After additional conversations with the FDA along with a consultant expert in manufacturing, Guggenheim analyst Rohit Vanjani stands by his Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) prediction: Warning Letter or not, the agency is raring to inspect Celltrion’s API plant; the only source supplier for migraine asset fremanezumab.
With a PDUFA date with destiny set for June 16th, this looks encouraging for the chances for the drug’s green light to still hit “on-time.”
The biotech giant’s team has confirmed to Vanjani that the API plant sourcing the API for the lead migraine asset is located at Plant 2- a different, albeit “adjacent” facility to the plant that the FDA pointed out in the Warning Letter to Celltrion back in January.
“Although technically part of the same facility, and even (we believe) the same FEI number (3005241015), Plant 2 has a different address from Plant 1 (the Warning Letter site), is completely separated in terms of drug product and drug substance activities, and has a drug substance area that has not yet been inspected by the FDA,” Vanjani notes.
Moreover, “While the FDA commentary from above seems fairly definitive that the Agency would not inspect the fremanezumab API facility until the Warning Letter is resolved, the FDA in its response to us also left itself some wiggle room. Although it indicated that a Warning Letter applies to all operations under the same FEI number, the Agency also stated, ‘however, a risk-based assessment is made at the time of application submission and exceptions may apply,'” continues the analyst.
In the past, Vanjani had spoken with a consultant who digested Celltrion’s Form 483/Warning Letter. The verdict: the consultant predicted the company has odds to “still get a separate inspection at the API facility.” Yet following the inspection outcome, the consultant nonetheless found it “still possible for TEVA to receive an on-time approval for fremanezumab.”
For now, the analyst reiterates a Neutral rating on TEVA stock without listing a price target. (To watch Vanjani’s track record, click here)
Wall Street absolutely echoes Vanjani’s neutral stance on the generic drug giant, with TipRanks analytics exhibiting TEVA as a Hold. Out of 20 analysts polled in the last 3 months, 5 are bullish on the stock, 11 remain sidelined, and 4 analysts are bearish.