Santarus, Inc. (NASDAQ: SNTS) announced today the U.S. commercial launch of UCERIS ™ (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis. UCERIS was approved by the U.S. Food and Drug Administration on January 14, 2013. UCERIS contains budesonide, a locally acting glucocorticosteroid, in a novel oral tablet formulation that utilizes proprietary MMX ® multi-matrix system colonic delivery technology. The approved dosing regimen for adult patients is one 9 mg tablet taken orally once daily in the morning for up to 8 weeks. “We believe that UCERIS fills an important therapeutic gap as a new prescription option available to physicians treating patients in the active phase of mild to moderate ulcerative colitis,” said Wendell Wierenga, Ph.D., executive vice president of research and development. “In our pivotal clinical studies, three times more patients achieved clinical remission and mucosal healing with UCERIS compared with patients taking placebo, and no clinically significant differences in glucocorticosteroid side effects were seen versus placebo after eight weeks of treatment.” William C. Denby, senior vice president of commercial operations said, “For the commercial launch of UCERIS we have added 85 new sales representatives, increasing our total number of sales reps to 235. We will use the entire sales organization to promote UCERIS and ZEGERID ® (omeprazole/sodium bicarbonate) to gastroenterologists, while also continuing to promote our three diabetes/metabolic products to endocrinologists and other physicians.” Mr. Denby added, “In addition to our physician outreach, we recognize that informing patients with ulcerative colitis about UCERIS is key to motivating them to seek treatment for the active phase of their disease. To that end, we are implementing patient education programs through social media and medical information websites to provide patients with helpful information about treatment options.” UCERIS was developed in collaboration with Cosmo Technologies Limited, a subsidiary of Cosmo Pharmaceuticals S.p.A. Upon first commercial sale of UCERIS, $7 million is payable to Cosmo in cash or Santarus common stock, at Cosmo’s option.
Important Safety Information About UCERISUCERIS is a prescription corticosteroid medicine used to help get mild to moderate ulcerative colitis under control. UCERIS is taken once daily in the morning with or without food for up to 8 weeks.
- Do not take UCERIS if you are allergic to budesonide or any of the ingredients in UCERIS.
- Before you take UCERIS, tell your doctor if you have liver problems, are planning to have surgery, have chickenpox or measles or have recently been near someone with chickenpox or measles, have or had a family history of diabetes, cataracts or glaucoma, have high blood pressure (hypertension), decreased bone mineral density (osteoporosis), stomach ulcers, any other medical condition, are pregnant or plan to become pregnant, or breastfeed or plan to breastfeed.
- Tell your doctor about all the medications you take, including prescription and over-the-counter vitamins and herbal supplements. UCERIS and other medicines may affect each other causing side effects.
- Do not eat grapefruit or drink grapefruit juice while taking UCERIS because these can increase the level of UCERIS in your blood.
- Long-time use of UCERIS can cause you to have too much glucocorticosteroid medicine in your blood (hypercorticism). Tell your doctor if you have any of the following signs and symptoms of hypercorticism: acne, bruise easily, rounding of your face (moon face), ankle swelling, thicker or more hair on your body and face, a fatty pad or hump between your shoulders (buffalo hump), or pink or purple stretch marks on the skin of your abdomen, thighs, breasts, and arms.
- When UCERIS is taken for a long period of time, the adrenal glands do not make enough steroid hormones. Tell your doctor if you are under stress or have any symptoms of adrenal suppression during treatment with UCERIS, including tiredness, weakness, nausea and vomiting, and low blood pressure.
- UCERIS weakens your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases such as chickenpox or measles while taking UCERIS. Tell your doctor about any signs or symptoms of infection, including fever, pain, aches, chills, feeling tired, or nausea and vomiting.
- If you take certain other corticosteroid medicines to treat allergies (e.g., eczema, rhinitis), switching to UCERIS may cause your allergies to come back. Tell your doctor if any of your allergies become worse while taking UCERIS.
- The most common side effects with UCERIS are headache, nausea, decreased blood cortisol levels, stomach-area pain, tiredness, stomach or intestinal gas, bloating, acne, urinary tract infection, joint pain, and constipation.
About SantarusSantarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company's current commercial efforts are focused on five products. UCERIS™ (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis and ZEGERID® (omeprazole/sodium bicarbonate) for the treatment of certain upper gastrointestinal disorders are promoted to gastroenterologists. GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes, and FENOGLIDE® (fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol, are promoted to endocrinologists and other physicians who treat patients with type 2 diabetes. Full prescribing and safety information for Santarus’ products are available at www.santarus.com. Santarus’ product development pipeline includes the investigational drug RUCONEST ® (recombinant human C1 esterase inhibitor) for treatment of acute attacks of hereditary angioedema. The company expects to submit a biologics license application (BLA) to the U.S. Food and Drug Administration for RUCONEST in the first half of 2013. Santarus is also developing rifamycin SV MMX ®, which is in Phase III clinical testing for treatment of travelers’ diarrhea. In addition, enrollment has been completed in a Phase I clinical program with SAN-300, the company’s investigational monoclonal antibody. More information about Santarus is available at www.santarus.com. Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. These forward-looking statements include statements regarding the timing and outcome of various matters relating to Santarus' development products, including the submission of a BLA for RUCONEST. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: Santarus' ability to successfully launch UCERIS and generate revenues from UCERIS, ZEGERID, GLUMETZA and its other currently promoted commercial products and its authorized generic ZEGERID product; Santarus' ability to successfully advance the development of, obtain regulatory approval for and ultimately commercialize, its development-stage products, including the timing and outcome of the UCERIS Phase IIIb clinical study, the submission of the RUCONEST BLA and the second Phase III clinical study for rifamycin SV MMX; Santarus' ability to maintain patent protection for its products, including the difficulty in predicting the timing and outcome of ongoing patent litigation; Santarus' ability to achieve continued progress under its strategic alliances, and the potential for early termination of these agreements; Santarus' dependence on strategic partners for certain aspects of its development programs, including risks related to their financial stability; adverse side effects, inadequate therapeutic efficacy or other issues related to Santarus' products that could result in product recalls, market withdrawals or product liability claims; competition from other pharmaceutical or biotechnology companies and evolving market dynamics; other difficulties or delays relating to the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus' products; fluctuations in quarterly and annual results; Santarus' ability to obtain additional financing as needed to support its operations or future product acquisitions; and other risks detailed in Santarus’ prior press releases as well as in prior public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Santarus ® , FENOGLIDE ® , UCERIS ™ , and ZEGERID ® are trademarks of Santarus, Inc. GLUMETZA ® is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET ® is a trademark of VeroScience LLC. MMX ® is a trademark of Cosmo Technologies Limited. RUCONEST ® is a trademark of Pharming Group N.V.