Sun Pharma launches Imatinib Mesylate in USA

Imatinib Mesylate is the therapeutic equivalent to Gleevec® for indications approved by FDA

Feb 01, 2016, 06:30 ET from Sun Pharma

NEW JERSEY, Feb. 1, 2016 /PRNewswire/ -- Sun Pharma announced launch of Imatinib Mesylate Tablets (therapeutic equivalent to Gleevec® for indications approved by the FDA) in the US market. Sun Pharma's subsidiary received final approval for Imatinib Mesylate from FDA in December 2015. Being a First-to-File product, it was granted 180 days of marketing exclusivity.

The company has rolled-out Sun Pharma Imatinib Mesylate Savings Card program.  This program aims to deliver greater access to the drug for patients who have commercial insurance but their out-of-pocket may exceed an affordable amount. The savings card will reduce patient's co-payment (out-of-pocket) to $10. Sun Pharma's Imatinib Mesylate Savings Card will also offer patients additional savings benefit of up to US$700 for a 30-day fill to offset any additional out-of-pocket cost should they be required to meet their deductible or co-insurance. Participating pharmacies across USA can use the patient's Sun Pharma's Imatinib Mesylate Savings Card as part of this program.

Sun Pharma has also launched an exclusive patient website www.imatinibrx.com providing detailed information about Imatinib Mesylate, its approved indications, side effects etc. Eligible patients can participate in the Sun Pharma's Imatinib Mesylate Savings Card program by registering online or requesting a savings card from their Oncologist.  Sun Pharma will be supplying its Imatinib Mesylate Savings Cards to over 4,500 Oncologists.

A Hub service has also been established where patients can dial-in toll-free helpline number +1 844-502-5950 to speak with a trained healthcare professional and discuss Imatinib Mesylate when used for indications approved by FDA under Sun Pharma's ANDA. 

Through its Patient Assistance Program (PAP), qualifying patients can receive  Sun Pharma's Imatinib Mesylate at no cost. Based on qualifications for applying and including doctor's prescription, the Hub service will determine if a patient is qualified to receive Sun Pharma's Imatinib Mesylate for free.  Upon acceptance,  the prescription will be processed and delivered to the qualifying patient at no cost.

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-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1­ PDGFRα fusion kinase negative or unknown
  • Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP)

As per FDA approval letter, Sun Pharma's Imatinib Mesylate ANDA contains a statement that its application did not seek approval for the method of treatment covered under  U.S. Patent No. 6958335 ('335 patent). According to FDA's Orange Book,  '335 patent covers the "indication for the treatment of patients with KIT (CD117) positive unrespectable and/or metastatic malignant gastrointestinal stromal tumors (GIST)."  FDA has not approved Sun Pharma's Imatinib Mesylate Tablet products for this indication.

For safety information please refer to U.S. Full Prescribing Information at www.imatinibrx.com

FOR DETAILS CONTACT:

Ruder-Finn Binder (US)
Della Burns | +1-847-331-6545
Karen Paff | +1-347-920-0248

Sun Pharma Corporate Communications
Frederick Castro | frederick.castro@sunpharma.com

SOURCE Sun Pharma



RELATED LINKS

http://www.imatinibrx.com