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): December 11, 1996
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DYNAGEN, INC.
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(Exact name of registrant as specified in its charter)
DELAWARE 1-11352 04-3029787
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(State or other jurisdiction of (Commission file number) (I.R.S. Employer
incorporation or organization) Identification No.)
99 Erie St., Cambridge, MA 02139
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number including area code: (617) 491-2527
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No change since last report
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(Former name or address, if changed since last report)
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ITEM 5. OTHER EVENTS.
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On December 11, 1996, DynaGen, Inc. issued a press release regarding
its relationship with BioLoc, Inc. On January 6, 1997, DynaGen, Inc. issued a
press release regarding its relationship with Nastech Pharmaceutical Company
Inc. On January 14, 1997, DynaGen, Inc. issued a press release regarding its
NicCheck(R) I product. The press releases are filed as Exhibits 99.1, 99.2 and
99.3 to this Current Report on Form 8-K.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(a) Not Applicable.
(b) Not Applicable.
(c) Exhibits.
99.1 Press Release of DynaGen, Inc. dated December 11, 1996.
99.2 Press Release of DynaGen, Inc. dated January 6, 1997.
99.3 Press Release of DynaGen, Inc. dated January 14, 1997.
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SIGNATURE
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.
DYNAGEN, INC.
By: /s/ DR. INDU A. MUNI
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Dr. Indu A. Muni
President, Chief Executive
Officer and Treasurer
Dated: January 15, 1997
EXHIBIT INDEX
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Exhibit
Numbers Exhibits
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99.1 Press Release of DynaGen, Inc. dated December 11, 1996.
99.2 Press Release of DynaGen, Inc. dated January 6, 1997
99.3 Press Release of DynaGen, Inc. dated January 14, 1997
Contacts:
Jim Janis Investor Relations
Martin E. Janis & Co. Inc. DynaGen, Inc.
(312) 943-1100 (617) 491-2527
DYNAGEN, INC. ACQUIRES BREAST BIOPSY TECHNOLOGY
CAMBRIDGE, MA, December 11, 1996--DynaGen, Inc. (NASDAQ:DYGN;BSE:DYG)
today announced that it has licensed technology from BioLoc, Inc. that is
intended to improve the accuracy and efficiency and reduce the overall cost of
breast surgical biopsy procedures. BioLoc, Inc., a privately held Boston-based
company, was founded in 1995 for the purposes of developing innovative
technologies and products for screening and diagnosis of breast cancer and other
tumors.
Breast cancer is the leading cause of cancer death among women in the
U.S. aged 40 to 55. According to the American Cancer Society, approximately
180,000 new cases of breast cancer are expected to be diagnosed and
approximately 44,000 women are expected to die from the disease in 1996. Each
year, approximately 8 million women in the U.S. undergo diagnostic evaluation
for breast cancer because of physical symptom or a mammogram which shows a
suspicious lesion. Of these, approximately 750,000 undergo surgical biopsies of
the suspicious lesions at a cost of $1,500 to $5,000 per biopsy.
Core needle biopsy, the most commonly used non-surgical procedure for
diagnosis of suspicious lesions in breasts, is limited in its ability due to the
difficulty in capturing the targeted tissue and the need for multiple attempts
to obtain accurate and sufficient samples, resulting in unnecessary pain,
scarring and anxiety. The BioLoc technology is intended to overcome the
shortcomings of the core needle biopsy procedure by accurately guiding the
surgical biopsy instruments directly to the suspected tissue lesion identified
during mammography examination.
"The acquisition of the BioLoc technology fits DynaGen's strategy of
developing unique healthcare products from novel technologies acquired by the
Company from outside sources," said Dr. Indu A. Muni, President and CEO of
DynaGen, Inc. "The broad-based BioLoc technology should not only allow us to
enter the estimated $1.0 billion breast biopsy market with a differentiated
product that will be an improvement over current procedures, and also provide
additional opportunities for future innovative product offerings in cancer
screening and diagnosis."
Any statements which are not historical facts contained in this press
release are forward-looking statements that involve risks and uncertainties. The
BioLoc technology is in an early stage of development and therefore is subject
to the risks of unsuccessful development, marketing and commercialization. This
proposed product will require substantial further development, and preclinical
and clinical testing and regulatory
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approval, at a substantial cost to the Company. Additional investment by the
Company in manufacturing, marketing and sales infrastructures will also be
required prior to commercialization. No assurance can be given that these
development efforts will be successfully completed or that the products, if
introduced, will be successfully marketed. Please refer to the other risks
identified in the Company's report on Form 10-K.
PRESS RELEASE
DYNAGEN, INC. TO LICENSE NicErase(R) NASAL SPRAY TO NASTECH
CAMBRIDGE, MA, January 6, 1997--DynaGen, Inc. (NASDAQ:DYGN;BSE:DYG)
today announced that it has licensed worlwide, exclusive, rights to develop a
lobeline sulfate nasal delivery formulation, NicErase(R)-NS, to Nastech
Pharmaceutical Company Inc. (NASDAQ:NSTK). Nastech, located in Hauppauge, New
York, is dedicated to developing nasally delivered drugs for pharmaceuticals
which are currently available in an oral and/or injectable dosage forms.
Nastech, a worldwide recognized leader in patented nasal delivery technology,
was recently granted an FDA approval for Nascobal(R), a nasal gel form of
Vitamin B12. Nastech has licensing and/or development agreements for nasal spray
formulations with Bristol Myers Squibb, DuPont Merck, Pfizer and others.
Under the terms of the agreement, Nastech will be responsible for the
development of nasal formulation(s), preclinical animal studies and limited
human studies and shall bear all the development costs. DynaGen and Nastech will
cooperate in licensing the product to a third party, and will share equally in
licensing fees and in royalties.
Nasally delivered nicotine was approved for marketing this past summer
for prescription use as an aid in smoking cessation. Transdermal patch and gum
products that deliver nicotine are available on the over-the-counter market.
Lobeline exhibits many of the pharmacological effects of nicotine, although it
is considered to be non-habit forming. DynaGen has shown in clinical studies
that NicErase(R)-SL reduces symptoms of tobacco withdrawal and is now evaluating
its effectiveness as an aid in smoking cessation in a 750 subject multi-center
pivotal Phase 3 trial.
"We believe in the importance of broadening the NicErase(R) product
portfolio by expanding the variety of lobeline drug delivery systems, thereby
offering a number of options to the consumer. These alternative drug delivery
forms have proven successful in the nicotine replacement therapy market," said
Dr. Indu Muni, President and Chief Executive Officer of DynaGen, Inc. "We are
pleased to be working with Nastech, a proven leader in nasal delivery
technology, as a first step in achieving this goal of product diversification."
Any statements which are not historical facts contained in this press
release are forward-looking statements that involve risks and uncertainties.
Please refer to the risk factors regarding commercialization of products
identified in the Company's recent report on Form 10-K.
Contacts:
Jim Janis Investor Relations
Martin E. Janis & Co., Inc.. DynaGen, Inc.
(312) 943-1100 (617) 491-2527
P R E S S R E L E A S E
DYNAGEN, INC. RECEIVES FDA CLEARANCE FOR NICCHECK(R) I
CAMBRIDGE, MA, January 14, 1997 -- DynaGen, Inc. (NASDAQ:DYGN; BSE:DYG)
today announced that the U.S. Food and Drug Administration (FDA) has granted
clearance to market NicCheck(R) I, a simple in vitro diagnostic test that
detects nicotine and its metabolites in urine to determine the smoking status of
an individual and in planning appropriate smoking cessation or other medical
treatment. The test will also aid in the identification of a smoker as a low or
high nicotine consumer.
NicCheck I is the first commercially available test cleared by the FDA
that detects nicotine and its metabolites. It offers a distinct advantage over
conventional laboratory methods of nicotine detection in that it is an easy to
use, rapid 15-minute test that requires no equipment and as a result would be
cost effective for both small- and large-scale testing.
"We believe that the availability of NicCheck I will broaden the
potential utility of smoking status verification beyond insurance companies and
into newer markets that would find information on nicotine consumption levels
valuable," said Dr. Indu Muni, President and CEO of DynaGen, Inc. "To that end,
DynaGen's NicCheck I marketing activities include not only efforts directed
toward life and medical insurance companies including HMO providers, but also a
marketing strategy for smoking cessation clinics, medical practitioners and the
military."
NicCheck I consists of a narrow strip coated with chemicals that
produce a pink color in the presence of nicotine and its metabolites. The
intensity of the color increases with increasing concentration of nicotine and
its metabolites, thus providing a means to categorize a smoker relative to
actual nicotine intake. A European patent has been granted for the NicCheck
technology and a U.S. patent application is pending.
DynaGen's management believes the NicCheck I test could play an
important role in reducing overall nicotine consumption. The Company believes
that potential uses of NicCheck I include:
o verifying the success of smoking cessation programs or
therapies;
o enhancing the success rate of smoking cessation programs by
allowing identification of the optimum nicotine replacement
dose level, accomplished by matching dosage to the amount of
nicotine consumed from tobacco use;
o providing motivational feedback during smoking cessation
efforts by directly confirming the disappearance of nicotine
from the body with continued abstinence;
o determining smoking status in specific population groups, such
as applicants for life insurance;
o assessing body nicotine levels in situations in which nicotine
consumption could have significant medical consequences.
Currently used laboratory assays for the detection of nicotine can vary
in cost between $7.00 and $40.00 per test and require up to seven days to obtain
results. In contrast, the NicCheck I test is the only one suitable for on-site
use without equipment and provides results in 15 minutes. With a wholesale price
below $2.00, the cost per test for NicCheck I will be competitive to that of
existing tests.
DynaGen is now developing NicCheck II, a test similar to NicCheck I but
configured for use in detection of passive exposure to tobacco smoke. According
to the U.S. Environmental Protection Agency (EPA), each year exposure to
second-hand smoke causes up to 300,000 lower respiratory tract infections in
children who are less than one and a half years old and which consequently
hospitalizes as many as 15,000 of them. Furthermore, parents who smoke ten or
more cigarettes a day in the presence of their children can cause as many as
26,000 new cases of asthma among their children each year.
Any statements which are not historical facts contained in this press
release are forward- looking statements that involve risks and uncertainties.
Please refer to the risk factors identified in the Company's recent report on
Form 10-K, including those relating to commercialization of products and the
Company's limited manufacturing and marketing experience.
Contacts:
Jim Janis Investor Relations
Martin E. Janis & Co., Inc. DynaGen, Inc.
(312) 943-1100 (617) 491-2527
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