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.
FDA to increase security for committee members in advisory meetings
WASHINGTON The Food and Drug Administration is planning on beefing up its security at advisory committee meetings, in hopes of restoring order after an incident at a recent meeting, according to The Regulation Policy Market Report.
According to reports, an intoxicated speaker in the audience at a recent meeting began a threatening rant. This isn’t the first time there have been disturbances at an advisory committee, they usually occur when the drug in question is used to treat rare-or life-threatening disease.
While the FDA hasn’t made a formal announcement of the policy changes, Office of New Drug director John Jenkins discussed the new procedures at the Drug Information Association’s annual meeting last week.
“We have put in place some new measures to help improve security at meetings,” Jenkins said. “If we anticipate that there may be an increased need for security at a particular meeting because it is a particularly controversial topic, we may have additional security procedures.”
Those procedures include:
1) Creating a physical barrier by roping off the committee from the public. The intent, Jenkins said, is “to put some separation between those who might become agitated in the audience and committee members.”
2) Increasing the presence of security guards in the committee room—both in uniform and street clothes.
3) Reading a statement at the start of the meeting about “good rules of behavior.”
FDA approves Eisai’s Aciphex for ages 12 and up
WOODCLIFF LAKE, N.J. The Food and Drug Administration has approved Aciphex for treatment of gastroesophageal reflux disease in adolescents age 12 and older, Tokyo-based Eisai’s North America subsidiary announced Monday.
Aciphex, known generically as rabeprazole sodium, is available in 20 mg tablets for treating GERD for up to eight weeks.
Eisai discovered and developed the drug and promotes it in the United States with PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals.