Full Press Release Details
Pharmaceuticals Completes Merger Transaction with Ariston
NEW YORK, NY MAR 11, 2010 -
Manhattan Pharmaceuticals, Inc. (OTCBB: MHAN) today announced it has entered
into a definitive agreement and plan of merger and completed the merger
transaction with Ariston Pharmaceuticals, Inc., a privately-held, specialty
pharmaceutical company. As a result of the merger, Ariston became a
wholly owned subsidiary of Manhattan Pharmaceuticals.
terms of the merger agreement, Manhattan Pharmaceuticals, upon the closing,
issued 7.06 million shares of its common stock to Ariston stockholders and
debtholders (which represents approximately 6% of Manhattan Pharmaceuticals
common stock on an issued and outstanding basis). Under the terms of
the merger agreement, Manhattan Pharmaceuticals could issue up to an additional
24.74 million shares upon completion of certain development milestones relating
to the Ariston product candidates. If all the product development
milestones are reached, former Ariston stockholders and debtholders will own 22%
of Manhattan Pharmaceuticals common stock on a currently issued and outstanding
addition, Manhattan Pharmaceuticals has reserved 43.63 million shares of its
common stock for the possible future conversion of $16.45 million of Ariston's
outstanding convertible debt. The debt holders have no recourse to
Manhattan Pharmaceuticals for repayment. They do have the right to
convert their notes into shares of Manhattan Pharmaceuticals common
all Ariston product candidate development milestones are reached, and if all of
Ariston's convertible debt converts into Manhattan Pharmaceuticals common stock,
Manhattan Pharmaceuticals could ultimately issue a total of 75.4 million shares
to the Ariston stockholders and debtholders. For the complete terms
of the merger agreement, including an explanation of the Ariston product
candidate development milestones, please see Form 8-K to be filed on or about
Management & Board of Directors
connection with the Ariston transaction, Manhattan Pharmaceuticals will appoint
Malcolm Morville, PhD, formerly President and CEO of Ariston Pharmaceuticals, as
Executive Chairman of Manhattan Pharmaceuticals. Michael G.
McGuinness will remain Manhattan Pharmaceuticals' Chief Operating and Financial
Officer and Mary C. Spellman, MD, will also continue to serve as Head of
Dermatology and Drug Development. Michelle Carroll will serve as Vice
President, Corporate Development.
the Ariston transaction, Manhattan Pharmaceuticals expects that its Board of
Directors will consist of 7 directors: Malcolm Morville, PhD and
David Shimko, formerly directors of Ariston, Michael G. McGuinness, and Timothy
McInerney, Richard Steinhart, Neil Herskowitz, and Douglas Abel, who will remain
as Manhattan Pharmaceuticals Directors. Michael Weiser and Malcolm
Hoenlein have resigned from the Manhattan Pharmaceuticals board in connection
with the Ariston transaction.
completion of the Ariston transaction, Manhattan Pharmaceuticals' pipeline has
been expanded from two to four product candidates.
- A novel, non-pesticide treatment for pediculosis (head lice). In
the U.S., Manhattan Pharmaceuticals, through a joint venture with Nordic Biotech
(the "Hedrin JV"), is pursuing the development of Hedrin as a Class III
prescription medical device. The company expects to initiate a
pivotal clinical study for Hedrin the second quarter of 2010 and to file a
Premarket Authorization with the FDA in 2010. Hedrin is the leading
head lice product in Europe. To date it has launched in 32 countries
and, according to Thornton & Ross Ltd., has achieved 2008 annual sales
through its licensees of approximately $48 million ( 35 million) at in-market
public prices, garnering approximately 23% market share across
Europe. According to the American Academy of Pediatrics an estimated
6-12 million Americans are infested with head lice each year. The
Hedrin JV is currently working to commercialize Hedrin in the U.S. and
AST-726 - A nasally delivered
treatment for Vitamin B12
deficiency. AST-726 has demonstrated pharmacokinetic equivalence to
the current gold standard treatment for Vitamin B12
remediation, a marketed intramuscular injection product. The company
expects to initiate a pivotal clinical study for AST-726 in
2010. Manhattan Pharmaceuticals believes that AST-726 may enable both
a single, once-monthly treatment for maintenance of normal Vitamin B12 levels in
deficient patients, and more frequent administration to restore normal levels in
deficiency. Further, the company believes that AST-726 could offer a
convenient, painless, safe and cost-effective treatment for Vitamin B12
deficiency, without the need for intramuscular injections. More than
9 million people in the US are deficient in Vitamin B12,
indicating substantial market potential for a facile, convenient, safe and
effective treatment that can replace the need for painful and frequent
intramuscular injections or other less than fully effective delivery forms. The
company also believes that substantial market opportunity also exists
AST-915 - An orally delivered
treatment for essential tremor. AST-915 is being studied under a
CRADA agreement with the National Institutes of Health and a Phase 1 clinical
study is currently underway in essential tremor patients. Essential
tremor is the most common involuntary movement disorder, affecting between 0.4
and 5% of the population, with increasing incidence as people
age. Essential tremor is characterized by involuntary shaking of the
hands, arms, head, voice, and upper body. The most disabling tremors occur
during voluntary movement, affecting common skills such as writing, eating and
drinking. There is no cure for essential tremor and the currently
available drug therapies do not work in certain patients, produce at best a 50%
response in others and have significant side effects. Manhattan
Pharmaceuticals believes AST-915 may provide a new treatment option for this
serious and prevalent disorder.
GEL - A topical gel for the
treatment of mild psoriasis. In 2007, Manhattan Pharmaceuticals
developed a topical gel that was used as the placebo in a Phase 2a clinical
study versus topical PTH (1-34). This proprietary topical gel showed
evidence of psoriasis improving properties and the company believes it may be
effective enough to market as an over-the-counter (OTC) treatment for mild
psoriasis. The National Psoriasis Foundation estimates that 5-7
million Americans suffer from psoriasis, with approximately 4.4 million being
classified as mild. According to Datamonitor, only half of psoriasis
sufferers have been formally diagnosed by a physician, therefore, the market
could be much larger. Currently there is no cure for
psoriasis. There are a number of OTC creams and ointments that reduce