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ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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Glenmark Kicks Off Monoclonal Antibody Pain Studies


 

 

Glenmark Pharmaceuticals S.A., a wholly owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd., announced that GBR 900, a novel monoclonal antibody is entering human trials. GBR 900 targets TrkA, a receptor for nerve growth factor (NGF) involved in chronic pain signaling.

In 2010, Glenmark gained an exclusive worldwide license from Lay Line Genomics S.p.A. (Italy) for anti-TrkA antibodies and their entire intellectual property portfolio in the TrkA field. GBR 900 is the optimized anti-TrkA antibody emerging from this exclusive worldwide license.

read all at

http://www.dddmag.com/news/2014/04/glenmark-kicks-monoclonal-antibody-pain-studies

Glenmark Kicks Off Monoclonal Antibody Pain Studies

Glenmark Pharmaceuticals today said its novel monoclonal antibody for potential treatment of chronic pain is entering human trials.

Glenmark Pharmaceuticals today said its novel monoclonal antibody for potential treatment of chronic pain is entering human trials. 

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Glenmark Pharmaceuticals Ltd. through its Swiss Subsidiary receives USD 5 Mn. as milestone fee payment from Sanofi


Glenmark Pharmaceuticals Ltd. through its Swiss Subsidiary receives USD 5 Mn. as milestone fee payment from Sanofi 

Total Payment received for GBR 500 monoclonal antibody programme from Sanofi is USD 55 Mn 

MUMBAI, April 15, 2014: Glenmark Pharmaceuticals Ltd. has informed the Stock Exchange today that the company through its Swiss subsidiary has received USD 5 million as

milestone payment from Sanofi on a collaboration of its VLA2 (alpha2-beta1) integrin monoclonal antibody. GBR 500 is a first-in-class therapeutic monoclonal antibody for chronicautoimmune disorders.

Glenmark has received from Sanofi already USD 50 Mn as an upfront payment in FY2011-12. Hence, the total amount received by Glenmark from Sanofi for its first in class VLA-2monoclonal antibody is USD 55 million

 

read at

Glenmark – Updates

http://www.moneycontrol.com/stocks/stock_market/corp_notices.php?autono=790416

(copy paste on browser)

MD and CEO Mr Glenn Saldanha

 

 

old updates

Glenmark GBR 500 enters into Phase II clinical development for ulcerative colitis

17 September 2012

Glenmark Pharmaceuticals, a wholly-owned subsidiary of Glenmark Pharmaceuticals, has commenced the Phase II study of GBR 500 for ulcerative colitis.

GBR 500, an antagonist of the VLA2 (alpha2-beta1) integrin, is a first-in-class therapeutic monoclonal antibody for chronic autoimmune disorders.

The randomised, double-blind, placebo-controlled study will investigate the efficacy and safety of GBR 500 in patients with moderate to severe ulcerative colitis (UC).

Glenmark Pharmaceuticals chief scientific officer Dr Michael Buschle said that UC represents an area of substantial unmet medical need, despite treatment advances in recent years.

“We’re pleased with the continued progress of our partnership with Sanofi and excited about the commencement of this trial,” Buschle said.

The trial, which will be conducted at multiple clinical sites in North America and Europe, is expected to involve approximately 84 patients.

Patients participating in the study will receive multiple doses of either GBR 500 or placebo, administered over a period of several weeks.

Glenmark has completed Phase I of GBR 500 in the US, won licensing rights to all therapeutic indications from Sanofi and is conducting the clinical development programme.

The trial is part of a strategic global collaboration between Glenmark and Sanofi to investigate GBR 500 for the treatment of chronic inflammatory disorders.

http://www.drugdevelopment-technology.com/news/newsglenmark-gbr-500-enters-into-phase-ii-clinical-development-for-ulcerative-colitis

 

MUMBAI, IndiaMay 16, 2011

Glenmark Pharmaceuticals Out-Licenses Novel Monoclonal Antibody, GBR 500, to Sanofi

Combined Upfront and Potential Development, Regulatory and Commercial Milestone Payments Could Total US$613 Mn

MUMBAI, India, May 16, 2011 /PRNewswire-FirstCall/ — Glenmark Pharmaceuticals S.A (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), announced today that it has entered into an agreement with Sanofi to grant Sanofi a license for the development and commercialization of GBR 500, a novel monoclonal antibody for the treatment of Crohn’s Disease and other inflammatory conditions. The transaction is expected to close in the coming month subject to customary closing conditions, including the expiration or early termination of the waiting period under the HSR Antitrust Improvements Act.

Under the terms of the agreement, Glenmark will receive an upfront payment of US$ 50 million, of which US$ 25 million will be paid upon closing of the transaction and US$ 25 million, which is contingent upon Sanofi’s positive assessment of certain data to be provided by Glenmark. In addition, Glenmark could receive potential success-based development, regulatory and commercial milestone payments. The total of these payments could reach US$613 Mn. In addition, Glenmark is eligible to receive tiered double-digit royalties on sales of products commercialized under the license.

GBR 500 is an antagonist of the VLA-2 (alpha2-beta1) integrin. It is a first-in-class therapeutic monoclonal antibody and has established proof of concept in animal models across a range of anti-inflammatory conditions. Glenmark has completed Phase I dosing of GBR 500 in the US and the drug has been well tolerated with a good pharmacokinetic profile. Plans are in place to initiate clinical proof of concept studies in Crohn’s Disease. Sanofi has licensed the rights to all therapeutic indications.

“There continues to be a strong medical need for safer and more efficacious products for the treatment of Inflammatory Diseases,” said Elias Zerhouni, M.D., President, Global Research & Development, Sanofi. “GBR500 brings an innovative approach to Sanofi’s Immuno-Inflammation portfolio, which we believe may address a significant gap in treating Inflammatory Diseases which would be of huge benefit to patients”.

Glenn Saldanha MD and CEO of GPL, “This collaboration on a novel first-in-class monoclonal antibody validates Glenmark’s world-class innovative R&D capabilities in the drug discovery arena. We are pleased to have this second licensing collaboration with Sanofi, one of the largest pharmaceutical companies in the world and the first one from Glenmark in the field of novel biologics”.

http://www.prnewswire.com/news-releases/glenmark-pharmaceuticals-out-licenses-novel-monoclonal-antibody-gbr-500-to-sanofi-121889273.html

Glenmark’s novel molecule ‘GRC 27864’ for chronic inflammatory diseases including pain entering human trials


Glenmark’s novel molecule ‘GRC 27864’ for chronic inflammatory diseases including pain entering human trials 

 

  • GRC 27864 is a potent, selective, orally bioavailable inhibitor of mPGES-1
  • The molecule has successfully completed pre-clinical and Phase 1 enabling studies. Regulatory submission has been filed for Phase 1 trial (first-in-human)with MHRA, UK
  • mPGES-1 inhibitors selectively block the production of PGE2 while sparing other prostanoids of physiological importance
  • With this announcement, Glenmark has reaffirmed its position globally in the development of novel pain therapies

 

Mumbai, India: April 3, 2014: Glenmark Pharmaceuticals today announced that its Novel Chemical Entity (NCE) ‘GRC 27864’ is entering human trials. This NCE program targets Microsomal Prostaglandin E synthase-1 (mPGES-1) as a novel therapeutic target in pain management. Selective mPGES-1 inhibitors are expected to inhibit increased prostaglandin E2 (PGE2) production in the disease state without affecting other prostanoid metabolites and, consequently, may be devoid of the GI(gastrointestinal) and cardiovascular side effects seen with NSAIDs and COX-2 inhibitors, respectively.

 

Glenmark has completed preclinical studies and Phase 1 enabling GLP studies for its selected lead molecule, GRC 27864 and has filed a Phase 1 application forfirst-in-human trial with the MHRA, UK. The Phase 1 studies are to be initiated soon and are likely to get completed by January 2015. Following this, Glenmark will also be initiating a proof of concept study in patients with acute pain.

Glenmark Pharmaceuticals Ltd. through its Swiss Subsidiary receives USD 4 Mn. as research fee payment from Forest Laboratories Inc.


 

Total Payment received for the mpges-1 program from Forest Laboratories is USD 15 million

 

March 25, 2014: Glenmark Pharmaceuticals Ltd. has informed the Stock Exchange today that the company through its Swiss subsidiary has received

USD 4 million as research fee payment from Forest Laboratories Inc. on a collaboration for the development of novel mPGES-1 inhibitors to treatchronic inflammatory conditions, including pain.

Under the terms of the agreement signed in FY 2012-13, Forest made USD 6 million upfront payment and also provided an additional USD 3 million

to support the next phase of work. In September 2013, Glenmark received an additional amount of USD 2 million as research fee payment from Forest Laboratories Inc.

Hence, the total amount received by Glenmark from Forest Laboratories Inc towards its novel mPEGS-1 inhibitors program is USD15 million.

read at

http://www.thehindubusinessline.com/companies/announcements/others/glenmark-pharmaceuticals-ltd-through-its-swiss-subsidiary-receives-usd-4-mn-as-research-fee-payment-from-forest-laboratories-inc-total-payment-received-for-the-mpges1-program-from-forest-laboratories-is-usd-15-million/article5829435.ece

pdf

http://www.thehindubusinessline.com/multimedia/archive/01808/Click_here_for_pdf_1808928a.pdf

Glenmark conferred with Best Biotech New Molecular Entity Patent award


GLENMARK PHARMA

IDMA best biotech NEW MOLECULAR ENTITY patent award to Glenmark

YEAR 2012-2013 YEAR in Mumbai India

PATENT  US 8236315

GLENMARK PHARMACEUTICALS, S.A., SWITZERLAND

INVENTORS

Elias LazaridesCatherine WoodsXiaomin FanSamuel HouHarald MottlStanislas BleinMartin BertschingerALSO PUBLISHED ASCA2712221A1CN101932606A,EP2245069A1US20090232804,WO2009093138A1

Publication number US8236315 B2
Publication type Grant
Application number US 12/358,682
Publication date 7 Aug 2012
Filing date 23 Jan 2009
Priority date 23 Jan 2008

USPTOUSPTO AssignmentEspacenetUS 8236315

The present disclosure relates generally to humanized antibodies or binding fragments thereof specific for human von Willebrand factor (vWF), methods for their preparation and use, including methods for treating vWF mediated diseases or disorders. The humanized antibodies or binding fragments thereof specific for human vWF may comprise complementarity determining regions (CDRs) from a non-human antibody (e.g., mouse CDRs) and human framework regions.

The present disclosure provides a humanized antibody or binding fragment thereof specific for vWF that comprises a heavy chain variable region sequence as set forth in SEQ ID NO: 19 and a light chain variable region sequence as set forth in SEQ ID NO: 28 ……….. CONT

MR GLEN SALDANHA

MD , CEO GLENMARK

INDIAN DRUG MANUFACTURERS’ ASSOCIATION   (IDMA)

102-B Poonam Chambers, Dr A B Road, Worli, Mumbai 400 018, INDIA
Tel : +91 – 22 – 24944625 / 24974308. Fax : ++91 – 22 – 24957023
email: ppr@idmaindia.com website : http://www.idma-assn.org

Glenmark receives final ANDA approval for Desoximetasone Ointment USP, 0.25%


            Desoximetasone                      382-67-2 cas   

         

September 23, 2013: Glenmark Generics Inc., USA the subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States Food

and Drug Administration (U.S. FDA) for Desoximetasone Ointment USP, 0.25% their generic version of Topicort® by Taro Pharmaceuticals USA Inc and shipping will commence immediately.

Desoximetasone Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. According to IMS Health sales data for the

12 month period ending June 2013, Desoximetasone Ointment garnered annual sales of approximately USD 40 million.

more info

Desoximetasone is a medication belonging to the family of medications known as topical corticosteroids. It is used for the relief of various skin conditions, including rashes. It helps to reduce redness, itching, and irritation. Desoximetasone is a synthetic corticosteroid, a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents.

There are two brand name products:

  • Topicort Emollient Cream (0.25% desoximetasone)
  • Topicort LP Emollient Cream (0.05% desoximetasone)

When using desoximetasone, some of the medication may be absorbed through the skin and into the bloodstream. Too much absorption can lead to unwanted side effects elsewhere in the body. To keep this problem to a minimum, avoid using large amounts of desoximetasone over large areas, do not use it for extended periods of time, and do not cover it with airtight dressings such as plastic wrap or adhesive bandages unless specifically told to by your doctor. Children may absorb more medication than adults do. Desoximetasone is for use only on the skin and should be kept out of the eyes.

Desoximetasone can also be used to treat some types of psoriasis.

Glenmark Gets USFDA Nod For Alcohol Abstinence Drug


Glenmark Pharmaceuticals  said it has received US health regulator’s approval to market generic version of Forest Laboratories’ Campral Delayed Release Tablets, a drug used for alcohol abstinence, in the American market.
Glenmark Generics Inc, the US-based subsidiary of Glenmark Generics Ltd (GGL), has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (USFDA) for Acamprosate Calcium Delayed Release Tablets, Glenmark Pharma said in a statement.  read all at

GLENMARK- ELOVERA , for dry skin disorders


Compositions:
Elovera extract 10% cream, Vitamin E 0.5%

Category–Locally Acting Skin Preparations

Description

* Aqueeze adequate amount of elovera moisturizing body wash onto wet hands or wet loran and work into a creamy lather. apply it all ovr the body, keep for some time and then rinse with water.

http://www.drugneed.com/glenmark-pharmaceuticals-elovera-moisturizing-body-wash-150ml-glenmak-p-2017.html#tab4

Products Name : Elovera Moisturizing Body Wash 150ml – (Glenmark)

 

Elovera Cream, manufacture by Glenmark pharmaceuticals limited , is cream enriched with vitamin E and Aloe Vera. It’s a very special cream specially for treating scars and other minor pimple spots on the face.

reviews from net

My skin is very much oily hence I get these ugly Pimples very profoundly. On top of it i have the habit of bursting out the puss from these pimples. I always play it with my hands and as a result forms some very ugly scars on my face which are visible from distant away.Though I am bit dark with my completion ,even then It’s clearly visible and my mother scolds me like hell for bursting the pimples out.Honestly I just can’t stop my hands reaching out for them no matter how busy I am so Finally has to resort to some ointments to reduce the visibility of the scars.

I did try few popular products but were of no use basically. The spots didn’t get reduced but instead effected the completion of my face.Finally my mother came to my rescue. She had hear about this Elovera Cream from some one and bought home one for me.Initially i was a bit skeptic but finally I thought of trying it. For the first few days it had no effect what-so-ever , but slowly it started clearing the skin blemishes. My skin started showing it’s effects and the scars became less visible. Not only does it clear the scars but it helped me to fight the ugly pimples as well.

My face became much more glowing and healthy and i use the cream regularly even now.It’s really a magical product and should try it for clearing the blemishes and other skin problem.

GLENMARK-A new way for a new world


GlenmarkLogo.jpg

http://www.glenmarkpharma.com/GLN_NWS/homepage.aspx?res=P_GLN

http://www.glenmark-generics.com/

Type Public
Traded as BSE532296NSEGLENMARK)
Industry PharmaceuticalsDrugs &Healthcare
Founded 1977
Founder(s) Gracias Saldanha
Headquarters MumbaiMaharashtra[1]India
Key people Glenn Saldanha, MD & CEO [2]
Products Medicines and Vaccines
Revenue INR1031.10 crore(US$160 million) (2009–2010)[3]
Employees 7,000 [4]
Subsidiaries Glenmark Generics Ltd[5]
Website www.glenmarkpharma.com

Glenmark Pharmaceuticals is a pharmaceutical company headquartered in MumbaiIndia[6] It manufactures and markets generic formulation products and active pharmaceutical ingredients (API), both in the domestic and international markets. In the formulation business, its business spans segments such as DermatologyInternal MedicinePaediatricsGynaecologyENT andDiabetes.

It has four manufacturing facilities for formulations and additional three facilities for APIs. These manufacturing facilities are located in the states of MaharashtraGoaHimachal Pradesh and Gujarat in India.

It operates in 95 countries through its subsidiaries, Glenmark Pharmaceuticals USA, Glenmark Pharmaceuticals UK. Glenmark Pharmaceuticals SA. [7]

HEAD OFFICE AT ANDHERI MUMBAI INDIA

  1.  http://www.glenmarkpharma.com/UITemplate/HtmlContainer.aspx?res=P_GLN_CONTACT
  2.  “If I were FM | Glenn Saldanha, managing director and CEO, Glenmark Pharmaceuticals – Economy and Politics”. livemint.com. 2009-07-01. Retrieved 2010-09-30.
  3.  “BSE Plus”. Bseindia.com. Retrieved 2010-09-30.
  4. Glenmark Pharmaceuticals Ltd. (2529483): Stock Quote & Company Profile – BusinessWeek”. Investing.businessweek.com. Retrieved 2010-09-30.
  5.  “Glenmark Pharmaceuticals | TopNews”. Topnews.in. Retrieved 2010-09-30.
  6.  “about Glenmark Pharmaceuticals”. http://www.ibef.org. Retrieved 2010-09-30.
  7.  “Glenmark Pharmaceuticals acquires Bouwer Bartlett, South Africa”. domain-b.com. 2005-12-26. Retrieved 2010-09-30.

WORLD-CLASS CAPABILITIEIS: Glenn Saldanha (left), Managing Director and CEO, along with Dr. Michael Buschle, President Biologics, Glenmark Pharmaceuticals at a press conference in Mumbai on Monday. Photo: Paul Noronha

http://www.thehindu.com/business/companies/glenmark-outlicenses-development-of-molecule-to-sanofi/article2023882.ece

RESEARCH CENTRE AT MAHAPE INDIA

Glenmark Pharma – The persevering innovator

Glenn Saldanha, chairman, Glenmark Pharmaceuticals Ltd

Every Tuesday, unmindful of the gridlocked traffic, Glenn Saldanha, the 43-year-old Chairman of Glenmark Pharmaceuticals Ltd, or GPL, makes it a point to visit his research centre at Mahape in Navi Mumbai. It is the hub of Glenmark’s focus on creating new chemical entities, or NCEs, R&Dspeak for original drugs. Leading the innovation for Saldanha are his lab coat-clad scientists and researchers peering into the test tubes, burettes and pipettes at the Mahape facility.

“Almost 30 to 40 per cent of my time spent on business goes into issues relating to innovation,” he says. That includes thinking about research strategy, deciding on which chemical targets to focus on and which therapeutic segments to chase, and even hiring key R&D talent. Today, out of Glenmark’s 600-odd scientists, 400 are involved in NCE research.

The past 13 years have convinced the ardent admirer of Steve Jobs, the iconic former CEO of Apple, that the future lies in innovation. “If you look at how some of the largest corporations of the world were built, it is clear you need to have innovative products,” says Saldanha, a pharmacist by training, who voraciously reads scientific journals to stay updated on current scientific thought and trends. “Look at what Apple has created… that is the way to build a mega corporation, and that is the key reason why, despite our setbacks, we believe so heavily in innovation.”

Creating an NCE has been the Holy Grail for Indian pharma companies, including giants such as Dr Reddy’s Laboratories and Ranbaxy Laboratories (now owned by Daiichi Sankyo of Japan), but without any major success so far. These companies have reviewed their focus on NCE research and some branched into related activities like differentiated products. So has Glenmark, but it also soldiers on with drug discovery as its key focus area. With five molecules currently undergoing trials in various phases, the company now leads the charge of the Indian drug research industry.

Even one successful launch, say that of revamilast (for asthma and rheumatoid arthritis), which has potential peak sales of $2 billion worldwide, could change the fortunes of the company, though one can never be sure till it actually happens. Next year, Glenmark is likely to have half a dozen compounds in Phase II human trials. Saldanha hopes to hit the market with one or more of his drugs between 2015 and 2017. This potential upside is precisely why Glenmark is in this listing of Tomorrow’s Goliaths, and not any of the other bigger or faster-growing companies.

Undiminished zest
“Every year we expect two more molecules to get into clinical trials,” says Saldanha, his zest undiminished by past failures. “In 2008, in a span of one or two quarters, our entire pipeline pretty much got wiped out, but we never lost our commitment and passion.” At that time its most advanced molecule, oglemilast, used for treating patients with chronic obstructive pulmonary disease, had to be abandoned when its Phase IIb trials produced unsatisfactory results. It also had to suspend clinical development of GRC 6211, a compound for treating osteoarthritis pain, because of side effects.

Unlike other companies that reduced NCE development efforts when faced with similar situations, Glenmark persevered. “We never downsized our research team and did not cut back on budgets,” says Saldanha. “We did not even cut travel and our scientists continued to participate in major global conferences.” It is hardly surprising that his core R&D team has stayed put. Consider Neelima Joshi, 48, Senior Vice President and Head of NCE R&D, who was part of the dozen-odd people who set up the Mahape facility in 2000.

Even then, she says, Glenmark’s management was clearly focused on innovation and the move was in anticipation of the product patent regime that was to come in 2005. It was the impending change in India’s patent law that shaped the mind of the 29-year-old Saldanha in 1998, when he returned to India after working with Eli Lilly and PricewaterhouseCoopers to run his father Gracias Saldanha’s formulations business. After India became a signatory to General Agreement on Tariffs and Trade, it changed its patent law in 2005 from a process patent, which encouraged creation of copies of blockbuster original drugs with minor process changes, to a product patent, where the original drug’s patent itself is recognised in India, thereby prohibiting the creation of copies. This key change, and Saldanha’s passion for research, convinced him to steer Glenmark the NCE way.

However, not everyone agrees with Glenmark’s approach to NCE development, especially of giving away a promising molecule in the early stages to big multinational companies for further R&D. The argument: outlicensing a molecule at a later stage can give a company better valuations. The alternative is to do what Piramal Healthcare wants to – not outlicense. “We believe in taking the drug from the bench to market,” says Dr Swati A. Piramal, Vice Chairperson of Piramal Healthcare, which hopes to deploy the funds it got from sale of its formulations business to Abbott for its R&D efforts. “We are now at the end of the 10 years, having begun in 2002, and we hope between 2012 and 2015, we will hit the market with a new drug.”

While Piramal’s approach is a bench-to-market one, others such as Sun Pharma have developed a different model. Sun Pharma has created a separate research entity called Sun Pharma Advanced Research Centre, better known as SPARC, whose sustainability is built by making differentiated and innovative “generic-plus” products (in simple language, the risk is less, as the basic ingredient is known, but the company is developing a patented technology and a better-targeted product with intellectual property built in). What is more, the returns from this are to help fund the research programme.

On the other hand, Hyderabadbased Dr Reddy’s, one of the pioneers of India’s drug discovery journey, has today rationalised its research programme. It had, in fact, tried out a unique model of creating the country’s first integrated drug development company, Perlecan Pharma, which had equity capital commitments from ICICI Venture and other investors. But it soon saw the outside investors exit and brought back Perlecan into the Dr Reddy’s fold after delays in progress of candidates were not acceptable to some partners who had wanted early monetisation.

Beyond NCEs
Dr Reddy’s has now widened its scope beyond NCEs to differentiated products and formulations where improvements are made on existing products that have limited competition in the market. Its only Phase III candidate, balaglitazone, a diabetes drug, has yet to deliver the goods; the asset class it belongs to, glitazone, has had to deal with an overhang of safety concerns, especially in cases where there is a prolonged use of the drug. Yet, Dr Reddy’s sees sense in Glenmark’s model. “It is a viable model and a right strategy for a small company as Indian companies do not have the capacity to take the drug on their own to the market,” says Satish Reddy, Chief Operating Officer and Managing Director of Dr Reddy’s. “They will need to depend on upfront and milestone payments, and royalties.”

Analysts are cautiously optimistic as Glenmark will have some six compounds in Phase II only next year. Plus the fact that Glenmark has still not hit the market with a new drug weighs it down. “It has had no material success so far; they may make it big but it is difficult to say right now,” says a Mumbai-based analyst.

Neelima Joshi Senior VP and Head, NCE R&D
Even in 2000, our management was clearly focused on innovation and the move was in anticipation of the product patent regime that was to come: Neelima Joshi

On his part, Saldanha argues that he has already recovered his R&D investments. “Till date, we have spent about $120 million in innovation research; against that we have got around $200 million as upfront and milestone payments.”

Says Nomura Financial Advisory and Securities in a recent report: “Glenmark has generated outlicensing income every year from 2004/05 to 2011/12 – except 2008/09. Average licensing income has been Rs 1 billion over the eightyear period. With seven development assets in the pipeline, we believe Glenmark will be able to continue to book licensing income, although the quantum and timing cannot be predicted.”

With standalone revenues of Rs 1,154.63 crore and consolidated revenues of almost Rs 3,000 crore, Glenmark hopes to hit the $1-billion mark soon. And if one of the NCEs sails through, the impact on the topline will be significant – a huge distance travelled for a company that clocked less than Rs 100 crore in the late 1990s. Certainly, Saldanha’s long drives on the Mumbai roads to his R&D headquarters are proving worthwhile.

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