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

June 3, 2023

Sanofi’s frexalimab shows early potential in in Phase II multiple sclerosis trial

Life sciences

In 2017, Sanofi partnered with the Lebanon, New Hampshire-based ImmuNext to develop an antibody for autoimmune diseases like lupus and multiple sclerosis, which included giving Sanofi a worldwide license to develop frexalimab. The agreement involved milestone payments upto $500 million.

June 3, 2023

Lonza to acquire Synaffix to strengthen ADC development

Life sciences

Global manufacturer for the pharmaceutical, biotech and nutraceutical markets, Lonza has announced that it has acquired Synaffix, a biotech company focused on the commercialisation of its clinical stage technology platform for the development of antibody-drug conjugates (ADCs).

June 3, 2023

BD taps Novartis, GSK alum Laura Boros to lead drug delivery device business

Life sciences

In its hunt for the new head of its pharmaceutical systems business—which makes syringes, self-injection systems and other drug delivery devices for 70% of the top 100 drugmakers in the world, according to the company—BD landed on a candidate with plenty of experience among that customer group.

How can we help you?

We're easy to reach