BioSpectrumIndia - the business of biotech - R&D: Way of Life at Panacea

Panacea Biotec, a BioSpectrum Top 20 company, has had an exciting phase in the past year. The company made significant strides not just on the numbers front but also in research. For the quarter ended December 2003, its income grew to Rs 103.89 crore. More importantly, the company has made significant inroads into the New Drug Delivery System arena. It filed a worldwide patent for new NDDS for an anti-TB combination drug, recently. Besides filing the PCT application (under the Paris Convention) for a worldwide product patent, the company has simultaneously filed its application with Drug Controller General of India for registration in India for its new NDDS drug.

Panacea Biotec’s anti-TBNDDS drug is code named "Mykit". What is important is that its discovery is claimed to give 25 percent higher bioavailability than the existing anti-TB drugs. Its new NDDS drug uses a combination of four anti-TB drugs—Rifampicin, INH, Ethambutol and Pyrizinamide. According to Joint Managing Director of the company, Rajesh Jain, Panacea has decided to take the NDDS-route for developing new products as a long-term strategy for growth. He further informed that besides Mykit, the company has some other NDDS-based products in the pipeline. Panacea Biotec is also in talks with some of the international laboratories for funding new NDDS products in diabetes and asthma segments.

A few years ago, the company envisioned long-term strategies to venture into new opportunities available in the horizon, namely, the health and disease management areas. With a special focus on biotechnology, Panacea Biotec has been making concerted efforts to improve the repertoire of its vaccines. A host of new vaccines, employing genetic engineering and recombinant technology, is being developed. The Hepatitis B vaccine- Enivac HB is being manufactured in collaboration with CIGB (Center for Genetic Engineering and Biotechnology), Havana, Cuba—a world leader in biotechnology. Amongst the forthcoming vaccines is anti-anthrax vaccine. Its vaccine and formulation plants are approved under WHO-GMP certification. Jain elaborated, "We have already signed an agreement with Biotech Consortium of India Limited (BCIL) to manufacture and market the anti-anthrax vaccine developed by Jawaharlal Nehru University. We plan to supply Anter (anti-anthrax vaccine) to the armed forces, paramilitary forces and establishments under the health ministry."

The company has more than 2,000 employees on its rolls. Out of this, around 1,000 are field sales personnel who promote the products of its five Strategic Business Units (SBUs)—Pain Care, Primary Care, Diacar, Germ Care and Critical Care to the medical profession. Besides pain management, diabetic management and vaccines, the company has significant presence in other therapeutic areas like renal transplantation, osteoporosis, antibacterial therapy, tuberculosis, peptic ulcers, cardiac emergencies, migraine, erectile dysfunction and dietary supplements. The company has worldwide patents for many of its products. This is just the beginning of the things to come.

Faiz Askari

"R&D has always been acore area of our interest."

Rajesh Jain, joint managing director, Panacea Biotec shares his views on the companies R&D efforts and future strategic direction for the company and the northern region.

Panacea Biotec is believed to have stepped up its R&D initiatives? What has been the progress?

R&D has always been a core area of our interest. At Panacea we intend to expand our scientific strength by delivering newer products to the industry. In other words, "research will be a way of life at Panacea".

Pursuing its mission, "In Support of Life", the company has been progressing towards development of products and technologies that improve quality of life. From the company’s R&D headquarters in New Delhi, to a major research campus in Lalru, near Chandigarh, Panacea Biotec works tirelessly to find new cures and drug delivery systems. The research conducted at our labs has led to successful filing and grant of product patents worldwide, in various categories. Our ultra modern 20,000 sq.ft R&D center in North India is equipped with high tech facilities and is supported by 60 scientists with specializations at par with the best laboratories in the world.

Today, we are taking on some of the world’s most intractable diseases, including polio, Hepatitis B, osteoporosis and diabetes. The results of our focused and intensive research programs are apparent in developing several outstanding medicines that can eradicate deadly and debilitating diseases.

In the past several years, the drug delivery research group has developed technologies and filed for grant of several patents. Some of these research outcomes have already been transferred to the industry and commercialized. The group is engaged in the development of different technologies like transdermal drug delivery, controlled release systems, biorhythm based delivery systems, microemulsions, targeted vesicular systems like liposomes and niosomes, mucoadhesive nanoparticles, taste masked fast dissolving formulations, osmotically controlled delivery systems and gastro retentive systems to improve bioavailability.

What does the drug delivery research focus on?

The drug delivery research at Panacea R&D involves detailed study at molecular level and of mechanistic approaches for drug absorption, distribution and elimination. This is a cross-functional R&D where drug delivery research is supported by departments like molecular biology, pharmacology, toxicology, advanced organic chemistry, advanced physical chemistry, and advanced analytical research and bio-analytical research.

Products developed and incorporating the formulation technologies outlined above are subjected to stability as per ICH guidelines. For preparation of clinical samples, a high tech pilot plant facility, equipped with latest machinery and conforming to GMP requirements is also available to the drug delivery research group.

Which are your flagship products?

We have three strategic business units. These are the vaccines, biopharmaceuticals, and pharma units. Each of these segments is coming out with a good range of products. Nemolate, Glizate, Enivac-HB and Ecovac are some of the products that are all doing well in the market.

Panacea has announced ThankGod Piles management kit. What has been your experience in bringing out the kit?

ThankGod took 10 years of extensive R&D. After conducting all toxico studies, clinical trials etc., the product is of international standard. It is a worldwide-patented product of Panacea Biotec. The ThankGod Piles Management Kit has been specially designed for integrated management of piles. Our vision was to provide a comprehensive solution to the first and second degree piles patients. The ThankGod Piles Management System consists of ThankGod Relief Capsules, ThankGod Anytime Cream, ThankGod Ispaghula Husk and ThankGod Pain and Itch Relief Cream. We are the only providers of such a 100 percent natural, worldwide-patented product, with successful clinical trials done in India. We collaborated with IHBT for developing the agronomy and clinical trials were conducted at Lok Nayak Jay Prakash hospital (LNJP), New Delhi.

Is it a commonly available product and how much does the kit cost?

The ThankGod Piles Management System Kit comes in a value pack along with a free Piles Patient Information Booklet and a free Internet Consultation Coupon worth Rs 250, which entitles the consumer to a free online consultation with a doctor for any specific queries. The ThankGod Kit has been designed for systematic and consistent treatment of piles, to be used in combination for 14 days.

Shouldn’t the industry vie for strong industry-academic partnership?

It is always good for research, if any industry collaborates with any research lab at the early phase of a research work. I think industry is the component, which needs to point out the opportunity and share their ideas and opinions to the research community that will be good for science. At Panacea we are open for such kind of collaborations.

It is frequently stated that public-private sector partnership is not an easy job, in terms of flawless productivity. What has been your experience?

Working with the government is a constant affair. Now the biotech industry in India is at very nascent stage. We need to take very effective and aggressive efforts to boost the industry. We need to evaluate our strengths and weaknesses so that we can improve in building good infrastructure and a platform for the biotech industry in India. And as we grow, we would understand the challenges ahead of us. Then we could work as a team to deliver good results.

What are the demands and needs of the industry?

Exemption in excise is rigorously expected by the industry. We strongly hope that soon biotech will be considered in a more serious manner. The tone of interim budget is also sounding good for the R&D-active industry. Hope it will take good shape in future.

Regulatory environment in India needs to be rechecked. Lack of venture capital funding is also an issue in this segment. We need to focus in that direction as well. And as an important need of biotech industry, the government should have representatives of the biotech industry as well.

Faiz Askari