Indian Biotech News & Discussion

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Aitareyan
BRFite -Trainee
Posts: 4
Joined: 31 Jul 2005 08:21
Location: USA

Postby Aitareyan » 21 Nov 2005 11:54

Ramanujan wrote:long text deleted


I am amazed you actually have time to make your long-winded and irrelevant posts.

My original post was (1) for information, and (2) to assert that the Indians have an opportunity to make good in Africa and also further our genuine concern for the natives of that continent who have ben exploited by others. There is no relation of malarial vaccines in India or Indian disease control problems to my post.

If you want to have a separate discussion with someone else on these issues, that is fine - but I am not interested. Don't link your claims to my post and waste my time with your incoherent argumentation, and then have the nerve to call me "less informed". I am not uninformed, but am merely uninterested in your other assertions which have nothing to do with my post.

Ramanujan

Postby Ramanujan » 21 Nov 2005 21:50

George J wrote:
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.


No drug company is really interested in altruism - not western, nor Indian.
I realize fully that GSK's motives were driven largely by market realities and worldwide public pressure. The point however is that one cannot paint Indian forays into African ARV market as a sign of altruism that will win India some goodwill. This is also driven primarily by profit-motives.
One of the reasons why African market for ARVs is bigger than that of India's is because a shit load of western aid is pouring into Africa to try and deal with African AIDS. Most Africans who are HIV-infected can pretty much get these drugs for free - same is not the case for Indians who are infected with HIV. The dichotomy is especially concerning because Indian drug companies who are/were actually churning out profits in the African market were not exactly funneling any significant fraction toward AIDS initiatives in India...there isnt any public pressure on them to help out in India. Instead their ability to churn out dated generics and sell them in the African market is being hailed as an achievement of Indian biotech - not just by stray posts on BRF but also in Indian media. Additionally, I was a bit irritated by the post in question because it was exhorting Indian companies to take "initiative" in Africa so as to score goodwill points. The idea is ludicrous for a good no. of reasons but primarily I found it bothersome because none of the Indian companies are taking initiative in going after a number of public health issues that are of primary concern to Indians. Its good to keep things in perspective while we hail the small advances made by Indian biotech/pharma.

George J

Postby George J » 21 Nov 2005 22:16

Ramanujan:
We have been through this before: its not easy go all the way with a new drug and there are NO incentives to do that for ANY company be it Indian or US. If a pvt firm creates a NEW drug for AIDS that shows more effectiveness than the current crop it will have immense social pressure to VL it, publicly listed Pharma is not in the business to create drugs for humanity, they are there "to create value for their shareholders." Hence the currently AIDS vaccine initiative is a good example of what it takes to spread the social and financial risk: govt level cooperation.

It may have been purely profit that got them to the African mkt...but the mkt pressure THEY exerted brought all these Big Pharma into line. Imagine what would have happened if Indian Pharma would not have entered the mkt??? They would still be buying what they would call "highly discounted" branded drugs paid for by US-EU aid. Thanks to the Indian companies that same $ goes a long way.

About the govt NOT doing anything in India..that again is your opinion. It's doing everything it can but there are too many fingers and too many distractions (Bill Gates Foundation is one of them). The other problem with India is the Indian's in general themselves are not fully aware of the disease, they just know it kills and to top it off even the frontline physicians treating them are no better in some cases.

In Africa thanks to the media and extremely high incidence of the disease there is far more symmetry of information (perhaps the only good thing about the African AID scourge).

PS: Whats "dated" about the generics? The only T-Class of drugs are the Fuzion-Fusion Inhibitors and they are not meant as first line tx anyway. And MOST IMPORTANTLY its an injectable....thats not going to work in areas where there is little or no public health infrastructures. The so called Dated meds (owned by different companies made by ONE indian company) are still effective in stemming the spread of the virus and are solid orals...which are the simplest dosage forms to make, transport, store and administer.

Ramanujan

Postby Ramanujan » 22 Nov 2005 02:13

George J:

As far as doing enough for AIDS in India is concerned, I am not so alarmed by the government not doing enough – although I do feel that more can and should be done by GOI. I am more alarmed by the fact that Indian public doesn’t demand a greater investment in biomedical research – be it HIV, malaria, heart disease or diabetes – all of great concern to Indian population. I don’t mean the average Indian farm worker who has other problems to worry about – I mean the rich Indian anglophone elite that is hooked up to broadband, logs in to BRF and talks about “grabbing initiative in Africa and helping the black man”. I realize its not easy to develop new drugs but I don’t see any real effort either. I am told, for instance, that Dr Reddys spends more on litigation in US than on annual research. As far as Indian companies forcing the US/EU pharma companies to a weaker negotiating table in Africa is concerned, it could be cutting both ways. Could it be that the reluctance of these companies to set up genuine research infrastructure in India and them playing a substantial role in enforcing a stringent TRIPS regime in India is the darker side of that same coin? Additionally, like I said before, African HIV patients get their ARVs for free, most Indian HIV patients don’t. Those who do get it for free need to thank BMGF, I guess. Now perhaps Indian companies can help out in India too? We all know that they can make good copies, perhaps they can show some ingenuity and develop new drugs that others wont for Indians. The least I can do is not join in the applause of such mediocrity when I know that Indians can do a lot better in research and development. I wouldn’t be surprised if the license for the newer fusion inhibitors is also given directly to African and Brazilian generic manufacturers. Hopefully the Africans will be happy to sell these in India at reasonably discounted prices as well – you know to take initiative and earn some goodwill from Indians.

By “dated” (hastily used word - I regret), I meant that the generics most widely disseminated by Indian companies (zidovudine and lamivudine) are RT inhibitors to which a significant portion of Indian and African HIV isolates are resistant to. The resistance comes from variations in a single HIV gene, namely the pol gene – which is quite a hotspot for mutations. It is therefore likely to get worse and these drugs are not going to stem the tide of newer HIV infections. The net result is that overall picture of AIDS in India or Africa is not looking any better. In the meantime, drugs such as Fuzeon (fusion inhibitors) are further compartmentalizing the HIV patients in the developed world from those in the developing world. BTW, although injectable and not as convenient, Fuzeon is supplied as a lyophilized powder that can be reconstituted in sterile water (supplied in vials) prior to injection. I think the drug is stable without refrigeration for quite some time but I am not sure. In any case, HIV infections in the western world continue to drop while they continue to increase (with drug resistant HIV) in India and Africa. If the Indian companies don’t see a market for new drugs in India, I cant think of any body else who will.

Div
BRFite
Posts: 327
Joined: 16 Aug 1999 11:31

Postby Div » 22 Nov 2005 07:50

For small pharma cos, the future is bright
http://in.rediff.com/money/2005/nov/21spec.htm

George J

Postby George J » 23 Nov 2005 01:13

Ramanujan wrote:........I am more alarmed by the fact that Indian public doesn’t demand a greater investment in biomedical research – be it HIV, malaria, heart disease or diabetes – all of great concern to Indian population. I don’t mean the average Indian farm worker who has other problems to worry about – I mean the rich Indian anglophone elite that is hooked up to broadband, logs in to BRF and talks about “grabbing initiative in Africa and helping the black man”.


I am pretty sure most anglophone Jingos dont have to worry about TB and Malaria due to their std of living. They might have to worry about HIV...but then they can very well afford the current crop of ARV in the mkt (and they get access to stuff like Triviro/Trimmue). This coupled with a healthy lifestyle (diet and exercise) will reduce HIV to a chronic disease like diabetes: look at Magic Johnson. Off course this all assumes they get tested and find out early. Thats a different kettle of fish (I cant argue the public health point and the pharmaceutical point at the same time).

Now diabetes/hypertension/CV diseases is another issue. These are lifestyle disease that come about mainly by a sedentary living coupled with a fat rich diet. From the pharma perspective everything thats available in the west is also available in India (50x cheaper). Like Singha alluded to in the DRDO thread...uncontrolled diabetes leads to kidney failure and then you need a dialysis machine...which is not that accessable. Dialysis machines are not pharma (I cant argue medical technology and pharma at the same time....) Lifestyle diseases need common sense...you need to alter your lifestyle. If you are educated enough to know what diabetes/hypertension/hyperlipidemia is and then you insist on NOT exercising moderately and insist on eating the same ghee rich, carb rich foods. Then perhaps you deserve to DIE for your stupidity.

And trust me a very close family member is highly educated aware about the consequences of diabetes and is not doing much to control it. I know EXACTLY the consequences in store for him, but I cant do anything (besides tell him repeatedly). The sheer apathy towards health amazes me.

I realize its not easy to develop new drugs but I don’t see any real effort either. I am told, for instance, that Dr Reddys spends more on litigation in US than on annual research.


If you knew the industry you will realize that its stupid for firms like DRL and Ranbaxy to do otherwise. The both have spent a TON of money getting US FDA approved mfg facilities outsides the US. They have hired the best patent lawyers in the business (outside of those with 7 figures incomes in US pharma) to help them bring out generics in the US mkt. By selling generics in the US mkt, they make a killing since the generic prices in the US mkt is still 5-44x more than the same pdt...made by the same plant and sold in the India. WHY WOULD ANYONE NOT USE THIS BUSINESS MODEL TO GAIN VALUE FOR THEIR SHAREHOLDERS???

On the other hand in the US it takes 15 years and about $877M to bring a NCE into the mkt. Indian companies dont have that sort of fiancial muscle nor do they have the trained manpower (trust me the HR implications of full spectrum of small molecule research is amazing). The only thing they can do out-license molecules to western companies for clinical testing. Which they have been doing. There are Indian CRO that now take over Phase I testing for US made drugs in India (thats another kettle of fish that deals with ethical medical research and outsourcing to India that I dont want to go into....I will find out more about the state of clinical research in India during my visit in Dec...but I suspect there are many many problems)

Could it be that the reluctance of these companies to set up genuine research infrastructure in India and them playing a substantial role in enforcing a stringent TRIPS regime in India is the darker side of that same coin?


Thats all BS. Indians are VERRRRRY good at preclinical and pre-formulation stages. They are very good in candidate screening, tox etc. And ALL PARENT companies have a busy research and development division in their Indian subsidiary. The new patents laws protect their work in India and there are more than enough US trained scientist willing to work in India for 24-50 lakhs. And 50 lakhs for a Sr. Principle Scientist (with 10-15 years of US experience and good track record) is nothing. They have more than that in yearly US stock options. But for 50 lakhs I am told you can live quite comfortably in most parts of India.

Those who do get it for free need to thank BMGF, I guess.


I know the India director for BMGF, they DO NOT help with access to medicine. That is an WB funded NACO run project. They are pumping in $200 million for AIDS Awareness.

BTW, although injectable and not as convenient, Fuzeon is supplied as a lyophilized powder that can be reconstituted in sterile water (supplied in vials) prior to injection.


Boss its an SC drug and need something called as STERILE WATER FOR INJECTION USP (WFI) for reconstitution. I donno what you know Sterile WFI or WFI but these are not your ordinary tap water or distilled water or bisleri water. Their exact specs are outlined in a monograph in USP or NF or even IP. They involve exacting std in suspended particulate matter, pyrogens, bioburden and many other things that I dont remember. Suffice to stay that enfuvirtide will be sitting on the shelf doing nothing if you dont have SWFI (not even WFI..they are different grades). AND you need a qualified healthcare provider AND you need sterile injectable devices to actually administer this drug.....remember we are talking sub-saharan africa here. Oh and before I forget its a BID SC injection....ummm yeah right. Real world Compliance to therapy is pretty much lost right there.

Ramanujan

Postby Ramanujan » 23 Nov 2005 03:42

This coupled with a healthy lifestyle (diet and exercise) will reduce HIV to a chronic disease like diabetes: look at Magic Johnson.


It will certainly be the case for people like Magic Johnson who can afford the latest drugs, best care, exquisite living conditions and a minimal exposure to infectious agents. This is not the case for most HIV patients in the developing world. Even with a pretty healthy immune system, the mortality that results from infectious diseases in India is quite significant. People with HIV who are on ARVs recover their T-cell count to a certain extent. Once the resistance builds up – I brought that up earlier – it’s a downward spiral. In India, the mortality from HIV infections HAS dropped since ARVs became widely available (they reach about 40% of HIV patients in India) but that’s primarily because it was ridiculously high in the first place. The presence of resistant strains makes your case especially soft. HIV infection is not going to be like diabetes in conditions that are prevalent in India and Africa. As far as the Anglophone jingos go, I am quite sure that they will manage fine but my point was about the health issues that are of concern to all of India including the other 99% of the population that doesn’t log into BRF.

Thats all BS. Indians are VERRRRRY good at preclinical and pre-formulation stages. They are very good in candidate screening, tox etc.


That’s the easy part. But even there, what is lacking is the ability to unravel new biology, validate new targets and develop new assays that allows primary screening. Its not hard to buy fluid transfer robots and setup trays for screening against a known target with a robust assay that is either copied or licensed. Indian pharmas are good at medicinal chemistry that allows hit optimization. It’s the same skill that allows them to attach a sugar moiety to known drug in an effort to challenge patents (with the help of 7-figure salary lawyers).

Talking about drug discovery, and to put things in context, enfuvirtide was the first of the “entry inhibitors” – it was developed not by a big pharma but by a bunch of academics from Duke. The breakthrough wasn’t screening – in fact there was no screening. It was figuring out that gp41 docks to CD4 on T-cell to enter the cell. The idea that disrupting this interaction would inhibit entry was patented, a small company was launched and a drug was developed to do just that using rational approaches. After extensive testing in animal models, when the drug clearly showed great promise, they teamed up with Roche to get it through clinical trials…I think the FDA approved it pretty quick (you know a lot more about that than I do). The point is that the most groundbreaking work that led to this drug was done without any significant financial muscle and by less than 30 people.

And ALL PARENT companies have a busy research and development division in their Indian subsidiary.


Yes, I visited one myself where a friend of mine now works after his training in the US.
The facilities (this one belongs to a German pharmaceutical) are not comparable to what you will find in the research facilities in US. For a US-trained scientist, the infrastructure would not be satisfactory for cutting-edge research. It is adequate for very specific development projects that are handed down from primary research facilities that are based in US and EU. That is why I said that they are NOT setting up genuine R&D infrastructure. We have different standards in mind.

Boss its an SC drug and need something called as STERILE WATER FOR INJECTION USP (WFI) for reconstitution. I donno what you know Sterile WFI or WFI but these are not your ordinary tap water or distilled water or bisleri water.


George J, I indicated previously that vials of sterile water come with the drug. A box contains vials of lyophilized drug, syringes and the vials of sterile water. Nonetheless, this drug is currently unsuitable for Africa and India – not because of sterile water but because of the cost of manufacturing the drug – current market value is about $15K/year per patient. It is possible to bring this price down…that’s where innovation would come in. I do know that sterile water is not tap water or bisleri water but reminders are always welcome.

George J

Postby George J » 23 Nov 2005 04:09

Does the Fuzeon kit come with a healthcare provider too? BID SC dosing is not as easy as it sounds. You are talking about taking injections twice a day. Which means a patient or the caregiver has to TRAINED by the healthcare provider in correctly administering the drug. In least developed countries this can be a tall order.

I donno what your friend does...but without specifics I am not sure if I believer your friends story of inadequate infrastructure. The work culture is very different but there is no paucity in the small molecule infrastructure (for protein theraputics a.k.a Biotech..its a different story...we are still new to that game).

There are many drugs that were born in academic settings in the US and then became a reality thanks to pvt industry participation (even in the US going clinical is a very tall order). Its suicidal for an academic insititution to actually finance and organize a clinical trail for a IND. We are talking upwards of $500M for the clinical stages alone. So it might just take 30 ppl to come up with this drug but it will take 3000 subjects in Phase III to get this drug approved. And thats the $500M problem.

Ramanujan

Postby Ramanujan » 23 Nov 2005 04:43

Fuzeon certainly does not come with a health care provider…more imporatantly, I conceded that its not suitable for India because of the costs associated with it. As far as injections go, Insulin is widely prescribed in India…its not a big deal.

Btw, if you don’t mind my asking, are you a scientist?
Indian pharmas do have good small mol infrastructure and that’s what makes them good at med chem. – I said that earlier. But drug discovery as you very well know starts with biology. The infrastructure necessary to understand molecular and cell biological processes is not adequate in India. This is what leads to: (1) identifying potential drug targets (2) validating these targets (3) developing novel assays that will allow screening of small molecules against this target – either in vitro or in an whole cell assay (4) Alternatively, take a rational approach and solve the protein structure of the target, build drug candidates in silico etc. The med chem. part comes after you get here…the small molecule infrastructure plays a role after this phase. Currently, few if any of the Indian pharmas have demonstrable strengths here. It tends to nip things in the bud. Things will of course get better and I do not doubt the ability or the potential of Indian scientists but your claim that Indian setups are at par rings hollow.

I am not exhorting Academia to get into clinical trials. I was merely indicating that intellectual leaps that do lead to successful drugs do not require a significant financial muscle or a wide spectrum of HR. If the science is solid and a drug candidate is in hand, its not hard to get into a strategic alliance with a big pharma. The key part that Indian companies do not have (as I have stressed earlier) is the ability to unravel new biology. Small molecule infrastructure, however necessary, is in the end slaved to biological know-how (and IP that protects that know-how).

George J

Postby George J » 23 Nov 2005 06:04

Ramanujan wrote:Indian pharmas do have good small mol infrastructure and that’s what makes them good at med chem. – I said that earlier...........Things will of course get better and I do not doubt the ability or the potential of Indian scientists but your claim that Indian setups are at par rings hollow.


It is not by accident that Indians are good at med chem and Novel drug delivery system. That was their bread and butter till 1995 till process patents ruled the roost. They had to innovate where it counted the most...production efficiency and product differentiation (XR DF). When the economy opened up in a big way they started exporting their products. There was NO NEED to pump in money into the R of R&D, it was all D.

Indians can read and comprehend whats written in peer reviewed journals. They understand whats happening in the world and what needed in the market. Thats how drugs like Balaglitazone were developed and out-licensed (it failed in Phase II BTW). You dont need to be master of all theraputic areas (you are in this business to make money not to cure humanity). You focus on specific areas and build your group around that. Thats why they good in certain areas and weak in others.

I know enough statistics to know that you dont build your conclusions around ONE sample. If you friend does not like his German company then he should go back, they will do pretty well without him. I know folks who are doing fine and dandy in DRL, Baxy and Cipla. Ranbaxy even heavily recruited last year at the AAPS.

I was merely indicating that intellectual leaps that do lead to successful drugs do not require a significant financial muscle or a wide spectrum of HR. If the science is solid and a drug candidate is in hand, its not hard to get into a strategic alliance with a big pharma.


Its not a drug untill it goes clinical...its not a medicine untill it successfully and safely completes Phase III. Why do you think they 15,000:5:1. Out of 15,000 molecules 5 will reach clinical and only 1 will succeed?? Its good that academia finds good candidates to go clinical but untill you go clinical it amounts to diddly squat. You only get royalties for the drugs that are in the mkt not the ones that failed.

Finally we have digressed quite a bit...I thought we were talking about AIDS in Africa and why a 2nd line like Fuzeon wont work and now you are talking about Insulin and Small Molecule R&D in India. What are we talking about?

Ramanujan

Postby Ramanujan » 23 Nov 2005 23:15

When the economy opened up in a big way they started exporting their products. There was NO NEED to pump in money into the R of R&D, it was all D.


Sure, nobody denies that Indian pharmas have been able to churn out generics and sell them overseas. What we have been talking about is having a research infrastructure – which you claim is at par with what one encounters in the west. The fact that they didn’t NEED to invest in R of R&D led them NOT to invest in R of R&D and as a result the research infrastructure is poor – it is certainly not at par with what you will find at the research facilities of Novartis in San Diego or Cambridge (MA). Nor would it be comparable to research facilities developed by a relatively smaller companies such as Biogen, Millenium or even Infinity pharmaceuticals which didn’t take off till 2001and has no FDA-approved product. If you think otherwise, you have either been misled or you have no idea how one compares biomedical research infrastructure – perfectly understandable if you are not a scientist. If you are still interested in debating this, we can get into specifics.

Indians can read and comprehend whats written in peer reviewed journals. They understand whats happening in the world …….Thats how drugs like Balaglitazone were developed and out-licensed (it failed in Phase II BTW). ….You focus on specific areas and build your group around that. Thats why they good in certain areas and weak in others.


Yes, Indians can read scientific literature but the understanding that is gleaned from reading papers is never a substitute for having experimental expertise in that area of interest. Your example about Balaglitazone is quite superficial and a closer look at that same example actually supports my view.
Balaglitazone came out of generating analogs of thiazolidinediones (TDD) which had been shown to function as agonists of PPARg, the molecular target of the drug. It doesn’t take much to make analogs and test them individually for their ability to function as PPARg agonists – so as to license the small molecule out for a more sophisticated look even in pre-clinical stages. Tests in rodent models were done by the Danish pharma that they licensed it out to and not by Dr Reddys. Additionally, even before Balaglitazone entered clinical trials, the PPAR researchers were becoming quite wary of TDD analogs leading to complicated side-effects. One TDD-analog was actually withdrawn from the market and although Avandia continues to be prescribed, people remain wary of the systemic fluid-retention and liver problems that it brings about in great many patients. The companies that do have cutting edge expertise in PPAR family of targets are therefore looking for non-TDD small molecules as partial or full agonists of PPAR. This requires a bit more than the ability to churn out analogs of TDD. Do you know if Dr Reddys has developed a novel high throughput assay to screen for PPARg agonists? Merck developed a really good one about 4 years ago – needless to say its patented and even if it weren’t, I doubt that Dr Reddys could set it up by themselves. IMO, theres a lot more that Dr Reddys cannot do even in preclinical stages- especially where cell biological/biochemical infrastucture and expertise is needed. This holds true for every Indian pharma and biotech. But if you still disagree, come back with some technical specifics and not just soundbytes of how Indian companies are very good at this and that. The proof is in the pudding…few if any new drugs have come from Indian companies. In addition to lack of financial muscle, this is because of lack of comparable research infrastructure and expertise. I realize fully well that its not because of lack of potential so don’t try to make it into “Indian people are just as smart...etc” - that’s obvious. Even now as research infrastructure improves, it is nowhere comparable to what you will find in US and EU- that is also evident to most biomedical scientists – Indian or otherwise.

I know enough statistics to know that you dont build your conclusions around ONE sample. If you friend does not like his German company then he should go back, they will do pretty well without him. I know folks who are doing fine and dandy in DRL, Baxy and Cipla. Ranbaxy even heavily recruited last year at the AAPS.


My conclusion is not based on that one anecdote – which would be meaningless as evidence. Just as meaningless, I might add, as the knowledge you claim to have acquired from people you know in X, Y and Z companies. Rhetoric aside, suffice it to say that the scientist that I am referring to and the German pharma he works for can manage their issues without your voluntary input – lets not get into him taking a hike etc – spoils the tone of this debate. If you know people who are satisfied with research at companies that primarily make generics – to each, his own. But I wonder how much “research” needs to go on – as you put it yourself- in companies that merely make copies of drugs.

Out of 15,000 molecules 5 will reach clinical and only 1 will succeed?? Its good that academia finds good candidates to go clinical but untill you go clinical it amounts to diddly squat. You only get royalties for the drugs that are in the mkt not the ones that failed.


You don’t get royalties only for drugs that are on the mkt. A research University can license out patented methodology, patents on targets, transgenic and knockout mice, disease models in lower organisms, small molecule probes…(the list is long) and they either get paid an upfront fee or can have a royalty arrangement. Similar issues help put a value on small biotech firms that get bought out by big Pharmas even though they may not have a drug on the market…some may not even have a drug candidate, just a really cool way to screen for an otherwise intractable target. All these things amount to much more than diddly squat.

Finally we have digressed quite a bit...I thought we were talking about AIDS in Africa and why a 2nd line like Fuzeon wont work and now you are talking about Insulin and Small Molecule R&D in India. What are we talking about?


I have said clearly that Fuzeon is unsuitable for India and Africa primarily because of the costs associated with current synthesis. You were making a case about the availability of sterile water and injections. I indicated that sterile water comes with the medicine and injections, although cumbersome, can be managed – as is evident by millions of diabetes patients in India that are on insulin. The issue is cost, not sterile water nor injections.
We can talk about any of these issues if you feel that I haven’t gotten it yet. My only request is that you don’t ask rhetorical questions about my ability to differentiate between sterile water and bisleri – lets keep the exchange tight with accurate information and free of rhetoric.

K Mehta
BRFite
Posts: 916
Joined: 13 Aug 2005 02:41
Location: Bangalore

India to import Chinese vaccine for Japanese encephelitis

Postby K Mehta » 23 Nov 2005 23:42

India to import Chinese vaccine for Japanese encephelitishttp://in.rediff.com/news/2005/nov/17vaccine.htm
A shame when so much money goes into the research in India on it. I know atleast half dozen profs "working" on it in IISc.
Think they can do a bit better.

George J

Postby George J » 24 Nov 2005 00:19

Ramanujan wrote:............ If you think otherwise, you have either been misled or you have no idea how one compares biomedical research infrastructure – perfectly understandable if you are not a scientist. If you are still interested in debating this, we can get into specifics..........

Balaglitazone came out of generating analogs of thiazolidinediones (TDD) which had been shown to function as agonists of PPARg, the molecular target of the drug.


Its TZD not TDD. One typo is fine but four times is ignorance. Is that specific enough? Are you being coached by someone coz you seem to miss too many details: Balaglit being outlicensed (as I had clearly stated) and you tell me that some danish firm did the pre-clin (its Novo Nordisk) and the original glit that was withdrawn was Rezulin (Troglitazone). Is that specific enough in point your mistakes? I can think of some more specifics with regards to Fuzeon (its a second line tx used in conjunction with first line...that does not mean you can do away with "dated" generics) and BMGF (you dont even know about Avahan).

You are pretty much out of depth here. So like I said you want to "learn" something specific...ask me. If not at least check your google sources before you type your reply.

Ramanujan

Postby Ramanujan » 24 Nov 2005 00:54

George J wrote:
Ramanujan wrote:............ If you think otherwise, you have either been misled or you have no idea how one compares biomedical research infrastructure – perfectly understandable if you are not a scientist. If you are still interested in debating this, we can get into specifics..........

Balaglitazone came out of generating analogs of thiazolidinediones (TDD) which had been shown to function as agonists of PPARg, the molecular target of the drug.




Its TZD not TDD. One is a typo is fine but four times is ignorance. Is that specific enough? Are you beign coached by someone that you seem to miss too many details?


Dude, I didnt want to spell thiazolidinediones all the time, so I indicated in parenthesis what I was going to refer to it as. I dont work with these class of drugs and wasnt aware that the standard nomenclature is TZD. So yes it is ignorance about a detail but what about your fundamentals? PPAR(gamma) similarly is best written as Peroxisome proliferator activated receptor- gamma - but if you go through the >10000 publications on this nuclear receptor, you will find some variations - especially from people whose primary focus is not this receptor. In informal correspondence, its not uncommon to refer to small molecules being talked about with certain logical abbreviations - especially if one is not aware of formalized nomenclature. If you want I can give you specific examples there as well.

Now, if you think I am being coached, thats your problem. I am not going to try and convince you otherwise. You, however seriously need some coaching on FUNDAMENTALS of biomedical research - it seems that you are just good at throwing around jargon and pretending to be an expert on drug discovery based on your work in regulatory affairs and your chats with people in the drug discovery. I dont see any deeper knowledge about the science of drug discovery - again quite understandable if you are not a scientist but stop the pretense.

I asked you politely to leave out the rhetoric but since you persisted, I had to reply in kind. You pulled out an incorrect abbreviation out of my post as a counterpoint - thats quite pathetic. If you want, we can get back to substance now -without the rhetoric. I am still willing to have a civilized debate.

Ramanujan

Postby Ramanujan » 24 Nov 2005 01:05

You are pretty much out of depth here. So like I said you want to "learn" something specific...ask me. If not at least check your google sources before you type your reply.


Precisely. Names and abbreviations can be looked up on google...but its a little harder to understand the fundamentals by doing a google search. For that you need to DO some research first. I am not the one who is out of depth here. As far as "learning" from you goes - sure, If I need to know abbreviations and names of drugs, I will ask you. It would be about half as good doing a search on google (which you are so good at using).

George J

Postby George J » 24 Nov 2005 02:02

........ I dont work with these class of drugs and wasnt aware that the standard nomenclature is TZD.


The devil is in the details son, if you know about PPAR(gamma) from a 10,000 pubs and you donno what TZD is its sheer ignorance. You are right about logical abbreviations thats why they have HCTZ, MAO and TZD (not TDD). I am sure your medline search for 10,000 publication for "PPAR + TDD" will yield lots of results? :twisted:

Oh...about the rhethoric? How is this rhethoric? I am not able to persuade you about your own mistakes? Unless you think I am being pretentious, insincere, or intellectually vacuous? But you are the one who does not know the what TZD is, Avahan is or that "dated generics" are first line for enfuvirtide. Sounds like malapropism to me.

So I ask you again...what are we talking about? Whats left to discuss?

Ramanujan

Postby Ramanujan » 24 Nov 2005 04:54

In my post, where I mistakenly “mis-abbreviated” Thiazolidinediones as TDD, it was quite clear to you what I meant i.e. there wasn’t any scope for a misunderstanding. If I had simply said TDD without indicating that I am talking about this chemical compound, your point would be valid. Scientists don’t go around calling Wortmannin as SL-2052 just because that is an accepted synonym for it…a simple WM suffices in informal communications and it also gets used in publications. The reviewers don’t go around making a big fuss about it if its clearly specified that your are referring to Wortmannin as WM. Now if you have ever published a peer-reviewed paper in a reputed journal, this would be obvious to you. Details are meaningless if the fundamentals are soft or non-existent. Anybody can monkey around names and abbreviations of drugs and pretend to be an expert on drug discovery. :evil:

I didn’t say that I had gone through 10K publications on PPAR…I don’t study PPAR either and I haven’t read a paper on it in a long time. But having strong fundamentals about the science that drives drug discovery and having published reasonably well in biomedical sciences, I can say here on BRF that your fuss about “wrong” abbreviations is laughable.

Rhetoric that I was referring to was when you started off asking me if I knew what the difference between sterile water and bisleri is. Rhetoric was when you wrote that my friend should to take a hike when you are in no position to judge how much his company may or may not value his services. Rhetoric was when you were saying that I was being coached to write on BRF.

Oh, and whats the big deal about knowing what Avahan is? Wouldn’t google tell me that if that was of relevance to the points I have been trying to make about biotech and drug discovery issues? If people are really interested in Avahan, I can paste a link for it that can be found by anybody using google. The website for BMGF (I dunno if thats an accepted abbreviation for Bill and Melinda Gates foundation either) probably links to info on Avahan.

It would be much more relevant to the discussion if I asked you to explain in simple terms (no regurgitations) how one assays for PPAR agonists, whats the logic behind it and what molecular events dictate that PPAR agonists are likely to cause systemic fluid retention. And remember, I wasn’t the one who brought up Balaglitazone or Balaglit (which targets PPARg) or whatever you would like to call it in your BRF posts. If you are uncomfortable with that class of targets, we can talk about other very important classes of targets such as kinases, GPCRs, and ion channels. Now that would be more relevant and fundamental to drug discovery.

About Fuzeon, I never said that Fuzeon was the first line of treatment of HIV – I always indicated its relevance in the context of drug-resistant HIV strains. If you want, we can discuss possible approaches to bring down the costs of synthesizing enfuvirtide or Fuzeon or whatever we prefer to call it in our posts on BRF - why dont we call it FZ just for simplicity. If you are uncomfortable with the chemistry and prefer to be at the physiological end of this anti-HIV drug, we can exchange our understanding (if any) of the molecular and physiological basis of entry inhibition and why it is harder for the virus to mutate toward resistant strains against this class of drugs. If you don’t understand the chemical and molecular logic of drugs and drug discovery, all else you know is just jargon –which can be easily looked up on the internet and regurgitated as "expertise". :evil:

So there are a lot of fundamental things that can be discussed if you want to see who is out of depth in this conversation. More importantly, I would like to "learn" from your expertise as it relates to basic fundamental foundations of drug discovery rather than abbreviations and names of drugs.

George J

Postby George J » 24 Nov 2005 05:41

Siiiiiiiiiiiiiiiiiiiggggggggggggh.

Let me ask you one last time...what are we arguing about?

1)This started off as discussion about AIDS in Africa, where using your superior drug discovery knowledge you contended that GSK sells drugs at subsidized prices though Aspen. Then somewhere in there we went off on a tangent about about utility of a second like tx like enfuvirtide where you were adament that injectable dosage forms are easy to deal with since ppl inject insulin too (there is a whole world of socioeconomic and demographic characteristics of DM and HIV patients/providers and access/quality of care that are completely ignored when making such irresponsible statments, and since I work on these issues for a living I find your purile assumptions laughable :twisted: among other things like ease of use and compliance to oral vs parentral df)

2)Oh and your incorrect assumption of what BMGF does in India: use $200M to subsidise access to ARV. Using your vastly superior drug discovery knowledge you gleaned what Avahan is, when I told you othewise.

3)Somewhere in there you state India should concentrate on TB, malaria and DM/CVD. And I told you that pharma go where the money is and gave Balaglitazone as an example of DM related preclinical research. You using your vastly superior drug discovery knowledge tried to teach me MOA/SAR of TDD :twisted: PPARg agonist. And somewhere why trying to explain the MOA you told us that Indian pharma's effort to develop a NCE like Balaglitazone no big deal.

4)Oh and there a final tangent about your friend who is not satisfied with what the some german companies subsidiary has done in India, but at the same time you say that he is very essential to their work.

5) And you want to know/learn from me about drug discovery since you have concluded that everything I know is from talking to small molecule: med chem, pre-form, analytical and reg affairs folks. Right.

Those are five distinct issues that you went off on a tangent about when you realized that you are pretty much out of depth about AIDS in Africe/India and what the national policy was and what foreign doners do and the utility of a new class of ARV.

Ramanujan

Postby Ramanujan » 24 Nov 2005 07:55

I will lay it out in very simple and blunt words.

We have been arguing about many things and tangential topics had to be dealt with whenever we had acute disagreements. Your summary of what we argued about is very self-serving and conveniently incomplete. In any case, in my previous posts, I have questioned your grasp of scientific fundamentals upon which the entire drug discovery efforts are based. This is important because, you have always responded to my posts with the attitude of a self-appointed expert on drug discovery and that I was to “learn” from you. That is evident by:

George J wrote:
You are pretty much out of depth here. So like I said you want to "learn" something specific...ask me . If not at least check your google sources before you type your reply.


So in my earlier post, I asked you – not for details of names and abbreviations but about some fundamental aspects of drug discovery. But it appears that there is nothing you can say about that. I guess that will come after you go around frantically consulting some online review articles written for lay people and consulting people who probably ARE experts…but lets see anyway.

Similarly, I doubt that you can actually comprehend primary literature on current happenings in synthetic chemistry, biochemistry, molecular biology or cell biology – all very relevant to drug discovery. Can you?

This is important because you claim to be able to tell whether the research infrastructure and drug discovery research being conducted in India is poor, reasonably adequate or equivalent to what one sees in the modern facilities in the US. You have consistently challenged my views on these issues and I have responded with polite rebuttals despite having the suspicion that you couldn’t tell between a lyophilizer and an ultracentrifuge. It seems to me now that you probably don’t even have an idea of what kind of instrumentation and expertise a company would NEED to generate structures of their drug targets in solution and in solid state. Do you? Or what does it take to generate knockouts, study tissue distributions, cellular localization, make split-pool combinatorial libraries –all very important aspects of drug discovery research. On what basis do you go around challenging people about the level of scientific infrastructure available to scientists working in an Indian drug companies and how it compares to places like Novartis, Biogen, Infinity or even some recent startup in an incubator space?

Let me ask you one last time...what are we arguing about?


I am telling you point-blank that in my very humble opinion, your understanding of basic scientific principles behind what you portray as your expertise about drug discovery research is hollow. What you can mouth out are abbreviations, names of drugs, buzzwords and soundbytes prevalent in drug discovery circles. So what we have here is a strong suspicion of a massive credibility gap in what you assert here on BRF and what you really understand about drug discovery. That’s what we are arguing about in addition to the tangential stuff that you have outlined self-servingly and incompletely. If you don’t understand something, at least don’t go around writing ridiculous things like:
So like I said you want to "learn" something specific...ask me

George J

Postby George J » 24 Nov 2005 10:38

To conveniently summarize what you inconveniently summarized for me (at the risk of repeating myself again). Your argument that you know know more than me about drug discovery has stood you in good standing about your scintillating knowledge about:
1) Utility of SC dosing over oral dosing for a second line ARV (you were more interested in explaining the MOA to me when I didnt ask you for it)
2) Your vast knowledge about what BMGF do in India. (they pay for drugs in India? right)
3) Your wonderfully uneducated views about the demographics of HIV and DM patients in India/Africa and hence the ultrasimplistic view about the ease of parentral self administration
4) And finally thiazolidinedione (TZD): (you were trying to justify the SAR for PPARg when I didnt ask you for it, and you got TZD).

Seems like as far as the core and genesis of this argument goes your vastly superior drug discovery knowledge has amounted to diddly squat, so you would rather draw this discussion in another wonderful tangent about...oh wait for it...ULTRACENTRIFUGES so that you are finally on firm footing to make a point about nothing thats related to this topic.

And before you think of retorting that I am trying to draw this topic BACK to the AIDS, Indian Pharm and R&D, let me remind you its was thanks to your incorrect notions (GSK reducing costs right!) that you drew me into this discussion. So its in my right to expect you to respond to those issue rather than argue ion channels, ligands and other stuff that are of NO Relevance to this discussion.

Like I said before is there something you would like to "learn" about the original issue for me? If not you are welcome to live in your wonderful little world of lyophilization (which incidentally I knew a lot about) and ultracentrifuges (nope you got me there...we were too poor to afford anything like that only table top centrifuges for us...and wait for it...hand cranked ones!!!) .

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STOP IT

Postby K Mehta » 25 Nov 2005 21:18

GUYS YOU ARE REACHING NOWHERE IT SEEMS STUPID FOR TWO OLD TIMERS LIKE YOU FIGHTING LIKE THIS

NO PHARMA COMPANY ESPECIALLY MULTINATIONALS THINK ABOUT THE PEOPLE, AND THE DIFFERENCE IN PRICING FOR THE PEOPLE WHO REALLY NEED IT IS NEGLIGIBLE. $500 A THERAPY IS AS MUCH UNAFFORDABLE AS $550 FOR ANYBODY IN AFRICA

I think it is better if we discuss the problems rather than test each other's knowledge. The problems of biotech industry are enough without you two fighting
with regards

George J

Postby George J » 26 Nov 2005 03:46

Whose fighting? I am merely 'educating' someone with vast "knowledge of drug discovery" how drugs are used, distributed and affected by policies in the real world. :twisted:

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Postby Laks » 26 Nov 2005 17:07

Peace GJ and R! Indian pharmas themselves are fighting it out.
Ranbaxy Laboratories is among the eight companies from across the world, which is in talks with Roche to outlicence the avian flu drug, Tamiflu. Roche is expected to finalise the names of the companies by November end.
Roche may prescribe Tamiflu to Ranbaxy

Since the drug is not yet granted a patent in the country, nobody can stop any generic manufacturers from producing it in the country. So Cipla is readying for the production of Oseltamivir as well as Zanamivir (invented by Biota and marketed by Glaxo SmithKline as Relenza) in India.

The company is currently in the process of preparing bioequivalence studies and will get necessary approvals from the regulators in due course, he added.

Cipla will make the drug available to Indian patients, as well as the patients in all the least developed countries, where there is no patent regulation yet, at the time of a health emergency, Hamied said.

“Cipla’s move is a part of its commitment to India and it is the same with any other poor country which cannot afford the high drug prices fixed by multinational companies who enjoy a monopoly in the name of patent protection, :eek:” he said.
Cipla opposes Roche flu patent
Heh. Will this guy say the same thing if Cipla one day becomes one of them. ok all is fair in luv and war.

George J

Postby George J » 26 Nov 2005 23:53

Dont worry about Oseltamivir. What Cipla is doing is just being proactive and polite. When the sh|t hits the fan and there is really an outbreak of Avian Flu or whatever, the compulsory licensing (CL) for pubic health emergency provisions will kick in and then Roche will have no say in this issue.

If CL kicks in then the GOI will have final say on "who mfg, sells the rx and at what price" and Roche will be given "appropraiate compensation". Roche knows that, Cipla knows that, they are just trying to pre-empt that situation by deciding beforehand on the terms of volunatary licensing.

And then when Cipla starts to sell this drug in India...NPPA will control the prices (most probably govt will distribute the drugs). Trust me, avian flu will affect babus and netas equally and you will be amazed at the alacrity with which they will steam roll any opposition from Industry over CL. The same cannot be said for US where they (PhRMA) have 2 lobbyist per congressman in DC.

Axe to grind: You are most likely to be without medicine in the US than in India when the sh|t hits the fan.

The big issue about Oseltamivir is the supply of its key ingredient: Shikimic Acid. This stuff comes from chincom plant Star Anise. Here is a good link to the current state of affairs about Shikimic acid. Note Hamid bhai (of Cipla) has said that he has a few tons of this stuff, which loosely translate to a few tons of oseltamivir (10-20% production losses). Also note his relative confidence when it comes to production of Oseltamivir.
______________________________
Please resist the temptations to post your vast knowledge about drug development by telling us the MOA/SAR (which itself is specious at best) of Oseltamivir. Understand what the discussion is about and if you have any specific inputs about the issue please do post. If not, LEARN.

Ramanujan

Postby Ramanujan » 27 Nov 2005 09:08

George J, I was a bit delayed due to Thanksgiving travel and festivities but here we go. I hope the wait wasnt too long.

Quite an interesting response from you I must say. Basically, you were unable to demonstrate any significant level of conceptual grasp over things that you claimed to be an expert on. Instead you prefer to pull out
stray issues where you feel you have a little bit of breathing room. But, I will play along just to stick it in for one last time. Lets have a look at them and deal with them appropriately. And about Oseltamivir's MOA,maybe it is specious and maybe it isnt - how would you know any way? You keep on doing what you do best - being duplicitous. :D

Your point#1:
1) Utility of SC dosing over oral dosing for a second line ARV (you
were more interested in explaining the MOA to me when I didnt ask you for it)


Fusion inhibitors were brought into this argument by you. I discussed Fuzeon because it is a great line of treatment against current variants of drug-resistant HIV strains. I NEVER argued that it was a first line ARV. I also indicated clearly that it was unsuitable for India and Africa primarily because of COSTS (>$15K/year/patient). The argument about oral vs. subcutaneous dosing is secondary because:
(i) Even if Fuzeon was an oral drug, its price would be prohibitive for widescale utility in India and Africa.
(ii) In contrast, if Fuzeon was as cheap as generic ARVs, SC dosing can be dealt with in a manner similar to SC dosing of insulin. Despite the relative complicated administration, a very cheap version of Fuzion could be rationed out to educated/skilled workers who are infected with drug-resistant HIV (doctors, nurses, some social workers, policemen, engineers etc.) This would help sustain the health care infrastructure and the economy in AIDS-infested regions of Arfrica. In short, it could be rationed out selectively. The logic is simple and if you still dont get it, in addition to being cenceptually bankrupt, you need to worry about your neurofunctional deficits that may be beyond salvage.

Your point #2:
2) Your vast knowledge about what BMGF do in India. (they pay for drugs in India? right)


This is what I wrote and you can check it yourself.
Those who do get it for free need to thank BMGF, I guess. Note the word "guess", which clearly telegraphs an element of uncertainty. You indicated that wasnt the case and I didnt challenge you on that. I realized I guessed wrong....after all, it was a guess.

Your point #3:
3) Your wonderfully uneducated views about the demographics of HIV and DM patients in India/Africa and hence the ultrasimplistic view about the ease of parentral self administration


I brought up diabetes because you were making a big deal about subcutaneous dosing. Insulin is injected subcutaneously by millions of Indians and its not a big deal. Even small children who have type I can be taught to self-administer SC injections. The primary issue with Fuzeon is cost and not the SC dosing and certainly not sterile water (as you claimed first (remember the bisleri comment :D). And what uneducated views did I express about demographics of HIV and DM in india and africa...pull out some quotes so that I know what you are talking about.

your point #4:
4) And finally thiazolidinedione (TZD): (you were trying to justify the SAR for PPARg when I didnt ask you for it, and you got TZD).


What do you mean by "SAR for PPARg"? Structure-activity relationship (SAR) studies are carried out on small molecules and not on proteins - but anyway, coming from you thats nothing new (conceptually vacuous, just flashy abbreviations :D). And no, I wasnt justifying anything, I was elaborating on how Dr Reddys came up with the drug. Your explanation about how they came up with it was superficial (and lets face it, you didnt really have a clue about PPARg agonists anyway - as was aptly demonstrated previously).

And before you think of retorting that I am trying to draw this topic BACK
to the AIDS, Indian Pharm and R&D, let me remind you its was thanks to your incorrect notions (GSK reducing costs right!) that you drew me into this discussion.

This is what I wrote about GSK:
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.


There may be more to the picture, but the statement is accurate.

So its in my right to expect you to respond to those issue rather than argue ion channels, ligands and other stuff that are of NO Relevance to this discussion.


That and more is of relevance because you are masquerading yourself as someone who understands the science behind drug discovery by making assertive challenges such as:

Thats all BS. Indians are VERRRRRY good at preclinical and pre-formulation stages. They are very good in candidate screening, tox etc.


Now we know that you are the one full of BS and VERRRRRY BAD with even the most basic aspects of preclinical and pre-formulation stages of drug discovery. If you dont understand things, dont go around making an ass out of yourself by making such statements.

Furthermore and in a very similar manner, you also asserted that there was "no paucity in the small mol infrastructure in Indian companies". You moron, how the hell would you know? You cant even recognize the most basic instrumentation in a research laboratory by your own admission. For all I know, you could be convinced that an undergrad lab in a community college has no paucity of small mol. infrastructure either. Difference between bisleri and sterile water, huh? :twisted:

George J

Postby George J » 27 Nov 2005 11:08

Ramanujan wrote:What do you mean by "SAR for PPARg"?


Agonist....PPARg agonist. Mea Culpa. Minor culpa compared to TDD for TZD. :twisted:

The rest of your stuff is just straws you are holding onto (using your vast knowledge of drug discovery, off course) to justify your putative notions of how drugs are used in the real world.

And about Oseltamivir's MOA,maybe it is specious and maybe it isnt - how would you know any way?


Err I can read, I am trained to know such things. I dont need "vast drug discovery knowledge" to read FDA's labeling and the PPI on Oseltamivir and the rest of the drugs out there.

Finally, you are a "scientist" (and according to you I am not), you can look up "Adherence to Pharmacotherapy + diabetes" and come to your conclusion about compliance with Oral anti-diabetic and injectable insulin. It is a big problem that we wrestle with on a daily basis, if it were that easy to "train" and "maintain adherence to threapy" with DM, we wouldnt be talking about surge of diabetes and its complications. It is a big problem that is centered around the patients socio economic background, health beliefs and attitudes towards provider and medications. And TRUST me HIV and DM patients are not the same, anywhere in the world. In my world BID SC is a big deal. For folks you are more concerned with lyophilization it may be a trivial thing, but there are enormous clinical aspects BID SC and BID PO dosage form.

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Postby Vasu » 11 Feb 2006 01:41

India to add 10 new biotech parks by 2010

Hyderabad: India will have 10 new biotechnology parks in the public-private partnership mode by 2010, a senior official said here Thursday.

The new parks will come up in states of Gujarat, Uttaranchal, Kerala, Himachal Pradesh, Uttar Pradesh, Punjab and Delhi.

Hyderabad, Bangalore, Mumbai and Pune already have biotech parks.

The announcement by M. K. Bhan, secretary in the department of biotechnology, coincided with the launch of BioAsia 2006, a three-day global bio business forum hosted by the Andhra Pradesh government.

It was also decided to create bio resources or centralised equipment facilities at the proposed biotech parks to ensure that companies shared the costly equipment that many of them cannot afford to buy.

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Postby Laks » 14 Feb 2006 14:12

SRL Ranbaxy launches bird flu test
SRL Ranbaxy has launched a diagnostic test for bird flu that could be employed for mass-screening with near accurate results within a day.

"Ranbaxy's RT-PCR Test, which is highly robust, has been developed indigenously. The fact that results can be reported within a day makes it extremely useful to fight any emergency situations like epidemics," an official statement said today.

Other tests available in the market for bird flu take two to ten days to diagnose the presence of virus, the statement added.

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Postby Singha » 14 Feb 2006 14:36

I dont think bangalore has a biotech park. a few hundred acres of land were promised near electronic city as also a new highway connecting sarjapur road via HSR layout by the previous regime.

expectedly nothing has moved on the ground. I guess chandigarh, delhi, pune, Hyd , chennai will have this lunch as usual.

junior Gowda is now musing about restarting the BATF.

Singha
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Postby Singha » 14 Feb 2006 22:49

business std:

Aurobindo acquires UK generics firm Milpharm
Our Corporate Bureau / Mumbai February 11, 2006
Aurobindo acquires 100% shares of Milphram held by Whyte Group and Iracot.

Aurobindo Pharma has acquired business assets of the UK-based generic drug maker Milpharm.

The Hyderabad-based company has signed a memorandum of understanding with the promoter of Milpharm — Whyte Group and Iracot — for acquisition of the £7.7 million company. Under the terms of the agreement, Aurex has acquired 100 per cent shares of Milpharm.

Although Aurobindo was not forthcoming on the deal value, sources close to the development said it had agreed to pay almost equal amount of the UK company’s sales.

The company would finance the acquisition by utilising a part the $600 million that it had raised through convertible bonds in 2005.

Sources at Aurobindo Pharma said the acquisition, the company’s first in Europe, would equip it with a wide marketing platform. Milpharm has 18 product licences in the pipeline. The company is pursuing inorganic growth in Europe to reduce time to market and enhance relationships in the generic value chain.

Aurobindo, which has bulk drug supply contracts with European companies, had been looking for front-end acquisitions in the European market.

Milpharm recorded sales of £7.7 million for the 12 months ended September 30, 2005. It enjoys about 100 per cent market share in some specific therapeutic segments in the UK and certain other European markets.

Milpharm has several technology proposals also in its hands now.

Aurobindo would reach out to critical mass with a readily available product portfolio.

The company sources also said the company would initially use the Milpharm licences for the UK market.

Raju

Postby Raju » 14 Feb 2006 23:05

Singha wrote:I dont think bangalore has a biotech park.


Then why do these Bangalore politicians keep on squaking "Eyetee/Beetee", "Eyetee/Beetee"...

When I first heard this term during the IISc incident, I kept on wondering what the heck were these people talking about ?? ittybitty...something...??

In any case I don't think there is any place in India where the politicians are as clueless about civic development than in Karnataka and esp Bangalore. Maharashtra and mumbai come a close second...oops wait a min, it could even be a photo-finish. :-?

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Postby Santosh » 14 Feb 2006 23:20

Singha wrote:junior Gowda is now musing about restarting the BATF.

The more the things change the more they remain the same :) BTW, was any work done by the BATF-like committee setup by DS after IT.in. I forget what it was called.

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Postby Laks » 16 Feb 2006 12:19

http://news.bbc.co.uk/2/hi/business/4718692.stm
Indian drug maker Dr Reddy's is buying German-based rival Betapharm for 480m euros ($572m; £328m).

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Postby Singha » 17 Feb 2006 10:11

http://edition.cnn.com/2006/BUSINESS/02 ... arma.reut/

India's drug industry buys scale

Friday, February 17, 2006 Posted: 0221 GMT (1021 HKT)

LONDON/MUMBAI (Reuters) -- India's drug industry is flexing its muscles with a series of increasingly ambitious overseas acquisitions, and analysts expect more to come as companies seek greater heft in generics.

Dr. Reddy's Laboratories Ltd. on Thursday announced the biggest acquisition by an Indian drug firm, agreeing to pay up to 480 million euros ($572 million) for German generic drug maker Betapharm.

The price paid, equivalent to three times annual sales, was higher than some analysts had expected, with Dr. Reddy's having to fight off rival interest from Ranbaxy Laboratories Ltd., which has made no secret of its own M&A ambitions.

The global generic drugs sector had a record year for deal-making in 2005 and industry executives believe the pace of consolidation will continue.

Cheap generic -- or unpatented -- medicines are increasingly popular, as governments seek to cut costs and more branded blockbuster drugs lose patent protection. But prices are under pressure, obliging manufacturers to seek economies of scale.

Indian firms, with their low production costs, are well placed to win share in these tough international markets.

"It's clear that Indian companies are making much more strenuous efforts to internationalise and they are also paying a lot more attention to Europe," said Frances Cloud, an industry analyst at Nomura Code Securities in London.

"They are still heading first for the United States but they are taking much more interest in Europe now."

Morgan Stanley analysts said in a note earlier this month that Indian drug makers were increasingly keen to acquire assets directly in both the United States and Europe.

There have already been a string of smaller deals, such as Matrix Laboratories Ltd. buying a controlling stake in Belgium's Docpharma last year, Torrent Pharmaceuticals Ltd. buying Heumann Pharma, Wockhardt Ltd. buying Esparma, Shasun Chemicals & Drugs Ltd. purchasing Rhodia Pharma Solutions and Jubilant Organosys Ltd. acquiring Target Research Associates.

Other Indian drug makers such as Cipla Ltd are also likely to look for acquisitions, analysts said.

"Indian firms are getting into a position to take on the large generic firms," according to Utkarsh Palnitkar, an analyst with Ernst & Young.

Most attention, however, is focused on the two leading players -- Ranbaxy and Dr. Reddy's.

Dr. Reddy's Chief Executive G.V. Prasad said his company had the "bandwidth" for further small and medium-sized acquisitions in Europe, while Ranbaxy announced on Thursday it had raised $400 million in convertible bonds, boosting its firepower.

Ranbaxy's new Chief Executive Malvinder Singh told Reuters he was now actively pursuing acquisition opportunities.

"The way the industry is moving, there is consolidation ... so we are looking actively at targets in the United States and Europe," he said.

India's biggest drugs group had worldwide sales of $1.2 billion in 2005 and aims to reach $5 billion by 2012, becoming one of the world's top five generic drug companies in the process.

A number of foreign rivals, however, are bringing the battle back to India's back yard.

Non-Indian generic companies are increasingly setting up directly in the country, with Novartis AG's Sandoz unit setting up a plant in Mahad, Teva Pharmaceutical Industries Ltd. planning to double the number of scientists it employs in India over the next three years and Watson Pharmaceuticals Inc. recently acquiring an Indian facility.

Vinod N
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Location: Philadelphia

Postby Vinod N » 09 Mar 2006 01:42

The journal Nature has a list of "who's who in biotech"
Two Indians are mentioned. Kiran Mazumdar Shaw and Asis Datta

http://www.nature.com/news/2006/060306/full/nbt0306-291a.html

http://ncpgr.nic.in/research1/Dr_A_Datta.htm

Some of the articles in Nature may require subscription.

Neshant
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Posts: 4368
Joined: 01 Jan 1970 05:30

Postby Neshant » 22 Mar 2006 08:35

Two Men Remain in Coma After Drug Trial

http://news.yahoo.com/s/ap/20060321/ap_ ... ug_trial_2


Note : The same company above Parexcel which put these british fellows in a coma are testing their drugs on Indians in India.


Boston's Parexel to tap India's potential in clinical research

29-April-2004

New York, Boston-based Parexel International Corp., a $615 million
biopharmaceutical outsourcing company, said Thursday it has entered
into a tie-up with Synchron Research Services of Ahmedabad to tap
India's emerging potential in the area of clinical research
outsourcing.


Under the alliance, Nasdaq-listed Parexel will leverage Synchron's
capabilities to benefit biopharmaceutical clients with expanded
geographic coverage and patient recruitment capabilities in India, the
company said in a statement.


The alliance also provides Synchron's customers with access to the
clinical trial expertise, advanced technologies, and project
management skills of the Parexel, whose operations spread across 37
countries.


"The collaboration with Synchron expands our global clinical research
services into regions that should help expedite the drug development
process for our clients," said Parexel chairman and chief executive
Josef H. von Rickenbach.


"Our alliance with an established company headquartered in India
underscores Parexel's commitment to providing clients with
comprehensive drug development services in emerging markets."


Commenting on the alliance, Shivprakash, chief executive officer of
Synchron Research, said the company will now be able to offer clients
an extensive portfolio of clinical development solutions

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Postby Singha » 29 Mar 2006 15:25

the trend of indian pharma cos buying small to midsized foreign cos continues. we must definitely look to buying up small research oriented cos in US, israel, EU, korea and canada.

RedHerring:

India’s largest biotech firm, Biocon, said Tuesday it won the bid for acquiring all the assets of insulin developer Nobex, with a total commitment of $5 million and certain back-end royalties, while Ranbaxy Laboratories made a different acquisition from GlaxoSmithKline.



The Indian pharma giant, Ranbaxy, said it would acquire the unbranded generics business of Allen S.p.A, a division of GlaxoSmithKline (GSK), in Italy, through its Italian subsidiary, Ranbaxy Italia S.p.A. The deal will take effect April 1. Financial details were not disclosed.

Ranbaxy CEO Malvinder Mohan Singh believes the acquisition will fast-track the company’s growth plan in Italy. The Italian arm of Ranbaxy is currently filing its portfolio of generic products with the Italian health authorities and plans to launch the portfolio over the coming years.

Ranbaxy will debut its first product, Sertralina Ranbaxy, in May of this year.

The $420-million Italian generics market is one of the fastest-growing markets in Europe, with an annual growth rate of 49 percent. According to IMS Health, the total pharmaceutical market in Italy is worth about $14 billion.


Nobex’s Intellectual Property

On the other hand, Biocon’s acquisition of North Carolina-based Nobex is a strategic deal that provides the Bangalore-based firm with a valuable intellectual property platform.

Biocon has collaborated with Nobex in developing oral insulin. The two companies have completed pre-clinical studies of the drug and are awaiting Indian regulatory approval for phase I trials.


“The deal gives us full ownership of our ongoing oral insulin and oral BNP [B-type natriuretic peptide] programs,â€

Neshant
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Postby Neshant » 25 Apr 2006 09:01

Recruiting patients for drug trials in India is big business

India's outsourced call centres are well known, but not its outsourced patients.


By 2010, some estimate there will be two million patients in India on clinical trials.


An entire industry has sprung up, specialising in recruiting patients and managing experiments.


And a BBC investigation into the conduct of these trials has found that some patients are unaware they are being experimented on at all.


Most of the world's largest pharmaceutical companies have a presence in India, but there is concern about how the country achieves its exceptional recruitment rates and questions about fully-informed consent.


Medical language


Six years ago, an experimental drug from the US called M4N was injected into cancer patients in India without being properly tested on animals first.


Later it was discovered that several patients had not known they were part of a clinical trial.


Dr Shashank Joshi
Most of the patients sign on the dotted line without understanding the nature and the consequences of what is being administered to them
Dr Shashank Joshi



One of the doctors who later blew the whistle, Dr V Narayan Bhattathiri, told the BBC: "I can only say that what they did is something unbelievable or incomprehensible.


"I couldn't find any example of such a thing being done, maybe in the last 50 years or so. Maybe something similar could have happened in say concentration camps."


Giving informed consent to be part of an experiment is the golden rule of all clinical trials which goes all the way back to the Nuremberg Code.


But one doctor at the prestigious Lilavati hospital in Mumbai, Dr Shashank Joshi, says the idea of all patients giving informed consent in India is "a myth according to me... because I do not think it's truly informed in the language the patient understands.


"Most of the patients sign on the dotted line without understanding the nature and the consequences of what is being administered to them."


Lack of understanding


Reporter Paul Kenyon tracked down a drug trial being conducted for a major drug company in a psychiatric unit at a hospital in Gujurat.


It was to test an anti-psychotic drug developed by the world's second largest drug pharmaceutical company Johnson and Johnson.


Parshottam Parmar
I didn't know that experiments were being carried out on me
Parshottam Parmar


There is already controversy over what is happening, with some doctors levelling the accusation that patients are being taken off their existing medication as part of the trial, with the potential they could suffer unnecessarily .


Dr Vikram Patel from the British Journal of Psychiatry says: "The most obvious problem is that they won't get better or they will continue to suffer this extremely severe psychiatric illness, much longer than they need to."


But the ethical concerns go deeper when Kenyon finds a patient who took part in the trial.


"I was just told that the drugs were American. They used to give me the tablets and I used to eat them," says Parshottam Parmar.


"We just sign because I believe the doctor takes the signature to help us. That's why I sign it."


He says he had no idea that he was part of a clinical trial.


"I didn't know that experiments were being carried out on me. I was told that the old drugs were discontinued and were no longer available in the pharmacies.


"I don't know a lot about all these things. I am poor and I live in a small hut and I don't understand many things. The doctors are intelligent. They write the drugs for me so I have to take them accordingly."


Johnson and Johnson's spokesman Dr Vivek Kusumaker told us: "We have looked at this particular trial and we've got consent from the patient or from a relative in every case.


"If there is any instance brought to our attention that something was not OK we will take that seriously. We have said that we shut down sites if we don't think we are carrying out research to the highest code of ethics in which we believe."


Drug Trials: The Dark Side will be broadcast on Thursday, 27 April, 2006 at 2100 BST on BBC Two.


http://news.bbc.co.uk/2/hi/south_asia/4932188.stm

Sanjay M
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cheap TamiFlu

Postby Sanjay M » 06 May 2006 05:14

The drug TamiFlu, which has until now been an expensive drug to produce in very limited quantities, may now ben manufactured cheaply and in bulk, as a result of a new synthesis method:

article here

arun
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Postby arun » 08 May 2006 19:41

[quote]Indian biotech dreams come true

Our News Bureau - Mumbai

Biotech is the buzzword of the decade. The year 2005 saw a robust growth in the global biotech sector with Asia Pacific countries achieving cumulative profitability. But 2006 has a lot more to offer. According to the Ernst & Young's Biotech Report 2006, the 20th edition of ‘Beyond Borders: The Global Bio-technology Report 2006’ promises a bright future.

The report says that the revenues of publicly traded biotech companies surpassed $60 billion for the first time in the sector's 30-year history. “Since our first report 20 years ago, we have seen historic scientific advances and dramatic changes in market conditions, which combine to produce a rapidly maturing industry,â€


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