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Phase 3 clinical findings submitted on use of ALBUNEX for fallopian tube patency.


ST. LOUIS--(BUSINESS WIRE)--Sept. 16, 1996--Mallinckrodt Group Inc. (NYSE NYSE

See: New York Stock Exchange
:MKG MkG Mit Kameradschaftlichen Grüßen (German: With Best Regards)
MKG Mitsubishi Kreditbank GMBH (German branch of Mitsubishi Bank)
MKG Muskegon, MI, USA - Muskegon County International Airport
) in conjunction with Molecular Biosystems (NYSE:MB) has submitted to the U.S. Food and Drug Administration its findings from Phase 3 clinical trials of ALBUNEX (albumin (human), 5 percent, sonicated), ultrasound imaging agent, for use in infertility diagnosis in women.

The specific, unapproved un·ap·proved  
adj.
Not approved or sanctioned: an unapproved vaccine; an unapproved protest march. 
 use is for diagnosing fallopian tube fallopian tube (fəlō`pēən), either of a pair of tubes extending from the uterus to the paired ovaries in the human female, also called oviducts, technically known as the uterine tube.  patency pa·ten·cy
n.
The state or quality of being open, expanded, or unblocked.



patency

the condition of being open.
, which refers to the extent to which the fallopian tube is open or obstructed.

The Phase 3 trial took place at 15 international sites in the United States, Sweden and France, and involved 433 women. ALBUNEX- enhanced ultrasound compared favorably to the two current clinical standards: hysterosalpinography (HSG HSG High School Graduate
HSG Housing
HSG Hysterosalpingogram
HSG Hysterosalpingography
HSG Hochschule St. Gallen (Switzerland)
HSG Huntington Study Group
HSG High Sierra Group
HSG Hotspot Gateway (802.
), an X-ray-based procedure, and laparoscopy laparoscopy
 or peritoneoscopy

Procedure for inspecting the abdominal cavity using a laparoscope; also surgery requiring use of a laparoscope. Laparoscopes use fibre-optic lights and small video cameras to show tissues and organs on a monitor.
, a surgical procedure.

"We are encouraged by the results of the Phase 3 trials," said Neal L. Muhilly, imaging vice president-ultrasound for Mallinckrodt.

"A contrast-enhanced ultrasound procedure for diagnosing fallopian tube patency may offer several advantages to women. Unlike surgery, it would be minimally invasive. It is non-surgical. There would be no exposure to X-rays, and an ultrasound procedure can be performed in the privacy of a physician's office under the control of a physician."

Kenneth J. Widder, M.D., Molecular Biosystems' chairman and chief executive officer, said: "This submission for ALBUNEX marks the achievement of another milestone which the company said it would accomplish this year. Fallopian Tube Patency may be a specialty application for ALBUNEX and a continuation of our strategy in building a worldwide business in ultrasound imaging agents with our partner Mallinckrodt."

Mallinckrodt also recently entered an agreement with Conceptus Inc. to be the exclusive marketer and distributor of Conceptus conceptus /con·cep·tus/ (-tus) the product of the union of oocyte and spermatozoon at any stage of development from fertilization until birth, including extraembryonic membranes as well as the embryo or fetus.  Fallopian Tube Catheterization catheterization

Threading of a flexible tube (catheter) through a channel in the body to inject drugs or a contrast medium, measure and record flow and pressures, inspect structures, take samples, diagnose disorders, or clear blockages.
 System in North, Central and South America. Under the agreement, Mallinckrodt will market and distribute Conceptus' Fallopian Tube Catheterization System to hospitals for the diagnosis of fallopian tube disorders.

"Mallinckrodt sees the minimally invasive diagnosis and treatment of fallopian tube disorders as an important and growing area of medicine, and we hope to provide products and services that will help both doctors and patients address these disorders more," Muhilly said.

ALBUNEX, a product of Molecular Biosystems Inc., is the first ultrasound contrast agent cleared by the U.S. Food and Drug Administration for use in the United States. Its current indication is for the diagnosis of cardiac disorders. It is marketed in the United States by Mallinckrodt.

Molecular Biosystems, based in San Diego, is a world leader in the development of ultrasound contrast agents for medical imaging. Its shares are listed on the New York Stock Exchange New York Stock Exchange (NYSE)

World's largest marketplace for securities. The exchange began as an informal meeting of 24 men in 1792 on what is now Wall Street in New York City.
 under the symbol "MB."

Mallinckrodt Group is a dynamic, international growth company serving specialty markets in human health care and chemicals and is dedicated to improving health care and chemistry.

Mallinckrodt is a major producer of analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs  pharmaceuticals, diagnostic imaging agents, medical devices, catalysts and laboratory and microelectronic chemicals. The St. Louis-based company, with fiscal 1996 net sales of $2.2 billion, sells more than 2,000 products in more than 100 countries. Mallinckrodt employs about 10,400 people worldwide.

This news release contains forward-looking statements that involve risk and uncertainties. The actual results of the trials described herein may differ from the company's expectations discussed. Among the factors that could result in a materially different outcome are the inherent uncertainties accompanying new product development.

CONTACT: Molecular Biosystems Inc., San Diego

Gerard A. Wills/Stephen F. Keane, 619/824-2248

or

Peter Faur, 314/854-5234 (media)

Barbara Abbett, 314/854-5230 (media)

Cole Lannum, 314/854-5370 (investors)
COPYRIGHT 1996 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Sep 16, 1996
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