Mannkind ($MNKD) officials signaled that FDA approval of its inhaled diabetes Afrezza Inhalation Powder is likely at the company's May 22 shareholder meeting.
The company played patient testimony in support of Afrezza from the combination product's April 1 advisory committee hearing in which it voted in favor of the drug 13-1 for the treatment of Type 1 diabetes and 14-0 for the treatment of Type 2 diabetes.
"We are done with CRLs [complete response letters]. We are certainly not expecting that. We just had a very good conference call last week with the agency, and we are confident that we are well on our way," COO Hakan Edstrom told investors.
After rejecting the product in 2010, the FDA did so again in 2011. Mannkind received a CRL from the FDA that year requesting two additional clinical trials due to concerns about the then next generation inhaler used to deliver the powder. The company website says that the latest version of Arezza is delivered via single use cartridges in a small handheld inhaler.
In addition, investors were once again spooked when the FDA delayed its upcoming decision deadline from April 15, 2014, to July 15, 2014. Also working against the product is Pfizer's flopped inhalable insulin product, Exubera, which was pulled from the market in 2007.
Afrezza is delivered using the Mannkind's Technosphere technology platform, allowing for rapid absorption into the arterial circulation system. According to the company's website, Afrezza delivers peak insulin levels 12 to 15 minutes after inhalation. It is meant to be taken at the start of a meal.
Company officials said the Technosphere delivery technology--which enables inhalation instead of injection--has widespread applications, but given prior setbacks and fact that the company has no other products on the market, they cannot afford to look far ahead into the future.
"The process offers a very very powerful way to deliver a drug very quickly into the blood and stabilize drugs that are not stable enough to deliver through many other technologies. A drug delivered for migraine headache now takes about an hour for a person to become comfortable. Imagine being able to deliver it [pain management medication] in two to three to four minutes and having freedom from a migraine. Wouldn't that be a big improvement? There are a lot of opportunities. But we have to concentrate first on getting Afrezza to market," said CEO Al Mann. The company has another inhaled diabetes drug in its pipeline.
In response to an investor question about pricing, Edstrom said, "We usually compare ourselves in our discussions with managed care corporations that we would be say in the insulin pen range, which is a premium to injectable insulin from a syringe, but still actually quite affordable in many ways if you compare it to the orals that are out there today."
Company officials did not give any updates on the search for a partnership with Big Pharma that could assist in the product's marketing. It will likely come following what looks like impending FDA approval.
- watch the investor meeting on YouTube