Jazz Pharmaceuticals (JAZZ -0.5%) has been the subject of takeover rumors for quite some time now thanks to its Irish domicile, but the company may have made itself even more attractive with the recent $1B deal for Gentium, Bloomberg notes.
JAZZ's operating margin and profit margin are "both [in the] top 96% of specialty pharmaceutical companies worldwide that have market values exceeding $1B," Tara Lachapelle says.
TEVA and Mylan (MYL -0.6%) are listed as "possible suitors."
Allegations of "significant violations of current good manufacturing practice," may cost Strides Arcolab a quarter of a billion in its deal with Mylan (MYL).
MYL's deal for the Bangalore-based company's injectable drugs business is now setup to exclude $250M unless the company can resolve the FDA's concerns.
Here's the language from MYL: "The final transaction terms have been restructured to include provisions such as a hold back, or contingent consideration, of $250M of the potential $1.75B total purchase price, which will be payable in whole or in part to Strides upon satisfaction of certain regulatory conditions."
Gerberry is increasingly confident "in MYL's ability to launch g-Advair in the U.S. against limited Gx competition."
"Based on extensive review of the patent portfolio of the respiratory assets acquired from PFE, we believe MYL’s inhaler technology bears close resemblance to Advair Diskus on key device attributes—which are critical to getting a substitutable generic approved," the analyst adds.
Mylan (MYL) turns in mixed results for Q3, coming up just shy on revenue but beating on the bottom line.
Sales fall 2% Y/Y (flat ex-currency impact).
Generics net sales growth by region: North America, -14%; EMEA, +11%; Asia Pacific, -2.5%.
Specialty segment sales rise 18.4% thanks largely to Epipen.
Here's MYL, summing things up: "The North American generics business accounted for the majority of the decline in new product revenues. Offsetting this decline in new product revenues, was revenue growth in the Generics segment outside of North America and double digit growth in the Specialty segment."
FY13 outlook: $2.80-2.90/share versus previous guidance of $2.75-2.95/share.
According to market chatter, BMO's David Maris apparently thinks an FDA warning letter to Agila alleging manufacturing norm violations may result in an import alert on Agila products, similar to the Ranbaxy debacle.
This would be bad news for Mylan (MYL) which acquired Agila for $1.6B. (more on the deal here)
As Forbes noted recently, the most disconcerting problem cited by the FDA revolves around "defective" gloves. Here's what the regulator had to say: "Defective gloves are especially concerning, in part, because they were used to perform manipulations directly over empty vials."
Mylan (MYL -1.7%) is suffering through a rough session, underperforming both the broad market and the NASDAQ Biotech Index.
Earlier, Morgan Stanley downgraded the shares to Equalweight from Overweight and removed a $41 price target.
Although analyst David Risinger believes the "long-term growth outlook remains robust [thanks in part to] a compelling pipeline of high-value, limited competition opportunities in the U.S.," he steps to the sidelines, saying the "market now better appreciates the strength and durability of Mylan's global platform."
Teva (TEVA) scores a favorable court ruling in the Netherlands, as a District Court of the Hague rejects the grounds of invalidity Mylan (MYL) raised against a European Copaxone patent.
Generic versions of the RRMS drug "would require a marketing authorization from the Netherlands Medicines Evaluation Board," TEVA notes, adding that the complexity of the drug opens the door for "unpredictable differences between a proposed generic product and Copaxone [which could] lead to immunogenic effects in patients." (PR)
"This proposed settlement will ensure that these important generic injectable medications ... remain available at a competitive price," the FTC says, mandating the divestiture of 11 injectable generics by Mylan (MYL) and Aglia Specialties before their $1.6B merger will get the regulator's blessing.
In its original form, the FTC said the deal would have limited competition in certain markets.