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Akaal Pharma, Australia Extends Collaboration with GVK BIO for Formulations Development Services to Support Phase II Clinical studies for the Topical Treatment of Psoriasis

Hyderabad, India — July 1, 2015 — Asia’s leading Discovery Research and Development organization, GVK BIO, announced the extended collaboration with Melbourne, Australia based clinical stage biopharmaceutical company, Akaal Pharma Pvt Ltd for the scale-up of its novel topical AKP-11 ointment to support Phase II clinical study in psoriasis.

GVK BIO’s Formulation Development business unit in Bengaluru has developed robust and scalable process for novel topical AKP-11 ointment. GVK BIO plans to support clinical studies of Akaal Pharma’s topical psoriasis drug by providing clinical supplies, manufacturing and analytical support. Discussions are also on-going to work towards exploring appropriate commercialization packaging and various formulations for the topical use in other inflammatory diseases.

Seetharaju Gembali, Senior Vice President, Formulation R&D of GVK BIO, said: “Strengthening of our partnership with Akaal Pharma is testimonial to our expertise in the Formulation Development and we look forward to working with other clients.”

Dr. Dale Dhanoa, CEO of Akaal Pharma, said: “We have had a very efficient CRO relationship with GVK for our clinical trials supplies support due to GVK BIO’s experience, capabilities and facilities. We are excited to advance our First-in-Class multimodal acting topical drug candidate AKP-11 into Phase 2 stage of clinical development for the treatment of psoriasis. There are several other inflammatory diseases that we are targeting with our clinical compound and are currently exploring various formulations for its topical applications.”

About AKP-11
AKP-11 is a novel, small molecule with multimodal mechanism of action that includes S1P1 modulation and additional anti-inflammatory mechanisms of action. AKP-11 reduces the overexpression of multiple pro-inflammatory cytokines and other factors involved in psoriasis and other inflammatory indications. AKP-11 has shown excellent pharmacokinetic and pharmacodynamics profile, safety, tolerability and efficacy both in preclinical and clinical studies. AKP-11 is undergoing development for topical treatment of psoriasis, atopic dermatitis, inflammatory skin diseases and other conditions.

About GVK BIO
GVK Biosciences (GVK BIO) is Asia’s leading Discovery Research and Development organization. GVK BIO provides a broad spectrum of services, stand-alone and integrated, across the R&D value chain. GVK BIO’s discovery services consist of Chemistry, Biology and Informatics; the development services include Clinical Research, Clinical Pharmacology and Process R&D. GVK BIO’s diverse portfolio of more than 250 customers includes some of the world’s largest pharmaceutical, biotechnology, agro, life science companies and leading academic institutions.

About Akaal Pharma
Akaal Pharma Pty Ltd (Akaal Pharma) is a clinical-stage drug discovery and development company focused on the development of novel small molecule drugs for the treatment of inflammatory and autoimmune diseases including psoriasis, atopic dermatitis, multiple sclerosis, ulcerative colitis, and rheumatoid arthritis. Akaal Pharma has created a robust pipeline of novel, potent, and highly selective S1P1 receptor modulators that have shown an excellent oral and topical drug profile. Akaal Pharma applies its medicinal chemistry and drug discovery platform to discover and develop novel, safer and highly effective topical and oral drugs for the treatment of inflammation and immune diseases with unmet or undermet need.
For more information, visit www.akaalpharma.com.

Contact
E: corpcomm@aragen.com