Compass Biotechnologies Inc (formerly Cyplasin Biomedical Inc)** is a public bio pharmaceutical company (COBI.OB) focused on the commercialization of life-saving products targeted on the multi-billion dollar generic, biosimiliar and bio-better markets. Our mission is to bring to market therapeutic drugs which are either at a lower price point (generics) or those which offer superior quality (biosimiliars) or enhanced drug properties (Bio Betters)products.
Compass Biotechnologies (COBI:OB)
The Company’s near-term plans are to submit market applications in multiple countries for Compass’s generic, biosimiliar and bio better products as well as to complete C-Pharma’s antiviral generic drugs and to complete Phase I safety, immunology & efficacy studies of the HCV vaccine in humans. The two Companies together will create value by achieving major developmental milestones, by generating revenue from the sales of drug products and obtaining proof in humans that VLP vaccine immunization leads to development of neutralizing antibodies that attack the HCV virus and prevent infection.
The Company will continue to advance the development of other anti-viral pipeline products and we plan to begin Phase I safety studies of the VLP vaccine as a potential anti-viral immunotherapy for treating chronicHCV infection. An antibody product derived from healthy volunteers administered VLP vaccine inoculations will be evaluated as a passive immunotherapy product in patients undergoing liver transplantation to prevent or significantly delay the liver graft re-infection by the hepatitis C virus.
Competitive Strategy
It is not our intent to compete with drug companies. Rather, we focus on strategic alliances, joint ventures and other strategies to execute the required pre-clinical, early clinical stage trials to get a product licensed out to commercialization partners.
Regulatory Situation
Of the developed regions, only Europe has an established regulatory approval system for biosimilars. Currently the global market for biosimilars is valued at $243.8m in 2009 and is expected to increase to $4,697m in 2016 at a compound annual growth rate (CAGR) of 52.6%.
Of the developed regions, only Europe has an established regulatory approval system for biosimilars. So far, over 10 biosimilars have been approved in Europe. In Japan, draft guidelines were published in September 2008. In November of that year, Kissei Pharmaceutical filed an application for an erythropoietin product as Japan’s first biosimilar. In the US, a legislative pathway is in sight. The European Commission created its legislative framework in 2004 and the European Medicines Agency (EMEA) issued general guidelines for applications in 2005. The agency has also published product-specific guidelines for certain types of biologics. Based upon extensive public consultation in a process that included key stakeholders, the success of this approach helps to demonstrate that a system for approval of biosimilars can be effective. The requirements for biosimilars are extensive when compared with small-molecule generics. However, they do not include full Phase III clinical trials and thus offer an abbreviated pathway for approval.
In the US, legislation has been under discussion since 2007. A key point of contention is the length of exclusivity provided for innovator drugs. Currently the global market for biosimilars is valued at $243.8m in 2009 and is expected to increase to $4,697m in 2016 at a compound annual growth rate (CAGR) of 52.6%. The market will be driven by increasing pressure on US and other governments to control rising healthcare expenditures by establishment of abbreviated regulatory approval pathway for biosimilars.
While the approval pathway still isn’t in place, many regulatory experts expect the US government to issue the guidelines by mid-2011 after a meeting that was held on biosimilars by the US Food and Drug Administration in February. The US market is especially expected to gather momentum after the launch of biosimilar monoclonal antibodies elsewhere.
About Generic Drugs
The term “generic” has several meanings when used regarding drugs. Simply put a generic drug generally refers to an off patent small molecular or chemical compound drug that is usually an exact duplicate of another “branded drug.” For example Diazepam which is the generic name of a sedative is marketed by some companies under its generic name and by other companies under brand names such as Valium or Vazepam. Generic drugs marketed without brand names are generally less expensive than brand-name drugs, even though they are chemically identical to brand-name drugs and meet the same standards of the FDA (US Food and Drug Administration) for safety, purity and effectiveness.
The global market for generic drugs was worth globally $81 billion in 2008, a figure expected to climb to $168.7 billion by 2014. Sales of U.S. generic drugs were estimated to be $33 billion in 2009 and are to grow to $54 billion by 2014. Japan is currently the world’s second largest generic market behind the US. In a market this big there are major competitors such as TEVA Pharmaceuticals, as well as multiple midsized and smaller players.(see Competitors)
Biologic Drugs are large-molecule drugs based on proteins. Biosimilar Drugs (or follow-on biologics): are “copies” of biologic drugs that have lost patent protection. They are distinguished from small-molecule generic drugs because of their size and complexity and that they are produced from living cells as compared to generic drugs; which are produced in a test tube. The global biologics and biosimiliars market is valued at an estimated $149 billion in 2010 and is expected to reach $239 billion by 2015, a compound annual growth rate (CAGR) of 9.9% from 2010–2015. These numbers are being driven by the fact that more than 30 branded biologics with sales of $51bn are set to lose their patent protection in the next few years. In addition the EU regulatory framework is in place to address the safety of biosimiliars and thus the opportunity presented by these products has been proven.
Bio Better Drugs are next-generation products that will increasingly compete with first-generation biological products in the market. Bio Better drugs offer defined benefits over the first-generation products while biosimiliars simply attempt to copy the first generation biologic products. Bio Better companies need to specifically formulate biologic drugs to turn them into Bio Betters. Because Bio Betters have superior properties at lower price points these new products are likely to be readily accepted by end-users, and could match — or even exceed — the first generation products in terms of revenue-earning potential.
**NOTE: The Company has recently completed a name change (formerly Cyplasin Biomedical Ltd.) to Compass Biotechnologies Inc (COBI:QB) to better reflect it new market strategy and Corporate mission.
Products and Product Candidates for COMPASS Representing a potential $239 billion market by 2015:
Top-selling biological drugs facing biosimiliar competition in the next few years and for which Compass Biotechnologies can acquire manufacturing rights for (ranked in descending order).
erythropoietins insulins etanercept interferon-beta G-CSFs coagulation factors enoxaparin human growth hormone interferon-alpha imiglucerase goserelin somatostatin cyclosporine dornase alfa tenecteplase calcitonin rHepB vaccine desmopressin botulinum toxin type A GM-CSF IL-2
COBI share structure per TA outstanding shares 20,655,629 Float: N/A Authorized shares 100mil On May 17, 2011, the shareholders' list showed 91 registered shareholders
$COBI Patents
COBI currently have the rights to the following patents in the US and in Europe with other territories: Patent(s) or Patent Application(s): entitled "Synthesis and Purification of Hepatitis C Virus-Like particles" (PHS Ref. E-009-1997/0). source 10K
RECENT NEWS COBI Friday, May 27, 2011 Dr. Joseph Sinkule Named as President and Chief Operating Officer of Compass Biotechnologies, Inc.(COBI:OB)PR Newswire (Fri 8:15AM EDT) http://biz.yahoo.com/prnews/110527/to755.html?.v=1
The Company’s management team, advisors and consultants possess a deep knowledge of the Company’s products and indications, and strong start-up company management experience. The Company currently operates through a system of nominal in-house officers and larger more accessible external consultants. The philosophy is to spend financial resources on the required product development and logistics as opposed to salaries. This approach also allows a younger company to avail itself of needed expertise required at each point or stage.
Garth Likes Chief Executive Officer and Chairman, Garth Likes is the founder and CEO of Compass Biotechnologies and of C-Pharma In, Hehas served as CEO and Board member of several public companies and been with the Comapny since its inception in 2007.
Previously Mr. Likes has held positions in large multinational companies and small start-ups. Garth brings considerable knowledge, expertise and energy to Compass and has the industry experience to successfully navigate the Company through financings, corporate operations, and overall management of this public company entity.
Dr. Joseph Sinkule Founder / Director Dr. Joseph Sinkule is a serial entrepreneur and a 28-year biotech veteran with extensive biotech start up experience. Joe has taken several drug and recombinant protein products from discovery thru FDA approval and licensure. He was previously Sr. VP of R&D at a NASDAQ-listed biotech company and Director of Clinical Research at Immunex. Joe founded five other biotech companies and two CROs, and currently serves on the Boards of four healthcare companies.
Mr. Garth Likes, President/CEO glikes@compassbio.net Compass Biotechnologies /C-Pharma Inc. Advanced Technology Center 9650-20th Avenue, Suite 131 Edmonton, Alberta, Canada Phone (780) 990-4539
06.08.2011 (290 Days Ago)
