WILMINGTON, Mass., Jan 27, 2000 /PRNewswire via COMTEX/ -- Ascent
Pediatrics, Inc., (OTC Bulletin Board: ASCTP) announced today that it
has received FDA approval to market Primsol(R) 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(R) and Bactrim(R),
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(R) acetaminophen suppositories and
Pediamist(R), 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.
SOURCE Ascent Pediatrics, Inc.
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