Aradigm (ARDM.OB) Developing Inhalable Drugs

As medical technology moves further and further away from the tools of the past, companies are developing new technologies to make life easier for people suffering from diseases that once led to extreme discomfort, or at least a severe crippling of one’s lifestyle. One of these companies, Aradigm Corporation (OTCBB: ARDM) is working on an interesting branch of drug delivery that few other companies have really paid any attention to – inhalants.”We are developing treatment for severe infections associated with chronic respiratory diseases,” Igor Gonda, CEO of Aradigm, recently told MN1. “So we’re developing an antibody treatment using an old antibiotic called ciprofloxacin, and we are putting it into a new formulation so that it will be inhaled. By applying it directly to the lung via inhalation, we expect that the incidence and severity of side-affects will be significantly reduced, and it will also provide convenience to the patient by [having him] taking it just once a day.”

Ciprofloxacin isn’t a new drug by any means. It’s generic, highly marketed form – Cipro – became a common buzzword in the pharmaceutical industry between 2000 and 2001, mainly for the drug’s effectiveness in treating and preventing anthrax. Now that the drug’s off-patent, entrepreneurs such as Gonda can work with it, improving it and altering it to suit their use.

In fact, Aradigm’s worked with Ciprofloxacin before.

“We built this formulation originally for the Canadian Ministry of Defence … for the purpose to treat or prevent inhaled anthrax,” Gonda said. “They were looking for a convenient way of delivering it by inhalation, and our doctors developed a delivery system that enables a rapid aerosolization into droplets of this drug that could then treat or prevent inhaled anthrax.”

And from that technology came Aradigm’s current product – an inhalable version of Ciprofloxacin that can help prevent and treat severe respiratory diseases such as cystic fibrosis, bronchiectasis, asthma, pulmonary hypertension, and other related respiration problems.

Unfortunately, the drug and it’s delivery system aren’t approved for public use yet. Aradigm still has years of testing ahead of it before they can even consider placing it on the common market. Still, Gonda is confident that the testing process will go by quickly.

“We expect this will be similar to the development of similar products, which is of the order of four to five years,” Gonda said. “[But] it’s an old antibiotic, so all of the stuff you would do when you discover a new drug, we won’t have to do because it’s an old drug – we’re just giving it by a different route of administration, and presenting it in a form where it is slowly released into the lungs.

“The challenges and hurdles along the way are very well-defined,” Gonda added. “You have to do your pre-clinical safety studies and typically, in our case, the pre-clinical safety is just looking at what is happening in the lung. We look at the safety of inhaling these drugs, and then there’s the Phase I to Phase III product development [for] safety efficacy, we typically would be relying a lot on the existing data.”

And that’s not the only beaker the company has on the burner. Gonda told MN1 that his company is working on inhalants to help people quit smoking, to help people with pulmonary arterial hypertension, and even with inhalable insulin for diabetics.

All of this adds up to a lot of investor interest for the company. At the end of its last quarter, the company reported over $56.4 million in cash equivalents and short-term investments.

“We were grossly over-subscribed with some high-quality investors,” Gonda said. “Our cash position is very strong. So, paradoxically, we are not trading too high above cash.”

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