News: Depomed's ProQuin(R) XR Achieves First Marketing …
Depomed, Inc. (NASDAQ:DEPO) and Rottapharm/Madaus announced today
that the Marketing Authorization (MA) for ProQuin XR has been received
from the Medical Products Agency in Sweden. Depomed’s ProQuin XR is
exclusively licensed to Rottapharm/Madaus for Europe and is a
once-daily extended-release formulation of ciprofloxacin hydrochloride
for the treatment of uncomplicated urinary tract infections.
“We are glad to see ProQuin XR be approved in Sweden as reference
member state which is a first step to make it commercially available
in Europe. We feel confident that our partner Rottapharm/Madaus with
their strong market presence and local expertise in individual
European countries will realize ProQuin XR’s commercial potential in
Europe. We anticipate the commercial rollout and pricing in other
European countries will progress through next year,” noted Carl A.
Pelzel, president and chief executive officer of Depomed.
Antonino Santoro, corporate business development and regulatory
affairs director of Rottapharm/Madaus, added, “ProQuin XR complements
our product portfolio and strengthens our position in urology. ProQuin
XR’s approval in Sweden paves the way for further regulatory approvals
in other European countries through the mutual recognition procedure;
we expect to launch the product under the trade-mark UTIMINX(TM)
starting in 2009 in different countries and in some of them we are
planning to co-market the product under the secondary trade-mark
URITENT(TM).”
About ProQuin(R) XR
ProQuin XR is a once-daily extended-release formulation of
ciprofloxacin hydrochloride and is intended to treat uncomplicated
urinary tract infections (UTIs). UTIs are bacterial infections
frequently caused by E. coli and are typically treated with
antibiotics. Patients should not take ProQuin XR if they are allergic
to, or have ever had a severe reaction to, ciprofloxacin or to any
other “quinolone” antibiotics. Proquin XR is generally well tolerated.
The most common side effects with Proquin XR include vaginal yeast
infection and headache. UTIs are the second-most common type of
bacterial infection, after those of the respiratory tract, with more
than 35 million medically treated infections across the seven major
markets each year. This translated into sales in excess of $1.1billion
across key markets.
Formulated with AcuForm(TM) delivery technology, Proquin XR is
delivered over a six-hour period to the upper gastrointestinal (GI)
tract where ciprofloxacin is best absorbed. This controlled, targeted
delivery allows for nearly 87 percent of the active ingredient to
enter into the blood stream and less unabsorbed drug to pass through
to the lower GI tract where it can cause irritation and give rise to
side effects. Proquin XR is the first version of ciprofloxacin with
nausea and diarrhea listed as “uncommon” adverse events in its label,
rather than “common” adverse events.
About Depomed
Depomed, Inc. is a specialty pharmaceutical company with two
approved products on the market and other product candidates in its
pipeline. The company utilizes its proven, proprietary AcuForm(TM)
drug delivery technology to improve existing oral medications,
allowing for extended, controlled release of medications to the upper
gastrointestinal tract. Benefits of AcuForm-enhanced pharmaceuticals
include the convenience of once-daily administration, improved
treatment tolerability and enhanced compliance and efficacy.
Glumetza(R) (metformin hydrochloride extended release tablets) is
approved for use in adults with type 2 diabetes and promoted by
Santarus in the United States. Proquin(R) XR (ciprofloxacin
hydrochloride) extended release tablets are approved in the United
States for the once-daily treatment of uncomplicated urinary tract
infections and is marketed in the United States within the urology,
Ob/Gyn and long-term care specialties by Watson Pharmaceuticals.
Product candidate Gabapentin GR(R) is currently in clinical
development for the treatment of neuropathic pain and for menopausal
hot flashes. Additional information about Depomed may be found on its
web site, www.depomedinc.com.
About Rottapharm/Madaus
Rottapharm/Madaus is an Italian multinational pharmaceutical
company, headquartered in Monza, with more than 2,000 employees,
branches in over 85 countries worldwide and seven manufacturing sites
located in Europe and India. Since its inception, the company has been
primarily focused on research: R&D activities are currently engaged in
different therapeutic areas such as gastroenterology,
bronchopneumology, psychiatry, rheumatology, urology, gynecology,
cardiovascular, oncology. The group also boats a leading position in
the personal care and nutraceutical segments.
After the acquisition of the German pharmaceutical group Madaus in
August 2007, Rottapharm has combined its well-known brands such as
DONA(R), EXTRANASE(R), FORTILASE(R), EPINITRIL(R), ESTROMINERAL(R) and
SAUGELLA(R) with new leading brands including AGIOLAX(R), REPARIL(R),
LEGALON(R), TROMALYT(R) and BEN-U-RON(R). This acquisition has
represented an important turning point for the new Rottapharm/Madaus
group in terms of R&D synergies and marketing growth.
“Safe Harbor” Statement under the Private Securities Litigation
Reform Act of 1995.
Statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties. The
inclusion of forward-looking statements, including those related to
the commercialization of ProQuin(R) XR should not be regarded as a
representation that any of our plans will be achieved. Actual results
may differ materially from those set forth in this release due to the
risks and uncertainties inherent in our business, including, without
limitation, risks and uncertainties related to: our research and
development efforts, including pre-clinical and clinical testing;
regulation by the FDA and other government agencies; the timing of
regulatory applications and product launches; our ability to
successfully commercialize our products; the success of our
collaborative arrangements with development and commercialization
partners; and other risks detailed in our filings with the Securities
and Exchange Commission filings, including our most recent Annual
Report on Form 10-K and Quarterly Report on Form 10-Q. You are
cautioned not to place undue reliance on these forward-looking
statements which speak only as of the date hereof. We undertake no
obligation to revise or update this release to reflect events or
circumstances that occur after the date of this release.