ET:
India tops drug filings with USFDA for '03
JEETHA D'SILVA
TIMES NEWS NETWORK[ SATURDAY, FEBRUARY 07, 2004 12:22:55 AM ]
MUMBAI: India has filed with the USFDA for supply of 20% of all drugs coming into the US market. DMFs — or drug master files are details of drugs intended for the US market, filed with the USFDA. Indian pharma companies have filed a total of 126 DMFs last year, higher than Spain, Italy, Israel, and China. DMFs by Indian pharmaceutical players have risen to 20% of the world filings in ’03 compared to 2.4% in 1991.
Cipla, Ranbaxy and Dr Reddy’s lead the pack of Indian companies, having filed 10-20 DMFs each. These three domestic majors together account for over half the DMFs from India.
DMFs are submissions made to the USFDA (Food and Drug Administration) providing details of the manufacturing facilities, process, ingredients used in manufacturing, processing, packaging and storing of drugs that are supplied to the US. There are five types of DMFs, but the Type II is most important because it details the composition of the drug and material used in preparation. The information contained in the DMF may be used to support an abbreviated new drug application (ANDA). The other countries among the top five— Italy, China, Israel and Spain —together had fewer DMFs than Indian companies. Each of them had between 20 and 35 DMFs. Ranbaxy has filed over 12 DMFs during the year. It also filed 26 ANDAs with the USFDA surpassing its annual target of 15-20 ANDAs. Ranbaxy received 21 ANDA approvals and its first new drug application approval for Metformin HCL Oral Solution, taking the cumulative number of approvals, at present, to 81, with 40 products pending approval.
Cipla’s DMFs were slightly higher than that of Ranbaxy. The company has so far filed about 11 abbreviated new drug applications in the US market. It plans to file about 90 DMFs in the near future. Dr Reddy’s filed over 10 DMFs in the last year, of which six were filed during the third quarter. The company had the highest number of filings from India for the October to December period. This takes the cumul ative DMFs to 50. Dr Reddy’s has submitted four ANDAs with Para IV certifications, taking the total ANDAs pending at the USFDA to 31. Of these, 23 include patent challenges.
Smaller companies are increasingly becoming aggressive with filings. Wockhardt, Cadila, Matrix, Divi’s, Lupin, IPCA, Unichem, Neuland, and Shasun were among Indian companies who filed with the USFDA.
Indian Biotech News & Discussion
Re: Indian Biotech News & Discussion
BioCon to be indias first bio IPO
http://timesofindia.indiatimes.com/articleshow/495522.cms
ps. interesting to know they have $120 mil revenue.
http://timesofindia.indiatimes.com/articleshow/495522.cms
ps. interesting to know they have $120 mil revenue.
Re: Indian Biotech News & Discussion
http://stlouis.bizjournals.com/stlouis/stories/2004/02/23/daily54.html
Sigma to build $8 million research center in India
Sigma-Aldrich Corp. plans to build an $8 million, 50,000-square-foot laboratory scale production complex in Hyderabad, India, the company said Thursday.
The building will eventually house 70 to 80 new chemists doing contract research, process development and other work primarily for pharmaceutical customers. It will serve as a "feeder site" for the company's other production operations in Germany, Switzerland, the United Kingdom and the United States.
The facility, expected to be operational by the first quarter of 2005, will be funded from the company's $88 million capital budget for 2004.
Jai Nagarkatti, president of scientific research, said the building is the next logical step in Sigma's expansion in India. "From simple beginnings as a liaison office in 1992, our business in India has grown rapidly, doubling to just under $11 million in sales over the past three years alone," the Hyderabad native said, in a statement.
St. Louis-based Sigma-Aldrich Corp. (Nasdaq: SIAL) produces biochemical and organic chemical products used in research, biotechnology, pharmaceutical development and chemical manufacturing.
Sigma to build $8 million research center in India
Sigma-Aldrich Corp. plans to build an $8 million, 50,000-square-foot laboratory scale production complex in Hyderabad, India, the company said Thursday.
The building will eventually house 70 to 80 new chemists doing contract research, process development and other work primarily for pharmaceutical customers. It will serve as a "feeder site" for the company's other production operations in Germany, Switzerland, the United Kingdom and the United States.
The facility, expected to be operational by the first quarter of 2005, will be funded from the company's $88 million capital budget for 2004.
Jai Nagarkatti, president of scientific research, said the building is the next logical step in Sigma's expansion in India. "From simple beginnings as a liaison office in 1992, our business in India has grown rapidly, doubling to just under $11 million in sales over the past three years alone," the Hyderabad native said, in a statement.
St. Louis-based Sigma-Aldrich Corp. (Nasdaq: SIAL) produces biochemical and organic chemical products used in research, biotechnology, pharmaceutical development and chemical manufacturing.
Re: Indian Biotech News & Discussion
Business Standard.
Rutter reveals India plans
Our Regional Bureau in Hyderabad
Published : March 1, 2004
William J Rutter, co-founder and former chairman of Chiron Corporation, US, announced his plans for India on Saturday. Rutter, well-known for his contributions to biotechnology like development of recombinant DNA technology, genetic engineering and Hepatitis B vaccine, said he would soon be setting up a hitech rapid diagnostics centre at Bangalore.
Rutter, along with M S Swaminathan, was conferred Genomic Valley Excellence Award for outstanding contribution to the biotechnology industry. He said the centre to be christened Hemo Genomics would specialise in identifying genetic disorders.
A rapid immunological diagnostic system at the centre could make quantitative analysis in just a few minutes, he said. He, however, declined to disclose the proposed investments in the centre.
The centre would also sell diagnostic instruments and kits by the last quarter of the year, he said.
It may be recalled that Rutter’s firm commitment to the funding of research into the causative agent of non-A, non-B Hepatitis supported the discovery, sequencing and cloning of Hepatitis C virus in 1987, one of Chiron’s most enduring achievements.
To a query on the development of AIDS vaccine, Rutter said that the vaccine was currently going through phase-1 clinical trials in the US.
Rutter reveals India plans
Our Regional Bureau in Hyderabad
Published : March 1, 2004
William J Rutter, co-founder and former chairman of Chiron Corporation, US, announced his plans for India on Saturday. Rutter, well-known for his contributions to biotechnology like development of recombinant DNA technology, genetic engineering and Hepatitis B vaccine, said he would soon be setting up a hitech rapid diagnostics centre at Bangalore.
Rutter, along with M S Swaminathan, was conferred Genomic Valley Excellence Award for outstanding contribution to the biotechnology industry. He said the centre to be christened Hemo Genomics would specialise in identifying genetic disorders.
A rapid immunological diagnostic system at the centre could make quantitative analysis in just a few minutes, he said. He, however, declined to disclose the proposed investments in the centre.
The centre would also sell diagnostic instruments and kits by the last quarter of the year, he said.
It may be recalled that Rutter’s firm commitment to the funding of research into the causative agent of non-A, non-B Hepatitis supported the discovery, sequencing and cloning of Hepatitis C virus in 1987, one of Chiron’s most enduring achievements.
To a query on the development of AIDS vaccine, Rutter said that the vaccine was currently going through phase-1 clinical trials in the US.
Re: Indian Biotech News & Discussion
Drug firm hit by US patent defeat
Shares in Indian drugmaker Dr Reddy's have lost almost one-fifth of their value, after the firm lost a crucial patent case in the US.
Re: Indian Biotech News & Discussion
http://www.reuters.com/locales/newsArticle.jsp?type=businessNews&locale=en_IN&storyID=4499144
Novartis eyes more Indian research tie-ups
BOMBAY (Reuters) - Swiss healthcare group Novartis AG will pitch for collaborations in research and development with Indian pharmaceutical firms as part of efforts to bolster its pipeline, a top executive said on Thursday.
"For us it is important because licensing complements our own efforts. And it is enriching our pipeline," Thomas Ebeling, head of Novartis's pharmaceuticals business told a news conference.
"We have already two collaborations -- with Dr. Reddy's and Torrent -- and I hope that as a result of tomorrow's symposium we will have more," he said, referring to a meeting scheduled with Indian pharmaceutical firms. "I am very impressed by the quality of Indian science."
So far, Novartis has held such "collaboration symposiums" only in the United States and Japan.
Novartis has tied up with Dr. Reddy's Laboratories on an anti-diabetes drug and Torrent Pharmaceuticals on a heart disease drug.
Both drugs were in very early stages of development, he said.
Novartis will decide later this year whether to exercise an option to acquire exclusive global rights for further development and commercialisation of Torrent's drug, he said.
The Swiss firm is also eyeing opportunities in India to get third parties to manufacture on their behalf, and for sourcing of bulk drugs, both for its pharmaceutical and generics businesses, he said.
"There are 70 FDA approved plants in India and more than 200 are compliant with good manufacturing practices, so it is a universe which is certainly interesting for us to source from," he said.
Novartis currently operates in India through its unit Novartis India Ltd. It also opened two years ago a clinical development centre, which processes safety data on drugs launched overseas, and more recently an information technology department that will work on software for its clinical development work.
Ebeling said China was currently Novartis's most important growth market and India was second.
"I would be very surprised if the Indian market did not grow very dynamically in the next five years," he said.
"If I look at GDP growth in India, increased awareness about health issues, (or) reflect about the patent protection for some products, I certainly think the Indian market will become a top 10 market for Novartis between five and 10 years," he said.
Novartis eyes more Indian research tie-ups
BOMBAY (Reuters) - Swiss healthcare group Novartis AG will pitch for collaborations in research and development with Indian pharmaceutical firms as part of efforts to bolster its pipeline, a top executive said on Thursday.
"For us it is important because licensing complements our own efforts. And it is enriching our pipeline," Thomas Ebeling, head of Novartis's pharmaceuticals business told a news conference.
"We have already two collaborations -- with Dr. Reddy's and Torrent -- and I hope that as a result of tomorrow's symposium we will have more," he said, referring to a meeting scheduled with Indian pharmaceutical firms. "I am very impressed by the quality of Indian science."
So far, Novartis has held such "collaboration symposiums" only in the United States and Japan.
Novartis has tied up with Dr. Reddy's Laboratories on an anti-diabetes drug and Torrent Pharmaceuticals on a heart disease drug.
Both drugs were in very early stages of development, he said.
Novartis will decide later this year whether to exercise an option to acquire exclusive global rights for further development and commercialisation of Torrent's drug, he said.
The Swiss firm is also eyeing opportunities in India to get third parties to manufacture on their behalf, and for sourcing of bulk drugs, both for its pharmaceutical and generics businesses, he said.
"There are 70 FDA approved plants in India and more than 200 are compliant with good manufacturing practices, so it is a universe which is certainly interesting for us to source from," he said.
Novartis currently operates in India through its unit Novartis India Ltd. It also opened two years ago a clinical development centre, which processes safety data on drugs launched overseas, and more recently an information technology department that will work on software for its clinical development work.
Ebeling said China was currently Novartis's most important growth market and India was second.
"I would be very surprised if the Indian market did not grow very dynamically in the next five years," he said.
"If I look at GDP growth in India, increased awareness about health issues, (or) reflect about the patent protection for some products, I certainly think the Indian market will become a top 10 market for Novartis between five and 10 years," he said.
Re: Indian Biotech News & Discussion
ranbaxy launches its first branded prescription medicine in uk
http://www.keralanext.com/news/index.asp?id=28474
http://www.keralanext.com/news/index.asp?id=28474
-
George J
Re: Indian Biotech News & Discussion
WTF ???? MECYSTEINE HYDROCHLORIDE is the generic name for this drug???? its a frigging old mucolytic, since when did Ranbaxy own the rights to this molecule?? Besides Visclair is made by Sinclair in the UK and I have not read of any tie ups between Sinclair and Ranbaxy UK. Unless Ranbaxy is making a generic mecysteine analogous to Sinclair's Visclair???Originally posted by Rudra Singha:
ranbaxy launches its first branded prescription medicine in uk
http://www.keralanext.com/news/index.asp?id=28474
Either way Ranbaxy does not own exclusive rights to tihs drug.
Re: Indian Biotech News & Discussion
theres a lot of money to be made from mundane but
widely used stuff. will take more time for blockbusters like lipitor or zantac to emerge from developing nations.
widely used stuff. will take more time for blockbusters like lipitor or zantac to emerge from developing nations.
Re: Indian Biotech News & Discussion
http://sify.com/finance/fullstory.php?id=13422138
It’s the turn of mid-sized pharma cos
Monday, 08 March , 2004, 07:57
Move over pharma big-daddies, Dr Reddy's and Ranbaxy. It's time for the next generation of domestic drug companies to get more active in the overseas markets. Without much ado, mid-segment pharma companies, including JB Chemicals, Aarti Drugs, Ind-Swift, Unichem and Suven Pharma, are taking big strides into regulated pharma markets such as the US, Europe and Japan.
And the product-patent regime knocking at our doors, come 2005, is part of the reason, says Satish Nachane, Managing Director, Aarti Drugs Ltd.
"Mid-sized pharma companies are investing in getting their production facilities GMP-compliant (Good Manufacturing Practices). The time is right to go in for regulatory approvals for manufacturing facilities and products. The reason for that is, as more new molecules come into the market, large innovator pharma companies are looking to align with smaller drug companies for production. For the large drug company, outsourcing manufacturing is cost-effective and the small companies are able to get a marketing route into regulated markets."
Equally optimistic about the opportunity ahead for mid-segment drug companies is D.G. Shah, Secretary General, Indian Pharmaceutical Alliance: "Mid-sized pharma companies have reported a 100 per cent growth in exports. Globally, there is a demand for supply to the regulated markets, and big pharma and generic drug manufacturers are looking to align with smaller companies for production. And with more medium-sized companies going in for global approvals for their production facilities and products, they are increasingly seen to fit the bill for a partner."
According to him, Indian exports that are currently at about $2.5 billion would go up to about $14 billion in 2007, on account of such activity in the market.
Analysts observe that multinational pharma companies are "less intimidated by the smaller companies and find them easier to work with. The large Indian pharma companies, who are aggressive in the global market - filing patent challenges, besides getting into research for new products - have the strength to make it in regulated markets on their own steam. Small pharma companies benefit in tying up with large companies abroad to facilitate their own marketing."
The progression is evident, they observe: "In the past, it was only the DRLs, Ranbaxys, Wockhardts, Lupins and Sun Pharmas. Then came Cadila, Shasun, Matrix, Suven. And now, there are companies such as Aurbindo which are poised to take that leap into the regulated market. Meanwhile, companies like Ranbaxy and Lupin are elevating themselves to launching their branded generics in global markets."
Points out Shirish B. Mody, Director, JB Chemicals and Pharmaceuticals Ltd: "There's been a change in the industry over the last couple of years with regard to regulated markets. The success stories of DRL and Ranbaxy have spurred other companies to think big. And with mid-segment companies like us getting active in the regulated markets, smaller companies will be encouraged to make ambitious plans."
It’s the turn of mid-sized pharma cos
Monday, 08 March , 2004, 07:57
Move over pharma big-daddies, Dr Reddy's and Ranbaxy. It's time for the next generation of domestic drug companies to get more active in the overseas markets. Without much ado, mid-segment pharma companies, including JB Chemicals, Aarti Drugs, Ind-Swift, Unichem and Suven Pharma, are taking big strides into regulated pharma markets such as the US, Europe and Japan.
And the product-patent regime knocking at our doors, come 2005, is part of the reason, says Satish Nachane, Managing Director, Aarti Drugs Ltd.
"Mid-sized pharma companies are investing in getting their production facilities GMP-compliant (Good Manufacturing Practices). The time is right to go in for regulatory approvals for manufacturing facilities and products. The reason for that is, as more new molecules come into the market, large innovator pharma companies are looking to align with smaller drug companies for production. For the large drug company, outsourcing manufacturing is cost-effective and the small companies are able to get a marketing route into regulated markets."
Equally optimistic about the opportunity ahead for mid-segment drug companies is D.G. Shah, Secretary General, Indian Pharmaceutical Alliance: "Mid-sized pharma companies have reported a 100 per cent growth in exports. Globally, there is a demand for supply to the regulated markets, and big pharma and generic drug manufacturers are looking to align with smaller companies for production. And with more medium-sized companies going in for global approvals for their production facilities and products, they are increasingly seen to fit the bill for a partner."
According to him, Indian exports that are currently at about $2.5 billion would go up to about $14 billion in 2007, on account of such activity in the market.
Analysts observe that multinational pharma companies are "less intimidated by the smaller companies and find them easier to work with. The large Indian pharma companies, who are aggressive in the global market - filing patent challenges, besides getting into research for new products - have the strength to make it in regulated markets on their own steam. Small pharma companies benefit in tying up with large companies abroad to facilitate their own marketing."
The progression is evident, they observe: "In the past, it was only the DRLs, Ranbaxys, Wockhardts, Lupins and Sun Pharmas. Then came Cadila, Shasun, Matrix, Suven. And now, there are companies such as Aurbindo which are poised to take that leap into the regulated market. Meanwhile, companies like Ranbaxy and Lupin are elevating themselves to launching their branded generics in global markets."
Points out Shirish B. Mody, Director, JB Chemicals and Pharmaceuticals Ltd: "There's been a change in the industry over the last couple of years with regard to regulated markets. The success stories of DRL and Ranbaxy have spurred other companies to think big. And with mid-segment companies like us getting active in the regulated markets, smaller companies will be encouraged to make ambitious plans."
-
Guest
Re: Indian Biotech News & Discussion
Biocon IPO oversubscribed 5 times
http://www.thehindubusinessline.com/businessline/blnus/05111507.htm
http://www.thehindubusinessline.com/businessline/blnus/05111507.htm
Re: Indian Biotech News & Discussion
A little dated but some interesting articles.
http://www.biospectrumindia.com/content/news/104010801.asp
http://www.biospectrumindia.com/content/news/104010801.asp
Re: Indian Biotech News & Discussion
global pharma catches india outsourcing bug
http://www.forbes.com/home_asia/newswire/2004/03/18/rtr1303188.html
http://www.forbes.com/home_asia/newswire/2004/03/18/rtr1303188.html
Re: Indian Biotech News & Discussion
http://business.timesonline.co.uk/article/0,,9068-1047251,00.html
India beats global drug firms at their own game
Ranbaxy, one of the country’s largest pharmaceutical companies, is growing rapidly thanks to its cheap and productive research skills. Paul Durman reports
IT now costs the pharmaceutical industry $1.7 billion (£930m) to develop each new drug, according to a recent study by the international consultants Bain & Co.
Tell that to the Indians. Ranbaxy, India’s largest pharmaceutical manufacturer, launched 20 new products in America last year, and another 32 in its domestic market. Yet its entire research and development budget last year amounted to only $55m.
The comparison underlines the huge advantages the fast-growing Indian industry enjoys in the cost of innovation. Brian Tempest, the Briton who is about to take over as Ranbaxy’s chief executive, said: “We are spending less on R&D but we are rich in products. That’s what made the difference in the past, and that’s what will make the difference in the future.”
Admittedly, these numbers do not compare like with like. The Bain study looked at innovative “new chemical entities” and included an estimate of $250m marketing costs, while Ranbaxy is a generics manufacturer, making copycat versions of proven medicines.
Yet it still takes considerable skill to reverse-engineer existing products, and to devise the manufacturing improvements needed to make money in a cut-throat industry. Tempest said Ranbaxy’s scientists can complete the job in three or four months.
In addition, the $55m figure includes the money Ranbaxy is spending on its own more innovative products.
Along with the IT and outsourcing industry, pharmaceutical is the sector of the Indian economy with the most obvious potential. Both draw on the large pool of graduates created by the country's highly competitive university system.
Tempest said: “There are two areas where India is extremely strong. One is chemistry and the other is mathematics. Of those working in (research) labs in America, 13%-14% are of Indian origin.”
Tempest believes the key to India’s competitive advantage is not lower wages but the much lower costs of innovation. Ranbaxy can now lure Indian research scientists away from larger US rivals. “If we have someone doing a global job, we pay a global salary,” he said.
Indian companies enjoy another edge. The country’s past refusal to recognise pharmaceutical product rights has allowed Ranbaxy and its 3,000 domestic rivals to hone their skills on patent medicines.
Ranbaxy has already launched a version of Crestor, the new cholesterol-lowering drug Astra Zeneca hopes will grow into a $5 billion blockbuster.
This made the Indian industry deeply unpopular with “big pharma” — even though few patients in the developing world could afford the full price of western medicines.
Despite the tensions, nobody doubts the expertise of Indian chemists. When Germany’s Bayer wanted to develop a once-a-day version of Cipro, the antibiotic treatment for anthrax, it turned to Ranbaxy. Tempest said the once-daily formulation now generates $1m of royalty income a month.
India’s agreement to adopt the World Trade Organisation’s intellectual-property agreement from next year has opened more doors and has already led to collaboration with Glaxo Smith Kline.
Further evidence of its scientific credentials came when Ranbaxy took over from Roche as the developer of a treatment for malaria, an international project sponsored by an offshoot of the World Health Organisation.
The company is also working with Bill Clinton, the former American president, to cut the cost of Aids drugs in Africa and the Caribbean.
Tempest, an industry veteran who previously worked for Fisons, Glaxo and Beecham, is unconcerned by India’s decision to adopt a new system of product patents.
He said: “In the Indian domestic market, instead of launching one product a week, as we do at the moment, we will do five or six a year. We will need to have products coming from our own innovation.”
The future growth of the business rests more heavily on the wealthier markets in America, Europe and Japan — and many opportunities are created as patents expire.
“What we are launching in America today, we actually launched in India six or seven years ago,” said Tempest.
In global terms, Ranbaxy is still small. It has annual sales of $1 billion and a market value of about $4 billion — big enough to make the lower reaches of the FTSE 100 if it were listed in Britain.
Although the value of its sales is smaller, Tempest is proud that in America Ranbaxy fills more prescriptions than Roche, Sanofi-Synthelabo or Bayer — three mid-sized European drug companies. Its 600 American sales representatives generate about $400m a year.
Tempest takes over as chief executive in July, succeeding DS Brar, the architect of Ranbaxy’s rapid growth since the death of its founder, Parminder Singh, in 1999. Singh recruited Tempest in 1995.
Tempest, who was regional director for the Far East when he was at Glaxo in the 1980s, said he had been looking for a job in Asia.
“I am very much at home in India. In Delhi you can ring up and order an elephant like you can order a pizza in London.” This is a favourite entertainment when children come to stay at his Delhi home.
He wants to double the size of the business again by 2007, and said that he would look at acquisitions to help him hit his target.
In December, Ranbaxy bought RPG Aventis, the generics arm of the French drugs group. The company is also keen to build its business in Germany, and would be interested in an American urology product. It already has a $50m-a-year business in Britain.
There is still plenty of life left in the generics business.Smaller-selling drugs can present more profitable targets for the generic firms. True blockbusters attract so much unbranded competition that prices can fall by more than 95%, making it hard to turn a profit unless the generics company can secure six months of “first-to-file” exclusivity.
“The ideal profile is to have a mixture of products coming through,” said Tempest.
Ranbaxy also has high hopes for its own product pipeline. The initial focus is on “drug delivery” products, improved or more convenient formulations of existing medicines.
Further down the line will come its own entirely new drugs: its lead product is a treatment for enlarged prostate, and it is working on other urological conditions.
“New chemical entities out of India will come in eight to nine years,” said Tempest. “We have only just started getting going.”
India beats global drug firms at their own game
Ranbaxy, one of the country’s largest pharmaceutical companies, is growing rapidly thanks to its cheap and productive research skills. Paul Durman reports
IT now costs the pharmaceutical industry $1.7 billion (£930m) to develop each new drug, according to a recent study by the international consultants Bain & Co.
Tell that to the Indians. Ranbaxy, India’s largest pharmaceutical manufacturer, launched 20 new products in America last year, and another 32 in its domestic market. Yet its entire research and development budget last year amounted to only $55m.
The comparison underlines the huge advantages the fast-growing Indian industry enjoys in the cost of innovation. Brian Tempest, the Briton who is about to take over as Ranbaxy’s chief executive, said: “We are spending less on R&D but we are rich in products. That’s what made the difference in the past, and that’s what will make the difference in the future.”
Admittedly, these numbers do not compare like with like. The Bain study looked at innovative “new chemical entities” and included an estimate of $250m marketing costs, while Ranbaxy is a generics manufacturer, making copycat versions of proven medicines.
Yet it still takes considerable skill to reverse-engineer existing products, and to devise the manufacturing improvements needed to make money in a cut-throat industry. Tempest said Ranbaxy’s scientists can complete the job in three or four months.
In addition, the $55m figure includes the money Ranbaxy is spending on its own more innovative products.
Along with the IT and outsourcing industry, pharmaceutical is the sector of the Indian economy with the most obvious potential. Both draw on the large pool of graduates created by the country's highly competitive university system.
Tempest said: “There are two areas where India is extremely strong. One is chemistry and the other is mathematics. Of those working in (research) labs in America, 13%-14% are of Indian origin.”
Tempest believes the key to India’s competitive advantage is not lower wages but the much lower costs of innovation. Ranbaxy can now lure Indian research scientists away from larger US rivals. “If we have someone doing a global job, we pay a global salary,” he said.
Indian companies enjoy another edge. The country’s past refusal to recognise pharmaceutical product rights has allowed Ranbaxy and its 3,000 domestic rivals to hone their skills on patent medicines.
Ranbaxy has already launched a version of Crestor, the new cholesterol-lowering drug Astra Zeneca hopes will grow into a $5 billion blockbuster.
This made the Indian industry deeply unpopular with “big pharma” — even though few patients in the developing world could afford the full price of western medicines.
Despite the tensions, nobody doubts the expertise of Indian chemists. When Germany’s Bayer wanted to develop a once-a-day version of Cipro, the antibiotic treatment for anthrax, it turned to Ranbaxy. Tempest said the once-daily formulation now generates $1m of royalty income a month.
India’s agreement to adopt the World Trade Organisation’s intellectual-property agreement from next year has opened more doors and has already led to collaboration with Glaxo Smith Kline.
Further evidence of its scientific credentials came when Ranbaxy took over from Roche as the developer of a treatment for malaria, an international project sponsored by an offshoot of the World Health Organisation.
The company is also working with Bill Clinton, the former American president, to cut the cost of Aids drugs in Africa and the Caribbean.
Tempest, an industry veteran who previously worked for Fisons, Glaxo and Beecham, is unconcerned by India’s decision to adopt a new system of product patents.
He said: “In the Indian domestic market, instead of launching one product a week, as we do at the moment, we will do five or six a year. We will need to have products coming from our own innovation.”
The future growth of the business rests more heavily on the wealthier markets in America, Europe and Japan — and many opportunities are created as patents expire.
“What we are launching in America today, we actually launched in India six or seven years ago,” said Tempest.
In global terms, Ranbaxy is still small. It has annual sales of $1 billion and a market value of about $4 billion — big enough to make the lower reaches of the FTSE 100 if it were listed in Britain.
Although the value of its sales is smaller, Tempest is proud that in America Ranbaxy fills more prescriptions than Roche, Sanofi-Synthelabo or Bayer — three mid-sized European drug companies. Its 600 American sales representatives generate about $400m a year.
Tempest takes over as chief executive in July, succeeding DS Brar, the architect of Ranbaxy’s rapid growth since the death of its founder, Parminder Singh, in 1999. Singh recruited Tempest in 1995.
Tempest, who was regional director for the Far East when he was at Glaxo in the 1980s, said he had been looking for a job in Asia.
“I am very much at home in India. In Delhi you can ring up and order an elephant like you can order a pizza in London.” This is a favourite entertainment when children come to stay at his Delhi home.
He wants to double the size of the business again by 2007, and said that he would look at acquisitions to help him hit his target.
In December, Ranbaxy bought RPG Aventis, the generics arm of the French drugs group. The company is also keen to build its business in Germany, and would be interested in an American urology product. It already has a $50m-a-year business in Britain.
There is still plenty of life left in the generics business.Smaller-selling drugs can present more profitable targets for the generic firms. True blockbusters attract so much unbranded competition that prices can fall by more than 95%, making it hard to turn a profit unless the generics company can secure six months of “first-to-file” exclusivity.
“The ideal profile is to have a mixture of products coming through,” said Tempest.
Ranbaxy also has high hopes for its own product pipeline. The initial focus is on “drug delivery” products, improved or more convenient formulations of existing medicines.
Further down the line will come its own entirely new drugs: its lead product is a treatment for enlarged prostate, and it is working on other urological conditions.
“New chemical entities out of India will come in eight to nine years,” said Tempest. “We have only just started getting going.”
-
George J
Re: Indian Biotech News & Discussion
And that my dear jingo's is what separates the wheat from the chaffe. Next year the patent laws come in and Excl. Mktg Rights (EMR) will be in full swing. An 8-9 year gestation means they DONT HAVE anything viable in the pipeline...all their drugs are in the discovery stage* nothing is in the pre-clinical or clincial stage**. I am disappointed with Ranbaxy...with all their moolah and royalting I thought they would have at least a 'me too' drug in the pipeline.Originally posted by Rudra Singha:
http://business.timesonline.co.uk/article/0,,9068-1047251,00.html
India beats global drug firms at their own game
Ranbaxy, one of the country’s largest pharmaceutical companies, is growing rapidly thanks to its cheap and productive research skills. Paul Durman reports
...........................
“New chemical entities out of India will come in eight to nine years,” said Tempest. “We have only just started getting going.”
__________________________
* where chemist while away their time looking for hypothetical molecules or concoct something just might be a drug.
** where something 'just might' be a drug and has not killed rats or monkey but has cured some animals and now you need to find a solvent to dissolve this stuff in so that you dont kill humans (at the very least). Note I said NOT KILL humans CURING humans is Clin Phase II and III.
Re: Indian Biotech News & Discussion
Most of the global big pharms cos seem to be about 100 years old. this is one area which doesnt seem very amenable to quick_fix_terabit_router_on_a_chip_scams!
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George J
Re: Indian Biotech News & Discussion
GD:
Well it was my educated belief that desi Pharma had nothing worthwhile in clinical phases, partly coz its way to expensive but what this dude is saying it has nothing in pre-clinical phases either and I am assuming that $ billion co it has something in discovery stage. This is important coz one of the BIGGEST excuse used by desi pharma was that we dont have patent protection and hence we are not 'originating' once patent laws come in we will go full flow. They even major sops in their favor like no price control restrictions. 8-9 years post patent laws is a LONG TIME for someone to start originating.
Maybe Ranbaxy likes being a el cheapo generic mfg it has huge margins and can milk the US good for it...why bother originating anything. And here I had huge hopes for desi pharma. Looks like MNC will lead the way in this field too for us.
Well it was my educated belief that desi Pharma had nothing worthwhile in clinical phases, partly coz its way to expensive but what this dude is saying it has nothing in pre-clinical phases either and I am assuming that $ billion co it has something in discovery stage. This is important coz one of the BIGGEST excuse used by desi pharma was that we dont have patent protection and hence we are not 'originating' once patent laws come in we will go full flow. They even major sops in their favor like no price control restrictions. 8-9 years post patent laws is a LONG TIME for someone to start originating.
Maybe Ranbaxy likes being a el cheapo generic mfg it has huge margins and can milk the US good for it...why bother originating anything. And here I had huge hopes for desi pharma. Looks like MNC will lead the way in this field too for us.
Re: Indian Biotech News & Discussion
Ranbaxy and other Indian companies have been doing drug development. Examples
http://www1.timesofindia.indiatimes.com/cms.dll/articleshow?art_id=5998674
http://www1.timesofindia.indiatimes.com/cms.dll/articleshow?art_id=5998674
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George J
Re: Indian Biotech News & Discussion
Thank you. If you notice this article is dated April 2002. I was very excited way back then. And now with Tempestbhai claiming it will take 8-9 years means they dont have anything viable yet. Their out licensed molecules didnt really work out as well as their 'once a day cipro' else we would have heard about it.Originally posted by kautilaya:
Ranbaxy and other Indian companies have been doing drug development. Examples
http://www1.timesofindia.indiatimes.com/cms.dll/articleshow?art_id=5998674
Re: Indian Biotech News & Discussion
George:
Here is some more recent ammunition --
Dr. Reddy's organizes international symposium on drug discovery
Dr Reddy's to present research findings at US meet
Added later:
Reddy's to step up discovery spend in FY04
Google search on Reddy discovery
GSK AND RANBAXY TO COLLABORATE ON DRUG DISCOVERY
Ranbaxy In Drug Discovery Pact With Anna University
Apr 2003: Ranbaxy also has three molecules in the late discovery stage and one in pre-clinical.
Google search on Ranbaxy discovery
Here is some more recent ammunition --
Dr. Reddy's organizes international symposium on drug discovery
Dr Reddy's to present research findings at US meet
Added later:
Reddy's to step up discovery spend in FY04
Google search on Reddy discovery
GSK AND RANBAXY TO COLLABORATE ON DRUG DISCOVERY
Ranbaxy In Drug Discovery Pact With Anna University
Apr 2003: Ranbaxy also has three molecules in the late discovery stage and one in pre-clinical.
Google search on Ranbaxy discovery
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George J
Re: Indian Biotech News & Discussion
Originally posted by kautilaya:
Apr 2003: Ranbaxy also has three molecules in the late discovery stage and one in pre-clinical.
Its been over a year since the news of Phase I CT. I have not heard much about Phase II (which is a BFD). And Tempest Bhai just said 8-9 years that would imply that RB 7644 didnt exact prove to be safe. Stuff like this happens....back to the drawing board...more research...more pre clin....more money. No one said drug discovery is gonna be cheep.Ranbaxy’s anti-asthma molecule, RBx 7796 (Clafrinast) is in phase I clinical trials in India. The company is awaiting approvals to conduct phase 1 clinical trials for RBx 7644 (Ranbezolid), an extended spectrum Oxazolidinone from the DCI for both its oral and intravenous usage in India. RBx 7644 (Ranbezolid) is presently undergoing phase I clinical trials in the UK.
Ranbaxy also has three molecules in the late discovery stage and one in pre-clinical. The company’s major research focus is in the areas of anti-infectives, urology, respiratory, anti-inflammatory, metabolic disorders and anti-cancer segments.
I am not trying to rubbish Indian Pharma research. Its just that knowing the folks who work in this line in both India and the US...i have great expectations from them and this 8-9 year bit was a bit disappointing.
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AjaySharma
- BRFite -Trainee
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Re: Indian Biotech News & Discussion
Lupin launches branded finished dosage in US
Source: IRIS (07 April 2004)
Lupin Limited (Q, N,C,F)* today announced that it has now launched its anti-infective product SupraxÒ (cefixime Oral Suspension) in the US.
The newly established 50 strong pediatric specialty sales force of the company`s subsidiary, Lupin Pharmaceuticals Inc.(LPI), has begun detailing Suprax®. The sales force will initially target over 10,000 physicians who prescribe oral suspension anti-infectives. Suprax® will be the primary product in every detail presentation. The market for branded anti-infectives` oral suspension is over US $ 1 billion. Lupin`s sales force will call upon physicians who account for over 50 per cent of the prescriptions written in this segment.
LPI has been distributing the product through wholesalers and pharmacy chains in the US, which in turn is sold to retail outlets across the country. Vinita Gupta, President, LPI, said: `We are very pleased by the initial response to
this new launch. We are encouraged that the product will be widely available in the US when physicians begin to prescribe Suprax®.`
The pediatric specialty sales force efforts are supplemented by additional promotional programs. LPI has planned a series of non-personal promotional campaigns such as direct mailing and through product website, to reinforce the sales effort. For several months, LPI has also been presenting the product to
managed care organizations to secure access and coverage for patients.
Lupin Limited earlier announced that the pediatric specialty sales force will also promote ZymarTM (gatifloxacin 0.3% ophthalmic solution), for which it entered into an agreement with Allergan, Inc. recently.
Lupin Pharmaceuticals, Inc is the wholly owned U.S. subsidiary of Mumbai based Lupin Limited, a leading Indian Pharmaceutical company. Lupin Limited develops, manufactures and markets finished products, active pharmaceutical ingredients and intermediates. Lupin Limited`s revenue in FY2002-03 was Rs.11.2 billion.
Lupin Limited is traded on all major exchanges in India. Nine of Lupin`s plants have been approved by the U.S. Food & Drug Administration and two plants have been approved by the UKMCA.
Source: IRIS (07 April 2004)
Lupin Limited (Q, N,C,F)* today announced that it has now launched its anti-infective product SupraxÒ (cefixime Oral Suspension) in the US.
The newly established 50 strong pediatric specialty sales force of the company`s subsidiary, Lupin Pharmaceuticals Inc.(LPI), has begun detailing Suprax®. The sales force will initially target over 10,000 physicians who prescribe oral suspension anti-infectives. Suprax® will be the primary product in every detail presentation. The market for branded anti-infectives` oral suspension is over US $ 1 billion. Lupin`s sales force will call upon physicians who account for over 50 per cent of the prescriptions written in this segment.
LPI has been distributing the product through wholesalers and pharmacy chains in the US, which in turn is sold to retail outlets across the country. Vinita Gupta, President, LPI, said: `We are very pleased by the initial response to
this new launch. We are encouraged that the product will be widely available in the US when physicians begin to prescribe Suprax®.`
The pediatric specialty sales force efforts are supplemented by additional promotional programs. LPI has planned a series of non-personal promotional campaigns such as direct mailing and through product website, to reinforce the sales effort. For several months, LPI has also been presenting the product to
managed care organizations to secure access and coverage for patients.
Lupin Limited earlier announced that the pediatric specialty sales force will also promote ZymarTM (gatifloxacin 0.3% ophthalmic solution), for which it entered into an agreement with Allergan, Inc. recently.
Lupin Pharmaceuticals, Inc is the wholly owned U.S. subsidiary of Mumbai based Lupin Limited, a leading Indian Pharmaceutical company. Lupin Limited develops, manufactures and markets finished products, active pharmaceutical ingredients and intermediates. Lupin Limited`s revenue in FY2002-03 was Rs.11.2 billion.
Lupin Limited is traded on all major exchanges in India. Nine of Lupin`s plants have been approved by the U.S. Food & Drug Administration and two plants have been approved by the UKMCA.
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AjaySharma
- BRFite -Trainee
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Re: Indian Biotech News & Discussion
Zydus Cadila gears up, files 12 ANDAs
Source: IRIS (02 April 2004)
Gearing up for its foray into the US formulations generic market, Zydus Cadila ended the financial year 2003-4 with 12 ANDA filings. The group, which had started the process in November with 2 ANDA filings, has rounded off the year with 12 filings. This is the largest number of ANDA filings by an Indian pharma company in the very first year itself.
The group plans to step up the momentum by improving the speed of filing ANDAs, and has set a target of 16 to 18 ANDA filings in 2004-5. On the API front, the group has filed 12 DMFs so far and plans to file 16 to 18 DMFs more in the coming year. ANDA approvals for generic formulations and DMF listings for APIs are a prerequisite for any pharma company looking to enter the US generic markets.
Zydus Cadila has already set up Zydus Pharmaceuticals USA Inc., to market finished dosage formulations to the US generic market place. The total US market for these 12 drugs is estimated at US $ 7.4 bn (2003 IMS data).
The group plans to launch 9 of these 12 drugs in 2005, the market for which is estimated at US$ 3.5 bn. The remaining three drugs with an estimated market size of US$ 3.9 bn will be launched after 2005.
This new development is in line with the various initiatives that group has been undertaking in the recent months to position itself as a global pharmaceutical provider.
Commenting on the announcement, Pankaj Patel, chairman and managing director of Zydus Cadila said, `Significant effort and progress has already been made to realise our plans to grow revenues from the generics markets. With a robust pipeline of ANDA filings, we will now be best placed to leverage our strengths in generic formulations and effectively participate in the world’s largest generic market place.` The group expects to market its products in the USA from July 2005.
Zydus Cadila which aims to be amongst the top ten global generic players has set up a strong infrastructure for filings of ANDAs and DMFs. Proven chemistry capabilities, an extensive talent pool and a world-class manufacturing base have buoyed Zydus Cadila’s strategic plans to enter the US generic market where an estimated US $ 40 billion worth of branded drugs will be going off patent over the next five years.
Source: IRIS (02 April 2004)
Gearing up for its foray into the US formulations generic market, Zydus Cadila ended the financial year 2003-4 with 12 ANDA filings. The group, which had started the process in November with 2 ANDA filings, has rounded off the year with 12 filings. This is the largest number of ANDA filings by an Indian pharma company in the very first year itself.
The group plans to step up the momentum by improving the speed of filing ANDAs, and has set a target of 16 to 18 ANDA filings in 2004-5. On the API front, the group has filed 12 DMFs so far and plans to file 16 to 18 DMFs more in the coming year. ANDA approvals for generic formulations and DMF listings for APIs are a prerequisite for any pharma company looking to enter the US generic markets.
Zydus Cadila has already set up Zydus Pharmaceuticals USA Inc., to market finished dosage formulations to the US generic market place. The total US market for these 12 drugs is estimated at US $ 7.4 bn (2003 IMS data).
The group plans to launch 9 of these 12 drugs in 2005, the market for which is estimated at US$ 3.5 bn. The remaining three drugs with an estimated market size of US$ 3.9 bn will be launched after 2005.
This new development is in line with the various initiatives that group has been undertaking in the recent months to position itself as a global pharmaceutical provider.
Commenting on the announcement, Pankaj Patel, chairman and managing director of Zydus Cadila said, `Significant effort and progress has already been made to realise our plans to grow revenues from the generics markets. With a robust pipeline of ANDA filings, we will now be best placed to leverage our strengths in generic formulations and effectively participate in the world’s largest generic market place.` The group expects to market its products in the USA from July 2005.
Zydus Cadila which aims to be amongst the top ten global generic players has set up a strong infrastructure for filings of ANDAs and DMFs. Proven chemistry capabilities, an extensive talent pool and a world-class manufacturing base have buoyed Zydus Cadila’s strategic plans to enter the US generic market where an estimated US $ 40 billion worth of branded drugs will be going off patent over the next five years.
Re: Indian Biotech News & Discussion
Ajay, can I have the source of this info please. I need this for work.Originally posted by Ajay Sharma:
Lupin launches branded finished dosage in US
Source: IRIS (07 April 2004)
Lupin Limited (Q, N,C,F)* today announced that it has now launched its anti-infective product SupraxÒ (cefixime Oral Suspension) in the US.
.
Suprax is used to rx gonorrhea!!
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AjaySharma
- BRFite -Trainee
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Re: Indian Biotech News & Discussion
Manju - Here is link for Lupin posting
Lupin launches branded finished dosage in US
Source: IRIS (07 April 2004) http://www.myiris.com/
Lupin launches branded finished dosage in US
Source: IRIS (07 April 2004) http://www.myiris.com/
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AjaySharma
- BRFite -Trainee
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- Contact:
Re: Indian Biotech News & Discussion
Ranbaxy wins US court battle against Glaxo
April 08, 2004 18:09 IST
Pharma major Ranbaxy Laboratories on Thursday said it has scored a legal victory with a United States court ruling that its Cefuroxime Exetil product does not infringe upon the patent rights of GlaxoSmithKline.
After a full trial, the United States district court of New Jersey has determined that Ranbaxy's product does not infringe GSK's patent rights and the former is not required to pay any damages to GSK, Ranbaxy said in a statement in New Delhi.
Jay R Deshmukh, vice president, intellectual property, worldwide, Ranbaxy, described it as a major victory for the company.
The lawsuit had been brought by GSK in October 2000 relating to Ranbaxy's Cefuroxime Exetil product, a generic version of GSK's antibiotic Ceftin.
The district court had originally granted GSK a preliminary injunction. However, in 2001, Ranbaxy prevailed on its appeal to the US Court of Appeals for the Federal Circuit, which vacated the preliminary injunction. After that Ranbaxy had commercially launched its product.
April 08, 2004 18:09 IST
Pharma major Ranbaxy Laboratories on Thursday said it has scored a legal victory with a United States court ruling that its Cefuroxime Exetil product does not infringe upon the patent rights of GlaxoSmithKline.
After a full trial, the United States district court of New Jersey has determined that Ranbaxy's product does not infringe GSK's patent rights and the former is not required to pay any damages to GSK, Ranbaxy said in a statement in New Delhi.
Jay R Deshmukh, vice president, intellectual property, worldwide, Ranbaxy, described it as a major victory for the company.
The lawsuit had been brought by GSK in October 2000 relating to Ranbaxy's Cefuroxime Exetil product, a generic version of GSK's antibiotic Ceftin.
The district court had originally granted GSK a preliminary injunction. However, in 2001, Ranbaxy prevailed on its appeal to the US Court of Appeals for the Federal Circuit, which vacated the preliminary injunction. After that Ranbaxy had commercially launched its product.
Re: Indian Biotech News & Discussion
USFDA nod for Ranbaxy's hypertension drug
NEW DELHI: Ranbaxy Laboratories has received the U.S. Food and Drug Administration approval to market Fosinopril sodium tablets in the U.S. The USFDA website today said that the company had been given the go-ahead for marketing Fosinopril sodium indicated for treatment of hypertension. — PTI
http://www.hindu.com/2004/04/27/stories/2004042707341804.htm
NEW DELHI: Ranbaxy Laboratories has received the U.S. Food and Drug Administration approval to market Fosinopril sodium tablets in the U.S. The USFDA website today said that the company had been given the go-ahead for marketing Fosinopril sodium indicated for treatment of hypertension. — PTI
http://www.hindu.com/2004/04/27/stories/2004042707341804.htm
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AjaySharma
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Re: Indian Biotech News & Discussion
Apollo Hospitals threatening jobs in US: WSJ
Wednesday April 28 2004 00:00 IST
PTI
WASHINGTON : Apollo Hospital 's emergence as a global health care provider in many ways tracks India 's economic trajectory over the past three decades, the Wall Street Journal (WSJ) has said.
The company had capitalised on the high cost of health care administration in US and demands of patients elsewhere, for "fast, inexpensive treatment" with the most modern equipment, the Wall Street Journal said in the article "India's new coup in outsourcing: Inpatient care".
It cited the experience of Terry Salo, a former commercial fisherman, who faced a wait of a year or more for free care from Canada 's National Health Services.
The pain became intolerable and he paid $4,500, one fourth of the cost for treatment in Europe or US, for surgery at Apollo. Salo is one of 60,000 foreign patients treated at Apollo Hospitals over the past three years.
Since its start as a single hospital, in 1983, Apollo has grown to 37 hospitals and one of Asia 's largest private hospital chains.
Hundreds of Apollo's data processors, says the paper, work late-night shifts providing billing services and processing insurance claims for US hospitals and insurers. Apollo laboratories perform clinical trials for Western companies such as Pfizer and Eli Lilly.
Apollo's range of medical services, said the paper, highlighted the contradictions of the global outsourcing debate. In seeking to provide a range of services at a large discount to Western competitors, Apollo is yet another Indian company threatening jobs in US and other countries.
On the other hand, Apollo's relatively inexpensive medical services have benefited patients from several nations besides helping India 's overburdened health care system, the Wall Street Journal said.
"We are showing that a field like medicine is very much a two-way street," said Dr Prathap C Reddy, the founder of Apollo Hospitals. "We can all grow from each other's strengths," he added.
Wednesday April 28 2004 00:00 IST
PTI
WASHINGTON : Apollo Hospital 's emergence as a global health care provider in many ways tracks India 's economic trajectory over the past three decades, the Wall Street Journal (WSJ) has said.
The company had capitalised on the high cost of health care administration in US and demands of patients elsewhere, for "fast, inexpensive treatment" with the most modern equipment, the Wall Street Journal said in the article "India's new coup in outsourcing: Inpatient care".
It cited the experience of Terry Salo, a former commercial fisherman, who faced a wait of a year or more for free care from Canada 's National Health Services.
The pain became intolerable and he paid $4,500, one fourth of the cost for treatment in Europe or US, for surgery at Apollo. Salo is one of 60,000 foreign patients treated at Apollo Hospitals over the past three years.
Since its start as a single hospital, in 1983, Apollo has grown to 37 hospitals and one of Asia 's largest private hospital chains.
Hundreds of Apollo's data processors, says the paper, work late-night shifts providing billing services and processing insurance claims for US hospitals and insurers. Apollo laboratories perform clinical trials for Western companies such as Pfizer and Eli Lilly.
Apollo's range of medical services, said the paper, highlighted the contradictions of the global outsourcing debate. In seeking to provide a range of services at a large discount to Western competitors, Apollo is yet another Indian company threatening jobs in US and other countries.
On the other hand, Apollo's relatively inexpensive medical services have benefited patients from several nations besides helping India 's overburdened health care system, the Wall Street Journal said.
"We are showing that a field like medicine is very much a two-way street," said Dr Prathap C Reddy, the founder of Apollo Hospitals. "We can all grow from each other's strengths," he added.
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George J
Re: Indian Biotech News & Discussion
Above post is neither biotech nor is it new. Its already posted on the Healthcare Industry Thread.
Re: Indian Biotech News & Discussion
Cross-post:
US sues EU over GM crop ban
US sues EU over GM crop ban
So far India has also not taken to GM crops, thought China has used it extensively AFAIK.The US has demanded that the EU abandon its ban on the growing of genetically modified crops and pay at least $1.8bn in compensation for loss of exports over the past six years.
[...]
The WTO is now facing the biggest case in its history, one that could spark a damaging trade war between the US and Europe and split the international community....
Re: Indian Biotech News & Discussion
Monsanto conducted field trails for GM cotton variety in Maharshtra and got burnt by the govt and villagers! Lucky us, the govt banned em!
Re: Indian Biotech News & Discussion
A Good Step, In Line With Global Norms
Recently, the Drug Tech-nical Advisory Board, proposed placing over 200 new drugs in Schedule ‘H’, which classifies them as prescription drugs. This step is in line with international norms. These include drugs, like statins for the heart, anti-hypertensives, NSAIDS, anti-malarial drugs etc.
In India, there is no specific category for OTC (over the counter) drugs and in fact OTC drugs are not in any schedule. OTC drugs are a vital part of a nation’s healthcare system.
Re: Indian Biotech News & Discussion
NYTIMES.
Made in India, the Ideal `Cocktail' for AIDS
By DONALD G. McNEIL Jr.
Published: May 4, 2004
three-year study of AIDS drugs has identified what the research leaders believe is the ideal triple-therapy cocktail for new patients.
The successful cocktail, known colloquially as "two nukes plus a non-nuke," is the same one that the World Health Organization has been recommending in poor countries since 2002. It is also the same combination that Indian suppliers of generic drugs have been putting in three-in-one pills since 2001.
Another drug cocktail examined in the study — a "three-nuke combination" — did so poorly that patients were taken off it. The failed cocktail is the only one made as a three-in-one pill by any Western pharmaceutical company.
The study, its authors said, suggests that patients who have never been on AIDS drugs should be started on a combination of two nucleoside reverse transcriptase inhibitors ("nukes") and a non-nucleoside reverse transcriptase inhibitor ("non-nuke").
Currently, American and European doctors prescribe many different mixes of the 20 drugs approved for fighting AIDS infections, and shift the mixes as patients develop resistance or side effects.
The study of 1,147 patients, published in the April 29 issue of the New England Journal of Medicine, looked for an ideal regimen for new patients that avoided protease inhibitors. Those drugs are effective and often prescribed by Western doctors, but they can damage the liver or shift body fat into unsightly humps.
The study was begun before any drugs in the two newest classes of AIDS drugs, fusion inhibitors and integrase inhibitors, were approved.
AIDS experts said a second conclusion from the study was that the three-in-one pills offered by generic drug makers from India were better for new patients than any of those sold or planned by Western drug companies.
The study "reinforces the point" that the type of cocktail recommended for poor countries by the World Health Organization is right for rich countries as well, said the study's lead author, Dr. Roy M. Gulick, director of the H.I.V. clinical trials unit at Weill Cornell Medical College in New York City.
The latest guidelines from the National Institutes of Health for American doctors recommend starting new patients either on the same two-nukes-plus-a-non-nuke regimen that the W.H.O. recommends, or a two-nukes-plus-a-protease-inhibitor regimen.
Most of the Weill Cornell study's 1,147 patients were nonwhite and 19 percent were women, Dr. Gulick said, so the study's conclusions should be applicable worldwide.
The AIDS expert who led the committee that formulated the W.H.O. guidelines, Dr. Scott Hammer, chief of the division of infectious diseases at Columbia Presbyterian Medical Center, said the W.H.O. made its 2002 recommendation because the combination worked well and the drugs were generally cheap.
Besides their toxicity problems, he said, protease inhibitors were expensive because only companies that held patents on the drugs made them, and some of the medications required refrigeration, which is impossible to guarantee in, for example, rural Africa.
In the new study, the cocktail that worked best was a mix of the "nukes," AZT and lamivudine plus the "non-nuke" efavirenz. After 32 weeks on the cocktail, 89 percent of the patients had almost undetectable levels of virus in their blood.
The cocktail that did less well was a mixture of AZT and lamivudine plus abacavir. After 32 weeks, only 79 percent of the patients had low levels of virus.
That cocktail is sold by GlaxoSmithKline as a three-in-one pill under the name Trizivir.
However, because it is "clearly inferior" at suppressing the virus, it is "no longer recommended for first-line use" said Dr. David Bangsberg, a professor of medicine at the University of California at San Francisco who monitors treatment around the world.
Most of the study was paid for and monitored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
Glaxo provided its drugs and paid part of the analysis costs, said Mary Faye Dark, a Glaxo spokeswoman.
"We aren't surprised that Trizivir alone didn't do as well," Ms. Dark said. The decision to take the study's patients off it was made in February 2003.
But she said the cocktail still worked in many patients and should play a role in AIDS therapy, especially for maintaining patients whose viral loads have first been lowered by other regimens.
Most three-in-one pills now made by Indian generics makers contain AZT, lamivudine and nevirapine.
Nevirapine is in the same "non-nuke" class as efavirenz and a recent study in Lancet, the British medical journal, found them to be equivalent. Nevirapine is a well-established drug, but it causes a serious rash in some patients, so generics makers are moving toward making compounds with efavirenz as well.
The N.I.H. guidelines prefer efavirenz because it causes fewer rashes, but accept nevirapine as a substitute.
Both the "nukes" and "non-nukes" block reverse transcriptase, an enzyme that allows the RNA in an AIDS virus particle to replicate itself inside the DNA of a healthy T cell, a trigger cell for the body's immune system. Unable to replicate, the virus cannot spread to other T cells and destroy the immune system.
Made in India, the Ideal `Cocktail' for AIDS
By DONALD G. McNEIL Jr.
Published: May 4, 2004
three-year study of AIDS drugs has identified what the research leaders believe is the ideal triple-therapy cocktail for new patients.
The successful cocktail, known colloquially as "two nukes plus a non-nuke," is the same one that the World Health Organization has been recommending in poor countries since 2002. It is also the same combination that Indian suppliers of generic drugs have been putting in three-in-one pills since 2001.
Another drug cocktail examined in the study — a "three-nuke combination" — did so poorly that patients were taken off it. The failed cocktail is the only one made as a three-in-one pill by any Western pharmaceutical company.
The study, its authors said, suggests that patients who have never been on AIDS drugs should be started on a combination of two nucleoside reverse transcriptase inhibitors ("nukes") and a non-nucleoside reverse transcriptase inhibitor ("non-nuke").
Currently, American and European doctors prescribe many different mixes of the 20 drugs approved for fighting AIDS infections, and shift the mixes as patients develop resistance or side effects.
The study of 1,147 patients, published in the April 29 issue of the New England Journal of Medicine, looked for an ideal regimen for new patients that avoided protease inhibitors. Those drugs are effective and often prescribed by Western doctors, but they can damage the liver or shift body fat into unsightly humps.
The study was begun before any drugs in the two newest classes of AIDS drugs, fusion inhibitors and integrase inhibitors, were approved.
AIDS experts said a second conclusion from the study was that the three-in-one pills offered by generic drug makers from India were better for new patients than any of those sold or planned by Western drug companies.
The study "reinforces the point" that the type of cocktail recommended for poor countries by the World Health Organization is right for rich countries as well, said the study's lead author, Dr. Roy M. Gulick, director of the H.I.V. clinical trials unit at Weill Cornell Medical College in New York City.
The latest guidelines from the National Institutes of Health for American doctors recommend starting new patients either on the same two-nukes-plus-a-non-nuke regimen that the W.H.O. recommends, or a two-nukes-plus-a-protease-inhibitor regimen.
Most of the Weill Cornell study's 1,147 patients were nonwhite and 19 percent were women, Dr. Gulick said, so the study's conclusions should be applicable worldwide.
The AIDS expert who led the committee that formulated the W.H.O. guidelines, Dr. Scott Hammer, chief of the division of infectious diseases at Columbia Presbyterian Medical Center, said the W.H.O. made its 2002 recommendation because the combination worked well and the drugs were generally cheap.
Besides their toxicity problems, he said, protease inhibitors were expensive because only companies that held patents on the drugs made them, and some of the medications required refrigeration, which is impossible to guarantee in, for example, rural Africa.
In the new study, the cocktail that worked best was a mix of the "nukes," AZT and lamivudine plus the "non-nuke" efavirenz. After 32 weeks on the cocktail, 89 percent of the patients had almost undetectable levels of virus in their blood.
The cocktail that did less well was a mixture of AZT and lamivudine plus abacavir. After 32 weeks, only 79 percent of the patients had low levels of virus.
That cocktail is sold by GlaxoSmithKline as a three-in-one pill under the name Trizivir.
However, because it is "clearly inferior" at suppressing the virus, it is "no longer recommended for first-line use" said Dr. David Bangsberg, a professor of medicine at the University of California at San Francisco who monitors treatment around the world.
Most of the study was paid for and monitored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
Glaxo provided its drugs and paid part of the analysis costs, said Mary Faye Dark, a Glaxo spokeswoman.
"We aren't surprised that Trizivir alone didn't do as well," Ms. Dark said. The decision to take the study's patients off it was made in February 2003.
But she said the cocktail still worked in many patients and should play a role in AIDS therapy, especially for maintaining patients whose viral loads have first been lowered by other regimens.
Most three-in-one pills now made by Indian generics makers contain AZT, lamivudine and nevirapine.
Nevirapine is in the same "non-nuke" class as efavirenz and a recent study in Lancet, the British medical journal, found them to be equivalent. Nevirapine is a well-established drug, but it causes a serious rash in some patients, so generics makers are moving toward making compounds with efavirenz as well.
The N.I.H. guidelines prefer efavirenz because it causes fewer rashes, but accept nevirapine as a substitute.
Both the "nukes" and "non-nukes" block reverse transcriptase, an enzyme that allows the RNA in an AIDS virus particle to replicate itself inside the DNA of a healthy T cell, a trigger cell for the body's immune system. Unable to replicate, the virus cannot spread to other T cells and destroy the immune system.
Re: Indian Biotech News & Discussion
Dr Reddy's sets up shop in the heart of US pharma biz
Go Nets!HYDERABAD: Dr Reddy's Laboratories has shifted its North American headquarters from its old home office in Upper Saddle River in New Jersey to more modern facilities in the Somerset Corporate Center at Bridgewater in central New Jersey.
New Jersey is often referred to as the medicine chest of the pharmaceutical industry and Bridgewater is at the centre of this medicine chest. Merck's global headquarters are down the road a short distance in Whitehouse Station. Aventis' North American headquarters for commercial operations are located in two buildings in the same Somerset Corporate Center. Johnson & Johnson's headquarters are close by in New Brunswick. Schering, Novartis and Bristol-Myers Squibb are a half hour drive away. A number of generic companies including Biovail, Sandoz (Novartis), Watson and Ranbaxy are also nearby, said a company press release here on Monday.
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George J
Re: Indian Biotech News & Discussion
For the record isn't this what I predicted a few months ago on this board?Originally posted by Rudra Singha:
http://www.atimes.com/atimes/South_Asia/FE07Df02.html
Aage aage dekho hota hai kya