Novartis Wins Two Prestigious Prix Galien Foundation Awards

Basel, November 2, 2016 /3BL Media/ – Novartis has been awarded the prestigious 2016 Prix Galien USA Award for Best Biotechnology Product for Cosentyx® (secukinumab), as well as the Prix Galien Foundation “Discovery of the Decade” Award for Best Pharmaceutical Product for the drug Gleevec® (imatinib mesylate). The awards were presented at a ceremony in New York City.

“We are honored to receive these prestigious awards for Cosentyx and Gleevec, which not only have changed the practice of medicine for certain conditions, but also represent years of hard work by our scientists,” said Joseph Jimenez, CEO of Novartis. “These wins underscore our commitment to addressing the unmet medical needs of patients through science-based innovation.”

Cosentyx was the first fully human interleukin-17A (IL-17A) antagonist approved by the US Food and Drug Administration (FDA) in 2015 for the treatment of adults with moderate to severe plaque psoriasis¹. Psoriasis affects an estimated 7.5 million people in the US². It is a chronic immune-mediated disease characterized by thick and extensive skin lesions (plaques), which can cause itching, scaling, and pain². Cosentyx was also approved for the treatment of active ankylosing spondylitis and psoriatic arthritis in 2016¹.

The discovery of Gleevec marked the first time in the history of cancer treatment that scientists were able to identify a chromosomal abnormality and then develop a drug that would target that specific protein. Gleevec, a molecularly targeted treatment, rapidly became a therapy of choice for Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and KIT (CD117)-positive gastrointestinal stromal tumors (KIT+ GIST)³. By showing that certain diseases can share a drug-sensitive target with seemingly unrelated ailments, and that molecular targeting can be medically and commercially successful, Gleevec helped establish a new paradigm for drug development.

About the Prix Galien Awards

Considered “the pharmaceutical industry’s Nobel Prize,” the Prix Galien rewards excellence in scientific innovation that improves the state of human health. The award was first established in 1970 by French pharmacist Roland Mehl and was inaugurated in the United States in 2007 to recognize the technical, scientific and clinical research skills necessary to develop innovative medicines. Since 1970, Novartis has received more than 40 national Prix Galien awards in fifteen countries for innovative therapies such as Gleevec® (imatinib mesylate), Rimactane® (rifampin), Parlodel® (bromocriptine mesylate), Sandimmune® (cyclosporine), Sandostatin® (octreotide acetate), Simulect® (basiliximab) and Visudyne® (verteporfin)⁴.

The “Discovery of the Decade” is a special once-in-10-years recognition for distinguished industry achievement in medical innovation. The awards honor extraordinary human health impact in three categories – Best Pharmaceutical Product, Best Biotechnology Product, and Best Medical Technology. In addition to Gleevec® (imatinib mesylate), two other Novartis products were nominated for “Discovery of the Decade,” including Coartem® (artemether/ lumefantrine) for Best Pharmaceutical Product and Promacta® (eltrombopag olamine) for Best Biotechnology Product. Gleevec won the Prix Galien International Prize in 2002, and was recognized again in 2009 by the Prix Galien USA committee for “Best Pharmaceutical Product”⁵.

About Cosentyx and interleukin-17A (IL-17A)

Cosentyx is a fully human monoclonal antibody (mAB) that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor¹.

Cosentyx is approved in more than 65 countries for the treatment of moderate to severe plaque psoriasis which includes the European Union countries, Japan, Switzerland, Australia, the U.S. and Canada⁶. In the U.S., Cosentyx is approved for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy). Cosentyx is also approved in the US for adult patients with active ankylosing spondylitis and active psoriatic arthritis¹.

More than 10,000 patients have been treated with Cosentyx in clinical trial settings across multiple indications, and over 50,000 patients have been treated in the post-marketing setting worldwide⁷.

About Gleevec (imatinib mesylate)

Gleevec® (imatinib mesylate) tablets are indicated for newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in the chronic phase (CP). Gleevec is also indicated for the treatment of patients with Ph+ CML in blast crisis (BC), accelerated phase (AP), or in CP after failure of interferon-alpha therapy.

Additionally, Gleevec is indicated for Patients with KIT(CD117)-positive gastrointestinal stromal tumors (GIST) that cannot be surgically removed and/or have spread to other parts of the body and for adult patients after surgery who have had their KIT (CD117)-positive GIST completely removed.

INDICATIONS

COSENTYX^® (secukinumab) is a prescription medicine used to treat adults:

• with moderate to severe plaque psoriasis that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light, alone or with systemic therapy)
• with active psoriatic arthritis
• with active ankylosing spondylitis

IMPORTANT SAFETY INFORMATION

Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.

COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as:

Infections

COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections.

• Your doctor should check you for tuberculosis (TB) before starting treatment with COSENTYX.
• If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX.
• Your doctor should watch you closely for signs and symptoms of TB during treatment with COSENTYX. Do not take COSENTYX if you have an active TB infection.

Before starting COSENTYX, tell your doctor if you:

• are being treated for an infection
• have an infection that does not go away or that keeps coming back
• have TB or have been in close contact with someone with TB
• think you have an infection or have symptoms of an infection such as:

After starting COSENTYX, call your doctor right away if you have any signs of infection listed above.Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor.

Inflammatory Bowel Disease

New cases of inflammatory bowel disease or “flare-ups” can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn’s disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea.

Serious Allergic Reactions

Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; or skin rash. If you have a severe allergic reaction, do not give another injection of COSENTYX.

Before starting COSENTYX, tell your doctor if you:

• have any of the conditions or symptoms listed above for infections
• have Crohn’s disease
• are allergic to latex. The needle caps contain latex.
• have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines.
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your doctor should decide if you will use COSENTYX.
• are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines to show your doctor and pharmacist when you get a new medicine.

How should I use COSENTYX?

See the detailed Instructions for Use that comes with your COSENTYX for information on how to prepare and inject a dose of COSENTYX, and how to properly throw away (dispose of) used COSENTYX Sensoready® pens and prefilled syringes.

• Use COSENTYX exactly as prescribed by your doctor.
   
• If your doctor decides that you or a caregiver may give your injections of COSENTYX at home, you should receive training on the right way to prepare and inject COSENTYX. Do not try to inject COSENTYX yourself, until you or your caregiver has been shown how to inject COSENTYX by your doctor or nurse.

The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory infections. These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.

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 accompanying full Prescribing Information, including Medication Guide.

Gleevec Important Safety Information

Gleevec can cause fetal harm when administered to a pregnant woman.  Women should not become pregnant, and should be advised of the potential risk to the unborn child.

Gleevec is often associated with edema (swelling) and serious fluid retention. Studies have shown that edema (swelling) tended to occur more often among patients who are 65 and older or those taking higher doses of Gleevec.

Cytopenias (reduction or lack of certain cell elements in blood circulation), such as anemia, have occurred. If the cytopenia is severe, your doctor may reduce your dose or temporarily stop your treatment with Gleevec.

Severe congestive heart failure and left ventricle dysfunction have been reported, particularly in patients with other health issues and risk factors. Patients with heart disease or risk factors or history of renal failure will be monitored and treated for the condition.

Severe liver problems (hepatotoxicity) may occur. Cases of fatal liver failure and severe liver injury requiring liver transplants have been reported with both short-term and long-term use of Gleevec.

Reactivation of hepatitis B can occur in patients who are chronic carriers of this virus after receiving TKI treatment.

Bleeding may occur. Severe gastrointestinal (GI) bleeding has been reported in patients with KIT+ GIST. GI tumor sites may be the cause of this bleeding; therefore, GI symptoms should be monitored at the start of treatment.

In patients with hypereosinophilic syndrome (a condition with increased eosinophils, which are a type of white blood cell) and heart involvement, cases of heart disease (cardiogenic shock/left ventricular dysfunction) have been associated with the initiation of Gleevec therapy.

Skin reactions, such as fluid-filled blisters, have been reported with the use of Gleevec.

Clinical cases of hypothyroidism (reduction in thyroid hormones) have been reported in patients taking levothyroxine replacement with Gleevec.

Long-term use may result in potential liver, kidney, and/or heart toxicities; immune system suppression may also result from long-term use.

GI perforation (small holes or tears in the walls of the stomach or intestine), in some cases fatal, has been reported.

Growth retardation has been reported in children taking Gleevec. The long-term effects of extended treatment with Gleevec on growth in children are unknown.

Cases of tumor lysis syndrome (TLS), which refers to a metabolic and electrolyte disturbance caused by the breakdown of tumor cells, have been reported and can be life-threatening in some cases. Correction of clinically significant dehydration and treatment of high uric acid levels are recommended prior to initiation of Gleevec.

Reports of motor vehicle accidents have been received in patients receiving Gleevec. Caution patients about driving a car or operating machinery.

Almost all patients treated with Gleevec experience side effects at some time. Some common side effects you may experience are fluid retention, muscle cramps or pain and bone pain, abdominal pain, loss of appetite, vomiting, diarrhea, decreased hemoglobin, abnormal bleeding, nausea, fatigue and rash.

Gleevec is sometimes associated with stomach or intestinal irritation. Gleevec should be taken with food and a large glass of water to minimize this problem. There have been rare reports, including deaths, of stomach or intestinal perforation (a small hole or tear).

If you are experiencing any of the mentioned side effects, please be sure to speak with your doctor immediately.

Do not take any other medications without talking to your doctor or pharmacist first, including Tylenol® (acetaminophen); herbal products (St. John’s wort, Hypericum perforatum); Coumadin® (warfarin sodium); rifampin; erythromycin; metoprolol; ketoconazole; and Dilantin® (phenytoin). Taking these with Gleevec may affect how they work, or affect how Gleevec works. 

You should also tell your doctor if you are taking or plan to take iron supplements. Patients should also avoid grapefruit juice and other foods that may affect how Gleevec works.

Please see full Prescribing Information.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by words such as “commitment,” or similar terms, or by express or implied discussions regarding potential new indications or labeling for Cosentyx, Gleevec, Coartem, Promacta and the other Novartis products which have received or been nominated for a Prix Galien award, or regarding potential future revenues from Cosentyx, Gleevec, Coartem, Promacta and the other Novartis products which have received or been nominated for a Prix Galien award. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Cosentyx, Gleevec, Coartem, Promacta or any of the other Novartis products which have received or been nominated for a Prix Galien award 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 Cosentyx, Gleevec, Coartem, Promacta or any of the other Novartis products which have received or been nominated for a Prix Galien award will be commercially successful in the future. In particular, management’s expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected safety, quality or manufacturing issues, 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 Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit http://www.novartis.com.

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References

1. Cosentyx (secukinumab) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp, 2016.
2. National Psoriasis Foundation. Psoriasis fact sheet. https://www.psoriasis.org/sites/default/files/publications/PsoriasisFactSheet.pdf.  Accessed February 29, 2016.
3. Gleevec® (imatinib mesylate) Prescribing Information. East Hanover, New Jersey: Novartis Pharma.
4. “Prix Galien - Winners Sorted by Company." Prix Galien Global Website. http://www.prixgalien.com/en/05/01/winners-sorted-by-company.htm. Last accessed October 2016.
5. “Prix Galien – Discovery of the Decade Candidates." Prix Galien Global Website. http://candidates.prix-galien-usa.com/docs/Discovery.pdf. Last accessed October 2016.
6. Novartis data on file. May 2016.
7. Novartis data on file. September 2016.

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