NANOMEDICINES RESEARCH IN NANOMEDICINES RESEARCH IN INDIA: FROM LABORATORY TO INDIA: FROM LABORATORY TO

INDUSTRY – SOME INDUSTRY – SOME ACHIEVEMENTSACHIEVEMENTS

Amarnath MaitraAmarnath MaitraDepartment of Chemistry,Department of Chemistry,

University of Delhi, Delhi – 110 007University of Delhi, Delhi – 110 007

maitraan@yahoo.co.in

Drug Delivery: A Short term Application Drug Delivery: A Short term Application of Nanobiopharmaceuticalsof Nanobiopharmaceuticals

Low investment and Quick returnLow investment and Quick return Stricter patent law from 2005Stricter patent law from 2005 India will become attractive to international drug India will become attractive to international drug

companies because of tighter patent laws, a vast companies because of tighter patent laws, a vast potential market and a highly skilled, low-cost work potential market and a highly skilled, low-cost work forceforce

Some Indian companies are adjusting to the new Some Indian companies are adjusting to the new law by investing in research to develop new ways to law by investing in research to develop new ways to deliver old medicines or develop new compounds.deliver old medicines or develop new compounds.

WORLD SCENARIOWORLD SCENARIO

According to the Financial Times Management report According to the Financial Times Management report [2005] the size of the worldwide pharmaceutical market [2005] the size of the worldwide pharmaceutical market in 2005 was about 78 billion US dollars, which is in 2005 was about 78 billion US dollars, which is expected to rise more than 100 billion US dollars in expected to rise more than 100 billion US dollars in 2010.2010.

The world market for drugs employing advanced drug The world market for drugs employing advanced drug delivery technologies is expanding rapidly and has delivery technologies is expanding rapidly and has surpassed by $7 billion in 2005surpassed by $7 billion in 2005 over the target over the target

Source: (Source: (www.MarketResearch.com))

WORLD SCNERAIOWORLD SCNERAIO(Cont.)(Cont.)

In biopharmaceuticals, in addition to the main In biopharmaceuticals, in addition to the main technologies covered—liposomal, monoclonal technologies covered—liposomal, monoclonal antibody-based, and polymer-based technologies antibody-based, and polymer-based technologies host of newer technologies such as nanoparticles host of newer technologies such as nanoparticles including various nanodimensional entities such as including various nanodimensional entities such as molecular imprinted polymers, metallofullerenes, molecular imprinted polymers, metallofullerenes, prodrug delivery, oral, injectable and implantable, prodrug delivery, oral, injectable and implantable, pulmonary, and transdermal and transmucosal pulmonary, and transdermal and transmucosal delivery have come up. delivery have come up.

Source:Source:The Market for Advance Drug Delivery The Market for Advance Drug Delivery SystemsSystems –Kalorama Information –Kalorama Information

Venture Capital Investment to different Venture Capital Investment to different Nanotechnology-based industry in USA in 2001Nanotechnology-based industry in USA in 2001

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CompanyCompany Funding Funding Investor(s) Investor(s)(million US$)(million US$)

1. Arryx1. Arryx $3.0 $3.0 Arche Venture, Arche Venture, (Tools for moving and cutting nano sized materials) Draper Fisher Jurveston (Tools for moving and cutting nano sized materials) Draper Fisher Jurveston 2. Capsulation Nanoscience $2.8 Berlin Seed Capital Funds2. Capsulation Nanoscience $2.8 Berlin Seed Capital Funds (Nano sized Drug Delivery Capsules )(Nano sized Drug Delivery Capsules )3. FeRx3. FeRx $18.0 Brentwood Associates, Whittier Venture $18.0 Brentwood Associates, Whittier Venture (Iron Nanoparticles for drug targeting) California Tech Venture Partner(Iron Nanoparticles for drug targeting) California Tech Venture Partner4. NanoGram4. NanoGram $35.0 Bay Partners, Vernock Assoc. NEC $35.0 Bay Partners, Vernock Assoc. NEC (Systems to make nanomaterials)(Systems to make nanomaterials)

5. Nano opto $11.4 Bessemer Venture Partners, Morgenthaler5. Nano opto $11.4 Bessemer Venture Partners, Morgenthaler ( (Nano optical components)Nano optical components) Ventures, New Enterprise Assoc.Ventures, New Enterprise Assoc.6. Nanostream6. Nanostream $11.0 Shamrock Holdins, Techno Ventures $11.0 Shamrock Holdins, Techno Ventures (Microfluid Chips on Nanoscale) (Microfluid Chips on Nanoscale)7. Nantero7. Nantero $0.5 Harris & Harris Group $0.5 Harris & Harris Group (Carbon Nanotubes for (Carbon Nanotubes for Holding Non-volatile memory)Holding Non-volatile memory)8. Quantum Dots $37.5 Versant, Abingworth, Frazier & Co.8. Quantum Dots $37.5 Versant, Abingworth, Frazier & Co. (Nano sized tags for drug developments) (Nano sized tags for drug developments) Out of total 119.2 million US$ 58.3 million US$ is spent for drug deliveryOut of total 119.2 million US$ 58.3 million US$ is spent for drug delivery

(Source: REDHERING, NOV, 2001)(Source: REDHERING, NOV, 2001)

INDIAN SCENARIO INDIAN SCENARIO Why is the drug delivery technology important to Why is the drug delivery technology important to

Indian Pharma Industry?Indian Pharma Industry?

Drug delivery formulations involve low cost research Drug delivery formulations involve low cost research

compared that for discovery of new molecule, compared that for discovery of new molecule, Minimizing the drug use would significantly reduce the Minimizing the drug use would significantly reduce the

effective cost of drug which would give financial relief to the effective cost of drug which would give financial relief to the patients, patients,

Delivery systems increase commercial opportunity by Delivery systems increase commercial opportunity by distinguishing a drug from competitive threats posed by “me distinguishing a drug from competitive threats posed by “me too” drugs and too” drugs and

Novel means of delivery particularly using nano-carriers, can Novel means of delivery particularly using nano-carriers, can allow branded drugs to be rescued from abyss of generic allow branded drugs to be rescued from abyss of generic competition (may be called “resurrection of drug”). competition (may be called “resurrection of drug”).

India is a signatory of GATT and committed to India is a signatory of GATT and committed to implement full-fledged patent system of Jan 2005. implement full-fledged patent system of Jan 2005.

Heavy investment of Indian companies in R&D. Heavy investment of Indian companies in R&D.

Heading for collaborations with multinationals for Heading for collaborations with multinationals for symbiotic relationship.symbiotic relationship.

INDIAN SCENARIOINDIAN SCENARIO(Cont….)(Cont….)

Several Indian companies have already made required Several Indian companies have already made required moves to compete with multinationals – they have moves to compete with multinationals – they have begun to invest intelligently into R&D - Ranbaxy, begun to invest intelligently into R&D - Ranbaxy, Torrent, Wockhardt, Dr. Reddy’s laboratories, Sun Torrent, Wockhardt, Dr. Reddy’s laboratories, Sun pharma and Nicholas Piramal etc. It is known that pharma and Nicholas Piramal etc. It is known that these companies together have made capital these companies together have made capital investments over Rs. 200 crores. Cadila Healthcare, investments over Rs. 200 crores. Cadila Healthcare, Cipla, Lupin and Aurobindo are making similar Cipla, Lupin and Aurobindo are making similar investments. By the end of the 1investments. By the end of the 1stst decade of this decade of this millennium, the total investment into R&D will be to millennium, the total investment into R&D will be to the tune of Rs. 500 crores. (Source: Pharmabiz)the tune of Rs. 500 crores. (Source: Pharmabiz)NRDC has played a significant role in transferring a NRDC has played a significant role in transferring a number of nano-based biotechnologies to pharma number of nano-based biotechnologies to pharma industry. industry.

INDIAN ENDEAVOURINDIAN ENDEAVOUR

Development of one dose a day ciprofloxacin Development of one dose a day ciprofloxacin using nanotechnologyusing nanotechnology

Tumor targeted taxol delivery using nanoparticles Tumor targeted taxol delivery using nanoparticles in Phase 2 clinical trial stagein Phase 2 clinical trial stage

Improved ophthalmic delivery formulation using Improved ophthalmic delivery formulation using smart hydrogel nanoparticlessmart hydrogel nanoparticles

Oral insulin formulation using nanoparticles Oral insulin formulation using nanoparticles carriers.carriers.

Liposomal based Amphotericin B formulationLiposomal based Amphotericin B formulation

SOME SIGNIFICANT ACHIEVEMENTS BY INDIAN SOME SIGNIFICANT ACHIEVEMENTS BY INDIAN PHARMA INDUSTRY USING NANODEVICES PHARMA INDUSTRY USING NANODEVICES

CHALLENGES CHALLENGES

Prevention of drug from biological Prevention of drug from biological degradationdegradation

Effective TargetingEffective Targeting Patient CompliancePatient Compliance Cost effectivenessCost effectiveness Product life extensionProduct life extension

PRIORITY AREASPRIORITY AREAS

Cancer NanotechnologyCancer Nanotechnology (i)(i) Dignosis using Quantum DotsDignosis using Quantum Dots (ii) Tumor Targeted Delivery(ii) Tumor Targeted Delivery (iii) Imaging(iii) Imaging (iv) Cancer Gene Therapy(iv) Cancer Gene Therapy DNA Vaccines for parasitic, bacterial and viral DNA Vaccines for parasitic, bacterial and viral

diseasesdiseases Oral and pulmonary routes for systemic delivery Oral and pulmonary routes for systemic delivery

of proteins and peptidesof proteins and peptides Nanotechnology in Tissue EngineeringNanotechnology in Tissue Engineering

NATIONAL ACTION AGENDANATIONAL ACTION AGENDA

Establishment of National Institutes of NanomedicinesEstablishment of National Institutes of Nanomedicines To establish close link between research institutes and To establish close link between research institutes and

industryindustry To make priority items on disease identifications and drug To make priority items on disease identifications and drug

formulationsformulations To encourage domestic companies and venture capitals to To encourage domestic companies and venture capitals to

invest more money in R&D of nanobiopharmaceuticals invest more money in R&D of nanobiopharmaceuticals

SOME INDIAN TECHNOLOGIESSOME INDIAN TECHNOLOGIES

First produced smart hydrogel nanoparticles for drug First produced smart hydrogel nanoparticles for drug delivery applications(US Patent delivery applications(US Patent 5847111)5847111)

Tumor Targeted Delivery of Taxol using nanoparticles (US Tumor Targeted Delivery of Taxol using nanoparticles (US Patent Patent 6,322,8176,322,817 ) )

Inorganic Nanoparticles as non-viral vectors for targeted Inorganic Nanoparticles as non-viral vectors for targeted delivery of genes (US Patent delivery of genes (US Patent 65553766555376 ); Technology ); Technology transferred to a California based Pharm Comtransferred to a California based Pharm Com

Once in 48 hours dose Ophthalmic deliveryOnce in 48 hours dose Ophthalmic delivery(US Patent 6579519) (Another improved formulation patent (US Patent 6579519) (Another improved formulation patent on ophthalmic gels is being submitted in India)on ophthalmic gels is being submitted in India)

Oral Insulin Delivery (Patent Pending)Oral Insulin Delivery (Patent Pending)

GAMMA PICTURE OF RABBIT AFTER GAMMA PICTURE OF RABBIT AFTER INJECTING INJECTING 99m99m Tc LABELED CHITOSAN Tc LABELED CHITOSAN

NANOPARTICLESNANOPARTICLES

Banerjee Tanima et al Int. J. Pharm. 2002; 243:93-105

Gupta Ajay etal, Int. J. of Pharm. 209,(2000), 1-14; US Patent 6579519

OPHTHALMIC DELIVERY USING POLYMERIC MICELLES NANOPARTICLES: TECHNOLOGY TRANSFERRED TO

PANACEA BIOTECH, CHANDIGARH

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Sheetal Soni etal Amer. J. Drug Delivery 2005; 3(3): 205-212

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THANK YOUTHANK YOU