LAMP chase will begin today: NEWS FDA approval OUT:
Permission to Market LAM IPM(TM) Wound Gel Received From the FDA By LAM Pharmaceutical Corporation
LEWISTON, N.Y., Apr 18, 2002 (Canada NewsWire via COMTEX) -- LAM
Pharmaceutical, Corp. (OTC Bulletin Board: LAMP; FRANKFURT STOCK EXCHANGE: LAM;
BERLIN: LAM), lampharm.com, is pleased to announce that the Company
has received permission to market its proprietary, patented wound product -- LAM
IPM(TM) Wound Gel-, pursuant to the Section 510(k), (FDA assigned number
K020325). The letter from the FDA, the Department of Health & Human Services,
Division of General, Restorative and Neurological Devices, Office of Device
Evaluation, Centre for Devices and Radiological Health, was dated April 15, 2002
and was received by the Company on April 17, 2002.
LAM IPM(TM) Wound Gel has demonstrated in human trials an 88.0% rate of
effectiveness in creating the necessary environment for wound healing of
refractory (hard to heal) leg and foot ulcers. The incidence of these types of
ulcers is increasing rapidly, as the baby boom generation ages and people live
longer. Last year, 26 million ulcers were reported in the United States alone,
of which approximately 6 million have been estimated as being chronic, difficult
to heal and requiring thousands of dollars in total treatment costs.
Alan Drizen, Chief Executive Officer of LAM stated, "I am most gratified to
receive the permission to market LAM IPM(TM) Wound Gel, especially since it
comes earlier than anticipated. While most important to LAM by itself, the
approval of this significant product for sale sets the stage for
commercialization of other major products in our portfolio."
Joseph Slechta, LAM President and Chief Operating Officer added, "Now that we
have received permission to market our IPM(TM) wound product, we will
immediately proceed with its introduction to market. The target date for the
product launch has been set for June 3, 2002."
"L.A.M. IPM(TM) WOUND GEL"
L.A.M. IPM(TM) Wound Gel is a clear, viscous, odorless, aqueous gel composed
principally of sodium hyaluronate, a derivative salt of Hyaluronic acid.
Hyaluronic acid is a naturally occurring molecule found in various parts of the
body. Hyaluronic acid used in L.A.M. IPM(TM) Wound Gel is derived from avian
sources. The gel has demonstrated to be of value in the management of certain
skin ulcers and wounds where maintaining a moist environment is supportive of
the healing process. In human skin hyaluronic acid is involved in such important
biological functions as tissue hydration and proteoglycan organization
(formation of proteins and sugars).
INDICATIONS
For over-the-counter use
L.A.M. IPM(TM) Wound Gel is suitable for:
-- Minor abrasions
-- Minor cuts
Under the supervision of a healthcare professional.
L.A.M. IPM(TM) Wound Gel is suitable for exuding wounds such as
-- Leg ulcers
-- Pressure ulcers
-- Diabetic ulcers
-- Management of mechanically or surgically debrided wounds.
CONTRAINDICATIONS
Do not administer to patients with known hyper-sensitivity to this product or to
avian proteins.
WARNINGS
-- The prolonged use of the product may give rise to sensitization
phenomena. Should this occur, discontinue use of the product
immediately and consult a healthcare professional.
-- To prevent the possibility of cross infection, a tube of L.A.M.
IPM(TM) Wound Gel should be used on one patient only.
-- Direct contact with the wound and the container should be avoided.
-- Do not use in case of package damage.
-- Do not use the product after the expiry date noted on package.
-- Keep out of reach of children
PRECAUTIONS AND OBSERVATIONS
For over-the-counter use:
-- If the wound appears to get larger after the first three or four
applications, discontinue use and consult a healthcare professional.
-- Should you observe irritation, reddening, inflammation, maceration
(whitening of the skin), hyper granulation (excess tissue formation)
or sensitivity (allergic reaction), consult a healthcare
professional immediately.
-- Consult a healthcare professional if:
1. Signs of infection occur, increased pain, bleeding, wound
drainage.
2. There is a change in wound color and/or odor.
3. The wound does not begin to show signs of healing in a few
days.
4. Any other unexpected symptoms occur.
-- When using L.A.M. IPM(TM) Wound Gel in combination with other wound
care products, always consult a healthcare professional.
Under the supervision of healthcare professional:
-- The treatment of any leg ulcers, pressure ulcers, diabetic ulcers
and surgically debrided wounds should be under the supervision of a
healthcare professional.
-- Appropriate supportive measures should be taken where indicated
(e.g. use of graduated compression bandaging in the management of
venous leg ulcers or pressure relief measures in the management of
pressure ulcers).
NOTE: The control of blood glucose as well as appropriate pressure relief
measures should be provided with diabetic foot ulcers.
-- Colonization of chronic wounds is common and it is not a
contraindication to the use of L.A.M. IPM(TM) Wound Gel. The
dressing may be used on infected wounds under medical supervision
together with appropriate therapy and frequent monitoring of the
wound by the healthcare professional.
HOW TO USE
1. First clean the ulcer or other wound with normal saline solution
(other cleansing agents are not recommended). Normal saline
solution can be obtained through your local pharmacy.
NOTE: Debridement (surgical cleansing) of the wound may be performed at
the discretion of a healthcare professional.
2. Remove excess moisture with a dry gauze.
3. Apply L.A.M. IPM(TM) Wound Gel liberally into the cavity of the
ulcer or wound site and the surrounding area.
4. Apply a non-stick gauze dressing (Telfa(R) pad, Vaseline(R)
Petroleum Gauze or other suitable non-stick pad) over the wound
site.
NOTE: Once L.A.M. IPM(TM) Wound Gel is applied the gel should not be
touched.
5. Finally, wrap a self-adhesive bandage over the non-stick gauze
dressing.
6. Repeat the entire process of wound cleansing, applying L.A.M.
IPM(TM) Wound Gel and bandaging daily.
7. Visit a healthcare professional as recommended.
STORAGE
Store in a cool, dry place at room temperature. Temperature should not exceed 35
degrees C/95 degrees F. Protect from freezing.
FURTHER INFORMATION
For further information, contact:
L.A.M. Pharmaceutical, Corp.,
Professional Services Department
755 Center Street, Unit 5
Lewiston N.Y. 14092
1-877-526-7717 or (716) 754-2002.
lampharm.com
In case of an emergency contact your healthcare professional.
Telfa(R) is a registered trademark of Tyco Health Care Group, L.P.
Vaseline(R) is a registered trademark of Cheseborough-Pond's, Inc.
IPM(TM) and Ionic Polymer Matrix(TM) are trademarks of L.A.M. Pharmaceutical,
Corp.
L.A.M. IPM(TM) Wound Gel is protected by one or more of the following patents:
5,897,880; 6,120,804; 6,007,843; 6,063,405.
About LAM Pharmaceutical, Corp.
LAM Pharmaceutical, Corp. is a biomedical company with laboratories in Lewiston,
New York, and a business office in Toronto. LAM focuses on the development and
commercialization of novel wound healing and transdermal drug delivery systems
that offer patients, among other benefits, safer and more effective treatment
for a variety of serious diseases. The technology is based on an original Ionic
Polymer Matrix(TM) technology (IPM(TM)), a proprietary and patented combination
(a total of ten U.S. issued and approved patents) of electrically charged and
non-charged molecules with wound-healing properties. IPM(TM) technology is also
appropriate for use with well-established drugs, allowing for the sustained
delivery of greater amounts to the target areas than is otherwise possible by
oral means, thus prolonging therapeutic activity.
The main ingredient of the Ionic Polymer Matrix(TM) technology is a derivative
of hyaluronic acid, a molecule normally found in the skin, joints and bones.
Hyaluronic acid is a non-immunogenic (the body does not react to it) and it is
involved in such important biological functions as tissue hydration and
proteoglycan organization (formation of proteins and sugars) to optimize tissue
repair and prevent tissue aging. As well, hyaluronic acid is present in high
concentrations in fetal skin where wound healing is rapid and leaves little
scarring.
- LAM IPM(TM) Wound Gel is a clear, viscous, aqueous, odorless gel composed
principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. LAM
IPM(TM) Wound Gel has demonstrated in both human and animal trials to be of
significant value in the management of certain skin ulcers and wounds where
maintaining a moist environment is supportive of the healing process. In human
skin, Hyaluronic acid is involved in such important biological functions as
tissue hydration and proteoglycan organization (formation of proteins and
sugars).
As of April 1, 2002, LAM had ten issued and allowed patents in the United
States. LAM IPM(TM) Wound Gel is protected by one or more of the following
patents: 5,887,880; 6,120,804; 6,007,843; 6,063,405. All referenced patents have
been issued to LAM Pharmaceutical, Corp. by the United States Patent Office and
have subsequently been filed on a global basis or are in the process of global
filing.
The Company's list of products under development include the following:
LAM IPM(TM) - Post Surgical Gel -- An advanced IPM(TM) (ionic polymer matrix)
designed for use on fresh surgical wounds (stapled or sutured) for the purpose
of creating an environment conducive to improved healing.
LAM IPM(TM) - Extreme Dry Skin Formula -- A gel formula designed to saturate the
stratum corneum, to relieve the symptoms of eczema, dermatitis and extremely dry
skin.
LAM IPM(TM) - Female Sexual Dysfunction Matrix -- a product that provides
enhanced lubrication while also allowing the external structures of the female
genitalia to be flushed with greater blood supply.
LAM IPM(TM) - Motion Sickness Matrix -- a product currently under development,
which is a topically applied delivery system, using a patch, of a well-known
motion sickness drug.
LAM IPM(TM) - Arthritic Pain Matrix -- is a clear aqueous gel that contains a
well proven off patent drug.
For more information please visit our website at lampharm.com or send
us an e-mail at info@lampharm.com to receive the latest information and press
releases.
Statements in this press release regarding our business which are not historical
facts are "forward-looking statements" that involve risks and uncertainties
which could cause the Company's actual results and financial condition to differ
materially from those anticipated by the forward-looking statements. These risks
and uncertainties include, but are not limited to uncertainties relating to the
need for additional funds and corporate partners, product liability, dependence
on third parties for manufacturing and marketing, the early stage of products
being marketed or under development, patent risk and competition.
Company Contact: Anthony Vespa
Toll Free in N. America (877) LAM-7717
(877) 526-7717
Tel (416) 633-7047
Fax (416) 633-2363
Website: lampharm.com
Press Contact: Barry S. Kaplan
Barry Kaplan Associates
(732) 747-0702
FAX (732) 758-1837
Email: smallkap@aol.com
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