Navigation Links
Ferring Acquires LYSTEDA(TM) From Xanodyne Pharmaceuticals, Inc.
Date:5/10/2010

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)

(Logo:  http://www.newscom.com/cgi-bin/prnh/20100510/NY01272LOGO )

"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.

About LYSTEDA™

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).

To learn more about Ferring or its products please visit www.ferring.com. For U.S.-specific information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.

(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
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. deCODE and Radboud University Discover Common Variants in the Human Genome Conferring Risk of Bladder Cancer
2. Ferring Pharmaceuticals Launches Phase IIIB Trial of Degarelix as Intermittent Therapy
3. Ferring Pharmaceuticals Unveils Six-Month Efficacy Data for EUFLEXXA(R) for the Treatment of Osteoarthritis Knee Pain
4. Timm Medical Technologies and Ferring Pharmaceuticals Enter Exclusive Co-Promotion Agreement for Prosed(R) DS
5. Dr. Harry Kovelman Joins Ferring Pharmaceuticals as Associate Medical Director for Orthopaedics
6. Ferring Pharmaceuticals and Gene Security Network Partner to Test Advanced Preimplantation Genetic Diagnosis (PGD) Technology
7. Upstream Biosciences Acquires Innovative Platform Technology and Drug Candidates for Tropical Parasitic Diseases
8. Image Solutions, Inc. Acquires Zurich Biostatistics, Inc.
9. U.S. Preventive Medicine Acquires Specialty Disease Management
10. MacroChem Acquires Rights to Pexiganan, a Novel Topical Anti-Infective for Treatment of Diabetic Foot Infections, From Genaera
11. Nastech Reacquires Teriparatide (Parathyroid Hormone; PTH1-34) Nasal Spray from Procter & Gamble
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... -- Story Highlights: , ... health care industry is causing providers to review operating ... offers a suite of solutions for health care providers ... optimization: labor resource analysis, revenue cycle optimization and physician ... and better economics ...
(Date:6/24/2016)... CAMBRIDGE, Mass. , June 24, 2016 /PRNewswire/ ... the Spaulding Rehabilitation Network,s Dean Center for ... of Physical Medicine and Rehabilitation, MIT Hacking Medicine, ... Center for Innovation, today announced the five finalists ... Hackathon for Lyme disease.  More than 100 scientists, ...
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical Systems ... "Company"), which develops, markets and sells medical devices and ... , signed a strategic cooperation agreement with Hongyuan Supply ... Supply Chain") on June 20, 2016, to develop Dehaier,s ... strategic cooperation agreement, Dehaier will leverage Hongyuan Supply Chain,s ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements owned by ... to enhance the health of felines. The formula is all-natural and is made from ... the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus Root Extract ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June ... , brings up a new, often overlooked aspect of head lice: the parasite’s ability to ... is not a common occurrence, but a necessary one in the event that lice have ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary ... Work award to iHire in recognition of their exemplary accomplishments in worksite health promotion. ... Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her ... would lash out at his family verbally and physically. , “When something upset him, he ... he would use it. He would throw rocks at my other children and say he ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway ... call for a minimum wage raise to $12 an hour by 2020 and then adjusting ... restore the lost value of the minimum wage, assure the wage floor does not erode ...
Breaking Medicine News(10 mins):