The $113 million investment by Rhone Poulenc Rorer Inc. (RPR)in Applied Immune Sciences Inc. (AIS) is now complete. OnTuesday, shareholders of record in AIS of Santa Clara, Calif.,voted to approve the transaction, which was first announcedJune 3.
Under the agreement RPR acquired 37 percent of AIS'outstanding stock. To accomplish this, the French firm(NYSE:RPR) bought approximately 4.3 million shares of newlyissued AIS stock (NASDAQ:AISX). At the same time, AIS made atender offer to purchase close to 3.1 million (or 30 percent) ofits outstanding shares at $30 per share. The actual self-tenderoffer, for 3,067,509 shares, closed Tuesday. And with thecompletion of the transaction, AIS now has about 11.4 millionshares of common stock outstanding, according to corporatecontroller Jim Logue.
Meanwhile, the FDA has chosen not to approve AIS' latest510(k) on its CELLector CD5/CD8 device, which is used to selecta patient's T-cells as part of an ex vivo immune therapytreatment. A 510(k) filing is intended to be a "short form"submission on a device which is substantially equivalent oridentical to a device that FDA has already approved formarketing. In AIS' case, however, FDA believes the CD5/CD8device is not substantially equivalent to the previouslyapproved device "since the proposed indication statement...isdifferent from that of the predicate device." According to AIS'Logue, the device approved in 1989 by FDA was for selectingCD34 stem cells, while the device for which AIS submitted a510(k) in April is for selecting CD5/CD8 T cells. Still, "theprinciple of cell selection is exactly the same," he told BioWorld.FDA and AIS intend to meet within the next two to three weeksconcerning this issue.
-- Jennifer Van Brunt Senior Editor
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