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| |  Cardizem Lyo-Ject Released for U.S. Market KANSAS CITY, Mo., March 25, 1996 -- Hoechst Marion Roussel announced the U.S. market release of Cardizem(R) (diltiazem HCI) Lyo-Ject(TM), an advanced delivery system for Cardizem(R) (diltiazem HCI) Injectable, the company's widely prescribed compound for treatment of certain heartbeat irregularities. Specifically, Cardizem Lyo-Ject is indicated for lowering heart rate in patients with atrial fibrillation or atrial flutter (AF/Fl). AF/Fl is rapid, irregular heartbeat (up to 300 beats per minute), and is the most common cardiovascular condition treated in hospital emergency departments. Cardizem Lyo-Ject provides physicians with a safe, fast (onset of action usually within 3 minutes of bolus injection), self-contained, easy-to-use treatment option. Cardizem Lyo-Ject is compatible with most needle or needle-free systems for continuous heart rate control for up to 24 hours through infusion. The delivery system consists of a dual-chamber, prefilled, calibrated syringe containing 25 mg of Cardizem (diltiazem HCI) in one chamber and 5 mL of diluent (water and 0.05% benzyl alcohol) in the other chamber. The active compound and diluent are combined within seconds inside the syringe prior to administration. "Cardizem Lyo-Ject will be an ideal product for use in the settings where initial or emergency therapy for atrial fibrillation or flutter is most likely to be administered," said Frank Ciriello, product manager, Cardiovascular Marketing for Hoechst Marion Roussel. "The settings encompass emergency departments, intensive care or coronary care units and medicine floors in hospitals, and crash carts and ambulances." The active ingredient in Cardizem Lyo-Ject comes as a lyophilized powder, prepared by rapid freezing and dehydration. Lyophilization eliminates the need for refrigeration and makes for more efficient delivery of the diltiazem HCI. "The advanced delivery system not only may eliminate drug waste but may also provide a quicker and more convenient way for medical professionals to administer the drug to patients," said Ciriello. Cardizem Lyo-Ject is indicated also for rapid conversion of paroxysmal supraventricular tachycardia (PSVT) to normal sinus rhythm (a return to regular heartbeat). Paroxysmal SVT comprises several types of irregular heartbeats that tend to have a rapid onset and ending. It often is not serious, but repeated episodes can serve as a warning of other heart problems. The most commonly reported adverse events are asymptomatic hypotension (4.3%), symptomatic hypotension (3.2%), injection site reaction (3.9%), flushing (1.7%), and arrhythmia (1.0%). Since its introduction in 1991, Cardizem Injectable has become one of the most frequently used drugs for AF/Fl, with total sales of $35 million in 1994. Cardizem Lyo-Ject joins a Hoechst Marion Roussel product line that includes Cardizem(R) CD, a once-daily oral dosing formulation for treating angina and hypertension. The Cardizem Lyo-Ject delivery system will remain under patent protection through 2010. Diltiazem HCI was developed in Japan and is licensed to Hoechst Marion Roussel for U.S. and Canadian distribution under agreement with Tanabe Seiyaku Company, Ltd. The lyophilized product in Cardizem Lyo-Ject will be manufactured by Vetter Pharma-Fertigung GmbH & Co. of Germany. Headquartered in Kansas City, Mo., Hoechst Marion Roussel develops, manufactures and markets prescription and over-the-counter pharmaceutical products in North America, Europe and the Pacific Basin.
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