FDA approves Sandoz Erelzi(TM) to treat multiple inflammatory diseases

Novartis International AG / FDA approves Sandoz Erelzi(TM) to treat multiple inflammatory diseases . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Erelzi is the first biosimilar etanercept approved by the FDA, offering expanded access to this important medicine
   
• Erelzi is approved for all indications included in the reference product's label
   
• Erelzi is the second biosimilar from Sandoz to receive FDA approval in the US, building upon established global leadership in biosimilars

Holzkirchen, August 30, 2016 - Sandoz, a Novartis division and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) approved Erelzi (etanercept-szzs) for all indications included in the reference product label, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA). Erelzi is the second biosimilar from Sandoz approved in the US through the FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act.

"We continue to increase patient access to key treatment options by expanding our offering of biosimilars which helps to reduce costs within the healthcare system" said Carol Lynch, Global Head Biopharmaceuticals, Sandoz.

"Sandoz is proud to have developed two of the three biosimilars that are currently FDA approved, which further demonstrates our commitment to US patients in a growing number of therapeutic areas. We are committed to bringing Erelzi to the US market as soon as possible".

The FDA approval follows a unanimous vote (20-0) by the FDA's Arthritis Advisory Committee (AAC) in July to recommend use in all indications of the reference product. The approval is based on a comprehensive package of analytical, nonclinical, and clinical data confirming that Erelzi is highly similar to the US-licensed reference product. Clinical studies included four comparative pharmacokinetic (PK) studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis. Extrapolation to all indications approved for use on the reference product label is on the basis that the Sandoz biosimilar etanercept and the reference product are essentially the same.

An application for Sandoz biosimilar etanercept has been accepted by the European Medicines Agency (Q4 2015) and is currently undergoing review.

Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. Sandoz is the pioneer and global leader in biosimilars and currently markets three biosimilars.

Sandoz has a leading biosimilar pipeline and plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020. This will be enabled by 11 filings over a three-year period (2015-2017), with six already submitted. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ERELZI(TM)?
ERELZI is a medicine that affects your immune system. ERELZI can lower the ability of your immune system to fight infections. Serious infections have happened in patients taking ERELZI. These infections include tuberculosis (TB) and infections caused by viruses, bacteria or other opportunistic pathogens that have spread throughout the body. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Some patients have died from these infections. Your doctor should test you for TB before you take ERELZI and monitor you closely for TB before, during, and after ERELZI treatment, even if you have tested negative for TB. Treatment with ERELZI should not be initiated in patients with an active infection, including clinically important localized infections. Patients have frequently presented with disseminated rather than localized disease. There have been some cases of unusual cancers reported in children and teenage patients who started using tumor necrosis factor (TNF) blockers before 18 years of age. Also, for children, teenagers, and adults taking TNF blockers, including ERELZI, the chances of getting lymphoma, leukemia, melanoma, non-melanoma skin cancer or other cancers may increase. Patients with RA or psoriasis may be more likely to get lymphoma.

Before starting ERELZI, tell your doctor if you:

• Have any existing medical conditions
• Are taking any medicines, including herbals
• Think you have, are being treated for, have signs of, or are prone to infection. You should not start taking ERELZI if you have any kind of infection, unless your doctor says it is okay
• Have any open cuts or sores
• Have diabetes, HIV, or a weak immune system
• Have TB or have been in close contact with someone who has had TB
• Were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure
• Live, have lived in, or traveled to certain parts of the country (such as, the Ohio and Mississippi River valleys, or the Southwest) where there is a greater risk for certain kinds of fungal infections, such as histoplasmosis. These infections may develop or become more severe if you take ERELZI. If you don't know if these infections are common in the areas you've been to, ask your doctor
• Have or have had hepatitis B
• Have or have had heart failure
• Develop symptoms such as persistent fever, bruising, bleeding, or paleness while taking ERELZI
• Use the medicine Kineret^® (anakinra), Orencia^® (abatacept), or Cytoxan^® (cyclophosphamide)
• Are taking anti-diabetic medicines
• Have, have had, or develop a serious nervous disorder, seizures, any numbness or tingling, or a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome
• Are scheduled to have surgery
• Have recently received or are scheduled for any vaccines.
• Are allergic to rubber or latex
• Are pregnant, planning to become pregnant, or breastfeeding
• Have been around someone with chicken pox
• Have moderate to severe alcoholic hepatitis

What are the possible side effects of ERELZI?
ERELZI can cause serious side effects including: New infections or worsening of infections you already have; hepatitis B can become active if you already have had it; nervous system problems, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes; blood problems (some fatal); new or worsening heart failure; new or worsening psoriasis; allergic reactions; autoimmune reactions, including a lupus-like syndrome and autoimmune hepatitis. Live vaccines should not be given concurrently with ERELZI. It is recommended that pediatric patients, if possible, be brought up-to-date with all immunizations in agreement with current immunization guidelines prior to initiating ERELZI therapy. 

Common side effects include: Injection site reactions, upper respiratory infections (sinus infections), and headache.

In a medical study of patients with JIA, side effects were generally similar in frequency and type as those seen in adult patients. The kinds of infections reported were generally mild and similar to those usually seen in children.

These are not all the side effects with ERELZI. Tell your doctor about any side effect that bothers you or does not go away.

If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see Prescribing Information and Medication Guide.

INDICATIONS

Moderate to Severe Rheumatoid Arthritis (RA)
ERELZI is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ERELZI can be taken with methotrexate or used alone.

Moderately to Severely Active Polyarticular Juvenile Idiopathic Arthritis (JIA)
ERELZI is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in children ages 2 years and older.

Psoriatic Arthritis
ERELZI is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. ERELZI can be used with or without methotrexate.

Ankylosing Spondylitis (AS)
ERELZI is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Moderate to Severe Plaque Psoriasis
ERELZI is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

- See more at: https://www.ERELZI.com

Click here for full prescribing information.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by words such as "offering," "continue to increase," "commitment," "growing," "committed," "as soon as possible," "undergoing review," "pipeline," "plans," "launch," "will,"  "well-positioned," or similar terms, or by express or implied discussions regarding potential marketing approvals for Erelzi(TM), Zarxio and other products in the Sandoz biosimilar pipeline, or regarding potential future revenues from Erelzi(TM), Zarxio or any other product in the Sandoz biosimilar pipeline. Such forward-looking statements reflect the current views of the Group 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 expressed or implied by such statements. There can be no guarantee that any product in the Sandoz biosimilar pipeline will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee Erelzi, Zarxio or any other product in the Sandoz biosimilar pipeline, will be commercially successful in the future. In particular, management's expectations regarding Erelzi, Zarxio and such other biosimilar pipeline products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; competition in general; global trends toward health care cost containment, including government, industry and general public pricing pressures; unexpected litigation outcomes; unexpected safety issues; unexpected manufacturing or quality issues; general economic and industry conditions, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. 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.

About Sandoz

Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people's lives. We contribute to society's ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2015 sales of USD 10.1 billion. In 2015, our products reached more than 500 million patients and we aspire to reach one billion. Sandoz is headquartered in Holzkirchen, in Germany's Greater Munich area.

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