Ferring Pharmaceuticals Receives FDA Approval for Growth Hormone Name Change, Acquires ZOMACTON™ [somatropin (rDNA origin)] for Injection and Needle-Free Device in the U.S.

Tuesday, March 31, 2015

PARSIPPANY, N.J., March 31, 2015 /PRNewswire-USNewswire/ -- Ferring Pharmaceuticals Inc. today announced U.S. Food and Drug Administration (FDA) approval of a name change enabling its newly acquired recombinant human growth hormone to be marketed in the U.S. as ZOMACTON [somatropin (rDNA origin)] for injection, and its needle-free delivery system to be marketed in the U.S. as ZOMA-Jet. Ferring purchased the U.S. rights to ZOMACTON, formerly TEV-TROPIN®, and to ZOMA-Jet, formerly Tjet®, in December 2014 from Teva Pharmaceutical Industries Ltd. Ferring developed and has marketed ZOMACTON outside of the U.S. since 1988 and in 47 countries globally.

In the U.S., ZOMACTON is indicated for the treatment of children who have growth failure due to an inadequate secretion of normal endogenous growth hormone. Growth hormone deficiency (GHD) in children can lead to short stature and delayed puberty.[1] An estimated one in 4,000 to 10,000 children has GHD, and with early detection and treatment, many of these children can reach a normal height.[2]

Because somatropin increases growth rate, patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis. Somatropin may alter the clearance of drugs metabolized by the CP450 enzyme system and careful monitoring is advisable. The following adverse reactions have been observed during appropriate use of somatropin: headaches (children and adults), gynecomastia (children), and pancreatitis (children and adults). In studies of growth hormone-deficient children, injection-site reactions (e.g., pain, bruise) occurred in eight of the 164 treated patients. Leukemia and new-onset Type 2 diabetes mellitus have been reported.

"Ferring Pharmaceuticals Inc. has a proud history of developing and commercializing specialty products for complex diseases and conditions that address unmet patient needs," said Aaron Graff, President & COO, Ferring Pharmaceuticals Inc. "Having ZOMACTON and ZOMA-Jet in the U.S. portfolio is important to Ferring because it will enable U.S. pediatric endocrinologists to expand options for their patients who need human growth hormone treatment."

ZOMACTON is expected to be available in the U.S. in the second quarter of 2015 as both a 5 and 10 milligram (mg) option, with the 10mg dose in a pre-filled diluent syringe. In addition, the ZOMA-Jet needle-free administration device is expected to be available for the 5mg dose and in a new 10mg dose later this year.

"Ferring is a worldwide leader in hormone treatments for both pediatric and reproductive health, and this acquisition furthers our commitment to market safe and effective treatments for endocrinology issues both across global markets and in the U.S.," said Michel Pettigrew, President of the Executive Board & COO, Ferring Group.

Consistent with the Ferring Philosophy that "People come first," Ferring will offer support services with

ZOMACTON to patients, providers and caregivers. Ferring's marketing of ZOMACTON in the U.S. lays the foundation for further expansion of the company's existing global product and research portfolio in the field of endocrinology.

About Ferring Pharmaceuticals Inc.

Ferring Pharmaceuticals Inc. is a member of the Ferring Pharmaceuticals group, a privately owned, international pharmaceutical group. Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, gastroenterology, infertility, obstetrics/gynecology, orthopaedics, and urology. For more information, call 1-888-FERRING (1-888-337- 7464); visit www.FerringUSA.com

About ZOMACTON

ZOMACTON is indicated for the treatment of children who have growth failure due to an inadequate secretion of normal endogenous growth hormone.

Important Safety Information

ZOMACTON stimulates linear growth in children lacking endogenous GH. Treatment of growth hormone-deficient (GHD) children with ZOMACTON produces growth rate and IGF-1 levels similar to those seen after treatment with hGH of pituitary origin.

Unless patients with Prader-Willi Syndrome (PWS) also have a diagnosis of GHD, ZOMACTON is not indicated for treatment of pediatric patients who have growth failure due to genetically confirmed PWS.

Because of reported fatalities, patients with PWS who are severely obese, have severe respiratory impairment, respiratory infections, or sleep apnea should interrupt use of GH.

Cases of pancreatitis have been reported rarely in children and adults receiving somatropin treatment.

Pancreatitis should be considered in any somatropin-treated patient, especially a child, who develops persistent, severe abdominal pain.

Patients should be observed for evidence of Type 2 diabetes mellitus, glucose intolerance, hypopituitarism, malignant transformation of skin lesions, hypothyroidism, slipped capital femoral epiphysis, and intracranial hypertension. Funduscopic examination of patients is recommended at the initiation and periodically during the course of GH treatment. ZOMACTON should not be initiated in patients with acute critical illness as a complication of open heart surgery, abdominal surgery, multiple accidental trauma, or those with acute respiratory failure. ZOMACTON should not be used in patients with evidence of an active malignancy, progressive or recurrent underlying intracranial tumor, active proliferative or severe nonproliferative diabetic retinopathy, or closed epiphysis. As with all therapeutic proteins, there is potential for immunogenicity.

When somatropin is administered subcutaneously at the same site over a long period of time, tissue atrophy may result. This can be avoided by rotating the injection site.

Because somatropin increases growth rate, patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis.

Somatropin may alter the clearance of drugs metabolized by the CP450 enzyme system and careful monitoring is advisable.

ZOMACTON should not be used by patients who have had an allergy to growth hormones (somatropin) or any of the other ingredients in ZOMACTON. Benzyl alcohol associated with toxicity in newborns is contained in the diluent supplied with 5mg ZOMACTON.

When administering ZOMACTON 5 mg to newborns, it should be reconstituted with sterile normal saline. Practitioners should consider the combined daily metabolic load of benzyl alcohol from all sources.

The ZOMACTON 10 mg vial is reconstituted with bacteriostatic water for injection containing metacresol and should not be used by patients who are allergic to it. Treatment of patients with coexisting ACTH deficiency should have glucocorticoid replacement dose adjusted to avoid inhibition of growth.

The following adverse reactions have been observed during appropriate use of somatropin: headaches (children and adults), gynecomastia (children), and pancreatitis (children and adults). In studies of growth hormone-deficient children, injection-site reactions (eg, pain, bruise) occurred in 8 of the 164 treated patients. Leukemia and new-onset Type 2 diabetes mellitus have been reported.

ZOMACTON and ZOMA-Jet are trademarks of Ferring B.V.

TEV-TROPIN® and Tjet® are registered trademarks of Teva Pharmaceuticals USA.

[1] Growth Hormone Deficiency – Children. Medline Plus – A service of the U.S. National Library of Medicine, National Institutes of Health. 2014.

Available at: http://www.nlm.nih.gov/medlineplus/ency/article/001176.htm.

[2] Growth Hormone Deficiency. Boston Children's Hospital. 2010. Available at: http://www.childrenshospital.org/conditions-andtreatments/conditions/growth-hormone-deficiency.

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SOURCE Ferring Pharmaceuticals Inc.

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