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Alaven exclusively licenses CystoProtek^® in the United States

April 15, 2007

Alaven Pharmaceutical LLC (Marietta, GA) and Algonot, LLC announced today that Alaven has acquired an exclusive license to manufacture and sell CystoProtek throughout the United States, its territories and possessions.

CystoProtek, a patent protected, natural oral dietary supplement in softgel capsule form, has been clinically demonstrated to relieve symptoms associated with Interstitial Cystitis.  The anti-inflammatory properties of the glucosamine, quercetin and rutin in CystoProtek’s¹ unique natural formula reduce bladder damage and pain, while its glucosamine sulfate, chondroitin sulfate and hyaluronate sodium help replenish the damaged glycosaminoglycan (GAG) protective layer in the bladder^2,3. CystoProtek’s beneficial effects in Interstitial Cystitis are believed to be due to this dual action⁴.   

CystoProtek is the result of years of research into Interstitial Cystitis by Theoharis Theoharides, PhD. Dr. Theoharides is a professor of Pharmacology, Internal Medicine and Biochemistry and Director of the Molecular Immunopharmacology and Drug Discovery Laboratory at Tufts University in Boston, MA (www.mastcellmaster.com). In two open label studies, CystoProtek was well tolerated by patients ingesting 4-6 softgel capsules per day for 4-6 months and reported to be effective in reducing the pain and improving overall symptoms in many patients with Interstitial Cystitis^2,3.

About Interstitial Cystitis and Cystitis:
According to the National Institutes of Health, Interstitial cystitis (IC), also called Painful Bladder Syndrome, is a condition that results in recurring discomfort or pain in the bladder and the surrounding pelvic region. The symptoms vary from case to case and even in the same individual. People may experience mild discomfort, pressure, tenderness, or intense pain in the bladder and pelvic area. Symptoms may include an urgent need to urinate (urgency), a frequent need to urinate (frequency), or a combination of these symptoms. Pain may change in intensity as the bladder fills with urine or as it empties. Women's symptoms often get worse during menstruation. They may sometimes experience pain with vaginal intercourse. IC often occurs together with other conditions, such as endometriosis, and is far more common in women than in men. Of the estimated 1 million Americans with IC, up to 90 percent are women.

Cystitis is inflammation of the urinary bladder. The condition more often affects women, but can affect either sex or all age groups.

For patients using CystoProtek:
CystoProtek is now being exclusively sold within the United States by Alaven Pharmaceutical, LLC.  To order CystoProtek, please call 1-888-317-0001 or click here.

References:

1. Issued patents include 6,689,748, 6,984,667, and 6,635,625. Other applications are pending.

2. Publications:

   • Theoharides TC, Vakali S, Kempuraj D, Sant R.  A retrospective open label study of CYSTOPROTEK in painful bladder syndrome/interstitial cystitis (PBS/IC). Proeedings NIDDK International Symposium: Frontiers in Painful Bladder Syndrome and Interstitital Cystitis (October 24-27, 2006; Bethesda, MD).

   • Theoharides TC. Treatment approaches for painflul bladder syndrome/interstitial cystitis.  Drugs vol.  67:215-235, 2007.

   • Theoharides, TC, O’Leary M.  Nutraceuticals in painful bladder syndrome/interstitial cystitis.  Seminars in  Preventive  Alternative Medicine vol. 2:6-14, 2006

   • Theoharides TC, Sant GR.  Immunomodulators for the treatment of interstitial cystitis.  Urology  vol. 65:633-638, 2005

   • Theoharides TC, Sant GR  A pilot open label study of CystoProtek in interstitial cystitis. International Journal of Immunopathology and Pharmacology vol. 18: 183-188, 2005.

3. Results of the two studies indicate that CystoProtek can be given to patients who have failed other therapies and can also be given with patients on other oral or intravesical therapies. There was stomach upset in less than 1% of subjects, especially those with concurrent irritable bowel syndrome (IBS). CystoProtek does not offer substantial relief of pain and other symptoms before 90-120 days of use at 4-6 softgel capsules per day. CystoProtek should best be taken with a meal and only in the suggested dosages. Patients allergic to eggs, soy, shellfish or olive oil should consult their doctor about CystoProtek.  CystoProtek should be kept in a cool place or refrigerator away from children.

4. This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any diseases.

Contact:

Deborah Lovin, 1-888-317-0001, extension 10116
dlovin@alavenpharm.com

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