Teva offers less for Bentley purchase
EXETER, N.H. Bentley Pharmaceuticals informed shareholders that they will receive a slightly lower price from purchaser Teva Pharmaceutical Industries now that the company has spun off its drug delivery business, CPEX Pharmaceuticals, according to published reports.
Teva agreed to buy Bentley for about $15.02 per share cash, or about $360 million, in March to boost its generic drug operations in Spain. It is now offering about $14.82 per share cash for Bentley.
Jerini acquired by Shire in $554 million deal
BASINGSTOKE, England Shire has agreed to buy Jerini in a deal worth $554 million cash, according to published reports. The deal will add Jerini’s new drug aimed at treating hereditary angiodema.
The drug Firazyr will enter the European market this year and is expected to generate as much as $400 million annually. The Food and Drug Administration rejected the product back in April, because the agency questioned the efficacy of the medicine. Both companies will now work on answering the questions posed by the FDA.
“It is highly likely that this is reparable in the United States,” Sylvie Gregoire, head of Shire’s human-genetics unit, said on a conference call. “Based on the fact that the European Union found that the product already works, there has to be a path forward to find sufficient evidence and analysis to approve the product.”
A late-stage test of Firazyr that failed to show a clear benefit versus a placebo “went in the same direction” as another trial that met its main goals, Gregoire said. She declined to be more specific on the FDA’s requirements. A response will be filed with the FDA within four months, the companies said.
Shire is hoping this deal will help with sales as it trying to make up for losses it will encounter next year when its best-selling drug, the hyperactivity drug Adderall XR will lose patent protection. The drug had sales last year of $1.03 billion or just about half of Shire’s total sales for the year.
Mylan gets tentative FDA approval for generic Zyvox tablets
PITTSBURGH The Food and Drug Administration has granted tentative approval to Mylan Pharmaceuticals’ application for 600 mg linezolid tablets.
The tablets are a generic version of Upjohn’s Zyvox antibiotic tablets, which had sales of about $422 million for the 12 months ended March 31, according to IMS Health data.
Mylan has 93 applications awaiting FDA approval, including 21 that may have first-to-file opportunities.