PATH (buy) 01.23.13 updated to strong buy
In last week of August we have a PDUFA for PATH Zelrix, a transdermal patch that delivers an older medicine, sumatriptan. Some subscribers are thinking about to short this company before PDUFA. My answer is: it's too risky.
"Zelrix met the pre-defined efficacy endpoints of a statistically significant improvement compared with placebo at two hours after patch application for pain free (p=0.0092), pain relief (p < 0.0001), nausea free (p < 0.0001), photophobia free (p=0.0028), phonophobia free (p=0.0002), and migraine free (p=0.0135)."
"The most common adverse events were itching, pain, and tingling at the application site. The majority of adverse events were reported as mild and transient."
I think that the probability of approval for PATH Zelrix is enough high (>70%). Transdermal delivery is safer than lung inhalation (MNKD, ALXA) and FDA will not worry about some occasional itching, pain and tingling after patch use.
These adverse events are not big deal for FDA. It’s just general side effects for any devices based on iontophoresis principle. Look at adverse effects of GlucoWatch Biographer approved by FDA.
"GlucoWatch was uncomfortable for many. In one particular study, 99 out of 99 participants experienced skin reactions during a 6-month period of use, with 48% of those reactions evaluated as moderately severe by doctors. In the same study, the primary reason (chosen by 76%) cited for the declining use of the device over the 6-month period was “skin reactions"
But it was approved by FDA. Well, this device is still not popular for use by diabetes patients.
Any pitfalls for PATH?
Some people worry that "the company says it may be asked by the FDA to conduct a skin sensitivity study."
Skin Irritation Study
In order to evaluate the skin irritation profile of Zelrix, we measured the amount of skin irritation resulting from repeated application of Zelrix in 10 healthy adult subjects. This study was successfully completed and the data included in our NDA.
May be it was not enough for FDA and they will sent one more CRL.
Disclosure: I will buy PATH at low before PDUFA.
01.23.13 by BiotechInvest
PATH is a acquisition target now: $55M cap is ridiculous for biotech with approved Zecuity (sumatriptan iontophoretic transdermal system) for the acute treatment of migraine with or without aura in adults.
Or big pharma managers become completely senile? They should buy PATH right now for 100-200% premium. PATH has innovative drug delivery technology that might be used for numerous drugs.
Disclosure: bought 10k PATH today for long position (2013 acquisition target #1).
Teva (TEVA) Acquires NuPathe (PATH) for $144 Million