Glenmark Pharmaceuticals Limited, the research-led global and integrated pharmaceutical company, has posted impressive performance during the second quarter ended September 30, 2007. Its net profit has increased by 99.3 per cent at Rs 63.86 crore from Rs 32.05 crore in the cumulative period of last year. The company has also increased its net sales over 41 per cent to Rs 280.96 crore from Rs 198.01 during the same period last year. Its EPS has also worked out to Rs 2.62 from Rs 1.34.
Glenn Saldanha, managing director and CEO, Glenmark Pharmaceuticals said, "We are happy to announce the out licensing deal with Eli Lilly in Q2 FY08. We have made excellent progress in our TRPV1 programme at Glenmark and are very excited to be partnering with Lilly, a world-class research-driven global pharmaceutical company. This quarter Glenmark has also received US FDA approval for 180 day shared exclusivity for marketing Oxcarbapezine (Trileptal) in the US 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."
The company's Latin American operations, comprising Glenmark Farmacêutica Ltda and Servycal S.A., and 10 other Latin American countries, posted revenues of Rs.57.17 crore for Q2, reflecting an increase of 113.07 per cent. Exports of branded formulations to semi-regulated markets brought in revenues of Rs 54.50 crore and a growth of 3.79 per cent over the previous year. Glenmark's formulations' business in India registered an increase of 27.95 per cent to Rs 141.81 crore, over Q2 of the previous year. Its API business for the quarter registered a 34.23 per cent growth in revenues to Rs 42.58 crore over Q2 in FY 2007.
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. 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.
Glenmark's lead molecules, GRC 8200 also continues to progress well in its phase II clinical trials. Merck has recently announced plans to curtail focus on diabetes and discussions are on with Merck to define future development for the compound. However, near term development program has not been compromised.
Glenmark's lead Vanniloid Receptor (VR1) antagonist compound 6211 has been out licensed to Eli Lilly. Under the terms of the agreement, Glenmark will receive an upfront fee of $45 million and could receive up to an additional $215 million in potential development and sales milestones for the initial indication, as well as royalties on sales if GRC 6211 is successfully commercialized. If other indications are successfully developed, Glenmark would be entitled to additional milestones up to $90 million. Lilly will have marketing rights for North America, Europe and Japan, while Glenmark will retain the marketing rights in all other countries. Further Glenmark will have the right to co-promote GRC 6211 in the United States
The company has three more molecules in advanced pre-clinical stages. Glenmark's candidate for rheumatoid arthritis, inflammation and multiple sclerosis - GRC 4039, a PDE 4 inhibitor, will commence phase I trials in the Q3/Q4 of FY08. GRC 10693 and GRC 10801 will also move into phase I in Q3/Q4 timeframe.
It has successfully completed the technology transfer of the antibodies acquired from Chromos in Q1 FY 08. GBR 500 (formerly CHR 1103), a broad anti inflammatory agent with a novel mechanism of action, being initially developed to treat acute multiple sclerosis would be advanced into Phase 1 in Q1 FY09. GBR 600(formerly CHR 1201), an anti-thrombolytic humanized monoclonal antibody is progressing as per plans. GBR 600 belongs to a novel target mechanism. Glenmark plans to start phase I in Q4 FY09.