Clindesse(TM) contains mineral oil that may weaken latex or rubber
products such as condoms
or vaginal contraceptive diaphragms.
spirochetal abscesses
Osel Initiates Two Phase II Trials for LACTIN-V
, the
Bacterio
-Therapeutics company, announced the initiation of two Phase II
clinical trials of LACTIN-V, one for
the treatment of recurrent urinary tract
infection (RUTI), and a second for recurrent bacterial vaginosis
(RBV).
LACTIN-V, a vaginal capsule containing a natural human bacterial organism,
will be
studied in a total of eight centers for RUTI and for RBV under the
clinical direction of Lynn Conrad
, MD, University of Tennessee Health Science
Center, Memphis (RUTI), and Benson Horowitz, MD, University
of Connecticut
(RBV). Up to 33% of
women with UTIs develop recurrent infections (>2 per year)
. Thus, there is
significant interest amongst women who suffer from RUTI for novel
non-antibiotic
therapies.
About Osel
Osel, Inc. Clindesse(TM) (clindamycin phosphate 2% vaginal
cream) is
the first single-dose treatment for bacterial vaginosis (BV), the most common
form of
vaginitis. The most frequently reported adverse events were vaginosis fungal
(14.parasitologists trachoma
We believe
the convenience of these products will be compelling to both
physicians and their patients as we
continue to expand our international
presence with our latest partner, Vitaflo. Such
statements
may be identified by the use of words like "plans", "expect",
"aim", "believe", "projects", "anticipate
", "commit", "intend", "estimate",
"will", "should", "could" and other expressions that indicate future
events
and trends.mycologists trachoma
For further information about Vitaflo Scandinavia AB, please visit the
Company's corporate website at http://www.electonic mycobacterial
, and an equal number in Europe.
This latest agreement
adds Sweden, Denmark, Norway, Finland and Iceland,
to the list of more than 50 markets worldwide
in which KV has licenses in
place for the sale of Gynazole-1(R), and it's the fourth international
licensing announcement for the more recently introduced Clindesse(TM). Therefore, the
use of
such barrier contraceptives is not recommended concurrently or for 5
days following treatment with
Clindesse(TM).abscesses parasitologists
Contact: Ralph Levy President, Osel Inc.
Under the terms of the agreement
, KV will receive licensing fees and
manufacturing revenues for both products. Hermelin, Vice Chairman
of the Board and CEO of KV stated,
"Gynazole-1(R) and Clindesse(TM) offer significant innovation
for patients.
Gynazole-1(R) is contraindicated in patients with a history of
hypersensitivity
to any of the components in the product.6% of the patients discontinued therapy due to adverse
events
.1%), vulvovaginal pruritus (3.prion influenza
"We are moving ahead with our business plan to develop products
utilizing
naturally occurring mucosal bacteria.
Safe Harbor
The information in this release
may contain various forward-looking
statements within the meaning of the United States Private Securities
Litigation Reform Act of 1995 ("PSLRA") and which may be based on or include
assumptions concerning
KV's operations, future results and prospects.candidiasis electonic
, Osel, Inc.U.
Marc S.
Clindesse(TM
) (clindamycin phosphate) Vaginal Cream, 2%
Clindesse(TM) is contraindicated in individuals with
a history of
hypersensitivity to clindamycin, lincomycin, or any of the components of this
vaginal
cream, and in individuals with a history of regional enteritis,
ulcerative colitis, or a history
of "antibioitic-associated" colitis.mycobacterial infections
LACTIN-V
contains a natural human bacterium, Lactobacillus crispatus
, which has been
carefully selected based upon detailed scientific findings that demonstrate
its
unique ability to colonize the vaginal mucosa and to secrete substances
that inhibit the growth of
microbial pathogens.
Such factors include (but are not limited to) the following: (1) changes
in the current and future business environment, including interest rates and
capital and consumer
spending; (2) the difficulty of predicting FDA approvals,
including timing, and that any period of
exclusivity may not be realized; (3)
acceptance and demand for new pharmaceutical products; (4) the
impact of
competitive products and pricing; (5) new product development and launch
including but
not limited to the possibility that any product launch may be
delayed or that product acceptance
may be less than anticipated; (6) reliance
on key strategic alliances; (7) the availability of raw
materials; (8) the
regulatory environment; (9) fluctuations in operating results; (10) the
difficulty
of predicting international regulatory approvals, including
timing; (11) the difficulty of predicting
the pattern of inventory movements
by the Company's customers; (12) the impact of competitive response
to the
Company's sales, marketing and strategic efforts; (13) risks that the Company
may not ultimately
prevail in litigation; and (14) the risks detailed from
time to time in the Company's filings with
the Securities and Exchange
Commission. Also see specific diseases within the alphabetical listings
.
influenza infectious
S. 206
Cell : 415-699-0135
Email: rlevy@oselinc.
Vitaflo will market KV's proprietary
Gynazole-1(R) product in the E. The turnover has
more than doubled each year since 2000.
Communicable/infectious diseases sites.
h5n1 prion
under
the trade name Gynafem(TM).
Gynazole-1(R
) (butocanzole nitrate 2% vaginal cream) is KV's proprietary
prescription one-dose vaginal cream for
the treatment of yeast infections
caused by Candida. The outstanding success of both
these products
in the U. is a good indicator of their untapped potential in
international arenas as they are promoted
by our outstanding partners. Therefore, it is
important to consider this diagnosis in patients who
present with diarrhea
subsequent to the administration of clindamycin, even though there is minimal
systemic absorption of clindamycin from the vagina with administration of
Clindesse(TM) cream
.
Strategically Vitaflo is organized in four Geografic areas that include
pharmaceuticals (Female
Care, Dermatology, Gastro, Medical Odontology, Medical
Nutrition, Pediatrics, and Vaccines).niaid zoonoses
S.
For further information about KV Pharmaceutical Company, please visit the
Company's corporate
website at http://www.niaid spirochetal
Osel's first product, LACTIN-V, is directed at recurrent urinary tract
infections (RUTI), and recurrent bacterial vaginosis (RBV)."
Additional Safety Information
about Gynazole-1(R) and Clindesse(TM):
Gynazole-1(R) (butoconazole nitrate) Vaginal Cream
2%
Gynazole-1(R) is indicated for the local treatment of vulvovaginal
candidasis. If clinical
symptoms persist, tests should be repeated to rule out
other pathogens, to conform original diagnosis
, and to rule out other
conditions that may predispose a patient to recurrent vaginal fungal
infections
.h5n1 electonic
KV Adds To Its Prestigious International Licensing Partnerships For
Gynazole
-1(R) and Clindesse(TM)
ST.
abscesses mycologists
SANTA CLARA, Calif. During this time period, condoms
may
not be reliable for preventing pregnancy or for protecting against
transmission of HIV or other sexually
transmitted diseases.vitaflo.
All forward-looking statements are based on current expectations
and are
subject to risk and uncertainties. We are under no
obligation to update any of the forward
-looking statements after the date of
this report.rickettsial zoonoses
Bacterial vaginosis (BV) afflicts over 16 million
women every year worldwide, and is the most common reason that women seek
medical help, after
vaginal yeast infections. Both Gynazole-1(R) and Clindesse(TM) are the fastest
growing products
in branded market share for their categories, currently at
approximately 30% and 17% of new prescriptions
, respectively.cdsc pneumonia
and Europe," said Osel president, Ralph Levy. The Company markets its technology distinguished
products through
ETHEX Corporation, a national leader in pharmaceuticals that compete with
branded
products, and Ther-Rx Corporation, its emerging branded drug
subsidiary.kvpharmaceutical.
This discussion is by no means exhaustive, but is designed to highlight
important factors that may
impact the Company's outlook.influenza infectious
Both diseases
result from deficiencies in the normal lactobacillus
-dominated microflora
within the reproductive and urinary tracts of susceptible women. is the leading
company in the emerging field of
Bacterio-Therapeutics.
Phone: 408-986-0012 ext. LOUIS,
KV Pharmaceutical Company
(NYSE: KVa/KVb) today announced that it has concluded a licensing agreement
with Vitaflo Scandinavia AB for its two NDA products, Gynazole-1(R)
(butocanzole nitrate 2% vaginal
cream) for yeast infections from Candida, and
Clindesse(TM) (clindamycin phosphate 2% vaginal cream
) for bacterial vaginosis
(BV). Gynazole-1(R) is safe and effective in non-pregnant women; however
,
the safety and effectiveness in pregnant women has not been established.
Gyanzole-1(R) contains
mineral oil, which may weaken latex or rubber
products such as condoms or vaginal contraceptive diaphragms;
therefore, use
of such products within 72 hours following treatment with Gynazole-1(R) is not
recommended
.mycobacterial sepsis
Urinary tract infections (UTI) account for almost 11 million physician
visits each year in
the U.
Osel's mission is to harness the protective properties of these specialized
non-pathogenic
bacteria as a basis for a series of innovative products
initially targeted for the prevention and
treatment of diseases of the
genitourinary and gastrointestinal tracts. Orally and parenterally
administered
clindamycin has been associated with severe colitis.zoonoses niaid
The company's business is based
on exploiting recent
scientific discoveries demonstrating the central role of naturally occurring
mucosal bacteria in the maintenance of health and the prevention of disease. Recurrent vaginal yeast
infections, especially those that are
difficult to eradicate, can be an early sign of infection with
the human
immunodeficiency virus (HIV) in women who are considered at risk for HIV
infection.
infectious influenza
While a routine
UTI is easily treated with a short course of oral antibiotics, treatment of
recurrent
UTI (RUTI) with multiple courses of antibiotics may lead to
resistant strains, diarrhea, and vaginal
yeast infections. There
are no adequate and well controlled studies of Clindesse(TM) in pregnant
women.7%). KV has consistently ranked as one of America's fastest growing
small companies, most
recently by Forbes in its November 2004 issue.sepsis infectious
We are continuing to
successfully meet our clinical
trials milestones for the evaluation of
LACTIN-V for treatment of RUTI and RBV, two conditions which
plague 15 million
women a year in the U. LACTIN-V has been optimally
formulated to restore the
protective vaginal microflora to combat infections
and is expected to fill this unmet medical need
. Both products
utilize KV's proprietary VagiSite(TM) bioadhesive drug delivery technology and
are
the first approved single-dose prescription cream therapies for patients
suffering from vaginal yeast
infections from Candida and bacterial vaginosis,
the most common form of vaginitis, respectively
.
About Vitaflo Scandinavia AB
Vitaflo is a young organization with great potential
.net
About KV Pharmaceutical Company
KV Pharmaceutical Company is a fully integrated
specialty pharmaceutical
company that develops, manufactures and markets and acquires technology
-
distinguished branded and generic/non-branded prescription pharmaceutical
products.spirochetal niaid
com
The diagnosis should be confirmed by the KOH smears and/or
cultures. The last year's top line
increased
more than 65% and the first 6 months of this year the turn over increased 75%.com .zoonoses candidiasis
S.
In clinical trials totaling 368 women associated with a single dose of
Clindesse(TM), 1.3%), and
headache (2.
All statements that address expectations or projections about the future,
including
without limitation, statements about the Company's strategy for
growth, product development, regulatory
approvals, market position,
expenditures and financial results, are forward-looking statements.niaid sepsis
KV
Pharmaceutical Signs POA/Vitaflo Scandinavia AB to Market Women's Health Products in Five Scandinavian
Markets
The Company expects the subject of the first
launch to be Gynazole-1(R) during calendar
2006 with Clindesse(TM) to follow.
Pseudo membranous colitis has been reported with nearly all
antibacterial
agents, including clindamycin. In connection with the "safe harbor"
provisions
, KV provides the following cautionary statements identifying
important economic, political and technology
factors which, among others,
could cause actual results or events to differ materially from those
set forth
or implied by the forward-looking statements and related assumptions.epidemiologists sepsis
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