Ranbaxy Laboratories : launches India’s first biosimilar of Infliximab drug, Infimab™

Gurgaon, India,: Ranbaxy Laboratories Limited (Ranbaxy), one of India's largest pharmaceutical company, today announced the launch of InfimabTM (BOW015), the first *Remicade® (Infliximab) biosimilar in India. The product was launched at the Indian Rheumatology Association Conference (IRACON) in Chandigarh, in the presence of over a thousand rheumatologists and doctors from around the country.

InfimabTM, is being introduced in the Indian market through a licensing partnership with EPIRUS Biopharmaceuticals, Inc. a US and Swiss-based Biopharmaceutical Company focused on the global development and commercialization of biosimilar monoclonal antibodies. InfimabTM will be manufactured by Reliance Life Sciences at a facility in Mumbai. The innovator reference product is currently marketed for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn's Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.

InfimabTM marks Ranbaxy's entry into mAb (Monoclonal Antibodies) biologics, and will help the company provide greater access to quality biologic medicines in management of conditions like rheumatoid arthritis.

Talking about the significance of the newly launched InfimabTM, Rajeev Sibal, Vice President & Country Head-India Region, Ranbaxy, said, "InfimabTM offers a new opportunity in the management of conditions like rheumatoid arthritis. The product has been developed as per global standards and delivers a similar clinical outcome to the innovator. It will be available in India at a very significant discount as compared to the innovator drug. More Indian patients will get the benefit of a world-class biologic treatment."

Rheumatoid arthritis is one of the most common chronic inflammatory diseases that cause disability. The literature estimates a prevalence of 0.5% to 0.75% in India. To manage the disease, Indian rheumatologists are using Infliximab to treat only a select set of patients because it is very expensive.

Dr. Arvind Chopra, Consultant Rheumatologist, Pune who was also the Principal Investigator of Clinical Trial conducted in India with InfimabTM (BOW015), stated, "There has been an inordinate interest among the medical fraternity in India regarding the launch of InfimabTM as it is an affordable therapeutic alternative to Infliximab with equivalent clinical effectiveness. The availability of the new drug has widened our options to treat several forms of arthritis. This will increase patient access and many more Indian patients will benefit from this biologic treatment. The drug will not only be able to stop progression of rheumatoid arthritis but effectively control several of its complications that include bone damage, deformities and osteoporosis. InfimabTM also has an excellent treatment potential to treat other crippling painful arthritis like ankylosing spondylitis and psoriatic arthritis".

Amit Munshi, president and CEO of EPIRUS, stated, "We are delighted to partner with Ranbaxy to bring InfimabTM to India. InfimabTM represents an affordable solution for patients and may expand patient access to this important medicine".

It is well established through studies that if a biologic treatment is started relatively early and patients adhere for the required duration as recommended by the physician, significant improvement in overall treatment outcome can be achieved. Along with the affordable pricing of InfimabTM, Ranbaxy has launched RAISE (Rheumatoid Ailment Infimab Support Endeavor) a patient support program for improving patient awareness and compliance on therapy. With a similar clinical safety and efficacy to Remicade®, a reduced cost of therapy, and patient support program, InfimabTM may encourage more patients to initiate and continue treatment, thus potentially improving the overall treatment outcome.

BOW015 is a biosimilar version of infliximab, a biologic therapy marketed under the name Remicade®. EPIRUS has previously reported positive Phase 1 and Phase 3 clinical data for BOW015. The Phase 3 trial met its predefined endpoint and demonstrated the comparability of BOW015 to Remicade®, as measured by ACR20 response in severe rheumatoid arthritis (RA) patients. The study also showed no meaningful differences between BOW015 and Remicade® with regard to safety or immunogenicity.

More data on the Phase 3 study is available at : http://acrabstracts.org/abstracts/bow015-a-biosimilar-infliximab-in-patients-with-active-rheumatoid-arthritis-on-stable-methotrexate-doses-54-week-results-of-a-randomized-double-blind-active-comparator-study/

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs. The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 150 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries. Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence. This is in line with the company's commitment to increase penetration and improve access to medicines, across the globe. For more information, please visit www.ranbaxy.com

Our Philosophy: Quality and Patients First.

EPIRUS is building a global biosimilar enterprise to improve patient access to important medicines. EPIRUS' pipeline of biosimilar product candidates includes BOW015 (infliximab), BOW050 (adalimumab), and BOW030 (bevacizumab). The reference products for these product candidates - Remicade®, Humira®, and Avastin®, respectively - together generated $26.2 billion in global sales in 2013. EPIRUS also has two additional undisclosed preclinical product candidates.

EPIRUS' strategy for commercial success relies on targeted approaches for diverse global markets.

For Developed Markets with an established biosimilar regulatory framework, such as Europe, EPIRUS plans to commercialize its products using a combination of direct sales and local distributors.

For Accessible Markets with accessible regulatory frameworks for biosimilars, EPIRUS develops partnerships with local companies to accelerate regulatory approval and commercialize its products.

For high-growth Local Production Markets where local manufacturing confers strategic and operational advantages, EPIRUS intends to use its SCALE™ platform to deliver an In Market, For Market™ manufacturing solution with local partners.

More information about EPIRUS can be found at www.epirusbiopharma.com

*Remicade® is a registered trademark of Johnson and Johnson (www.jnj.com)

InfimabTM is a trademark filed for registration by Ranbaxy Laboratories Ltd.

InfimabTM in combination with methotrexate reduces the signs and symptoms, inhibits the progression of structural damage, and improves physical function in patients with moderate to severe active RA. It not only offers relief from the signs and symptoms of RA, it also provides rapid disease control and improves the outcome by reducing the Disease Activity Level / progression. In contrast, the routine treatment modalities offer symptomatic benefits only. Educational support for patients through Ranbaxy's RAISE program (Rheumatoid Ailments INFIMABTM Support Endeavour) aims to improve adherence by minimizing the treatment withdrawal. All this will vastly increase access of Indian patients to world-class biologic therapy and improve the treatment outcome by ensuring better compliance.

InfimabTM needs to be given as intravenous infusion along with methotrexate in moderate to severe conditions like RA. Induction dose is 3mg/kg given on 0, 2 and 6 week, followed by the maintenance phase which comprises of one infusion every 8 weeks at the dose of 3mg/kg. A physician may consider adjusting the dose up to 10 mg/kg or treating as often as every 4 weeks, bearing in mind that the risk of serious infections is increased at higher doses.