Hanmi formulations deal set to extend GSK's emerging markets reach
This article was originally published in Scrip
GlaxoSmithKline is continuing its push into emerging markets through a new alliance with the South Korean firm Hanmi Pharm that will focus on the co-development and global commercialisation of "evidence-based formulations".
The exact products to be taken up by the collaboration have yet to be decided by a joint management committee, but "several candidates are in discussion" and should be selected within the first half of the year, Hanmi said. The hope is to launch the first of these in 2015 at the earliest.
Given Hanmi's current focus and capabilities, the tie-up looks likely to concentrate on novel presentations, although whether these will be of GSK products or value-added generics is not yet clear. The Seoul-based firm is developing a number of fixed-dose combinations and has other expertise in new salts, micro-emulsions, taste-masking, extended release and oral-dissolving tablet formulations.
It has already commercialised in South Korea Amosartan, a fixed-dose combination of the antihypertensives amlodipine and losartan, and its current Phase III development projects include single-pill combinations of irbesartan and atorvastatin, levocetirizine and pseudoephedrine, and montelukast and levocetirizine.
Hanmi is also working on oral delivery systems for injectable anticancer agents, while its proprietary LAPSCOVERY formulation technology allows reduced administration frequency and lower dosing for biologics. This makes use of a non-peptidyl linker to attach active molecules, which can be either proteins or peptides, to the non-glycosylated Fc domain of immunoglobulin G, resulting in reduced renal clearance and the avoidance of vascular endothelial clearance mechanisms.
Hanmi's LAPSCOVERY clinical pipeline at present includes long-acting versions of an exendin-4 analogue, human growth hormone, erythropoietin and interferon-alfa.
The GSK alliance will see Hanmi conduct formulation research, early clinical studies and manufacturing, while its partner will be responsible for late-stage clinical research and regulatory approvals. Clinical development costs are to be shared under agreed terms and Hanmi said that it will also be eligible for undisclosed development milestones.
The two firms will conduct co-promotion and co-marketing activities for products emerging from the alliance in South Korea and China, with GSK to be responsible for these activities in other markets worldwide.
The UK giant already has a range of deals with partners in and for emerging markets, which it sees as a core component of its mid-term growth. A 2009 alliance with Dr Reddy's Laboratories for a basket of products in emerging markets (excluding India) includes selected biosimilars, for instance, with the Indian firm to manufacture the products and co-market these in selected countries.