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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
January 17, 1996
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(Date of Report; Date of Earliest Event Reported)
Organogenesis Inc.
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(Exact name of registrant as specified in its charter)
Delaware
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(State or other jurisdiction of incorporation)
0-15246 04-2871690
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(Commission File Number) (IRS Employer Identification No.)
150 Dan Road, Canton, Massachusetts 01876
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(Address of principal executive offices) (Zip Code)
(617) 575-0775
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(Registrant's telephone number, including area code)
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Item 5. Other Events.
On January 17, 1996 Organogenesis Inc. ("Organogenesis") and Sandoz
Ltd. ("Sandoz") announced an agreement between the parties that gives Sandoz
licensing rights to Graftskin[TRADEMARK], a manufactured human skin product.
Under the terms of the agreement, Sandoz will have exclusive worldwide
marketing rights to Graftskin[TRADEMARK] and Organogenesis will supply Sandoz'
global requirements for the product. Sandoz will provide Organogenesis up to a
total of $37.5 million in equity investments, milestone payments and research
support, including an initial $5 million equity investment at $23.37 per share
and additional equity investments of $10.5 million upon achievement of
specified milestones. The initial equity investment will give Sandoz
approximately 1.6% of the outstanding shares of Organogenesis. The agreement
also provides for manufacturing payments and royalty revenues.
Item 7. Financial Statements and Exhibits.
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<TABLE>
(c) Exhibits.
<CAPTION>
Exhibit No. Exhibit
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<S> <C>
99.1 Press Release, dated January 17,
1996, announcing Graftskin[TRADEMARK] License
Agreement between Organogenesis and
Sandoz and equity investment in
Organogenesis by Sandoz.
</TABLE>
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
Date: January 31, 1996
/s/ HERBERT M. STEIN
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By: Herbert M. Stein
Title: Chief Executive Officer
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SANDOZ PHARMA LTD Exhibit 99.1
CH-4002 BASLE/SWITZERLAND [SANDOZ LOGO]
TEL 061 324 1111
TELEGR. SANDOPHARM BASEL
TELEX 96 50 50 11
TELEFAX
FOR IMMEDIATE RELEASE
SANDOZ LTD. SANDOZ ORGANOGENESIS INC.
In Switzerland: In the U.S.: In the U.S.
Bert Cahannes Janice McFarland Carol Hausner
011-41-61-324-9001 201-503-8428 617-575-0775
SANDOZ LICENSES GRAFTSKIN[TRADEMARK] FROM ORGANOGENESIS
14 MILLION CHRONIC-WOUND SUFFERERS AND OTHERS ARE
POTENTIAL BENEFICIARIES OF THE FIRST LIVING SKIN EQUIVALENT
Basel, Switzerland and Canton, Massachusetts, USA, January 17, 1996 -- Sandoz
Ltd. and Organogenesis Inc. today jointly announced the execution of an
agreement that gives Sandoz the licensing rights to Graftskin[TRADEMARK], a
manufactured human skin product.
Under the terms of the agreement, Sandoz will have exclusive worldwide
marketing rights to Graftskin[TRADEMARK], and Organogenesis will supply Sandoz'
global requirements for the product. Sandoz will provide Organogenesis up to a
total of $37.5 million in equity investments, milestone payments, and research
support, including an initial $5 million equity investment at $23.37 per share
and additional equity investment of $10.5 million upon achievement of specified
milestones. The initial equity investment will give Sandoz approximately 1.6%
of the outstanding shares of Organogenesis. The agreement also provides for
manufacturing payments and royalty revenues.
The Graftskin[TRADEMARK] premarket approval application (PMA) for venous stasis
ulcers is currently under review by the U.S. Food and Drug Administration. The
FDA has granted "expedited review" status to this PMA, which means it will
receive priority in review. According to FDA guidelines, expedited review
status is reserved for products that offer the potential for "clinically
meaningful benefit," or "a revolutionary advance," over available treatments.
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2
Developed by Organogeneis, Graftskin[TRADEMARK] is the first living skin
equivalent to be submitted to the FDA for marketing approval. Potential
beneficiaries of Graftskin[TRADEMARK] could include up to 14 million
individuals worldwide, most of whom suffer from chronic wounds which do not
respond well to standard treatment. In addition to venous ulcer patients,
others who potentially may benefit from Graftskin[TRADEMARK] include patients
with diabetic ulcers, pressure sores, burn victims, and individuals undergoing
dermatologic surgery for conditions such as removal of skin cancers and
birthmarks. These additional indications will be subject to further premarket
approval applications.
Daniel L. Vasella, M.D., Chief Executive Officer of Sandoz Pharma Ltd., said:
"Sandoz is pleased to have entered into this agreement for Graftskin[TRADEMARK]
since we are dedicated to bringing innovative products to market, and
Graftskin[TRADEMARK] offers a unique treatment for chronic venous ulcers.
This agreement represents just one of the many efforts Sandoz is making to
expand its presence in the dermatology area."
Herbert M. Stein, Chief Executive Officer of Organogeneis and Chairman of the
Board, said, "We are delighted to have Sandoz as the global marketing partner
for Graftskin[TRADEMARK]. In addition to its strong sales and marketing
presence in the U.S. and internationally, Sandoz also has tremendous expertise
in marketing breakthrough medical products. We feel Sandoz has the capacity to
rapidly achieve the full commercial potential of Graftskin[TRADEMARK]."
ABOUT SANDOZ LTD.
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Sandoz is a global, research-based pharmaceuticals and nutrition group focused
on health, with additional activities in crop protection, seeds, and
construction technologies. In 1994, Group sales exceeded $11.6 billion.
Headquartered in Basel, Switzerland, Sandoz Pharma Ltd., the pharmaceutical
division of Sandoz, is one of the world's leading companies in the fields of
immunology (transplantation), skin diseases, bone diseases, cancer,
cardiovascular diseases, and diseases of the central nervous system. The
company's commitment to innovation through research is reflected in its
expenditure on R&D (17.4% of Pharma sales) in addition to financial support for
studies to expand the U.S. Graftskin[TRADEMARK] market.
ABOUT ORGANOGENESIS
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Organogenesis, headquartered in Canton, Massachusetts, designs, develops, and
manufactures innovative medical therapeutics using living human cells and
natural connective tissue components. Its products are designed to foster new
tissues that restore, maintain, or improve biological function. Organogenesis
is the first company to have successfully taken a medical product comprised of
living cells from concept through clinical trials to regulatory submission for
marketing approval with the FDA. The company's strategy is to partner with
major companies having worldwide sales and marketing capabilities in relevant
therapeutic areas in order to maximize the commercial success of its products.
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3
FACTS ABOUT GRAFTSKIN[TRADEMARK]
OVERVIEW
Graftskin[TRADEMARK] is a living skin equivalent consisting of two layers. The
upper layer contains human keratinocytes (the most common cell type in human
epidermis), which form a well differentiated epidermal layer. The lower dermal
layer contains the human skin's most common structural protein -- collagen --
with its most common cell type -- fibroblasts.
MARKET IMPLICATIONS
- - Sandoz Ltd. will have exclusive worldwide marketing rights to
Graftskin[TRADEMARK]
- - Organogenesis will supply Sandoz's global requirements for the product
- - Potential beneficiaries of Graftskin[TRADEMARK] include up to 14 million
individuals worldwide, most of whom suffer from chronic wounds. The original
premarket application (PMA) is limited to venous stasis ulcers.
CLINICAL TRIAL RESULTS
Results of a large-scale, pivotal clinical trial, presented at the 1995
Symposium on Advanced Wound Care, show that:
- - Graftskin[TRADEMARK] provides biologic wound closure contributing directly
to the wound-healing process.
- - Graftskin[TRADEMARK] therapy heals more patients and in a shorter time than
standard compression therapy.
- - Graftskin[TRADEMARK] was shown to be highly effective, even in
difficult-to-heal ulcers, such as deep dermal ulcers and ulcers of extended
duration.
- - Graftskin[TRADEMARK] was demonstrated to have an excellent safety profile,
with no sign of tissue rejection.
MARKET APPROVAL STATUS
- - In November 1995, the FDA determined that the Graftskin[TRADEMARK] PMA for
venous stasis ulcers, as submitted by Organogenesis, was "sufficiently
complete to permit a substantive review," and officially filed the PMA.
The PMA was given a filing date of October 4, 1995 by the FDA.
- - This PMA was previously granted "expedited review" status by the FDA.
According to FDA guidelines, expedited review status is reserved for
products that offer the potential for "clinically meaningful benefit" or
"a revolutionary advance," over available treatments.
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