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FDA Approves Once-A-Day InnoPran XL(Propranolol) For Hypertension

Breakthrough Chronotherapy Treatment for Hypertension Utilizes Eurand's Diffucaps® Technology -

MILAN, ITALY -- March 13, 2003 -- Eurand today announced that the US Food and Drug Administration (FDA) has granted final marketing clearance to Reliant Pharmaceuticals LLC for InnoPran XL™ (propranolol hydrochloride) Extended Release capsules, a once-a-day chronotherapy, which utilizes Eurand's novel Diffucaps® technology.

InnoPran XL is a beta-blocker and will be used in the treatment of hypertension. InnoPran XL provides 24-hour blood pressure control in a once daily formulation and a flexible dosing range from 80 mg to 120 mg. It is the only product in its class approved for administration in the evening and can be used alone or in combination with other anti-hypertensive agents. With evening administration, clinical trials have shown a reduction in blood pressure in the early morning hours and sustained control throughout the day. According to the American Heart Association, approximately 60 million Americans suffer from hypertension. These patients often experience an increase in blood pressure and heart rate in the early morning hours and, as a result, are more vulnerable to cardiac events during that time.

To address patients' early morning susceptibility to cardiovascular events, InnoPran XL was developed as a chronotherapy using Eurand's Diffucaps technology. As a result, patients can take the drug at bedtime and have optimal protection during the early morning hours when the risk of experiencing adverse cardiovascular events, including heart attack, is heightened. When taken at bedtime, InnoPran XL has a delayed release of approximately four hours, after which drug plasma levels rise progressively to provide peak plasma concentrations approximately 12-14 hours after dosing.

"The approval of InnoPran XL is the second regulatory approval in the US in the past two years for products developed using Eurand's Diffucaps technology. These approvals demonstrate the value of Eurand's technology platforms and are a testament to our success as a leader in drug delivery," said Gearoid Faherty, Chief Executive Officer of Eurand. "The development of InnoPran XL showcases the flexibility of our Diffucaps technology and confirms Eurand's ability to develop products with unique drug release profiles."

The New Drug Application (NDA) for InnoPran XL was filed in November 2001 and was accepted for review by the FDA in February 2002. Eurand has received product development payments for this program and will receive royalties on product sales as well as manufacturing revenue for supplying the product.

"InnoPran XL represents a pioneering concept in the treatment of high blood pressure," said Joseph Krivulka, President and Co-Founder of Reliant. "Working with our partner Eurand and their Diffucaps technology, we were able to formulate a drug release profile to mirror the body's natural circadian rhythm such that maximum anti-hypertensive protection effect is available during the period of greatest risk for adverse cardiovascular events." Dr. Domenic Sica, Chairman of Clinical Pharmacology and Hypertension at Virginia Commonwealth University in Richmond, Virginia said, "InnoPran XL represents a breakthrough in the treatment of hypertension. 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 management and treatment of hypertension."

Eurand's Diffucaps® technology provides customized release profiles for optimal therapeutic results. This technology is a multi-particulate system in which individual beads of the drug are prepared with specific rate-controlling membranes providing a unique release profile. Customized release profiles can then be achieved by combining different types of beads in a capsule.

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(R), 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 proprietary drug delivery technologies. 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.


SOURCE: Eurand

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