Glenmark - Type II Diabetes GRC 8200

Glenmark Pharmaceuticals Ltd on January 14, 2008 has announced that its lead candidate for Type II Diabetes GRC 8200 has received the International Non-proprietary Name (INN) "Melogliptin", from the World Health Organization (WHO). This name was selected during the recently held 45th Consultation on Non-proprietary names and was made by the International Panel for Pharmacopoeia and Pharmaceutical Preparations.

GRC 82O0, Glenmark's lead DPPIV inhibitor, is a novel, oral DPPIV inhibitor in development for type 2 diabetes. It is currently in Phase II clinical trials. Phase I studies showed that the compound was very well tolerated by the subjects at all dosage lebel and there were no significant adverse events reported. More than 90% inhibition of the DPP-IV enzyme was observed within 1 hour at all doses tested. In preclinical studies, the compound appears to be effective and well tolerated when given at pharmacological doses.

Glenmark Pharma - Outcome of board meeting

Glenmark Pharmaceuticals Ltd has informed that the Board of Directors of the Company at its meeting held on December 20, 2007 has transacted the following:

1. Allotted 4,05,420 Equity shares to the employees of the Company / subsidiaries on exercise of options granted to them pursuant to ESOP'2003.

2. Approved conversion of Zero Coupon Foreign Currency Convertible Bonds amounting to US$ 29,90,000 into 5,15,757 Equity Shares at a price of Rs 253.11 per share of face value Re 1/- each out of US$ 50,000,000 Zero Coupon Foreign Currency Convertible Bonds issued in 2005.

3. Further to the communication on November 07, 2007 regarding the approval by the board for the re-organisation of the business, the board, on December 20, 2007 has approved the postal Ballot notice for seeking approval of the shareholders.

Glenmark into Nigerian Market

Glenmark Pharmaceuticals Ltd has informed that Glenmark Pharmaceuticals Nigeria Ltd, a subsidiary of the Company, announced its plans for expanding presence in the Nigerian market. Glenmark started operations in April 2007 and has successfully created a market for its products in the country expecting sales of USD 1.3 million by the end of this fiscal. Currently in Nigeria, the Company is present in the areas of Dermatology / Gynecology, Anti-Infectives & Gastroenterology, and plans to additionally launch its products in the areas of Respiratory, Oncology and Metabolic diseases.

Mr. A S Mohanty, Director - Formulations of the Company, said, "Nigeria is the biggest market in West Africa and Glenmark has established its presence there in a very short span of time. We plan to double our business in 2008 - 09 and meet the US$ 10 million mark by 2012-13. Our gastroenterology product Relcer-gel has done really well in Nigeria and we expect to sell more than half a million bottles by the end of FY 08."

At present the Company has 14 SKU registered in 12 months and plans to have another six new products in Nigeria. In additional, the Company also has plans to substantially increase its team in Nigeria in the coming fiscal, and increase the presence of local talent in its sales and marketing team.

The Company is one of the leading players in the Indian branded generics market, specifically in areas of dermatology and respiratory. Its products, Candid B and Ascoril, feature among the top 300 pharmaceuticals products in India.

Glenmark Pharma to spin off Glenmark Generic company

Glenmark Pharmaceuticals Ltd on November 07, 2007 has announced its plans to reorganize its businesses into Specialty and Generics. The new Generic entity called Glenmark Generics Ltd will be a wholly owned subsidiary of the Company and will be listed on the Indian bourses by Q1 FY 2008-09.

Mr. Terrance Coughlin, currently President API and US Generics, will take over the role of the CEO while Mr. Glenn Saldanha will function as the Chairman of Glenmark Generics Ltd.

Speaking on this development, Mr. Glenn Saldanha, CEO & MD of the Company, said, "both our Specialty and Generics business have now grown immensely, posing a growth challenge of managing two large, but diverse businesses. The sheer size of the business now has its own set of management challenges. To address these challenges, strengthen our focus in R&D and accelerate our growth in the generics and API business, we are happy to announce a plan to reorganize our businesses by moving the generics and API businesses into a wholly owned subsidiary Glenmark Generics Ltd. The new Company will handle the development, manufacture and marketing of generic formulation and API businesses."

The objective of the reorganization of the business is to build end to end integration, scale and capabilities in pursuing a generic business, on the GGL side, and to build end to end Global capabilities similar to a Big Pharma Company on the Specialty side. The new Company will handle the development, manufacture and marketing of generic formulation and API businesses. The Company will continue to directly manage the novel R&D and branded formulation businesses of the Glenmark group including India, Brazil, Rest of Latin America (excluding Argentina), Russia/CIS, Africa and Asia.

The Generics business will inherit Glenmark's Goa plant for formulations, the three API plants in India, our sales units in the USA and UK and the Argentina oncology operations. in addition, a group from R&D focused on API and Formulation development will also move to the generics Company.

The branded business will remain in the Company and retain all remaining assets, branded generic sales groups in India and overseas and all remaining R&D operations related to NCEs, Biologics and formulation development for brands.

The 2015 target for GCL is to become a global, integrated generic & API leader, with more than 170 generics on the US market, more than 70 generic dossiers for EU markets,, build presence in Japan, South Africa & other generic markets, be a preferred supplier of APIs and build front ends in Japan and key EU markets in addition to North America.

Speaking of the objectives of the planned IPO for GCL, Mr. Terrance Coughlin, currently President - US Operations, and Head API Sales, of the Company Said, "We would not be diluting more than 30% of Glenmark Generics Ltd (GGL) through a fresh issue of shares. We will use capital in GGL to acquire / build specialty US front end with late stage pipeline and / or marketing, further expand GGL's generic foot print globally through acquisitions, expand capacity for generics and focus on expansion into other niche segments".

After the reorganization the Company will play two roles. The first will be investor in the generics business through its subsidiary. The second will be running the specialty, original drug development and branded generics businesses of the Glenmark group "In effect, the biggest benefit of the reorganization is the advantage the organization will get from giving both the generic and the brand businesses the separate focus they deserve, managing the scale that both businesses have now achieved" Mr. Saldanha added.

Glenmark USFDA approval

Glenmark Pharmaceuticals Ltd has announced that Glenmark Pharmaceuticals SA (GPSA), the wholly owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd (Glenmark), on October 29, 2007, announced that USFDA has provided a favorable partial response to the submission made by Forest, allowing it to initiate an additional Phase II study in COPD for Oglemilast (GRC 3886), Glenmark's lead PDE4 inhibitor molecule. The approval came after Forest satisfactorily addressed FDA's outstanding non-clinical questions.

Glenmark is working closely with Forest Labs, which is Glenmark's North American partner for Oglemilast, to detail out plans for further longer term development, while additional communication is expected from the FDA in the next 2-3 months. Glenmark views this as an important positive step in continuing overall clinical development of Oglemilast.

Speaking on this development, Mr. Glenn Saldanha, CEO & MD, Glenmark Pharmaceuticals Ltd, said, "The favourable response to Oglemilast from the FDA is an affirmation of Glenmark's research capabilities and our focussed approach towards drug discovery. Today we have a pipeline of 11 lead molecules at various stages of development, with an increasing focus on NBE research along with NCE research. This progress reiterates Glenmark's commitment towards setting benchmarks in speed, efficacy and monetisation of drug discovery & research."

GRC 3886 is a novel, orally available PDE4 inhibitor in development for Chronic Obstructive Pulmonary Disorder (COPD), and may also have utility in other conditions such as Asthma. According to the Centers for Disease Control, COPD affects approximately 24 million people in the United States and Asthma affects approximately 20 million. Combined, these markets are worth over $10 billion and are growing at a significant rate. PDE4 inhibitors target the underlying cause of both COPD and Asthma by blocking inflammation through a non-steroid dependent mechanism.

GPSA had entered into a collaborative agreement with Forest in September 2004, wherein Forest would develop, register and commercialize GRC 3886 for the North American market, while Glenmark will retain commercialization rights for the rest of the world. Forest paid Glenmark an up-front payment upon initiation of the agreement, and Will pay other milestones if the development and commercialization of the product is successfully completed in the North American market, the total value of these payments could be $190 million. Additionally, after commercial launch, Glenmark will earn a royalty from Forest on net sales of the product, and, in addition, will supply all API for sale by Forest.

This was followed by a similar collaboration agreement with Teijin Pharma Ltd for the territory of Japan in April 2005.

Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd has announced that the Company has received final approval from the U.S. Food and Drug Administration for the marketing the first generic version of Trileptal (Oxcarbazepine). The approval is for marketing Oxcarbazapine tablets in three strengths - 150 mg, 300 mg and 600 mg.

The Company was one of the first ANDA applicants to submit a Paragraph IV certification to the '525 patent'. Therefore, with this approval, the Company has been awarded for 180 days of shared generic drug exclusivity for these strengths.

Trileptal is a widely used medication to treat epilepsy that has FDA approval.

Oxcarbazepine sales were approximately US$ 643 million, for the 12-month period ending June 30, 2007, according to IMS Health.

With this approval, GPI now has a portfolio of 20 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process / launch.

Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd has announced that the Company has won the award for Emerging Company of the Year 2007 at The Economic Times Corporate Excellence Awards. The winners were selected by an eminent jury co-chaired by Mr. Azim Premji, Chairman of Wipro and Mr. NR Narayana Murthy, Chairman and Chief Mentor of Infosys Technologies with Mr. Praful Patel, Union Civil Aviation Minister, as a special guest. The other members of the jury comprised Mr. Deepak Parekh, Chairman of HDFC, Mr. Kumar Mangalam Birla, Chairman of the AV Birla Group, Mr. Harish Manwani, President (Asia-Pacific), Unilever, Mr. Rajiv Bajaj, Managing Director, Bajaj Auto, Mr. Sanjay Nayar, Citi Country Officer, Mr. Ravi Dhariwal, Publishing, Bennett Coleman & Company Ltd and Mr. Rahul Joshi, Executive Editor of The Economic Times.

Mr. Glenn Saldanha, CEO & MD, of the Company, said, "It is an honour for Glenmark to receive this award and is a very special occasion for me and my team. We will continue our efforts to build Glenmark into a global research based Company and retain our competitive edge in everything that we do."

The Emerging Company of the Year Award seeks to honour the capacity to take calculative risks, display explosive growth and discover a business model for others to emulate. As per The Economic Times, "Glenmark Pharmaceuticals emerged the winner in a tight race that was led, at the outset, by Pantaloon. The other Companies in the shortlist for Emerging Company of the Year were Aban Offshore, Axis Bank and Marico. Glenmark, to its credit, had registered a spectacular rise in profits. The fact that it has got a global leader like Merck to partner its new drug development and has lined up quite a few new molecules, tilted the scales decidedly in its favour. 'Blue chip' was used by more than one juror to describe Glenmark."

Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd has announced that the Company has received approval from MHRA of UK for its state of the art semi-solids (ointments & creams) manufacturing plant at Baddi, Himachal Pradesh. This is the 3rd of the Company's manufacturing plants to have been approved for GMP by the UK regulatory agency - MHRA. This will enable the Company's foray into supply of creams and ointments in Europe soon. The Baddi plant had already received GMP approval from TPD, Canada, and is well on course to receiving USFDA approval in the near future, which would enable the Company to enter the niche segment of semi-solid dosages in most of the regulated markets of the world.

Speaking, on this development Mr. Glenn Saldanha, CEO & MD, of the Company said, "The approval from MHRA, UK will provide further impetus to our current expansion efforts in the European region. Our plant at Baddi has been built to the highest international standards and has been producing batches for filing in Europe and the US. Glenmark has been constantly upgrading its manufacturing facilities to efficiently meet the anticipated demands of the global markets and we look forward to the US FDA approval for Baddi as the next milestone."

The Company's facility at Baddi is fully commissioned with more than Rs 2300 Mn (>US$52Mn) worth of production coming from this facility. Baddi presently supplies the Company's Indian requirements and has produced batches for filing in the US and Europe. The Company hopes that the Baddi facility will break-even in its first two years of operation.

The Company has its formulations manufacturing facilities in Goa, Nasik, and Baddi in India, in Sao Paulo, Brazil and in Vysoke Myto, Czech Republic. The manufacturing facility Goa is USFDA approved and produces solid orals, external ointments and capsules, for the regulated markets, while the facility at Nasik produces solid orals, liquid orals, external creams, powders and capsules for the regulated markets. The Nasik facility approved by WHO-GMP, ANVISA apart from other international approvals. The manufacturing plant at Sau Paulo, Brazil produces solid orals, semi solid and liquid orals and ANVISA approved, while the facility in Vysoke Myto, Czech Republic produces soild orals and semi-solids and is approved by SUKL, a Czech regulatory authority.