Gliatech Halts Distribution Of Sole U.S. Product Following Supplier Recall
This article was originally published in The Gray Sheet
Executive Summary
Clinical trials in support of premarket approval applications for Gliatech's Adcon-A and Adcon-P anti-adhesion solutions will go unaffected by the firm's decision to temporarily discontinue distribution of Adcon-L gel on account of a supplier recall. The recall also affects another gel formulation, Adcon-T/N.
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Gliatech Adcon-L
Gel anti-adhesion product for lumbar surgery is relaunched internationally May 22 following a January recall "due to potential particulates in the raw material from the aluminized paper lid liner" (1"The Gray Sheet" Jan. 15, 2001, p. 23)
Gliatech Adcon-L
Gel anti-adhesion product for lumbar surgery is relaunched internationally May 22 following a January recall "due to potential particulates in the raw material from the aluminized paper lid liner" (1"The Gray Sheet" Jan. 15, 2001, p. 23)
Gliatech
Anti-adhesion gel maker raises $15-30 mil. in a staged equity financing from Paul Capital Partners. The funds include an up-front payment of $5 mil. to be used for preparing a submission to FDA for commercial re-launch of Adcon-L anti-adhesive gel in the U.S. The company discontinued distribution of the product, approved in June 1998 to inhibit scarring following lumbar surgery, in January 2001 following a recall initiated by the product's supplier (1"The Gray Sheet" Jan. 15, 2001, p. 23). An additional $2.5 mil. will be placed following the re-launch of the product outside the U.S., slated for June 2001. Another $7.5 mil. will be paid following the product's re-launch in the U.S. The agreement includes an option for a further investment of $15 mil. Under the terms of the deal, Paul Capital Partners will receive either roughly 2.5% of net sales of the Adcon product line, or minimum annual royalty payments beginning in 2003 at a rate of $1.6 mil. a year, depending on which amount is greater. The initial $5 mil. cash infusion leaves Gliatech with about $13 mil. in cash and short-term investments. The firm reported no revenues in the first quarter (ended March 31) of 2001