Momenta (MNTA) and Pfizer (PFE) are unexpectedly giving Teva Pharmaceutical (TEVA) some breathing room on a generic version of MS drug Copaxone after a manufacturing delay announced late Friday for a Teva rival drug — prompting Teva stock to rebound Tuesday.
In the stock market today, Teva stock lifted as much as 7.8% to a six-week high of 37.94, closing Tuesday's regular session at 36.64, up 4.1%. Momenta stock, on the other hand, tumbled 15% to 16.05, crashing below its 50-day moving average. Momenta is partnering with Novartis (NVS) subsidiary Sandoz on the generic drug. Novartis stock slipped 0.21% Tuesday to 77.04.
The Food and Drug Administration issued Pfizer a warning letter following an inspection of one of its fill/finish factories. That factory is a key piece of Momenta/Sandoz's supply chain for 40-milligram Glatopa, the generic rival to Copaxone.
Momenta says it's unlikely the FDA will approve the 40-mg drug in Q1.
"Under FDA policy, an approval of the application is dependent on the satisfactory resolution of the compliance observations at the Pfizer facility used to make the final product," Momenta said late Friday.
IBD'S TAKE: Teva stock is ranked ninth in IBD's 17-company generic drugs industry group with a Composite Rating of 28 out of a best-possible 99 based on key growth metrics. Head to IBD's Stock Checkup for a list of the top five generic drugmakers.
Analysts broadly pushed back their timelines for Glatopa's 40-mg launch to Q2 and Q3. The letter doesn't restrict the production or shipment of 20-mg Glatopa already marketed by Sandoz in the U.S.
The delay could also put Mylan (MYL) and partner Natco in the lead on generic filing, Mizuho analyst Irina Koffler wrote in a research report. She has an underperform rating and 27 price target on Teva stock.
"Mylan previously indicated to us that the Copaxone first-filer status is shared, which may unexpectedly put Mylan's molecule in the lead if it can gain FDA approval ahead of Momenta," she wrote. "We currently model both generic launches in the second half of 2017."
Mylan stock edged up 0.59% Tuesday to 42.30.
Koffler expects Momenta's 40-mg Glatopa to launch in Q3 and Mylan's product in Q4.
RBC analyst Randall Stanicky called the delay on Glatopa 40-mg opportune for Teva.
RELATED:
Acorda Must Stave Off Mylan, Teva Generics To Protect Ampyra
Teva Maintains 2017 Guidance Despite Copaxone Patent Losses; Q4 Tops
Teva CEO Steps Down After Patent Losses, Bribery Settlement; Stock Dives
