Apligraf User Base Continues to Grow; Number of Sites Exceeds 950.CANTON, Mass.--(BW HealthWire)--Oct. 5, 1999-- Organogenesis organogenesis /or·ga·no·gen·e·sis/ (or?gah-no-jen´e-sis) the origin and development of organs.organogenet´ic or·gan·o·gen·e·sis n. The formation and development of the organs of living things. Inc. (AMEX AMEX See: American Stock Exchange :ORG) today provided September updates on the number of centers ordering and re-ordering Apligraf(R) (Graftskin) and on US unit sales. During September, the number of centers that have ordered Apligraf continued to increase: growing from 901 in August to 959 by the end of September. The number of centers that have re-ordered Apligraf also continued to increase, from 517 in August to 551 by the end of September. US commercial unit sales of Apligraf reached 615 in September. While sales of launching medical products can decline during the summer months - due to vacationing physicians and patients - Apligraf US commercial sales for the third quarter 1999 held to the levels achieved in the second quarter. Apligraf is marketed by Novartis Pharmaceuticals Corporation. -0-
# US SITES ORDERING
# Sites # Sites
Time Period Ordering Re-Ordering
Apligraf(1) Apligraf(2)
3Q98 135 56
4Q98 316 170
1Q99 523 280
2Q99 757 427
July 1999 839 464
August 1999 901 517
September 1999 959 551
(1) Have ordered Apligraf one or more times
(2) Have re-ordered Apligraf one or more times
US COMMERCIAL UNIT SALES
Apligraf Commercial Units
Time Period Month Quarter
3Q98 548
4Q98 1070
1Q99 1585
2Q99 1755
July 1999 547
August 1999 655
September 1999 615 1817
"We are continuing to see strong interest in Apligraf, as indicated by the growing number of medical centers that have ordered and that have re-ordered the product," said Alan Tuck, Chief Strategic Officer. "Sales development is being affected by the lack of widespread standardized reimbursement for Apligraf, which is a top priority at both Novartis and Organogenesis. The case for reimbursement is strong. Apligraf has been shown to heal difficult-to-heal ulcers that have remained open with standard care, raising ethical issues about denial of product access. In addition, Apligraf can save the medical system money. A study published earlier this year by the Cleveland Clinic found that current standard care averages $2400 per month per venous ulcer patient. Apligraf has been shown to heal approximately the same amount of ulcers in three months as standard care heals in six months, making Apligraf a cost-effective therapy for many patients." "We are continuing to build the clinical support behind Apligraf, with data on Apligraf in diabetic foot ulcers presented and published, data on Apligraf in burns presented and submitted for publication, and an 18-patient study in epidermolysis bullosa Epidermolysis Bullosa Definition Epidermolysis bullosa (EB) is a group of rare inherited skin diseases that are characterized by the development of blisters following minimal pressure to the skin. completed and results forwarded to the 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. . At the same time, Novartis is expanding the marketing of Apligraf by beginning to introduce Apligraf into select European countries. In late September, Novartis sponsored a multinational Apligraf investigator meeting in New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. which included opinion leaders from the initial European markets as well as US clinicians. Next week, at the American College of Surgeons This article or section needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. national meeting in San Francisco, Novartis is sponsoring an educational symposium which will include medical presentations on Apligraf." Like human skin, Apligraf is living, all-natural and bi-layered, with both an 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 and a lower dermal layer. It contains living human skin cells - epidermal 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. and dermal fibroblasts Fibroblasts A type of cell found in connective tissue; produces collagen. Mentioned in: Skin Grafting . The keratinocytes are differentiated to form the strata of the human epidermis, including the outer stratum corneum. Unlike human skin, Apligraf does not contain 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, or 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 and sweat glands. 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. In addition to Apligraf, the pipeline includes Vitrix(TM) living soft tissue replacement product, a bioartificial liver and a vascular graft. Statements in this 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. Apligraf(R) is a registered trademark of Novartis. |
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