July 30, 2008
Noven Announces Final FDA Approval of Stavzor(TM) for the Treatment of Bipolar Disorder, Seizures and Migraine Headaches
Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) today announced that the U.S. Food and Drug Administration (FDA) has approved Stavzor(TM) (valproic acid delayed release capsules) in 125 mg, 250 mg and 500 mg strengths. Stavzor is approved for the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures, and for prophylaxis of migraine headaches. The product will be marketed and sold by Noven Therapeutics, LLC, Noven's specialty pharmaceutical subsidiary, and is expected to be available in pharmacies in the second half of August.
Stavzor soft gel capsules are small (up to 40% smaller than Depakote(R) and Depakote ER(R) tablets at the 500 mg dosage strength) and easy to swallow, with an advanced enteric technology designed to reduce reflux and gastric irritability. Banner Pharmacaps Inc., Noven's development partner for this product, developed Stavzor using its EnteriCare(TM) enteric soft gelatin capsule delivery system, and submitted the Stavzor New Drug Application to the FDA.
"Valproate, the active ingredient in Stavzor, is recommended by the American Psychiatric Association as a first-line therapy for patients living with bipolar disorder and experiencing manic episodes," said Dr. Miguel Martelli, a psychiatrist in private practice in Georgia. "The small size and soft gel capsule formulation of Stavzor should make this new product easy to swallow, which in my experience is critical to helping valproate patients start - and stay on - their medication."
"Our research indicates that valproate patients would prefer a small, soft gel capsule - like Stavzor - that is easy to swallow," said Anthony Venditti, Noven's Vice President - Marketing & Sales. "In a recent survey of 400 valproate users, more than two-thirds reported difficulty swallowing their other valproate medications, and 85 percent said they would have preferred a small soft gel capsule had it been available when initiating therapy. These are some of the patients who we expect to help with the launch of Stavzor."
"The approval of Stavzor is an important development for patients who use valproate products and for our company," said Peter Brandt, Noven's President and Chief Executive Officer. "For patients, it represents a new, easy-to-swallow treatment option that may help with compliance. For Noven, it represents a significant step toward our goal of establishing Noven as a high-growth specialty pharmaceutical company."
By visiting www.stavzor.com, consumers can access additional information on Stavzor and request a Stavzor Easy Save Pharmacy Card that can provide a significant savings off every co-payment. The Stavzor website also explains how the Stavzor Pharmacy Locator Service can help patients fill their Stavzor prescription at their preferred pharmacy. In addition, physicians can use the website to request Stavzor samples.
Important Product Safety Information about Stavzor
Valproate products should not be administered to patients with hepatic disease or significant hepatic dysfunction. Hepatic failure resulting in fatalities has occurred in patients receiving valproic acid and its derivatives, usually during the first six months of treatment.
Valproate may produce teratogenic effects in the offspring of women receiving the drug during pregnancy. Benefits of valproate should be weighed against risk of injury to the fetus in women of childbearing potential.
Cases of life-threatening pancreatitis, some rapidly progressing to death, have been reported in both adults and children receiving valproate. Valproate is contraindicated in patients with known urea cycle disorders (UCD), a group of uncommon genetic abnormalities, due to reports of sometimes-fatal cases of hyperammonemic encephalopathy. Concomitant administration of valproic acid and topiramate has been associated with hyperammonemia with and without encephalopathy.
The frequency of adverse effects, particularly elevated liver enzymes and thrombocytopenia, may be dose-related. Multi-organ hypersensitivity reactions have been reported after the initiation of valproate therapy. In a clinical trial of valproate in elderly patients with dementia, some patients taking valproate experienced somnolence, sometimes requiring discontinuation.
Common adverse events (greater than 5 percent incidence) associated with valproate in clinical studies were nausea, somnolence, dizziness, vomiting, asthenia, abdominal pain, dyspepsia, rash, diarrhea, increased appetite, tremor, weight gain, back pain, alopecia, headache, fever, anorexia, constipation, diplopia, amblyopia/blurred vision, ataxia, nystagmus, emotional lability, thinking abnormal, amnesia, flu syndrome, infection, bronchitis, rhinitis, thrombocytopenia, ecchymosis, peripheral edema, insomnia, nervousness, depression, pharyngitis, dyspnea and tinnitus.
Banner Pharmacaps Inc., headquartered in High Point, North Carolina, is a global drug delivery and specialty pharmaceutical company developing a proprietary portfolio of unique products and oral dosage forms, including soft gelatin capsules. EnteriCare(TM) is a trademark of Banner.
Depakote(R) and Depakote ER(R) are registered trademarks of Abbott Laboratories.
About Noven Pharmaceuticals
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. Noven's business and operations are focused in three principal areas - transdermal drug delivery, the Novogyne joint venture, and Noven Therapeutics, Noven's specialty pharmaceutical unit. For more information about Noven Pharmaceuticals, visit www.noven.com.
About Noven Therapeutics
Noven Therapeutics, LLC is a wholly-owned subsidiary of Noven Pharmaceuticals, Inc. In addition to Stavzor, Noven Therapeutics currently offers other medications in the mental health area, consisting of Pexeva(R) (paroxetine mesylate) for the treatment of depression, generalized anxiety disorder, obsessive/compulsive disorder and panic disorder, and Lithobid(R) (lithium carbonate) for the treatment of manic episodes of bipolar disorder. Through its Give Back Program, Noven Therapeutics supports non-profit, grassroots organizations that provide increased awareness, education, and training opportunities in mental health areas for healthcare professionals, patients and their families.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
Except for historical information contained herein, the matters discussed in this press release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve substantial risks and uncertainties. Statements that are not historical facts, including statements that are preceded by, followed by, or that include, the words "believes,""anticipates,""plans,""expects" or similar expressions and statements are forward-looking statements. Noven's estimated or anticipated future results, product performance or other non-historical facts are forward-looking and reflect Noven's current perspective on existing trends and information. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the current expectations of Noven and are subject to a number of risks and uncertainties that are subject to change based on factors that are, in many instances, beyond Noven's control. These risks and uncertainties include, among others, risks related to actions that may be taken by competitors; the possibility that product launch and/or availability may be delayed; and the many risks that face new products, including the impact of competitive products and pricing, the risk that product acceptance may be less than anticipated, the risk of unexpected adverse side effects or inadequate therapeutic efficacy of a product, risks related to compliance with extensive, costly, complex and evolving governmental regulations and restrictions, and reimbursement policies of government and private health insurers and others. For additional information regarding these and other risks associated with Noven's business, readers should refer to Noven's Annual Report on Form 10-K for the year ended December 31, 2007 as well as other reports filed from time to time with the Securities and Exchange Commission. Unless required by law, Noven undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.