• 7 October 2009
  • News
  • By Nayantara Som

VC funding-making a difference

VC funding-making a difference

Biotech being an inherently risky business, many private funding agencies appear reluctant to supply cash. Here is a look at the current biotech financing scenario and the withering gaps in funding.

India might be a late entrant to the race but this has not stopped venture capitalists, private equity players and funding agencies being bullish about the Indian biotech industry. Over the past five years, India has been seeing a decent investment of over a  billion dollar into this space both by foreign and domestic players. The Venture Intelligence survey of leading Private Equity (including Venture Capital) fund managers suggest a strong appetite adding to over $2 billion (about Rs 9,589 crore) investments that they have already made in the healthcare and life sciences (HLS) industry over the past five years. The report also goes on to mention that given the fragmented nature of both the hospitals and pharmaceuticals sectors, investors see clear potential for tapping into consolidation opportunities in partnership with growth-oriented entrepreneurs.
Says Kapil Khandelwal, founder and board member at Disease Management Association of India, and former vice-president of Healthcare and Life Sciences Business at Jubliant Biosys, “The investments into the Indian life sciences sector ranges from $150 million to $250 million (about Rs 719 crore to Rs 1,198 crore, respectively). The financing ranges from PE, debt to alliance funding. On the other hand,  foreign financing is coming through the route of  debt financing, PE funds, joint venture investment, drug discovery alliances, dndowments through academic medical research centers and/or NIH from the US, donations/social funds, other routes such as acquisition/divestments, in/out licensing are sought.” Other ways of funding also include annual development fees payment, R&D funding, equity, quids, milestone payments and royalties.
The year 2006-07 saw the maximum number of investments into the life sciences space, where about $150-200 million (about Rs 719-1,198 crore) worth of deals were signed, with Hyderabad-based Ocimum Biosolutions getting in investments worth $20 million (about Rs 95 crore) and four CROs seeing the exit route. It has also been observed by industry experts that among the top 10 areas of investments (across all sectors) by VCs and PEs in India- healthcare and life sciences features in this priority list. 
Comments Dr Jasmin Patel, MD, Fidelity International, “Over the past five years, at least a billion dollar has been invested into pharma life sciences space which includes traditional
generic companies, biopharma, diagnostics, pure biotech companies and CRAMS.”

With sectors like IT and real estate reaching a saturation point, the number of VC and PE firms investing in life sciences has also seen an upward trend. Altogether, there are around 20 Indian as well as foreign VC firms which are active in the biotech space.
According to Dr Patel, there are five or six types of sources of funding for young biotech and venture capital companies. “The obvious one is VC funding because there's a high risk in a highly technologically driven company; VCs are comfortable in investing in such risks. In India, there are the PEs, and the growth capital players who are a subset of PE players who might not invest in a start ups, but they might invest in the next round. The first two are more of financially-driven investors,” he adds. He maintains that there are the strategic investors, who could be categorized as the 'big pharma companies'. These companies look at finances in their balance sheet, how can they mitigate their risk in the R&D portfolio, and then, take over another company. “They are a mix of a commercially driven, financially-oriented and R&D oriented investors. Funding is also done by government and NGOs who are not financially motivated but are driven more by public health or philanthropy. Their main aim is to foster biotech research by giving in loans and grants,” says Dr Patel.
Corpus funding by an academic institution, which is a popular phenomenon in the West, has not yet picked up in India.  “Academic institutions in the west plays a potential role in providing seed capital like the Havard Medical School's Harvard Partners, Cleveland Clinic, Mayo Clinic, have endowments of over $6 billion (Rs 28,767 crore) from NIH, and industry from which they are successful in spinning off innovative enterprises. In India, universities do not have that capability despite the fact that some brilliant ideas and technologies are being developed there,” adds Khandelwal.

Sector influx of funds
Over the years, investor behavior towards this space has been moving on a whimsical route. Excitement to invest in this sector goes back to 2000, when the sequencing of the human genome project was first announced. Subsequently, that saw a spurt of investments in sub sectors like bioinformatics, clinical trial development and integrated drug discovery projects. Money rushed into the sector with the announcements of product approvals and companies rushed to go into IPOs. However,  long gestation cycles, realization that biotech was an altogether different ball game from its pharmaceutical counterpart led to investor sentiment dying out.
Giving a global perspective, PriceWaterHouse Coopers' report mentions that in 2008, funding was seen to be stronger in seed/start up companies and early stages while it fell in later stages. The report further mentions that VC-backed human biotech companies drew 16.2 percent of financing, while early stages drew around 9.6 percent of financing. Therapeutic and diagnostic biologics brought in the maximum amount of VC investments into the space. Vaccines is another segment which has been attracting investors.  
Deepam Mishra, CEO of i2india Ventures, says, “Early stage research driven innovation involves very high risk, but is highly rewarding. Areas in life sciences in which a lot of ideas are coming out are point of care diagnostics -the simple to use tools that can be made available even in small cities and towns. Other than that, regular areas like vaccines is an attractive area for investment.”

He believes that from the financial investment point of view, many diseases are not getting enough cash flow; they may be the country's need but not good money making propositions for private investors. Private money doesn't often go for neglected diseases.
i2india Ventures is also keen at novel imaging technologies. Mishra says, “A lot of work is happening in this field, the whole area of biological enzymes. Having enzymes to replace the industrial use of catalysts which are polluting, non-degradable and at times expensive is also attractive. There is a lot of interesting work going on in the area of bioseperation, biocatalysis and process chemistry.”
He further admits that although a lot of interesting innovations are happening in cell biology and molecular chemistry, most of them are very complicated and difficult to understand, therefore, not too many investments happen.
Giving the Indian overview, a Venture Intelligence survey report mentions that between 2004-08, around 40 percent of all PE investments went into the pharmaceutical sector, 24 percent into hospitals, 10 percent into CROs, 13 percent pure biotech while the remaining portion of the pie constituted sectors like medical devices, diagnostics and wellness.
Diagnostics, medical devices and the services sector today are posing to be lucrative sectors. Again, Venture Intelligence conducted a poll among private equity and venture capital firms during April-May 2009. Fund managers from over 60 firms participated in the poll. According to 87 percent of the fund managers polled, Healthcare and Life Sciences (HLS) should constitute at least 10 percent of portfolios of new funds being raised for investing in India. Investors chose diagnostic services, medical devices / equipment, hospital chains, wellness products and services and CROs as their favourite sectors for investments within the HLS industry. Other areas of interest include specialized chains in areas like diabetes, orthopedics, optics, geriatrics and psychiatric.
Mentions Dr Patel, “In India, the CRO businesses are very interesting because they have the potential to scale up and expand. Investors in China for instance invested in a lot of CRO deals, and have been successful. Innovation companies mainly those doing drug discovery business look lucrative but there are very few of them in India. Companies providing services, more consumer based services are interesting in addition to pharmacy chains and path labs.”
With a nosedive drop of real estate prices, infrastructural investments in biotech is another interesting area for investments. “With the downturn, there has been a sharp fall in real estate prices. We shall see return of investments in SEZs, biotech parks and health cities,” adds Khandelwal.
From a futuristic point of view, biosimilars is another area investors are cashing on. So far Biocon, Dr Reddys Labs and Lupin Pharma, are some of the prominent names successful in this field. Other prominent companies who have started initiatives in the field includes Glenmark, Cipla and Intas Biopharmaceuticals. The latest in the news is Cipla entering into a 50:50 joint venture with a Chinese company for bio-similars. The joint venture would be called Biomab. Cipla has said it was looking to bring out the JV's first product by 2010.
“The biosimilar segment in India continues to attract huge interest, intent and is intensely controversial. Most generic manufacturers are trying to actively get involved in it, either directly or indirectly. The flow of  investments and investors will be to the successful ones that demonstrate the patience, resources and above all money to invest now, to show proofs and validation in order to gain in the future,” adds Khandelwal.
There have been options which was presumed to open up a world of opportunities but went bust towards early stages. Spinning out of R&D units for example, was mooted by pharmaceutical companies as the next big thing with Sun Pharma, Dr Reddys, Glenmark, Nicholas Piramal hiving out their units. But the failure of Percelan Pharma, a spin out of Dr Reddys Labs and the early backing out of  ICICI Venture and CVS international turned the tables for investors. Nicholas Piramal was forced to hold back further plans of raising funds for Piramal Healthcare, its hived out R&D unit, because it failed to attract investors at its expected valuation. Hence, investors now have given the thumbs down to this model.

Activities of investment firms
There have been trigger factors in the Indian economy which had led firms put on their thinking caps, and start seriously looking at the life sciences sector.  Agrees Nitin Deshmukh, CEO, Private Equity, Kotak Private Equity Group (KPEG),  “Over a period, surely there had been some trigger factors in the economy which has led us to invest classic growth capital funds into this sector. In the 1990's, when capital was down, we thought of shifting our focus to non-capital sectors. Life sciences was one of them. Similarly,  in the same period de-licesning came about which made us invest in companies like Sun Pharma and Neuland Laboratories. In 2005, there was the GATT policy which came up. This made us look at drug discovery, and healthcare was an upcoming sector.”
Kotak Private Equity Group (KPEG) today is a specialist India Private Equity firm of Kotak Mahindra Group, and is focused on helping emerging corporates and mid-size enterprises. Today, it has three types of funds namely, India Growth Fund I and India Growth Fund II and Venture Capital for Life Sciences. It has allocated around $100 million (about Rs 479 crore) into the life sciences sector. The firm started investing in biotech in 2000 with companies like Biocon, Avesthagen and Syngene in its portfolio. Later,  it also looked at companies specializing in global manufacturing and services. Today, its current investments include Siro Clinpharm, Metahelix Life Sciences, VLife Sciences, Rubicon Research and Indus Biotech. “We have a 70 percent stake in Siro Clinpharm along with another investor,” adds Deshmukh.
Some of these companies have made impressive progress. Rubicon Research, which is into developing formulations has till date developed seven platform technologies which has been patented (which it further out licenses). It has also ventured into the field of OTC drugs. Indus Biotech looks into plant extracts wherein they extract molecules, isolate and purify them, and then take them through the NCE route. It is developing a Parkinson's drug wherein 40 patients were recruited in Mumbai while studies were done outside. Indus has also been given a fast track approval for a HIV drug. “Most importantly, it recently established that this drug was also active against the H1N1 virus for swine flu,” adds Deshmukh. Metahelix Life Sciences has product pipeline of Genetically Modified (GM) seeds in cotton, rice, cabbage, maize and tomato with specific traits like insect control, drought and salinity resistance. It is expected to be the first indigenous company to commercialize GM technology while Siro Clinpharm has emerged to be one of the largest Indian CROs, today.
Fidelity Fund Management, part of Fidelity International, is also cashing in on the life sciences sector. The amount of allocation for this sector was not revealed by the management. Dr Patel mentions, “We are actively looking at this sector. Out of a team of seven people, we have four members who are wholly focused on this sector.” But other reliable sources confirm that the allocation for this sector comes up to $12.9 million (about Rs 61.84 crore).
Some of the other firms who have invested into the sector include Nadathur Holdings and Investments, Actis Capital, HSBC Investments in Glenmark, Tamasek, New Bridge Capital, ChrysCapital in Matrix Labs, Claris Life Sciences has Carlyte Asia Pacific as their investor, Ocimum from IFC, Sai Advantium from ICICI Ventures, GVK BioSciences from Sequoia, Sphaera Pharma from Barring Equity and Cellworks from Artiman Ventures.
i2india Ventures, the Indian arm of Imperial Innovations, UK, the technology commercialization venture of Imperial College London, is a hybrid of a VC and technology/research comercialization company. It has been working in partnership with research and innovation centres, to create an ecosystem for early stage technology commercialization. In India, i2india has signed agreements and is working with leading institutions such as IITs, IISc, and has conducted over an year of field studies to understand the opportunities and challenges in this space.

Is innovation happening?
There is no dearth of funding into the biotech sector, but there are surely bottlenecks in terms of innovation, claim industry experts. “People say that there is not enough venture capitalists in India which is true. But that is because there isn't any innovation in India. To create an investment climate, one should look at investing in innovative ventures and make them successful so that, the cycle is broken,” adds Dr Patel.
A well renowned expert from the venture capital field, who does not wish to be named  maintains, “I do not believe that there is no innovation at all. The problem here really is that the ideas are not maturing, and that, the business models are not sustainable. I would go to admit because we have a strong foundation in chemistry, and not the requisite structure for biotech.”
Above all, an important fact to bear in mind is that Indian scientists have their chemistry strong but are still lagging behind in biotech. Hence,  generics was an easier option because it was easy to emulate and the returns were high. Agrees Dr Patel, “About 10 years ago if you were a young scientist who wanted to start a company, you would rather go in and start an API or generics formulation business because it was easier to do. The markets were there, risk was low, and the demand was huge so people would not be innovative in that sense. Innovation is not just about creating new drugs but about knowing and understanding things differently.”
Dr Rajeev Soni, president and COO, Premas Biotech, a start-up company funded by a VC based in UK, suggests, “The like-minded VC's and PE's should have to take some degree of risk and come forward to fund start-ups (of-course after complete due diligence), so that they can innovate and increase more opportunities for other entrepreneurs and VCs to join the game. In addition, detailed planning in terms of an executable business plan with respect to return on investment is often lacking from the scientists, who would like to be entrepreneurs which usually does not go well with most VC's/PE's.”

Gaps in funding
Barring a handful of firms which houses a dedicated team for life sciences and has allocated separate investments for this sector, there are may firms for whom the sector still remains in the periphery of their priorities. VCs have a limited understanding of life sciences due to the complexities involved. Also the long drawn gestation period in a product cycle is another reason for VCs and PEs being reluctant.
This is a stark contrast to their counterparts in the US and Europe, who have been majorly investing in life sciences. This is also because of a team which is made up of experts who have hands-on-experience in biotech. Firms in the US for example have a team which has an in depth knowledge of the industry, acquainted with the dynamics of the field, hence are able to channelize their investments. In India, there are firms headed more by financial investors than those with a scientific background. “The VC community needs to hire a few PhDs on their rolls and some patent attorneys. I don't think there is any true biotech VC fund in India,” says Dr Villoo Morawala-Patell, CMD, Avesthagen.
Says Deepam Mishra, CEO of i2ventures, “In India there are very few VCs who are biologists or PhDs. Most of them are business people and bankers. In the west, most of the VCs are biologists themselves. They have started a company sold a company, and then have become VCs. They are scientists turned venture capitalists. So there, the degree of comfort while investing is higher. That's the gap we are trying to fill-in in India. We bring the mix of very high technology understanding with PhDs at the same time we bring in investors who are experts in finances.”
Highlighting the challenges while investing in life sciences, he says, “Technical understanding is the biggest challenge. The other is that the research works happening in government research labs are not very well connected with the industry. The maturity of technology is lower, so the validation needs to be done a lot more after the scientists thinks he/she has finished the project.”
He adds, “I don't agree that there is a lack of innovation in the country. There are lots, they may be guided, unguided or unknown. Often scientists do not have enough interest in taking it to the market.”

Funding from government/NGOs
Apart from VCs and PEs,  the Indian government along with a handful of  NGOs play a potential role in funding biotech initiatives, especially R&D initiatives coming out of universities.  The DBT's latest initiative-the Biotechnology Industry Partnership Program (BIPP)-could provide a fillip for research,  more so,  in the light of industry facing a credit squeeze following the meltdown.
Another initiative is The Biotechnology YES (Young Entrepreneurs Scheme). This is an innovative competition developed to raise awareness of the commercialization of bioscience ideas amongst postgraduate / postdoctoral scientists. The program is organized by the University of Nottingham, Institute for Enterprise and Innovation and Biotechnology and Biological Sciences Research Council. 

Nayantara Som and
Jahanara Parveen
Emphasis on product expertise

Emphasis on product expertise

Indigenously developed drug metabolism enzymes from Premas Biotech have generated considerable interest among  pharmaceutical players.

Founded by a group of scientific experts and experienced industry professionals, Gurgaon-based Premas Biotech is a cGMP compliant contract research and manufacturing services (CRAMS) organization. With a strong foundation of scientific expertise and technology that are dedicated to developing and providing integrated research solutions in the area of life science research, Premas Biotech has indigenously developed the drug metabolism enzymes known as CYP P450 suite of enzymes.
Premas Biotech has co-expressed major human drug metabolizing enzymes (DMEs) along with human NADPH-dependent cytochrome P450 reductase in Saccharomyces cerevisiae (yeast host system). The yeast system enables efficient expression of complex, multi-subunit proteins along with post-translational processing which essentially mimics the human system. The presence of a single enzyme that enables specific applications and read-outs required in drug metabolism and drug-drug interactions are the advantages for this recombinant expression.

“We wanted to develop this product, as we have the right expertise. This product is owned by only four companies in the world. There are several major enzymes and pathways that are involved in drug metabolism, CYP450s form an integral and important core in determining safety, efficacy and toxicity for testing new drugs. This is a very complex protein family, and it is quite difficult to express in a recombinant fashion. The range covers enzymes that metabolize 90 percent of the human drugs consumed/xenobiotics. This also covers the major enzymes which leads to maximum sales (about 80 percent),” informs Dr Rajeev Soni, COO, Premas Biotech.
The company has filed two patents for the technology. “It was an extremely challenging task to produce these recombinant enzymes and to scale them up for mass production, and the credit goes to the entire DME (drug metabolism enzymes) team,” adds Dr Soni.
Premas Biotech believes in focusing on a niche area rather than playing in a crowded space. According to the founders, this niche helps to maintain healthy margins where most companies are adjusting by dropping prices. The company's focus is on biomolecules, proteins, receptors, cell-based assays, customized reporter gene assays, microarray technology and SNP genotyping. Premas also has significant experience in handling 'difficult-to-express' proteins and high-value-low-yield biomolecules.
The company has a cGMP compliant facility with a capacity for proteins, receptors and enzyme manufacturing of up to 1,400 liters from E.coli and yeast cells, along with continuous high speed and ultra centrifuges, high pressure homogenizers, purification and downstream equipments for large scale work. 

Jahanara Parveen
Thrust on healthier future

Thrust on healthier future

Being a premier company to launch chikungunya kit in India, Bhat Bio-Tech India (BBI) plans to enhance its business growth by rolling out new diagnostics kits.

Bangalore-based Bhat Bio-Tech India (BBI), which was established in 1994 as a manufacturer of diagnostic kits and biotechnological products, has become one of the leading diagnostic and biotech companies in the country. With a vision to reach out to global markets, BBI has launched chikungunya kit, Bhat Bio-Scan Chikungunya IgM Spot Test kit, for the detection of IgM antibodies to chikungunya in human serum or plasma.
This indigenously developed kit has the sensitivity to detect the virus about four to seven days after infection. Recombinant E1 and E2 antigens derived from structural protein of chikungunya has been used to give high specificity. The platform technologies used in manufacturing the product are lateral flow immunochromatography and flow through immunoflitration. “These technologies are being used for the past 15 years and most of our kits are based on these techniques,” says Dr Shama Bhat,  promoter and managing director of BBI.

With a total investment of nearly Rs 50 lakh, it took almost a year to develop the product. Marketing of the product is done through the company's channel partners. “We are looking for the domestic as well as international markets. The kits were sold in several countries in Asia and domestic market as well,” says Dr Bhat.
Claiming that these are not killer technologies but a useful rapid test, Dr Bhat says, “We can get the result in less than three minutes. Even a layman can perform the tests with minimal training. They are robust and stable for more than one year at room temperature. No equipment is needed, the result is in the form of red lines or red dots. The rapid test is a single or two step procedure, and contains all the reagents to perform the tests. Being a seasonal product, the company has the capacity to produce over 50,000 tests per day, and could be upped to 100,000, if needed,” adds Dr Bhat. 
In 1996 BBI started selling its pregnancy kits. “Today, we produce nearly 100 products. And there has been a consistent growth of 20-30 percent  in most of these products,” says Dr Bhat, a former professor of the University of Pennsylvania. He strongly believes that technological development has provided a major thrust for the growth of biotech business, and has made several tests simple and rapid.  
BBI is a leading player in the domestic market and caters to the needs of Union government, National AIDS Control Organization (NACO) and the World Health Organization (WHO). BBI, which has a considerable overseas presence in 40 countries, is also looking for an opportunity to expand its presence in Brazil, Russia and China.
The company, which started with an initial investment of Rs 1.5 crore, today records a turnover of over Rs 12.5 crore, and this year, it expects a growth of  20-30 percent. BBI will be commissioning its new production plant and R&D center, which was built over an area of 40,000 sq.ft. “With the addition of three more units, we will double the production to 200,000 kits per day. Plans are underway to increase the number of production units to 10 to produce 300,000 kits a day,” Dr Bhat adds.
BBI ventured into contract research arena in 2006. “For contract research, we've tied up with Defense Research and Development Organization (DRDO). Talks are on with a US-based company for drug discovery by using herbals,” he informs.
BBI is committed to continuous quality improvement and delivers products that strictly comply with quality standards like ISO 9001, ISO 13485, CE certification and Good Manufacturing Practices (GMP). Besides chikungunya kit, other products of BBI include pregnancy, HIV, Hepatitis B and C and urine chemistry diagnostic kits. The company plans to expand its business growth by rolling out more new kits, viz; molecular biology, micro-array and H1N1 diagnostic kits.  „

Anjana Pradhan
Innovating affordable solutions

Innovating affordable solutions  

ReaMetrix is the first company in the world to successfully pioneer an FDA cleared dried-down product to measure CD4 counts that needs no refrigeration.

Rather than importing solutions developed elsewhere, Bangalore-based Reametrix believes in innovating affordable solutions locally, to address the diagnostic needs of a developing nation within the challenges of the local environment.

Reametrix firmly believes in the adage 'Process is our Product', and that, robust processes lead to accelerated innovation. The medical diagnostics company has developed the 'Dry Tri-T Stat' product used in HIV management for the global market. This is claimed to be the only US FDA cleared dried-down CD4 enumeration product available in the world today for the flow cytometry instrumentation market. This unitized, dried-down delivery format eliminates the need for refrigeration, exhibits nearly 99 percent correlation with conventional liquid format, and is at least three times more affordable than other products existing in the market.
Expressing delight that a company in India has treaded a new and commendable path impacting the global medical diagnostics industry, Dr Bala Manian, CEO, ReaMetrix, says, “ReaMetrix is proud to have pioneered a revolution in global diagnostics. At ReaMetrix, we believe in inverting the conventional thinking by solving the diagnostic needs defined under the constraints of the developing nation context, and then, deploying these solutions globally. The 'dried-down' innovation is a successful validation of our thinking, as this is an innovation that is set to have a global impact.”

According to NACO estimates, national adult HIV prevalence in India is approximately 0.36 percent of total population (2.5 million people, approx). Currently, there are 197 government Antiretroviral Therapy (ART) centers and some private ART clinics, in India where CD4 testing is available. Access to reliable, accurate and affordable CD4 testing solutions, is key in the clinical management of HIV patients. Some of the predominant issues with CD4 testing in the Indian context are the high cost of testing,  poor access to testing, poorly developed cold chain for transport, storage and use of products and a complicated work flow, requiring skilled labor. The real challenge lies in transporting blood samples from remote areas to centralized testing centers. In most cases, this leads to 'aged' blood samples (> 48 hrs), making it unusable for testing. ReaMetrix's innovative dried-down CD4 enumeration product helps address this need.
With the unitized, dried down products, the cost of the CD4 enumeration test per patient will see nearly a four-fold reduction in costs, while, at the same time, producing accurate diagnosis. Blood can be collected, stained and fixed at the point of collection before being shipped to a central testing facility at room temperature. The stained samples can be stored for up to seven days at room temperate eliminating the issue of “aged” blood samples.
Using ReaMetrix HIV dried-down products, doctors can derive quality diagnostic information at an affordable price. This translates to lower cost of testing for the patient. Since, there is no need for cold chain for the use of these products, diagnostic laboratories will be able to access samples from far-off locations, enabling better cost efficiencies on their centralized and capital-intensive equipments. From a public-health perspective, the affordability will enable frequent testing which in turn will enable a doctor to take treatment decisions based on trends rather than on just a single test result.
Driven by the 'Think Locally, Act Globally' paradigm, ReaMetrix is powered by a cross disciplinary team of engineers, chemists, biologists and doctors; offers innovative solutions in the field of medical diagnostics. The company portfolio of products currently includes products for monitoring HIV progression, stem cell enumeration, screening patients for ankylosing spondylosis, and staging cancer patients.   „

Jahanara Parveen
An affordable oral cholera vaccine

An affordable oral cholera vaccine

Shanchol, the oral cholera vaccine, is one of the most recent innovations from Shantha Biotechnics. Shanchol is easy to administer, cheaper and provides more coverage.

The Shanchol has been developed in collaboration with the International Vaccine Institute (IVI) and the VA Biotech of Vietnam, with the funding from the Bill and Melinda Gates Foundation. The company has spent $1million (about Rs 4.78 crore) for setting up its facilities. Initially, 50 lakh doses will be produced at the facility. Among the dozen vaccine projects supported by the Bill Gates Foundation, Shanchol is the first to reach the commercial scale.
Every year, Cholera kills about 1.2 lakh people worldwide. In the past 10 years, there has been a 70 percent increase in cholera cases. Cholera continues to create havoc in India and in some cases leads to death within 24 hours when left untreated.
Two doses of cholera vaccine is recommended by doctors for children above one year old, and is priced at Rs 300 a dose. The only other World Health Organization (WHO) approved oral cholera vaccine available is Dukoral, a Swedish vaccine, which costs about $40 (about Rs 1,920) and is difficult to administer, especially in public health setting.
Shantha Biotechnics has got enquiries from Bangladesh and Zimbabwe for the supply of the bivalent oral cholera vaccine. Supplies are to be routed through the Gates Foundation. The WHO pre-qualification would be obtained in a couple of months.  „

AML diagnosis made easy

OncQuest Laboratories has introduced an effective tool for prognostication in Acute Myeloid Leukemia patients with normal karyotype.

After building trust with its innovative diagnostic tools, OncQuest Laboratories, one of the  pioneers in the Indian oncology clinical testing, have developed NPM 1 Exon 12 mutation analysis for defining prognosis (outcome of disease) in Acute Myeloid Leukemia (AML) patients, who have normal chromosomal arrangement as determined by conventional karyotype.
AML, the most common form of acute leukemia (blood cancer) in adults, is a heterogeneous group of diseases that are clinically, molecularly, and cytogenetically curable in about 30 percent of cases. These cases display recurrent chromosomal abnormalities, which help to define distinct entities and often confer a favorable prognosis, which is amenable to specific therapies.
However, in 40-50 percent of cases no chromosomal abnormality is visible by conventional karyotyping (chromosome analysis test). Such patients are considered to have an intermediate prognostic risk. Mutations in nucleophosmin (NPM1) are the most frequent genetic change known in patients with normal karyotype acute myeloid leukemia (NK-AML) and NPM1 mutation positive patients have a better prognosis with longer event-free and overall survival. These tests will be available at all the patient service centers of OncQuest including 45 major towns in India, Sri Lanka and Nepal.
Thus knowledge of the NPM 1 Exon 12 mutation could help in predicting favorable/unfavorable response in AML patients, who have normal karyotype, and in predicting good response to diagnose such patients; and monitoring of minimal residual disease in AML patients after chemotherapy. 

Jahanara Parveen

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