Forest Laboratories and partner Mylan have received a conditional letter of approval for their hypertension drug nebivolol from US regulators.
The US Food and Drug Administration has issued an approvable letter for nebivolol, a novel beta blocker which the firms plan to sell as B
ystolic. However the agency has expressed some concerns about a back-up manufacturing facility in Belgium that it recently inspected and says that final approval “would be contingent upon satisfactory resolution of these deficiencies”.
The drugmakers said that they expect “an expeditiou
s resolution to this issue” and Forest noted that it is continuing to plan for a January 2008 launch for Bystolic. They also noted that the approvable letter did not raise any questions related to the safety or efficacy of the drug.
Mylan licensed the US and Canadian rights to nebivolol fro
m Janssen Pharmaceutica in 2001, while Forest signed a development, sales and marketing deal with Mylan in January 2006. The latter has retained an option to co-promote the product which is already being marketed in more than 50 other countries outside of North America.
Caraco gets tentati
ve OK to selll generic Lexapro
Less good news for Forest came with the announcement from Caraco Pharmaceutical Labs that the FDA has granted tentative approval for its generic version of the blockbuster antidepressant Lexapro (escitalopram).
Caraco noted that Lexapro had sales of about
$2.5 billion for the 12-month period up to the end of September, and chief executive Daniel Movens noted that his firm is currently involved in litigation with Forest that will determine whether it can launch its generic product prior to the expiration of Forest’s patents. He said that “though
the outcome of this litigation is uncertain, we remain confident in our position and continue to expect a favourable conclusion”.
Goldman Sachs likes Mylan
There was better news for Mylan, however, as a Goldman Sachs analyst upgraded the stock, placing it on a list of recommended securities. The firm’s shares have taken a bit of a bashing since Mylan announced its 4.9 billion euro acquisition of Merck KGaA’s generics business and hit a five-year low of $12.93 last week.
However, Randall Stanicky raised his rating to “buy” from “neutral,” and placed the stock on the Goldman Sachs America’s Conviction Buy List. He said Mylan should post solid earnings growth over the next three years, claiming that it is “a longer-term investment story hampered by near-term trading concerns which we believe have largely passed”.
