Glenmark launches Nabumetone and Hydroxyzine Tablets
Date: 13 March 2008
Glenmark launches Nabumetone and Hydroxyzine
Hydrochloride Tablets
Mumbai, March 13, 2008: Glenmark Pharmaceuticals Inc (GPI), the US subsidiary of
Glenmark Pharmaceuticals Limited (Glenmark), one of the world's leading, integrated
specialty pharmaceutical and high-quality generic companies, has initiated the marketing
and distribution of Nabumetone tablets and Hydroxyzine Hydrochloride tablets in the
U.S. market.
Glenmark commenced shipping immediately upon final approval from the U.S. Food and
Drug Administration for an Abbreviated New Drug Application (ANDA) for: Nabumetone
tablets in 500mg and 750mg strengths and Hydroxyzine Hydrochloride tablets in 10mg,
25mg and 50mg strengths, through its partnership with InvaGen Pharmaceuticals Inc
(InvaGen).
The Company will exclusively market and distribute Nabumetone and Hydroxyzine
Hydrochloride tablets while InvaGen will be responsible for their manufacture and
supply. All development, regulatory costs and profits on Nabumetone and Hydroxyzine
Hydrochloride tablets’ sale in the US will be shared equally between Glenmark and
Invagen.
Nabumetone is a non-steroidal anti-inflammatory drug and is used to treat pain or
inflammation caused by arthritis. According to IMS Health data, for the 12 month period
ending December 2007, the market size of Nabumetone was USD 97 million.
Hydroxyzine belongs to a group of medicines called sedating antihistamines. Its main
use is to help in the treatment of anxiety. According to IMS Health data, for the 12 month
period ending December 2007, the market size of Hydroxyzine Hydrochloride was USD
60 million.
In FY 06, Glenmark and InvaGen entered into a collaboration agreement for the joint
development, filing and marketing of seven generic pharmaceutical products for the US
market. The product list included a mixture of off-patent and patent-protected molecules
with cumulative annual sales in the US of about USD 4.1 billion.
This recent approval expands Glenmark’s portfolio to 28 generic products for the US
market. The Company has over 35 ANDAs undergoing review with the US FDA for
approval/launch.About Glenmark Pharmaceuticals Inc., USA [GPI]
This document is not an offer of securities for sale in the United States or elsewhere. The shares of the Company and its subsidiaries and affiliates are not being registered under the Securities Act and may not be offered or sold in the United States unless registered under the Securities Act or pursuant to an exemption from such registration. There will be no public offering of shares in the United States
Glenmark’s US subsidiary, Glenmark Pharmaceuticals Inc., USA [GPI], was established
in 2003 to enter into the world's largest pharmaceutical market. GPI is responsible for
sales and marketing of generic drug formulations in the USA as well as APIs to
customers in the regulated markets. GPI closed last Fiscal year with sales of USD 50 Mn
from its formulations business.
About Glenmark
Glenmark Pharmaceuticals Ltd. is a research-led, global, fully integrated pharmaceutical
company headquartered in Mumbai, India. The Company is a leader in India in the
discovery of new molecules. Glenmark has 11 lead molecules at various stages of
development in NCE & NBE research. Three of the leads are in Phase II whereas eight
other leads are into the pre-clinical and discovery stages in the broad areas of
inflammation, metabolic disorders and oncology.
The Company has generic formulation and API business interests in over 80 countries
across the world including the highly regulated markets of USA and Europe. The
formulation business spans several product segments such as Dermatology, Internal
Medicine, Paediatrics, Gynaecology, ENT, Cardiology, Diabetes and Oncology.
Glenmark’s first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to
Forest Laboratories and Teijin Pharma Limited for the North American and Japanese
markets, respectively, in two landmark deals. The second molecule, GRC 6211
(targeting pain), which is undergoing Phase II clinical trials in Europe, has recently been
out-licensed to Eli Lilly & company. [www.glenmarkpharma.com]
About Invagen
InvaGen Pharmaceuticals, Inc. is a leading US generic pharmaceutical company based
in Long Island, New York. The company is vertically integrated with a leading active
pharmaceutical manufacturer based in India. InvaGen has filed 28 ANDAs till date with
the USFDA. [www.invagen.com
]
For further information, please contact:
Ms. Shraddha Bothra
Manager, Corporate Communications
Glenmark Pharmaceuticals Ltd.
Tel: [+91 22] 67589913
Fax: [+91 22] 67589986
Email: media@glenmarkpharma.com
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