Until now, Korean company Dong-A Socio Holdings has focused on selling its products, including biosimilars, in its domestic market. But the firm has ambitions to expand into new countries, including the US, as well as to develop novel drugs.
“We are striving to become an innovative pharma company,” Chae-Joon Lee, vice-president and head of global strategy, tells EP Vantage. “From 2020 we’re looking to develop first-in-class biologics and new chemicals.”
Dong-A has chosen oncology, Alzheimer’s disease and pain as its key areas for R&D.
But first, the company needs to make sure its foundations are strong. “We have to bridge appropriately until then, because it takes time to develop those first-in-class [drugs],” Mr Lee says. “So I think things like botanicals, biosimilars and best-in-class drugs, those are all strategic pipeline segments that we need to work on and make sure this is a growing company. That will enable us to go to the global stage.”
In the hot area of biosimilars, Dong-A started with recombinant proteins mainly targeted at Korea and other select emerging markets, because the barriers for approval are lower, Mr Lee explains.
But the company now has about four monoclonal antibody biosimilars designed for developed markets, he adds, including Herceptin and Aranesp biosimilars, “which might reach the US by 2020-21”.
For the foreseeable future, Dong-A will continue with its existing strategy of using partners to sell its products outside Korea. But this is set to change, with Mr Lee saying there is definitely an aspiration to build an in-house sales force in the US or Europe.
The company could have a direct presence in these markets in five to seven years, he believes – but Dong-A is taking a measured approach. “I think the first thing we need to have is a stable pipeline, before creating anything too early.”
The company has one drug on the US market already, indirectly: antibacterial drug Sivextro, which it licensed to Trius Therapeutics in 2007 in one of Dong-A's early forays into the US. Trius was acquired by Cubist Pharmaceuticals in 2013, and Sivextro got the go-ahead from the FDA the following year; Cubist has since itself been acquired by Merck & Co.
The next Dong-A product to reach the US market will likely be PDE5 inhibitor Zydena, which has been available for erectile dysfunction in Korea since 2005.
Zydena is not yet approved by the FDA, and Dong-A is expecting a decision there in the next six to nine months. The company is looking for US and European partners.
Another key asset in Dong-A’s pipeline is DA-9801, a botanical product that recently showed a benefit in a phase II study in diabetic neuropathy.
At two of the three doses trialled, 300mg and 600mg, patients had a significant reduction in their mean pain score from baseline. The change did not reach statistical significance in the placebo or 900mg groups.
According to Dong-A, '9801 has shown similar or better efficacy than current drugs for diabetic neuropathic pain such as pregabalin, duloxetine and tapentadol, but with a more favourable side-effect profile. “From a safety perspective, you can’t get better than a botanical drug,” Mr Lee says.
The company is looking for a global partner for DA-9801, but plans to move it into phase III in 2016 whether it has a deal in place or not. Dong-A hopes to launch the drug in the US first by 2020 if all goes to plan. After this, it intends to enter Europe and Korea and eventually target the global market.
One thing Dong-A might have to overcome is scepticism about botanicals “given that the US and Europe are not so familiar with these”, Mr Lee concedes. But on the company’s side is the unmet need in diabetic neuropathy, he adds.
Around 5-20% of diabetics suffer from diabetic neuropathic pain – nearly 30 million Americans are estimated to have diabetes. In the future, the company plans to expand the indication for DA-9801 to include HIV-associated and chemotherapy-induced neuropathy, giving it access to a bigger market.
Acquisition off the cards
With many pharma companies looking to Asia for growth, could Dong-A be a takeover target? “I don’t think we’re up for entertaining any kind of acquisition discussion at this moment,” Mr Lee replies.
“We’re a very stable, well-established company, and although we are public we’re owned by a family, like many emerging market companies. And usually if the founders don’t want to sell, you can’t really buy.”
So Dong-A will continue to focus on its pipeline. The company seems to be happy doing this alone or at the most with the help of partners – for now.