Medical Device Daily National Editor
NEW YORK – "Was it really launched?"
Such was the question that billionaire entrepreneur and philanthropist Al Mann used to respond to a question from a session moderator on the first day of the Piper Jaffray Health Care Conference at the New York Palace Hotel.
The question: What was Mann's reaction to the launch by Pfizer (New York) of its inhaled insulin Exubera, followed by reports that it was associated with incidents of lung cancer? – resulting in abandonment of the drug by the pharma giant.
Exubera "was the No. 3 product in their detailing," Mann told Medical Device Daily, reinforcing the fairly widely held view that Pfizer had failed to put the full force of its marketing clout behind the product.
Based on its much easier use, Exubera had been projected as the first-approved inhaled insulin to carve away a large share from injected insulin for those with diabetes. But it had posted a meager low-single-digit piece of this sector pie, even before being linked to lung cancer risk.
Mann made it clear that there should be little concern that Afresa (trade name for the Technosphere Insulin System), the inhaled insulin product being developed by MannKind (Valencia, California), will get short shrift in marketing if eventually FDA-approved.
During his presentation, he focused on this "lead product," issuing an impassioned plea concerning the need for an inhaled insulin and delivered a rousing review of the product's benefits and lack of side effects, declaring an aggressive faith in the product and the need it will fulfill.
Mann noted that besides being hit with the reports of lung cancer among a few Exubera users, the product also was found difficult to use, requiring delivery by means of a tennis ball can-sized inhaler device.
By contrast, he flourished for attendees an inhaler used to deliver Afresa, no larger than the basic asthma "rescue" inhaler.
Mann told MDD that he didn't know whether the smaller, user-friendlier size of the Afresa inhaler would be a big advantage if the drug is approved and moves to commercialization, but that certainly the inhaler required for Exubera "was a big disadvantage."
In his presentation, Mann said that diabetes was becoming a "worldwide epidemic" that is so "devastating" it could "bankrupt the world."
Needed, he said, is a "bolus of insulin" that "will metabolize within a three-hour period, rise quickly and be gone after those three hours."
Afresa meets that need, Mann said. He described it as a "unique, super-rapid-acting insulin" for better glucose control.
The drug metabolizes and reaches its "kinetic peak," Mann said, in "12 to 14 minutes [and is] almost gone in three hours."
He said the product has been used by 5,000 patients without any indications of safety problems. And he rapidly checked through a list of potential hazards, saying that none were found for Afresa, adding: "no, nothing, except success in glucose control."
The drug currently is being tested in three pivotal trials and that "a lot of data" from those trials will be made available within a couple of weeks," he said.
While not previewing any of that data, he said that the "folks analyzing the data are always smiling these days."
Mann also downplayed the implication of a cancer side effect with inhaled insulin products, saying that the lung cancers of Exubera users probably had initially occurred before use of the product and that the FDA did not see the cancers as "a sector problem" and "did not ban anything."
While he acknowledged a slight chance that Exubera may have accelerated a cancer already present, he called this unlikely and that all those found with lung cancer had been smokers.
All the finding of cancers in these patients had proved, he said, "is that smoking causes cancer" and that any cancer fears would gradually subside and not impact the marketing of any approved inhaled insulin in the future.
The abandonment of Exubera had resulted in MannKind's putting on hold its discussions with a prospective partner for the product.
But Mann in his presentation reported that the company has resumed discussions with that unnamed party, as well as with other possible partners, while declining to reveal who these might be.
And he expressed a view about such ongoing delicate negotiations that probably reflect the strategy of many companies at the conference.
"You have to be flexible in this crazy world, and you can't necessarily do what you'd like to do," Mann said, "but we've done the heavy lifting."
Piper Jaffray, in its conference book, characterized Afresa as potentially a "best-in-class" product.
However, it said that the recent history for Exubera casts doubt on MannKind's ability to find the necessary partner for Afresa, and that the prospects for the entire inhaled insulin sector are "uncertain."
Building on this concern, the session moderator asked Mann what particular skill sets will be sought in identifying any future partner.
In answer, he cited the ability "to generate a sales and marketing program to the primary physician community – we can handle the specialists" – and an ability to provide this effort "in the rest of the world."