arestat™ provides enormous benefit to patients in both developed and developing countries by providing assurance of potency despite potential mishandling or lack of refrigeration," said Thomas Saylor, CEO of Arecor Limited.
Dr. Joseph Sinkule, a Director and Co-Founder of Compass Biotechnologies, agreed, saying, "Current Hepatitis B vaccines require refrigeration and a cold chain to maintain stability and viability, yet freezing must also be avoided. Transportation, storage, and delivery to the end user require an intact cold chain, which is difficult and exceedingly costly to maintain. Successful development of heat stable vaccine products will simplify vaccine storage and delivery, reduce waste, and improve vaccine availability."
"We are very pleased to be partners with ARECOR and will proceed immediately to complete a definitive licensing agreement for this important product," commented Mr. Garth Likes, CEO of Compass Biotechnologies. He went on to say, "C-Pharma, our wholly-owned subsidiary company, will be responsible for development of the heat stable hepatitis B vaccine as the product lies within our ongoing strategy to develop a comprehensive Hepatitis franchise. We will obviously look at other heat stable formulations for products within Compass as well."
About Compass Biotechnologies
Compass Biotechnologies (COBI: OB) is an Edmonton based biotechnology company focused on generic, biosimilar and bio-better product development. From a development perspective, these types of products have lower development costs and lower development risk due to well-established mechanisms of action, a known safety profile, with broad clinical indications for physician use. Comparability testing in preclinical and clinical trials will be needed to show the added benefits of the biosimilar and bio-better drug product.
The Company has recently signed with PanGen Biotech for a manufacturing/supply agreement for development of various biologically-active pharmaceutical ingredients for development of biosimilar and bio-better drug products. Compass has also recently announced a $10 million financing agreement to further our product development programs. The agreement with Arecor will now allow us to differentiate our biosimilar products from others and to commercialize and develop novel, patented bio-better vaccines and drug therapies.
About ARECOR Ltd.
Arecor Limited was established to provide formulation solutions to pharmaceutical and biotech companies developing drugs, vaccines, medical devices and diagnostics. Arecor has developed Arestat™, a patented set of tools for stabilization, to enable the presentation of labile biologicals as stable aqueous formulations even at high concentrations or in situations where cold storage is not practical or desirable. Arestat™ has shown to successfully address the major pathways of degradation including aggregation, hydrolysis, oxidation and deamidation. As a simple reformulation, Arestat™ can be readily incorporated into standard manufacturing practice, without covalent modification of the biological and using excipients approved for the route of delivery. Arecor currently has active feasibility programs and licenses with many of the top pharmaceutical and biotech companies on a wide range of proteins and vaccines.
Compass has a private wholly-owned subsidiary company called C-Pharma Inc. The Company is charged with the creation of a Hepatitis product(s) franchise. C-Pharma acquired the rights to a novel vaccine technology which is currently being developed for Hepatitis C applications. This technology was developed at the National Institutes of Health (NIH) and licensed to the Company on a worldwide exclusive basis. In addition C-Pharma is developing its own generics for two anti-hepatitis drugs known as ribavirin and pegylated alpha interferon. These two drugs are used in patients who are chronically infected with the Hepatitis and in combination are the current standards of care for Hepatitis disease. These two drugs exceed over $2 billion a year in sales worldwide.
This news release contains "forward-looking statements", as that term is defined in Section 27A of the United States Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this current report which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainty of financial estimates and projections, the competitive and regulatory environments, stock market conditions, unforeseen technical difficulties and our ongoing ability to operate a business and obtain financing. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that our beliefs, plans, expectations and intentions contained in this current report are reasonable, there can be no assurance that such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our quarterly reports on Form 10-Q and our other periodic reports filed from time-to-time with the Securities and Exchange Commission pursuant to the Securities Exchange Act.
SOURCE Compass Biotechnologies Inc.