The Swiss giant biotechnology firm, Basilea's grand plans to launch the first ever antibiotic to beat the growing number of drug resistant bacteria, today suffered a major delay after regulators refused the accept filing by the company while questioning the key data presented.
On back of the news, the company's shared fell 20% to 61 Swiss Francs on Wednesday. The plunge has come after the stock has already lost about 50% of it value during the current year, as the company suffered major setbacks on ceftobiprole.
The rapid emergence and spread of highly drug resistant superbugs like MRSA, which manage to resist all existing antibiotics, has excessively raised the need for drugs which could help combat the problem, and more and more companies are involved in their developed.
The US Food and Drug Administration, however, decided that it could still not approve the application for Basilea's ceftobiprole in its current form due to concerns over the integrity of the data shared by two important studied that were funded by Johnson & Johnson, the company confirmed.
"The response means a further delay of ceftobiprole's entry to the US market. Depending on the outcome of the discussions with the FDA we reckon the delay could be three years", shared Vontobel analyst Silvia Schanz.
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