-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, OuqXIDaq+QiLjZt8sVePQtizHmEYdDi29gNKYt3qKxZgVlwDVi0LXhgJLD9mx7n1 MlsR6YtEeHodbP8nKmRzuQ== 0001144204-07-035831.txt : 20070710 0001144204-07-035831.hdr.sgml : 20070710 20070709181125 ACCESSION NUMBER: 0001144204-07-035831 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070709 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070710 DATE AS OF CHANGE: 20070709 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MANHATTAN PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001001316 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 363898269 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32639 FILM NUMBER: 07970449 BUSINESS ADDRESS: STREET 1: 810 SEVENTH AVENUE STREET 2: 4TH FLOOR CITY: NEW YORK STATE: NY ZIP: 10019 BUSINESS PHONE: (212) 582-3950 MAIL ADDRESS: STREET 1: 810 SEVENTH AVENUE STREET 2: 4TH FLOOR CITY: NEW YORK STATE: NY ZIP: 10019 FORMER COMPANY: FORMER CONFORMED NAME: ATLANTIC TECHNOLOGY VENTURES INC DATE OF NAME CHANGE: 20000330 FORMER COMPANY: FORMER CONFORMED NAME: ATLANTIC PHARMACEUTICALS INC DATE OF NAME CHANGE: 19960703 8-K 1 v080579_8k.htm
UNITED STATES
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): July 9, 2007
 
Manhattan Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
 
Delaware
 
001-32639
 
36-3898269
(State or other jurisdiction
of incorporation)
 
(Commission File Number)
 
(IRS Employer
Identification No.)
 
810 Seventh Avenue, 4th Floor
New York, New York 10019
(Address of principal executive offices) (Zip Code)

(212) 582-3950
(Registrant's telephone number, including area code)
 
Not applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 
 

 

Item 8.01 Other Events
 
Manhattan Pharmaceuticals, Inc.’s (the “Company”) press release dated July 9, 2007, which announced the results of the Company’s Phase 2a studies for Oral Oleoyl-estrone and information on accessing a management discussion teleconference to be held at 8:30am ET on Tuesday, July 10, 2007, is attached hereto as Exhibit 99.1 and incorporated by reference herein.

Item 9.01. Financial Statements and Exhibits

(d)
Exhibits.

Exhibit No.
 
Description
99.1
 
Manhattan Pharmaceuticals, Inc. press release dated July 9, 2007.
 
 
 

 

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 hereunto duly authorized.
 
 
 
 
 
MANHATTAN PHARMACEUTICALS, INC.
 
 
 
 
 
 
Date: July 9, 2007
By:  
/s/ Michael G. McGuinness
 

Michael G. McGuinness
 
Chief Financial Officer
 
 
 

 
 
EXHIBIT INDEX

Exhibit No.
Description
99.1
 
Manhattan Pharmaceuticals, Inc. press release dated July 9, 2007.
 
 
 

 
EX-99.1 2 v080579_ex99-1.htm
Exhibit 99.1
 
News From:
 
Contact:
Douglas Abel
President & Chief Executive Officer
Manhattan Pharmaceuticals, Inc.
212.582.3950
Michelle Carroll
Corporate Communications
Manhattan Pharmaceuticals, Inc.
212.582.3950
 
Manhattan Pharmaceuticals Announces Results of
Phase 2a Studies for Oral Oleoyl-estrone
 
·  
Results Fail to Demonstrate Meaningful Placebo Adjusted Weight Loss; Obesity Program to be Discontinued
 
·  
Company to Focus Efforts on Development of Its Pipeline of Four Clinical Stage Products
 
·  
Company Will Seek to Outlicense Propofol Lingual Spray
 
·  
Management discussion call to be held tomorrow, Tuesday, July 10, 2007 at 8:30 AM ET
 
NEW YORK, NY JULY 9, 2007 - Manhattan Pharmaceuticals, Inc. (AMEX: MHA) today announced results of the company’s two Phase 2a clinical trials of oral Oleoyl-estrone (OE). The results of both randomized, double-blind, placebo-controlled studies, one in common obesity and the other in morbid obesity, demonstrated no statistically or clinically meaningful placebo adjusted weight loss for any of the treatment arms evaluated. Based on these results, Manhattan Pharmaceuticals will discontinue its OE programs in both common obesity and morbid obesity.
 
Both studies also showed dose-dependent increases in estrone and estradiol and concomitant suppression of testosterone. In addition, thyroid hormone changes were observed as well as changes in other hormones related to reproductive function (i.e., FSH, LH, prolactin, sex hormone binding globulin). Despite these changes returning to baseline during off therapy periods they preclude exploration of higher doses of OE.
 
“Unfortunately, the study results were disappointing but definitive,” said Douglas Abel, president and chief executive officer of Manhattan Pharmaceuticals.  “With all our development programs, Manhattan Pharmaceuticals is committed to the practice of excellent science and the highest standard of clinical research to ensure both accurate outcomes and patient safety.  Based on positive preclinical data on OE, confirmatory results recently reported by Columbia University, and the Phase 1 clinical profile, we had been encouraged regarding the compound’s potential as an effective weight loss agent.  However, due to the findings from the two Phase 2a trials, we believe it is the correct decision to discontinue our work with OE.  These well designed Phase 2a trials produced quality data that permits us to make a clear cut decision at an early stage of the program.”
 
 
 

 
 
Going forward the company intends to continue with the advancement of its four clinical stage product candidates, and the exploration of other opportunities in the areas of dermatology/immunology and endocrine/metabolic disorders. The four clinical-stage product candidates include topical PTH (1-34) for psoriasis, as well as recently-acquired Altoderm for atopic dermatitis (eczema), Altolyn for mastocytosis, and Hedrin for head lice.
 
In keeping with this strategic focus, Manhattan Pharmaceuticals also announced today that it intends to pursue appropriate out-licensing opportunities for Propofol Lingual Spray for pre-procedural sedation.

Management Discussion Call and Webcast
 
Manhattan Pharmaceuticals will hold a management discussion call and webcast to describe the OE results in further detail, and to discuss the advancement of its four clinical stage product candidates at 8:30 AM ET on Tuesday, July 10, 2007. To access the call, please dial 800.289.0468 (domestic) or 913.981.5517 (international) five minutes prior to the start time. A replay of the call will be available approximately 2 hours following the event and will last until Friday, July 13, 2007 at 6:00 PM ET. To access a replay, please dial 888.203.1112 (domestic) or 719.457.0820 (international), and provide the pass code 1451123. To access the live audio webcast please visit the “Investors & Media” section of the company’s website located at www.manhattanpharma.com. An archived webcast will be available on the website approximately 2 hours after the event and will be available in the archive until Friday, July 13, 2007 at 6:00 PM ET.

About Manhattan Pharmaceuticals, Inc.
 
Manhattan Pharmaceuticals, Inc., (Amex: MHA) is a clinical-stage pharmaceutical company that acquires and develops novel, high-value drug candidates primarily in the areas of dermatologic/immunologic and endocrine/metabolic disease disorders. With a pipeline consisting of four clinical-stage product candidates, Manhattan Pharmaceuticals is developing potential therapeutics for large, underserved patient populations seeking superior treatments for conditions including psoriasis, atopic dermatitis (eczema), mastocytosis, and head lice. Please visit our new corporate website at http://www.manhattanpharma.com for more information.

Note Regarding Forward-Looking Statements
 
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that could cause Manhattan Pharmaceutical's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," “will,” and similar words or phrases. These statements are based on Manhattan Pharmaceuticals’ current expectations, forecasts and assumptions, which are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that Manhattan Pharmaceuticals' development efforts relating to its PTH (1-34), Altoderm™, Altolyn™ or Hedrin™ product candidates, or any future product candidates, will be successful, or that Manhattan Pharmaceuticals will be able to out-license its discontinued programs to other companies on terms acceptable to Manhattan Pharmaceuticals, or at all. Other risks that may affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of Manhattan Pharmaceuticals' product candidates, the risk that the results of clinical trials may not support the company’s claims, the risk that the company’s product candidates may not achieve market acceptance in North America or elsewhere, the company’s reliance on third-party researchers to develop its product candidates, availability of patent protection, the risk that sufficient capital may not be available to develop and commercialize the company’s product candidates, and the company’s lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the year ended December 31, 2006. Manhattan Pharmaceuticals assumes no obligation to update these statements, whether as a result of new information, future events, or otherwise, except as required by law.

# # #
 
 
 

 
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-----END PRIVACY-ENHANCED MESSAGE-----