Sun Pharma Extends Imatinib Mesylate Savings Card Program Benefits For Patients In USA

MUMBAI, India & CRANBURY, N.J.--(BUSINESS WIRE)--As part of the company’s philosophy of putting patients' interests first, Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies) announced the extension of its Imatinib Mesylate Savings Card Program beyond July 31, 2016. Sun Pharma launched this program as part of the Imatinib Mesylate launch in February 2016. The program is aimed at delivering greater access to the drug by patients who have commercial insurance, but whose out-of-pocket cost may exceed an affordable amount.

“indication for the treatment of patients with KIT (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).”

As part of the Imatinib Mesylate savings card program extension, Sun Pharma will continue to offer up to US$ 700 reduction on each eligible patient’s initial out-of-pocket cost from their commercial insurer thereby reducing the patient’s out-of-pocket co-payment to as low as $10. This benefit will cover a patient’s monthly fills for a 30-day supply of Sun Pharma’s Imatinib Mesylate prescribed for Ph+CML, a form of chronic myeloid leukemia, through the extension period.

During the first six months following its launch on February 1st, more than 5,000 prescriptions for Sun Pharma’s Imatinib Mesylate have been filled by patients utilizing this savings card program. The benefit to patients was in the range of a 50% to 60% reduction in out-of-pocket costs. Patients in USA who wish to utilize this program can download the savings card by visiting Sun Pharma’s Imatinib Mesylate website at www.imatinibrx.com. The company will also continue its Hub service wherein patients can call and speak with a trained healthcare professional and discuss FDA approved uses for Imatinib Mesylate (under Sun Pharma’s ANDA). Patients in USA can access Sun Pharma’s Hub service through the toll-free helpline number +1 844-502-5950. Since the launch of Imatinib Mesylate in February 2016, www.imatinibrx.com received over 560,000 hits.

IMATINIB MESYLATE - INDICATIONS AND USAGE

Imatinib Mesylate is a kinase inhibitor indicated for the treatment of:

• Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in chronic phase
• Patients with Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy
• Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
• Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements
• Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown
• Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRa fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1­ PDGFRa fusion kinase negative or unknown
• Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP)

As stated in the FDA approval letter, Sun Pharma’s Imatinib Mesylate ANDA contains a statement under section 505(j)(2)(A)(viii) of the FD&C Act representing that its application did not seek approval for the method of treatment covered under U.S. Patent No. 6958335 (‘335 patent). According to the FDA’s Orange Book, the ’335 patent covers the “indication for the treatment of patients with KIT (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).” As a result, the FDA has not approved Sun Pharma’s Imatinib Mesylate Tablet products for this indication.

Please see Full Prescribing Information at:
http://www.imatinibrx.com/wp-content/uploads/2016/01/Imatinib_Mesylate_Tablets_PI.pdf

Sun Pharma is the world's fifth largest specialty generic pharmaceutical company. A vertically integrated business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high-quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun Pharma's global presence is supported by 47 manufacturing facilities spread across 6 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. The consolidated revenues for 12 months ending March 2016 are approximately US$ 4.3 billion, of which US contributes US$ 2.1 billion. In India, the company enjoys leadership across 13 different classes of doctors with 30 brands featuring amongst top 300 pharmaceutical brands in India. Its footprint across emerging markets covers over 100 markets and 6 markets in Western Europe. Its Global Consumer Healthcare business is ranked amongst Top 10 across 4 global markets. Its API business footprint is strengthened through 14 world class API manufacturing facilities across the globe. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2,000 scientists and R&D investments of over 8% of annual revenues.

For further information please visit www.sunpharma.com & www.imatinibrx.com

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