Zosano Pharma Corporation ZSANQ

ZSAN gets a date with the FDA FOR POSSIBLE APPROVAL OF DRUG

[Humanist]

this could explain what casuing the surge ofthe zsan stock this month..

Nearly $300M, six CEOs and dead-ends later, East Bay drugmaker gets date with FDA for migraine treatment 

Steven Lo is CEO of Zosano Pharma Corp.
COURTESY OF ZOSANO PHARMA
By Ron Leuty  – Staff Reporter, San Francisco Business Times
Mar 4, 2020, 2:58pm PST Updated Mar 4, 2020, 3:03pm PST
After an often-painful, 14-year journey to use tiny needles to deliver drugs, an East Bay company could win regulatory approval by the end of the year to cut through the pangs of severe migraines.

Zosano Pharma Corp. (NASDAQ: ZSAN) said Wednesday that the Food and Drug Administration accepted its new drug application for Qtrypta, setting off a 10-month review process that will lead to an approval decision by Oct. 20 for its microneedle patch carrying the generic migraine drug zolmitriptan.

It is the 55-employee Fremont company's deepest trip into the FDA drug-approval process — and what a strange trip it's been. The microneedle technology — loading hundreds of drug-tipped needles less than one one-hundredth of an inch on a patch — was spun out of the former ALZA Corp. 14 years ago, after Johnson & Johnson (NYSE: JNJ) bought it for $10.5 billion.

Zosano has tested the technology and lined up Big Pharma partners to deliver drugs for the bone condition osteoporosis and for severe hypoglycemia as a result of diabetes treatment. Both of those projects fizzled, though, as partners Eli Lilly and Co. (NYSE: LLY) and Novo Nordisk A/S (NYSE: NVO) pulled out.

So in 2015, then-CEO Konstantinos Alataris — one of at least six CEOs as Zosano burned through nearly $300 million — opted to focus on migraines. Some 1,926 microneedles, visible only with a magnifying glass, are coated with zolmitriptan to give severe migraine sufferers pain relief within 30 minutes.

Zolmitriptan is available as a pill and as an injectable or nasal spray, marketed as Zomig. But those routes have side effects, said current Zosano CEO Steve Lo: The pill isn't good for people feeling nauseous and likely to vomit, and the self-administered injections can cause dizziness.

Enter Zosano. Within 30 minutes, Lo said, Qtryptan eliminates migraine pain. After late-stage clinical studies, Zosano submitted the drug for approval in December, and on Wednesday the agency accepted the application.
"We're thrilled that this little company here in Fremont, after all these years of developing this technology, has taken another step closer to seeing patients in the commercial setting," Lo said.
Three or four of Zosano's employees have been with the company since its ALZA days.
Qtrypta targets patients who have five or more migraines a month. Patients apply the quarter-size patch to an arm if, for example, they wake up with a migraine and need quick relief to get through the morning.
If approved, the company could build its own sales force — right now it has just one commercial employee — or look at licensing the drug to a larger company with a dedicated migraine sales team.
"I'm keeping my options open," Lo said. "There may be potential partners out there who call on migraine specialists who may license it and carry it in their bag."
Lo, who joined Zosano in October, has a background in sales, but he wouldn't say how much the company might charge for Qtrypta on the specialty drug market. it would get "premium pricing," which is above the generic price.
"We are able to price this at a level where, ultimately, we can make money from it," he said.