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Pharmion Launches First U.S. Product; New Sales Force Will Market Innohep -- tinzaparin sodium injection -- to Hematologists and Oncologists.


Business Editors/Health & Medical Writers

BOULDER, Colo.--(BUSINESS WIRE)--Oct. 3, 2002

Pharmion Corporation enters the world's largest pharmaceutical marketplace this week with the launch of its first commercial product in the United States, Innohep(R) (tinzaparin sodium injection). Using its newly formed U.S. commercial field force, Pharmion will market the product to the U.S. hematology and oncology communities.

Innohep(R) is a once-daily low molecular weight heparin In medicine, low molecular weight heparin (LMWH) is a class of medication used as an anticoagulant in diseases that feature thrombosis, as well as for prophylaxis in situations that lead to a high risk of thrombosis.  for the treatment of acute symptomatic deep vein thrombosis A blood clot (thrombos) in a vein deep within the muscle, typically in the thigh or calf. It is caused by disease or the lack of activity such as sitting for hours at a computer screen.  (DVT See deep vein thrombosis. ) with or without pulmonary embolism when administered in conjunction with warfarin sodium (such as Coumadin(R)) in hospitalized patients. The product is currently approved in 55 countries and has been used for over 11 years to treat approximately 12 million patients worldwide (estimated based on number of units sold). Global sales of Innohep(R) were approximately $100 million in 2001.

"Innohep(R) is an excellent product for our first offering to U.S. hematologists and oncologists," said Patrick J. Mahaffy, president and chief executive officer of Pharmion. "It delivers the high therapeutic impact we want our products to provide, and we believe it represents an important therapeutic option for cancer patients who develop DVT as a consequence of their disease or treatment."

Although Innohep(R) is Pharmion's first product marketed in the U.S., it is the fourth product acquired since the company's founding in January 2000. Pharmion also has the global rights to azacitidine, acquired from Pharmacia Corporation in June 2001; the rights in Europe and Australia for THALOMID(R) (thalidomide thalidomide (thəlĭd`əmĭd'), sleep-inducing drug found to produce skeletal defects in developing fetuses. The drug was marketed in Europe, especially in West Germany and Britain, from 1957 to 1961, and was thought to be so safe that ), acquired from Celgene in November 2001, and the rights in all countries outside the U.S. for Refludan(R) from Schering AG in June 2002.

Pharmion obtained U.S. rights to Innohep(R) from LEO Pharma of Denmark in July 2002. The U.S. rights were originally licensed to DuPont Pharmaceuticals by LEO Pharma in 1998. The product received U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) approval in July 2000 and was initially launched in the U.S. in October 2000. Following acquisition of DuPont Pharmaceuticals by Bristol-Myers Squibb in January 2002, Innohep(R) rights were returned to LEO Pharma. Under the agreement with LEO, Pharmion will pursue additional clinical development for the product as well.

DVT, a blood clot (thrombus thrombus /throm·bus/ (throm´bus) pl. throm´bi   a stationary blood clot along the wall of a blood vessel, frequently causing vascular obstruction. ) that develops most commonly in one of the major veins in the leg and inhibits or blocks blood flow, is a potentially life-threatening condition that affects up to five percent of American adults. In the United States alone, approximately two million people develop DVT annually, and an estimated 600,000 of these develop pulmonary embolism, a potentially fatal complication in which the blood clot breaks off and obstructs blood flow to the arteries of the lungs. Research shows that pulmonary emboli emboli /em·bo·li/ (em´bo-li) plural of embolus.
Emboli
Plural of embolus. An embolus is something that blocks the blood flow in a blood vessel.
 are a major contributory factor in some 10 percent of all hospital deaths.

DVT is a major complication in orthopedic, pelvic, abdominal and thoracic surgical patients, as well as those with other chronic diseases such as congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. , lung disease and diabetes. In addition, cancer patients have an especially high risk of DVT. Studies indicate that thrombosis is one of the most frequent complications and the second leading cause of death in patients with known cases of cancer.

"Deep venous thrombosis deep venous thrombosis
n. Abbr. DVT
A condition in which one or more thrombi form in a deep vein, especially in the leg or pelvis, resulting in an increased risk of pulmonary embolism.
 and pulmonary embolism are major causes of morbidity and mortality Morbidity and Mortality can refer to:
  • Morbidity & Mortality, a term used in medicine
  • Morbidity and Mortality Weekly Report, a medical publication
See also
  • Morbidity, a medical term
  • Mortality, a medical term
 in the cancer patient population," said Steven R. Deitcher, M.D., head of the Section of Hematology and Coagulation coagulation (kōăg'ylā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or  Medicine at The Cleveland Clinic Foundation. "Greater attention to effective treatment of thrombosis in these patients is needed. Innohep(R) has proven efficacy for DVT in cancer patients and can be easily added to their overall treatment."

In two pivotal studies, 22 percent and 8 percent of Innohep(R) (tinzaparin sodium injection) patients had cancer.

In controlled clinical trials comparing treatment with Innohep(R) to standard heparin therapy, including a landmark study of 435 hospitalized patients with symptomatic proximal DVT published in the New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. , Innohep(R) was shown to be as safe and effective as heparin for the treatment of DVT with or without pulmonary embolism when administered in conjunction with warfarin sodium. In addition, studies indicate that Innohep(R) significantly reduces the risk of major bleeding compared with intravenous heparin. The absolute risk reduction was 1.9 percent during the initial treatment period. There was no statistical significance in the long-term reduction of bleeding at Day 90. The 95 percent confidence interval (CI) of the difference in major bleeding event rates was 0.33 percent, 3.47 percent.

Innohep(R) is convenient for patients. It is formulated for once-a-day administration and is dosed based on body weight. No dose adjustments are required for elderly or obese patients. Consistent with expected age-related changes in renal function, elderly patients and patients with renal insufficiency may show reduced elimination of Innohep(R). Innohep(R) should be used with care in these patients.

Spinal or epidural hematomas can occur with the associated use of low molecular weight heparins and spinal/epidural anesthesia or spinal puncture, which can result in long-term or permanent paralysis. The risk of hematomas is increased by the use of postoperative indwelling indwelling /in·dwell·ing/ (in´dwel-ing) pertaining to a catheter or other tube left within an organ or body passage for drainage, to maintain patency, or for the administration of drugs or nutrients.  epidural catheters or by the concomitant use of drugs affecting hemostasis such as NSAIDs, platelet inhibitors or other anticoagulants Anticoagulants
Drugs that suppress, delay, or prevent blood clots. Anticoagulants are used to treat embolisms.

Mentioned in: Embolism, Heart Valve Replacement
. Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Please see Full Prescribing Information.

Patients with active major bleeding, patients with (or a history of) heparin-induced thrombocytopenia, or patients with known sensitivity to heparin, tinzaparin sodium injection (or any of its constituents) or pork products should not be treated with Innohep(R). Innohep(R) should be used with extreme caution in conditions with increased risk of hemorrhage.

Bleeding is the most common adverse event associated with Innohep(R) (tinzaparin sodium injection) and can occur in any tissue or organ. The most common adverse events in controlled clinical trials with Innohep(R) were injection site hematomas (16 percent), abnormal elevations of AST (AST Computer, Irvine, CA) A PC manufacturer founded in 1980 by Albert Wong, Safi Quershey and Tom Yuen (A, S and T). It offered a complete line of PCs that sold through its dealer channel.  (8.8 percent) and ALT (13 percent), urinary tract infection urinary tract infection (UTI),
n infection in one or more of the structures that make up the urinary system. Occurs more often in women and is most commonly caused by bacteria.
 (3.7 percent), pulmonary embolism (2.3 percent) and chest pain (2.3 percent). Other bleeding events associated with Innohep(R) at a frequency of greater than or equal to 1 percent were epistaxis epistaxis /ep·i·stax·is/ (-stak´sis) nosebleed; hemorrhage from the nose, usually due to rupture of small vessels overlying the anterior part of the cartilaginous nasal septum.

ep·i·stax·is
n.
 (1.9 percent), hemorrhage (1.5 percent), hematuria hematuria

Blood in the urine. It usually indicates injury or disease of the kidney or another structure of the urinary system or possibly, in males, the reproductive system. It may result from infection, inflammation, tumours, kidney stones, or other disorders.
 (1 percent) and thrombocytopenia Thrombocytopenia Definition

Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets.
 (1 percent).

Innohep(R) cannot be used interchangeably (unit for unit) with heparin or other low molecular weight heparins as they differ in manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units and dosage. Each of these medications has its own instructions for use. Please see Full Prescribing Information for Innohep(R).

About Pharmion

Pharmion is a global specialty pharmaceutical company focused on developing and marketing hematology and oncology products with high therapeutic impact. The company is headquartered in Boulder, Colo. with additional offices in Overland Park, Kans., Australia, Thailand and the United Kingdom. For additional information, please visit Pharmion's web site at www.pharmion.com.

Note to Editors: Innohep(R) is a registered trademark of LEO Pharma. THALOMID(R) is a registered trademark of Celgene Corporation.

For more information or full prescribing information, contact:

Anne de Schweinitz

MS&L

805/898-1652

anne.deschweinitz@mslpr.com

or visit the Innohep(R) website at www.InnohepUSA.com
COPYRIGHT 2002 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2002, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Geographic Code:1USA
Date:Oct 3, 2002
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