Novartis Pharmaceuticals Corporation stands behind medication adherence activities and reaffirms commitment to patient safety
- Patient safety and well-being are highest priority at Novartis Pharmaceuticals Corporation (NPC)
- Patient adherence activities provide important education and support to help patients follow doctor-prescribed treatments
- NPC disputes allegations related to NPC's interactions with specialty pharmacy BioScrip regarding Exjade® (deferasirox) patient medication adherence
- NPC is committed to the highest standards of ethical business conduct and compliance in all aspects of its business
EAST HANOVER, N.J., Jan. 8, 2014 /PRNewswire/ -- Patient safety and well-being are the highest priority at Novartis Pharmaceuticals Corporation (NPC). NPC is dedicated to improving patient health and supports patient medication adherence programs integral to this goal. These include outreach by pharmacies aimed at helping patients appropriately take their medicines as prescribed by their physician.
Specialty pharmacies play an important and accepted role in patient medication adherence. NPC expects that the specialty pharmacies it works with conduct vital patient outreach in a manner wholly consistent with NPC's commitment to patient care. To that end, NPC worked with BioScrip to ensure it had the information needed to reach out to patients. BioScrip reached out to patients using its own protocols to provide education, counseling and information about proper administration of the medicine and to fulfill prescriptions that have been prescribed by a patient's treating physician.
"At NPC, patients are the focus of all that we do. We want to support the best possible outcome for a patient taking a Novartis medication prescribed by their physician," said André Wyss, President, Novartis Pharmaceuticals Corporation, and President, Novartis Corporation. "We believe that adherence efforts help patients manage their disease and that specialty pharmacies play a key role in these patient medication adherence efforts and in ultimately improving outcomes."
These efforts help patients manage serious diseases. Exjade® (deferasirox), which is complex to administer, is an important treatment option for patients with serious blood disorders who have chronic iron overload due to blood transfusions. Chronic iron overload is potentially life-threatening, and does not always have symptoms that are recognizable until serious complications occur. For that reason, adherence is important. NPC supported patient adherence activities to provide important treatment education and support for patients taking Exjade.
The use of specialty pharmacies to support patients with complex medical conditions is an effective, well-established practice to help ensure patients comply with their physician-directed treatment plan. Government agencies most involved in US healthcare policy have recognized that adherence efforts improve care and reduce costs.
NPC is committed to high standards of ethical business conduct and compliance in all aspects of its business and invests significant time and resources to ensure it does business in a responsible manner. The Company disputes the allegations and intends to defend itself in this litigation.
Since November 2005, Exjade has been approved in the US for the treatment of chronic iron overload due to blood transfusions in patients two years of age and older. This indication is based on a reduction of liver iron concentrations and serum ferritin levels. An improvement in survival or disease-related symptoms has not been established.
In the US, as of January 2013, Exjade is now also indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 mg of iron per gram dry weight (mg Fe/g dw) and a serum ferritin measurement greater than 300 micrograms per liter. The basis of this indication is data showing achievement of an LIC less than 5 mg Fe/g dw after treatment with Exjade. An improvement in survival or disease-related symptoms has not been established.
Exjade is approved in more than 120 countries including the US, Switzerland, Japan, China, and the countries comprising the European Union. The approved indication varies depending upon the individual country.
Exjade Important Safety Information
Exjade is contraindicated in patients with creatinine clearance <40 mL/min or serum creatinine >2 times the age-appropriate upper limit of normal; poor performance status and high-risk myelodysplastic syndromes or advanced malignancies: platelet counts <50 x 109/L; known hypersensitivity to deferasirox or any component of Exjade.
There have been postmarketing reports of acute renal failure, hepatic failure and cytopenias. Renal failure requiring temporary or permanent dialysis, renal tubulopathy and interstitial nephritis have been reported. Upper gastrointestinal ulceration and hemorrhage, sometimes fatal, have been reported. Caution should be used in elderly patients due to a higher frequency of adverse reactions. Exjade is not recommended in patients with a short life expectancy (e.g., high-risk myelodysplastic syndromes), especially when co-morbidities could increase the risk of adverse events.
Skin rashes, serious hypersensitivity reactions, decreased hearing and lens opacities have been reported. The most common adverse reactions are nausea, vomiting, diarrhea, abdominal pain, rash, non-progressive increases in serum creatinine, increased transaminases, abdominal distension, constipation, dyspepsia, proteinuria and headache.
Please visit www.exjade.com. The full prescribing information including the Boxed Warning for Exjade is available at www.pharma.us.novartis.com/product/pi/pdf/exjade.pdf
This press release contains expressed or implied forward-looking statements, including statements that can be identified by terminology such as "committed," "dedicated," "commitment," "intends," or similar expressions. 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. These expectations could be affected by, among other things, uncertainties inherent in legal proceedings, and other risks and factors referred to in the Risk Factors section of 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 it in the future.
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets innovative medicines aimed at improving patients' lives. We offer a broad range of medicines for cancer, cardiovascular disease, endocrine disease, inflammatory disease, infectious disease, neurological disease, organ transplantation, psychiatric disease, respiratory disease and skin conditions. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which 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, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 133,000 full-time equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
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