REGURIN(R) XL (trospium chloride) Once Daily Tablets Now Available in the UK for the Treatment of Overactive Bladder

September 7, 2009

LONDON, September 7 /PRNewswire/ — Regurin(R) XL (trospium chloride), a
once-daily, prolonged-release capsule to treat patients with overactive
bladder (OAB) has been launched in the UK. Regurin(R) XL provides rapid,
significant and consistent improvements in the symptoms of OAB1 and has a
reduced potential for central nervous system (CNS) side effects(2-7).

OAB, also known as irritable bladder, is a condition that results from
sudden, involuntary contraction of the muscle in the wall of the urinary
bladder. Key symptoms of OAB include frequent urination, urgency of
urination, and urge incontinence. Urinary incontinence is a distressing and
often embarrassing problem estimated to affect over a third of women in the
UK over 40(8).

By rapidly, significantly and consistently improving the symptoms of OAB
as early as day 5 of treatment., a statistically significantly higher number
of patients in placebo controlled clinical trials achieved a reduction in
urgency and wet days by week 12 with Regurin(R) XL (1). Furthermore,
Regurin(R) XL has the benefit of not crossing the blood- brain barrier, or
the blood eye barrier(2,4,7) reducing the CNS side effects sometimes
associated with OAB treatments(2-7).

“Overactive bladder has a significant, and often underestimated, impact
on the quality of life of all patients. In elderly dependent patients OAB can
cause breakdown in care-giving relationships and even increase the likelihood
of patients being admitted to a nursing home , said Professor Linda Cardozo,
Kings College Hospital, London. “It is important to effectively treat OAB, to
maintain confidence and independence in all patients. Ensuring patient
compliance is an important consideration in treating patients with OAB.
Therefore, the availability of cost effective, tried and tested treatment,
with the convenience of once-daily dosing, and minimal side effects is
welcome news for physicians and their patients”.

Clinical trials showed the incidence of dry mouth, and constipation also
occurs less frequently in patients on Regurin(R) XL compared to all other
antimuscarinic agents, and approximately 50% less than Regurin(R) 20mg twice
daily(9,10). In addition, Regurin(R) XL has a low potential for interaction
with concomitantly administered medications.(11- 13).

Geoff McMillan, Chief Executive Officer of SEP, said: “As a young Company
with a focus on Urology, the launch of Regurin XL is very exciting. Urinary
incontinence is a very common and embarrassing problem and we believe that
Regurin XL offers significant benefits for patients, their physicians and the
health service as a whole.”

Regurin(R) XL is licensed for use in men and women to treat the symptoms
of urge incontinence and/or increased urinary frequency and urgency as may
occur in patients with OAB.

Exclusive distribution rights in the UK for Regurin(R) XL (trospium
chloride), have been granted to Specialty European Pharma Ltd (SEP), a UK
based, urology focused, specialty pharmaceutical company by Rottapharm|Madaus.

About Regurin(R) XL

Regurin is trospium chloride, a member of the anti-muscarinic class, used
to treat the symptoms of OAB. The efficacy has been well established.
Trospium chloride has been recommended by NICE for the second line treatment
of UI in women after immediate release oxybutynin(14). Regurin XL has a high
selectivity for two receptors in the detrusor muscle, M sub(2) and M

Regurin(R) XL is a quaternary amine: as such it is a positively charged
molecule that does not cross the blood brain barrier or the blood eye
barrier(2,4,7) hence unwanted side effects such as impairment of cognitive
function are minimal2-7 – an important consideration especially for the
elderly population.

    About Speciality European Pharma

Founded in April 2006, SEP is a privately owned speciality pharmaceutical
company. Its mission is to become the leading Urologist focused specialty
pharmaceutical business in Europe.

SEP owns worldwide rights to Plenaxis(R). Plenaxis is a novel product -
it is the first in a new class of hormonal products (the GnRH blockers) and
it is used to treat advanced and metastatic prostate cancer. Plenaxis has
been launched in Germany and is going through the regulatory process in other
EU countries.

SEP has distribution rights in certain European countries for two further
products, Amphocil(R), an antifungal agent and Haemopressin(R), a product for
the treatment of Bleeding Oesophageal Varices. Both of these products are
delivered to clinicians in a hospital setting.

SEP has established its own commercial operations in the UK, Germany,
France and Italy and will market its products in other regions and
territories through relationships with expert partners.

About Rottapharm|Madaus

Established in 1961, Rottapharm is a multinational pharmaceutical company
primarily engaged in the research, development and global distribution of new
pharmaceutical products in different therapeutic areas including
rheumatology, cardiology, gastroenterology, gynaecology paediatrics,
dermatology, urology, oncology, bronchopneumology, psychiatry.

The Headquarter and main R&D site are located in Italy.

Rottapharm has recently acquired the global German pharmaceutical Group
Madaus Pharma and today the Rottapharm|Madaus Group has subsidiaries or
direct commercial operations throughout Europe and in the vast majority of
Middle East, Asia (excluding Japan) and Central/South America countries.

Currently Rottapharm’s main products include: the original Glucosamine
Sulfate EU prescription product that paved the way for several nutraceutical
glucosamines with yet unsurpassed clinical expertise in the development of
Disease Modifying Drugs in Osteoarthritis; a line of matrix transdermal
delivery systems for HRT and CVD; and others out of a list of 19 new drugs
derived from over 300 patents. Moreover, the Group has recently implemented a
line of effective and successful nutraceuticals for dyslipidemias, women’s
health, inflammation, and entered the area of personal care that includes a
line of leading products in intimate hygiene/paediatric/skin care and in
which the company is ranked as the sixth largest in the world market.

Finally, with the acquisition of Madaus, Rottapharm’s expertise in the
genito-urinary area has been strongly improved. Important synergies have been
identified in this area, where the Rottapharm|Madaus Group is benefiting not
only the ongoing clinical research activities but also the presence on the
market of leading products such as Spasmo Urgenin (relief of painful urinary
symptoms) and Spasmolyt/Uraplex/Regurin (overactive bladder), and Uralyt

    1. Data on file, Rotterpharm 2009.
    2. Pietzko A, et al, Eur J Clin Pharmacol 1994;47:337-343.
    3. Lobenberg R, et al Eur J Biopharm 2000; 50: 3-12.
    4. Herberg KW. Med Weit 1999;50:217-222.
    5. Napier C, Gupta P Neurourol Urodyn 2002;21: A 444
    6. Ikeda K, et al. Naunyn-Schmiedberg's Arch Pharmacol 2002; 366:97-103.
    7. Staskin D, Harnett M, Curr Urolo Rep 2004;5:423-6.
    8. National Collaborating Centre for Women's and Children's Health.
       Urinary incontinence: the management of urinary incontinence in women.
       October 2006.
    9. Staskin D, et al. J Urol 2007;178:978-984.
    10. Dmochowski R, et al. Urology 2008;71:449-454.
    11. Schladitz-Keil, et al.Arzneim-Forsch/Drug Res 1986;36(I)Nr.6:948-987
    12. Sandage B, et al. Poster Pres. ICS and IUGA Joint Meeting, Paris
        2004. Abstract 584.
    13. Regurin XL Prescribing Information.
    14. NICE clinical guideline - Urinary incontinence - the management of
        urinary incontinence in women CG40, 2006
    15. Regurin XL 60 MG - Summary of Product Characteristics Available at


    Billy Hargan
    General Manager, UK
    Speciality European Pharma Ltd
    Direct: +44(0)207-421-7408
    Mobile: +44(0)7872-600022
    Email: billy.hargan@spepharma.com

    Hugh McKinney
    Ruder Finn, UK
    Direct: +44(0)20-7462-8942
    Mobile: +44(0)7961-323810
    Email: hmckinney@ruderfinn.co.uk

SOURCE Speciality European Pharma

Source: newswire

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