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KDDF-201204-03 Study for Global Clinical Trials and Production of a next-generation diabetes drug, HM11260C(Metabolic Disorders, Protein) [01.04.2013]

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Development and Market Objectives

We are aiming to commercialize a next generation GLP-1 agonist that can be administered in single doses weekly or monthly, resulting in high efficacy and low side effects. This will be achieved through the development of a next generation long-acting GLP-1 agonist, which overcomes the disadvantages of existing long-acting types, through the development of a novel Exendin-4 derivative (Exendin-4 analog) combined with the use of long-acting Platform base technology.

Unmet Medical Need & Target Patients

In 2010, the diabetes treatment market in 7 major countries recorded sales of approximately 22 billion USD (CAGR 9.9% 2006 ~ 2009).The diabetes market is expected to grow rapidly in the near future, with an increase in patients and the launching of new medicines. By 2019, it will reach a market cap of 35 billion dollars (Datamonitor, 2010).

The ultimate goal of diabetes treatment is to maintain normal blood glucose levels. However, when taken for an extended period of time, oral medications that are widely used as treatments can irreversibly damage beta cells, which create insulin. They have also been known to cause various side effects including hypoglycemia, an increase in weight, excess lactic acid or hepatotoxicity. There are also many disadvantages of insulin usage, including a need to be injected 2-3 times daily, as well as weight gain or hypoglycemia. Accordingly, it is necessary to develop a treatment with excellent efficacy and safety, which can also solve the problem of insulin tolerance.

Status

HM11260C has completed Phase 1 clinical trials with healthy adults in Korea and a Phase 1b clinical trial with diabetes patients in Europe.  HM11260C has also completed 26 weeks repeat dose toxicity and Phase 2 clinical MAD (Multiple Ascending Dose) trial in the USA.  The multinational Phase 2 dose finding study (US, Europe, and Korea) is currently ongoing. 
 

Intellectual Property

Our research team has completed patent applications by successively developing novel Exendin-4 derivatives that present excellent titers when made as a long-acting version, outside the scope of leading novel Exendin-4 derivatives. This was done while developing a next generation long-acting version. We also confirmed human translation in various proteins and peptides by securing a next generation, continued type peptide development platform technology (LAPSCOVERY, Long Acting Protein/Peptide Discovery) by using a novel bio-carrier. We are applying for patents for the materials, methods and the use of this technology, and it is already registered in both Korea and the USA (US 7737260: Protein complex using an immunoglobulin fragment and method for the preparation thereof, US 7736653: A pharmaceutical composition comprising of an immunoglobulin Fc region as a carrier) 

Competitive Advantages


 

Competitive Advantages

○ Securing Excellent Treatment Efficiency by Developing Exendin-4 Analog
The majority of currently developed long-acting GLP-1 agonists exhibit low efficacy, compared with liraglutide (Victoza Novo), despite their relatively high use in once-daily medical administration. The Exendin-4 analog developed by our research team, and the resultant complex (HM11260C), demonstrate unique kinetics against the GLP-1 receptor. It has already proven its high efficacy at low doses in animal models, and is also expected to show excellent efficacy in humans.
 
Developing Weekly- or Monthly–dose Medicines with LAPSCOVERY Technology
LAPSCOVERY technology, which is a next generation long-acting platform, can be applied not only for proteins such as human growth hormones, but also for peptides including synthetic amino acids.
The majority of GLP-1 agonists currently being developed or under clinical study are once-weekly versions. HM11260C is manufactured by applying LAPSCOVERY technology to an Exendin-4 analog, and it can be developed into a once-weekly or once-monthly version (70 times more effective when compared to natural type), since its safety in the blood has been increased.
Because it is slowly absorbed after injection, negative side effects such as vomiting and nausea caused by rapid release injections are expected to be substantially reduced.

○ Maximizing Convenience
HM11260C has been confirmed as appropriate for a 31-gauge needle through verification of high solubility and low glide force. We are also planning to develop it into a form that patients can inject at their own convenience.

Indication

Diabetes

Research Period

July, 2012 ~ Oct, 2015

Company

Hanmi Pharmaceutical Co., Ltd.

Developmental Stage

Phase 2

Additional Information

Contact Information

Contact
Address Company Name: Hanmi Pharmaceutical Co., Ltd.
WebSite Homepage: http://www.hanmi.co.kr Contact Person: Chang Ju Choe
E-mail: cjchoi@hanmi.co.kr Contact: 82-31-371-5027

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