Indian Biotech News & Discussion

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Postby Sohum » 07 Mar 2005 21:11


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Postby Raj » 11 Mar 2005 06:33

Merck plans to set up 100% subsidiary in India

http://economictimes.indiatimes.com/art ... 048259.cms

MUMBAI: German drug major Merck KGaA plans to set up a 100% subsidiary in India.

In a statement received by the BSE, Merck KGaA’s wholly owned subsidiary Merck Holding Gmbh has submitted an application to the Foreign Investment Promotion Board (FIPB) to set up a subsidiary in the country.

Merck KGaA, Germany, through their affiliates holds 51% of the share capital of Merck in India.

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Postby Laks » 21 Mar 2005 21:08

Cross-posted to the new patents thread.
Last edited by Laks on 21 Mar 2005 22:31, edited 1 time in total.

George J

Postby George J » 21 Mar 2005 22:25

I think patents are big enough for their own thread. Could you cross post your link there?

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Postby Sohum » 28 Mar 2005 17:54

Dr. Reddy's Laboratories gets funds to expand in U.S.

Dr. Reddy's Laboratories, the second-largest Indian drug maker, said Monday that it would receive as much as $56 million from ICICI Venture Funds Management to develop drugs for sale in the United States and pay for research and legal costs.
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ICICI Venture, a unit of ICICI Bank, India's second-largest lender, will fund the development, registration and legal costs of most of Dr. Reddy's generic drugs for the U.S. market until March 2006, the drug maker said.
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The agreement may help Dr. Reddy's increase profit, which has declined for nine quarters in 10 as competition erodes sales in the United States.
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Research costs, including expenditure for discovering new drugs and developing generics for sale in the United States, rose 37 percent in the quarter that ended Dec. 31.
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Legal costs are rising as Dr. Reddy's challenges patents held by drug makers like Pfizer and Merck in order to accelerate the introduction of generics in the United States.
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"There have been a lot of issues about the risk Dr. Reddy's has been taking," said Suhas Naik, a fund manager at ING Investment Management in Mumbai.
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The agreement "takes some load off the company's balance sheet. It will definitely help the company get more aggressive on filing" to sell drugs in the U.S. market, Naik said.
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See more of the world that matters - click here for home delivery of the International Herald Tribune.
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< < Back to Start of Article NEW DELHI Dr. Reddy's Laboratories, the second-largest Indian drug maker, said Monday that it would receive as much as $56 million from ICICI Venture Funds Management to develop drugs for sale in the United States and pay for research and legal costs.
.
ICICI Venture, a unit of ICICI Bank, India's second-largest lender, will fund the development, registration and legal costs of most of Dr. Reddy's generic drugs for the U.S. market until March 2006, the drug maker said.
.
The agreement may help Dr. Reddy's increase profit, which has declined for nine quarters in 10 as competition erodes sales in the United States.
.
Research costs, including expenditure for discovering new drugs and developing generics for sale in the United States, rose 37 percent in the quarter that ended Dec. 31.
.
Legal costs are rising as Dr. Reddy's challenges patents held by drug makers like Pfizer and Merck in order to accelerate the introduction of generics in the United States.
.
"There have been a lot of issues about the risk Dr. Reddy's has been taking," said Suhas Naik, a fund manager at ING Investment Management in Mumbai.
.
The agreement "takes some load off the company's balance sheet. It will definitely help the company get more aggressive on filing" to sell drugs in the U.S. market, Naik said

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Postby svinayak » 16 Apr 2005 07:49

Karnataka Printer Friendly Page Send this Article to a Friend

UAS strain a big hit in Indoneisa

Special Correspondent

DHARWAD: A wheat variety (DWR 162) developed by the University of Agricultural Sciences, Dharwad, is making waves in Indonesia.

S.A. Patil, Vice-Chancellor of the university, said the variety has been named "Devata".

It has been giving a yield of four tonnes a hectare in Indonesia.

Dr. Patil said he and R.R. Hanchinal, Senior Wheat Breeder, have been invited by the Indonesian Government and Bogasari Mills in Jakarta to popularise the wheat variety.

The university has signed a five-year pact with Indonesia for a collaborative research project on this variety.


Printer Friendly Page Send this Article to a Friend

Indigenous cattle breeds dwindling, scientists term it dangerous

By Our Staff Correspondent

Cattle census: 8 per cent decrease compared to the last count in 1997

BIDAR: While a debate is raging about the reported decrease in the number of tigers, the cattle census has thrown up a startling fact: there is a serious decline in the number of indigenous breeds of cattle.

According to the 17th cattle census conducted in 2003, there are 2.83 crore head of cattle in the State.

There were 3.06 crore head of cattle in the State in 1997. This shows an 8 per cent decrease.

There has been a marked reduction in the number of indigenous breeds while there has been an increase in the population of cross-breeds between 1997 and 2003.

Krishna Valley

While the number of Krishna Valley breed of cattle has reduced by 97.96 per cent, the number of Deoni breed has come down by 72.22 per cent.

The number of Hallikar breed of cattle has come down by 39.97 per cent, Kilari breed by 30.89 per cent, Malenadu Gidda by 24.96 per cent and Amrut Mahal by 2.62 per cent.

The population of cross-breed cattle has increased by 23.98 per cent. Similarly, the number of indigenous breeds of buffaloes has come down by 6.18 per cent, sheep by 7.21 per cent, goats by 8.02 per cent and pigs by 18.6 per cent.

In the case of sheep, goat and pigs, the population of mixed breeds has come down.

Friends of farmers

Scientists say that the reduction in the population of indigenous breeds is a dangerous trend and needs to be arrested immediately.

Indigenous cattle are the real friends of the farmer. While the bull can be used to plough the fields, the cow yields good quality milk.

In some breeds such as Deoni, even the cow can be used for draught purposes.

These breeds are disease resistant and drought resistant. Compared to exotic breeds, farmers need to spend little on their maintenance.

The money saved on their maintenance and healthcare compensates for the reduced yield, says M.M. Appannanavar, Professor of Genetics in the Veterinary University.

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Postby AJay » 19 Apr 2005 00:52

[quote=Dr. Reddy's Laboratories gets funds to expand in U.S.]
... $56 million from ICICI Venture Funds Management to develop drugs for sale in the United States and pay for research and legal costs.
[/quote]

A non-startup, supposedly well-established company getting what amounts to Stage 3 venture capital. If venture funding is sucked by the big established corporates, where is the money (and motivation) for small but innovative startups?

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Postby Gerard » 21 Apr 2005 04:23


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Postby Aruni » 08 Jun 2005 14:09


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Postby Aruni » 11 Jun 2005 15:08

Bio-tech revenues cross $1 billion

The Telegraph wrote:The biotechnology industry has garnered more than $1 billion as revenues in 2004-05 because of a spurt in exports and vaccine sales.

The industry has set a target of $5 billion by 2010, with a projected growth of 30 per cent this fiscal (2005-06).

In 2004-05, the revenues increased to $1.07 billion (Rs 4,745 crore), up 36 per cent from the previous year’s Rs 3,475 crore ($788 million). The top twenty companies recorded sales of Rs 2,478 crore in 2004-05, while six companies garnered revenues in excess of Rs 100 crore.

Of a global biotech market of $91 billion, India's share stands at 1.1 per cent.

Releasing a report on the industry’s performance, Kiran Mazumdar-Shaw, president of the Association of Biotechnology-Led Enterprises (ABLE) and chairperson of Biocon Ltd, said, “The domestic biotechnology sector is rapidly gaining global visibility. It has emerged as a billion-dollar business, thanks to the entrepreneurship of a group, which has braved many a hurdle and poor financial support.”

“The national biotechnology strategy document that is under preparation promises extensive support to this emerging sector, which has set a revenue target of $5 billion by 2010,” she added.

Mazumdar-Shaw said, “Reaching the $2-billion mark will be easier as India is one of the largest producers of vaccines and will emerge as an important producer of protein therapeutics.”

With domestic sales picking up rapidly in 2004-05, the market share of biotech exports declined to 42 per cent (Rs 2001 crore) from 55.65 per cent in 2003-04. Bio-pharma companies accounted for 75 per cent of the total sales in the sector.

The survey ranked the top 20 home-grown biotech firms.

George J

Postby George J » 11 Jun 2005 22:22

Aruni wrote:Bio-tech revenues cross $1 billion

The Telegraph wrote:............Mazumdar-Shaw said, “Reaching the $2-billion mark will be easier as India is one of the largest producers of vaccines and will emerge as an important producer of protein therapeutics.”.............


Protein theraputics??? Thats easier said that done in the Patent Raj!! Biocon is developing a monoclonal AB for head and neck tumors lets see how far that gets.

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Postby Sai.U » 21 Jun 2005 06:31

Ranbaxy Laboratories Limited in Guragon and Aurobindo Pharma Limited in Hyderabad get FDA approval for generic nevirapine tablets.

FDA Tentatively OKs Generic AIDS Drugs
http://news.yahoo.com/s/ap/20050621/ap_ ... /aids_drug

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Postby Vick » 22 Jun 2005 00:04

From FT
India in fivefold biotech expansion
By Clive Cookson in Philadelphia
Published: June 20 2005 18:10 | Last updated: June 21 2005 03:43

India plans to expand its biotechnology sector by fivefold over the next five years as part of an ambitious strategy outlined on Monday at BIO 2005, the world's largest biotech conference. Steps under consideration range from new financial incentives for scientific entrepreneurs to industry-friendly regulations for testing drugs on animals and people.

Kapil Sibal, India's science minister, launched the government's strategy - intended to make India as successful in the life sciences as it has been in software and information technology. It will require substantial investment by foreign companies attracted by India's skilled scientific workforce and lower costs than in the west.

Gautam Thapar, chairman of the Confederation of Indian Industry biotechnology committee, said the plan showed the government was listening to industry and working with it, rather than at cross purposes as so often in the past.

The policy will introduce new tax incentives and grants for entrepreneurs starting or expanding biotech companies. The government's Department of Biotechnology aims to create and support at least 10 biotech parks with incubator units by 2010.

These will be promoted by a new Biotechnology Parks Society of India modelled on the Software Technology Parks of India, which did a lot to smooth the path of foreign IT companies to the country.

On the regulatory front, a crucial change in policy will allow companies for the first time to test drugs on "large animals" such as dogs. Indian authorities have restricted animal testing to rodents - a serious handicap, given that most regulatory authorities such as the US Food and Drug Administration require new drugs to be tested for toxic effects on at least one non-rodent species.

The revenues of India's biotechnology sector grew by 37 per cent to $1.1bn in 2004-05.

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Postby vsunder » 07 Jul 2005 12:22

Kiran Mazumdar-Shaw(CEO BIOCON) will give a lecture 18.15-19.15 tomorrow Friday(July 8th) in the Faculty Hall of IISc, on Initiatives between Industry and Academia, can we repeat the US model.

Today July 7th there are a series of lectures in Central College, Basavanagudi, Bangalore, in part to commemorate the Year in Physics, the 100th anniversary of the annus mirabilis of Einstein.
At 4pm, Narlikar will talk on Einstein and Cosmology.

The lectures by Mazumdar-Shaw and Narlikar and others are part of the annual meeting of the Indian Academy of Sciences where in addition newly initiated fellows will give 30 min lectures on their work in IISc.

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Postby svinayak » 18 Jul 2005 04:24

U.S. firm's big offer for U.P.

4-billion dollar investment offered for 5000-acre biotech park

# Lucknow to be made biotechnology hub
# Project to start once land is allotted by the State
# Several foreign companies show special interest

LUCKNOW: Boston-based Investment Corporation of International Biotechnology (ICIB) has offered to invest four billion dollars in Uttar Pradesh to set up of a 5,000-acre biotechnology park and bio-pharma campus between the State Capital and Kanpur.

The proposed endeavour aims at developing Lucknow as the country's biotech hub and attracting leading companies to set up their research and production facilities at the campus.

The ICIB proposal is already under consideration of the Uttar Pradesh Government, Lucknow Biotech Park CEO P K Seth told UNI.

``Foreign companies have shown special inclination for biotech Park in Lucknow. Investors of 40 companies belonging to the US, Canada, Australia and Israel want to conduct business with the biotech park and other institutions here,'' he added.

Since Lucknow already boasts of several international-level scientific, medical and management institutions such as NBRI, CDRI, ITRC, SGPGI, CIMAP and IIM-L, it would provide the best input and infrastructure to the biotech proposal of such a large magnitude, claimed Dr Seth.

The work on the proposed campus would start once the State Government allots land for the project, he said. The ICIB representatives were also scheduled to arrive in Uttar Pradesh soon in this regard.

The proposal was made during the recent visit of a high-level delegation of the State Government to participate at the World Bio Conference in the US. Another CII delegation was also part of the visit, headed by Union Minister Kapil Sibal.

The delegation also comprised Union Secretary for Biotechnology M K Bhan, State Principal Secretary (Science and Technology) P L Loi, Science and Technology Secretary Navneet Sehgal, special secretary to U.P. Chief Minister Chandrama Prasad, Udyog Bandhu Executive Director Narendra Bhushan and NBRI Lucknow Deputy Director H M Bahel apart from Mr Seth.

The delegation held detailed discussions with ICIB chairman Jitendra Seth and vice-chairman Paul Woods on other related issues.

``We provided information regarding the steps taken by the U.P. Government for encouraging biotech and general industries with an intention of developing Lucknow as a new centre of biotechnology,'' Dr Seth said.

``The campus would act as a catalyst in boosting industrial and scientific development of UP and provide enormous job opportunities to the youth,'' he asserted.

ICIB is an umbrella organisation comprising leading US biotech scientists and companies and investors.

``The talks brought to light that foreign companies are interested in investment in the field of biotech especially in the sector of developing new medicines and clinical trials,'' he claimed.

Similarly, several companies of Israel, Australia, Japan and the US participating in the conference held detailed discussions with the delegation on investment possibilities in Uttar Pradesh.

The state delegation also assured the representatives of Bill and Millenda Gates Foundation of full cooperation for the development of biotechnology in the State. The Foundation offers millions of dollars financial assistance to the Andhra Pradesh Government. -- UNI

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Postby svinayak » 09 Aug 2005 06:48

Gandhigram Trust exports `curative textiles' to treat Japanese patients

Staff Reporter

Mitsubishi group places orders for second batch

DINDIGUL: : The Centre for Documentation, Research and Training on Nature Dyes, a unit of Gandhigram Trust in Gandhigram, has successfully exported first batch of `curative textiles' to Japan to cure lunacy, skin diseases, hypertension and respiratory ailments.

After successful tests and trials, these curative textiles have been widely accepted among Japanese to cure many diseases in a natural way. The Mitsubishi group has placed orders for second batch also.

The Centre has successfully developed garments that have medicinal values for curing mental disorders, hypertension, skin diseases, arthritis and even to change violent or arrogant mental behaviour of children.

When contacted, Bharathan, natural dyes expert and in charge of the centre, said that the centre took nearly two years to convince the Japanese company. A Japanese team camped in Gandhigram for one month and inspected various processing systems. Advanced tests were conducted in Japan also. Having developed a method to forecast future mental behaviour of babies, the Japanese used curative clothes to change arrogant or violent mental behaviour of the children. They manufactured caps made of curative textiles for Japanese babies.

Briefing production process, the expert said the yarn manufactured in Rajapalayam had been eco-bleached and dyed using medical plants and natural dyes at the centre. Later, dyed yarn was sent to Tirupur for knitting. After knitting, it was brought back to the centre for medical processing. After soaking clothes in different juices of medicinal plants for curing various diseases, these clothes were dried and sent for making garments. The Centre has been supplying even threads for stitching to avoid mixing of chemically processed threads. Finished products were packed in a specially designed packing materials supplied by Japanese company to preserve its medicinal values for a long time. Japanese wet the processed cloth by keeping it in refrigerators before wearing. Its medicinal value could be maintained for two months from the date of wearing. Demand for these garments in Japan was high. Japanese have prepared to pay the amount for curative textiles, four times higher than they paid for ordinary textiles in Japan he said.

"While cloth made of `kumkum' extracts lessened hyper-tension, durva grass (arugam pul) and marjarum (mari kozhundhu) extracts soaked cloth cured mental disorders. Our intensive research has proved that these clothes ensured permanent cure for skin diseases without any sideeffects.

We have intensified research in this direction further", Mr. Bharathan said.

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Postby Div » 20 Aug 2005 20:38

Single dose Hepatitis B vaccine, courtesy Shantha Biotech
http://www.ciol.com/content/news/2005/105082009.asp
Shantha Biotechnics Ltd, a biotech healthcare products company, is making a pioneering attempt to reduce the dosage of Hepatitis B vaccine from three doses to single dose. The company said that, presently, no other firm globally is offering the vaccine in single dose.

Varaprasad Reddy, managing director, Shantha Biotechnics Ltd, said, “We are undertaking research and development work in developing new generation vaccines. One such activity is to bring down Hepatitis B vaccine's dosage from three doses to single dose.”

Shantha Biotech's-Shanvac B, which is now administered in three doses, is certified by WHO and the company is supplying this vaccine thereby meeting 40 percent of UNICEF's requirement.

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Postby Vasu » 21 Aug 2005 05:50

Regarding the 5000 Acre Biotechnology park in LKO, I hope the UP Govt. doesnt scuttle this opportunity for its own petty interest.

If members will recall, Dell was all set to set up a call center in Lucknow, and they wanted a building previously owned by now defunct Uptron, but the Samajwadi party wanted to make that building into their office and Dell left.



http://www.biotechcitylucknow.org/

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Postby Amarko » 21 Aug 2005 15:19

Shantha develops 4-in-1 vaccine


Hyderabad, Aug. 19: The Hyderabad-based Shantha Biotechnics, which is credited with developing indi-genously India’s first vaccine against Hepatitis-B (jaundice), on Friday said it has developed a combination vaccine against four virus that afflict children — diphtheria, tetanus, pertussis and Hepatitis B.

Union minister of state for science and technology and ocean development, Kapil Sibal, will be formally launching the vaccine, Sha-ntetra, on Saturday, Varaprasad Reddy, managing director of Shantha Biotechnics, told reporters.

Mr Reddy said Shantha Biotechnics, an Indo-Om-ani joint venture, had developed the technology and the process for Shantetra had been developed in-house. “This is the first combination vaccine developed by an Indian company. Companies like GSK are already in the market with such a vaccine, but because of our in-house development of Shantetra, we will be able to compete on price and quality with MNCs,” Mr Reddy said.

Shantha had applied for pre-qualification from the WHO to bid for supplying Shantetra to organisations like UNICEF and the Pan American Health Organisation. WHO had completed the scrutiny of Shantetra and inspected the company’s facilities in Hyderabad, and the pre-qualification is expected by December, he said. Shantha’s Hepatitis-B vaccine, Shanvac-B, is pre-qualified by the WHO to bid for UNICEF contracts, to supply the vaccine around the world, he added.

http://www.deccan.com/Business/Business.asp#Shantha%20develops%204-in-1%20vaccine

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Postby Singha » 21 Aug 2005 23:45

from Ranbaxy website

3rD FACILITY ON GURGAON CAMPUS TO FOCUS ON
NCE DISCOVERY RESEARCH

Gurgaon ( Haryana) India - August 16, 2005

Ranbaxy Laboratories Limited (RLL) today announced the opening of its third state-of-the-art drug discovery research centre, at Gurgaon, India. The research facility was formally inaugurated by the Honourable President of India, Dr. A.P.J. Abdul Kalam.

Commenting on the opening of the research facility, Dr. Brian Tempest, CEO & Managing Director, RLL, said, “We are delighted that the Honourable President of India, himself an accomplished scientist, inaugurated our new R&D centre. We believe that R&D is one of our key competitive strengths and the addition of this facility further enhances our capabilities in the area of drug discovery and development systems.”

Salient features of the New R&D centre:

* The new R&D centre is housed in a brand new building in the same campus as Ranbaxy’s earlier research facilities. The entire campus is spread over an area of 9.1 Acres

* The new four storied building has a built up area of ~ 400000 square feet and provides a workspace for ~ 700 people. It has a twin level basement for car parking & services. An auditorium for ~ 400 people; Centralized library; two level Cafeteria for ~ 450 people; High-speed elevators and a modern high quality Intelligent Security Surveillance system.
* The state-of-the-art laboratories and contemporary offices are amongst the best in the country.

* The new R&D centre will focus on New Drug Discovery and the Development Functions of Medicinal Chemistry, Analytical Development (NDDR), Pharmacology, Molecular Technologies, Infectious Diseases, Metabolism & Pharmacokinetics

With the commissioning of the new R&D centre, Ranbaxy now has in place a total of three modern research facilities in the same campus. R&D centres I and II focus on the development of generics and Novel Drug Delivery Systems; the new R&D centre III, is dedicated to New Drug Discovery Research. Besides these, Ranbaxy has another R&D building, which houses its regulatory and administrative departments. The focus areas for research for Ranbaxy are infectious diseases, urology, respiratory/inflammatory and metabolic diseases The Company presently has around 8-10 NDDR programs including two NCEs (New Chemical Entities) in the clinical phase of development.

Ranbaxy is among the few Indian pharmaceutical companies in India to recognize the importance of R&D and invest early in it. The first basic research activity was initiated way back in the year 1973. Later when Ranbaxy drew its ambitious plans of going global, it embarked on R&D in a significant way by establishing its first R&D centre in Gurgaon (on the outskirts of New Delhi), in 1994. Today, Ranbaxy has the largest R&D budget in India amongst pharmaceutical companies. R&D productivity gains have been high and its strong research and innovation capabilities have led to the delivery of a robust product pipeline.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, manufactures and markets brand and generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. Ranbaxy's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies" resulting in a number of products under development. The Company is selling its products in over 100 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 44 countries and manufacturing operations in 7 countries.


Photo gallery of prior buildings:
http://www.ranbaxy.com/newsroom/rnd_center.htm

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Postby Raj » 05 Sep 2005 02:25

Biocon plans to double headcount
http://www.thehindubusinessline.com/200 ... 320300.htm
THE headcount of Biocon Ltd will double from around 2,000 now to 4,000 within two years, according to Ms Kiran Mazumdar-Shaw, Chairman & Managing Director.

The Bangalore-headquartered biotechnology company has decided to invest around Rs 100 crore every year in new initiatives for the next few years, she said during an interaction with newspersons.

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Postby Raj » 17 Sep 2005 06:43

Ranbaxy drug gets US nod

Ranbaxy Laboratories Ltd has received approval from the US Food and Drug Administration, to manufacture and market Gabapentin tablets used to treat seizures.

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Postby A Sharma » 19 Sep 2005 19:11

From WSJ

Indian Firm Targets Cancer Drugs

By a WALL STREET JOURNAL Staff Reporter
September 19, 2005; Page C8

Indian traditional-medicine maker Dabur India Ltd. said it plans to spend 1.2 billion rupees ($27 million) to produce generic versions of cancer drugs that will lose U.S. patent protections in the next five to seven years.

Dabur, which in the past has primarily produced herbal medicine, will use the money to improve the capacity of the company's new pharmaceutical arm, which currently produces some modern medicines.

Dabur said it has identified 15 cancer drugs that it plans to replicate so it can tap into the lucrative generic-drug market. It didn't name the drugs, but said their combined U.S. sales currently range between $8 billion and $10 billion.

Scores of Indian companies have entered the U.S. market in recent years by selling generic versions of drugs after patents expired.

Cancer medications and bulk drugs accounted for 63% of Dabur's sales of $55 million in its latest fiscal year. The company sells cancer drugs in 35 countries.

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Postby Laks » 15 Oct 2005 12:01

Cipla is taking a calculated risk I hope. Either they'll get caught in legal proceedings in Western courts or their governments might simply make an exception and order sh!tloads of this.
Indian firm plans to make generic Tamiflu

George J

Postby George J » 15 Oct 2005 13:46

It was okayed in 1999 its a post 1995 drug so technically it can get an Exclusive Mkt. Right (EMR) under our new patent laws. But the innovator Roche has NOT applied for the same and its unlikely that it will be granted EMR in a hurry given all the hullabaloo about a flu pandemic.

So if Cipla is ready with its generic oseltamivir and there is a pandemic/epidemic, I am sure all the bets will be off given that its a public health emergency and there is no EMR so there is no real Compulsory License issue (since patent holder does not have EMR there is no royalty needed to be paid), this means that its win win for Cipla too. They dont need to pay royalty, they have the ablity to mfg the drug on a large enough scale for public good.

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Postby Laks » 15 Oct 2005 14:55

Even if legal issues are set aside, what about clinical trials? won't it take a while.

George J

Postby George J » 15 Oct 2005 22:56

There are no trials for generics. Ciplia only have to prove bioequivalence and bioavilablity of their rx is the same as Tamiflu. They can get this info from the US FDA filings (public info). Thats what makes generics so cheap...you dont have to go through the hyper expensive clinical trial process.

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Postby Laks » 15 Oct 2005 23:07

Thanks for the clarification GJ.

I saw in local news that France has around 14 million doses of Tamiflu (population 60m) and it is one of the highest among Western nations. No wonder amidst the latest discovery of virus trace in farms in Turkey and Romania, Roche is increasing the production 8-fold.

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Postby Singha » 15 Oct 2005 23:07

same news, but a girl has been found in vietnam with a strain that resistant to Tamiflu.

My spider sense tells me the yellow matter is heading straight for the
fan.

--

Cipla to make a generic bird flu drug
REUTERS
Posted online: Friday, October 14, 2005 at 1903 hours IST

LONDON/MUMBAI, OCTOBER 14: Indian drugmaker Cipla is making a generic version of Roche's Tamiflu, an anti-influenza drug in critically short supply as governments stock up ahead of a possible epidemic of bird flu.

"We have finalised a process a few weeks ago, and now we are starting manufacture," Cipla Chairman Y.K. Hamied told Reuters on Friday, confirming a story in the New York Times. Tamiflu is the most effective anti-viral drug available for avian flu, and governments are rushing to build up stocks amid fears a virus that has claimed more than 60 lives in Asia since 2003 could mutate into a more deadly form for humans.

Switzerland's Roche said on Wednesday it would outsource some stages of production as it comes under pressure to boost supplies, but added it would not relinquish its patents.

"Roche and its partners fully intend to remain the only manufacturer of Tamiflu and are best qualified to scale up production," spokesman Daniel Piller said on Friday.

Hamied said Cipla would not target US and European markets being served by Tamiflu, but would offer supplies to any government that wanted to buy.

"We are not targeting essentially those markets unless there is a real emergency and these countries declare a compulsory licence," he said in a telephone interview, adding Cipla planned to sell its version of Tamiflu in developing countries.

Hamied said Cipla was initially aiming to produce enough generic Tamiflu to treat 50,000 patients by the end of January, and could step up production thereafter.

"We are in the beginning stage now, and we could escalate next year," he said.

Laks
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Postby Laks » 18 Oct 2005 13:40

Roche says could allow others to produce Tamiflu
The company said in a statement it was willing to discuss all options to increase output of the treatment, including granting sub-licences to produce Tamiflu for emergency pandemic use to governments and other companies.

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Postby Laks » 21 Oct 2005 13:21

Follow-up:
"We will have much more Tamiflu available than if Roche produced it itself," said New York Senator Charles Schumer after talks with Roche.

The firms Teva, Barr, Mylan and Ranbaxy aim to start production within a month.

Roche to license bird flu drugs

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Postby Ujjal » 21 Oct 2005 13:25

Laks should be given BRF Spam Whore Award of the year 2005. :D

10 months = 1045 posts :eek:

Laks
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Postby Laks » 21 Oct 2005 13:45

Me: [1.93% of total / 3.69 posts per day]

GD: [6.27% of total / 7.82 posts per day] :eek:

still a drop in the bucket pal! :twisted:

assure you, the numbers will go down once I start writing my dissertation :(

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Postby Div » 22 Oct 2005 20:38

Let enterprise drive research: Bhan
http://www.ciol.com/content/news/2005/105102112.asp
M.K. Bhan, secretary, Department of Biotechnology (DBT), today emphasized the need to build enterprise-driven research efforts that could unravel real problems.

Addressing the sixth foundation celebration of the CSIR Unit for Research and Development of Information Products (URDIP) in Pune, Bhan cited the example of clinical trials and pointed out that, while clinical trials were considered big business in India, there was no information available on who was involved.

Bhan stressed the need to build inter-disciplinary efforts, voicing concern that universities and education institutes could not become leaders of transformation since they were inward looking.

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Postby Aitareyan » 20 Nov 2005 10:28

Indian drug firms have a field day in South Africa

http://www.atimes.com/atimes/South_Asia/GK19Df01.html

I hope the Indian pharma outfits will use this opportunity to establish a hold over the anti-AIDS drugs supply all over Africa. The Africans are dying like flies from the disease, and it is a challenge for the Indians to ameliorate the disease all over Africa as well as use the goodwill generated to strengthen its strategic position in Africa (South Africa, East Africa, Nigeria etc). India has always been a great friend of the black man unlike the Chinese who are out to exploit Africa.

Ramanujan

Postby Ramanujan » 21 Nov 2005 06:04

Aitareyan wrote:I hope the Indian pharma outfits will use this opportunity to establish a hold over the anti-AIDS drugs supply all over Africa. The Africans are dying like flies from the disease, and it is a challenge for the Indians to ameliorate the disease all over Africa as well as use the goodwill generated to strengthen its strategic position in Africa (South Africa, East Africa, Nigeria etc). India has always been a great friend of the black man unlike the Chinese who are out to exploit Africa.


The concern for black man is quite touching considering the fact that the goodwill is to be bought by making generic copies of drugs that Indian companies had no role in developing....none at all in basic research on HIV or validating targets or identifying lead candidates or pushing these small molecules through primate models and then the very expensive clinical trials. You would think that the goodwill would go to those who did all that. So dont count on the goodwill...the "black man" is not so naive.

Anyways, what about actually working on diseases that are killing Indians like flies? How about winning some goodwill from Indians by actually doing some worthwhile research on malaria for instance? Or are these Indian pharmas going to just wait for Americans to do that and then copy the vaccine? The idea would actually work and it would be quite "chankian" if malaria were a problem to Americans, British and the Germans. But ya see, its not and there arent too many Americans clamoring for a vaccine for malaria falciparum. If you find the capacity to churn out copies of drugs to be worth a drumbeat and an opportunity to score strategic points on the dark continent, you ought to rethink a few things about your concern for the "black man".

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Postby Aitareyan » 21 Nov 2005 07:10

Ramanujan wrote:
Aitareyan wrote:The concern for black man is quite touching considering the fact that the goodwill is to be bought by making generic copies of drugs that Indian companies had no role in developing....none at all in basic research on HIV or validating targets or identifying lead candidates or pushing these small molecules through primate models and then the very expensive clinical trials. You would think that the goodwill would go to those who did all that. So dont count on the goodwill...the "black man" is not so naive.


The Africans have more goodwill for someone that can produce the drug cheaply and save their lives. The billions spent on basic research and drug development is all well and good but if doesn't work for them, what goodwill are you talking about ?

I never said we have nothing to owe to basic research - preaching to the choir again, I see ! I said that Indian pharma cos. should take the initiative in Africa - or someone else will do it.

But ya see, its not and there arent too many Americans clamoring for a vaccine for malaria falciparum. If you find the capacity to churn out copies of drugs to be worth a drumbeat and an opportunity to score strategic points on the dark continent, you ought to rethink a few things about your concern for the "black man".


Tch tch, something has got you all excited. Please read post again. I am not interested in the details of the malaria vaccine - if Indian pharma cos are planning work on this, well and good. The Indians' concern for the African is genuine, if you don't agree you can take a hike. I am not here to argue with your likes.

Ramanujan

Postby Ramanujan » 21 Nov 2005 09:30

Look dude, since you are talking so much about initiative, goodwill and concern for africans, you should know that companies like GSK for example (who actually did the research behind ARVs) gave a voluntary license to South African generics firm Aspen to produce AZT, 3TC and Combivir without charge. In return, Aspen had to promise 30% of their revenue to NGOs fighting AIDS in Africa. Now, even that is not enough to earn any significant goodwill. As far as Indian firms go, its mostly about profit and even there, since the start of 2005, TRIPS makes it difficult for them to bring more recent (and more effective) ARVs to African market. Many Chinese companies are trying to procure licenses to these drugs - and they might succeed. Also if you take a look at grants provided by China to African AIDS initiatives, you will see that figures are fairly impressive- for goodwill or exploitation is your call, I guess.
Secondly, as far as Indian concern for fighting AIDS in Africa is concerned, its a bit hypocritical because HIV is not being dealt with in India. Why dont we make sure that every Indian HIV-infected gets his years supply of ARVs if we are in a philantrophic mood. The problem is that we cant even provide a free diagnostic test for most Indians. While you talk about grabbing a 50% share of $2bil in Africa, you should be aware that barely $150mil are allocated to fighting AIDS in India by Indian funding agencies (and AIDS in India is going to be a bigger deal that you can imagine). Here Bill and Melinda GAtes fundation has given a grant of $200mill to India - and a fat lot of goodwill it earns them :D . Now the reason, I brought up malaria is that despite the fact that AIDS is such a huge problem in India and Africa, we lose a lot more people to malaria. But if you dont want to hear about that, go ahead and beat your chest about "grabbing initiative in Africa by selling them copied drugs - and earning their goodwill" (the later being the really funny part). I am not trying to argue with you...just presenting a view that is a shade more informed.

George J

Postby George J » 21 Nov 2005 11:34

Ramanujan wrote:.......you should know that companies like GSK for example (who actually did the research behind ARVs) gave a voluntary license to South African generics firm Aspen to produce AZT, 3TC and Combivir without charge.............


Your statement is correct but out of context. Its out of context coz you ASSUME that GSK et. al. did this out of altruistic zeal. This deal was signed in 2001!!! Why 2001? Why not earlier? Who else was in the mkt by 2001? Ans: Cipla and Ranbaxy.

So its not that GSK and Shire were proactive, they were just reacting to immense negative publicity after making TONS of money selling these drugs for years to the South Africa till Cipla/Hetero/Ranbaxy actually started screwing them.By granting patents to a native south african mfg GSK/BMS/Gilead/Merck checkmated the whole Indian gang from bringing in their versions of currently patented drugs.


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