Biocon Group's FY 2007-08 revenues touch Rs 1,044 cr

Biocon Ltd announced its financial performance for the financial year ended March 31, 2008. Its consolidated revenues (excluding enzymes) increased 19 percent from Rs 881 crore in 2007 to Rs 1,044 crore. The operating margins were at 31 percent for the year. Its R&D revenue expenditure increased by 26 percent to Rs 48 crore.

The profit growth has been maintained at the consolidated level despite the divestment of the enzymes business, currency appreciation and increased depreciation. "We have a strong balance sheet with high reserves and Rs 193 crore in net cash. Revenues from research services grew 29 percent to Rs 176 crore from Rs 136 crores, accounting for 16 percent of the consolidated revenues in FY 2008," said Dr Kiran Mazumdar-Shaw, CMD, Biocon Ltd.

"We are pleased with our overall performance and have delivered the highest profits to date. We have increased our capital expenditure to support the business expansion that we anticipate across the Group. We expect the year ahead to realize a good return on these investments especially at Syngene and Clinigene. We have a strong balance sheet which we will use for strategic acquisitions and investments. The recent AxiCorp acquisition is a significant move that provides us key access to the European market. We wish to make similar inroads into other markets to expand our global footprint. We have delivered a 13 percent increase in PAT despite a Rs 27 crore increase in depreciation. The strong financial base enables us to recommend a 1:1 bonus issue that we believe will improve market liquidity to support Biocon's growing profile as a bellwether stock in the life science sector," added Shaw.

Some of the major announcements during 2007-08 include:

• Biocon is close to completing the acquisition of 70 percent stake in German pharmaceutical company, AxiCorp GmbH for a consideration of €30 million. This will enable the marketing and distribution of a range of pharmaceuticals including generics, biosimilars, biologics and innovative pharmaceutical products in Germany and Europe.

• An open label, multi-centric, placebo controlled, single ascending dose study designed to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of IN105 under fed conditions in type II diabetic patients currently on Metformin therapy has been commenced at five investigation sites. The study is expected to be completed in August 2008 and will provide the data necessary to commence Phase IIb clinical trials.

• A randomized, open label, Four Arms Parallel Phase II clinical study to evaluate the safety and efficacy of anti-CD6 monoclonal antibody (T1h mAb) in combination with Methotrexate in Patients with active rheumatoid arthritis has been initiated at seven investigation sites.

• Another phase II clinical trial to evaluate the safety, efficacy and pharmacokinetics of anti-CD6 monoclonal antibody (T1h mAb) in patients with active psoriasis is also due to commence at five investigation sites.

• An open label, prospective, multi-centric study to evaluate the safety and efficacy of BIOMAb-EGFR (Nimotuzumab) as induction and maintenance therapy in combination with radiotherapy plus temozolomide (concomitant and adjuvant) in Indian patients with Glioblastoma Multiforme is ongoing at eight investigational sites across the country.

• These clinical trials will enable Biocon's oncotherapeutics division to expand its market share through label extensions. Biocon has decided to split up its cardio-diabetes group by launching a stand alone cardiology division. This new division is being launched to focus on brand building for its flagship statin based product Statix as well as other products like Telmisat, Eptifibatide and its recombinant streptokinase product Myokinase.

Avesthagen and Limagrain launch innovative biodegradable plastic

Bangalore-based Avesthagen and its joint venture partner Limagrain have launched an eco-friendly and biodegradable plastic for the Indian market. This biodegradable plastic is manufactured using a process unique, from whole cereal grains, mainly wheat, maize and a number of specific Limagrain varieties. The products innovation lies in the combination of cereal fractions with a biodegradable polymer. Unlike the usual non-degradable plastic material, this alternate plastic introduced by Avesthagen and Limagrain, breaks down and becomes compost in a matter of 120 days in industrial composting conditions under the norm EN13432 .

This innovative biodegradable plastic is India's first product aimed to curb white pollution and the hazards of environmental pollution. Alternate biodegradable materials are the need of the hour, to curb the unimaginable pollution caused by way of plastic bags and other plastic films, which stay in our ecology for hundreds of years strangulating cattle and destroying ecology. With an annual usage of over 150 million tons of non-degradable plastic, the twentieth century may well be called the "Plastic Age". Further, as most non-degradable plastic used is from non-renewable resources such as petroleum, our increased consumption of plastic increases our reliance on imported oil as well.

Dr Villoo Morawala-Patell, founder, chairperson and managing director, Avesthagen, said, "We are extremely glad that our partnership with Limagrain has resulted in the introduction of this alternative plastic material. This is our way of contributing back to the environment we live in. As research and innovation is core to Avesthagen, we would not stop here, but continue our work to introduce more environment friendly products."

Advinus achieves milestones in Merck collaboration

Bangalore-based Advinus Therapeutics, which is engaged in pharmaceutical R&D, has announced that it has achieved two more milestones, one each in the two programs, under the drug discovery and development collaboration between Advinus Therapeutics and Merck & Co. The second milestone for one of the programs was achieved within four months of achieving the first milestone in November 2007.

The companies have been working together since November 2006 to develop clinically validated drug candidates in metabolic diseases, with Merck retaining the right to advance the most promising of these candidates into late-stage clinical trials.

Under the terms of the agreement, Advinus will receive milestone payments upon meeting agreed upon criteria at various stages of discovery and development. Advinus could potentially receive $74.5 million per target and is also eligible for royalties on the sales of any products that result from the collaboration.

Intas Biopharma and Kwizda complete phase I clinical trial of Neukine in Europe

Intas Biopharmaceuticals (IBPL) and European pharmaceutical major Kwizda Pharma GmbH has jointly completed phase I clinical trial study of Neukine, biosimilar form of recombinant GCSF. As per results of study conducted by European counterpart, Neukine, IBPL's registered trademark for Filgrastim, is safe and exhibits an identical pharmacokinetic and pharmacodynamic profile compared to a reference product.

Neukine promotes growth of white blood cells, which help to fight infections after cancer chemotherapy treatment. Upon completion of an upcoming clinical phase III trial, both companies, IBPL and Kwizda, will lodge an application to get the product approved for European market. The market launch is planned for early 2010.

Avesthagen, DuBiotech sign pact

Avesthagen and TECOM Investments FZ LLC acting through its Dubai Biotechnology and Research Park (DuBiotech) signed an over-arching framework agreement to join forces to market and launch new products, furthering the growth and development of biotechnology. In this joint effort, longstanding knowledge from traditional Indian medicine and state-of-the-art genomic research, and a diverse array of technologies will be integrated in a focused manner to bring innovative solutions to predictive, preventive and personalized healthcare to mankind.

The agreement was signed by Dr Villoo Morawala-Patell, founder and CMD, Avesthagen and Dr Abdulqader Alkhayat, executive director of DuBiotech. The first project to be undertaken will include the launch and commercialization of BioPercept, an eco-friendly and biodegradable plastic in the Gulf Cooperation Council (GCC) region and also establish a conversion plant to process BioPercept within the next two years.

Ocimum Biosolutions launches Genowiz 4.0

Hyderabad-based Ocimum Biosolutions has announced the release of Genowiz 4.0, a comprehensive solution for gene expression analysis. The latest version makes the process of microarray data analysis simpler with a host of features such as AutoGuide to execute automated work flows for analyzing data, addition of organisms/genomes, automatic update of annotations, PLIER algorithm, data export in different formats, box plots and enhanced scatter plots.

Anuradha Acharya, CEO of Ocimum Biosolutions, said, "Ocimum aims to be the number one genomics outsourcing partner in the world. Genowiz is a key product central to our vision of providing integrated end-to-end genomic solutions for our valued customers by combining biology and IT in an easy-to-use interface to handle different kinds of expression and genotyping formats such as Affymetrix, Agilent and Ocimum."

"Unlike most of the other tools of the same genre in the market, Genowiz is envisioned by expert biologists and implemented using sound algorithms. This means that it has great features which are tailor-made for experimental biologists," added Dr Ashwin Sivakumar, director, marketing alliances and outreach, Ocimum Biosolutions.

The release noted that Genowiz is a comprehensive microarray data analysis package that effectively assists researchers in generating significant biological conclusions, right from data upload through analysis and visualization. The algorithms of Genowiz can analyze microarray data formats from various sources, be it academics or industries. It also allows researchers to organize experimental information (MIAME), import data files quickly and easily, work simultaneously with multiple experiments, import gene annotation files, pre-process and normalize data, perform cluster analysis, classify and view gene information, perform functional classification and track down intricate correlations in data by performing pathway analysis. All analysis performed is saved in database and can be retrieved as required.

SIRO acquires leading European CRO

SIRO Clinpharm has signed an agreement for the acquisition of the companies within the Omega Mediation Group, a leading midsized European CRO, for an undisclosed amount in all cash deal. The deal will give SIRO 100 percent stake in Omega.

The acquisition will provide SIRO with operational capabilities in five key European countries and Israel and access to Omega's longstanding client relationships with major European pharmaceutical and biotech clients. The European arm will continue to be known as Omega Mediation – a SIRO group company. The promoters and the current management of Omega will continue with the organization and contribute to the further planned growth and expansion in Europe.

"We are pursuing our vision of creating CRO capabilities in non traditional geographies including Central Eastern Europe, Asia Pacific and South America," said Dr Gautam Daftary, chairman of the board, SIRO Clinpharm. "This acquisition is the first step of creating capabilities in these regions in near future".

Dr Chetan Tamhankar, COO of SIRO Clinpharm, said, "We are delighted to add the highly successful operations of Omega to our growing organization. This will help us to offer our existing and future customers a wider geographical coverage and more comprehensive service. Through the addition of expertise and capabilities, Omega will also contribute significantly to SIRO's objective of building a global CRO."

Sofia Hofmann, managing director of Omega Mediation, commented, "We are excited about moving into global operations with SIRO. This was the right move for us to address the changing dynamics of the clinical research sector".

Parexel expands relationship with Synchron Research in India

US-based Parexel International Corporation has expanded its minority interest ownership in the clinical pharmacology business of Synchron Research in Ahmedabad. The company also announced the sale of a bioanalytical laboratory in Poitiers, France to a subsidiary of Synchron, Synexel Research International.

Under the terms of the new agreement, Parexel's ownership interest in the Ahmedabad Phase I business has increased from 19.5 percent to 31.0 percent on a fully diluted basis, at a cost of approximately $5.0 million. In a separate transaction, Parexel sold the Poitiers business to Synchron's Synexel Research International for approximately $6.7 million. Staff of the bioanalytical lab in Poitiers, France will join Synchron's bioanalytical business unit.

"Over the past several years, Parexel has developed a strong global clinical pharmacology capability, through both organic growth and acquisitions. As a result, we are an industry leader in expertise-based Phase I studies," said Josef H. von Rickenbach, chairman and CEO, Parexel International.