Biocon crosses Rs 500 crore mark

Kiran Mazumdar–Shaw

Biocon has announced its financial results for the financial year ended March 31, 2004. The group’s total income through sales increased by 94 percent to Rs 549.3 crore from Rs 283.3 crore in the last fiscal. And its operating profits moved up 142 percent to Rs 179.5 crore from Rs 74.1 crore. The strong growth has come on account of its strong growth in biopharmaceuticals. Revenues from the biopharmaceuticals business improved by 117 percent to Rs 435.4 crore from Rs 200.7 crore, contributing 79 percent to operating revenues in FY 2004 compared to 71 percent in FY 2003. Revenues from statins increased by 153 percent to Rs 302.8 crore from Rs 119.9 crore. The custom and clinical research business grew higher by 40 percent to record Rs 38.8 crore from Rs 27.7 crore. The overall growth has been spearheaded by strong performance in the US and European markets as exports registered 151 percent in FY 2004, contributing 63 percent to overall revenues compared to 48 percent in FY 2003.

Kiran Mazumdar–Shaw, chairman and managing director, Biocon, said, "All our key businesses, viz. statins, enzymes and research services demonstrated exceptional growth. The numbers reported reflect the success of strategic capital investments made two years ago. We expect our current expansion program to deliver substantial growth in the near future. Our R&D programs are creating a pipeline of exciting products and technologies that are rapidly transforming Biocon into a discovery-led enterprise. Our outlook for the year ahead is very positive. We expect substantial growth to be delivered by sales of Pravastatin to Europe and from our new products including Insulin, Immunosuppressants and branded formulations. Research services will also be a key growth driver."

In other developments during the year, Biocon signed a letter of intent for supply of recombinant human insulin to Bristol Myers Squibb. It has scaled up recombinant human insulin to a commercial scale. Biocon has completed Phase III clinical trials and is currently awaiting regulatory approvals for its branded recombinant human insulin, Insugen, which is slated to be launched in Q2 FY 2004. It also launched a range of branded formulations targeted at the cardio-diabetes therapeutic segment. This includes 11 formulations based on Atorvastatin, Glimeperide, Losartan and Ramipril. It has received US FDA acceptance for its prava-statin, simvastatin, lovastatin and pioglitazone manufacturing facilities. "This acceptance allows Biocon to access the lucrative $6 billion market slated to go off patent in the US in 2006. We have already established ourselves as a leading exporter of lovastatin to the US and simvastatin to Europe," added Shaw.

Wockhardt increases R&D investment

Wockhardt Ltd has increased its R&D investments to 7.9 percent of the total sales in 2003 from previous year’s investment of 6.2 percent. Wockhardt has registered a sales turnover of Rs 980 crore in 2003. It invested Rs 360 crore in the multidisciplinary research programs in the recent years. Habil Khorakiwala, chairman, Wockhardt Ltd, said "Our R&D investment is amongst the highest in the country. Our technological capabilities and strong commitment of a team of 350 scientists have kept Wockhardt in the forefront of the emerging fields of biotechnology and pharmaceuticals."

Khorakiwala pointed out that the strategic growth will come from two areas—value-added generics sale to developed markets like the US and Europe and supply of biogenerics to less regulated markets. We have received marketing registrations for biopharma-ceuticals in three countries.

He further noted that the new drug discovery program at Wockhardt has promising lead molecule in its pipeline in addition to WCK –771, which will soon undergo Phase II clinical trials. This will be useful in treating Methicillin and Vancomycin resistant, life threatening infections and sepsis. Another chemical entity WCK –1457 shows potent activity against enterococci and is undergoing toxicity studies. Wockhardt has also filed investigational new drug application for WCK-1152 for treating hospital and community acquired a respiratory tract infection that has completed pre-clinical trials.

A promising new biopharmaceutical for Wockhardt, Interferon alfa 2b, is undergoing phase III clinical trials, he said and added that the project to manufacture monoclonal antibodies is also shaping up well.

Center for Genomic Application inaugurated

Dr Samir K Brahmachari

On the eve of Technology Day, the first ever public-private partnership Genomic Application Research facility was inaugurated at Okhla Phase III, New Delhi. The R&D facility will be a world class Genomic and Proteomics facility, which can be used as a shared resource for all the research centers in the country.

The facility has been set up as a 50:50 financial participation between Institute of Genomics and Integrative Biology (IGIB), a constituent institute under CSIR, and The Chatterjee Group (TCG), through the Institute of Molecular Medicine. The Center for Genomic Application (TCGA) is being set up at an investment of Rs 25 crore, which is being funded by The Chaterjee Group, the Department of Science & Technology (DST) and Council of Scientific and Industrial Research. CSIR and DST would provide the technical and research support.

Speaking at the inauguration, Dr Samir K Brahmachari, director, IGIB said, "TCGA is landmark step in the genomic application based research area, as it will fulfill critical need of research infrastructure, which otherwise is difficult for individual small companies and entrepreneur to afford. It will be cost effective due to its centralized operations and will serve as a single stop shop to outsource their research requirements."

"TCGA, by drastically reducing the cost of research and making leading edge capabilities widely available, will allow Indian science to excel globally and enhance the pace of drug discovery," said Dr Purnendu Chatterjee, chairman, The Chatterjee Group. Meanwhile Dr VS Ramamurthy, secretary, DST said, "This is a unique initiative of the Government, Research & Development institutions and industry to offer world class research facilities in the area of genomics and proteomics facilitating industry to come out with competitive products."

TCGA will initially undertake, genotyping and sequencing for medical genetics, population genetics. It will provide services like protein sequencing, fingerprinting, primer design and synthesis, expression profiling using micro arrays, and incubation for start-ups in biotechnology.

TCGA already provides services to large pharmaceutical and biotechnology companies and research institutions in the country. Advanced genomic research is critical in nature and much in demand worldwide. TCGA will tap this growing industry. In India, this demand is expected to grow at 30 percent every year for the next five years, from the current size of Rs 100 crore to Rs 300 crore in 2006-07 approximately. Services, including genotyping, sequencing and microarray services are expected to grow rapidly over the next five years.

Biotech can grow exponentially with value creation

Bio business in Asia has seen exponential growth over the last few years but can grow even further through innovative approaches in fostering and cultivating new and improved methodologies opined Dr Gurinder Shahi, CEO and principal consultant, Bio Enterprise Asia, at a CII organized seminar on the occasion of National Technology day in Mumbai. This seminar was part of the ongoing CII Mahabioyatra series. "Bio Business is a commercial activity based on an understanding of life sciences and life science processes which could be classified as biomedical, agri, vet and food, and environmental/ industrial," noted Dr Shahi.

He urged the Indian biotech industry to look for opportunities that could create value propositions through partnering leaders in technology and research. Further he added that branding, marketing and positioning were the key points in differentiating Indian companies from the competition. As Asia was a late entrant into the biotech market he felt that this late start had benefits wherein we could learn from the mistakes of the current leaders and we should capitalize on the mature scientific knowledge and technical base available. This late start too gave us the opportunity to partner with these leaders and further the growth that this industry has seen.

Vimta to focus more on phase II and III trails

Hyderabad based Vimta Labs, leader in the areas of Phase-I clinical trials and bioanalytical/bioequivalence studies and central lab services, starting this year, will be focusing more on Phase-II and III trials and clinical data management.

V Nageswara Rao, business manager, clinical research, Vimta Labs informed BioSpectrum, "We have already completed building systems for Phase-II and III trials and clinical data management. We are commencing some projects in these areas very soon." Vimta Labs is also setting up a new facility at Genome Valley being promoted by government of Andhra Pradesh. It is investing about Rs 60 crore on this project.

Vimta Labs, a provider of multi-disciplinary contract research and testing services, operates in the areas of testing and validation, clinical research, clinical pathology, pre-clinical safety evaluations, environment assessment, and inspection and certification services. Its clinical research services consist of bioavailability and bio-equivalence studies; pharmaco dynamic and pharmaco kinetic studies; clinical trials (phase I- IV); and central lab services. Vimta Labs has so far completed 600 studies in Phase-I and BA/BE studies and PK studies completed. It has also developed 120 bioanalytical assays.

With staff strength of 345 (including 14 medical doctors and 17 PhDs) it was able to garner revenue of Rs 35.13 crore for the year 2003-04 registering 81 percent increase over the previous year’s revenue of Rs 19.38 crore. And it recorded a net profit of Rs 8.5 crore for the financial year 2003-04, an increase of 312 per cent over Rs 2.06 crore in the previous year.

Cadila to launch biotech products

Ahmedabad-based Cadila Pharmaceuticals Ltd is planning to launch about half a dozen technologies including diagnostics for HIV, thrombolites for myocardial infarction and a pro-biotic this year. An equal number of products are in the pipeline for immuno-prophylaxis, diagnosis of hepatitis C, therapeutics for cancer, viral hepatitis, diabetes mellitus and anemia. Amongst the products, HIV diagnostics include the mandatory ELISA format and highly advanced rapid autologous red blood cells agglutination test referred to as Naked-Eye Visible Agglutination Assay (NEVA) based on a technology developed for the first time that can be used on the bedside or in the office of the doctor. Results are available in 3-5 minutes as against the mandatory ELISA.

Over the past few years, Cadila has evolved a strong biotechnology R&D focus and established good working relations with key R&D institutes in the country, outsourcing R&D activities. The collaborative R&D is being carried out in national and international research laboratories like IMTECH, Chandigarh, NII and CBT, New Delhi, ICGEB, New Delhi and Trieste, Italy. It has also set up its own research facility at IISc Bangalore. Currently about 20 products including conventional and recombinant vacancies, anti cancer bio-therapeutics, diagnostics using recombinant antigens and natural thrombolites with high market potential are in various stages of development.

Cadila has already launched streptokinase. Besides, it has also developed Sodium Hyaluronate, another biotech product on the basis of technology obtained from Center for Biochemical Technology, Delhi. It has been commercialized in pre-filled syringes for ophthalmic procedures as a surgical aid under the brand name VISIAL. It is the third company in the world to market it. Besides ophthalmology, it has got applications in osteoarthritis and rheumatism.

The biotech R&D team comprises of 30 scientists, many of them with doctorates in their respective disciplines. Its research areas in biotechnology include development of rDNA proteins for prophylaxis, therapy and diagnosis; isolation, purification and characterization of biopolymers from natural sources (proteins, enzymes and carbohydrates) for development of surgical aids, therapeutics; development of PCR-based gene probe assays, polyclonal antibodies for use in passive immunizations (passive vaccines) and immunodiagnostics, etc.

AQUAS to forge more alliances

Avesthagen Gengraine Technologies’ (Avesthagen) joint venture company Avesthagen Quality Agriculture Services (AQUAS), which is into food, water, and seed testing has signed an agreement with Kerala government for certification of herbal products. Avesthagen had earlier signed an agreement with the Hyderabad-based International Crop Research Institute for Semi Arid Tropics (ICRISAT ). According to Manan Bhatt, vice president, business development, AQUAS, "GMO testing, food testing, and seed testing represent an opportunity worth $400 billion, $32 billion and $800 million, respectively." Explaining the reason why AQUAS is exclusively focused on these services, Manan added, "AQUAS is offering these services to exporters of processed foods. AQUAS certification about the food consignments containing no traces of GM foods have helped export houses like HLL, ITC, Ruchi group, Satnam Overseas, Vikas, TastyBytes and Raptakos. AQUAS is also a member of AIFPA. We have entered into an alliance with global leader in GMO identification, Genetic-ID, and the AQUAS certification, therefore, is accepted as valid in the European Union, Korea and Japan."

Also there are reports that AQUAS is attempting to raise over $1.5 million. The company is claimed to be the first company in the south-east Asian region to offer globally accepted testing and certification for GMOs. It is also looking at signing up with other state governments on this qualification.

Jubilant Organosys acquires generic pharma companies in Europe

Jubilant Organosys Ltd, a leading Custom Research and Manufacturing Services (CRAMS) and API company, has announced the acquisition of 80 percent equity stake of the Belgium-based Pharmaceutical Services Incorporated nv and PSI Supply nv (both Companies collectively referred to as ‘PSI’ and ‘acquisition’). Jubilant will acquire the equity stake by paying Rs 75 crore) in cash.

With this acquisition Jubilant will now have presence across the pharmaceuticals value chain from manufacturing of API’s to sale of formulated products. It will enhance the strength of Jubilant’s Life Sciences business in the high opportunity European market. PSI has an attractive portfolio of 19 dossiers with 31 more at different stages of filing and development. The company also has entered into various long-term supply contracts for the dossiers and generic drugs.

Dr Reddy’s acquires dermatology company

Dr. Reddy’s Laboratories announced that it has acquired Trigenesis Therapeutics, a US based privately owned dermatology company. This acquisition provides Dr Reddy’s with access to certain products and proprietary drug delivery technology platforms for developing a pipeline of differentiated drugs in the dermatology segment. The total investment outlay is $11 million. Dr. Reddy’s will make additional contractual payments during the course of development of the products and technology platforms and royalties on sales to Skye Pharma PLC and SilvaFoam LLC pursuant to existing Trigenesis agreements.

Commenting on the acquisition, GV Prasad, CEO of Dr Reddy’s Laboratories, said, "We are excited about this acquisition and see it as an important element of our overall corporate strategy in facilitating our transition into a specialty pharmaceutical Company focused on the US market. This deal provides us an exciting opportunity to apply various proprietary drug delivery technologies in creating a pipeline of differentiated drugs that will broaden the range of available treatment options and establish Dr. Reddy’s in the prescription dermatology segment."

Government creates PHARMEXCIL

The central government has created a separate specialized and dedicated Export Promotion Council for Pharmaceuticals-PHARMEXCIL. Associations like BDMA (I), IDMA, IPA and OPPI along with the government of Andhra Pradesh had been pursuing with the Ministry of Commerce for setting up of PHARMEXCIL. PHARMEXCIL will be headquartered in Hyderabad, with a regional office at Mumbai and they have been designated as the authorities to issue Registration cum Membership Certificate (RCMC) to exporters of drugs and pharmaceuticals under the Exim Policy. The council is abuzz with activity, finalizing action plans and coordinating with various agencies, including the Indian missions abroad. This activity is to tap the huge export opportunities waiting upfront. For instance, over $50 billion worth of drugs are coming off patent in USA in the next few years and with India having largest number of US FDA approved manufacturing facilities outside USA, India has a tremendous potential to get a substantial share of this pie. Similarly, with WTO inclining to allow exports to least developed countries that do not have manufacturing capabilities through Compulsory Licensing route, even unregulated markets open up tremendous opportunities for export.

ETHICON introduces antibacterial suture in India

ETHICON, a division of Johnson & Johnson Ltd, the market leader in the medical device industry and other healthcare products launched VICRYLPlus, the world’s first and only antibacterial suture. VICRYL Plus sutures offer protection against bacterial colonization on the suture and are considered a breakthrough in wound closure technology. India is the only third country after the US and Canada and the only country in the Pan Asian continent to benefit from this advanced generation medical implant. It represents a major breakthrough in suture technology that holds the promise of making surgery safer for all patients who undergo surgery, as it is the first device ever to inhibit bacterial colonization of the suture.

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