Hyderabad - Biotech & Pharmaceutical Hub Updates

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Source: http://www.mydigitalfc.com/news/auro...cts-pfizer-254

Aurobindo Pharma, which has been facing ire of the USFDA coupled with drop in sales, hopes to launch three-four products along with pharma major Pfizer in three months. This could help the company improve revenues from mid-February to June, according to its chairman Ramprasad Reddy.

The US formulations’ sales for the company remained flat this year, partly owing to the import alert by the USFDA on its manufacturing plants based out of Hyderabad. The company is also stepping back from its earlier guidance of $2 billion revenues by 2014, and extending it for a year.

Aurobindo now hopes the regulator would inspect its sites under scanner in the next 20-45 days. “Audit of unit III should have happened on February 13 but it was postponed by another 20 days. Now, it will happen between February 29 and March 4. Audit of unit VI will happen during June-July,” Reddy said.

Investors had, however, raised concerns that the company may attract a 483, which calls for a detailed corrective action plan of the company in writing, for these plants.

Talking about how the US market would do better for them, Reddy said, “Pfizer has some of the smaller low margin products. They are going to launch at least three products in next three months. We will have at least 8-10 million new orders for these products,” he said.

Aurobindo’s in-licencing deal with Pfizer covers 44 generic drugs which will be sold in emerging markets as well as developed ones like the US, Europe and Australia. Meanwhile, the company also plans to go slow on capex over the next six quarters, restricting it to Rs 25 crore per quarter towards maintenance. According to the chairman, the company has a pending capex commitment of Rs 175 crore as on December, which will, however, be complete only by July. This financial year, they had invested around Rs 400 crore.

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Source: Biogenex at the Annual Molecular Medicine Tri-Conference, San Francisco 2012

Hyderabad, Andhra Pradesh -- (SBWIRE) -- 02/21/2012 -- Biogenex laboratory is participating in Annual Molecular Medicine Tri-Conference, San Francisco in line with our mission to bringing affordable healthcare solutions for improved wellness of humanity. Biogenex is a technology leader in Molecular Pathology and provides total solution for the complete automation of cell and tissue diagnostics through its cutting-edge and patented technologies. It enables disease diagnosis at molecular level primarily targeting DNA, RNA and protein.

At this year’s Annual Molecular Medicine Tri-Conference from Feb 19 – 23, 2012 at Moscone north Convention Center, San Francisco. BioGenex, will offers total solution for the complete automation of cell and tissue diagnostics through its cutting-edge patented technologies and instruments Xmatrx, i6000 and EZ-Retriever.

Xmatrx is most advanced platform technology for molecular pathology laboratories of today, tomorrow and beyond. It automates more technologies and staining steps than any other system available today. It supports IHC, ISH, and FISH.

i6000 platform has two variants i6000Diagnostics and i6000 Infinity.

I6000 Diagnostics is Walk-away automation which providers high throughput, unsurpassed speed and versatility for IHC.

i6000 Infinity Is a research system which provides superior flexibility and freedom to customized protocols.

EZ Retriver System enables dewax, re-hydration and antigen retrieval all in one step.

BioGenex, is keen on attracting the medical research community at the Annual Molecular Medicine Tri-Conference at Booth no #606 with it latest technologies such as:

- micorRNA
- Co-detection of IHC & ISH and
- Double Staining techniques

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MSD receives Genome Valley Excellence Award at BioAsia 2012, India
http://pharmabiz.com/NewsDetails.aspx?aid=67663&sid=2
MSD, subsidiary of Merck & Co., Inc, has been awarded the prestigious Genome Valley Excellence Award at BioAsia 2012, India. MSD received this award for its commitment to patient health & vaccine research, its vision, cutting edge research & continual leadership status in the biopharmaceutical space, particularly vaccines and its support and contributions to the initiatives focused on preventing female cancers.

Kevin Ali, President, Emerging Markets, MSD was presented the Genome Valley Excellence Award - 2012 by Andhra Pradesh Chief Minister N.Kiran Kumar Reddy, who formally inaugurated the 9th edition of BioAsia 2012, at Hyderabad. The award ceremony was attended by members of the global biotech fraternity and other dignitaries.

While discussing MSD's commitment to research and the significance of the award, Kevin Ali, said, “It is an honour to accept the Genome Valley Excellence Award on behalf of MSD. We are proud that the State of Andhra Pradesh has recognized our commitment to cutting edge research and leadership status in the biopharmaceutical space, particularly vaccines. The award encourages us to continue developing better vaccines for the world's major infectious diseases, to innovate, and to work hard to find ways to make our products even more accessible to those who need them."

Instituted in 2004 by the Government of Andhra Pradesh, the Genome Valley Excellence Award recognizes and honours eminent individuals and organizations for their exceptional contribution to Life Sciences research & development and encourages path-breaking innovations and achievements. Since then it has been continued in every edition of BioAsia. The Awards reflect BioAsia 2012's commitment to enabling the proliferation of ideas and discoveries intended to elevate the quality of human life itself.

MSD operates its human health business in India through three separate legal entities: MSD Pharmaceuticals Pvt. Ltd., Organon India Limited and Fulford India Limited, which are subsidiaries of Merck & Co. Inc. MSD in India currently operates in various therapeutic areas including metabolics, cardiovascular, vaccines, critical care, immunology, virology, oncology, women's health, dermatology, respiratory, virology, musculoskeletal and primary care and offers a strong and diversified product portfolio of over 75 brands, of which 13 are already category leading products.

[Gudavalli]

Source: http://pharmabiz.com/NewsDetails.aspx?aid=67725&sid=2

Yashoda Group of Hospitals recently conducted an international conference of neuroscience focusing on stroke and cerebral haemodynamics at Hotel Marigold in Hyderabad. The objective of this international conference was to exchange ideas and introduce cutting-edge research and therapy-oriented technologies in the key areas of clinical neurology.

The programme was inaugurated and presided over by chief guest, D Sridhar Babu, state minister for consumer affairs, food & civil supplies. The conference presented the latest technical advances and contemporary treatment options on stroke and cerebral hemodynamics. A panel of experts in neurology and stroke offered their perspectives on a series of cases that demonstrated the myriad challenges faced by physicians who treat patients with stroke or at risk of stroke.

A stroke or ‘brain attack’ occurs when a blood clot blocks an artery or a blood vessel breaks, interrupting blood flow to an area of the brain. As per the estimates of World Health Organisation (WHO) about 5.5 million people die from stroke worldwide making it second major cause of death in the world.

During this conference, Yashoda Group also organised a neurosonology workshop on extracranial doppler and transcranial doppler which was conducted by distinct neurologists who are certified in neurosonology by American Society of Neuroimaging (ASN).

Speaking on the occasion, Dr G S Rao, managing director of Yashoda Group of Hospitals said, “We have always maintained sustainable quality and continuous improvement in patient care over the last two decades. A perpetual effort to strive for excellence in medical education and research inspired us to organise this international conference on neuroscience. The conference is aimed at creating space for both international neuroscience experts and aspiring students to share thoughts and research results, as well as to develop a sense of community that will lead to future cooperation.”

Elaborating on the need to organise an international conference on stroke and cerebral haemodynamics, Dr R N Komal Kumar, senior neuro physician at Yashoda Hospitals and organising secretary of the programme said, “Stroke and its potentially debilitating consequences necessitate expedient and effective therapies that will minimize residual effects and ensure the best-possible quality of life for patients. This conference is an educational initiative, designed to bring eminent neuro specialists from India and other countries closer to stroke care by providing up-to-date and clinically relevant information applied to a variety of situations.”

About 150 eminent neurologists, neurosonologists, neurosurgeons and stroke specialists from India and abroad, including close to 200 general physicians attended the scientific sessions. The scientific sessions in the international conference covered key topics that include stroke prevention, acute stroke and cerebral haemodynamic.

[Gudavalli]

Source: http://pharmabiz.com/NewsDetails.aspx?aid=67744&sid=1

The Andhra Pradesh Neuroscientists Association (APNSA) organized a Brain Tumour awareness campaign by conducting a solidarity walk at Necklace Road in Hyderabad.

Many dignitaries, neurosurgeons and celebrities took part in the walk to highlight about its noble cause of creating awareness and express solidarity with brain tumour patients and families. Prominent people present at the walk were D L Ravindra Reddy, Honourable Health Minister, A K Khan, Commissioner of Police and V V S Laxman, Indian test cricketer.

Speaking on the occasion Dr M R C Naidu, former professor & HOD Neuros, Osmania Hospital, said brain tumour can be prevented and can be cured if it is diagnosed at the early stage. He emphasized that there is a need to create greater awareness among the general public regarding the brain tumour and its available treatment.

“This is our endeavour to make the people aware and get proper treatment. We will conduct the camps in the rural areas and create awareness to them also. Services are available in all government and private hospitals. Neuro surgeons have to come forward and we are inviting eminent persons to share their scientific knowledge,” said Dr Naidu.

Recently there have been lots of cases emerging relating to brain tumour in the state. General population in the country is unaware of the dangers of brain tumour and they are also not able to identify the symptoms of brain tumour in the initial stages because of which many are approaching the hospitals after entering into serious conditions. Therefore it is high time the general public should be aware of the brain tumour and its causes.

Brain tumour is mainly caused when brain cells multiply excessively in an uncontrolled manner and do not function like normal brain tissue instead cause pressure on the adjacent parts of the normally functioning brain thereby producing various symptoms.

Usually the brain tumour develops from the local, native, brain cells. However, such cancerous (malignant tumour) cells can also come from distant body organs like lungs, breast, etc. This disease is not infectious and it will not spread from one person to another person as it is in case of T.B., skin contact Scabies, Sexual contact HIV, Malaria etc. In no case it is transmitted by one human being to another. However, they can be transmitted from one generation to another genetically. So far nobody knows fully about the actual cause of primary (native) brain tumours.

Brain tumours are relatively common and can occur in any age group including children less than one year old to elderly people. There is no sex predilection. Symptoms related to a brain tumour are directly related to the location of tumour and its size. Tumours in critical locations are likely to present much earlier than tumours in non eloquent regions of the brain. The most common symptom of presentation is headache. Headache is predominantly in the forehead region more in mornings and associated with vomiting. Vomiting usually relieve the headache. Headache can occasionally be associated with blurring of vision at the peak of headache. Other possible symptoms of a brain tumour include a new seizure in an adult, gradual loss of movement or sensation in an arm or leg, unsteadiness or imbalance while walking, loss of vision in one or both eyes, double vision etc. Diagnosis and confirmation of tumour is usually done by doing a CT scan or MRI of the brain.

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Australian firm to pick up 74% stake in Hyderbad pharma firm Cheminnova
http://www.thehindubusinessline.com/...cle2942603.ece

HYDERABAD, FEB. 29:
Hyderabad-based pharmaceutical manufacturer Cheminnova has entered into a joint venture with Brisbane-based neutraceuticals firm Rapid Nutrition Ltd.

“The joint venture has been formed on the basis of our phased equity dilution up to 74 per cent,” Mr Vasudeva Rao, Managing Director, Cheminnova, told newspersons here on Tuesday.

The joint venture will result in the addition of significant business, brands of Rapid Nutrition and intellectual property rights to Cheminnova, he said.

Mr Simon St Ledger, Managing Director, Rapid Nutrition, said his company would have immediate advantage of access to manufacturing facilities of Cheminnova according to the agreement.

The deal, which is being described by Cheminnova as a creeping joint venture, would result in acquisition of 74 pc stake in Cheminnova by Rapid Nutrition in next 18-24 months.

The financial details and valuations were not disclosed. The joint venture will be executed by a special purpose vehicle to be formed by Rapid Nutrition in India.

The current turnover of Cheminnova is about $20 million with three facilities. “Our on-going contract manufacturing for the markets in West Asia, Africa and Asia will be shifted immediately to Cheminnova units in India,” Mr Ledger said.

Cheminnova has three facilities for injectiables and oral liquids – two in Hyderabad and one in Baddi, Himachal Pradesh.

Rapid Nutrition had a turnover of $68 million and is in the process of getting listed on the German Stock Exchange by end of March.

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Source: http://timesofindia.indiatimes.com/c...w/12182414.cms

HYDERABAD: City-based eye specialists will take up a major campaign this World Glaucoma Week, between March 11-17, to spread awareness about glaucoma and the need for its early diagnosis.

Doctors say that the silent eye condition is the leading cause behind irreversible blindness in the country with as many as 1.1 million losing their eyesight to the disease. Doctors said that 90% of glaucoma cases are undetected, mostly due to a lack of awareness.

Speaking at a news conference on Wednesday, Dr Sirisha Senthil, glaucoma specialist at LV Prasad Eye Institute (LVPEI,) said that the disease was second only to cataract as a causal factor for blindness.

But while a cataract is curable, in glaucoma, there is no cure once a patient loses vision. Senthil said that diagnosis remained a major challenge as the disease has quite a late onset of symptoms, apparent only when the patient begins to experience a loss of vision.

A study conducted by LVPEI found that 50% of those diagnosed with glaucoma at an advanced stage had consulted an eye specialist in the last six months notwithstanding which the disease went undetected due to improper examination.

Glaucoma occurs when the optic nerve (which connects the eyes to the brain) gets damaged by increased pressure on the eyes due to accumulation of excess fluid.

The theme this year is: 'Don't let glaucoma darken your life". Explaining possible risk factors, LVPEI's senior glaucoma specialist, Dr G Chandrasekhar, said that people with a family record of glaucoma are the most vulnerable. Others at risk of developing glaucoma are those who have suffered an injury to the eye, or have used steroids over a long period of time for treating kidney diseases, depression. Also, those with diabetes, thyroid problems and hypertension, too, are susceptible to the disease.

Doctors say that no age-group was immune to glaucoma. They added that the disease would not be detected by specialists unless the patient went for a full eye check-up.

Dr Anil K Mandal, the glaucoma consultant at LVPEI who has performed the largest number of surgeries on paediatric glaucoma patients in India, said that several generations of consanguineous marriages had added to the paediatric glaucoma burden.

The incidence of childhood glaucoma, is a high one per every 3,300 live births due to the large number of consanguineous marriages. In the US, that figure is 1 per every 10,000 live births.

As part of the awareness drive, a continuing medical education (CME) programme - "Glaucoma- The Known and the Unknown - will be held at LVPEI on March 11. Week-long free glaucoma evaluation and family screening camps, too, will be organized at various LVPEI centres.

Also planned is a public glaucoma forum with patients, their families along with celebrity participation.

[Gudavalli]

Source: http://economictimes.indiatimes.com/...w/12194162.cms

HYDERABAD: Indegene Lifesystems, a company backed by a former Infosys founder and a former employee, is close to acquiring a US-based call centre providing medical education and communication services to doctors and patients. Two potential targets have been identified and a Canadabased boutique investment banking firm is assisting Indegene with the valuation, the Bangalore-based company's chief executive Manish Gupta said.

The value of the acquisition will be $10-15 million (Rs 50-75 crore), Gupta said, declining to identify the potential targets. Indegene was started in 1998 by Infosys ex-employee Gupta, four of his associates and the Nadathur Holdings investment firm of Infosys cofounder NS Raghavan.

The acquisition will help Indegene gain a strong foothold in the United States and increase its ability to expand its service offerings to top pharmaceutical companies, Gupta said. Indegene also wants to provide patient analytics services to insurance companies in the United States. Once the acquisition is completed, Indegene, which at present employs 750 staff, would have increased its headcount by 100 and revenues by about $15 million a year, Gupta said.

The acquisition will help Indegene reach its target $100 million in revenue by 2015, he added, but declined to say what the turnover is now. Indegene, which has six delivery centres in the United Kingdom, United States, Australia, China, Singapore and India, gets 90% of its revenues from the world's top 10 pharmaceutical companies, among them GlaxoSmith-Kline, Novartis and Merck.

Big Pharmaceutical have been vigorously cutting costs after some of their top drugs, fetching billions of dollars in revenue, have gone off patent, opening up the market for generic players. As a result, they have begun outsourcing not just clinical trials but also marketing and medical content for new and mature drugs.

A 2011 survey by the Boston Consulting Group on the strategies adopted by pharmaceutical companies showed that 51% of their global departments outsource activities such as medical education, communication, publications, marketing and analytics, among others. This helps companies focus on research and development and minimise their outlay on marketing and other selling expenses.

"Big Pharma wants us to develop strategies for developing countries as the companies have their own infrastructure in bigger markets like the United States and Europe. They want partners who can accelerate the go-tomarket strategies for them in many of the emerging markets," Gupta said.

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Source: http://pharmabiz.com/NewsDetails.aspx?aid=67924&sid=1

The much hyped organ transplantation ‘Jeevandhan” project which was proposed by the health department of Andhra Pradesh in 2010 has not yet been taken up beyond its initial stage and it still remains just on paper even after 2 years of its launch.

A gazette notification was issued in August 2010 to set up Jeevandhan organ transplantation project in the state. As there is a huge list of patents waiting for organ transplantations in the state, the government of Andhra Pradesh had proposed to form a committee to streamline cadaver transplants and create a centralized registered waiting list.

Every year thousands of people are being killed in accidents due to organ damages. It is estimated that every 15 minutes there is a name added in India to the waiting list of persons who needs transplantation. For every 10 minutes one death is recorded due to unavailability of organs.

Medical experts feel that with the delay of the project, it is even more confounding as thousands are added each year to the list of patients awaiting the transplants.

“So far Rs.1 crore has been sanctioned for the purpose of the Jeevandhan project, but nothing positive has happened. Even the proposed web portal has not been launched to provide information, despite a government order,” said Dr A Gopal Kishan, a leading nephrologist and former president of the Indian society of Organ Transplantation.

Experts and doctors feel that the government is showing a callous attitude” towards this important project. They feel that this project is essential in view of thousand of accidental deaths each year. They said organ harvesting centres are also required at government medical institutions.

In Osmania General Hospital alone the doctors have performed 430 kidney transplantations since past 1982. In the recent past now, the cases of transplantations have enormously increased and there is a huge dearth in the availability of organs. In view of this scenario experts feel that a committee should be formed and laws should be made regarding brain deaths to facilitate organ transplant in the state.

Accepting the fact, Dr Vasant Prasad, director of Medical Education, said, “There has been no progress on the project so far, the scheme needs coordination between various stakeholders, nodal officers, counsellors, patient’s attendants, NGOs, doctors and a panel to decide on brain deaths and transplantations. We also need organ-harvesting centres in public hospitals and a state-level registry.”

Taking the issue of the project further, the director said he would take the issue to the special chief secretary G Sudhir and give a report on its status.

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Source: http://www.business-standard.com/ind...market/467319/

Global majors are trying to get into the high-growth vaccine market in India through standalone launches and alliances with local partners.

Introduction of the National Immunisation Programme (NIP) and aggressive rollout of innovative products by domestic companies is prompting multinational corporations (MNCs) to strengthen presence in the India market.

A McKinsey report on the Indian pharmaceutical sector states, “At two per cent penetration, the vaccines market of India is significantly under-penetrated. The private segment accounts for two-thirds of the $250-million market.” McKinsey expects the market to grow to $1.7 billion by 2020.
Last month, Sanofi Pasteur, the vaccines division of Sanofi-Aventis, signed a marketing and distribution agreement with Emcure Pharmaceuticals for Verorab, its anti-rabies vaccine. Verorab is to be imported and supplied by Sanofi Pasteur India, while Emcure would market and distribute it. Sanofi-Aventis is setting up Asia’s largest vaccine making facility in Hyderabad, for an investment of Rs 500 crore. It already enjoys a strong presence in the Indian vaccine space, following the buyout of Hyderabad-based Shantha Biotechnics in 2009 for Rs 3,000 crore.

“For driving growth in the vaccine segment, the companies need to produce locally or leverage supply partnership,” said Palash Mitra, partner at Mckinsey & Co.

GlaxoSmithKline is strengthening presence through launches. Last year, GSK India had launched Synflorix, a vaccine against invasive pneumococcal disease, the latter being a leading cause of childhood mortality in India. Hasit B. Joshipura, managing director, GSK India, had said, “The vaccine business showed a high growth trajectory, with the company continuing to expand its portfolio.”

Tapan Ray, director-general, Organisation of Pharmaceutical Producers of India (OPPI), comprising MNC majors, said, “If appropriate policy measures are initiated in the country without further delay, the domestic vaccine market , in turn, will receive further growth momentum, with newer players coming in and introduction of more and more novel vaccines by the global players.”

To tap the under-penetrated market, Indian counterparts are launching innovative vaccines and exploring niche segments. Panacea Biotec is in the process of launching a tetravalent chimeric dengue vaccine and a Japanese encephalitis vaccine by 2013-14. Rajesh Jain, joint MD of Panacea, told Business Standard: “The total demand for vaccines in the coming years will be driven by developed countries. Of the 131 million children born worldwide annually, 121 million are from developed countries. Also, the warcry for affordable healthcare forces MNCs to shift focus to countries like India as a low-cost manufacturing hub.”

Indian Immunologicals Ltd (IIL), the Hyderabad-based vaccine maker, says it is in the process of developing the world’s first vaccine for chikungunya. The other advanced stage candidates of IIL are a paediatric pentavalent vaccine against diphtheria-pertussis-tetanus, Hepatitis B, and H. influenza. Plus, a vaccine for preventing cervical cancer in women.

Bharat Biotech has rotavirus vaccines in its pipeline, expected to be marketed in two to three years.

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there are other institutes like NGRI and CFTRI also in habsiguda uppal area

[Gudavalli]

Source: http://timesofindia.indiatimes.com/b...w/12257293.cms

HYDERABAD: It may be older than Hyderabad's most wellknown drug giant Dr Reddy's Laboratories, but recognition has come rather belatedly in the day for Hyderabad-based Natco Pharma.

The pioneering judgement of the Controller General of Patents granting Natco a compulsory licence to make and sell Bayer's anti-cancer drug Nexavar in India has finally pushed this relatively unknown Hyderabad company firmly into the limelight. Natco was set up with an initial investment of Rs 33 lakh in 1981 by VC Nannapaneni, a US-returned technocrat and son of a farmer from Guntoor district of Andhra Pradesh much before Dr Anji Reddy set up Dr Reddy's Laboratories in 1984 in Hyderabad.

The 67-year-old Nannapaneni, who heads Natco as chairman and managing director, has over 42 year experience in the pharma industry and currently focuses his efforts on new drug discovery and development with his son Rajiv Nannapaneni looking after the day to day running of the company as director and COO. VC Nannapaneni spent nearly 15 years in the US working with pharma companies and has a bachelor's and master's degree in pharmacy from Andhra University. The Nannapaneni family controls around 57% stake in Natco Pharma that is gunning for Rs 550 crore revenues for the fiscal ending March 31, 2012. The company was performing rather indifferently till son Rajiv came back from the US and persuaded his father to give up his plans to diversify into the port sector. After that the company has been looking up.


With humble beginnings of a single unit manned by 20 employees, Natco today has 2500 employees and five manufacturing facilities spread across India with dedicated modern research laboratories, capabilities in new drug discovery. The company makes formulations and decided to focus on oncology in 2003 and went on to sharpen focus on the US with its first para IV filing in 2008. In fact the company's statement on the website states its mission is "to manufacture and market affordable medicines that comply with global standards and to achieve market leadership".

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http://www.expresshealthcare.in/201203/market28.shtml
Covidien's New R&D Centre in Hyderabad
Covidien, a global provider of healthcare products has opened its first R&D centre in India. Known as the Covidien India Engineering Center (CIEC), it is a 40,000 sq ft facility based in DLF Cybercity Special Economic Zone (SEZ), Hyderabad and will be expanded into a larger facility in the future. The CIEC offers a range of engineering services for the company’s medical products business and in the course of time could employ up to 350 staff members.

Randel Frazier, Vice President, R&D, Emerging Markets said, “Innovation is at the heart of everything Covidien does. The company devotes significant resources to invent and develop technology that physicians utilise to improve patient outcomes. Our company is expanding our R&D capabilities worldwide and this new facility in India is playing an integral role in our global strategy.”

Covidien has increased its R&D investments substantially in the last five years and has launched more than 100 new products. The company intends to devote five to six per cent of sales to R&D activities in the next few years.

CIEC will provide engineering services to Covidien’s R&D organisation in the areas of design, hardware, software and testing etc.

Robert Frechette, Vice President, Engineering Services, said, “India has a strong base of highly-talented engineers. Bringing this talent into Covidien’s organisation is critical for our continued growth. By establishing this presence in Hyderabad, we are expanding Covidien’s R&D capabilities as well as enhancing the city’s reputation as a hub for life sciences.”

“Our new facility is up and running with more than 30 engineers and staff involved in Covidien’s global R&D efforts,” added Frechette.

“With a fast-growing economy, the demand for healthcare in India is growing at a rapid pace,” said Arjun Sarker, Managing Director, Indian subcontinent. “The establishment of this R&D facility expands Covidien’s presence and commitment to India,” he said.

[Gudavalli]

Source: http://www.dailynews.lk/2012/03/19/news04.asp

The Sri Lanka Institute of Nanotechnology (SLINTEC) in a landmark agreement entered into a strategic collaboration with Nagarjuna Fertilisers and Chemicals Limited (NFCL) of Hyderabad, India, to develop the next generation of nanotechnology based plant fertiliser solutions.

It was the first technology providing programme from the country to the international market, SLINTEC science team leader, Professor in Chemistry, University of Peradeniya, Professor Veranja Karunaratne said.

The agreement was signed in the presence of Technology and Research Minister Pavithra Wanniarachchi and India High Commissioner Ashok K Kantha at the Cinnamon Grand Hotel on March 15.

These are next generation nanofertliser products aimed at increasing productivity and income for farmers and creating a sustainable business for stakeholders engaged in agri-business, he said.

As part of this strategic partnership, SLINTEC is selling two patents covering their first generation nano plant fertiliser products, taking it from proof of concept to proof of value for commercialisation, he said.

“In addition we are entering into a long-term strategic technology development programme for the second and third generation nano

plant nutrition products. For SLINTEC, this is an opportunity to work with a global partner to take the product development journey from the lab to the field,” Professor Karunaratne said.

Head of Research and Innovation (Professor of Electronics Engineering Cambridge University) Professor Gehan Amaratunga, said however that SLINTEC has reserved the rights for Sri Lanka to exploit this technology on its own. Sri Lanka is known only for selling commodities and this deal between SLINTEC and NFCL heralds a new era in technology development in Sri Lanka, he said.

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Source: http://www.globalatlanta.com/article/25413/

Metro Atlanta is continuing to position itself as a prime entry point for Indian firms looking to sell medical devices or conduct clinical research in the U.S.

David Hartnett, the Metro Atlanta Chamber's vice president for bioscience industry development, spent 10 days in February meeting prospective investors and gathering information in the Indian tech hubs of Bangalore, Hyderabad and Mumbai.

Since Atlanta hosted the Biotechnology Industry Organization's 2009 annual conference, the chamber and its partners have made a consistent effort to woo Indian firms and researchers to Georgia, Mr. Hartnett told GlobalAtlanta.

He and Jorge Fernandez, the chamber's vice president for global commerce, travel to the country separately at least once per year. They also invite Indian prospects to visit Atlanta when they happen to be in the U.S. for industry conferences.

India is lower than Europe on the chamber's life-sciences priority list, mainly because European firms are closer and have fewer problems dealing with Food and Drug Administration regulations.

India is a strong No. 2. After traveling there multiple times, Mr. Hartnett concluded that Indian firms have two main objectives in approaching the U.S.: exporting their products to the largest medical market in the world and advancing research that could help commercialize their devices and drugs.

Many are small companies that starting with research partnerships that could blossom into viable businesses. Others are large, healthy firms looking to buy facilities that already meet FDA standards to smooth the market-entry process, he said.

Not only is Atlanta a good place for companies to set up shop, boasting inexpensive land, labs and offices, but it also boasts some strong research assets, said Mr. Hartnett, who spent 20 years as an executive in the medical device industry before joining the chamber's staff.

He cited the Centers for Disease Control and Prevention, as well as universities like Emory University and Georgia Institute of Technology.

"The universities are a great way to play our first phase of the relationship. It's hard to go to a foreign country and convince a board of directors that they need to uproot and come here," he said, adding that relocation often comes only after relationships are formed.

He also noted Atlanta's hospitals and organizations like St. Joseph's Translational Research Institute, which was recently purchased by Emory.

The Global Center for Medical Innovation, a $2.6 million center that will help medical device startups create and develop prototypes, is set to open in April in Midtown.

But Atlanta also has a less evident advantage: a diverse patient pool, in terms of both ethnicity and diseases, which makes it easier to enroll participants in clinical trials, he said.

That's partially because the baby boomer generation is "retiring and they're moving South, and Atlanta is the capital of the South, so in a very interesting way, the business is coming to us," Mr. Hartnett said.

Closer ties with India will also help Atlanta medical-device startups looking for a place to develop products without the cost of FDA compliance. India has strict regulations, but they're not nearly as expensive to satisfy, he said, noting that some American firms first build up sales in India to prepare financially for the "holy-grail" U.S. market.

Mr. Hartnett visited India as a representative of chamber and as the co-chair of the Innovation Crescent Regional Partnership, an effort by more than 12 counties and organizations to showcase the life sciences assets of the region stretching from Atlanta to Athens.

The crescent is an answer to the Research Triangle in North Carolina, the Boston-Cambridge life sciences cluster in Massachusetts and LifeScience Alley in Minnesota, promoting Georgia's advantages in a field where it already excels.

"Atlanta is rapidly becoming known as the center for global health," Mr. Hartnett said. Georgia is the No. 1 state for health-care information technology, boasting more firms in that field than any other state.

Atlanta is also home to organizations like the American Cancer Society, CARE, the Carter Center, the Task Force for Global Health and others. United Parcel Service Inc. is the largest distributor of FDA-regulated products in the world.

"We like to say that if there's an emergency in the world, and its a public safety issue, they come here," Mr. Hartnett said.

Conversation between India and Georgia on such topics is growing. The Emory India Summit March 2-3 had a panel on medical tourism, while the USA India Business Summit, to be held in June, aims to attract Indian life sciences executives visiting the country for the BIO International Convention in Boston.

Though there have been few big wins validating the trips and recruitment efforts, the future will prove them successful, Mr. Hartnett said.

“There's a very optimistic pipeline of very active projects that will come to fruition within a short period of time, and within the next two years you will see some strong bioscience activity in Atlanta,” he said.

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Source: http://pharmabiz.com/NewsDetails.aspx?aid=68086&sid=1

Joint Director General of Foreign Trade (DGFT) and Pharmaceuticals Export Promotion Council of India (Pharmexcil) had conducted a seminar on ‘anti-dumping’ of drugs, and cosmetics here in Hyderabad. The objective of the seminar was to create awareness among the traders and industry bodies about the unfair trade practices adopted by the overseas companies in India.

The seminar was basically aimed at sensitizing the pharmaceutical traders and industry about trade remedy instruments available under World Trade Organization (WTO) frame work to counteract the unfair competition from overseas companies and to protect the domestic industry.

In the recent times there have been growing incidents of unfair trade practices being adopted by certain overseas companies to counter the domestic Indian players. Most of them are flooding with cheap quality low cost products. Taking this in to consideration the DGFT wants to bring awareness among the domestic traders and local manufactures about the menace of anti-dumping and its impact on the local market players.

Under the existing WTO arrangement, and in terms of various provisions under the Customs Tariff Act of 1975 (as amended in 1995) and Rules framed thereunder, anti-dumping and allied measures constitute the legal framework, within which the domestic industry can seek necessary relief and protection against dumping of goods and articles by exporting companies and firms of any country from any part of the world.

‘As some of the overseas companies are taking advantage of certain terms and provision in the WTO agreement these measures have assumed a great deal of relevance in India in recent times, pointed an official at the seminar. Competitors from across the borders are resorting to anti-dumping tactics to the detriment of the domestic industry. This motive of certain foreign companies is viewed as a threat to local manufactures in the country.

In view of this the DGFT has asked the local trade bodies and industry to be vigilant. “In order to bring awareness among the traders and industry bodies we have organized seminars workshops across the country, this will sensitize the traders and enable them to take remedial measures under the WTO frame work,” said Dr P V Appaji, executive director, Pharmexcil.

Dr Neeraj Varshney, director, Department of Anti Dumping, and senior officials from office of Jt. DGFT and others, attended the seminar.

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Source: http://www.moneycontrol.com/news/cnb...e-_685973.html

The world of pediatric vaccines is about to be shaken. And it's Hyderabad-based Shantha Biotech that's going to do all the shaking, reports CNBC-TV18's Appaji Reddem and Animesh Das.
Offices belonging to Hyderabad-based Shanta Biotech look calm from the outside, but inside, plans are brewing to take the pediatric vaccine market by storm. This Sanofi-Aventis-owned drug manufacturer is all set to launch Pentavalent, a single vaccine aimed at protecting children from five illnesses- Diphtheria, Pertussis, Tetanus, Hepatitis B and Haemophilus Influenzae. This launch will bring global prices for the vaccine down drastically.
Harish V Iyer, managing director and chief executive officer of Shantha Biotech says, "One assumption you have to make in this market unfortunately is that the prices may come down. We are thinking in those lines and I don't want to speculate on where the prices would end up."
This will be the second time Shanta Biotech launches this vaccine.
It's first attempt had to be aborted after the World Health Organization (WHO) recalled the vaccine due to concerns over quality issues. Shanta now says the new process prescribed by WHO has been implemented and is betting on competitive pricing to corner a major piece of the international Penta and Hexavalent vaccine market, and giving competitors like Serum Institute and Panacea Biotec a run for their money. Shanta says prices could fall to below USD 2 a dose. It is also betting on high demand in India to boost sales.
"25 million children are born every year," says Iyer. "If you assume three doses, 75 million is the opportunity in India every year. Depending upon the rates of coverage and how thing work out, it could be somewhere in the range of 25-50 million at least if you assume 50% penetration," he says.
Shanta Biotech will invest over USD 300 million on a vaccine manufacturing facility at Hyderabad to supplement vaccine production.
Government of India had included Pentavalent in its universal immunization program in Kerala and Tamil Nadu last December. The vaccine is expected to be extended to six more states. However, regulatory approvals, safety concerns and pricing will be the major challenges.

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Source: http://www.business-standard.com/ind...panies/469363/

Indian pharmaceutical and IT majors, including Biocon, Bharat Biotech and Dr Reddy’s, are likely to invest and do research and development (R&D) activities in Scotland in the coming years, according to a top official from Scotland.

“We are now under discussion with almost all pharma companies, besides stem cell research companies including Reliance Life Science and Stempeutic, to set up their research centres, and for collaborative research activities with Scotland,” Mark Dolan, country manager, Scottish Development International (SDI), told Business Standard.

SDI, an investment arm of the Scotland government to promote overseas business opportunities, entered India in 2000 to promote investment opportunities. It is now eyeing big for Indo-Scottish partnerships across verticals including oil and gas, water drilling, off-shore wind technology, IT, pharma, renewable energy, healthcare and education from India.
Indian companies including Piramal, Hero BPO, Reid & Taylor, Infosys, Wipro and TCS, employing more than 5,000 people, have already done business in Scotland. And, around 15-16 companies from Scotland, including Standard Life Insurance, IES, Pixel and AGGreKo, have invested in India. The number of companies, which have shown interest in investing in India, increased to 84 this year from 34 in 2010, he said.

India now ranks among top 10 countries that have invested in Scotland along with US, Germany, France and Spain. “Seeing the current interest and the number of projects we have in the pipeline, we are bullish that India may become one of our top-5 investors,” he said.

“Scotland is on the high-investment radar for Indian companies across verticals like Essar, Reliance, Tata, Suzlon and Bharat Forge, besides pharma and IT majors,” Dolan said.

Outlining the advantages of investing in Scotland, he said Scotland worked out about 30 per cent cheaper than London. The Scotland government gives 35 per cent regional grant, 35 per cent R&D grant. Also, the government has reduced the corporate tax burden to 10 per cent from the earlier 24 per cent.

He said that contrary to the gloomy news coming about the Euro Zone crisis, there was brisk business happening on the ground, especially in sectors like financial services, utilities and life sciences. Dolan was here to promote Indo-Scottish business opportunities and encourage business partnerships.

Scotland, with key strengths in knowledge, quality manpower, innovative technology, has recently doubled its presence in India. It is also scouting for a new office location in Hyderabad or Bangalore.

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Source: http://www.livemint.com/2012/03/2920....html?atype=tp

Vaccine maker Bharat Biotech International Ltd attracted global attention in June last year when it offered to sell its version of the infant diarrhoea vaccine Rotovac for as little as $1 a dose when it was retailing for $20 in India. International vaccine makers were forced to cut the prices of their own shots in response.

Six months later, the Hyderabad-based company was back in the headlines, but not of the welcome kind, when the World Health Organization (WHO) disqualified it from supplying the hepatitis B vaccine Revac-B+ to UN procurement agencies. WHO also suspended the evaluation of all Bharat Biotech products awaiting so-called pre-qualification status that would make them eligible for use in UN-backed immunization programmes.

The punitive action came after an audit of Bharat Biotech’s plant in Hyderabad by an inspection team of the UN health agency found deficiencies in the “implementation of good manufacturing practices” and “quality management system of the company.”

For Bharat Biotech, a privately held company with revenue of Rs.270 crore in the year ended 31 March 2011, the order was a blow from which it may take months, if not years, to recover although Rotavac, which is still being tested on babies across the country in phase III clinical trials, was unaffected by the WHO action.

“We are in dialogue with WHO,” said Krishna M. Ella, chairman and managing director of Bharat Biotech, at a recent conference in Hyderabad. He gave no further details, did not respond to email queries and declined interview requests.

Bharat Biotech was the third Indian vaccine maker to attract such penal action from WHO in less than two years over quality issues, raising concern in the domestic pharmaceutical industry as well as agencies that procure vaccines for national immunization programmes.

Panacea Biotec Ltd lost WHO pre-qualification for three of its vaccines in August 2011. In July 2010, Shantha Biotechnics Ltd, a unit of French drug maker Sanofi SA, had its pentavalent vaccine Shan5 disqualified. Shan5 is a paediatric combination vaccine that includes protection against diphtheria, tetanus, whole cell pertussis, hepatitis B and haemophilus influenzae type B (Hib). Both companies said they are in discussions with WHO to address the issues.

A WHO spokesperson said in response to queries from Mint that “reassessment in the short-term is unlikely and may take months.”

Inexpensive vaccine supplies from India are integral to the success of global immunization programmes, explaining the worry among vaccine procurement agencies. Vaccine sales by Indian companies are estimated by the industry organization Pharmexcil to be worth $900 million in fiscal 2011 and are growing at an annual average growth rate of 23%. The country accounts for almost 43% of total vaccines exported globally by volume.

“Indian vaccine suppliers are critical to global security of vaccine supplies,” said Sandeep Sinha, director of the healthcare practice, South Asia and Middle East, at consultancy Frost and Sullivan. “Not only do they supply in huge quantities at a decent quality but they supply it at an affordable price.”

According to Pharmexcil, eight WHO-prequalified manufacturers in India produce 22 vaccines for export to 150 countries. The eight are Bharat Biotech, Serum Institute of India Ltd, Shantha Biotechnics, Panacea Biotec, Biological E Ltd, Chiron Behring Vaccines Pvt. Ltd, Haffkine Bio-Pharmaceutical Corp. Ltd, and Zydus Cadila.

“That (quality) is certainly the worry,” said Seth Berkley, chief executive of GAVI, a major buyer of Indian vaccine companies, in a recent interview. “One of the reasons it’s critical to have high quality is because you want people to know that India produces not only large quantity, not only produces inexpensively but it produces them (vaccines) at global quality,” said Berkley, whose organization was formerly known as the Global Alliance for Vaccines and Immunization, a public-private partnership that focuses on saving children’s lives by increasing access to immunization in developing nations.

WHO acted against Shantha Biotechnics when it received quality complaints from Colombia, Comoros and Nepal about the presence of a white sediment sticking to glass vials containing the Shan5 vaccine. Studies later traced it to the manufacture of the pertussis component. Pertussis, also known as whooping cough, is a highly contagious bacterial disease.

WHO ordered the recall and destruction of all the batches of Shan5 vaccine because of the problem, which also caused the agency to terminate the pre-qualification evaluation of a three-in-one combination vaccine that had the same anti-pertussis component.

For the vaccine makers, there’s plenty at stake. For instance, the suspension of the Shan5 vaccine has cost Sanofi $340 million in sales from 2010 to 2012 on a contract with Unicef, or the United Nations Children’s Fund, Bloomberg News reported in November 2010. Sanofi acquired Shantha Biotechnics for €440 million from another French company, Mérieux Alliance, in July 2009.

As part of the corrective process, Shantha Biotechnics has to make changes to the manufacturing process, which mean it has to perform clinical trials again on Shan5, a costly and time-consuming process, to establish the safety and efficacy of the vaccine.

“We are living in an arena where standards are changing and becoming higher and higher,” said Harish V. Iyer, chief executive of Shantha Biotechnics. “A few years ago, maybe WHO may not have said this...I don’t know. But now they feel that it’s important. Again, I think it’s part of raising standards.”

Iyer took charge in September as part of a management overhaul at Shantha Biotechnics after the Shan5 debacle, with his immediate priority being to restore confidence in quality standards followed by the company. Shantha Biotechnics is investing around $300 million in augmenting capacity and improving overall quality standards.

“We are investing heavily in quality,” Iyer said. “We are trying to make sure that we have global standards, we are using Sanofi, our parent group, to help augment quality standards. This requires heavy investment in training, investment in infrastructure.”

Shantha Biotechnics expects to regain WHO’s pre-qualification status vaccine sometime in 2012.

“We are trying to recover from key events that have happened in 2010; we are well on our way back,” Iyer said.

For the year ended 31 March 2011, Panacea Biotec reported revenue of Rs.1,170.44 crore, of which vaccines account for 73.7%. One-third of the vaccine revenue was contributed by the five-in-one shot Easyfive, one of the three vaccines to be disqualified by WHO.

Mumbai-based brokerage Avendus Securities Pvt. Ltd has estimated a loss of Rs.66 crore in FY12 for Panacea because of WHO’s action.

The company reported losses of Rs.33.64 crore and Rs.71.72 crore in the second and third quarter, respectively. Panacea’s stock has declined by around 61% since WHO passed the order on delisting of two of its products. The stock closed up Rs.4.90, or 7.21%, on Thursday at Rs.72.85, compared with a 63.01 point, 0.37% decline in the benchmark Sensex to 17,058.61.

Panacea Biotec, in August 2009, won a Unicef contract worth Rs.1,067 crore to supply 75 million doses of Easyfive in the following three years, making it one of the largest suppliers to the world children’s agency.

“We are in constant discussion with WHO to resolve the problem,” said Rajesh Jain, joint managing director of Panacea Biotec. “It’s not a problem of one company; it’s a problem that the industry is facing.”

WHO’s pre-qualification status, attesting that vaccines are safe and effective, is essential for vaccine makers to bid for supplying their products to immunization programmes backed by the United Nations. The process of evaluation includes close scrutiny by the world health agency, which studies manufacturers’ production methods, vaccine composition and quality control and clinical evaluation systems, among others.

WHO teams undertake reassessments of prequalified products at regular intervals—at least every two years—apart from site audits and testing of lots supplied by UN agencies to monitor continued compliance by suppliers with the organization’s standards.

“The pre-qualification programme must continually evolve in order to keep pace with the progress in vaccine quality standards and the growing number and complexity of applications being submitted year after year,” WHO spokesperson Mansi Kumar Joshee said in response to emailed questions.

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Source: http://pharmabiz.com/NewsDetails.aspx?aid=68264&sid=1

In a great sigh of relief to heart patients, top international researchers here in Hyderabad revealed that Stem Cell Technology can be used to repair damaged heart tissues without actually performing surgical incision into the chest.

While participating in the International stem cell conference at International School of Business at Gachibowli, scientists revealed that the stem cell technology can be used to repair heart tissues damaged by myocardial infraction commonly known as heart attack.

Taking it as a great break through in the medical sciences, doctors and heart surgeons felt that the stem cell technology will be a great boon to the millions of patients suffering from heart attacks.

According to eminent Scientist Prof. Minger, head global research and development at GE Healthcare UK, the heart tissues are usually damaged by the myocardial infraction. This is also commonly known as heart attack. By using the stem cell technology, it is easier and simpler to heal the heart tissues,” revealed the Scientist.

Usually in a conventional method of heart surgery doctors cut open the chest muscles to gain access to the heart, but now with the use of stem cell technology this practice can be put on halt.

By using the stem cell technology, the heart cells cultured in laboratory can be implanted in heart through a catheter from one of the arms. As this kind of treatment is not involving any physical incisions on the body, the patients can be discharged on the same day.

Further explaining in detail, Prof Minger said that heart attack occurs when blood supply to the heart is stopped for a long time and this damages the heart tissues. By using stem cell technology such damaged tissues can be treated without any complicated surgery.

The scientist advocated that as India is having a huge population of more than a billion, the country can play a key role in stem cells and regenerative medicine. “There is a need to create awareness among the population. If India and China could bank even one per cent of their annual births, they could supply stem cells to the whole world,” said Prof Minger.

“Public banking of cord blood will enable to treat many diseases which are incurable such as Parkinson’s and Alzheimer’s. In the next 4-5 years developing heart tissues damaged by myocardial infraction will become a real possibility,” revealed the scientist.

Throwing light on recent developments, the professor said that heart cells derived from bone marrow have been implanted successfully in a patient, and the technology is helpful in transplanting new insulin-producing cells for diabetics and myelinating cells for individual afflicted with multiple sclerosis.