Glenmark posts consolidated revenue growth of 88%

Glenmark Pharmaceuticals Limited, the research-led global and integrated pharmaceutical company, has posted gross [total] consolidated revenues of Rs.3594.24 Mn [USD[1] 87.01 Mn] for the first quarter of the financial year 2007-08 ended June 30, 2007, a growth of 88% compared to the corresponding period of the previous year. Consolidated profits for the quarter were Rs.571.51 million [USD.13.83 Mn], a growth of 206% as compared to Q1 of the previous year.

Formulations: In the period under review, Glenmark’s US business posted revenues of Rs.826.22 Mn [USD 20 Mn], registering a growth of 258% over the first quarter of the previous year. The Company’s Latin American operations, comprising Glenmark Farmacêutica Ltda and Servycal S.A., and 10 other Latin American countries, posted revenues of Rs.552.74 Mn [USD 13.38 Mn] for Q1, reflecting an increase of 173%. Exports of branded formulations to semi-regulated markets brought in revenues of Rs.446.38 Mn [USD 10.81Mn], and a growth of 22% over the previous year. Glenmark’s formulations’ business in India registered an increase of 49% to Rs.1280.60 Mn [USD 31.00 Mn], over Q1 of the previous year.

API: The API business for the quarter registered a 55% growth in revenues to Rs. 395.15 Mn [USD 9.56 Mn] over Q1 in FY 2007.

Drug Discovery:

NCEs

Development of Oglemilast is ongoing and Glenmark’s partner, Forest Laboratories, have now completed additional preclinical work requested by the FDA which will soon be submitted for their review. Post FDA concurrence, the drug will move into a larger Phase IIB study.

Glenmark’s lead molecules, GRC 8200 also continues to progress well in its Phase II clinical trials.

We completed Phase I clinical trials for GRC 6211, Glenmark’s lead Vanniloid Receptor (VR1) antagonist compound in Europe on 72 healthy human subjects using single and multiple doses during the quarter. It was found that GRC 6211 was well tolerated by the subjects at all dosage levels and was found to have a good safety profile and predictable pharmacokinetic properties.

Glenmark has now initiated a Phase IIA proof of concept study for dental pain in Europe and hopes to complete this study by December 2007. Additionally, Glenmark plans to initiate 2 large Phase II studies for neuropathic pain and osteoarthritis.

Glenmark has three more molecules in advanced pre-clinical stages. Glenmark plans to file GRC 4039 for Phase 1 clinical testing in Q2. GRC 10693 and GRC 10801 will move into Phase 1 in Q3/Q4 timeframe.

Biologics

Glenmark Pharmaceuticals S.A., the wholly-owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark) has purchased two new biological entities from Chromos Molecular Systems Inc., in Q1 FY08. These New Biological Entities (NBE’s), CHR-1103 and CHR-1201, are humanized monoclonal therapeutic antibodies.

Under the terms of the transaction agreements between Glenmark and Chromos, Glenmark has purchased all rights to the two products as well as rights to use Chromos’ proprietary ACE System technology for cell line development for use with respect to CHR-1103 and CHR-1201.

CHR-1103 and CHR-1201 are part of a validated class of drugs known as SAMI’s (selective adhesion molecule inhibitors) that includes such drugs as ReoPro (Centocor/Lilly), Raptiva (Genentech/Xoma) and Tysabri (Biogen/Elan). CHR-1103 is a broad anti inflammatory agent with a novel mechanism of action, being developed initially to treat acute multiple sclerosis, for which there is no treatment approved at present. Glenmark plans to initiate Phase I clinical trials in 2008 and complete Phase 1 on CHR-1103 by March 2009. CHR-1201 is an anti-thrombolytic humanized monoclonal antibody, which Glenmark plans to develop initially to treat acute stroke. Glenmark plans to start Phase I on CHR-1201 by March 2009.

Glenn Saldanha, Managing Director and CEO of Glenmark said: “We have expanded our portfolio in the area of biologics research with the buy-out of the two new biologic entities from Chromos, Canada. We are also very happy with the way the research on our out-licensed molecules are progressing. The strategic acquisition of Medicamenta in the Czech Republic has given us an initial foothold in the European market. On the generics and branded generics front, we are happy with the positive growth shown by our US, Latin American and India businesses and we expect them to contribute significantly to overall revenues.”

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