Mission Pharmacal Launches New Uribel™ Capsules to Treat Irritative and Debilitating Symptoms of Urinary Tract Conditions

SAN ANTONIO, TX (August 3, 2010) – Mission Pharmacal Company announced today the introduction of prescription Uribel™ (Methenamine, Sodium Phosphate Monobasic, Phenyl Salicylate, Methylene Blue, Hyoscyamine Sulfate) Capsules for Oral Administration to help relieve local discomfort and inflammation associated with lower urinary tract infections (UTIs), interstitial cystitis, painful bladder syndrome, and prediagnostic and postdiagnostic urinary tract procedures. Unlike single-agent analgesic therapies, Uribel relieves urinary tract symptoms with five integrated analgesic, antispasmodic, and antiseptic ingredients that work together to alleviate pain and spasms and eliminate bacteria. Uribel capsules will be manufactured for Star Pharmaceuticals, LLC and distributed and marketed by Mission Pharmacal.

"Uribel is an important expansion of our urology and women's health product portfolio, and we're excited to be partnering with Star Pharmaceuticals to bring this product to patients," said Terry Herring, President of Commercial Operations, Mission Pharmacal. "Uribel provides three complementary ways to treat uncomfortable urinary tract conditions — an analgesic to relieve pain and burning, an antispasmodic to reduce urinary urgency, and antiseptic that inhibits the growth of bacteria."

Uribel may be used in conjunction with antibiotic therapies or other medicines, and is prescribed as one capsule orally four times per day followed by liberal amounts of fluid. Symptom relief can begin within 30 minutes. There is no restriction on the length of therapy. The components in Uribel are generally well tolerated, well-absorbed from the gastrointestinal tract and excreted from the urine in 12 – 24 hours.

Uribel capsules are purple and printed with S 111. They are supplied in bottles of 100 capsules for retail or professional sample cartons of 20 individually pouched capsules, and should be stored at controlled room temperature 15°ndash;30°C (59°–86°F) in a cool, dry place.

Uribel Launch Support

Uribel capsules are available for ordering (since mid-July). Mission Pharmacal will roll out a multi-faceted marketing program directed to prescribing physicians and other healthcare providers, pharmacies and patients.

Patients prescribed Uribel will be offered a coupon through their physician's office to be redeemed at the pharmacy when the prescription is filled. The coupon, good for 12 Uribel prescription fills, enables a patient to pay the first $10 of out-of-pocket (OOP) expense for each fill then receive $40 off of any remaining OOP expense. The Uribel launch will be supported by urologist and ob/gyn in-office sampling and pharmacy promotions. A web site, www.uribelinfo.com, will provide information about Uribel geared to both physician and patient audiences.

Infections of the urinary tract are the second most common type of infection in the body. UTIs account for about 8.3 million doctor visits each year. One woman in five develops a UTI during her lifetime. UTIs in men are not as common as in women but can be very serious when they do occur. Symptoms may include a frequent urge to urinate and a painful, burning feeling in the area of the bladder or urethra during urination. Another condition known as interstitial cystitis (IC)/painful bladder syndrome (PBS) includes all cases of urinary pain that can't be attributed to infection or urinary stones. IC/PBS can cause mild discomfort, pressure, tenderness, or intense pain in the bladder and pelvic area, and also may cause an urgent and/or frequent need to urinate. Of the estimated 1.3 million Americans diagnosed with IC/PBS, more than 1 million are women.

About Uribel Capsules

Uribel is manufactured as a capsule form, while most other therapies for relief of urinary tract pain and discomfort are in tablet form. Uribel capsules are a multi-ingredient therapy for the treatment of local symptoms associated with irritative voiding, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Uribel capsules are also indicated for the relief of urinary tract symptoms associated with prediagnostic and postdiagnostic procedures. Uribel capsules contain a combination of analgesic, antispasmodic, and antiseptic ingredients: phenyl salicylate (relief of pain and burning); hyoscyamine sulfate (relaxation of smooth muscle tissue); methenamine (bactericidal/bacteriostatic action); methylene blue (mild antiseptic); and sodium phosphate monobasic (to aid the bactericidal/bacteriostatic action of methenamine).

Uribel capsules are contraindicated in patients with hypersensitivity to any of its ingredients. Uribel use should be discontinued immediately if rapid pulse, dizziness, or blurring of vision occur. Patients intolerant of belladonna alkaloids or salicylates may be intolerant of Uribel capsules. Management of gastric ulcers may be complicated by delay in gastric emptying caused by Uribel. Patients' urine may turn blue to blue-green and stool may also be discolored, a harmless effect of excretion of one of the antiseptic ingredients in Uribel (methylene blue) that will subside after Uribel is stopped.

Risk-benefits should be carefully considered when prescribing Uribel for patients with certain medical conditions, including cardiac disease, gastrointestinal tract obstructive disease, glaucoma, urinary bladder neck obstruction, or myasthenia gravis. Adverse reactions include: rapid heartbeat, flushing, blurred vision, dizziness, drowsiness, difficult micturition, acute urinary retention, dry mouth, nausea and vomiting, shortness of breath, or trouble breathing.

Uribel capsules are manufactured for Star Pharmaceuticals, LLC, and are distributed and marketed by Mission Pharmacal. Mission's growth as a pharmaceutical company has been fueled by its commitment to providing the best-quality products in the best therapeutic form. In the field of urology, the company's commitment is reflected in an innovative portfolio of products, including Urocit®-K 15 mEq, Thiola®, and Lithostat®.

About Mission Pharmacal

Mission Pharmacal is a privately held pharmaceutical company based in San Antonio, Texas. For more than 60 years, the company has been committed to meeting the unique needs of women throughout all stages of life, identifying unmet health needs in the marketplace, and developing innovative prescription and over-the-counter products to meet them. Currently, Mission Pharmacal provides physicians and consumers with pharmaceutical and nutritional products. For more information, visit www.missionpharmacal.com.

About Star Pharmaceuticals

Star Pharmaceuticals LLC, a specialty pharmaceutical company, founded in 1960, develops quality urology and women's health care products. Star has remained committed to the urology and women's healthcare community for 50 years, focusing on serving the unique needs of physicians by identifying opportunities and selectively developing and commercializing medicines to fill these needs. Careful tests, controls, and procedures are employed to provide products of the highest quality. For more information on Star Pharmaceuticals, visit www.starpharm.com/.

Media Contact: 
Andrea Ziltzer
Chandler Chicco Agency
(212) 229-8433