Apligraf Sales Exceed 1000 Units in May; A New Monthly Sales Record.Business Editors and Health/Medical Writers CANTON, Mass.--(BW HealthWire)--June 2, 2000 Organogenesis Inc. (AMEX AMEX See: American Stock Exchange :ORG) today announced that Apligraf(R) US commercial sales reached 1032 units in May 2000, its strongest month to date. By month's end, over 1600 medical centers across the US had ordered Apligraf and over 950 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 `00 1538 889
May `00 1632 956
(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 `00 853
May `00 1032
"We are seeing sustained momentum behind Apligraf sales development," said Philip M. Laughlin, President and Chief Executive Officer. "While sales continue to be affected by reimbursement issues, important progress is being made towards gaining the diabetic foot ulcer indication. The May 8 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 recommended approval of Apligraf for use in diabetic foot ulcers and we are working with the FDA to gain a final decision as quickly as possible. Additionally, Novartis and Organogenesis are continuing activities towards gaining standardized reimbursement of Apligraf." Mr. Laughlin continued, "The Apligraf diabetic foot ulcer pivotal trial results will be presented at the American Diabetes Association The American Diabetes Association, or the ADA, is an American health organization providing diabetes research, information and advocacy. Founded in 1940, the American Diabetes Association conducts programs in all 50 states and the District of Columbia, reaching hundreds of (ADA Ada, city, United States Ada (ā`ə), city (1990 pop. 15,820), seat of Pontotoc co., S central Okla.; inc. 1904. It is a large cattle market and the center of a rich oil and ranch area. ) national meeting being held in San Antonio the second week of June. Novartis will also be sponsoring an educational symposia "New Directions in the Management of Diabetic Foot Ulcers" at the ADA meeting, as well as a separate educational symposium at the Wound Healing Society meeting next week." 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 dermal replacement product, a coronary 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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