For Immediate Release
Reliant Pharmaceuticals, LLC Release: FDA Approves Novartis Pharmaceuticals Corporation's (NVS) Lescol And Lescol XL For Secondary Prevention Of Coronary Events In Patients With Coronary Heart Disease
May 29, 2003
LIBERTY CORNER, N.J., /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) yesterday approved Lescol® (fluvastatin sodium) and Lescol® XL (fluvastatin sodium) 80 mg extended-release tablets to reduce the risk of undergoing coronary revascularization procedures in patients with coronary heart disease. Reliant Pharmaceuticals LLC markets Lescol® (fluvastatin sodium) and Lescol® XL (fluvastatin sodium), extended release tablets developed by Novartis Pharmaceuticals Corporation and its affiliates for cholesterol management under an exclusive promotion agreement with Novartis Pharmaceuticals Corporation.
Each year approximately one million patients in the U.S. undergo percutaneous coronary intervention (PCI) procedures, such as angioplasty and stenting, to open blocked arteries. Of those patients, nearly 40 percent will undergo a second procedure or have a heart attack within five years.
"Reliant is very excited about the implications of this new labeling enhancement for Lescol and Lescol XL. Through our exclusive promotion agreement with Novartis, Reliant has been very successful in communicating Lescol's safety and tolerability benefits to primary care and specialty physicians throughout the U.S.," said Dr. Ernest Mario, Chairman and Chief Executive Officer of Reliant. "This new indication represents the culmination of the first and only prospective evaluation of the long-term benefits of statin therapy in this particularly high risk population and further supports the safety and efficacy of Lescol."
The FDA approval is based on the positive findings of the landmark Lescol Intervention Prevention Study (LIPS), which demonstrated that treatment with Lescol 80 mg (40 mg twice daily), routinely initiated shortly after a first PCI procedure, significantly reduced the chances of a recurrent cardiac event by 22 percent (p=0.013) versus placebo, even in patients with normal cholesterol levels with or without a history of myocardial infarction. Additionally, treatment with Lescol was associated with a 32 percent (p=0.002) reduction in the risk of late revascularization procedures, defined as those procedures performed at any site more than six months after the initial procedure.
Both Lescol and Lescol XL 80 mg extended-release tablets have already been approved for a similar indication in several countries, including the United Kingdom and applications are pending in other markets.
About the LIPS Trial
LIPS was designed to investigate whether cholesterol lowering with Lescol, initiated within days following successful completion of a first PCI, with or without stenting, would prolong cardiac disease-free survival. LIPS was the first prospective, randomized, placebo-controlled trial to examine any statin specifically in this patient population. This four-year study followed 1,677 patients from 57 centers in 10 countries. The study looked at the time to first major adverse cardiac event (MACE), which was defined as cardiac death, nonfatal heart attack, coronary artery bypass grafting or repeat PCI. Patients were randomized to receive either Lescol 80 mg (40 mg twice daily) or placebo, before hospital discharge after their first coronary surgical procedure.
The LIPS data further underscored the excellent safety profile of Lescol. In the study, there were no significant elevations of creatine phosphokinase (CPK) above 10 times the upper limits of normal (ULN) over the three to four years of follow up. Elevated CPK is an indication of muscle breakdown and is a potential side effect of statin therapies. These safety data match those from a recent analysis involving approximately 9,000 patients in randomized, controlled clinical studies who were taking Lescol or Lescol XL as monotherapy. That analysis found the rate of clinically relevant CPK elevations was not significantly different than the rate seen in patients receiving placebo. Additional pooled analysis demonstrates no difference in CK elevation with Lescol in combination with fibrates compared to monotherapy and placebo.
About Lescol and Lescol XL
In addition to the new indication, Lescol and Lescol XL are indicated to reduce elevated total cholesterol, LDL-C, TG and apolipoprotein B (Apo B) levels and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia. Lescol and Lescol XL are also indicated to slow the progression of atherosclerosis in patients with coronary heart disease. The effect of Lescol and Lescol XL on cardiovascular mortality has not been determined. The independent effects of raising HDL-C or lowering TGs on the risk of coronary and cardiovascular morbidity and mortality have not been determined.
Lescol capsules and Lescol XL tablets are well-tolerated prescription medications for the treatment of high cholesterol. Physicians should perform blood tests before and during treatment to check for liver problems. Patients should not take Lescol or Lescol XL if they are nursing; are pregnant or may become pregnant; have liver problems; or are allergic to any of the ingredients. Possible side effects may include upset stomach, insomnia, upper respiratory tract infections, flu-like symptoms, back pain or headache. Unexplained muscle pain, tenderness or weakness could be a sign of a serious side effect and should be reported to the patient's doctor immediately. For full prescribing information, please contact Christine Landy at 862-778-8026 or consult http://www.pharma.us.novartis.com.
About Reliant Pharmaceuticals
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. Reliant markets a portfolio of products including: Lescol® (fluvastatin sodium) and Lescol® XL (fluvastatin sodium), 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 also markets its first internally developed product, InnoPran XL(TM) (propranolol hydrochloride), a novel bedtime-dosed, extended-release formulation of propranolol hydrochloride, for the treatment of hypertension. Reliant's three national sales forces, totaling over 850 representatives, target over 80,000 high volume primary care and specialty physicians throughout the U.S. Reliant develops and implements sophisticated life cycle management strategies and is also engaged in late stage development of new chemical entities. For further information, please consult www.reliantrx.com, or contact Lawrence (Larry) Gyenes, Chief Financial Officer, Reliant Pharmaceuticals, LLC at (908) 580-1200 or send inquiries to lgyenes@reliantrx.com.
About Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS - News), a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of CHF 32.4 billion (USD 20.9 billion) and a net income of CHF 7.3 billion (USD 4.7 billion). The Group invested approximately CHF 4.3 billion (USD 2.8 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 72,900 people and operate in over 140 countries around the world. For further information, please consult www.novartis.com.
This press release contains forward-looking statements relating to the business of Novartis and Reliant Pharmaceuticals, which can be identified by the use of forward-looking terminology, such as "reduce the risk," "will undergo," "have the opportunity," "new patient population," "may benefit," "beyond lipid lowering" or similar expressions, or by discussions regarding potential new indications or labeling for Lescol/Lescol XL, or regarding the impact of a patient's use of Lescol/Lescol XL. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Lescol/Lescol XL to be materially different from any future results, performance, or achievements expressed or implied by such statements. There can be no guarantee that Lescol/Lescol XL will be approved for any additional indications or labeling in any market. There can be no guarantee regarding the potential future sales of Lescol/Lescol XL. In particular, management's ability to ensure satisfaction of the health authorities' further requirements is not guaranteed and management's expectations regarding commercialization of Lescol/Lescol XL could be affected by, amongst other things, additional analysis of Lescol/Lescol XL clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the ability to obtain or maintain patent or other proprietary intellectual property protection; and competition in general, as well as other risks and factors discussed in the current Form 20-F of Novartis on file with the Securities and Exchange Commission of the United States. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated, or expected.
Print this release.
