Zydena, Home Grown Erectile Dysfunction Agent, Standing Tall

Dong-A Pharm.'s drug establishes itself as one of the blockbuster medicines available in Korea; seeks to make diverse applications and inroads in foreign markets

Zydena, developed as the first homegrown erectile dysfunction drug by Dong-A Pharm. in Korea in 2005, the world's fourth such drug, has become one of the success stories with the creation of added values surpassing its symbolic meaning of a new drug developed in Korea. Back in 1997, when the foundation for developing new drugs had not been laid, a project on the development of an erectile dysfunction drug was launched through fast decision making at a cost of about 20 billion won in R&D outlays over nine years.
Dong-A Pharm.'s strenuous efforts have finally paid off. Zydena has established itself as one of the blockbuster medicines available in Korea, with the 10 billion won sales mark reached in 2006 ― just one year after making its debut ― due to its excellent safety. Zydena has earned a reputation as the most exemplary new drug development case thanks to its efficacy and safety and by chalking up 20 billion won in sales in 2010 through continually increasing its market share.
Dong-A Pharm. has been actively accelerating its bid to put Zydena on the global market by capitalizing on its strong points of efficacy and safety. Starting with a contract to export the drug to Saudi Arabia in 2006, the company has inked export deals with countries such as Thailand, Colombia, Malaysia and the Philippines in that order and began to sell Zydena on the Russian market in 2009.
On top of its economic spillover effects, Dong-A Pharm. has secured knowhow on the development of new drugs, which has been a preserve of a few multinationals in Japan and advanced Western countries. Its building and overhauling of R&D systems has been introduced as an exemplary practice for the industry.
Recently, Dong-A Pharm.'s release of a once-daily oral administration of Zydena, a new product with a low dose formulation, has enjoyed popularity. Dong-A Pharm. is challenging anew for the development of its new applications for treating lower urinary tract symptoms, caused by benign prostatic hyperplasia, pulmonary arterial hypertension and portal hypertension.
The prostate is one of the male sexual organs. People with prostatic hyperplasia suffer inconveniences such as a failure to endure urination, a constant desire to urinate and a sense of residual urine since an enlarged prostate places the higher pressure on the bladder and urinary tract.
Available now on the market are alpha-adrenergic blockers for restricting the contraction of muscles surrounding the prostate and 5-alpha reductase inhibitors for reining in the proliferation of cells comprising the prostate, but they have side effects such as severe hypotension, decreased libido, erectile dysfunction and other sexual problems.
Zydena, which proved to have efficacy for an animal model of prostatic hyperplasia, was patented in Korea in 2007, and applications for its patent have been screened in advanced countries such as the United States, Japan and European countries.
A clinical trial conducted in Korea recently showed that patients with erectile dysfunction and prostatic hyperplasia with an IIPS (International Prostate Symptom Score) of higher than 8 who have taken Zydena for 12 weeks have seen considerable improvements compared to the placebo group, confirming the possibility that the drug can be developed as a treatment for prostate hyperplasia.
Patients with pulmonary arterial hypertension have symptoms such as thick blood vessel walls and a rising pressure in the pulmonary artery, critically leading up to heart failure. Even though the incidence rate is two out of every 1 million people, patients could die in an average of less than three years after being diagnosed with pulmonary arterial hypertension.
Sildenafil, more commonly known as Revatio, and Tadalafil, dubbed Adcirca, which cover the same symptoms as Zydena, are now available. Sildenafil has such inconveniences as taking a pill three times per day, while Zydena can be taken once each day, and the latter could possibly be used for treating such adverse effects as visual disturbance and myalgia.
This past February, Zydena obtained approval on Phase II clinical trial from the Korea Food and Drug Administration (KFDA), which is being conducted at Samsung Medical Center in Seoul.
Portal hypertension, one of the other conditions Zydena is being considered for, is hypertension in the portal vein that could cause secondary complications such as varix, ascites and hemorrhages in the stomach and esophagus. Recognizing its efficacy for treating the disease in animals, Dong-A Pharm. has already completed the process for registering a patent in Korea, and is also in the process of applying for a patent in major advanced countries.
Dr. Falk Pharma, a German pharmaceutical company specializing in the development of digestive agents, is now conducting Phase II clinical trial for portal hypertension patients. But no drugs are available for treating portal hypertension, caused by viral hepatitis or alcohol-related hepatitis, so if the efficacy and safety of Zydena's application to the disease is confirmed, the Korean drug is expected to be catapulted ahead as a breakthrough drug for treating the disease.
Dong-A Pharm. is also accelerating its bid to employ its application to chronic diseases such as chronic heart failure and chronic obstructive pulmonary disease. It is the first time a homegrown drug has been linked to the development of diverse applications in Korea and abroad, drawing keen attention on its development from the related industries and predicting rosy prospects for the drug. nw

Models celebrate Dong-A Pharm.'s release of a once-daily oral administration of Zydena 50mg, a new product with a low dose formulation. The Korean pharmaceutical company is seeking to make Zydena's diverse applications and inroads in foreign markets.

Chairman Kang Shin-ho of Dong-A Pharm. poses for the group photo with the youths who completed a 577.6 km-long nationwide walkathon that began in Busan on July 1 and arrived at the Han River Ttuksom area in Seoul via such cities as Gimhae, Gimcheon, Chungju, Gwangju and Hanam. The march, the 14th since its debut in 1998, was sponsored by Dong-A Pharm., the maker of the energy drink Bacchus.

Photo on Courtesy of Dong-A Pharm.