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Monoclonal Antibodies: the medicine for the 21st century

Recent developments in immunology are opening up a huge range of potential new therapies. Other promising areas include vaccine development, recombinant or modified growth factors and their receptors, and the possibilities of therapy with whole cells. However, the very diversity and exquisite specificity of these new approaches pose huge new challenges to the pharmaceutical industry and drug regulatory mechanisms. Exploitation which is based mainly on market potential, intellectual property rights and dividend forecasts will produce a few commercially successful products.

Monoclonal antibodies (mAbs) are nature’s biological warheads, able to target and help eliminate foreign or abnormal agents from the body. In theory, replicating this powerful defense system could cure some of humanity’s most deadly diseases.  It is able to directly target and destroy cancer cells through use of the immune system, reducing the debilitating side effects currently experienced with radiation and chemotherapy, offering patients an alternative and more effective therapy. An antibody is a protein our own body makes to fight infections. For treatment of diseases such as cancer these quantities are not enough, so one needs to make antibodies outside the human body using modern biotechnology methods and take those antibodies and give them back to the human body in the form of injections.

In 1895 Hericourt and Richet described the first trials in which cancer cells were injected into animals to raise an antiserum for treating the patient. In 1975 Kohler and Milstein found the key to aiming the "magic bullets" first envisaged 80 years earlier. For this discovery, they were awarded the 1984 Nobel Prize for medicine. The first generation of mAbs, derived from the progeny of a single immune cell, was of the mouse origin which showed only limited potential as therapeutics. The human immune system recognized mouse mAbs as foreign material producing human anti-mouse antibodies (HAMA) to clear them from the body thereby limiting their therapeutic benefit. To make mAbs successful in the clinic biotechnologists using the tools of molecular biology needed to create non-immunogenic mAbs with high binding affinities that could work effectively. Subsequent efforts concentrated on using these techniques to produce human or human like monoclonal antibody products such as chimeric and humanized mAbs.

Monoclonal antibodies represent one of the success stories of the biotech industry. With a broad range of therapeutic and diagnostic applications, this class of drug has a huge market potential. As of early 2002, 18 monoclonal antibodies had been approved for use in the US, 11 as human therapeutics and eight as diagnostics. Close to 100 antibodies are in clinical trials and hundreds more in preclinical development to treat diseases such as cancer, inflammatory, autoimmune diseases, allergic disorders, transplantation, cardiovascular and infectious diseases.  A conservative estimate points to about 1,100 biotherapeutic products currently in preclinical studies. MAbs offer a glimmer of hope in the battle against cancers such as breast and Non-Hodgkin's Lymphoma (NHL). As products begin to emerge from phase III trials and approvals are seen across Europe, the market place will develop and more confidence will be instilled in the capabilities of these 'magic bullets'. Quality of life is an area of ever increasing importance in oncology and these novel therapies offer a vast improvement for a patient already in emotional and physical suffering.  The cost of drug therapy accounts for a minority of the total cost of cancer care, with patients requiring expensive supportive care in order to manage the side effects of cytotoxic therapy. In Europe in 2000, $291.4 million (U.S.) was spent on anti-emetic therapy alone. Monoclonal Antibodies will eliminate the need for support care and significantly improve the quality of life for cancer patients. .

The investment group, UBS Warburg has given projections in their Sept 2001 Pharmaceutical and Biotechnology report that of mAb market is forecast to grow to US$6 billion in 2005 and US$ 24 billion in 2010.

As interest in the antibody field grows in both the biotechnology and pharma sectors, primarily due to their versatility as therapeutics, diagnostics, and as reagents in drug discovery research, so grows the legal rambling about intellectual property (IP) situations. While controversy regarding IP position is nothing new to the antibody field, the court rulings of these patent skirmishes will have far-reaching monetary and product development repercussions for those companies involved in the lawsuits that also have major alliances with first-tier pharma companies.

Shantha West has filed world wide patent for TB94 and also has been granted the same.  The company has filed PCT patent for RM-2 and RM-4.

Shantha Biotechnics is a leading Biotechnology company in India and has the laurels of developing India’s first rDNA-based hepatitis B vaccine. It has also developed and launched interferon alpha 2b. A number of other recombinant therapeutic proteins are undergoing toxicology studies and clinical trials. Shantha Biotechnics is playing a leading role in the development of therapeutic antibodies in India. Along with its US subsidiary Shantha West based in San Diego, California the company is utilizing the body’s own human immune system to produce effective cancer specific antibodies. The company’s lead pharmaceutical products are fully human monoclonal antibodies designated TB94, RM2, RM3 and RM4. These unique monoclonal antibodies have the potential to be used both as a diagnostic tool as well as therapeutic reagent. The target diseases are lung cancer, melanoma, pancreatic cancer, neuroblastoma, breast and colon cancer. The company’s clinical approach is to use a cocktail of antibodies to treat each target disease. The estimated potential value for multi-mAb therapeutic products is in excess of US$ 700 million. 

Shantha Biotechnics has recognized the need to keep the manufacturing process in mind when developing biological products such as monoclonal antibodies. Current manufacturing capacity for biopharmaceuticals in general is fast becoming a rate-limiting factor in the growth of the biotech sector. Antibody therapeutics are likely to be the hardest hit by this shortage, as they are required in much larger quantities than other protein therapeutics. With the above in mind and also to make it affordable in India the company has explored several potential methods of large scale production and chosen transgenic plants as the primary production method. Using this methodology we will be able to produce in a cost effective manner and in commercially viable quantities.

 
 
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