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: January 27, 2000 Commission File No. 000-22347
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(Date of earliest event reported)
ASCENT PEDIATRICS, INC.
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(Exact name of Registrant as specified in its Charter)
Delaware 04-3047405
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(State or other jurisdiction of (IRS Employer Identification No.)
incorporation or organization)
187 Ballardvale Street, Wilmington, Massachusetts 01887
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(Address of principal executive offices) (Zip Code)
(978) 658-2500
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(Registrant's telephone number, including area code)
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ITEM 5. OTHER EVENTS
Change in President
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On January 27, 2000, Ascent Pediatrics, Inc. ("Ascent") issued a press
release announcing that it received the approval of the U.S. Food and Drug
Administration to market Primsol Solution (trimethoprim HCl oral solution), for
the treatment of acute otitis media, or middle ear infection, caused by
susceptible organisms in children age six months to twelve years. Ascent expects
commercial shipment of Primsol, which will be available only by prescription, to
commence the beginning of February with physician detailing activity to begin in
March.
A copy of the press release has been filed with this Current Report on Form
8-K as Exhibit 99.1 and is incorporated herein by reference.
ITEM 7. EXHIBITS
99.1 Press release dated January 27, 2000.
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SIGNATURES
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.
Dated: February 9, 2000 ASCENT PEDIATRICS, INC.
/s/ Eliot M. Lurier
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Eliot M. Lurier
Chief Financial Officer
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INDEX TO EXHIBITS
EXHIBIT
NO. DESCRIPTION
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99.1 Press release dated January 27, 2000.
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EXHIBIT 99.1
FOR IMMEDIATE RELEASE
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ASCENT PEDIATRICS, INC
Emmett Clemente, Ph.D., President & Chairman
Eliot Lurier, CFO
Tel: 978-658-2500
Fax: 978-658-3939
ASCENT PEDIATRICS RECEIVES FDA APPROVAL OF PRIMSOL SOLUTION
Targets Market of 3.9 Million Rxs With Safer Alternative to Combination Product
Wilmington, MA, January 27, 2000 - Ascent Pediatrics, Inc., (OTCBB: ASCTP)
announced today that it has received FDA approval to market Primsol Solution
(trimethoprim HCl oral solution), for the treatment of acute otitis media, or
middle ear infection, caused by susceptible organisms in children age six months
to twelve years. Otitis media is the leading pediatric infection in the U.S.,
accounting for over 23 million annual patient visits. The Company expects
commercial shipment of Primsol, which will be available only by prescription, to
commence the beginning of February with physician detailing activity to begin in
March.
Primsol contains only trimethoprim as its single active ingredient. Two other
commonly used liquid antibiotics, Septra and Bactrim , contain trimethoprim and
sulfamethoxazole, the latter ingredient being associated with allergic reactions
that, though rare, may be severe or even fatal. Thus, while Primsol is
contraindicated in certain patients and, like all drugs, may produce adverse
events, it will be positioned as a safer alternative to the combination products
of trimethoprim and sulfamethoxazole. These products account for approximately
3.9 million prescriptions dispensed in the U.S. during the latest twelve months.
``Ascent has proven that a sulfa component isn't needed for efficacy in the
treatment of acute otitis media,'' said Emmett Clemente, Ph.D., President and
Chairman. ``In its new drug application to the FDA, Ascent showed in a clinical
study with 262 children that Primsol, containing only trimethoprim, was just as
effective as the combination trimethoprim and sulfamethoxazole. And importantly,
Primsol was shown to have significantly fewer side effects.''
``Pediatricians will welcome this product and will not be surprised to learn
that removing the sulfa component will lessen side effects,'' explained Dr.
Edward J. O'Rourke, Assistant Professor of Pediatrics at Harvard University.
``In addition, there is the risk of severe and fatal hypersensitivity reactions
to sulfamethoxazole, and although rare, they nevertheless can occur. If we can
eliminate that risk,'' added Dr. O'Rourke, ``we should do it.''
``With the launch of Primsol, the company's first marketed prescription product,
Ascent continues to pursue its mission of being the only pharmaceutical company
devoted to marketing products just for kids,'' said Gregory A. Vannatter,
Executive Vice-president of Ascent. ``Primsol will be promoted to pediatricians
by the Ascent Pediatrics' sales force and supported with journal advertising and
direct mail. Primsol has a pleasant bubble gum flavor for children, requires no
shaking or refrigeration, contains no alcohol or dyes, and has convenient
twice-a-day dosing.''
Ascent Pediatrics, Inc., is a drug development and marketing company focused
exclusively on the pediatric market. The Company's strategy is to address unmet
medical needs of children through the development of differentiated; proprietary
products based on approved compounds with well- known clinical profiles. Ascent
currently markets two non-prescription products, FeverAll acetaminophen
suppositories and Pediamist , nasal saline mist.
Investors are cautioned that this press release contains forward-looking
statements that involve a number of risks and uncertainties. For this purpose,
any statements that are not statements of historical fact may be deemed to be
forward-looking statements. Without limiting the foregoing, the words
``believes'', ``anticipates'', ``expects'', ``intends'', ``will'' and similar
expressions are intended to identify forward-looking statements. Information
contained in these forward looking-statements is inherently uncertain, and
actual performance and results may differ materially due to numerous factors,
including but not limited to the following: the uncertainty of market acceptance
of Primsol, the Company's capital needs, seasonality and variable operating
results, the Company's dependence on new product development, the Company's
dependence on obtaining regulatory approval to market products, the Company's
ability to retain or attract customers due to competition, uncertainty in the
healthcare industry, and risk of product liability claims. These factors, as
well as a number of other important factors, are more fully described in the
Company's Annual Report on Form 10-K for the fiscal year ended December 31,
1998, under the caption ``Management's Discussion and Analysis of Financial
Condition and Results of Operations-Certain Factors That May Affect Future
Results'', which description is incorporated herein by this reference, and in
the Company's other filings with the Securities and Exchange Commission.
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