Will GSK-Hanmi Deal Trigger Similar Tie-ups With Korean Pharmas?

Korea’s Hanmi Pharmaceutical is positioning itself as a partner of choice for reformulations and fixed-dose combinations after inking its second major deal with a multinational.

SEOUL – South Korea’s Hanmi Pharmaceutical Co. Ltd. may be turning into a partner of choice for multinational pharmaceutical companies looking to develop new formulations and fixed-dose combinations in response to the patent cliff, as evidenced by a recent agreement with GlaxoSmithKline PLC that focuses on what the partners call evidence-based formulation products.

Under the deal, signed in Singapore March 26, Hanmi and GSK will co-develop selected EBF products and market them worldwide. The companies will share clinical development costs with Hanmi in charge of formulation research, early clinical studies and manufacturing, and GSK in charge of late-stage studies and product registrations.

Hanmi and GSK will co-market the products in Korea and China, with GSK responsible for marketing in the rest of the world. The companies will also set up a joint operation committee and joint steering committee to manage the co-development process. Terms of the deal were not disclosed, although Hanmi noted it is eligible for development milestones.

Hanmi said the first product for co-development could be announced during the first half of this year, and the companies expect to launch the first combination product in 2015.

The Korean company specializes in developing incrementally modified drugs that are clinically safer, more effective and convenient to use, such as new dosage forms (including fixed-dose combinations), drug delivery systems and routes of administration. Hanmi has disclosed a pipeline of at least eight incrementally modified drugs in development, all fixed-dose combinations.

Hanmi’s Pipeline – Fixed-dose Combinations

Project	Combination	Stage	Domestic Launch (est.)
Amosartan	Amlodipine/Losartan	Clinical studies in other countries	Launched in Korea
HCP1102	Montelukast/Levocetirizine	Phase III	2013
HCP0912	Irbesartan/Atorvastatin	Phase III	2013
HCP0703	Pseudoephedrine/Levocetirizine	Phase III	2013
HCP1007	Omega-3 acid ethyl ester/Rosuvastatin	Phase I	2014
HCP1103	Ambroxol/Levodropropizine	Phase I	2014
HCP1104	Aceclofenac/Eperisone	Phase I	2014
HCP0613	Mosapride/Bacillus subtilis /Streptococcas feacium	Phase I	2014

Source: Hanmi Pharmaceutical; Hanwha Securities

First Merck, Then GSK

Importantly, the GSK deal builds upon an earlier deal Hanmi inked in June 2010 with Merck Sharp & Dohme Ltd. for the combination product Cozaar XQ (launched as Amosartan in Korea). Cozaar XQ is a combination of Pfizer Inc.’s amlodipine (Norvasc) and MSD’s losartan.

Analysts say the two deals could spur additional alliances between Korean companies like Hanmi and MNCs like Merck and GSK, which are increasingly expected to focus on combination products and superior formulations to cope with patent expirations on blockbuster products.

Kiwoom Securities Co.’s analyst Kim Ji-Hyun highlighted Hanmi’s deal with MSD as a game changer that paved the way for Hanmi’s GSK deal (Also see "Korea's Hanmi And Merck in Discussion to Sell Hanmi's Hypertension Drug In Other Countries including Six Asia-Pacific Countries" - Scrip, 31 May, 2010.).

“MNCs, under their ever-greening strategy, will focus on the development of combination products as part of their bid to cope with the termination of the patents of their blockbuster products,” Kim said. “The initial deal between Hanmi and MSD for its first combination product Cozaar XQ was the starting point of such activities with MNCs, which are trying to extend patents of their products.”

Kim said global demand for reasonably priced combination products is expected to rise as countries, including South Korea, try to reduce their medical expenses (Also see "Lawsuit Over Korea Price Cuts Fails To Pick Up Speed" - Scrip, 26 Mar, 2012.).

Hanmi Searching For Antithrombotic, Other Hypertension Combination Products

“Amlodipine is a super generic whose patent is protected until 2024, thus the patent of the Cozaar XQ combination product will be protected until 2024, which is enough to replace existing Cozaar,” Kim said in an interview.

“As its development capacity of combination products is strong and positive, we think Hanmi is seeking two other such combination chances for antithrombotic and additional hypertension combination products.”

As the analyst noted, Hanmi said it would focus on combination drugs under its pipeline strategy for the coming years.

“There are four sectors we are pursuing for our future pipeline such as bio-betters, anti-cancer drugs, botanical drugs and of course combination drugs,” Hanmi told PharmAsia News. “In the combination drug sector, we think we can generate more combination deals with multinational companies in such chronic diseases as hypertension and diabetes.”

Hanmi also credited its successful deal with MSD as a reason for GSK to seek a similar deal.

“The deal with MSD has created a consensus in the global pharmaceutical industry that Hanmi is capable of developing and marketing combination products in partnership with foreign companies,” Hanmi said.

For its part, GSK Korea said GSK has decided to team up with Hanmi due to Hanmi’s development technology for combination products.

“We reached the deal with Hanmi in consideration of Hanmi’s technology,” said GSK Korea.

MNCs Seeking To Enter Korea’s Generic Market

Another reason for deals with companies like Hanmi is to gain a better foothold in the Korean domestic market.

“Multinational pharmaceutical companies are favoring Hanmi Pharmaceutical as their partner for combination drug development in order to expand the generic drug business in and outside Korea,” Hanwha Securities analyst Irene Kim told PharmAsia News, adding that more deals between Korean pharmas and MNCs are expected.

“Hanmi Pharmaceutical is considering entering into strategic alliance with multinational pharmaceutical companies which are eyeing the domestic pharmaceutical market and wish to secure global items like in a strategic partnering between Dong-A Pharmaceutical Co. Ltd. and GSK,” she said.

Before the deal with Hanmi, GSK had acquired a 9.9% stake in Dong-A to expand its share in the rapidly growing Korean pharma market (Also see "GSK Expands In Korea With Purchase Of 9.9 Percent Equity Stake In Dong-A Pharma" - Scrip, 12 May, 2010.). Interestingly, Hanmi also owns more than 9.6% of Dong-A through its own holdings and others.

Through dealmaking, Kim also noted that foreign companies will look to partner with local Korean companies to enter Korea’s well-established generics market, like Pfizer recently did with LG Life Sciences Ltd. (Also see "Pfizer And LG Life Sciences Team Up For Branded Generics Franchise In Korea" - Scrip, 22 Feb, 2012.).

In addition to combination products, Hanmi also is focused on developing bio-betters via its long-acting protein/peptide discovery platform technology called LAPSCOVERY. It has signed an agreement with U.S-based Spectrum Pharmaceuticals Inc. to co-develop and commercialize Hanmi’s SPI-2012, a Phase I product formerly known as LAPS-GCSF. The product is a longer-acting, bio-better of Amgen Inc.’s granuloycyte colony-stimulating factor Neulasta (pegfilgrastim) for neutropenia (Also see "Korea’s Hanmi, U.S. Spectrum To Co-Develop Biobetter Of Amgen’s GCSF Neulasta For Neutropenia" - Scrip, 3 Feb, 2012.).

“We believe the agreement with Spectrum has opened doors for additional technology exports with validated LAPSCOVERY generic technology,” Kiwoom’s Kim said. “We expect LAPS G-CSF’s market penetration to reach 30-50% upon commercialization as it lasts 3x longer than second-generation drugs (once in every three weeks) and is optimized for chemotherapy cycles.”

All told, Hanmi has disclosed six bio-betters in development.

Hanmi’s Pipeline – Bio-betters

Project	Characteristics	Stage
LAPS-Exendin	Long-acting Exendin-4 analog	Phase II (EU/U.S.)
LAPS-hGH	Long-acting hGH	Phase II (Korea, EU)
LAPS-GCSF	Long-acting G-CSF analog	Phase I
LAPS-EPO	Long-acting EPO	Phase I
LAPS-IFNα	Long-acting IFNα	Phase I
LAPS-Insulin	Long-acting Insulin	Preclinical

Source: Hanmi Pharmaceutical