Apligraf Monthly Unit Sales Sustained Above 800; Apligraf for Diabetic Foot Ulcers Confirmed for May 8 FDA Advisory Panel Meeting.Business Editors and Health/Medical Writers CANTON, Mass.--(BW HealthWire)--May 2, 2000 Organogenesis Inc. (AMEX AMEX See: American Stock Exchange :ORG) today announced that Apligraf(R) US commercial sales reached 853 units in April. This was the second highest monthly sales level since launch. By month's end, 1538 medical centers across the US had ordered Apligraf and 889 centers had re-ordered the product at least once. Apligraf is marketed by Novartis Pharmaceuticals Corporation.
# US Sites Ordering
# Sites # Sites
Time Period Ordering Re-Ordering
Apligraf(a) Apligraf(b)
3Q98 135 56
4Q98 316 170
1Q99 523 280
2Q99 757 427
3Q99 959 551
4Q99 1195 687
1Q00 1450 842
April 2000 1538 889
(a) Have ordered Apligraf at least once since launch
(b) Have re-ordered Apligraf at least once since launch
US Commercial Unit Sales
Apligraf
Time Period Commercial Units
Month Quarter
3Q98 548
4Q98 1070
1Q99 1585
2Q99 1755
3Q99 1817
4Q99 2192
1Q00 2555
April 2000 853
The Company also announced the Apligraf diabetic foot ulcer regulatory submission is confirmed for FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Advisory Panel review on Monday, May 8, 2000. The General and Plastic Surgery Devices Panel will be reviewing this PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy supplement seeking to expand approval of Apligraf to include use in diabetic foot ulcers. "Progress continues to be made with Apligraf in its first indication, venous leg ulcers," said Philip M. Laughlin, President and Chief Executive Officer. "We are pleased that this second potential indication for Apligraf, diabetic foot ulcers, has been scheduled for FDA Panel review. Diabetic foot ulcers represent a significant medical need due to the risk of serious infection and amputation amputation (ăm'pyətā`shən), removal of all or part of a limb or other body part. Although amputation has been practiced for centuries, the development of sophisticated techniques for treatment and prevention of infection has greatly . Activities are also continuing by Novartis and Organogenesis towards gaining standardized reimbursement for Apligraf." Like human skin, Apligraf is made of skin cells and structural protein. The lower dermal layer combines collagen and human fibroblasts Fibroblasts A type of cell found in connective tissue; produces collagen. Mentioned in: Skin Grafting (dermal cells), which produce additional matrix proteins. The upper epidermal Epidermal Referring to the thin outermost layer of the skin, itself made up of several layers, that covers and protects the underlying dermis (skin). Mentioned in: Antiangiogenic Therapy, Histiocytosis X epidermal layer is formed by prompting human keratinocytes Keratinocytes Cells found in the epidermis. The keratinocytes at the outer surface of the epidermis are dead and form a tough protective layer. The cells underneath divide to replenish the supply. (epidermal cells) first to multiply and then to differentiate to replicate the architecture of the human epidermis. Unlike human skin, Apligraf does not contain structures such as blood vessels, hair follicles Hair follicles Tiny organs in the skin, each one of which grows a single hair. Mentioned in: Alopecia or sweat glands or other cell types such as Langerhans' cells, melanocytes Melanocytes Skin cells derived from the neural crest that produce the protein pigment melanin. Mentioned in: Malignant Melanoma, Skin Pigmentation Disorders melanocytes , macrophages Macrophages White blood cells whose job is to destroy invading microorganisms. Listeria monocytogenes avoids being killed and can multiply within the macrophage. or lymphocytes. Novartis Pharma AG has global Apligraf marketing rights. Organogenesis Inc. designs, develops and manufactures medical products containing living cells and/or natural connective tissue. The Company's product development focus includes living tissue replacements, cell-based organ assist devices and other tissue-engineered products. The Organogenesis research pipeline includes the VITRIX(TM) living soft tissue replacement product, an off-the-shelf vascular graft and a liver assist device. Statements in the press release which are not historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 and involve risks and uncertainties. There can be no assurance as to the rate of development of Apligraf sales, that standardized reimbursement of Apligraf will be gained in a timely manner, if at all, or that Apligraf will be approved for diabetic foot ulcers in a timely manner, if at all. Apligraf(R) is a registered trademark of Novartis. |
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