Almirall Drops on U.S. Regulator’s Scrutiny of Lung DrugTodd White
Almirall SA dropped the most in more than two months after the Spanish drugmaker said it must hold an additional meeting with U.S. regulators before seeking approval to sell a new treatment for a lung disorder.
Almirall fell 5.8 percent to 11.15 euros in Madrid, the steepest decline since Jan. 23. That pushed the stock into losses for the year, cutting the pharmaceutical producer’s value to 1.93 billion euros ($2.67 billion).
The company and U.S. partner Forest Laboratories Inc. will probably seek a meeting with the Food and Drug Administration in the third quarter to “address questions” about chemistry, manufacturing and control of the drugmakers’ treatment for chronic obstructive pulmonary disease, Barcelona-based Almirall said today in a filing.
“Although no new issues have arisen, further discussion is needed with the agency” regarding the partners’ fixed-dose combination of the drugs aclidinium and formoterol, Almirall and New York-based Forest Laboratories said.
The news is a setback that may postpone a filing to the FDA for clearance for U.S. sale of the treatment amid a race with Novartis AG, which is seeking to bring competing drug Ultibro to market, analysts at Credit Suisse, Berenberg Bank and Goldman Sachs Group Inc. said in separate reports.
“Our ‘buy’ thesis was predicated on Almirall undergoing transformational change, driven by growth of its respiratory franchise,” analysts at Goldman Sachs, including Eleanor Fung, wrote in a note to clients. Goldman put Almirall’s rating, price target and estimates under review.
Charles Cooper, an analyst at Berenberg, retained his stock-price estimate of 15.70 euros for Almirall. Credit Suisse reiterated its outperform recommendation and 16-euro target price.