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Alaven Pharmaceutical Introduces Kit for UC Patients

Monday, June 9, 2008 General News J E 4
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MARIETTA, Ga., June 9 When patients with ulcerativecolitis (UC) flare, their normal life can be completely disrupted. Bloodydiarrhea, frantic urgency and abdominal pain make the bathroom the center ofattention.

Alaven Pharmaceutical LLC, a specialty pharmaceutical company focused ondeveloping and commercializing products to treat gastrointestinal conditions,today announced the introduction of a convenience Kit at the American Societyof Colon and Rectal Surgeons' annual meeting in Boston. The Kit containsROWASA(R) (mesalamine) Rectal Suspension Enema 4g/60mL, a treatment for flaresymptoms associated with active mild to moderate left-sided UC,proctosigmoiditis, or ulcerative proctitis, and a personal cleansing wipe foradded convenience for those inevitable restroom stops.*

"There is a continued need in the marketplace for convenient UC therapyfor all patients living with the disease and facing the inevitability offlares," said Connie Swanson, VP, Sales and Marketing at Alaven. "Our hope isthat by offering ROWASA in a convenience kit, patients will have access to asoothing topical treatment for more immediate flare relief and that they willbe more comfortable with their medication-taking routine."

ROWASA is a prescription medication administered at bedtime for the reliefof UC flare symptoms. Applied directly to the site of inflammation, ROWASAreduces rectal bleeding in as little as 3 days(1) and provides fast relief ofdiarrhea, abdominal pain, and other flare symptoms(2). The full course oftreatment with ROWASA (3-6 weeks) is recommended for more complete flarerelief(2).

Due to the unpredictable course of UC that is marked by periods ofinactivity and then incidences of intermittent flares, patients are at anincreased risk for poor adherence to medications. An estimated 34% of patientswith left-sided UC have been shown to be non-compliant to prescribedmedications(3). Research also shows that innovative ways, including providingconvenient medications, may help to motivate patients to adhere(3).

The ROWASA convenience kit helps to improve the delivery and accessibilityto reliable UC flare therapy while offering value-added convenience from apersonal cleansing wipe that leaves UC patients clean and fresh.*

For additional information, visit www.ROWASA.com .

Important Safety Information

Contraindications: ROWASA is contraindicated for patients known to havehypersensitivity to the drug or any component of this medication.

Warning: ROWASA contains potassium metabisulfite, a sulfite that may causeallergic-type reactions including anaphylactic symptoms and life-threateningor less severe asthmatic episodes in certain susceptible people. The overallprevalence of sulfite sensitivity in the general population is unknown butprobably low.

Precautions: Mesalamine has been implicated in the production of an acuteintolerance syndrome characterized by cramping, acute abdominal pain andbloody diarrhea, sometimes fever, headache and a rash; in such cases promptwithdrawal is required. Caution should be exercised when mesalamine isinitially used in patients known to be allergic to sulfasalazine.

Adverse Reactions: ROWASA is usually well tolerated. Most adverse effectshave been mild and transient. The most frequently reported adverse eventsinclude abdominal cramps, headache, gas, nausea, flu, fatigue, fever and rash.For Full Prescribing Information - www.ROWASA.com . *Wipe is optional and not a required part of treatment 1 Sutherland LR, et al. 5-aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis. Gastroenterology. 1987;92(6):1894-1898. 2 ROWASA Prescribing Information. Rev 05/08. 3 Kane SV, et al: The Challenge of Compliance and Persistence: Focus on Ulcerative Colitis. J Manag Care Pharm. 2008;14(1)(suppl S-a
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