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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
Date of Report (Date of Earliest Event Reported): September 26, 1996
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DIACRIN, 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)
000-20139 22-3016912
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(Commission File Number) (IRS Employer Identification No.)
Building 96 13th Street, Charlestown Navy Yard, Charlestown, MA 01581
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(Address of principal executive offices) (Zip Code)
(617) 242-9100
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Registrant's Telephone Number, Including Area Code
Not Applicable
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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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On September 26, 1996, Diacrin, Inc. ("Diacrin") issued a press
release entitled "Genzyme Tissue Repair, Diacrin Form Joint Venture to
Advance Neurocell[Trademark] Products for Parkinson's, Huntington's
Diseases", a copy of which is attached hereto as an exhibit and
incorporated herein by reference.
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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 hereunto duly authorized.
Date: October 2, 1996 DIACRIN, INC.
(Registrant)
/s/ Mark J. Fitzpatrick
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By: Mark J. Fitzpatrick
Director of Finance and
Administration & Treasurer
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INDEX TO EXHIBITS
Exhibit
Number Description Page No.
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99.1 Press Release issued September 26, 1996
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GENZYME [LOGO] DIACRIN
tissue repair
FOR IMMEDIATE RELEASE Diacrin contact: Genzyme contacts:
September 26, 1996 --------------- ----------------
Thomas H. Fraser, Ph.D. Caren Arnstein (investors)
President and CEO 617-252-7635
617-242-9100 Cheryl Greenhouse (media)
617-252-7785
GENZYME TISSUE REPAIR, DIACRIN FORM JOINT VENTURE TO ADVANCE
NEUROCELL[TRADEMARK] PRODUCTS FOR PARKINSON'S, HUNTINGTON'S DISEASES
Genzyme Corp.'s Tissue Repair Division (Nasdaq: GENZL), Cambridge, Mass., and
Diacrin Inc. (Nasdaq: DCRN), Charlestown, Mass., today announced the formation
of a 50-50 joint venture to speed development and commercialization of two
NeuroCell[Trademark] porcine neural cell products for transplantation into
people with advanced Parkinson's or Huntington's disease.
Both products, NeuroCell-PD for Parkinson's disease and NeuroCell-HD for
Huntington's disease, are in Diacrin-sponsored phase I clinical trials at major
medical centers. In animal studies published in the November 1, 1995, issue of
Nature Medicine and in other scientific journals, Diacrin demonstrated that
grafts of fetal pig neural cells integrate into a host's brain tissue and
restore damaged neural circuitry. Other researchers have shown promising results
by transplanting human fetal brain cells into patients with Parkinson's disease.
Under the terms of the joint venture agreement, Genzyme Tissue Repair will
provide 80 percent of the next $50 million in funding for the two products.
After that, all costs will be shared equally. The joint venture plans to
manufacture the products, and Genzyme Tissue Repair will provide sales and
marketing services on a cost-
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Genzyme Tissue Repair, Diacrin Form Joint Venture - page 2
reimbursement basis. Profits of the joint venture will be shared equally by the
two parties.
To provide initial funding for the joint venture, Genzyme Corp.'s board of
directors has approved the allocation of up to $20 million in cash from
Genzyme's General Division (Nasdaq: GENZ) to the Tissue Repair Division, in
exchange for an increase in the number of Tissue Repair designated shares
allocated to the General Division. The number of Tissue Repair shares will be
determined by dividing the amount of allocated cash by the average market value
of a share of Tissue Repair common stock during the 20 trading days prior to the
date the funding is drawn down.
"Diacrin has developed a remarkable new technology that could revolutionize
the treatment of neurodegenerative diseases," said Gregory D. Phelps, executive
vice president of Genzyme Corp.
"This technology fits perfectly with Genzyme Tissue Repair's other
cell-based therapies. It is an extremely important expansion of our product
portfolio into the field of neural tissue repair, helping us accomplish our goal
of building a comprehensive tissue repair business."
Said Thomas H. Fraser, Ph.D., Diacrin's president and chief executive
officer: "We believe that Genzyme has a proven track record in the development,
manufacturing, and marketing of novel biological products. This is the ideal
partnership to effectively move NeuroCell-PD and NeuroCell-HD toward
commercialization so that they will be available to patients as soon as
possible."
Parkinson's Disease
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Approximately 500,000 Americans have Parkinson's disease, and another
50,000 cases are diagnosed each year. Patients experience a variety of motor
symptoms, including tremors, falls, rigidity, slowed movements, and difficulties
with speech and swallowing. Therapy with the drug L-dopa is initially effective
but begins to lose its efficacy in 6 to 12 years. Approximately 150,000 people
in the United States
(more)
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Genzyme Tissue Repair, Diacrin Form Joint Venture - page 3
are in the late stages of the disease, during which L-dopa provides little
benefit. The resulting medical expenses, early retirement, and nursing home care
cost $5.6 billion a year.
NeuroCell-PD is aimed at these late-stage patients. A phase I study of 12
patients is being conducted at Lahey Hitchcock Clinic, Burlington, Mass., and
Boston University Medical Center. Eleven patients have already been treated. If
the phase I trial is successful, the companies plan to seek approval from the
U.S. Food and Drug Administration to start a pivotal phase II/III trial next
year.
The initial results of the phase I trial are similar to those obtained in
Parkinson's patients treated with human fetal cells, some of whom showed marked
improvement in symptoms and restored efficacy of L-dopa. Commercialization of
treatments using human fetal cells is not practical, because of supply
constraints, ethical concerns, and inconsistent quality of the human cells.
Huntington's Disease
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A genetic disorder usually not evident until middle age, Huntington's
disease is always fatal. It causes uncontrolled movements, gait and postural
defects, and dementia. Approximately 20,000 Americans are in the late stages of
this disease, and an additional 1,500 are diagnosed each year.
NeuroCell-HD is in a 12-patient phase I clinical trial at Lahey Hitchcock
Clinic, Boston University Medical Center, and Brigham and Women's Hospital,
Boston. Two patients have been treated so far.
With both products, rejection of the porcine cells can be prevented with
the immunosuppressive drug cyclosporin. Diacrin has a license to patented
technology developed at Massachusetts General Hospital, Boston, designed to
protect the donor cells from the host's immune system without the need for
immunosuppressive drugs.
Diacrin has applications pending for use and composition-of-matter patents
for both NeuroCell-PD and NeuroCell-HD. Diacrin has also applied to the FDA for
(more)
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Genzyme Tissue Repair, Diacrin Form Joint Venture - page 4
orphan drug status for both products.
One of the world's top five biotechnology companies, Genzyme focuses on
developing innovative products and services for major unmet medical needs. The
company's Tissue Repair Division is a leading developer of biological products
for the treatment of cartilage damage, severe burns, and chronic skin ulcers.
The Tissue Repair Division has its own common stock intended to reflect the
division's value and track its performance.
Diacrin develops and produces transplantable porcine cells for the
treatment of intractable human diseases characterized by cell dysfunction or
cell death. Product candidates in preclinical development include NeuroCell-FE
for focal epilepsy, NeuroCell-CD for cognitive disorders, HepatoCell[Trademark]
for hypercholesterolemia and liver failure, CardioCell[Trademark] for repair of
damaged heart muscle, and IsletCell[Trademark] for diabetes.
This news release contains forward-looking information, including
statements about the progress of clinical trials and the planned
commercialization of NeuroCell-PD and NeuroCell-HD. Actual results may differ
materially based on a number of factors, including scientific results obtained
in the clinical trials, the timing and content of decisions made by the FDA,
market acceptance of any approved products, and the accuracy of the companies'
information about the potential value of other therapies in development for
Parkinson's disease.
# # #
Genzyme's releases are on the World Wide Web at http://www.prnewswire.com. They
are also available from Genzyme's fax-on-demand service at 1-800-436-1443 within
the United States or 1-201-521-1080 outside the United States.
