SAINT-PREX, Switzerland, May 10 /PRNewswire/ -- Ferring Pharmaceuticals today announced an agreement that will expand its Women's Health product portfolio with the acquisition of the global rights to Xanodyne Pharmaceutical's LYSTEDA™ (tranexamic acid), a first-in-class, non-hormonal therapy indicated specifically for treatment of women with cyclic heavy menstrual bleeding (HMB). The company will initially market LYSTEDA in the U.S., and is evaluating opportunities in other markets. LYSTEDA oral tablets received approval on November 13, 2009 following a Priority Review by the U.S. Food and Drug Administration (FDA). It is estimated that up to 22 million women suffer from HMB in the U.S.(1,2)
"Ferring, as a global, privately held biopharmaceutical company, has a long-standing commitment to the health of women worldwide," said Michel L. Pettigrew, President of the Executive Board, and President and CEO, Ferring Holding Inc. "The acquisition of LYSTEDA, in addition to our ongoing support of research and medical education in the field of Reproductive Health, demonstrates this significant commitment and represents an important addition to our Women's Health portfolio."
Added Olivier Delannoy, Vice President, U.S. Infertility Business Unit, "In the U.S., the acquisition of LYSTEDA enables us to expand into the field of obstetrics and gynecology. Ferring is a well-established leader in reproductive endocrinology with the broadest portfolio of infertility treatments in the U.S., including MENOPUR®, BRAVELLE® and ENDOMETRIN®. The addition of LYSTEDA furthers our goal of providing treatments for every stage of a woman's reproductive health, including before, during and after pregnancy."
Ferring will introduce LYSTEDA to the Obstetric and Gynecology community at the upcoming American College of Obstetricians and Gynecologists (ACOG) 58th Annual Clinical Meeting, May 15-19, 2010 in San Francisco. For more information, visit www.lysteda.com.
LYSTEDA™ (tranexamic acid) tablets are indicated for the treatment of cyclic heavy menstrual bleeding. Prior to prescribing LYSTEDA, exclude endometrial pathology that can be associated with heavy menstrual bleeding.
Important Safety Information
Do not prescribe LYSTEDA to women who are known to have: active thromboembolic disease, a history of thrombosis or thromboembolism, including retinal vein or artery occlusion, an intrinsic risk of thrombosis or thromboembolism. Venous and arterial thrombosis or thromboembolism, and retinal artery and retinal vein occlusions, have been reported with tranexamic acid.
Do not prescribe LYSTEDA to women with known hypersensitivity to tranexamic acid.
Because LYSTEDA is antifibrinolytic, concomitant use with hormonal contraception may exacerbate the increased thrombotic risk (blood clots, stroke, and myocardial infarction) associated with combination hormonal contraceptives. Women using hormonal contraception should use LYSTEDA only if there is a strong medical need and the treatment benefit will outweigh the potential increased risk of a thrombotic event.
In case of severe allergic reaction, discontinue LYSTEDA and seek immediate medical attention. A case of severe allergic reaction (dyspnea, tightening of the throat, and facial flushing) to LYSTEDA was reported in clinical trials and a case of anaphylactic shock was reported in the literature, involving a patient who received an intravenous bolus of tranexamic acid.
Retinal venous and arterial occlusion has been reported in patients using tranexamic acid. Immediately discontinue LYSTEDA if visual or ocular symptoms occur. Ligneous conjunctivitis also has been reported in patients taking tranexamic acid which resolved with drug discontinuation.
LYSTEDA is not recommended for women taking either Factor IX complex concentrates or antiinhibitor coagulant concentrates because the risk of thrombosis may be increased.
Exercise caution when prescribing LYSTEDA to women with acute promyelocytic leukemia taking all-trans retinoic acid for remission induction because of possible exacerbation of the procoagulant effect of all-trans retinoic acid.
Cerebral edema and cerebral infarction may be caused by use of LYSTEDA in women with subarachnoid hemorrhage.
The most common adverse reactions in clinical trials (> 5%, and more frequent in LYSTEDA subjects compared to placebo subjects) were: headache, sinus and nasal symptoms, back pain, abdominal pain, musculoskeletal pain, arthralgia, muscle cramps and spasms, migraine, anemia and fatigue.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals, headquartered in Switzerland, is a privately owned, research driven specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynaecology, fertility and urology. Ferring Pharmaceuticals Inc. offers a line of products in the U.S. market. They include: BRAVELLE® (urofollitropin for injection, purified), MENOPUR® (menotropins for injection, USP) and REPRONEX® (menotropins for injection, USP), Novarel® (chorionic gonadotropin for injection, USP), ENDOMETRIN® (progesterone) Vaginal Insert, 100 mg, FIRMAGON® (degarelix for injection), PROSED® DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), DESMOPRESSIN, and EUFLEXXA® (1% sodium hyaluronate).
(1) U.S. Census Bureau, 2006-2008 American Community Survey. Available at: http://factfinder.census.gov/. Accessed April 7, 2010.
(2) Tufts Medical Center website. Heavy Menstrual Bleeding. Available at: www.tufts-nemc.org. Accessed April 7, 2010.
|SOURCE Ferring Pharmaceuticals|
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