SEP Signs REGURIN(R) Deal

LONDON - Speciality Urology Company Gains Exclusive UK Distribution Rights

Speciality European Pharma Limited (SEP), the UK based, urology focused, specialty pharmaceutical company, is pleased to announce that it will obtain the exclusive distribution rights to Regurin(R) (trospium chloride) for the UK and Ireland, as of the 1st July 2009. Regurin, owned by Rottapharm-Madaus, is currently marketed under different brand names in European countries including Germany, Italy, Austria, Spain and Switzerland.

Regurin 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 overactive bladder (OAB). Urinary incontinence is an embarrassing problem estimated to affect over a third of women over 40[1]. Regurin is an anti-muscarinic, which reduces the contractions of the detrusor muscle in the bladder and increases bladder capacity.[2] It is well tolerated with a low incidence of the common anti-muscarinic side effect, dry mouth.[3],[4] Regurin also does not cross the blood-eye or blood-brain barrier[5],[6],[7] reducing the incidence of confusion in people taking this treatment.[8],[9],[10],[11]

“Trospium chloride is central to managing certain types of urinary incontinence and is one of the recommended options by the National Institute for Health and Clinical Excellence (NICE) for use in women with mixed urinary incontinence of OAB after generic oxybutynin,” said Professor Linda Cardozo, Kings College Hospital, London. “It’s side effect profile is particularly beneficial to patients.”

Commenting on the deal, Geoff McMillan, Chief Executive Officer of SEP, said: “This agreement provides us with a well established and clinically superior product in the field of urology, an area that remains the focus of our company. This deal demonstrates our ability to secure rights to launched / late stage specialist products for the European market.”

SEP has also obtained exclusive rights to a new presentation of Regurin, the once daily Regurin XL. The availability of Regurin XL will enable it to compete more effectively in the market, which is currently dominated by once daily products. Regurin was developed by Madaus AG of Germany.

About Regurin

Regurin is trospium chloride, a member of the anti-muscarinic class, used to treat the symptoms of OAB. The efficacy has been well established.[12], [13] Trospium chloride has been recommended by NICE for the second line treatment of UI in women after immediate release oxybutynin.[14] Regurin has a high selectivity for two receptors in the detrusor muscle, M sub(2) and M sub(3).[15]

Regurin 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[16],[17],[18] hence unwanted side effects such as impairment of cognitive function are minimal[19], [20], [21], [22]- 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), the world’s first approved GnRH blocker for the treatment of prostate cancer. Plenaxis(R) gives a rapid and sustained decline in testosterone levels, which gives quick and sustained control of prostate cancer and its symptoms. On stopping treatment with Plenaxis, testosterone levels rapidly recover while disease activity remains under control for some time. Plenaxis(R) was launched in Germany in February 2008.

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.

Current 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 (urolithiasis).

References

———————————

[1] National Collaborating Centre for Women’s and Children’s Health. Urinary incontinence: the management of urinary incontinence in women. October 2006

[2] British National Formulary, 57, March 2009 - Urinary Incontinence.

[3] Staskin D, Sand P, Zinner N and Dmochowsky R. for the Trospium Study Group: Once daily trospium chloride is effective and well tolerated for the treatment of Overactive Bladder: results from a multicenter phase III trial. The Journal of Urology 178: 978-984 (2007)

[4] Dmochowski R, Sand PK, Zinner RN and Staskin D: Trospium 60 mg once daily (qd) for Overactive Bladder Syndrome: results from a placebo- controlled interventional study. Urology 71: 449-454 (2008)

[5] Pietzko A, et al. Influence of trospium chloride and oxybutinin on quantitative EEG in healthy volunteers. Eur J Clin Pharmacol 47: 337-343 (1994)

[6] Herberg KW, Füssgen I: Einfluss von Trospiumchlorid, Oxybutynin-HCl und Propiverin-HCl auf sicherheitsrelevante Leistungen. Geriatrie Forschung 7 (2): 77-83 (1997)

[7] Staskin DR, Harnett MD: Effect of trospium chloride on somnolence and sleepiness in patients with overactive bladder. Current Urology Reports 5: 423-426 (2004)

[8] Pietzko A, Dimpfel W, Schwantes U, Topfmeister P: Influences of trospium chloride and oxybutynin on quantitative EEG in healthy volunteers. Eur J Clin Pharmacol 47: 337-343 (1994)

[9] Todorova A, Vonderheid-Guth B, Dimpfel W: Effects of Tolterodine, Trospium chloride, and Oxybutynin on the Central Nervous System. J Clin Pharm 41: 636-644 (2001)

[10] Diefenbach K, Arold G, Wollny A, Schwantes U, Haselmann J, Roots I: Effects on sleep of anticholinergics used for overactive bladder treatment in healthy volunteers aged 50 years. BJU International 95: 346-349 (2005)

[11] Herberg KW, Füssgen I:Einfluss von Trospiumchlorid, Oxybutynin- HCl und Propiverin-HCl auf sicherheitsrelevante Leistungen. Geriatrie Forschung 7 (2): 77-83 (1997)

[12] Zinner N, et al. Trospium chloride improves overactive bladder symptoms: a multicenter phase III trial. The Journal of Urology 171(6): 2311-2315 (2004)

[13] Rudy D, et al. Multicenter Phase III Trial Studying Trospium chloride in Patients With Overactive Bladder. Urology 67: 275-280 (2006)

[14] NICE clinical guideline - Urinary incontinence - the management of urinary incontinence in women CG40, 2006

[15] Regurin XL 60 MG - Summary of Product Characteristics

[16] Pietzko A, et al. Influence of trospium chloride and oxybutinin on quantitative EEG in healthy volunteers. Eur J Clin Pharmacol 47: 337-343 (1994)

[17] Herberg KW, Füssgen I: Einfluss von Trospiumchlorid, Oxybutynin-HCl und Propiverin-HCl auf sicherheitsrelevante Leistungen. Geriatrie Forschung 7 (2): 77-83 (1997)

[18] Staskin DR, Harnett MD: Effect of trospium chloride on somnolence and sleepiness in patients with overactive bladder. Current Urology Reports 5: 423-426 (2004)

[19] Pietzko A, Dimpfel W, Schwantes U, Topfmeister P: Influences of trospium chloride and oxybutynin on quantitative EEG in healthy volunteers. Eur J Clin Pharmacol 47: 337-343 (1994)

[20] Todorova A, Vonderheid-Guth B, Dimpfel W: Effects of Tolterodine, Trospium chloride, and Oxybutynin on the Central Nervous System. J Clin Pharm 41: 636-644 (2001)

[21] Diefenbach K, Arold G, Wollny A, Schwantes U, Haselmann J, Roots I: Effects on sleep of anticholinergics used for overactive bladder treatment in healthy volunteers aged 50 years. BJU International 95: 346-349 (2005)

[22] Herberg KW, Füssgen I:Einfluss von Trospiumchlorid, Oxybutynin- HCl und Propiverin-HCl auf sicherheitsrelevante Leistungen. Geriatrie Forschung 7 (2): 77-83 (1997)

Billy Hargan General Manager, UK Speciality European Pharma Ltd Email: billy.hargan@spepharma.com

Source: Speciality European Pharma

Hugh McKinney, Ruder Finn, UK, Direct: +44(0)20-7462-8942, Mobile: +44(0)7961-323810, Email: hmckinney at ruderfinn.co.uk; Billy Hargan, General Manager, UK, Speciality European Pharma Ltd, Email: billy.hargan at spepharma.com