For Immediate Release
RELIANT PHARMACEUTICALS, LLC RECEIVES FDA APPROVAL FOR INNOPRAN XL™; THE FIRST BEDTIME DOSED BETA BLOCKER FOR THE TREATMENT OF HYPERTENSION
March 6, 2003
Liberty Corner, NJ -- Reliant Pharmaceuticals, LLC announced today that the United States Food and Drug Administration (FDA) has approved InnoPran XL (propranolol hydrochloride), a novel bedtime-dosed, extended-release formulation of propranolol hydrochloride, for the treatment of hypertension. InnoPran XL provides 24-hour blood pressure control in a once-daily formulation and a flexible dosing range from 80mg to 120 mg. It is the only product in its class approved for administration in the evening. InnoPran XL can be used alone or in combination with other anti-hypertensive agents. With evening administration, clinical trials have shown reduction in blood pressure in the early morning hours and sustained control throughout the day.
“A key aspect of Reliant’s business model is the development of innovative and therapeutically meaningful enhancements to currently marketed products. As the first beta-blocker, propranolol has a proven track record of safety and efficacy spanning more than three decades. InnoPran XL is the first of Reliant’s internal development programs to gain FDA approval, an important milestone for the company,” said Joseph Krivulka, President and co-founder of Reliant. “InnoPran XL represents a pioneering concept in the treatment of high blood pressure. Our strategy was to formulate a drug release profile to mirror the body’s natural circadian rhythm such that maximum anti-hypertensive effect is available during the period of greatest risk for adverse cardiovascular events. Nighttime dosing results in clinically efficacious blood levels in the early morning hours—the time when the majority of adverse cardiovascular events, such as heart attacks, occur. With the introduction of InnoPran XL, physicians now have an important new option in the treatment of hypertension.”
As many as 60 million Americans, or nearly 25% of the population, suffer from hypertension. Hypertension, when untreated, can lead to increased morbidity and mortality due to renal failure, stroke, coronary artery disease, myocardial infarction and other conditions. When compared to the healthy population, individuals with high blood pressure have up to three or four times the risk of developing coronary heart disease, and up to seven times the risk for stroke. The Sixth Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC-VI), published by the National Institutes for Health (NIH) in 1997, recommends beta-blockers as the preferred first-line therapy for the treatment of hypertension. In 2002, over 100 million prescriptions for beta-blockers were written, an increase of nearly 8%.
In a double blind, parallel dose-response study in 434 patients with mild-to-moderate hypertension, doses of InnoPran XL from 80 to 640 mg were taken once daily at approximately 10 PM. InnoPran XL significantly lowered sitting systolic and diastolic blood pressure when measured 16 hours later. The anti-hypertensive effects of InnoPran XL were also seen in patients 65 years and older. Other clinical trials showed dose proportional increases in plasma levels after single and multiple administration of 80, 120 and 160 mg of InnoPran XL. At steady state, the bioavailability of 160 mg of InnoPran XL and propranolol hydrochloride long-acting capsules were not statistically different. The most commonly reported side effects were fatigue, dizziness, and constipation. InnoPran XL is contraindicated in cardiogenic shock, sinus bradycardia and greater than first-degree block, bronchial asthma and in patients with known hypersensitivity to propranolol hydrochloride.
InnoPran XL was developed in partnership with Eurand using its proprietary Diffucaps® technology. It will be available in 80mg and 120mg capsules. Reliant expects initial shipments to the trade of InnoPran XL to begin in early April.
Reliant Pharmaceuticals is a privately held company founded in 1999 to market branded, patent protected, ethical pharmaceutical products to primary care and targeted specialty physicians and to create and develop innovative solutions for better treatments and therapies. In addition to InnoPran XL, Reliant markets a portfolio of products, including: Lescol® (fluvastatin) and Lescol® XL, extended release tablets developed by Novartis for cholesterol management under an exclusive promotion agreement with Novartis Pharmaceuticals Corporation; DynaCirc® (isradipine) and DynaCirc CR®, an extended release formulation, also developed by Novartis for the treatment of hypertension; and Axid® (nizatidine) developed by Eli Lilly for the treatment of GERD and peptic ulcers. Reliant’s national sales force of over 750 representatives is focused on high volume primary care and specialty physicians. Reliant develops and implements sophisticated life cycle management strategies to extend marketing exclusivity or provide additional patent protection for its products and is also engaged in late stage development of new chemical entities. In addition to investments by members of the company's management team and its Board of Managers, Reliant investors include Alkermes, Inc. and prominent private investment firms.
Eurand is a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug delivery technologies. The company specializes in bioavailability enhancement of poorly soluble drugs, modified release and taste masking and is currently developing a pipeline of products based on its Biorise Solubility Enhancement technology. Eurand also works with many of the world’s leading pharmaceutical and biotechnology companies to develop enhanced forms of their existing products and their compounds in development. Eurand’s principal operating offices are in Milan, Italy with commercial offices in New York. The company has research, development and manufacturing facilities in Italy, the United States and France.
“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company’s filings with the Securities and Exchange Commission
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