Aradigm Corporation (NASDAQ:ARDM) and Puma Biotechnology, Inc. (NASDAQ:PBYI) both served up key updates in the biotechnology space this week, with each relating to a respective in-house development program.
Here’s what happened with each company and what comes next for both.
Aradigm
Aradigm announced on Thursday that the FDA Antimicrobial Drugs Advisory Committee did not recommend approval for one of its lead development assets, a drug called Linhaliq. Linhaliq is a potential therapy for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung Pseudomonas aeruginosa infections.
Bronchiectasis is a disease that causes permanent enlargement of parts of the airways of the lung and is generally characterized by symptoms such as shortness of breath, coughing up blood and chest pain. It’s particularly common in patients with cystic fibrosis but this therapy is targeting patients without cystic fibrosis. These types of infections are common in patients that have been hospitalized for more than one week and, when combined with something like NCFBE, they can quickly become life-threatening.
Linhaliq is a mixture of both liposome encapsulated and unencapsulated ciprofloxacin. Ciprofloxacin is a commonly used antibiotic and the company is hoping that by mixing it with a liposome encapsulated formulation and allowing it to be inhaled by the patient, it can treat NCFBE patients without the safety concerns of systemic administration.
The advisory panel recommended against approval and this decision is based on a discrepancy between two late stage trials. One trial is called ORBIT-3 and the other ORBIT-4. ORBIT-3 failed to demonstrate efficacy, while ORBIT-4 succeeded. Despite the success of ORBIT-4, committee members felt that the NDA in question doesn’t addresses the reasons behind the drug performing differently in two very similar trials.
While the FDA doesn’t have to follow the recommendation of its panel, in this instance, it’s unlikely that it will diverge from the recommendation. Chances are that Aradigm is going to have to conduct another trial and hope that the outcome is in line with that of ORBIT-4, or, alternatively, dig deeper into the data from both trials and see if there is any obvious reason as to why one succeeded and the other failed.
The FDA’s action date for the application is January 26, so all eyes are on this date near term.
Puma Biotechnology
Puma is another advisory committee driven move but, in this instance, the news comes out of Europe. On Thursday, it was announced that following feedback from the Committee for Medicinal Products for Human Use (CHMP) Scientific Advisory Group on Oncology (SAG) it will modify the label for its European iteration of a drug called neratinib.
This is a breast cancer drug that already picked up approval in the US but has demonstrated certain safety concerns that prompted the company to refine its target population to make it a last resort treatment for those who have no other choice.
The restrictions don’t really limit the market all that much – breast cancer, and especially the type of breast cancer this drug targets, HER2-positive, generally requires a spectrum of treatments as it progresses – but if the regulatory authorities feel that it needs to alter its labeling in order to pick up a positive review ahead of the European Medicines Agency (EMA) coming to a final decision on approvability, it’s seemingly well worth complying.
The CHMP is set to conduct an oral hearing to discuss the MAA for neratinib on January 23, so this becomes the next major catalyst associated with both this development program and Puma as a company near term.
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