InterMune Inc.'s stock took a slight hit Friday, falling 7.2 percent when the company said inconsistent safety data related to oritavancin prompted the FDA to ask for an additional safety study, a request expected to delay submission of the new drug application by about six months.
InterMune's stock (NASDAQ:ITMN) closed Friday at $18.28, down $1.42.
Company officials could not be reached from comment.
In two small clinical pharmacology studies of oritavancin, InterMune noted adverse events, mainly phlebitis and rash, which were inconsistent with the safety profile in earlier trials, including two Phase III studies. Oritavancin is a candidate for complicated-skin/skin-structure infections caused by Gram-positive bacteria.
The company released a prepared statement saying that while the delay is disappointing, oritavancin is not part of its core focus in pulmonology and hepatology. The delay does not change the company's goal of profitability in 2005, the statement said.
Previously, InterMune, of Brisbane, Calif., had anticipated filing the oritavancin NDA during the first quarter of 2004, but now expects to file it toward that year's end.
According to InterMune, Eli Lilly and Co., of Indianapolis, manufactured the oritavancin that was used in the earlier Phase III trials. InterMune has been transferring the manufacturing process to a contractor, therefore the FDA wants a new study using product made by the contractor.
InterMune acquired exclusive worldwide rights to oritavancin from Lilly in a deal that included a $50 million up-front fee for Lilly. While specifics weren't released on the financial arrangement, InterMune said it involved potential milestones and royalties. (See BioWorld Today, Sept. 21, 2001.)
Oritavancin is a semi-synthetic glycopeptide potentially useful in a range of Gram-positive bacterial infections. It is designed to kill bacteria instead of just inhibiting them, and acts on cell-wall synthesis and appears to have binding properties that augment its effectiveness.
InterMune believes pairing oritavancin with Actimmune, the company's product marketed for chronic granulomatous disease and severe, malignant osteoporosis, will create a strong product. Actimmune is a possible candidate for other indications such as ovarian cancer, idiopathic pulmonary fibrosis, cryptococcal meningitis, cystic fibrosis and atypical mycobacterial infections.
The company projects total net product sales for 2003 to be in the range of $145 million to $165 million, with Actimmune net sales projected to be in the range of $135 million to $150 million.
In a pivotal double-blind Phase III trial, oritavancin achieved its primary endpoint and demonstrated that the candidate was as effective as the comparator regimen of vancomycin followed by cephalexin, the company said. The secondary endpoint of bacteriological eradication also was met. The most commonly observed side effects in the clinical trials were headache, nausea, vomiting, constipation and dizziness, which occurred at similar rates in the two treatment arms.