Adult Trial Results Expected in June;
Enrollment
in Pediatric Phase III Trial Ahead of Expectations
GERMANTOWN, Md.
"We completed enrollment
in our adult and adolescent Phase III trial on
schedule, and expect that our rapid enrollment of
pediatric patients will
continue to meet or exceed our expectations," said Dr."
Advancis is
comparing its Amoxicillin PULSYS dosage form for the treatment
of pharyngitis/tonsillitis in adults
delivered in a once-daily, 775 milligram
tablet for a period of seven days to 250 milligrams of penicillin
dosed four
times daily, for a total of one gram per day, for 10 days. The words, "believe," "expect
," "intend," "anticipate," and
variations of such words, and similar expressions identify forward
-looking
statements, but their absence does not mean that the statement is not forward-
looking
.
A replay of the call will be available at (800) 642-1687 (domestic) or
(706) 645-9291 (international
), access number 3553822 for 3 days following the
call, and the web cast will be archived on the company
's website,
http://www.
symptoms tinnitus
For its pediatric
Phase III trial, Advancis is comparing its Amoxicillin
PULSYS once-daily
sprinkle dosage form for the treatment of pharyngitis for a period of seven
days
to 10mg/kg of penicillin VK dosed four times daily for 10 days.
Advancis has partnered with Par
Pharmaceutical Companies, Inc. Advancis undertakes no obligation to update or revise the
information
in this announcement, whether as a result of new information,
future events or circumstances or otherwise
.com.conditions tinnitus
More than 54 million prescriptions for amoxicillin were written in 2004
with total retail
sales of approximately $600 million.
ABOUT ADVANCIS PHARMACEUTICAL:
Advancis Pharmaceutical
Corporation (Nasdaq: AVNC) is a pharmaceutical
company focused on the development and commercialization
of pulsatile drug
products that fulfill substantial unmet medical needs in the treatment of
infectious
disease.matrixxinc.
About Matrixx Initiatives, Inc. is engaged in the development, manufacture
and
marketing of over-the-counter (OTC) pharmaceuticals, which utilize innovative
drug delivery
systems.
About Matrixx Initiatives, Inc.health shopping
These statements are
not guarantees of future
performance and are subject to a number of risks and
uncertainties that would cause actual results
to differ materially from those
anticipated.
The actual results realized by Advancis could
differ materially from these
forward-looking statements, depending in particular upon the risks and
uncertainties described in the Company's filings with the Securities and
Exchange Commission.
To listen to the teleconference via the
Internet, go to http://www.com, or Bill
Barba, investor
relations, at 602-385-8881, bbarba@matrixxinc.com. In studies published in the October 2000 issue of
ENT -- Ear, Nose and
Throat Journal, and separately in the January 2003 issue of QJM: An
International
Journal of Medicine, the Zicam Cold Remedy product was shown to
reduce the duration of the common
cold. Additionally, in July 2004, Matrixx began
distributing six new Cough Mist(TM) products.privacy tinnitus
Advancis
Pharmaceutical Completes Enrollment in Adult/Adolescent Amoxicillin PULSYS Phase III Trial
com and
click on the 2004 financial
results teleconference icon.
(Nasdaq: MTXX), a high growth, over-the
-counter healthcare company that
develops and markets products that provide consumers with "better
ways to get
better," announced today that financial results for the first quarter ended
March
31, 2005 will be released after the market closes on Wednesday, May 4,
2005.discomfort faqs
PHOENIX, Matrixx
Initiatives, Inc.matrixxinc.diseases symptoms
Over the coming weeks, patients will complete their
treatment and follow
-up visits, and Advancis and its clinical research
organization will collect and analyze the clinical
data.
(Nasdaq: MTXX), an innovator in the development and marketing of branded
over-the-counter
pharmaceuticals, announced today that financial results for
the fourth quarter and fiscal year 2004
will be released after the market
close on Wednesday, February 9, 2005. For additional information
, contact William
Hemelt, chief financial officer, 602-385-8888, whemelt@matrixxinc.
Matrixx
Initiatives, Inc.vertigo symptoms
nose ear
Barry Hafkin, Advancis
senior vice president and chief scientific officer. In
December 2004, Advancis announced that it modified its collaboration with Par
to include a pulsatile
version of the antibiotic combination
amoxicillin/clavulanate for acute otitis media in children
.
Based on this finding, Advancis has developed a proprietary, once-a-day
pulsatile delivery technology
called PULSYS. For more information regarding Matrixx products, go to http://www.com.ear throat
These statements
are
based on Advancis' current expectations and assumptions.com, for 30 days.matrixxinc. For
additional
information, contact William Hemelt, Chief Financial Officer,
602-385-8888, whemelt@matrixxinc.com
or Max Ramras at The RCG Group,
max@thercggroup.com, 480-675-0400.diseases hearing
Advancis also announced
that it has enrolled a total of 421 pediatric
patients to date in its Amoxicillin PULSYS Phase III
trial for the treatment
of pediatric patients with acute pharyngitis/tonsillitis. Amoxicillin is
indicated for a broad range of infections, and is commonly prescribed as a
first-line therapy
for common infections such as otitis media (middle ear
infection), pharyngitis (sore throat), and
sinusitis (sinus infection). Matrixx is
located at 4742 N. 24th Street,
Suite 455, Phoenix, Arizona
85016.your tinnitus
To access the teleconference, please call (877) 356-5706 (domestic) or
(706) 643-0580
(international).matrixxinc.Matrixx Initiatives Inc. Sets Time for Discussion of First Quarter 2005
Financial Results
Matrixx is located at 4742 N.instructions symptoms
This 500-patient,
investigator-blind, non-inferiority
Phase III trial for a "sprinkle"
formulation of Amoxicillin PULSYS is being conducted in 75 investigator
sites
across the country and was begun on January 5, 2005. "We look forward to
reporting the
results of our adult trial in June, our pediatric trial in July,
and if successful, filing our NDAs
for the products by the end of 2005 and
commercially launching by the end of 2006. In studies published
in the October 2000 issue of ENT --
Ear, Nose and Throat Journal, and separately in the January 2003
issue of QJM:
An International Journal of Medicine, the Zicam Cold Remedy product was shown
to
reduce the duration of the common cold.zicam.
To access the teleconference, please call (877
) 356-5706 (domestic) or
(706) 643-0580 (international).matrixxinc.instructions throat
This announcement contains
forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933, as amended
, and Section 21E of
the Securities and Exchange Act of 1934, as amended. These include, without
limitation, risks and
uncertainties relating to the Company's financial results and the ability of
the Company to (1) reach profitability, (2) prove that the preliminary
findings for its product
candidates are valid, (3) receive required regulatory
approvals, (4) successfully conduct clinical
trials in a timely manner with
favorable results, (5) establish its competitive position for its
products,
(6) develop and commercialize products that are superior to existing or newly
developed
competitor products, (7) develop products without any defects, (8)
have sufficient capital resources
to fund its operations, (9) protect its
intellectual property rights and patents, (10) implement
its sales and
marketing strategy and reach its sales goals, (11) successfully attract and
retain
collaborative partners, and (12) retain its senior management and other
personnel.Reminder - Matrixx
Initiatives Inc. to Discuss Fiscal Year 2004 Results at Teleconference on Thursday February 10 2005
wax vertigo
, Advancis
Pharmaceutical Corporation (Nasdaq: AVNC), a pharmaceutical company focused on
developing
and commercializing novel anti-infective products, today announced
that it has enrolled 504 adult
/adolescent patients in the Company's
Amoxicillin PULSYS Phase III clinical trial for the treatment
of
pharyngitis/tonsillitis due to Group A streptococcal infections. The
primary endpoint for
both studies is bacterial eradication, as measured by
throat swabs both before and after treatment
. If successful, physicians prescribing Amoxicillin
PULSYS would be able to dose approximately one
-third the amount of amoxicillin
in adult and adolescent patients with pharyngitis/tonsillitis, while
at the
same time providing the convenience of once-daily dosing and the likely impact
of reduced
drug-related side effects and increased patient compliance.com. 24th Street, Suite 455, Phoenix, Arizona
85016.
An earnings conference call will be held the following morning on
Thursday, May
5, 2005 at 11:00 AM ET.your hearing
For more on Advancis, please
visit http://www.
The Company
also manufactures and
markets a full line of Zicam brand pharmaceuticals, including Zicam Cold
Remedy
Chewables(TM); Zicam Cold Remedy Oral Mist(TM); and Zicam Cold Remedy
RapidMelts(TM); Zicam Allergy
Relief; Zicam Cold Remedy Swabs(TM); Zicam Kids
Size Cold Remedy Swabs(TM); Zicam Extreme Congestion
Relief; Zicam Sinus
Relief; and Zicam Nasal Moisturizer. The Company's
flagship product, Zicam
Cold Remedy nasal gel, a patented homeopathic remedy,
has been clinically proven to reduce the duration
and severity of the common
cold.symptoms privacy
Advancis' adult and adolescent pivotal program is designed
as a 500-
patient, double-blind, double-dummy, non-inferiority Phase III trial and began
on October
15, 2004. The combination
replaces the previously envisioned amoxicillin-only product for otitis
media,
as Advancis and its advisors believe that amoxicillin/clavulanate may become
more appropriate
front-line therapy for acute otitis media over the next few
years. To find out more about Matrixx
Initiatives, Inc (Nasdaq: http://www.otitis remedy
Advancis' Amoxicillin PULSYS dosing of 775 milligrams
for seven days -- or
just over 5 grams in total for this new therapy -- compares to the most common
amoxicillin therapy for pharyngitis that is dosed 500 milligrams three-times
daily for a period
of 10 days -- or a total of 15 grams of amoxicillin over
the full course of therapy. By examining
the resistance
patterns of bacteria and applying its delivery technologies, Advancis has the
potential
to redefine infectious disease therapy and significantly improve
drug efficacy, shorten length of
therapy, and reduce drug resistance versus
currently available antibacterial products.matrixxinc
. To listen to the teleconference via the
Internet, go to http://www. Zicam, LLC, its wholly-owned
subsidiary, produces,
markets and sells Zicam(R) products in the cough and cold category; and plans
to launch a new brand, Nasal Comfort for nasal health in 2005. For more information regarding
Matrixx
products, go to http://www.health ear
Advancis has
informed all 60 investigator sites across the country that
they may continue
to enroll scheduled patients through close-of-business today.advancispharm.
PHOENIX, Matrixx Initiatives, Inc. An earnings conference call will be
held the following morning
on Thursday, February 10, 2005 at 11:00AM ET.
A replay of the call will be available at (800
) 642-1687 (domestic) or
(706) 645-9291 (international), access number 5708408 for 3 days following
the
call, and the web cast will be archived on the company's website,
http://www.com, for 30 days
.privacy ear
The Company now expects
to conclude this second Phase III trial in April and to announce its top
-line
results in July 2005.
Matrixx Initiatives, Inc.com and click on the first quarter 2005
teleconference icon. The Company also manufactures and
markets a full line of Zicam brand pharmaceuticals
, including Zicam Cold
Remedy Chewables(TM); Zicam Cold Remedy Oral Mist(TM); Zicam Cold Remedy
RapidMelts
(TM); Zicam Allergy Relief; Zicam Cold Remedy Swabs(TM); Zicam Kids
Size Cold Remedy Swabs(TM); Zicam
Extreme Congestion Relief; Zicam Sinus
Relief and Zicam Nasal Moisturizer.zicam.
privacy remedy
health positional
Existing
and prospective investors are cautioned not to place
undue reliance on these forward-looking statements
, which speak only as of
today's date. is engaged in the development, manufacture and
marketing
of over-the-counter (OTC) pharmaceuticals, which utilize innovative
drug delivery systems.com.faqs removal
(Par
) to
develop Amoxicillin PULSYS.
To find out more about Matrixx Initiatives, Inc (Nasdaq: MTXX
), visit our
website at http://www.com.wax throat
The Company expects
to publicly report top-line results
on or around mid-June 2005. If the trials are successful, Advancis expects to file
separate 505
(b)(2) New Drug Applications (NDAs) with the FDA for each product
in the fourth quarter of 2005.faqs diseases
According
to data from IMS Health, a pharmaceutical research company,
approximately one-quarter of amoxicillin
prescriptions are written for
pharyngitis, strep throat, and tonsillitis in adults and children.
The Companies have agreed to jointly market the
adult and pediatric products and to split operating
profits equally. The Company is developing a broad portfolio of anti-
infective drugs based on its
novel biological finding that bacteria exposed to
antibiotics in frontloaded staccato bursts, or
"pulses," are killed more
efficiently and effectively than those under standard treatment regimens
. Zicam, LLC, its wholly-owned subsidiary, produces,
markets and sells Zicam(R) Cold Remedy nasal
gel, a patented, homeopathic
remedy that has been clinically proven to reduce the duration and severity
of
the common cold. Additionally, in July 2004 Matrixx began
distributing six new Cough Mist
(TM) products for the 2004-2005 cough/cold
season.com, or Bill Barba, Investor Relations, at
602
-385-8881, bbarba@matrixxinc.faqs symptoms
A community sponsored library.
-> Show WiseVault's Web Sites Listing For This Topic
Loading...
(Note: These pages use the Atlas Content Safeguard System (ACSS) and require that Javascript is enabled for viewing.)