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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 8, 1999 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
On December 30, 1998, Ascent Pediatrics, Inc. (the "Company") issued a
press release announcing that it had received a Not-approvable letter from the
United States Food and Drug Administration (the "FDA") on the Company's NDA for
its acetaminophen extended release product, Feverall Extended Release Sprinkles.
In the Not-approvable letter, the FDA primarily referred to deficiencies
relating to the manufacture and packaging of the product.
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 December 30, 1998.
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: January 8, 1999 ASCENT PEDIATRICS, INC.
/s/ John G. Bernardi
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John G. Bernardi
Vice President, Finance and Treasurer
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INDEX TO EXHIBITS
EXHIBIT
NO. DESCRIPTION
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99.1 Press release dated December 30, 1998.
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Exhibit 99.1
ASCENT PEDIATRICS, INC. RECEIVES FDA COMMENTS ON FEVERALL ER NDA APPLICATION
WILMINGTON, Mass., December 30, 1998 -- Ascent Pediatrics, Inc. (Nasdaq: ASCT)
today announced that it received a Not-approvable Letter from the FDA on its NDA
for its acetaminophen extended release product Feverall Extended Release
Sprinkles. In the letter, the FDA primarily referenced deficiencies relating to
the manufacture and packaging of the product.
Dr. Emmett Clemente, Chairman and Founder of Ascent commented, "The FDA letter
was not unexpected based on a number of conversations with the FDA that have
transpired over the past weeks. Most of the deficiencies listed in the Letter
were previously communicated to Ascent and Ascent had been working with the FDA
to address the FDA's concerns prior to the receipt of the Letter. We intend to
amend the NDA to address the listed deficiencies and, subject to ultimate FDA
approval, we do not anticipate, at this time, that the Not-approvable Letter
will have a material effect on the product introduction."
Ascent Pediatrics, Inc. is a drug development and marketing company focused
exclusively on the pediatric market. The Company's strategy is to address the
unmet needs of children through the development of differentiated, proprietary
products based on approved compounds with well-known clinical profiles. Ascent
is developing a range of pharmaceuticals designed to improve upon currently
available products for common pediatric illnesses through the application of its
drug delivery and reformulation techniques.
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: capital needs and uncertainty of additional funding,
the Company's early stage of development, history of operating losses and
cumulative deficit, uncertainly relating to regulatory approval of the Company's
products, including the Feverall Extended Release product referenced above,
seasonality and variable operating results, dependence on new product
development and acceptance, management of growth, dependence on third parties,
inability to retain or attract customers due to competition and uncertainty in
the healthcare industry.
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These factors are more fully described in the Company's Annual Report on Form
10-K for the fiscal year ended December 31, 1997, under the caption
"Management's Discussion and Analysis of Financial condition and Results of
Operations -- Certain Factors That May Affect Future Results", which is
incorporated herein by this reference.
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