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Glenmark cuts back drug discovery spend

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Thursday, October 29, 2009, 15:37 This news item was posted in Discoveries, Featured, Industry category and has 0 Comments so far.

At least 3 of Glenmark lead molecules failed or got suspended in mid-stage trials in the recent months

Indian generic maker Glenmark Pharmaceuticals Ltd has cut back its research and development spend for the year to March 2010 as some new of the company’s new drug discovery programme encountered troubles.

Glenmark, which wanted to position itself among the drug discovery-led companies’ league after spinning off its generic business recently, has reduced the yearly spending for research and development (R&D) operations to Rs 1.5 to Rs 1.6 billion rupees.

Glenmark was earlier targeting to spend $40-45 million for R&D programme which included new discovery and development of several molecules currently in pipeline.

“Some of the projects on the NCE (new chemical entity) side have got pushed back for various reasons. This is typical of any drug discovery programme,” said managing director and chief executive officer Glenn Saldanha on an analysts’ call, following the announcement of financial results for quarter ending on September 30, 2009.

“It is just a question of some of the spends getting postponed because of some of the studies getting delayed,” Seldanha was quoted as saying.

Of late, Glenmark has suffered a series of setbacks in its ambitious drug discovery programme.

In August, Glenmark Pharmaceuticals and US partner Forest Laboratories said oglemilast (GRC 3886) – a drug they were developing to treat chronic obstructive pulmonary disease (COPD) failed in a mid-stage trial COPD has an estimated market worth about $5 billion.

Glenmark signed a deal worth USD 190 mn with Forest Laboratories for developing and marketing Oglemilast for the North American region in 2004.Following the deal, Glenmark received USD 15 million as milestone payments from Forest Labs in the year 2008.

Glenmark Pharmaceuticals’s drug drug discovery programme suffered another setback when Eli Lilly and Co of US suspended clinical trials of its pain drug molecule GRC 6211, in October 2008.

GRC 6211 has been outlicensed to Eli Lilly as potential treatment for arthritis-related pain in a $260 million (about Rs1,290 crore) deal signed in October 2007.

Eli Lilly said it has decided to stop further development of the drug molecule, GRC 6211, after certain adverse findings in early October.

Last year, German drug company Merck KGaA also ended a licensing deal with Glenmark for its diabetes drug after it decided to withdraw diabetes projects from its research portfolio.

In 2004, Glenmark also signed a deal worth USD 53 mn with Teijin Pharma Ltd for developing and marketing oglemilast for the Japanese territory.

Glenmark is among the few Indian pharmaceutical players targeting new drug discovery and biologics research. Glenmark has a strong pipeline of 13 research programs.

Glenmark has completed preclinical development for initiating Phase I trials for GBR 500 – a monoclonal antibody for inflammation.

Glenmark’s molecule for neuropathic pain, osteoarthritis – GRC 10693, was to enter Phase I trials last year. GRC 10693 was Glenmark’s fifth molecule to enter clinical trials.

Glenmark initiated Phase I studies for GBR 500 – a novel biologic molecule – by filing its IND application with the US-FDA, in 2008.

GBR 600, an anti-platelet monoclonal antibody, received approval from MHRA, UK to commence Phase I studies.

Meanwhile, Glenmark Pharmaceuticals Ltd clocked profit of 808.9 million rupees, on revenue of 5.9 billion rupees, up 5 percent for the quarter ended Sept. 30.

Glenmark’s speciality formulations sales rose 7 percent to 3.33 billion rupees, while Glenmark’s generics business registered a 4 percent rise to 2.58 billion rupees, a company statement said.

Revenue from Africa, Asia and CIS region was Rs. 802.19 mn (USD 16.36 mn] as against Rs. 704.61 mn (USD 16.49 mn) for the previous corresponding quarter, recording an increase of 14%.

Glenmark’s India formulations business grew by 18 %, while generics business registered sales growth of 4 %.

Glenmark’s interest cost rose to 456.1 million rupees from 187.1 million a year earlier.

Glenmark Generics Inc., USA registered revenue of Rs. 1,771.15 mn (USD 36.13 mn) for the second quarter of FY’10 against revenue of Rs. 1,761.29 mn (USD 41.23 mn).

The European subsidiary posted revenue of Rs. 93.94 mn (USD 1.92 mn) in Europe for the second quarter of FY10 as against a revenue of Rs. 31.63 mn (USD 0.74 mn) in the same quarter of the previous year, a growth of 197%. Revenue from sale of API to regulated and semi-regulated markets globally was Rs. 592.17 mn (USD 12.08 mn) for Q2 FY10 against Rs. 539.26 mn (USD 12.62 mn) for Q2 of the previous year, recording an increase of 10%.

“For the remaining part of the year, we expect demand conditions to further improve across all our operating regions,” Glenn Saldanha, said in the statement.

Glenmark Pharmaceuticals Ltd has announced that the Board of Directors of the company at its meeting held on October 29, 2009, has approved the conversion of 64,100 stock options issued to its employees into 64,100 equity shares pursuant to the ESOS 2003.

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