Biomonitor operates in the biopharmaceutical market as a key enabler and theranostics solution provider both in terms of product development and disease management.
The term theranostics describes the use of testings to diagnose diseases, choose the correct treatment regimen and monitor patient responses to therapy. Theranostics is key to improving the efficacy of drug treatment by helping physicians identify patients who are best candidates for the treatment in question.
The emerging theranostics sector remains largely untapped, but the movement towards individualized medicine and focus on elimination of unnecessary treatment of patients resulting in significant drug cost savings for these patients, is boosting the sector in these years. The European Diagnostics Manufacturers Association (EDMA) forecasts the theranostics market will grow by 20% per year until 2009 and many of the major diagnostics companies have invested heavily in this dynamic sector.
The key factors fuelling the growing demand for theranostics are:
- Aging population.
- Significant unmet needs across major disease areas.
- Rapidly growing number of patients being treated with biopharmaceuticals, particularly in the area of inflammatory conditions.
- Rapidly growing number of biopharmaceuticals entering market.
- Theranostics enabes drug development.
- Greater push for personalized medicine.
- Increased push from regulatory authorities.
- Increased healthcare spending in emerging markets.
The biotechnology revolution in the pharmaceutical industry has brought to the market a large number of protein-based therapies, which must be injected into the patient for optimal efficacy. Biopharmaceutical therapies are basically characterized by large molecules that have very specific and narrow disease management capabilities and are injected into the human body. The biopharmaceutical market is significant with 9-digit sales figures and double digit growth rates that are expected to continue in the foreseeable future.
Almost all currently used protein drugs such as cytokines as well as MAbs are immunogenic, that is, the patient develops an immune response against the “foreign” protein. These antibodies can be divided into two groups:
- (BAbs); antibodies that bind to the drug, but not necessarily neutralizes the drug
- (NAbs); antibodies that neutralize the therapeutic activity of the drug
Biomonitor introduced its binding (BAb) and neutralizing antibody (NAb) assays for monitoring therapy of MS patients treated with IFN-beta, and cancer patients treated with IFN-alpha from the company’s inception in 2003.
Even though BAbs may not neutralize the drug in in-vitro tests, these antibodies may alter the uptake from local depots and change the pharmacokinetics of protein drugs and therefore ‘neutralize’ the therapeutic activities of the drugs.
The consequences are that many patients undergo painful and expensive therapies without the desired benefits, with increased risk of side effects and without the benefit of receiving alternative and effective therapies.
Other types of assays, to monitor compliance, bioavailability and immunogenicity of anti-TNF-alpha therapies, were introduced by Biomonitor in 2005. These assays are liquid-phase RIAs, and can be used for quantifications of all three currently approved anti-TNF drugs as well as semi-quantifications of antibodies to anti-TNF drugs developed in patients treated with these drugs.
Customers
We serve clinical departments that treat patients with protein drugs as well as customers in all segments of the biopharmaceutical drugs lifecycle:
- Pharma/Biotech companies
- Clinical laboratories
- Public and private research institutions
- Contract manufactures
Our theranostics services are used in the drug discovery phase as support during pre-clinical trials, while in the drug development phase during clinical trials as support on individual toxicity testing and drug efficacy studies.
In later phases biotech and biopharmaceutical companies perform clinical trials to reveal new disease management indication or differentiate current indications through new documentation of effect. We assists in this process as well as when the focus for production is to ensure appropriate API and formulation qualities. Patient Monitoring Services are typically in the hands of the public healthcare sector and focus for us here is to ensure an appropriate individualized treatment regime.
Target Markets
A majority of the biopharmaceuticals under development are cytokines, cytokine modulating MAbs, and so-called growth factors. The major indication areas are autoimmune diseases and other inflammatory disorders such as reumatoid arthritis, multiple sclerosis, psoriasis, infections, allergies, blood disorders, cancer and cancer related conditions, cardiovascular diseases, diabetes and related conditions.
Biomonitor’s current business focus is the very large market segments of:
Multiple Sclerosis
MS is a chronic, inflammatory, demyelinating disease that affects the central nervous system. Read more about it here.
Rheumatoid Arthritis
RA is one of the most widespread chronic inflammatory diseases. It is a debilitating disease affecting millions of people worldwide. Read more about it here.
Cancer
After heart disease, cancer is the second leading cause of mortality in the developed world. Read more about it here.
Pipeline
Biomonitor has a promising pipeline of new clinical services and products that are currently under development that will support growth of the company for the good of shareholders, employees and patients alike.
Programs are initiated to assure Biomonitor’s leadership position in the monitoring of patients on biopharmaceutical therapy. The company’s new projects are related to the monitoring of patients being treated with a class of biotherapeutics that have been labeled the anti-TNF drugs.
Back to About us