Hyderabad - Biotech & Pharmaceutical Hub Updates

[Gudavalli]

Source: http://pharmabiz.com/NewsDetails.aspx?aid=68281&sid=1

Bringing back the concept of family doctor, Srikon Healthcare services limited had launched a unique and first of its kind “Family Physician” programme here in Hyderabad.

Rechristening the tradition of appointing family physicians the new healthcare service concept is likely to provide a more comfortable, secure and continued healthcare service right at the doorsteps to the patients.

Explaining about the concept Dr Subrahmanyam Nanduri, chairman, Srikon said, “A family physician is the one who knows an individual’s health history, and reduces confusion during acute medical emergencies. Healing is not just about treatment but also human attachments, which is why family doctors were preferred a few decades ago. Today, doctors do not have adequate time for each patient. So, the family physician concept is again gaining steam.”

The main aim of the new concept is to develop and foster physicians and healthcare to provide best medical care to the targeted patients. The firm is targeting to serve families above the age group of 30 years and below 65 years.

With the growth of multiple specialities and an increasing number of care providers, options often leave the patients confused. In such a situation a family doctor can assess better the patient’s clinical, psychological and social situation. The family doctors can also counsel them about their medical condition, suggests various care options and refer to appropriate specialties in the existing hospitals.

In the recent times, the modern life styles have increased the stress burden on minds of the people. According to a study done by the National Institute of Mental Health and Neuro Sciences, around 50 per cent of the employees in India are under stress, 20 per cent suffer from depression and 30 per cent have problems such as addictions and marital discord.

India is expected to have the largest cardiovascular disease burden in the world by 2020 between the age group of 30 and 69 years, reflecting its loss in terms of losing potentially productive years.

Stressing up on the need for a family doctor, Dr Nanduri said, “Lifestyle diseases, including obesity, hypertension, diabetes and heart attacks, are growing and even affecting youngsters at an early age. In this case, a family doctor will play an important role.”

Srikon Healthcare has in-house doctors, who will be individually assigned for specific patients. Families can avail the service with an annual subscription package of Rs.8,000-Rs.10,000. Interested members can visit the website www.srikon.com to enrol for the service.

Initially the firm is operating its services from Hyderabad and in the next two to three years it is also planning to launch in Vizag and other parts of the state based on the demand and response.

[Gudavalli]

Source: http://www.thehindubusinessline.com/...ue&ref=wl_home

HYDERABAD, APRIL 8:
The Indian stem cell industry is in a nascent stage. There is potential for fast growth and global players will enter the market through mergers and acquisitions, says a study by YES Bank and the Federation of Asian Biotech Associations (FABA).

At present, the top five players in the Indian private sector space in stem cells are — Reliance Life Sciences, Life Cell, Cryobanks India, Stempeutics and Trans-Scell Biologics. Most of the Indian companies are focussed on stem cell banking and research, the study released recently stated.

With the benefits of stem cell therapy growing, it is attracting several organisations and industry to invest, create and commercialise promising technologies. The global stem cell therapy market was pegged at $21 billion in 2010. It is projected to grow to $60 billion by 2015, the study pointed out.

Stem cells are unique as they have the ability to divide indefinitely and give rise to specialised types. Under specific conditions they can be induced to become tissue or organ specific cells with special functions. The main sources of these cells are embryos and adult tissues.

When it comes to treatment, it serves as an internal repair mechanism, dividing to replenish other cells. These characteristics of the stem cells are helping scientists to even tackle difficult diseases such as Alzheimer's or Parkinson's.

The market for stem cells will include specific products, services and technologies to aid in diagnosis to cure.

GOVERNMENT INITIATIVES

Though, the report did not give the size of the Indian market, it forecasts an annual growth rate of around 15 per cent, mainly driven by investments from the Government and private players.

The Indian Government has been quite proactive in promoting work in stem cells, especially in clinical trials, basic research and creating applications. The Department of Biotechnology has invested $60 million into stem cell research during 2005-2010.

The National Centre for Biological Sciences, Bangalore, is a major player. Similarly, the Hyderabad-based Centre for Cellular and Molecular Biology has set up a clinical research facility for stem cell technologies with an investment of Rs 24 crore last year. Other important centres for stem cell work are National Centre for Cell Sciences at Pune, LV Prasad Eye Institute, Hyderabad, Centre for Stem Cell Research at CMC, Vellore, National Brain Research Centre, New Delhi and so on, the report identified.

[ygvjs2000]

http://www.thehindubusinessline.com/...cle3306482.ece
DuPont sets up ballistics unit in Hyderabad
HYDERABAD, APRIL 12:
DuPont has set up an integrated ballistics facility that helps in development and testing of protective gear.

Set up at IKP Knowledge Park here, the centre can calculate the velocity of a bullet and impact of a bullet on a vest.

Mr Rajeev Vaidya, President (South Asia) of DuPont, said this centre would address the local needs by customising products for law enforcement agencies and manufacturers of such products.

This is the first such facility for Dupont in the Asia-Pacific region and third outside the US.

[ygvjs2000]

http://online.wsj.com/article/BT-CO-...17-701842.html
Cathay Pacific To Expand Air Cargo Services To India
HONG KONG (Dow Jones)--Cathay Pacific Airways Ltd. (0293.HK) plans to expand its air cargo services to India by launching a twice-weekly freighter service to Hyderabad and adding a third weekly freighter flight to Bengaluru, both from May 17, the Hong Kong-based carrier said Tuesday.

The plan will give shippers more choice and flexibility in connecting to the airline's international cargo network through the Hong Kong hub, the blue-chip carrier said in a statement.

"Hyderabad is one of the major hubs for the manufacturing of pharmaceuticals in India, accounting for around one-third of the country's drug production," said Cathay Pacific Director Cargo Nick Rhodes.

The Hyderabad service will operate on a Hong Kong-Delhi-Bengaluru-Hyderabad-Hong Kong routing on Thursdays and a Hong Kong-Chennai-Hyderabad-Hong Kong routing on Sundays, it said.

The third weekly flight to Bengaluru will operate via Mumbai on Saturdays, in addition to the current flights every Monday and Thursday.

[ygvjs2000]

http://www.expresspharmaonline.com/2...market14.shtml
Aurobindo Pharma receives approvals
Aurobindo Pharma has received final approvals from the US Food & Drug Administration (US FDA) to market Quetiapine Fumarate Tablets 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg and 400 mg (ANDA 091388) Quetiapine Fumarate Tablets 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg and 400 mg are the generic equivalent of AstraZeneca LP’s Seroquel Tablets 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg and 400 mg.

Quetiapine Fumarate Tablets are indicated for the treatment of serious psychotic disorders such as Schizophrenia and Bipolar Disorder and falls under the Neurological (CNS) therapeutic category. The product has been approved out of Unit III facility in Hyderabad. Aurobindo now has a total of 147 ANDA approvals (118 Final approvals and 29 Tentative approvals) from USFDA.

[Gudavalli]

Aurobindo Pharma Gets US FDA Final Nod For Olanzapine Tablets

(RTTNews) - Aurobindo Pharma Ltd. announced that the company had obtained final approvals from the US FDA to manufacture and market Olanzapine tablets 2.5mg, 5mg, 7.5mg, 10mg, 15mg and 20mg covered under ANDA 091388.

Olanzapine tablets 2.5mg, 5mg, 7.5mg, 10mg, 15mg and 20mg are the generic equivalent of Eli Lilly and company's Zyprexa tablets 2.5mg, 5mg, 7.5mg, 10mg, 15mg and 20mg. Olanzapine tablets are indicated for the treatment of serious psychotic disorders such as Schizophrenia and falls under the neurological (CNS) therapeutic category.

The company said the product was ready for launch. The annual sale of Olanzapine tablets is around $3.2 billion.

The product has been approved out of Unit VII (SEZ) formulations facility in Hyderabad, India.

The company now has a total of 149 ANDA approvals (121 Final approvals including one from Aurolife Pharma LLC and 28 Tentative approvals) from US FDA.

At the BSE, Aurobindo Pharma closed Wednesday's trading at Rs.127, down 1.89 percent from the previous close.

[ygvjs2000]

http://www.thehindu.com/news/states/...cle3369758.ece
State to become focal point in achieving bulk drug and pharma targets
The Stage is set for the State to emerge as a focal point in achieving the ambitious targets being planned for accelerating the growth of pharmaceutical and bulk drug industry.

The Centre is focussing on achieving turnover of Rs. 2.87 lakh crore (Rs.1.3 lakh crore exports and Rs. 1.5 lakh crore domestic markets) by the end of the Plan period from the current level of pegged at over Rs. 1 lakh crore. The State, Hyderabad in particular which has the reputation as the Bulk Drug Capital of the country contributing more than one-third of the total bulk drug production of the country, is all set to continue its contribution during the Plan period.

The State accounts for 30 per cent of the total pharma and bulk drug turnover with a naturally evolved pharma cluster around Hyderabad and two special economic zones proposed in Mahabubnagar and Visakhapatnam districts, is expected to maintain the tempo in the coming years too. In value terms, the State's share is likely to be around an estimated US $ 15 billion by the year 2020 from the current export level of US $ 500 million.

There are presently 391 companies, 266 bulk drug manufacturers and 125 engaged in formulations, contributing significant chunk to the employment potential in the sector. Several reputed names in the bulk drug and pharma sectors including Dr. Reddy's Labs, Aurobindo Pharma, Matrix Laboratories, Granules India Limited have their manufacturing bases located here with capital investment expected to be close to Rs. 10,000 crore including over Rs. 2,400 crore in the small and medium sector.

After its contributions to the IT and ITeS segments, the State will be a major hub for providing talented manpower in the pharma research sector if the plans of the Centre fructify.

Building on the city's reputation, the National Institute for Pharmaceutical Education and Research will be upgraded to a national centre for research and development in bulk drugs that will aim at building up competitiveness in active pharma ingredients and a hub for tapping opportunities in the global generics market.

Institutions of international reputation such as CCMB, IICT and CDFD around the city are expected to act as catalysts in accelerating the R&D activities as also providing qualitative human resource to meet the emerging requirements of the sector which is expected to achieve a turnover of close to US $ 15 billion by 2020.

Research should, however, not be at the expense of the environmental concerns and a majority of the large units realized that unless they complied with quality assurance, including validation of equipment, premises, environment and processes it would be difficult to survive in the regulatory regime. Accordingly, all the major units introduced Quality Assurance measures, Good Manufacturing and Laboratory Practices as a preparation for the post-2005 regime.

IDPL TO BE REVIVED

As the pitch for research into emerging areas like Biosimilars is increasing, the State has been selected by the Centre to house one such centre, a regional centre for expertise in Biosimilars.

This is in addition to the financial assistance proposed for pharma growth cluster, one among the 10 proposed across the country meeting all regulatory and environmental standards and revival of the IDPL with over Rs. 960 crore.

[Prodigist]

---wrong thread----

[ygvjs2000]

http://timesofindia.indiatimes.com/b...w/12987184.cms
Desi companies dominate US generic space
MUMBAI: India is playing a dominant role in the US generic pharma space, having cornered over half the certified dossiers filed globally for active pharmaceutical ingredients (API). Drug companies from India filed 51% of the overall global applications, also called drug master filings (DMF), in the US market during calendar year 2011. DMFs are essentially approvals to supply complex raw materials to all generic manufacturers servicing the US market, which is the most lucrative of all global markets.

Over the last three years, there has been a sustained increase in the trend of such applications from India. Of the global DMF filings in the US, India accounted for 45% in 2009, which increased to 49% in 2010 and 51% in 2011 (see chart).

Against this, China which is the leading API supplier in emerging markets, cornered only 18% of the total DMFs filed in the US in 2011, down from 20% in 2010. Interestingly, mid-rung companies like Hetero, and even smaller ones like USV, Nectar Life Sciences, Shilpa Medicare and Gland Pharma are now filing for such approvals from the US Food and Drug Administration.

Says Glenn Saldanha, chairman and MD, Glenmark Pharma, "Indian companies are playing a huge role in providing tangible, long-term value to generic players in the US market. US being the largest standalone generic market, continues to offer attractive partnership opportunities as most US dosage manufacturers (barring the top four or five) are not backward integrated."

Among the companies, Hyderabad-based Hetero had the maximum new filings at eight during the fourth quarter of 2011.Others like Alembic, Emcure and Gland have filed four DMFs each. Among large players, Lupin and Dr Reddy's filed three each, while Sun Pharma had two filings, and Cadila filed for one. Other significant filers were Jubilant, Aurobindo, Ipca (two each), while Orchid and Torrent filed for one each.

It was the first time that domestic players filed for 22 molecules during the quarter (higher than eight in 3Q11), of which the Prasugrel filing by Dr Reddy's may lead to a new chemical entity, according to a JM Financial analyst.

Says Sujay Shetty, partner, PwC India, "Domestic companies have moved up the value curve by filing complex certified dossiers. These filings are important for domestic as well as US companies, which are filing for approvals to launch generic drugs (abbreviated new drug application), and are truly indicative of the quality and regulatory compliance, which has become critical. Also, for Indian manufacturers in the US, sourcing APIs from Indian companies, lowers costs." Sales of APIs in the US have also started augmenting US revenues of these Indian companies.

In the past, industry experts say domestic companies targeted less-regulated markets for API and this space is now extremely competitive. So, many of them decided to make the transition of supplying APIs to regulated markets. And to do this they naturally had to build on their R&D capabilities to meet the stringent requirements of countries like the US.

"Basically, two aspects have emerged... Not only are Indian companies offering standalone APIs but are also increasingly offering finished dosages as part of vertically integrated partnership deals. This is most true for mid-rung players which presently do not have a direct presence in the US market," adds Saldanha.

[Gudavalli]

DBT's SBIRI scheme receives good response, more than 100 projects get funding

The Department of Biotechnology's (DBT) Small Business Innovation Research Initiative (SBIRI), an innovative scheme to promote research and development (R&D) in small and medium size biotech companies in the country, has received tremendous response from the industries during the last more than three years since the launch of the programme. The department has assisted more than 100 companies under the scheme so far.

The DBT has funded a total of 98 companies under the programme till January 10, 2012 through 17 batches and the process for the 18 th batch of companies for funding is going on in the DBT.

SBIRI was launched by the government for funding early stage, pre-proof of concept research in the field of biotech under the National Biotechnology Development Strategy. The scheme provides early stage funding to enable scientists in private industries for high risk, innovative and ready-to commercialisation product proposals.

The scheme aims to strengthen existing private units with in-house innovative R&D and to create opportunities for starting up technology-based or knowledge-based businesses in biotechnology and to stimulate technological innovation and product commercialization. The department also uses the scheme to support public-private partnership model between industry and public funded institutions.

Some of the companies which have availed the scheme successfully included ABL Biotechnologies, Chennai; Virchow Biotech, Hyderabad; Actis Biologics, Mumbai; Ara Healthcare, Gurgaon; Bejo Sheetal Seeds, Jalna; Reliance Life Sciences, Navi Mumbai. Bharat Biotech, Hyderabad; Bharat Serum and Vaccines, Mumbai; Bharavi Laboratories, Bengaluru; Stempeutics Research, Bengaluru; and Bhat Bio-Tech India, Bengaluru in collaboration with National Institute of Malaria Research, New Delhi.

Other companies which have availed the scheme successfully are Customised Technologies, Bengaluru; Yashraj Biotechnology, Navi Mumbai; Cadila Pharmaceuticals Ahmedabad; Excel Matrix Biological Devices, Hyderabad in collaboration with National Institute of Immunology, New Delhi; Frontier Lifeline, Chennai; Healthline, Bengaluru; Hydrolina Biotech, Chennai; IMGENEX India, Bhubaneswar in collaboration with Institute of life Sciences, Bhubaneswar; Labland Biotech, Mysore; and Lead Invent Technologies, New Delhi in collaboration with Indian Institute of Technology, New Delhi.

[Gudavalli]

Skilled Professionals, Lower Costs and Increasing Government Support Drives the Biotechnology Industry in India, According to New Report by Global Industry Analysts, Inc.

GIA announces the release of a comprehensive report on the Biotechnology Industry in India. The Indian Biotechnology Industry is forecast to garner revenues of $11.7 billion by the year 2017. Skilled professionals, lower costs, increasing government support, well established infrastructure, strong private and public sector participation, and a large domestic market are some of the key factors driving growth in the Indian Biotechnology Industry. Other growth drivers include improving incomes, growing population, increasing R&D and infrastructure investments by private and public sectors, rising lifestyle diseases, increasing opportunities to outsource manufacturing, and an emerging market for contract research.

Although biotechnology as a science is not new to India, the area developed into an established and promising industry only during the past two to three decades. Presently, biotechnology represents a fast-growing, knowledge-based sector in India, which plays an important role in the rapidly growing economy of the country. Biotechnology in India is a highly technology-based industry, which presently accounts for a share of 2% in the global biotech industry. From playing a supplemental role until the recent years, biotechnology industry in India is expected to play an increasingly important role in the global biotechnology arena. Major growth areas within the industry include bio-pharmaceuticals, bio-agriculture, and bio-services, although other sectors are expected to post substantial growth in the coming years.
The Indian biotech industry managed to emerge out of the global recession largely unscathed, registering only a slowdown in revenue growth. In the upcoming years, the industry is estimated to witness another period of high growth, as drug developers worldwide are looking to India as a low-cost destination for outsourcing their discovery and production work, and as global developers continue to scout for more efficient and cost-effective ways to develop novel therapies. For instance, multinational biotechnology and pharmaceutical companies from the US and Western Europe are using India and China to undertake phased studies on markets in the emerging countries. Due to the stringent policies and escalating R&D expenses, producers in the regulated markets are expected to undertake increased cost cuttings. To offer improved outsourced and collaborative R&D services, pharmaceutical production hubs, such as Bangalore, Hyderabad, Chennai, Delhi, Ahmedabad, and Mumbai, are expanding at a brisk pace.
Biopharmaceutical represents the largest sector in the Indian biotechnology industry, as stated by the new market research report on Biotechnology in India. Bio-services trails behind Bio-Pharmaceuticals. Growth in the market is primarily expected to emerge from the Bio-agriculture sector, which is forecast to emerge as the fastest growing sector in terms of revenues during the analysis period. Exports continue to account for the largest share in the revenues of the Indian biotech industry, reflecting the continued focus of Indian biotech companies on the international markets. While segments, such as Bio-pharma, bioinformatics and bio-services represented a substantial chunk of the export market, bio-industrial and bio-agri generated a major share of revenues serving the domestic market.
However, some of the biggest challenges that the Indian biotech industry currently faces is the need for superior organized resources in the form of large animal and transgenic animal facilities, molecular and chemical screening libraries, wide accessibility of technology platforms, trade related testing as well as accreditation facilities, and level-3 biosafety facilities to assist research on the infectious diseases. The industry also faces challenges in the form of manpower shortage, especially in finding skilled manpower at the high-end. This includes experienced high-end personnel in the area of oncology, medicinal chemistry, drug delivery, and in-vivo pharmacology. Besides, the industry is also in serious shortage of experts in the areas of intellectual property rights management, technology transfer, technology management, clinical services, and early drug discovery and innovation.
Over 350 companies operate in the biotechnology sector in India. Major players profiled in the report include Biocon, Serum Institute of India, Panacea Biotec, Nuziveedu Seeds, Reliance Life Sciences, Quintiles, Rasi Seeds, Novo Nordisk, Shantha Biotechnics, Mahyco, Bharat Biotech International Limited, Jubilant Life Sciences Limited, Dr. Reddy's Laboratories Ltd., GlaxoSmithKline Pharmaceuticals Ltd., among others.
The research report titled “Biotechnology In India: An Indian Market Report” announced by Global Industry Analysts Inc., provides a comprehensive review of the Indian Biotechnology Industry, current market trends, key growth drivers, overview of major sectors, recent product approvals, recent industry activity, and profiles of major/niche global as well as regional market participants. The report provides revenue estimates and projections for biotechnology industry in India for the years 2009 through 2017 by the following sectors – Bio-Pharmaceutical, Bio-Agriculture, Bio-Industrial, Bioinformatics, and Bio-Services. Also, a six-year (2003-2008) historic analysis is provided for additional perspective.

[deepakhearthacker]

Global generics sales growth lifts Dr Reddy's Q4 profit

Hitting $2-b mark: Mr K. Satish Reddy, Managing Director, Dr Reddy’s Laboratories Ltd, at a press conference in Hyderabad on Friday
Hyderabad, May 11:

Pharma major Dr Reddy's Laboratories Ltd's net profit increased two per cent at Rs 343 crore in the fourth quarter ended March 31 compared with Rs 334 crore in the year-ago period.

The total revenue had gone up by 32 per cent at Rs 2,658 crore (Rs 2,017 crore) driven by growth in revenue from global generics, among others.

After adjusting the interest on debentures and impairment in Germany, the net profit grew 38 per cent at Rs 423 core, Mr G.V. Prasad, Chief Executive Officer, Dr Reddy's told newspersons here on Friday.

“The year 2011-12 had seen very good overall growth. We have crossed the $2-billion mark in total revenues at an average dollar rate of Rs 47.9,” said the Managing Director, Mr Satish Reddy.

The growth in revenue and profit was driven by significant sales growth in global generics segment in the US market and Russia.

“The revival of pharmaceutical services and active ingredients and over-the-counter business also resulted in good growth during the year,” Mr Satish Reddy said.

While North America, Russia, Russia and India grew, revenue from Germany declined 15 per cent due to tenderisation of German market and pricing pressures.

The domestic business grew by 11 per cent to yield Rs 1,293 crore, while the market growth as per industry estimates was at 15 per cent.

“We are not happy with the performance in India. We are working on improving the sales further,” Mr Prasad said. During the year, 16 and 23 products were launched in the US and India, respectively.

The company has lined up a higher number of products for launch during the present financial year subjected to regulatory approvals.

“The sales growth during the current financial year could be similar to what we achieved in FY 12,” Mr Satish Reddy said.

On the US FDA ban on import of products from Mexico plant imposed last year, he said the US regulator had visited the plant in March and the outcome was awaited.

The board proposed a divided of Rs 13.75 (275 per cent) an equity share of Rs 5 face value subjected to the approval of shareholders.

Dr Reddy's scrip declined 2.24 per cent to end at Rs 1661.65 on the Bombay Stock Exchange on Friday.

[deepakhearthacker]

US generics provide a lift to Dr Reddy's sales

May 12, 2012:

Dr Reddy's reported operating margins look muted (decline of 340 basis points year-on-year) due to the impairment charge taken in the quarter under review. Excluding this, operating profit margins have improved by 60 basis points to 24.9 per cent.

The sharp reduction in the reference prices in the German market and signing up of new tenders at lower rates, led to writing down of brand values to the tune of Rs 100 crore.

Dr Reddy's revenue growth of 32 per cent for the quarter was facilitated by strong performance in the US generics (32 per cent), Russia (19 per cent) and pharmaceutical services and active ingredients segment (21 per cent).

The low base effect in the India formulations did not help in the last quarter and the segment posted a dreary 11 per cent growth (in rupee terms) lagging the market. Europe was yet another laggard with a decline of 16 per cent largely due to severe pricing pressure in the German market.

US growth was led by older OTC products such as omeprazole Mg, lansoprazole as well as tacrolimus and new launches like ziprasidone, fondaparinux, in addition to products from Shreveport facility. Lower-than-expected offtake of olanzapine by Teva due to tardy generic substitution led to inventory write down, which, coupled with withdrawal of DEPB benefits, unfavourable business mix, dragged Dr Reddy's gross margin down by 170 basis points (bps) to 52.6 per cent.

Reported net profit for the quarter showed a paltry two per cent growth, on the back of 520 bps increase in tax rate (19.6 per cent). The company has filed 17 ANDA's (Abbreviated new drug application) during the year and 80 filings cumulatively are pending approval, of which 41 are Para IV's and seven are first-to-file (FTF's).

Though the company has commenced filing for bio-similars in the emerging markets, filings in the key regulated markets is likely to be back-ended, pending clarity on the regulatory pathways and delays in roping in a development/marketing partner.

While the management is confident of meeting their FY13 guidance of $2.7 billion (Rs 14,000 crore) and return on capital employed of 25 per cent, with a slew of launches lined up for the next 12 months, the real challenge lies in sustaining growth beyond FY13.

[Gudavalli]

Shantha Biotech hopes for revival as it aims to relaunch Shan5

NEW DELHI: Two years after surrendering a $340-million supply contract, there is a glimmer of hope for ailing vaccine maker Shantha Biotech. Its French owner, Sanofi Aventis, has endorsed a revival plan that aims to win a part of the multi-million dollar WHO supply programme this year.

A five-in-one drug of Shantha was disqualified, and subsequently banned, by the World Health Organisation in 2010, pushing the Hyderabad-based drugmaker into the red, within nine months of it being acquired by Sanofi for 3,770 crore.

"We are on track to participate in the UNICEF bidding process for Shan5 for the 2013-2015 period. This should allow Shantha to be back on track in terms of revenues by 2015," a spokesperson for Sanofi India said.

Last month, India's Foreign Investment Promotion Board gave approval to Paris-based Sanofi Pasteur Meriexu to infuse 514 crore this fiscal to "meet its operational deficits and fund requirements".

The spokesperson said the money would be used to build capacity, upgrade quality standards for vaccine production in India, and develop new vaccines for infections such as those caused by rotavirus and human papillomavirus. However, some experts say Shantha's revival may not happen so soon.

Shantha is not yet allowed to supply Shan5 to WHO programmes. The vaccine was developed to treat diphtheria, pertussis, tetanus, haemophilus influenza B and hepatitis B.

"Companies have to submit their bids for the 2013-15 contract by early next month, and Shan5 is yet to get approval from either the Indian regulator or pre-qualify for WHO supply," a senior vaccine industry executive said. "I am not sure Shantha has time on its side," the executive added.

The UNICEF contract is likely to be awarded by October, around the time Shantha is planning the vaccine's relaunch.

The executive, however, pointed out that WHO allows companies whose vaccines are in the process of getting pre-qualification to participate in the bidding process, provided they are able to spell out details of delivery plan, capacity and price. Besides, if there is fresh demand, WHO may also give the contract to firms that missed out in the initial round.

In August 2010, WHO banned Shan5 after the vaccine maker failed to address the issue of white sediments sticking to glass vials. This cost the company a $340 -million WHO contract it had won the previous year. According to reports, the company's annual sales subsequently fell to a fifth from about 450-500 crore when Shan5 was in the global markets.

But Sanofi says it bought Shantha to make it its vaccine hub for emerging markets and sell them at affordable rates. "The fundamentals that led us to acquire Shantha are still in place," the spokesperson said.

Shantha's original promoter, Varaprasad Reddy, continues as its chairman, though his stake, which was around 10% in 2009, has fallen to 3%. His shareholding will further drop as the latest fund infusion would be done through a combination of rights issue and issue of fresh shares to the foreign firm.

[Gudavalli]

Aurobindo Pharma receives final approval for Lamivudine+Zidovudine Tablets

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market for Lamivudine & Zidovudine tablets USP 150/300 mg (ANDA 202418) and is ready for launch.

Lamivudine & Zidovudine tablets USP 150/300 mg is the generic equivalent of ViiV Healthcare company's Combivir® tablets USP 150/300mg and is indicated as part of antiretroviral (ARV) combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children. The annual sale of the product is approximately US$265 million.

The product has been approved out of Unit VII (SEZ) formulation facility in Hyderabad, India.

Aurobindo now has a total of 150 ANDA approvals (122 final approvals including 1 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.

The Aurobindo Pharma Ltd stock was trading at Rs.103.80, down by Rs.2.45 or 2.31%. The stock hit an intraday high of Rs.104.90 and low of Rs.102.

The total traded quantity was 0.53 lakhs compared to 2 week average of 1.03 lakhs.

[ygvjs2000]

http://pharmabiz.com/NewsDetails.aspx?aid=69021&sid=2

Aurobindo Pharma Limited, Hyderabad-based pharma major, has received final approval from the US FDA to manufacture and market lamivudine and zidovudine tablets USP 150/300mg (ANDA 202418) and is ready for launch.

Lamivudine and zidovudine tablets USP 150/300mg is the generic equivalent of ViiV Healthcare company's Combivir tablets USP 150/300mg and is indicated as part of antiretroviral (ARV) combination therapy for the treatment of human immunodeficiency virus (HIV) infected adults and children. The annual sale of products is approximately US$ 265 million.

The product has been approved out of Unit VII (SEZ) formulation facility in Hyderabad, India.

Aurobindo now has a total of 150 ANDA approvals (122 final approvals including 1 from Aurolife Pharma LLC and 28 tentative approvals) from US FDA.

Aurobindo Pharma has manufacturing facilities that are approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, Anvisa Brazil.

[Gudavalli]

Goose launches pharma project management solution

Hyderabad, May 21 (IANS) City-based Goose Monday launched API (Active Pharmaceutical Ingredient) manager, a fully configurable solution that enables pharmaceutical companies manage complex projects.

The API manager will also improve project delivery, quality, yield and significantly bring down the cost of project management.

It is an essential component of any quality by design initiative, providing the necessary automation, integration and database reporting functionality that ensures all multi-variety data are tracked and measured, said the specialist pharmaceutical business re-engineering solutions provider in a statement.

"In an environment of extreme cost containment a well-integrated project management solution contributes significantly to pharmaceutical business that require product quality enhancements and compliance with strict regulations, as well as improved efficiencies which can lead to reduced costs," said Goose founder Deb Pattnaik.

Goose has been able to rapidly introduce new pharmaceutical industry solutions to meet growing market demands by leveraging its pharmaceutical re-engineering expertise having worked closely with a number of big pharmaceutical companies offering regulatory compliance and enterprise management solutions.

[ygvjs2000]

http://www.drugstorenews.com/article...=ManualSitemap

Dr. Reddy's launches heartburn treatment
HYDERABAD, India — Dr. Reddy's Labs has launched a generic version of a popular over-the-counter drug for treating heartburn, the company said Monday.

Dr. Reddy's announced the launch of lansoprazole delayed-release capsules in the 15-mg strength in pack sizes of 14, 28 and 42. The drug is a generic version of Novartis Consumer Health's Prevacid 24 HR capsule brand, which had sales of $115 million during the 12-month period ended in March, according to SymphonyIRI InfoScan Reviews.

[Gudavalli]

Nephroplus introduces 'Nocturnal Dialysis' for working patients in Hyderabad

Nephroplus, the leading kidney care organization based at Hyderabad has recently introduced ‘Nocturnal Dialyses’ for working professionals. Nocturnal dialysis can be a real boon for working professionals as it allows patients to work at day and get treated at night without affecting their normal lives.

In India around two to four lakh people develop end stage kidney disease each year indicating alarming rise in problems related to kidney. At times, the kidney patients are required to undergo dialysis three to four times a week, affecting their work schedules and at times their treatment. Nocturnal dialysis or dialysis done during night can provide the much needed panacea for working professionals who are undergoing dialysis regularly.

Coining out the new concept, Kamal Shah, co founder and director, patient services, Nephroplus kidney care clinics says, “Nocturnal dialysis is a new concept and yet to gain momentum in India. However, it can help people balance their personal and processional lives better. It also provides very good quality of life and patients generally feel very close to normal.” Interestingly, Kamal Shah is a dialysis patient himself for the last 15 years and undergoes nocturnal dialysis at his house every night.

Dr Krishna, medical director of Nephroplus says, “Nocturnal dialysis helps reduce stress level among patients. It is popular among corporate executives and young kidney patients, who have hectic professional life. It is a slow, gentle and lengthy process compared to normal hemodialysis as it purifies the blood better.”

According to other experts, apart from helping patients lead a normal life, nocturnal analysis has many benefits both emotionally and medically. Patients undergoing nocturnal dialysis respond better to treatment. This in turn improves the health of patients and they are allowed to live a less restrictive life. Not only that, nocturnal dialysis also helps patients to correct sleep apnoea and increase restorative sleep. These benefits can continue even on the dialysis off-nights.

In addition to this, studies have found that psychologically, nocturnal dialysis patients have better control over their lives. As the treatment is done during night, patients undergoing nocturnal dialysis are able to do more with their life. They are able to channelize their time to work, attend school, take care of their children and enjoy social events during the day. Moreover, as the schedule does not interfere with their working or social lives they need not tell people they are on dialysis and makes them feel more normal.

[Gudavalli]

Camp BizSmart develops the entrepreneurs of the next generation

TWEENPRENEURS: Where are tomorrow's entrepreneurs going to come from? Well, the next generation, obviously, and Los Gatans Mike and Peggy Gibbs want to make sure these fledgling leaders get organizational exposure early on. And so they offer Camp BizSmart to 11- to 15-year-olds.
The cost for the five- or 10-day programs ranges from $450 to $1,400. Sounds like a pretty steep ticket, but the camp's success speaks for itself: since its start in 2008, enrollment has doubled each year. Mike is a former executive in a Fortune 500 company; his wife was an executive with nonprofit agencies.
The camps are held at Stanford, Santa Clara U., Punahou School in Honolulu and Hyderabad, India. There will be 11 camps this year where students will learn about team building, problem solving, cost analysis and how to put a business plan together. At Stanford they can pitch their ideas to Microsoft execs for possible development.
Grads of the camp are working with the nonprofit HopeLab to develop a fitness monitor to help teens become more physically active.
SHEDDING LIGHT ON ALZHEIMER'S: Turn of Mind is written in the voice of a 64-year-old orthopedic surgeon who is undergoing the terrifying stages of Alzheimer's. When her best friend is murdered and found to have four fingers surgically removed, the former surgeon is also suspected of murder.
This provocative murder mystery is local author Alice LaPlante's first novel and won the California Book Award. LaPlante teaches creative nonfiction at San Francisco State and Stanford and spoke at the Saratoga library recently. The author has three relatives in the throes of Alzheimer's now, so knows whereof she writes.
Since her mother, grandmother and so on back in her maternal line have had the disease, writing about Alzheimer's had been on her mind for years. She tried various approaches, but nothing clicked until her husband suggested a murder mystery with Alzheimer's at its core.
LaPlante is an intuitive writer, she says: She doesn't plot out her book as do most mystery authors. She didn't even know who the murderer was herself until she wrote the final 50 pages. The book is LaPlante's take on how Alz-heimer's victims must feel: that they are visitors from another country--and the natives are unfriendly.
It's life in the shadows, like going to a party when you don't know any of the other guests. There are laughs and joy, though, along with the tragic, when one is in the grip of Alzheimer's. This was what she wanted to show: that there was still a whole person there. "Your book made me feel better" about the grim subject, said one reader.
POETRY ON THE MOVE: These poetic insights are from Los Gatans who answered the call of county poet laureate Sally Ashton to write about Silicon Valley's inventiveness. The winning five poems showed up on placards on county public transit vehicles during the month of April.
"Going Home" by Stan Garber: People come from everywhere and wind up on Stevens Creek/Some talk to friends on their cell phones, while others, they don't speak/Some read a book, others sleep as down the road they sail/I'm happy to be headed home today on the light rail.
"The Little Spider" by J. Richard Gaskill: Designer and builder/No degree from a school/She builds what she needs/Without blueprint or tool./Climbing, rappelling/Trailing silk all the way/Constructing radials and circulars/ It's done in a day./Apprehending a fly/ She binds him up tight/Using loops of her silk/He'll be dinner tonight.
BABY SECRETS: Here's the answer to a new mother's qualms about taking care of her newborn. Its titled Secrets of a Baby Nurse: How to Have a Happy, Healthy and SLEEPING Baby from Birth and is written by Marsha Podd, 63, a baby nurse for more than 30 years, and former Saratogan.
Podd, the daughter of Gretchen Podd, now lives in Novato and works at Marin General. Her nursing degree is from UC-Davis. Marsha dedicated the book to her sister, Jennifer Kresge, who shared her four children with her.
Much of the book's advice focuses on how to create a calm and comforting environment to establish healthy sleeping patterns, as well as tips on what to do at each age when that pattern is disrupted. Podd includes advice about how to read your baby's signals and how to build comforting daily rhythms.