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BARD/COLLAGEN'S CONTIGEN BARD TO BE PRICED AT $300/SYRINGE

This article was originally published in The Gray Sheet

Executive Summary

BARD/COLLAGEN'S CONTIGEN BARD TO BE PRICED AT $300/SYRINGE, according to Bard, which will be marketing the urinary incontinence implant. The injectable bovine collagen device was approved by FDA on Sept. 30; Bard will commence shipping the device the week of Oct. 11. At $300 per syringe, the product could generate as much as $5,400 per treated patient. Clinical studies, Bard says, found that 89.4% of all patients achieved continence in one to three treatment sessions. Each treatment uses between one and six syringes. Bard anticipates that 10,000-20,000 patients will be treated with the device in the first year of marketing. Contigen is indicated for 1-2 mil. of the 10 mil. Americans with urinary incontinence, Bard estimates. FDA's Sept. 30 approval letter notes that the device is indicated for use in the treatment of stress urinary incontinence (SUI) "due to intrinsic sphincter deficiency (poor or non-functioning bladder outlet mechanism) that may be helped by a locally injected bulking agent." FDA also indicates that the implant is intended only for "patients who have shown no improvement in their incontinence for at least 12 months." Physicians are required to administer a skin test to each Contigen candidate, 28 days prior to the scheduled treatment to check for hypersensitivity to bovine collagen; patients who are hypersensitive, which the company estimates at less than 3% of those tested in clinicals, would not receive the implant. The letter also spells out several conditions for approval. FDA notes that the company has agreed to conduct a postapproval study on the safety of the device, with the "special objective of evaluating the long-term immunological responses in young patients treated with Contigen collagen." Postapproval study reports are to be submitted annually. The device is restricted to prescription use by doctors, trained in cytoscope use, who have completed the Contigen implant training program. Satisfactory completion of the training program may be achieved in two ways: the physician may either attend a four and a half hour videoconference, or attend a preceptor training program. The first videoconference, to be broadcast at 34 downsites, will be held on Nov. 20. The preceptor training programs will be administered by a network of 100 specially trained urologists at sites around the country. Both types of training will address patient selection and diagnosis issues, as well as provide demonstrations of the injection procedure. The approval of Contigen is the result of four years of dialogue between Collagen, Bard and FDA. Collagen, the manufacturer of the device, submitted a PMA for the product in March 1989 and received an approvable recommendation from FDA's gastroenterology-urology devices panel in October 1990 ("The Gray Sheet" Oct. 22, 1990, p. 3). The PMA was subsequently amended to respond to FDA data requests in August 1991 and the fall of 1992 ("The Gray Sheet" Oct. 26, 1992, p. 15). The company received an "approvable" letter on March 19 ("The Gray Sheet" March 29, In Brief). Anticipating the approval, Collagen began Contigen shipments totaling $4.3 mil. to Bard during its fourth quarter ended June 30 ("The Gray Sheet" March 29, In Brief). Under their 1987 agreement, Collagen will manufacture the product and supply it in syringe form to Bard, which will package and distribute it under a worldwide exclusive marketing license.
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