Sandoz expands Omnitrope® offering with FDA approval for a sixth indication
• Omnitrope gains US Food and Drug Administration (FDA) approval for treatment of children with Turner syndrome
• Now approved in US for full range of reference product indications
Princeton, New Jersey, August 31, 2011 - Sandoz announced today that the US Food and Drug Administration (FDA) has approved its human growth hormone Omnitrope® (somatropin [rDNA origin] for injection) for a sixth indication, the treatment of children with growth failure due to Turner syndrome. Omnitrope is now approved for all of the same indications as the reference product, Genotropin®, thus making the Sandoz product available to more than 90% of patients in the US who are eligible to receive human growth hormone treatment.
"Sandoz is pleased to continue to expand patient access to this high-quality biopharmaceutical product, having received approvals for four new indications over the past two years," said Don DeGolyer, President of Sandoz Inc. "The approval of Omnitrope for Turner syndrome will further allow us to meet the diverse needs of patients with growth-related conditions."
Omnitrope was originally approved for the treatment of pediatric patients who have growth failure due to growth hormone deficiency and for replacement therapy in adults with growth hormone deficiency. In 2010, Omnitrope received approvals for three additional indications: treatment of children with growth failure due to Prader-Willi syndrome, children who are small for gestational age (SGA), and children with Idiopathic Short Stature (ISS).
Turner syndrome is a genetic condition that affects development in females, and is commonly associated with short stature. Turner syndrome affects approximately one in every 2,500 girls.1
Sandoz offers Omnitrope patients a host of services under OmniSource, a comprehensive insurance services and product support program. As part of this service, Sandoz enhances patient access through the Omnitrope Patient Assistance Program, which is designed to ensure that patients who do not have health insurance, or whose insurance does not cover growth hormone therapy, have access to this treatment. 1 National Institutes of Health, Genetics Home Reference. "Turner Syndrome." Available from: http://ghr.nlm.nih.gov/condition/turner-syndrome. Accessed: August 3, 2011.
Omnitrope was originally approved in May 2006 under the 505(b)(2) pathway of the Federal Food, Drug and Cosmetic Act (FFDCA) for the treatment of pediatric patients who have growth failure due to growth hormone deficiency and for replacement therapy in adults with either adult onset or childhood onset growth hormone deficiency (GHD). Omnitrope first launched in the US in January 2007 and Sandoz launched the Omnitrope Pen 5 and 10 with liquid cartridge in 2008, providing increased dosing flexibility for physicians and a more convenient, easy-to-use dosage form for patients. Omnitrope was approved in April 2010 to treat children with growth failure due to Prader-Willi syndrome and those who are small for gestational age (SGA), and in August 2010 to treat children with Idiopathic Short Stature (ISS). Omnitrope was the first follow-on biologic to be approved in the EU, Japan, Canada and Taiwan. It was also approved as the first follow-on version of somatropin in Australia and in the US. Omnitrope is backed by a comprehensive set of comparative studies including clinical phase I and phase III head-to-head studies showing the product is highly similar to the reference product, Genotropin ® , in its pharmacokinetic and pharmacodynamic safety and efficacy profiles and is comparable with regards to quality, safety and efficacy. Omnitrope Important Safety Information Omnitrope is contraindicated for acute critical illness, children with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death when somatropin was used in such patients. Omnitrope is also contraindicated in active malignancy, active proliferative or severe non-proliferative diabetic retinopathy, children with closed epiphyses, and known hypersensitivity to somatropin or any of its excipients. Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of somatropin. The potential benefit of treatment continuation with somatropin in patients experiencing acute critical illnesses should be weighed against potential risk. Children with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment and treatment should be discontinued if these signs occur due to reports of sudden death. Patients with pre-existing tumors or GHD secondary to an intracranial lesion should be monitored for progression or recurrence as there is an increased risk of a second neoplasm in childhood cancer survivors treated with somatropin, in particular meningiomas in patients treated with radiation to the head for their first neoplasm. Patients should be monitored carefully for potential malignant transformation of skin lesions. Impaired glucose tolerance and diabetes mellitus may be unmasked in patients taking somatropin, therefore glucose levels should be periodically monitored in all patients. Doses of concurrent antihyperglycemic drugs in diabetics may require adjustment. Intracranial hypertension may develop and is usually reversible after discontinuation or dose reduction. Preexisting papilledema should be excluded. Fluid retention (i.e., edema, arthralgia, carpal tunnel syndrome - especially in adults) may occur frequently and dose should be reduced as necessary. Patients with hypopituitarism (multiple pituitary hormone deficiencies) should have their other hormonal replacement treatments closely monitored. Hypothyroidism may first become evident or worsen. Children with the onset of a limp or hip/knee pain should be evaluated as slipped capital femoral epiphysis may develop. Somatropin may also cause the progression of preexisting scoliosis. Patients with Turner syndrome should be evaluated for otitis media and other ear disorders and monitored for cardiovascular disorders. Consider pancreatitis in patients with persistent severe abdominal pain, especially children. Formulations containing benzyl alcohol (5 mg/1.5 mL Omnitrope Cartridges and the Bacteriostatic Water for Injection diluent for the 5.8 mg/vial Omnitrope) should not be used in premature babies or neonates. Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy and headaches. Patients taking 11β-Hydroxysteriod Dehydrogenase Type 1 may require the initiation of replacement glucocorticoid therapy. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance doses. Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment should be carefully adjusted in patients taking somatropin. Patients using cytochrome P450 metabolized drugs and somatropin should be monitored carefully. A larger dose of somatropin may be required in women taking oral estrogen. Insulin and/or oral hypoglycemic agents may require adjustment while taking somatropin. Disclaimer The foregoing release contains forward-looking statements that can be identified by terminology such as "will," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Omnitrope or regarding potential future revenues from Omnitrope. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Omnitrope will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Omnitrope will achieve any particular levels of revenue in the future. In particular, management's expectations could be affected by, among other things, competition in general; government, industry and general public pricing pressures; unexpected regulatory actions or delays or government regulation generally; unexpected FDA approval of additional versions of follow-on biologic somatropin drugs; unexpected patent litigation outcomes; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from Page 4 of 4 those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Sandoz, a Division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by valid and enforceable third-party patents. Sandoz has a portfolio of approximately 1000 compounds and sells its products in about 130 countries. Key product groups include cardiovascular medicines, anti-infectives, treatments for central nervous system and alimentary tract disorders, oncology and respiratory therapies, as well as medications for blood and blood forming organ disorders. Sandoz develops, produces and markets these medicines along with pharmaceutical and biotechnological active substances. In addition to strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), and Oriel Therapeutics (US). In 2010, Sandoz employed more than 23,000 people (full-time equivalents) worldwide and achieved net sales of USD 8.5 billion for the full year. * * * For further information Sandoz US Communications: Ted Deutsch +1 609 627 5287 Sandoz Global Communications: Chris Lewis +49 8024 476 2550 Omnitrope is a registered trademark of Novartis AG. Genotropin is a trademark of Pfizer Health AB.