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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
__________
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
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Date of Report: May 29, 1998
ORGANOGENESIS INC.
(Exact name of registrant as specified in its charter)
001-09898
(Commission
File Number)
Delaware 04-2871690
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(State or other (IRS Employer
jurisdiction of Identification No.)
incorporation)
150 Dan Road
Canton, Massachusetts 02021
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (781) 575-0775
N/A
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(Former name or former address, if changed since last report.)
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Item 5. Other Events
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The Company issued a press release on May 26, 1998 to announce that the
U.S. Food and Drug Administration (FDA) granted U.S. marketing approval for
Apligraf/TM/ (Graftskin) for the treatment of venous leg ulcers. A copy of the
press release is attached and filed as Exhibit 99.1 to this Form 8-K and is
incorporated herein by reference as though fully set forth herein.
Item 7. Financial Statements and Exhibits
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(c ) Exhibits.
The following exhibit is filed as part of this report of Form 8-K pursuant
to Item 601 of Regulation S-K:
Exhibit No. Description
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99.1 Press Release, dated May 26, 1998, announcing FDA
marketing approval for Apligraf/TM/ (Graftskin).
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934,
Organogenesis Inc. has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
Date: May 29, 1998 ORGANOGENESIS INC.
/s/ Herbert M. Stein
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By: Herbert M. Stein
Title: Chairman and Chief Exectuive Officer
(Principal Executive Officer)
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Exhibit 99.1
CONTACT: CAROL HAUSNER
DIRECTOR, INVESTOR AND PUBLIC RELATIONS
APLIGRAF RECEIVES MARKETING APPROVAL IN US
FOR TREATMENT OF VENOUS LEG ULCERS
May 26, 1998, Canton, MA - Organogenesis (AMEX:ORG) announced today that
Apligraf(tm) (Graftskin) was granted US marketing approval for the treatment of
venous leg ulcers. the apligraf treatment population includes patients with
venous leg ulcers of greater than one month duration. Novartis Pharmaceuticals
Corporation will market Apligraf in the US. Organogenesis developed Apligraf
and manufactures the product for Novartis.
"We are delighted with the Food and Drug Administration's decision," said
Herbert M. Stein, Chairman and Chief Executive Officer, Organogenesis Inc.
"when the Company was founded, it was with the vision of advancing tissue
engineering to achieve new treatments for conditions inadequately served with
traditional technologies."
"Novartis is very proud to be able to offer Apligraf as the first significant
therapeutic advance for venous leg ulcers in a century," said David Epstein,
vice president, Marketing and Sales, Specialty Business Sector, Novartis
Pharmaceuticals Corporation.
Novartis Pharma AG acquired the marketing rights to Apligraf on January 17,
1996. Novartis Pharmaceuticals Corporation, located in East Hanover, NJ, is an
affiliate of Novartis AG and will market Apligraf in the US. Novartis AG is a
world leader in Life Sciences, with core businesses in Healthcare, Agribusiness
and Nutrition. Headquartered in Basel, Switzerland, the Novartis group of
companies annually invests more than 3 billion Swiss francs in research and
development. the group employs about 87,000 people and operates in more than 100
countries around the world.
Organogenesis manufactures Apligraf for Novartis at its facility in Canton, MA.
"Organogenesis' physical and human resources have already been expanded in
preparation for commercialization," said David T. Rovee, Ph.D., President and
Chief Operating Officer, Organogenesis. "We are ready for the US launch."
An estimated one million people in the US suffer from venous leg ulcers. Among
venous leg ulcers of greater than one month duration, Apligraf has been shown to
heal more ulcers, faster, than compression therapy alone. Differences in
healing rates were particularly pronounced among patients with difficult to heal
ulcers, such as ulcers that have been open for over a year. Among these
persistent wounds, Apligraf healed over twice as many patients as compression
therapy alone (47% vs. 19%) at six months.
"We are pleased with the working relationship that developed between
Organogenesis and the FDA during their rigorous review process," said Michael
L. Sabolinski, M.D., Senior Vice President, Medical and Regulatory Affairs,
Organogenesis. "We believe the experience gained with this PMA review will be
helpful as we seek approval for additional Apligraf indications, as well as when
we advance other innovative products into clinical trials."
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PAGE 2 OF 3
In addition to venous leg ulcers, an Apligraf trial has been completed in burns
and in two skin surgery applications, with data from each presented/published.
Studies in the other two major types of chronic wounds are also in progress: an
Apligraf pivotal trial is underway in diabetic ulcers and one is expected to
begin in pressure sores in 1998.
The profile of bi-layered Apligraf is unique. The product is composed of living
human epidermal cells (keratinocytes) and dermal cells (fibroblasts) organized
as in skin. This is achieved via Organogenesis' patented organotypic cell
culture technology. During the manufacture of Apligraf, the human fibroblasts
produce matrix proteins and interact with provided dermal protein to establish a
living dermal layer. Similarly, the human keratinocytes establish the five
strata of the human epidermis.
"Our goal in developing Apligraf is to provide not only the key elements of
skin - dermal cells, epidermal cells, structural protein - but also its organ-
ization, "said Nancy L. Parenteau, Ph.D, Chief Scientific Officer,
Organogenesis. "skin's organization is important to its function and contrib-
utes to the performance of skin grafts, which are used for the treatment of
an array of wound types. unlike skin grafts, however, Apligraf can be applied
without the expense and pain of harvesting skin from the patient.
Organogenesis' unique expertise in culturing and optimizing cells is demon-
strated with Apligraf. we are applying this expertise to the development of
other cellular therapies."
Organogenesis has a pipeline of skin-related programs. These include Vitrix, a
living, all natural, connective tissue replacement product. Currently in
preclinical studies, potential applications for Vitrix include replacement of
tissue loss due to surgery or injury, as well as for plastic/reconstructive and
oral surgery procedures. Organogenesis' proprietary cell culture technologies
also offer potential for gene therapies. Research programs include genetic
modifications to company tissue products to produce proteins which can
compensate for patient genetic abnormalities.
Organogenesis is also applying its Apligraf-demonstrated cell culture expertise
to develop an extracorporeal liver assist device. Liver disease afflicts
approximately 360,000 people and causes about 40,000 deaths per year in the US
alone. Currently, transplantation is the only treatment for end-stage liver
disease. Organogenesis, in collaboration with the Massachusetts General
Hospital, has a research program to develop a device that provides critical
liver function until either a transplant becomes available or the patient's own
liver regenerates. Such a device could ultimately reduce the need for liver
transplants, an invasive, expensive and risky procedure.
Organogenesis inc. designs, develops and manufactures medical therapeutics
containing living cells and/or natural connective tissue components.
Organogenesis' pipeline is focused on programs to replace, repair or support
damaged tissues and organs. In addition to Apligraf, Vitrix /TM/, and the liver
assist device, the Company's portfolio includes the Graftpatch /TM/ surgical
product (FDA cleared for marketing in the US), a vascular graft for coronary
artery bypass procedures and a tissue filler product for such applications as
female urinary incontinence and soft tissue bulking and repair.
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PAGE 3 OF 3
Full prescribing information available upon request.
Statements in this press release which express "expectation," as well as other
statements which are not historical fact, and statements as to product
compatibility, design, features, functionality and performance insofar as they
may apply prospectively, are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 and involve risks and
uncertainties. The Company's actual results may differ significantly from the
results discussed on this press release or in other forward-looking statements
presented by management. Factors that might cause such a difference include,
but are not limited to, development by the Company's competitors of new
technologies or products that are more effective than the Company's, risks of
failure of clinical trials, dependence on and retention of key personnel,
protection of proprietary technology, compliance with U.S. Food and Drug
Administration regulations, continued availability of raw material for the
Company's products, availability of product liability insurance upon
commercialization of the Company's products, ability to transition from small-
scale manufacturing to full-scale commercial production of products, uncertainty
as to the availability of additional capital on acceptable terms, if at all, and
the demand for the Company's products, if and when approved.
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