Full Press Release Details
Pharmaceuticals Acquires Tarpan Therapeutics
Abel Becomes Chief Executive Officer
Portfolio Now Includes Therapeutics for Psoriasis, Obesity and
Lingual Spray for Pre-Procedural Sedation
YORK--(BUSINESS WIRE)--April 4, 2005-- Manhattan Pharmaceuticals, Inc.
("Manhattan" OTCBB: MHTT), has acquired Tarpan Therapeutics, Inc. ("Tarpan"), a
privately-held, New York-based pharmaceutical company, in an all stock
transaction that resulted in Tarpan shareholders owning approximately 20% of the
shares of Manhattan on a fully-diluted basis.
Abel, formerly CEO of Tarpan, has been named President and Chief Executive
Officer of Manhattan as of the completion of the transaction. Abel is a biotech
and specialty pharmaceutical veteran with more than 15 years of high-level
experience in the field. He has also been appointed to Manhattan's board of
corporate development strategy is to address various large, underserved medical
markets. Towards that goal, Manhattan now has three product candidates:
(1-34), which was being developed by Tarpan, is a peptide under development for
psoriasis and other dermatological conditions believed to be a regulator of
epidermal cell growth. An initial Phase I/II has been completed; Company
initiation of a Phase II trial is anticipated in 2005.
estrone (OE) is an orally administered small molecule in Phase I trials that has
been shown in extensive preclinical animal studies to cause significant weight
loss, without the need for dietary modifications. On February 3, 2005, under a
U.S. Investigational New Drug application (IND), Manhattan began dosing patients
in its first Phase I clinical trial being conducted in Basel, Switzerland to
evaluate the safety and tolerability of defined doses of orally administered OE
Lingual Spray (Propofol LS) is a fast-acting, quick-recovery sedative for use
during diagnostic and therapeutic procedures that is being jointly developed
with Novadel Pharma Inc. (AMEX: NVD -
January 27, 2005, the U. S. Food and Drug Administration (FDA) accepted an IND
from Manhattan for the initiation of the Phase I human clinical
is now well positioned with an advancing and diversified product pipeline," said
Doug Abel, new CEO of Manhattan. "Our products have tremendous potential in
their respective markets. I am fully committed to driving shareholder value by
assembling and deploying a world-class development team to guide our ongoing
clinical trials towards commercialization."
becoming President and CEO of Tarpan, Mr. Abel served as Vice President of the
Dermatology Business Unit at Biogen Idec where he worked from August 2000 to
November 2004. While at Biogen, he led the creation of the U.S. dermatology
commercial operation, building the team from two to more than 100 employees to
support the launch of AMEVIVE . Before that, Mr. Abel was at Allergan
Pharmaceuticals from December 1987 to August of 2000, with his most recent
position being Director of BOTOX Marketing. Mr. Abel received his A.B. in
chemistry from Lafayette College and an M.B.A. from Temple University.
led by Michael Holick, MD, PhD, Professor of Medicine, Physiology, and
Biophysics at Boston University Medical Center, recently reported positive
results from a U.S. Phase I/II clinical trial evaluating the safety and efficacy
of PTH (1-34) as a topical treatment for psoriasis. This double-blinded,
controlled trial in 15 patients comparing PTH (1-34) formulated in the Novasome
technology versus the Novasome vehicle alone, showed PTH (1-34) to be a
potentially safe and effective treatment for plaque psoriasis. Following eight
weeks of treatment, the application of PTH (1-34) resulted in complete clearing
of the treated lesion in 60% of patients and partial clearing in 85% of
patients. Additionally, there was a statistically significant improvement in the
global severity score. Ten patients continued into an open label extension study
in which the Psoriasis Area and Severity Index (PASI) was measured. In this
study, PASI improvement across all ten patients achieved statistically
significant improvement compared to baseline. No patients experienced any
significant adverse events.
the high response rate seen in psoriasis patients in the initial trial, PTH
(1-34) may have an important clinical advantage over current topical psoriasis
treatments. Manhattan intends to initiate additional clinical activities with
PTH (1-34) in 2005. Manhattan has the rights to issued and pending patents for
all topical uses of PTH (1-34) as well as access to the Novasome technology and
patents for these applications. Novasome is a registered trademark of IGI,
Inc., Buena, NJ (Amex: IG -
estrone is an orally administered form of a naturally occurring molecule shown,
in extensive preclinical animal studies, to cause significant weight loss
without the need for dietary modifications. In such studies, OE appears to be
safe and effective with no evidence of rebound weight gain after treatment has
been discontinued. OE may prove to be a safe and effective treatment for
obesity, representing a significant improvement over currently available
anti-obesity medications. On February 3, 2005, following permission from the
FDA, the first dosing of patients in a Phase I clinical trial began in Basel,
Lingual Spray is being developed as a safe and convenient, non-invasive
formulation of propofol, the world's best selling intravenous general
anesthetic. Manhattan believes that the delivery of propofol via a lingual spray
will provide many advantages over currently formulated sedatives, to the benefit
of patients undergoing innumerable diagnostic and therapeutic procedures each
year. In particular, clinicians would have the ability to tightly control the
onset, duration, and depth of sedation, with a level of reliability and accuracy
previously unknown, promoting improved procedural outcomes as well as patient
comfort and satisfaction.
pilot Phase I study of Propofol LS, conducted in the United Kingdom, was a
single-center, randomized, double-blind, placebo-controlled dose-escalating
study of propofol lingual spray in twelve healthy adult volunteers. The study
was conducted using a formulation of Propofol LS packaged in single-dose
actuators designed to deliver the formulation in a fine mist to the oral
mucousmembranes. Propofol LS was detectable in blood as early as four minutes
following spray administration and resulted in a mean time to maximum blood
concentration of approximately 30 minutes across all doses. The mean maximum
blood concentrations plateaued at the highest of the three doses tested, with
mean bioavailability of the current spray formulation up to 18% of that of the
intravenous formulation. No serious adverse events, nor dose-dependent changes
in laboratory parameters or vital signs, occurred in any group.
characteristics and stability data for the formulation of Propofol LS used in
this trial were recently presented by Manhattan at the 79th Clinical and
Scientific Congress of the International Anesthesia Research Society, in
Honolulu in March 2005.
January 27, 2005, the FDA accepted an IND from Manhattan for the initiation of
the human clinical trials that will be required for FDA approval of Propofol LS.