|
 |
| |
Tamarkin Pharmaceutical Innovation Ltd.
OVERVIEW
Tamarkin Pharmaceutical Innovation Ltd. is a biopharmaceutical company
engaged in the discovery and development of drugs, including topical
treatments for skin disorders as well as systemic diseases, including
life threatening ones. Our novel synthetic "Dual Action Pro-drugs"
(DAPDRUGs), are programmed to penetrate the target organ and simultaneously
exert a plurality of therapeutic effects.
Our most advanced product, TU-2100, is an innovative topical medication,
based on the DAPDRUG concept. It was discovered by our founder and
CEO, Dr. Dov Tamarkin. TU-2100 was designed to treat acne, psoriasis,
seborrhea and hair growth disorders, which afflict many millions of
people worldwide, for which there are currently no satisfactory treatments.
TU-2100 has been tested in a Phase II clinical trial and found effective
in alleviating the symptoms of acne without causing skin irritation.
We are currently in the process of evaluating TU-2100's effects in
psoriasis and seborrhea.
In line with our pipeline expansion strategy, we have recently initiated
a joint project with a Weizmann Institute - based company, BALM Ltd.,
whereby our DAPDRUG concept is utilized in the creation of new peptide
drugs, aimed to treat bacterial and fungal infections, as well as
cancer. Initial results indicated that these new molecules possess
very potent antibacterial activity, with no anticipated side effects.
MANAGEMENT
The names and ages of our existing executive officers and directors
as of August 2001 are as presented below.
| Name |
Age |
Position |
| Dov Tamarkin, Ph.D. |
47 |
Chairman of the Board, CEO and
R&D Director |
| Arie A. Giniger, Ph.D. |
59 |
Director of Business Development
and Director |
| Mr. Yaakov Ben-Bassat |
64 |
Director |
| Mr. Gerald Dogon |
63 |
Director |
| Stanley Hirsch, Ph.D. |
46 |
Director |
Dov Tamarkin, Ph.D. Chairman of the Board, CEO & R&D Director.
Dr. Tamarkin has been active in innovative drug development
since 1987, when he started up the R&D of Clilco Ltd. In 1990, he
joined Teva Pharmaceuticals as a senior R&D section manager and in
1994 became VP of R&D at Portman Pharmaceuticals. Dr. Tamarkin is
the founder of Tamarkin pharmaceutical Innovation Ltd., and the inventor
of the company's technology. Dr. Tamarkin holds a Ph.D. degree in
chemistry from The Hebrew University of Jerusalem, Israel.
Arie A Giniger, Ph.D., Business Development Director.
Dr. Giniger spent 5 years at Schering-Plough R&D. During
the years of 1975-1990 he served as COO and CEO at Taya, Isreal Cosmetics
Ltd. In 1991 Dr. Giniger joined Careline (Agis) as managing director
and currently he is a senior partner at Taya Investment Company Ltd.
Dr. Giniger holds a Ph.D. degree in pharmaceutical sciences from Columbia
University, New York.
Mr. Yaakov Ben-Bassat, Director.
Mr. Ben-Bassat is an Aeronautical Engineer with 18 years
experience in R&D in aerospace and 22 years experience in senior management
positions. Among his positions: Project Manager and chief engineer
of the Kfir fighter aircraft; Corporate VP and General Manager of
the Aircraft Manufacturing Div. of I.A.I; VP of Clal Industries; Chairman
and CEO of several public and private companies, including Urdan,
Lipski, Middle East Tube, United Steel Mills, etc.
Mr. Gerald Dogon, Director.
Mr. Dogon is an economist, who served 17 years as vice president
and CFO at Scitex Corp. Ltd. (since 1970). Thereafter he held senior
positions at Indigo Ltd., the international division of Israel General
Bank, Nilit Ltd., Mul-T-Lock Ltd. and DSP Communications Inc. Mr.
Dogon holds a Bachelors degree from the University of Cape Town, South
Africa.
Stanley Hirsch, D.Phil. Director.
Dr. Hirsch is the President and CEO at CBD Technologies,
Inc. From 1989 to 1997 he held various management positions at the
Eryphile Group, as vice president, with responsibilities as general
manager in several companies in the group and at Portman Pharmaceuticals,
Inc., as general manager. Dr. Hirsch was awarded the degree of D.Phil.
in immunology from Oxford University.
MARKET OPPORTUNITY
The market potential for our dermatological productsis vast and the
competition is limited mainly to old medications with known adverse
effects. This is a multi-billion dollar market, as follows:
|
USA |
Worldwide |
| Acne (mild to moderate)
|
$ 0.7 Billion |
$ 2-3 Billion |
| Psoriasis |
$ 1 Billion |
$ 2-3 Billion |
| Hair Growth Disorders |
$ 1-2 Billion |
$ 3 Billion |
| Total |
$ 4-5 Billion |
$ 8-10 Billion |
OUR SOLUTION
DAPDRUGs
Dual Action Pro-Drugs (DAPDRUGs) are TPI's innovative therapeutic
molecules. The DAPDRUG family has unique and most desirable medical
qualities. They can be used effectively to treat dermatological, inflammatory
and infectious disorders. DAPDRUGs penetrate the skin effectively,
liberate active moieties inside the skin and treat the disorders in
multiple ways. DAPDRUGs can be marketed on several categories, such
as: prescription medications, OTC (over the counter) products and
cosmetics. Our first DAPDRUG, TU-2100 is in an advanced stage of development,
as detailed below. Further DAPDRUGS have been synthesized in our laboratory
and our biological studies revealed that three of them inhibit keratinocyte
proliferation at micro-Molar concentrations, suggesting their potential
use in psoriasis and other hyperproliferation disorders. The synthesis
and evaluation of additional compounds is underway.
The Lead Product - TU-2100
TPI's lead product, TU-2100, is a DAPDRUG, aimed to treat acne,
psoriasis, seborrhea and hair growth disorders. Due to its unique
molecular structure, it seeps deep into the skin and simultaneously
exerts anti-proliferative, antibacterial, anti-inflammatory and sebostatic
effects. Particularly, TU-2100 can penetrate the sebaceous gland,
acne's origin and affects the overproduction of oil, while also treating
the bacteria and the inflammation. TU-2100 was tested in clinically,
and found effective in alleviating the symptoms of acne, psoriasis
and seborrhea, without causing skin irritation.
TU-2100 is Safe and Effective in the Treatment of Oily Skin
A "cosmetic" clinical study was undertaken to assess the safety
of TU-2100 lotion and to determine its effect on sebum excretion rate
(SER). The study, which was performed by Dr. A. Kligman, a leading
dermatologist from the University of Pennsylvania. Sebum excretion
rates declined by 30-44%, reaching normal levels within 4 weeks of
treatment in all study volunteers. This observation is particularly
important, in light of the current belief that "No topical therapies
influence the production of sebum" (Leyden J, New England Journal
of Medicine, 1997). Thus, TU-2100 possesses a unique mode of action.
It does not appear to act like any of the existing topical agents
in the alleviation of excessive sebum excretion.
TU-2100 is Safe and Effective in Acne Therapy
A double blind, placebo controlled Phase II study in acne patients
revealed that TU-2100 10% is safe and effective. The study, which
was randomized, double blind and placebo controlled, was conducted
in three European university hospitals, in full compliance with the
international regulations of clinical studies.
TU-2100's effect was noted soon after commencement of treatment, reaching
statistically significant reduction in lesion count after three weeks.
Fifty-nine percent (59%) reduction in lesion count was recorded after
12 weeks of treatment. The Placebo reduced lesion number by 23%, with
no statistical significance comparing to baseline. TU-2100 was found
to be non-irritant. No occurrence of skin irritation was noted in
the TU-2100 10% group.
As presented below, the response to TU-2100 treatment was very high
- all patients experienced 25% improvement and 10 out of 12 had more
than 50% decrease of total lesion count.
|
Vehicle |
TU-2100 10% |
p-Value |
| |
Responders |
Non Responders |
Responders |
Non Responders |
|
| >25% Decrease of Total Lesion
Count |
7 |
6 |
12 |
0 |
<0.001 |
| >50% Decrease of Total Lesion
Count |
6 |
7 |
10 |
2 |
0.097 |
Comparison with Current Topical
Acne Therapy
In an effort to assess the clinical significance of TU-2100's
effects, we compared our Phase II results with published data
on the effect of Avita Gel 0.025% and Retin A, which is considered
the "gold standard" in acne. As illustrated, Retin A therapy
exerted 37% reduction of lesions after 6 weeks of treatment
and 45% improvement after 12 weeks. From our Phase II study
results, TU-2100 seems to be superior to Retin A in several
ways: |
 |
All TU-2100-treated patient respond to treatment
TU-2100 acts faster than the current medications.
TU-2100's magnitude of effect seems to be higher than other topical medications.
TU-2100 inhibits sebum production (and consequently, skin oiliness), unlike other topical medications.
TU-2100 is non-irritant.
TU-2100 is Potentially Effective in Seborrheic Dermatitis
Based on the results of the described above "cosmetic" study,
we initiated a Phase II study in seborrheic dermatitis patients.
The results of this study may expand the applicability of TU-2100
and further increase the value of this project in terms of licensing
arrangements.
TU-2100 is Potentially Effective in Psoriasis (initial results)
In an exploratory experiment, five patients with psoriasis
were treated with TU-2100 Gel. The interim results look very promising.
3 of the five patients had marked clearance of the psoriatic plaques
and skin thickness was markedly reduced after 7-10 days of treatment.
Additional Active Dermatological Agents
Following the success of our lead product, new dual action
pro-drugs have recently been synthesized and tested for their effects
on keratinocyte cell cultures. Our initial studies have revealed
that three such compounds inhibit keratinocyte proliferation at
micro-Molar concentrations, suggesting their potential use in psoriasis
and other diseases of cell proliferation. The synthesis of additional
compounds is underway in our laboratories.
Modified Antimicrobial and anti-cancer Peptides
Recently, we have initiated a 50:50 joint project with a Weizmann
Institute - based company, BALM Pharmaceutical Ltd., whereby our
DAPDRUG technology principles are utilized in the creation of new
peptide drugs, aimed to treat bacterial and fungal infections, as
well as cancer. Initial results indicated that these new molecules
act against gram-negative bacteria, e.g., Pseudomonas aeroginosa
and other pathogens, which are involved in several systemic infectious
diseases, including life threatening ones.
Current Product Portfolio
The following Table outlines the Company's project portfolio, objectives
and milestones:
| Project |
2001 |
2002 |
2003 |
2004 |
| TU-2100 - Acne |
Phase IIa |
Phase IIb |
Phase III |
Registration |
| TU-2100 - Seborrheic dermatitis
and Psoriasis |
Pilot Phase II |
Phase II |
Phase II |
Phase III |
| Additional Active Dermatological
Agents (new DAPDRUGS) |
Synthesis; Feasibility studies |
Preclinical studies; Phase
I |
Phase II |
Phase II |
| Antibacterial Peptides |
Synthesis; Feasibility studies
|
Preclinical studies |
Phase I (lead compound) |
Phase I/II |
OUR STRATEGY
We have made a strategic decision to be a leading drug development company, utilizing our proprietary DAPDRUG platform. While our original focus was solely in dermatology, we gradually recognized that the DAPDRUG concept is effective in systemic therapy. With this idea in mind, we initiated our collaboration with BALM Pharmaceuticals. We are currently evaluating other joint ventures in the same fashion.
In order to expedite our potential opportunities we undertake the following actions:
Accelerate global adoption of our solution by continuing to form and develop strategic alliances and corporate partnerships with leading pharmaceutical companies.
Enhance our R&D capabilities and expand our project line.
Continue to develop additional molecules from the DAPDRUG platform.
In-license new projects.
BUSINESS DEVELOPMENT - TOWARDS STRATEGIC PARTNERSHIPS
Our intensive efforts in business development are on-going.
In July 2001, we signed an MOU with the Italian company Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. (IBI). IBI will conduct and fund Phase IIb and subsequently, Phase III studies with our lead molecule TU-2100. The drug will then be registered in Europe and IBI will have exclusive right to sell TU-2100-based products in Italy. IBI has paid us an initial upfront payment and will pay further sums according to milestones, as well as royalties on sales upon commercialization.
In November 2002, TPI signed an additional license agreement with Giangzhoe Consun Pharmaceutical Corp, a Chinese company, granting Consun marketing rights for TU-2100 based cosmetics in China, Hong Kong and Taiwan. Further negotiations with companies around the globe are underway.
Side by side with the primary track of TU-2100, new molecules from the DAPDRUG technology platform have been synthesized and tested successfully in laboratory experiments.
PROPRIETARY RIGHTS
Patents, to protect the use TU-2100 and related dual action pro-drugs and their uses in skin disorders have been prepared and submitted worldwide. In January 2001, our first patent, covering a broad range of therapeutic molecules and a wide domain of applications patent issued in the USA (6,180,669), Australia and Singapore. We expect further approvals in the very near future.
|
|
|
