Biotech Sizzlers

There are several interesting products on horizon.

According to IBM, in 2010, the pharmaceutical industry will not only make white powders; it will sell a variety of products and therapeutic healthcare packages that include diagnostic tests, drugs and monitoring devices and mechanisms, as well as a wide range of services to support patients. "Targeted treatment solutions" will deliver bigger shareholder returns than they have ever delivered before. Drug discovery and development will be underpinned by an understanding of how different disease function both at a molecular level and as part of a biological system. The molecular sciences will enable the industry to define diseases much more accurately and to create a collection of treatments and services for patients with specific disease subtypes, rather than making one-size-fits-all drugs for patients with similar symptoms but essentially different diseases.

Similarly things will change of the agriculture and environmental side. There will be genetically engineered crops with better protection against diseases but also those with high nutrients and high yielding capacities.

India is also taking several initiatives. We have seen the transgenic potato and rice developed here, indigenous Bt cotton, India’s the world’s only country to be working on buffalo genome, Pune University has developed VirGen, an indigenous virus identification software programme. So things are happening here too.

On another count, biotech has been in news in the last three months for acquisitions, mergers, and IPOs. Pfizer Inc. entered into an agreement to acquire Esperion Therapeutics, a biopharmaceutical company focused on the development of high-density lipoprotein (HDL) targeted therapies for the treatment of cardiovascular disease. Esperion brings a novel approach to the emerging area of HDL therapy and reverse lipid transport for the acute treatment of cardiovascular disease. GE and Amersham agreed to merge. With this, GE wants to accelerate the development of molecular imaging and personalized medicine.

We present to some of the top recall products of 2004 and why they would make a difference to the world.

India’s Bt genes

Indians are known for copycatting. But not always. It is mainly because of brain drain of intellectuals. We do find talents working on different innovative ideas at various labs in India to come out with indigenous products. A team of scientists at National Botanical Research Institute (NBRI), Lucknow has indigenously synthesized two Bt genes Cry 1AC and Cry 1 EC, which may launch a tug of war with Monsanto’s Bollgard. These two genes may bring down the actual production cost and put a full stop to the production and sale of spurious Bt cottonseeds, which is rampant at Gujarat.

Gene scan in 3D

Chromosomal disorders occur in 0.7 percent of live births. They increase in frequency with advanced maternal age. To provide equivalent accuracy and more comprehensive diagnostic capabilities, Biocept is developing a 3D HydroArray Chromosomal Disorders Diagnostic. This 3D HydroArray diagnostic is for prenatal diagnosis of a broad range of aneuploid and deletion disorders. Clinical trial results to date indicate that the diagnostic will be a major advance over currently available methods. Biocept currently offers two theme 3D HydroArray systems, the 3D HydroArray Apoptosis System, and the 3D HydroArray Signal Transduction System. In addition, Biocept can produce customized 3D HydroArray Systems to meet the needs of individual investigators and labs.

Cancer-tackling antibodies

Are you a victim of a deadly illness, cancer? Then look at Immunomedics Inc, which is developing, manufacturing and marketing innovative antibody-based products to combat deadly illnesses. It is in the process of developing antibody against cancers expressing carcinoembryonic antigen called CEA-Cide (labetuzumab). At present CEA- Cide is in Phase I/II clinical trials for the treatment of certain solid tumors. The antibody has been humanized, a process that depletes by about 90 percent all murine components in the antibody by replacement with human immunoglobulin, or antibody, structures. This antibody is in clinical studies as a naked (unlabeled) and a radiolabeled conjugate, for the therapy of diverse cancers expressing CEA, including colorectal, pancreatic and breast cancers.

It’s GM Canola now

After making inroads in India by launching three hybrids of Bt cotton with product called Bollgard, Monsanto, a provider of agricultural products and solutions based at St Louis, US is entering Australia with Roundup Ready canola. It is also planning to take up field trials for GM corn in India. Developed by Monsanto Australia Roundup Ready canola got the approval from the Federal Government’s Office of the Gene Technology Regulator (OGTR), Australia for commercial cultivation. GM Roundup Ready canola has undergone field trials in Australia and is tolerant to the herbicide glyphosate that will help in weed control while the canola crop is growing. It is a special type of herbicide tolerant canola developed using plant biotechnology. It offers farmers a safe and more effective way to control weeds in their crops than existing herbicide tolerant canola, including Triazine Tolerant canola, which is the current market leader in Australia. Triazine Tolerant canola makes up more than 60 percent of Australia’s canola crop.

Genetic skin care

Are you suffering from a chronic skin disorder, Psoriasis? Don’t scratch head or skin either. Genentech has developed a humanized therapeutic antibody, Raptiva, designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that lead to the development of psoriasis. Genentech has got the US Food and Drug Administration (FDA) approval in October 2003 for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy. In clinical studies, Raptiva demonstrated a rapid onset of action, in some patients by four weeks, in the reduction of symptoms associated with psoriasis. Raptiva prevents T-cells from becoming activated and entering the skin. This, in turn, inhibits the process that leads to plaque formation. As Raptiva starts working in the body and plaque formation is slowed, psoriasis symptoms start to clear.

5-in-one vaccine from Serum

Pain of injecting the vaccines at regular intervals is over. Now the babies can have relief of taking one vaccine instead of four against the deadly diseases Hepatitis -B and DPT. The scientists at the Pune based Serum Institute of India, a leading manufacturer of DPT vaccines are working on a combination vaccine, which is expected to be launched by end of first quarter of 2004. This combination vaccine will reduce the number of injections required for children from four to one. Serum, a Rs 450 crore vaccine manufacturing company is exporting its products to over 160 countries. Its path-breaking clinical trials include; a sero-conversion study to assess the impact of Measles Vaccine at 9 months of age and MMR vaccine at 15-18 months of age, Reacto-genicity and safety of Measles Vaccine with regard to neurological side-effects, Immunogenicity and Reacto-genicity of indigenously produced MMR vaccine, Sero-conversion following Rubella immunization in girls aged 9-11years, Reactogenicity of Rubella Vaccine in adolescent girls.

Pesticide-killer protein

Growers look at using traditional chemical pesticides and growing crops of genetically engineered for pest resistance to reap profits. Due to widespread criticism from environmental groups, government regulators, consumers, and labor advocacy groups, growers are finding it difficult to use these approaches. To overcome the problems faced by the growers, EDEN Bioscience Corp. has developed Harpin technology, which provides growers with a highly effective alternative approach to crop production that addresses these concerns. Messanger is the first of a series of products based on the Harpin Protein technology. Harpin Proteins induce disease resistance and promote increased yield in a broad range of agriculture and horticulture crops. Harpin Proteins induce the natural disease immune system and growth pathways inherent within each plant.

Antidote for anthrax

Human Genome Sciences Inc. has developed a human monoclonal antibody drug called ABthrax that protects against anthrax in animals. It is a synthetic antibody that neutralizes the main toxin produced by the anthrax germ. ABthrax could prove to be useful as an adjunct to or replacement for antibiotics currently used to treat anthrax. The human trials will only determine if the drug can be safely administered, as it is not considered ethical to expose humans to anthrax spores to determine its efficacy. The company has also got the USFDA permission for conducting clinical trials under the Bioterrorism Act of 2002.

Narayan Kulkarni