2014

Ferring Pharmaceuticals Inc. Receives FDA Approval for the First and Only Mixed Protocol IVF Treatment -- Combines MENOPUR® (menotropins for injection) and BRAVELLE® (urofollitropin for injection, purified) in Single Syringe

PARSIPPANY, N.J., March 19, 2014 /PRNewswire-USNewswire/ -- Ferring Pharmaceuticals Inc. today announced FDA approval of new labeling for their fertility products, MENOPUR and BRAVELLE. The label update is a result of the COMBINE trial which demonstrated that both MENOPUR and BRAVELLE can be safely mixed and administered in a single injection. Approval was granted on February 19, 2014 and designates Ferring's mixed protocol as the only combination of IVF stimulation gonadotropins to have regulatory backing for being mixed together in a single syringe.

"Ferring is excited to provide an IVF treatment option that requires fewer injections," said Nick Hart, Ferring's Business Unit Head for U.S. Reproductive Health. "We are pleased with the FDA's response and look forward to offering physicians and patients the ability for customization and a simplified treatment protocol."

Support for the safety and stability was provided by a pharmacodynamics study indicating that the mixed protocol does not interfere with the efficient delivery of the indicated dosage of either medication.

About MENOPUR

MENOPUR is a prescription medicine that contains hormones. MENOPUR contains follicle stimulating hormone and luteinizing hormone activity. These hormones stimulate healthy ovaries to make eggs. MENOPUR is used for women who need medical help to get pregnant. Your doctor may prescribe more than one medicine as part of a pregnancy plan.

MENOPUR, administered subcutaneously, is indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in an ART program.

Important Safety Information for MENOPUR

MENOPUR is contraindicated in women who have: a high FSH level indicating primary ovarian failure, presence of uncontrolled non-gonadal endocrinopathies, tumors of the pituitary gland or hypothalamus, sex hormone dependent tumors of the reproductive tract and accessory organs, abnormal uterine bleeding of undetermined origin, ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome, or prior hypersensitivity to menotropins or MENOPUR. MENOPUR is not indicated in women who are pregnant.

MENOPUR should only be used by physicians who are thoroughly familiar with infertility problems. MENOPUR is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS), with or without pulmonary or vascular complications, in women undergoing therapy for infertility. Ovarian torsion has been reported after gonadotropin treatment. Serious pulmonary conditions and thromboembolic events have been reported with MENOPUR. There have been infrequent reports of ovarian neoplasms with MENOPUR. Multiple pregnancies, spontaneous abortion, congenital malformations and ectopic pregnancies have occurred following treatment with MENOPUR.

The most common adverse reactions (≥2%) in ART include: abdominal cramps; abdomen enlarged; abdominal pain; headache; injection site pain and reaction; injection site inflammation; OHSS.

Please see full Prescribing Information for MENOPUR.

About BRAVELLE

BRAVELLE is a prescription medicine that contains hormones. BRAVELLE contains follicle stimulating hormone which stimulates healthy ovaries to make eggs. BRAVELLE is used for women who need medical help to get pregnant. Your doctor may prescribe more than one medicine as part of a pregnancy plan.

BRAVELLE, administered SC or IM in conjunction with hCG, is indicated for ovulation induction in patients who have previously received pituitary suppression. BRAVELLE administered SC in conjunction with hCG is indicated for multiple follicular development (controlled ovarian stimulation) part of an ART cycle in patients who have previously received pituitary suppression.

Important Safety Information for BRAVELLE

BRAVELLE is contraindicated in women who have: a high FSH level indicating primary ovarian failure, presence of uncontrolled non-gonadal endocrinopathies, tumors of the pituitary gland or hypothalamus, sex hormone dependent tumors of the reproductive tract and accessory organs, abnormal uterine bleeding of undetermined origin, ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome, and a prior hypersensitivity to urofollitropins, purified. Hypersensitivity/anaphylactic reactions associated with urofollitropins for injection, purified administration have been reported in some patients.   BRAVELLE is not indicated in women who are pregnant and may cause fetal harm when administered to a pregnant woman.

BRAVELLE should only be used by physicians who are thoroughly familiar with infertility problems. BRAVELLE is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS), with or without pulmonary or vascular complications in women undergoing therapy for infertility. Ovarian torsion has been reported after treatment with gonadotropins.  Serious pulmonary conditions and thromboembolic events have been reported with BRAVELLE. There have been infrequent reports of ovarian neoplasms with both benign and malignant, in women who have had multiple drug therapy for controlled ovarian stimulation; however, a causal relationship has not been established.  Multiple pregnancies, spontaneous abortion, congenital malformations and ectopic pregnancies have occurred following treatment with BRAVELLE.

The most common adverse reactions (≥5% incidence) in ovulation induction include: headache, hot flashes, OHSS, pain, and respiratory disorders.  The most common adverse reactions (≥2% incidence) in ART include: abdominal cramps, abdominal fullness/enlargement, headache, nausea, OHSS, pain, pelvic pain, and post retrieval pain.

Please see full Prescribing Information for BRAVELLE.

For more information, please visit www.FerringMixedProtocol.com.

About Ferring Pharmaceuticals Inc.

Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of products in the U.S. market.

Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and in the fields of Reproductive Health, Gynecology, Orthopaedics and Gastroenterology. For more information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com

For more information about Ferring Reproductive Health, please visit www.ferringfertility.com.

SOURCE Ferring Pharmaceuticals Inc.



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