US drugmaker Forest Laboratories has posted an 8.5% increase in fiscal second-quarter revenues to $918.9 million, helped by a pick-up in sales of flagship antidepressant Lexapro, although analysts are disappointed as net income fell.
Earnings were down 6.6% to $225.2 million, or $0.71 per share, but Forest pointed out that the decline was mainly due to a $70 million licensing charge, equivalent to $0.15 per share, to Microbia, for the right to co-develop and co-market linaclotide, a compound being investigated in Phase II for chronic constipation and constipation predominant irritable bowel syndrome.
Back to the sales and Lexapro (escitalopram oxalate), which is licensed from Denmark’s Lundbeck, contributed $559.1 million, a 7% increase year-on-year. Sales of Namenda (memantine), Forest’s N-methyl-D-aspartate (NMDA) receptor antagonist for the treatment of moderate and severe Alzheimer's disease, reached $192.9 million during the quarter, up 24%, while other income was $76.6 million, which included $49.6 million from Forest's Benicar (olmesartan medoxomil) co-promotion agreement with Japan’s Daiichi Sankyo, up 2.6%.
Chief executive Howard Solomon said that the firm is progressing reasonably well in terms of its pipeline and arrangements have just been concluded with Daiichi Sankyo for the launch this month of the new high blood pressure drug Azor, a fixed-dose combination of two antihypertensives – amlodipine (Pfizer’s Norvasc which recently went off-patent in the USA) and Benicar. Another antihypertensive, nebivolol, is expected to be approved this quarter with a launch scheduled for the fiscal fourth quarter and both products “should soon begin to contribute to earnings”. He added that Forest expects to file a New Drug Application for milnacipran, for fibromyalgia, in this quarter.
Schizophrenia drug works at low-dose only
However, mixed news came with the announcement by Forest and Hungarian partner Gedeon Richter which noted that their experimental schizophrenia drug RGH-188 (cariprazine) showed statistically significant benefits only in low doses (1.5- 4.5 mg/day) in a 389-patient Phase IIb study but not in the high dose (6-12 mg/day) group. Subject to a complete review of the full study results, the companies intend to continue the development of RGH-188, while results from a proof of concept study for the drug in bipolar mania will be reported in the middle of 2008.