Pharmaceutical firms vie for new drugs

Since the early 1990s, local pharmaceutical companies have been stepping up research and development activities to develop new drugs with in-house technology.

The focus on R&D reflected a growing realization among the drug companies that they could hardly sustain growth by relying on their old way to play the game - produce foreign-developed drugs by importing technology.

But the development of new drugs with homegrown technology is easier said than done. Even for the world`s leading pharmaceutical companies, creating a new drug calls for a long R&D process and often an astronomical amount of investment.

For Korean companies lacking in basic human and physical resources, drug development could take far more time with a lower possibility of success.

Despite the heavy odds against Korean pharmaceutical companies, Korea became the 11th country in the world to develop a new drug with homegrown technology in 1999.

SK Chemicals Life Science, a unit of the SK Group, created an anticancer agent called "Sunpla" and obtained approval from the Korea Food and Drug Administration.

It took the company almost a decade to successfully develop the landmark cancer drug. SK Chemicals started R&D on Sunpla in 1990. The long development process indicates the difficulty involved in creating a new drug without borrowing technology from outside.

Sunpla has proven highly effective in the treatment of gastric cancer, a leading cause of cancer death in Korea.

The successful development of Sunpla encouraged other Korean drug companies to reinforce R&D efforts for new drug development.

But since Sunpla hit the market, only nine new drugs have been approved by the KFDA. The administration approved two new drugs in 2003, one in 2002, another three in 2003 and two in 2005.

Korea`s second new drug was a diabetic foot ulcer therapy called "Easyef" developed by Daewoong Pharmaceutical Co. in 2001.

Known as the first drug in Korea developed through bioengineering technology, Easyef relieves or slows the decaying of a diabetic`s feet. Since diabetic patients have difficulty with blood circulation, their feet can be easily decayed when hurt.

Daewoong began to sell the drug on a trial basis in 2001 after completing the second-phase clinincal trial. The company is in the middle of the third-phase clinical trials with market launch slated for next year.

The drug was exported to Jordan and will be exported to other Middle East regions, the United States and China in 2007, according to the company.

SK Chemicals Life Science has also expanded into drug development based on bioengineering technology by acquiring Dong Shin Pharmaceuticals in 2001. Dong Shin is a leader in vaccine development.

Bio-medicine still represents a small fraction of domestic drug output. In 2004, Korea produced about 9.64 trillion won worth of pharmaceuticals. Of the total, bio-medicines accounted for about 860 billion won or 8.9 percent, with the remainder accounted for by chemcial products.

But bio-medicines offer bigger growth potential for Korean drug companies as the technology gap between them and the world`s leading companies is narrower. Hence the recent rush in Korea toward bio-medicine development.

But it is likely to take more years before efforts toward bio-medicines bear fruit.

"There are only a couple of bio-medicines formally approved in Korea," said an official at R&D Department of Dong Shin Pharmaceuticals.

Dong Shin has been focusing on the development of bio-medicines, though what types of medicine it is working on is not known. The company said it plans to sharply increase its R&D investment next year, which currently stands at 5 percent of its revenue.

Recently, Donga Pharmaceutical Co., announced it acquired KFDA approval on "Zydena," an erectile dysfunction treatment. Donga started to launch the new product, the 10th local drug to be approved by KFDA, in the market this month.

The world`s fourth pill for treating erectile dysfunction, Zydena competes against Pfizer`s Viagra, Bayer and GlaxoSmithKline`s Levitra and Lilly`s Cialis.

"Our new prescription medicine showed fewer side effects, such as face flushing, headache, etc., compared to the existing products," a Donga official said. "Zydena`s improved safety and efficacy and affordable price will increase consumer benefits."

Zydena is currently undergoing phase II clinical trials conducted by the U.S. Food and Drug Administration and acquired patents in 30 nations. If approved by the FDA, Donga plans to launch the new drug in the U.S. in 2009.

SK Chemicals Life Science has also developed an anti-arthritis patch "Trast" and anti-arthritis herbal drug "Joins."

The world`s first patch formulation Trast sold 1 million in the first three months of its local market launch in 1996. It generated about 10 billion won in annual sales that year and was exported first to Italy in 1998. It now sells in the Philippines, and is scheduled for a Chinese market launch next year.

Korean companies` zeal toward new drug development is expected to intensify as the government is set to promote the biotechnology industry as a key growth engine of the next decade.

The government intends to raise the nation`s global ranking in biotechnology from the current 14th to 7th by 2010, hoping to develop 20 or more top-notch bio-medicines.

It plans to invest a total of 1 trillion won for five years between 2006 and 2010, or 200 billion won every year, in the biotechnology industry.

Spurred by the government`s blueprint, participants in the government-funded project dubbed "brain science frontier" have recently developed a potential Alzheimer`s medicine called AAD-2004, short for anti-Alzheimer`s drug-2004. They are set to conduct clinical trials to commercialize it by 2013.

Experts predict the new Alzheimers drug development will create 700 billion won in value by 2009, if the first-phase clinical trials are successfully carried out.

If the drug is commercialized after second- and third-phase clinical tests, Korea will be able to hold at least 5 percent of the global market for Alzheimer`s treatments and reap 400 billion won in sales revenue by 2013, experts said.

(siyoungh@heraldm.com)





By Hwang Si-young