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The founding members of Chimera Research Group have over 50 years of combined experience in the biotech and pharmaceutical sector. Their experience includes work at Investment Banks, Hedge Funds, Pharmaceutical Companies, top-tier Universities, and the U.S. Food and Drug Administration (FDA).... More
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  • Is Pharma Over Invested in Antibody Therapeutics? 0 comments
    Sep 28, 2010 1:47 PM
    There is no doubt that antibody therapeutics have revolutionized medicine in the last decades. Sales of antibody drugs are estimated to be $30 billion in 2009 and expected to grow at a 14% rate through 2012- this is more than double the rate of growth for all drug sales. Biotech companies have produced blockbusters such as Avastin, Humira, Remicade, and Rituxan based on the technology. Antibody drugs are seen as having an easier development path, from target validation through regulatory review. They are also viewed as having stronger IP protection due to their more complicated method of production compared to small molecule compounds.
     
    Antibody drugs are touted as being highly selective with fewer side compared to their small molecule cousins due to a lack of off-target effects. While it is true they are highly selective, their side effect profile may not be as rosy as it appears. This is due to on-target effects, injection/infusion reactions, and immune reactions to the foreign antibody. Take Humira for example, this self-administered treatment for rheumatoid arthritis and Crohn’s disease often leaves patients feeling tired and at risk for infection. But that’s the nature of a TNF alpha blocker; these same effects are seen with competitors Remicade and Enbrel.
     
    Big Pharma has jumped on the antibody technology bandwagon. Through acquisitions, partnerships, and internal research efforts, antibody drugs now make up a significant portion of most pharma company’s drug pipelines- in some cases 30% or more. Have they gone too far?
     
    There are several mechanisms of action for antibody drugs:
    • Bind to a cell surface receptor, directly inhibit aberrant cell signaling
    • Bind cell surface receptors or antigens, recruit immune cells to kill the targeted cell in a process called Antibody Dependent Cell Mediated Cytotoxicity (OTCPK:ADCC)
    • Recruit Complement proteins which form pores in the cell, leading to cell death- termed Complement Dependent Cytotoxicity (NASDAQ:CDC)
    • Bind signaling proteins, preventing its downstream activity
     
    These mechanisms lend themselves to diseases involving cell killing and modulation of the immune system. Antibodies are used mainly in oncology and immunological diseases- particularly rheumatoid arthritis, the two accounting for the vast majority of sales. Global sales for all oncology and RA drugs were $68.6 billion in 2008, just 9% of all drug sales for the year. While sales in both indications are growing quickly thanks to the uptake of and high prices of new antibody drugs, neither compare to the size of the CNS or cardiovascular markets, both of which top $100 billion.
     
    In light of such a limited market, it appears to me pharmaceutical companies are dedicating substantial resources for what may be marginal returns. With every biotech and now, pharma, crowding the oncology space, it will become increasingly difficult for companies to differentiate their products.
     
    To take antibodies to the next level, companies will need to go after new markets. This is happening to a degree, with drugs now approved for Multiple Sclerosis and Osteoporosis. Late stage molecules are in testing for diseases ranging from Alzheimer’s to Diabetes. Yet oncology continues to takes the lion’s share of the effort by far. Additional scientific advances will be required before the full potential of antibodies will be reached in these other indications.
     
    Perhaps the biggest Achilles heal of antibody drugs is their method of administration. All antibody drugs must be administered either by injection or infusion; none are orally available. This is okay in debilitating diseases such as cancer and RA, but as these drugs move into less severe indications such as CNS and asthma, patients may be more inclined toward easy to use oral medications.
     
    Convenience has long been a selling point for pharmaceuticals. It has led to the multidrug combinations that are now a staple in HIV treatment, and though antibodies have a stronghold in oncology, small molecule drugs continue to hold their own due in part to their relative ease of use. Most recently, the drug Gilenya from Novartis, was hailed as the first orally available Multiple Sclerosis therapy.
     
    For antibodies to maintain their robust growth and succeed outside their core therapeutic area, a non-invasive, or minimally invasive delivery system will need to be development. Potency and selectivity once thought attainable only with antibodies is now possible with small molecules. Only continued innovation will keep antibodies relevant.


    Disclosure: Long NVS
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