Glenmark Pharmaceuticals Limited

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Glenmark Pharmaceuticals Ltd.
Image:GlenmarkLogo.jpg
Type Public
Founded Mumbai, India (1977)
Founder Gracias Saldanha
Headquarters Mumbai, India
Key people Gracias Saldanha
Mrs. B. E. Saldanha
Glenn Saldanha
Industry Pharmaceuticals
Subsidiaries Glenmark Pharmaceuticals Inc
Glenmark Farmaceutica Limitada

Glenmark (Glenmark Pharmaceuticals Limited) is an Indian-based pharmaceutical company headquartered at Mumbai. Incorporated in 1977, the Company is focused on the manufacture and marketing of formulation products and active pharmaceutical ingredients (API) in India as well as globally and enjoys a diversified and growing presence in regulated and developing international markets. Over the past five years, the Company has also catalysed its growth through investment in dedicated research and development including cutting-edge New Chemical Entity research.

[edit] History

Year Event
1977 Gracias Saldanha started Glenmark Pharmaceuticals Limited with a staff of three and a modest capital of Rs.1 million.
1979 Launched its first specialty product, in the topical antifungal Dermatology segment, Candid Cream (Clotrimazole) and went on to create medical marketing history in the Indian pharmaceutical world. Even today, Candid Cream is still the number one product in its category in India.
Mid 1980's Entered the Russian and African territories for marketing its formulations.
1998 Glenn Saldanha became Managing Director and CEO of Glenmark Pharmaceuticals Limited.
1999 The company floated its IPO which was oversubscribed by 64 times
2000 Glenmark built its state-of-the-art research centre at Mahape, Navi Mumbai.
2002 The company acquired an API manufacturing facility in Ankleshwar, Gujarat from Glaxo SmithKline [GSK]
2003 Glenmark Pharmaceuticals Inc, a wholly owned US subsidiary of Glenmark was established in order to spearhead its entry into the world's largest pharmaceutical market.

December: Glenmark set up its wholly owned subsidiary, Glenmark Farmaceutica Limitada [GFL], in Sao Paolo, the commercial capital of Brazil.

2004 April 2nd: GFL acquired Laboratorios Klinger in Brazil for a consideration of USD 5.2 million for spearheading Glenmark's entry into the Latin-American market.

April 20th: Glenmark announced the discovery of a lead molecule, GRC 3886, a highly selective PDE IV enzyme inhibitor associated with the Chronic Obstructive Pulmonary Disorder [COPD] and Asthma disease conditions.

May: Glenmark's API plant at Ankleshwar received US FDA approval for two of its DMFs, Amiodarone and Cilastazol.

May 28th: Glenmark was awarded the 4th Express Pharma Pulse Awards in the category of Overall Performance [Group C]

August 23rd: Glenmark filed for Phase I clinical trials for GRC 3886, its leading PDE IV compound with the Medicines and Health care Products Regulatory Agency [MHRA] in the U.K. The Phase I study was conducted by Quintiles U.K, a leading global CRO.

September 23rd: Glenmark signed the largest NCE licensing deal of its kind by an India pharmaceutical company with Forest Laboratories, Inc. [Forest] for GRC 3886. In accordance with the agreement, Forest would develop, register and commercialize GRC 3886 for the North American market, while Glenmark will retain commercialisation rights for the rest of the world.

2005 January 10th: Launched its US marketing front end with 2 products, Naproxen and Nitroglycerin.

January 24th: Glenmark successfully completed Phase 1 single and multiple dosing studies on its novel oral PDE4 inhibitor GRC 3886 that were being conducted in the U.K. Phase I results demonstrated that GRC 3886 was well tolerated and exhibited predictable pharmacokinetics and safety profile in human volunteers.

January 31st: Glenmark launched an FCCB issue for USD 70 million. The bonds were issued in two tranches which, in turn, achieved two firsts for Asia:Tranche A - Premium Redemption Bonds represent the highest ever conversion premium achieved in Asia.Tranche B of the ROSES Bonds, a pioneering instrument represents the first time that a forward setting conversion premium structure has been launched in Asia or Europe.

April 26th: The company received the first milestone payment of USD 10 million from Forest Laboratories, Inc. [NYSE:FRX] upon successful completion of Phase I clinical trials on Glenmark's PDE4 inhibitor GRC 3886.

April 26th: Glenmark signed a collaboration agreement with Teijin Pharmaceutical Ltd. for the territory of Japan for its lead Asthma/COPD NCE, GRC 3886.

July 07th: Glenmark signed a collaboration agreement with Napo Pharmaceuticals Inc. [Napo] for its proprietary anti-diarrhoeal compound Crofelemer - the first in-licensing deal for its operations in India. With this agreement Glenmark obtained the exclusive license to develop, register and commercialise Crofelemer for the indications of acute infectious diarrhoea, paediatric diarrhoea and AIDS-related diarrhoea in over 140 countries, almost all markets outside North America, Japan, China and Europe. Glenmark expects to launch the product in India and several other territories starting in 2007. Napo will receive royalties ranging from high single digits to early teens on net sales of the product in different geographies. Additionally, Glenmark will exclusively supply Napo's global API requirements for development and commercial sales under cGMP manufacturing according to US FDA requirements.

August 24th: GRC 3886, Glenmark's lead PDE-4 inhibitor received approval from the US FDA to conduct Phase II clinical testing within the United States. The Phase II studies will commence by early 2006 and would be conducted by Forest Laboratories, Inc. [Forest], Glenmark's development partner for "Oglemilast" in North America.

August 24th: GRC 3886 was granted its International Non-proprietary Name [INN] "Oglemilast" by a WHO body, based on an expert advisory panel's recommendations.

September 22nd: Glenmark filed for Phase I clinical trials for GRC 8200, its leading DPP-IV inhibitor compound, with the Medicines and Healthcare Products Regulatory Agency [MHRA] in the U.K. The Phase I study which will be conducted by Parexel U.K., a leading global CRO is expected to be completed in February 2006 and will be conducted using single and multiple oral doses on healthy volunteers. The objective of this study is to assess the safety and bioavailability of GRC 8200 in humans.

October 03rd: Glenmark's solid dosage plant in Goa that manufactures formulations for the international regulated markets was inspected by and received approval from the US FDA. It also obtained cGMP approvals by two other international regulatory bodies, viz. Therapeutics Products Directorate, Canada and Medicine Control Council, South Africa. The Company has filed 7 ANDAs to date from this facility and has plans to file 13 more this financial year.

October 26th: Glenmark acquired an Argentine marketing company Servycal S. A. [Servycal], with a focused oncology portfolio, marking the direct entry of an Indian pharmaceutical company for the first time ever in Argentina.

December 21st: Glenmark launched a Foreign Currency Convertible Bond [FCCB] offering with the intention to raise USD 30 million. The Bonds which have a maturity of 5 years and 1 day are convertible at a conversion price that is higher of either a] Rs 317.25 per share or b] at a 35% premium to the average of the Company's volume weighted average closing price for the period commencing 10 September 2007 and ending 10 November 2007. The Bonds carry a zero coupon with a yield to maturity set at 6.80%.

December 26th: Glenmark acquired Bouwer Bartlett Pty. Ltd. [Bouwer Bartlett], a South African sales and marketing company, providing it a strategic entry point into the market of South Africa, one of the largest and fastest growing pharmaceutical markets in the continent of Africa.

[edit] Research and Development

Its state-of-the-art R&D centre in Navi Mumbai employs over 350 scientists who possess a vast experience across several disciplines and technology platforms. The research activities encompass process engineering for APIs, new chemical entity research and novel drug delivery systems (NDDS). The Company also operates a second research facility at Sinnar (near Nasik, India) that focuses on developing formulations for India and markets across Asia, Africa, Latin America and CIS/Russia.

Glenmark is amongst the few Indian Pharmaceutical Companies to have taken initiative to invest proactively in original drug discovery research. In a span of three years Glenmark's R&D team has also successfully developed one Novel Drug Lead for Asthma and COPD. This PDE-4 inhibitor has successfully completed Phase I clinical trials in the UK and has been licensed out to Forest Laboratories, USA for North America and Teijin Pharma Limited for the Japanese territory. The Company is further researching PDE-4 inhibitors for CNS indications, cognitive disorders and inflammatory conditions such as atopic dermatitis, ulcerative colitis and rheumatoid arthritis. Other research areas includes Diabetes segment in which the company has a DPP-IV target, GRC 8200, in Phase I clinical trials

[edit] External links