FDA bars Basilea antibiotic from U.S. market, demands new PhIII data

Close to a year ago Switzerland's Basilea ($BSLN) raised a red flag about its U.S. strategy for its antibiotic ceftobiprole, noting that the FDA's new standard requiring two late-stage studies for a program like this could present a major hurdle. Today company execs confirmed that the regulatory path into the U.S. is closed for now, noting the FDA's insistence on more Phase III data and adding that it has no plans to launch a new study without a U.S. partner in hand.

Ronald Scott

"The FDA confirmed that the current ceftobiprole studies should be complemented with prospective data in community and hospital-acquired pneumonia in accordance with its new guidelines," the company said in an announcement. "Basilea does not currently intend to initiate new Phase III trials for ceftobiprole without a partner for the U.S."

That may have been expected by investors, but Basel-based Basilea's shares nevertheless tumbled more than 10% today on the news. Basilea CEO Ronald Scott said that the company is pushing ahead with plans to launch the antibiotic in Europe, with a follow-up program headed to regulators in Europe as well as the U.S. And he told Reuters that the FDA's stance will figure prominently in any discussions it has with prospective partners.

"I need to be able to see what the response from potential partners is with the clear indication from the FDA that we will have to do additional trials," Scott told Reuters.

"We are currently focused on preparing the launch of ceftobiprole for the treatment of community and hospital-acquired pneumonia in Europe with a pharmaceutical distributor or contract sales organization," Scott said in a statement. "We anticipate that ceftobiprole will be available in the first key European markets in the second half of this year."

"Another major milestone for Basilea will be the regulatory submission of isavuconazole for the treatment of invasive aspergillosis and mucormycosis," he added. "We anticipate filing in Europe mid this year and we also anticipate a mid-year filing by our partner Astellas in the U.S. We are excited to potentially adding a second anti-infective to our commercial portfolio of hospital drugs. The significant overlap in the prescribing base between ceftobiprole and isavuconazole could provide a unique opportunity to optimize the value of both drugs by leveraging significant promotional synergy."

- here's the release 
- here's the story from Reuters