Sector News

Aradigm executives jump ship after FDA snub

February 14, 2018
Life sciences

Strapped for cash after an FDA rejection, Aradigm is hemorrhaging executives. CEO Igor Gonda, Chief Medical Officer Juergen Froehlich and Chief Financial Officer Nancy Pecota are all bidding the troubled biotech farewell.

The FDA served up a complete response letter on Jan. 29 for Aradigm’s Linhaliq, an inhaled form of ciprofloxacin for non-cystic fibrosis bronchiectasis patients with chronic lung infections. The letter recommended Aradigm run a two-year phase 3 trial before it can refile for approval, effectively dashing the company’s hopes of a cheap and quick fix.

In addition to data that the treatment has a “significant effect on clinically meaningful endpoints,” the agency had a laundry list of requests, from a human factors study, microbiology-related product quality information and a new in vitro drug release method development report, “among other things.”

The CRL came shortly after an FDA advisory committee voted 12-3 against Linhaliq. The majority of the panel did not think Aradigm provided sufficient evidence of the safety and efficacy of Linhaliq in delaying the first exacerbation in patients with chronic lung infections.

If Aradigm is to fulfill the FDA’s demands and get Linhaliq back on track, it needs to raise some serious capital, which might be a tall order with its stock price at rock bottom.

In the wake of the rejection, the company’s board settled on “temporary measures” to conserve what cash it has while it looks for more. These measures include slashing the salary of “certain officers”—including, but not limited to, Gonda, Froehlich and Pecota—by 50% and dumping its executive officer severance plan, according to an SEC filing.

Gonda, Froehlich and Pecota resigned their positions effective Sunday, while the board appointed Acting Chairman John Siebert as executive chairman and interim principal executive officer.

By Amirah Al Idrus

Source: Fierce Biotech

comments closed

Related News

March 2, 2024

Seeking blockbuster status, UCB eyes 4 new indications for psoriasis med Bimzelx in 2024

Life sciences

After 14 regulatory approvals on three continents last year, UCB is positioned to grow for “a decade-plus,” CEO Jean-Christophe Tellier said in the company’s full-year earnings press release. Meanwhile, eight regulatory reviews are ongoing.

March 2, 2024

Argenx goes again, ramping up unbranded campaign ahead of hoped-for label expansion

Life sciences

Vyvgart Hytrulo, the subcutaneous version of argenx’s FcRn blocker, is already approved in generalized myasthenia gravis (gMG). Supported by data published last year, the biotech has filed for approval in a second setting, chronic inflammatory demyelinating polyneuropathy (CIDP), and is now counting down the weeks until the FDA rules on its submission.

March 2, 2024

EuroAPI appoints new CEO and lays out restructuring plan as manufacturer’s losses mount

Life sciences

Overseeing the four-year plan, dubbed FOCUS-27, will be new chief executive officer Ludwig de Mot—an industry veteran with a track record at “companies undergoing transformation,” EuroAPI said in an earnings release Wednesday. De Mot, who will take up the reins on Friday, joined the company in January as EuroAPI’s chief transformation officer.

How can we help you?

We're easy to reach