Glenmark Pharmaceuticals Limited (GPL), the research-led global integrated pharmaceutical company, announced its consolidated revenues of Rs.5822.35 Mn [USD144.55 Mn] in Q4 FY08, against Rs.3581.58 Mn [USD 81.14 Mn] for the fourth quarter of the previous year, recording a growth of 62.56%. Revenues from Generics business, Glenmark Generics Ltd. (GGL), presently a subsidiary of Glenmark Pharmaceuticals Ltd. were Rs.2622.83 Mn (USD 65.11 Mn ), as against Rs.1214.82 Mn (USD 27.52 Mn )  which was reported in the same quarter of previous year, registering a growth of 115.9%.  The Speciality business (including out licensing revenues) a part of GPL, had revenues of Rs.3199.52 Mn ( USD 79.43 Mn) as against Rs.2366.76 Mn (USD 53.62 Mn) for the quarter of the previous year, recording a growth of 35.19%.Consolidated profits for the fourth quarter of FY 08 increased to Rs.2189.63 Mn [USD54.36 Mn] from Rs.622.03 Mn [USD14.09 Mn] for the previous year, an increase of 252%.

Glenn Saldanha, Managing Director and CEO, Glenmark Pharmaceuticals Ltd., & Chairman Glenmark Generics Ltd., said: “We have posted good results with the Forest milestone this quarter and a good performance of our US business. We are also happy to take our biologics program forward with GBR 500 moving into Phase I trials. This is Glenmark’s first NBE to enter the clinics from our pipeline of 13 NCEs and NBEs, and demonstrates our steady progress in the drug discovery space.”

Specialty Business:

Revenues from Glenmark’s formulation business in India increased to Rs. 1540.88 Mn [USD 38.25 Mn] in  Q4 FY 08 against Rs. 1292.03 Mn [USD 29.27 Mn] in the previous year, recording a growth of 19.26%.  The semi regulated markets posted revenues of Rs. 532.63 Mn [USD 13.22 Mn] against Rs. 454.42 Mn [USD 10.29 Mn] for Q4 of the previous year, recording a growth of 17.2%. The company’s Latin America business posted revenues of Rs. 432.71 Mn [USD 10.74 Mn] whereas Medicamenta, Glenmark’s wholly owned subsidiary in EU, posted revenue of Rs.83.46 mn (USD 2.07mn) in the fourth quarter

Generics Business:

Glenmark Generics Inc., U.S.A. [GGI], Glenmark’s wholly owned US subsidiary posted revenues of Rs. 1962.57 Mn [USD 48.72 Mn] for the fourth quarter of FY 08 against revenues of Rs. 803.35 Mn [USD 18.20 Mn] registering an increase of 144.30 % over the fourth quarter of the previous year. Glenmark’s revenues from EU operations were Rs. 9.20 Mn [USD 0.23 Mn] whereas revenues from Oncology division , Argentina operations were Rs. 60.19 Mn [USD 1.49 Mn] in the fourth quarter of 2007-08 against Rs. 55.54 Mn [USD 1.26 Mn] of the previous year reflecting an increase of 8.4%.

API 

International

Revenues from sale of API to regulated and semi-regulated markets globally were Rs. 283.17 Mn [USD 7.03 Mn] for Q4 FY 08 against Rs. 187.79 Mn [USD 4.25 Mn] for Q4 of the previous year, recording an increase of 50.8 %.

Domestic  

Revenues from the domestic API and co-marketing business amounted to Rs. 307.70 Mn [USD 7.64 Mn] in Q4 FY 08 against Rs. 168.14 Mn [USD 3.81 Mn] for Q4 of the previous year, recording an increase of 83%. 

Drug Discovery

NCEs:

Glenmark received USD 15 million as milestone payment from Forest Laboratories for Oglemilast, GRC 3886. USFDA has provided a favourable 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. Glenmark’s DPPIV inhibitor, Melogliptin , GRC 8200 , a treatment for Type II diabetes has completed Phase IIA studies and is currently undergoing Phase IIB studies. Glenmark plans to complete all Phase II’s on Monotherapy by the mid 2009 and would initiate Phase III’s by end of 2009. The company has initiated discussions with other partners to out-license Melogliptin. Glenmark Pharmaceuticals S.A. (GPSA) a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL) has out licensed its molecule GRC 6211 to Eli Lilly and Company. Under the terms of the agreement, Lilly will acquire the rights to a portfolio of transient receptor potential vanilloid sub-family 1 (TRPV1) antagonist molecules, including a clinical compound, GRC 6211. GRC 6211 is currently in early clinical Phase II development as a potential next-generation treatment for various pain conditions, including osteoarthritic pain. Glenmark’s candidate for Rheumatoid Arthritis, Inflammation and Multiple Sclerosis,  GRC 4039, a PDE 4 inhibitor, is expected to complete Phase I trials in the coming quarters , whereas its candidate for Neuropathic Pain, Osteoarthritis and other Inflammatory Pain, GRC 10693, a CB 2 agonist, is in its pre-clinical development stage and is expected to enter the clinics in Q1 FY 2009

Biologics

GBR 500, a monoclonal antibody is an antagonist of the VLA-2 (Alpha2 âeta1)  integrin has completed crucial IND-enabling preclinical studies.   VLA -2 mediates interactions of cells with the extra cellular matrix.  Glenmark intends to file an IND application with the US FDA by August 2008 for initiation of Phase I trials and expects to complete Phase I in this fiscal year immediately followed by a proof of Concept Phase IIa study. 

This is Glenmark’s first NBE to enter the clinics from the pipeline of 13 NCEs and NBEs , and demonstrates steady progress in the drug discovery space .GBR 600 an antithrombolytic humanized monoclonal antibody is showing good results in pre-clinical testing and is being scaled up for further IND enabling studies. 

Sourced From: Glenmark Pharmaceuticals Limited