FDA setback the last straw for Merck's women's health portfolio?
This article was originally published in Scrip
Executive Summary
Merck admission that it has received a complete response letter from the FDA for its novel contraceptive Nomac E2 (nomegestrol acetate/17 beta estradiol) may spell the end for more than just this product, analysts at Datamonitor say.
You may also be interested in...
Novartis’s failure in osteoporosis could be bad break for Tarsa
Novartis’s SMC021 failed to meet main fracture reduction endpoints in osteoporosis Phase III trial. While the result is arguably unsurprising for a calcitonin candidate, it is a setback for other companies such as Tarsa Therapeutics aiming to stimulate growth of the class. Tarsa may now struggle to secure a partner willing to bring its pipeline drug Ostora to the market. Novartis is expected to discontinue development of SMC021 and focus on more attractive targets for osteoporosis treatment.
Lilly poised for windfall following FDA approval of Cialis for BPH indications
Eli Lilly is poised to benefit from a windfall after FDA granted marketing authorisation for once daily Cialis (tadalafil) to treat men with BPH symptoms alone or with both BPH and erectile dysfunction. This is the first drug to offer this convenient option to patients. These new indications will provide Eli Lilly with an estimated additional $150m in annual sales for Cialis in the US.
Pfizer’s combo pill could reinvigorate troubled HRT market
New positive Phase III data suggests Pfizer’s new combination pill BZA/CE is safe and effective in treating menopausal symptoms and preventing osteoporosis. While this is promising, approval is not guaranteed as the FDA has had a tough stance on such therapies. Assuming it reaches the US market in 2013, the challenge for Pfizer will be to dispel safety concerns associated with women taking HRT.