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

Thursday, September 17, 2009 General News
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LONDON, September 7 Regurin(R) XL (trospium chloride), aonce-daily, prolonged-release capsule to treat patients with overactivebladder (OAB) has been launched in the UK. Regurin(R) XL provides rapid,significant and consistent improvements in the symptoms of OAB1 and has areduced potential for central nervous system (CNS) side effects(2-7).

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

By rapidly, significantly and consistently improving the symptoms of OABas early as day 5 of treatment., a statistically significantly higher numberof patients in placebo controlled clinical trials achieved a reduction inurgency 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, orthe blood eye barrier(2,4,7) reducing the CNS side effects sometimesassociated with OAB treatments(2-7).

"Overactive bladder has a significant, and often underestimated, impacton the quality of life of all patients. In elderly dependent patients OAB cancause breakdown in care-giving relationships and even increase the likelihoodof patients being admitted to a nursing home , said Professor Linda Cardozo,Kings College Hospital, London. "It is important to effectively treat OAB, tomaintain confidence and independence in all patients. Ensuring patientcompliance 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 iswelcome news for physicians and their patients".

Clinical trials showed the incidence of dry mouth, and constipation alsooccurs less frequently in patients on Regurin(R) XL compared to all otherantimuscarinic agents, and approximately 50% less than Regurin(R) 20mg twicedaily(9,10). In addition, Regurin(R) XL has a low potential for interactionwith concomitantly administered medications.(11- 13).

Geoff McMillan, Chief Executive Officer of SEP, said: "As a young Companywith a focus on Urology, the launch of Regurin XL is very exciting. Urinaryincontinence is a very common and embarrassing problem and we believe thatRegurin XL offers significant benefits for patients, their physicians and thehealth service as a whole."

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

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

About Regurin(R) XL

Regurin is trospium chloride, a member of the anti-muscarinic class, usedto treat the symptoms of OAB. The efficacy has been well established.Trospium chloride has been recommended by NICE for the second line treatmentof UI in women after immediate release oxybutynin(14). Regurin XL has a highselectivity for two receptors in the detrusor muscle, M sub(2) and Msub(3)(15).

Regurin(R) XL is a quaternary amine: as such it is a positively chargedmolecule that does not cross the blood brain barrier or the blood eyebarrier(2,4,7) hence unwanted side effects such as impairment of cognitivefunction are minimal2-7 - an important consideration especially for theelderly population.

Founded in April 2006, SEP is a privately owned speciality pharmaceuticalcompany. Its mission is to become the leading Urologist focused specialtypharmaceutical 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) andit is used to treat advanced and metastatic prostate cancer. Plenaxis hasbeen launched in Germany and is going through the regulatory process in otherEU countries.

SEP has distribution rights in certain European countries for two furtherproducts, Amphocil(R), an antifungal agent and Haemopressin(R), a product forthe treatment of Bleeding Oesophageal Varices. Both of these products aredelivered 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 andterritories through relationships with expert partners.

About Rottapharm|Madaus

Established in 1961, Rottapharm is a multinational pharmaceutical companyprimarily engaged in the research, development and global distribution of newpharmaceutical products in different therapeutic areas includingrheumatology, 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 GroupMadaus Pharma and today the Rottapharm|Madaus Group has subsidiaries ordirect commercial operations throughout Europe and in the vast majority ofMiddle East, Asia (excluding Japan) and Central/South America countries.

Currently Rottapharm's main products include: the original GlucosamineSulfate EU prescription product that paved the way for several nutraceuticalglucosamines with yet unsurpassed clinical expertise in the development ofDisease Modifying Drugs in Osteoarthritis; a line of matrix transdermaldelivery systems for HRT and CVD; and others out of a list of 19 new drugsderived from over 300 patents. Moreover, the Group has recently implemented aline of effective and successful nutraceuticals for dyslipidemias, women'shealth, inflammation, and entered the area of personal care that includes aline of leading products in intimate hygiene/paediatric/skin care and inwhich the company is ranked as the sixth largest in the world market.

Finally, with the acquisition of Madaus, Rottapharm's expertise in thegenito-urinary area has been strongly improved. Important synergies have beenidentified in this area, where the Rottapharm|Madaus Group is benefiting notonly the ongoing clinical research activities but also the presence on themarket of leading products such as Spasmo Urgenin (relief of painful urinarysymptoms) and Spasmolyt/Uraplex/Regurin (overactive bladder), and Uralyt(urolithiasis).About Speciality European Pharma(

SOURCE Speciality European Pharma

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