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Biocon's group revenue gains 46 percent
Biocon's group revenues for the nine months ended December 31, 2008, has increased by 46 percent from Rs 811 crore in FY 2008 to Rs 1,187 crore in FY 2009. The biopharma sales (excluding Axicorp) registered 13 percent growth, bolstered by a 42 percent growth in the retail healthcare business. Research services of the company touched 21 percent sales growth in the last nine months of FY 2009.
Syngene continued its growth run by delivering a 16 percent quarter on quarter increase in revenues in Q3 of FY 2009. AxiCorp delivered modest profitability in line with expectation. Currently, AxiCorp is a pure distribution business with relatively low margins. The strategic relevance of AxiCorp will crystallize when the bio-similar Insulin opportunities open up in Europe.
Exceptional charge relating to forex hedging in Q3 of FY 2009 has increased to Rs 46 crore. This is on account of MTM provisioning and cancellation of certain longer term forward covers. This charge on year-to-date basis stands at Rs 106 crore. Biocon's EBITDA (excluding AxiCorp) for the nine months ended December 31, 2008 stands at Rs 270 crore (Rs 240 crore, last year) with an operating margin of 30 percent. The company's IN105 (Oral Insulin) program has received regulatory permission to commence phase-III clinical trials in type 2 diabetics.
Biocon has won the IDMA (Indian Drug Manufacturers Association) award for the best patent during the Year 2007-2008 by an Indian company. The said patent forms the basis of Biocon's oral insulin molecule, IN105.
Commenting on the results, Kiran Mazumdar Shaw, chairman and managing director, Biocon Limited, said: “Biocon's operational performance remains on a growth track. At a time when many sectors face a severe slowdown, we believe that Biocon has a unique opportunity to leverage affordable R&D base and forge partnerships that will deliver large contract research, manufacturing and co-development opportunities over the next five years. Syngene continues to improve its performance by delivering its best ever sales and operating profit in Q3.”
“Clinigene is positioned to be a key player in the CRO segment where India is emerging as an important global destination for clinical development. We are making excellent progress on the research front with our oral insulin IN105 program, that is set to enter phase-III clinical trials during this quarter. We have also completed a successful non-inferiority phase-III clinical trial for Glargine, a basal Insulin analog. The trial data has been submitted to the DCGI for marketing approval,” Kiran added.

Apotex, Intas extend collaborative development
Apotex Inc. of Canada and Intas Biopharmaceuticals Limited (IBPL) of India have extended their business agreement to develop a biosimilar version of pegfilgrastim, a protein that is used to treat neutropenia (a side effect of cancer chemotherapy). Neupeg, a recombinant pegylated granulocyte colony stimulating factor is already manufactured and marketed in India and other countries by IBPL.
Both companies, IBPL and Apotex are eying a significant share of total Peg GCSF market in North America, which is currently estimated to be around $3.5 billion annually. This collaboration gives Apotex the rights to market the product in North America (US and Canada), Europe and selected other countries. After announcing the launch of first GSCF generic for North America in May 2008, the extension of collaboration between the two companies makes IBPL the first Indian biopharmaceutical company to announce the launch of Peg GCSF for North America and European markets.
Dr Jeremy B Desai, executive vice president, Apotex said, “This agreement represents an important milestone for Apotex, as it continues to build the organization's biosimilars pipeline.”
Speaking on the development, Mani Iyer, executive director, Intas Biopharmaceuticals Limited, said, “This agreement is a step forward to the vision that we all work for to become a global biopharmaceutical company. This will provide accessibility of Neupeg to people outside the subcontinent, who are currently relying heavily on innovator's brand and other substitutes.”

Ocimum Biosolutions ties up with NuGEN
Ocimum Biosolutions, a leading integrated genomics company, based in Hyderabad, announced that it is now an authorized provider for services using NuGEN Ovation systems for sample preparation. This partnership enables researchers in India, for the first time, to conduct gene expression profiling from a wide range of clinically relevant sample types, such as small, compromised, or formalin-fixed, paraffin-embedded (FFPE) tissues.
Anu Acharya, CEO of Ocimum Biosolutions says, “We are very happy to announce this partnership with NuGEN since we believe that this is an important step towards becoming a truly integrated, world-class genomic service provider. Our subsidiary, Gene Logic, has had a long-standing and fruitful relationship with NuGEN for many years to support our customers' clinical studies in the drug development process. By leveraging NuGEN's expertise and established presence in RNA amplification and sample preparation, we have enhanced our genomic services repertoire and now can also better meet our international customers' needs, especially when working with limited and challenging clinical samples.”
The family of Ovation RNA amplification and labeling products from NuGEN enables life scientists to conduct sensitive, robust, global gene expression profiling and novel signature discovery using a variety of challenging biological samples and gene expression platforms. Ovation Systems are designed for use with a broad range of sample types such as FFPE tissues, whole blood, tissue biopsies, laser-captured micro-dissected cells, and sorted cells. NuGEN achieved ISO 13485:2003 certification in early 2008 for its quality management systems to support the company's customers in meeting mandated regulatory processes.
As an authorized service provider, Ocimum will receive specialized training from NuGEN's technical team. This will ensure they are highly proficient with NuGEN's technology and can generate high-quality data from customers' precious samples. To provide advanced support to their customers, Ocimum Biosolutions and NuGEN will work together to develop additional customer resources, such as online seminars and technology updates.

Syngene to expand integrated drug discovery offerings
Syngene International, a subsidiary of Biocon group, has announced that it will offer fully integrated drug discovery services by partnering with Sapient Discovery, a US based biotechnology company.
Syngene provides integrated chemistry, biology and biologics services to support development programs of pharmaceutical and biotech companies worldwide on a platform of confidentiality and intellectual property protection. While Sapient Discovery is an established leader in structure-guided drug discovery company with a number of proprietary algorithms and capabilities for efficient protein structure based drug discovery and optimization.
“Sapient Discovery's proprietary genes-to-leads, fragments-to-leads and X-ray crystallography technologies provide dramatic reductions in the time and costs associated with compound synthesis and screening and expands the horizons of chemical diversity potentially applicable to novel or even well studied drug targets”, according to Kal Ramnarayan, president and CSO, Sapient Discovery. He also added that Sapient Discovery's fragments-to-leads assures the novelty of identified lead molecules for protein targets, since the 10,000 plus fragment collection at Sapient Discovery can aid in the ultimate synthesis of novel, patentable lead molecules in a short time span.
“The challenges posed by the rapidly growing number of new drug targets will be greatly benefited by the integration of supercomputer-based virtual screening and X-ray crystallography methods with laboratory screening technologies. These techniques are likely to play an increasingly important role in drug discovery and optimization in the future”, said Dr. Goutam Das, COO of Syngene International.
The companies intend to provide a highly integrated platform for structure-based drug discovery with one stop shop for structure-guided discovery, chemistry, biology and structural biology capabilities.

GVK BIO, Crelux set up drug discovery platform
GVK Biosciences and Crelux have announced that they have set-up a fragment-based drug discovery (FBDD) platform to deliver rapidly, viable lead molecules. Crelux's structural biology technologies together with GVK BIO's computer-assisted drug design (CADD) tools and other components of its drug discovery and development engine, encompass all steps from challenging targets to novel drug candidates.
“Collaborating with GVK BIO in a fast emerging competitive area like fragment-based drug discovery is a strong appreciation of our high quality services. Together we have generated a one-stop-shop from target to Investigational New Drug (IND) and support our customers with comprehensive drug discovery services,” commented Dr Michael Schäffer, CEO, Crelux.
“GVK BIO is committed to further advance the discovery tools and services that are needed to systematically profit from the enhanced understanding of biochemical pathways and important molecular target families,” said Sven Wagner, vice president, business development, GVK BIO.
“With a strong alliance partner like Crelux, GVK BIO is moving in the direction of its vision of being a global leader in life-sciences services,” said Manni Kantipudi, president, GVK BIO.

Celestial Biologicals, GE Healthcare to set up plasma fractionation facility
Celestial Biologicals Ltd (CBL) and GE Healthcare have announced a collaboration to set up India's first good manufacturing practice (GMP) compliant plasma fractionation facility in Ahmedabad. The facility will be first of its kind in India. The collaboration will include appropriate technology, products, processes and project development for establishing the plasma fractionation facility. A MoU was signed between Celestial Biologicals and GE Healthcare at the Vibrant Gujarat Global Investors Summit 2009. The facility will be fully functional by early 2010.
The market demand for blood products is dynamic and currently plasma products are imported from other countries. It is estimated that one million liters of plasma is required annually in India to meet current clinical demands. Hence, local manufacture is the key to providing plasma products at affordable prices to Indian patients.
“With a comprehensive life sciences facility such as the CBL, a diverse range of solutions and process support are required. GE Healthcare demonstrated an attractive proposition because as a key healthcare and life sciences infrastructure provider, they presented a holistic approach to cater for multiple aspects of CBL projects seamlessly,” said Dr Urmish Chudgar, managing director, Intas Biopharmaceuticals Limited.
Under this collaboration, CBL and GE Healthcare will jointly set up a pilot Plasma Fractionation facility of approximately 15,000 liter to 40,000 liter capacity for at least four products at CBL's existing GMP-compliant facility. The companies will plan scale-up of the plasma fractionation facility to 300,000 liter capacity simultaneously. Celestial Biologicals will also explore the possibility of utilizing the facility for the purpose of contract fractionation. Celestial Biologicals is the first company to undertake organized collection of plasma, which is key to the plasma fractionation process. It will also explore the possibility of utilizing the facility for the purpose of contract fractionation.
Both companies will work together in the area of developing the desired technology for plasma fractionation thereby enabling the companies to leverage their respective strengths in the areas of biotechnology and transfusion medicine and research. The joint plan of action is to successfully execute the implementation of well-established chromatography technology for processing plasma (recovered and source plasma) and recover high yields of purified products on scales of up to 300,000 liter annually. The laboratory facilities have already been set up along with plans to include dedicated collection, testing and storage facilities for plasma as well as other ancillary utilities.

India's first insulin guidelines for management of diabetes
India's first premix insulin guideline was launched by the former president Dr A P J Kalam on the sidelines of 64th annual conference of Association of Physicians of India, APICON-2009 in Greater Noida.
The premix guideline is formulated by 27 experts (Indian National Consensus Group) comprising diabetologists, physicians and endocrinologists across India. There were no specific guidelines in insulin therapy for the Indian diaspora. The western guidelines (the only ones that are in force) rarely get implemented in countries like India and China. Hence, the panel of experts on the Indian National Consensus Group discussed and defined the problem of insulin usage in primary care in India.
Majority of patients in India are dealt and cared by primary care physicians (PCPs), and making insulin therapy more user friendly to PCPs is imperative to contain diabetes in the country. Premix insulin stands out as the most suitable and effective regimen as it addresses the condition in a simple and efficient way (controls both post prandial and fasting plasma glucose). The premix guideline will now arm a primary care physician with a simple algorithm that can be implemented. NovoMix 30 from Novo Nordisk is the leading modern premix insulin in India
“These much-needed guidelines will empower physicians with a simple and doable algorithm for starting and treating with insulin therapy,” said Dr A.K. Das, medical superintendent, JIPMER, Pondicherry and one of the members of the national consensus group.
“The insulin guideline will immensely help in reducing the huge burden of mortality and morbidity caused by uncontrolled hyperglycemia,” commented Dr A K Jhingan, chairman, Delhi Diabetes Research Centers.

Merck India launches Sharp and Active initiative
The consumer health care division of Merck Limited (India), a subsidiary of Merck KGaA of Darmstadt, Germany, has announced the launch of the Sharp and Active initiative. The initiative aims to spread awareness about iron deficiency and the dangers that lie in ignoring its seemingly innocuous symptoms, which could ultimately result in iron deficiency anaemia.
While commenting on the initiative Dr Marek Dziki, managing director, Merck Limited (India) stated, “The women's health care segment is very nascent in India. India has a comparably young population with a high proportion of children (364 million). Therefore the health of women and children remains a priority. The Sharp and Active initiative aims to cater to the huge unmet health need of the Indian woman. We plan to launch this initiative through health care practitioners and the media and reach out to the masses. The aim is to create opinion leaders or 'multipliers' who will carry forward the message of awareness.”
Speaking at the launch, Shishir Ranjan Mishra, head, consumer health care business, Merck Limited, said, “We are delighted to launch Femibion – Sharp and Active for women for quick replenishment of iron reserves, which will not only enhance their efficiency but also keep them fit and healthy. With more and more women entering the formal work place, there is a rise in their spending power along with a growing demand for female-specific products.”
A single Femibion – Sharp and Active capsule contains four types of different micro-pellets for essential nutrients like Iron (ferrous fumarate), Folic Acid, Vitamin B12 and Zinc. The multiple unit dosage formulations technology used ensures that, once the capsule is swallowed, the individual drug constituents are uniformly released over a large gut area, thereby minimizing the side effects. It also leads to better absorption of iron in the gut and stability enhancement due to minimal interaction between the components.

Arcadia Biosciences, Advanta to develop efficient sorghum
Arcadia Biosciences, an agricultural technology company focused on developing technologies and products and Advanta, a multinational seed company, announced the completion of a research and commercial development agreement for the development of nitrogen use efficient (NUE) sorghum. Under terms of the agreement, Advanta receives exclusive global rights to the use of Arcadia's NUE technology in sorghum. Arcadia receives an upfront payment, milestone payments and a share of commercial sales.
Sorghum is an important feed crop that is grown on more than 100 million acres globally. In addition, sweet sorghum is a highly productive potential biofuel source. Like most grain crops, sorghum is extremely dependent upon nitrogen fertilizer to achieve attractive commercial yields.
Also like most grain crops, it is an inefficient user of nitrogen-barely more than half of the nitrogen applied to sorghum fields is utilized for plant growth. As a result, the remainder may run off into area waterways or volatize as nitrous oxide, a potent greenhouse gas. Availability of NUE sorghum varieties can significantly reduce the amount of nitrogen farmers apply to fields, which can increase on-farm productivity and profitability while decreasing the potential environmental impacts from nitrogen fertilizer use. Reduced use of nitrogen fertilizer will also reduce the carbon footprint and increase the net energy of biofuels based on sorghum crops.
“Sorghum does not have as much widespread visibility as other grain crops. Sorghum is an extremely important global crop, and its importance will continue to grow as a function of the increasing interest in biofuels. Development of NUE sorghum varieties can help farmers who produce sorghum for feed or fuel to farm more efficiently, cost-effectively and in a way that's better for our global environment. Advanta is a world leader in sorghum seed development, distribution and sales and are the perfect partner for this program,” said Eric Rey, president and CEO of Arcadia.
“This is an important step forward for us in our effort to bring the latest technologies to the sorghum farmers around the world. By increasing the efficiency of the sorghum plants in their utilization of nitrogen we will be able to enhance the yields, reduce the consumption of nitrogen and eventually reduce the costs for the farmer. We are very excited by this development. Arcadia has a leadership position in the NUE technology and we are very happy to partner with them in this process,” said VR Kaundinya, CEO and managing director of Advanta.

ICRISAT's hybrid pigeonpea takes roots in China
The world's first commercial pigeonpea (red gram) hybrid developed by the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT), using the cytoplasmic-nuclear male sterility (CMS) technology, is now taking roots in China. Earlier pigeonpea was successfully tested in India.
The first pilot hybrid seed production program is presently being undertaken by a farmers' organization in Yuanmou county in Yunnan province of China. Pigeonpea is mainly grown for soil conservation in about 150,000 hectares on the hilly slopes of Southern China. The hybrids perform better due to their fast canopy development, greater biomass production and strong root system. Pigeonpea hybrids are known not only for their 30-40 percent yield advantage compared to pure line cultivars, they also resist major yield-reducing stresses such as drought, soil borne diseases, water-logging and soil salinity.
According to Dr William Dar, director general of ICRISAT, China's interest in promoting ICRISAT's hybrid pigeonpea is an indication of the benefits that the new hybrid has over the existing pigeonpea varieties. “I am confident that the revolution we started in India with hybrid pigeonpea will soon spread to different parts of the world,” Dr Dar said.
Besides China, the other countries where pigeonpea hybrids technology will be introduced shortly are Myanmar, Brazil, Tanzania, and Malawi.

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