InterMune secured the FDA's breakthrough therapy designation for an in-development treatment for a rare lung disease, evening the regulatory score with rival Boehringer Ingelheim as the two angle for position on the U.S. market.
The European Medicines Agency has agreed to an accelerated review of Boehringer Ingelheim's much-watched lung disease therapy, likely shortening its path to market.
The latest download of data on a pair of rival therapies for lethal cases of idiopathic pulmonary fibrosis wowed researchers in the field, producing clear evidence of their ability to slow down the lung disease and offering patients a possible set of game-changing treatments.
InterMune watched its shares jump more than 15% after Boehringer Ingelheim posted some mixed results for its rival idiopathic pulmonary fibrosis treatment, all while the biotech has nearly tripled in value over the past 30 days.
Fresh off positive results for its late-stage lung drug, InterMune has attracted some M&A interest from a flock of pharmaceutical companies, according to Reuters, sending the biotech's shares up roughly 12% on Friday.
More than three years after the FDA sent InterMune back to the clinic for another Phase III study of its lung drug pirfenidone--Esbriet--for idiopathic pulmonary fibrosis, the biotech says it scored a win on the primary as well as two secondary endpoints for the lung-scarring treatment. And now InterMune says it's ready to go back to the FDA and lay out the data, hoping for an approval that will greatly expand the market for a drug now sold in Europe.
While W. Scott Harkonen, the former InterMune CEO convicted over an overzealous press release, is notorious in biotech circles, he and his nuanced case of wire fraud could land on a much bigger stage if the Supreme Court decides to listen in.
AbbVie and InterMune may have won at least a temporary reprieve in their fight to stop the EMA from releasing trial data on their drugs.
As a pioneer in the fibrosis field, InterMune has often been at the center of considerable buyout buzz. In the spring of 2011, for instance, the company had to pour cold water on fevered speculation that a deal was in the making after its drug Esbriet (pirfenidone) was approved in Europe.
One of the pioneers in the fibrosis drug field is opting to sell off an aging commercial product to help finance its pipeline work and what it hopes will be a final push for its top prospect in the U.S. market.