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Zydena (Udenafil)
 Zydena (Udenafil), a New Erectile Dysfunction (ED) Drug, Receives
Marketing Approval in Korea
Product Market Launch Set for December, 2005
SEOUL, KOREA -- November 30, 2005 -- Dong-A Pharmaceutical Co., Ltd.,
announced today that they received marketing approval from the Korean
Food and Drug Administration (KFDA) for udenafil, their new
phosphodiesterase type 5 (PDE5) inhibitor for erectile dysfunction (ED).
Udenafil will be marketed in Korea under the brand name Zydena in 100 mg
and 200 mg tablet strengths.
Dong-A Pharmaceutical Co., Ltd.'s new oral tablet for ED will compete
with Viagra (sildenafil, Pfizer), Cialis (tadalafil, Lilly/ICOS), and
Levitra (vardenafil, Bayer/GSK) for a share of the estimated 100 million
dollar ED market in Korea. Various Phase 2 and 3 clinical studies have
shown that udenafil produced highly significant improvement in erectile
function after 12 weeks of drug therapy with up to a 92% vaginal
penetration success rate compared to 53% for the placebo group and up to
76% intercourse completion rate compared to 15% for the placebo group.
Additionally, 48% of the patients in Phase 3 clinical studies at the
high dose level returned to normal function after 12 weeks on drug
compared to only 4% on placebo. The overall patient satisfaction as
measured by the standard global assessment question (GAQ) was up to 89%
in the high dose treatment group compared to 26% in the placebo group.
The most frequently noted side effects were mild to moderate facial
flushing and headache which are expected for this class of drug.
Previous Phase 1 studies have shown that udenafil has a unique
pharmacokinetic profile (Tmax of 1.0-1.5 hours and a half-life of 11-13
hours) suggesting that the drug could have a relatively rapid onset and
sufficiently long duration to make it effective for up to 24 hours.
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 Dr. Shin-Ho KANG, the Chairman of Dong-A Pharmaceutical
and Chairman of the Federation of Korean Industries which recently
hosted APEC's CEO conference in Busan, Korea, stated that "We are
extremely pleased to see the marketing approval of Zydena in Korea. This
is an important milestone in our plan to develop udenafil globally, not
only for erectile dysfunction but also for numerous other indications."
Dong-A PharmTech, Co., Ltd, an affiliate of Dong-A Pharmaceutical Co.
Ltd. filed an IND with the US FDA in February 2005 and is conducting a
Phase 2b clinical study in the USA involving 300 ED patients. Mr. Dong
Hyun PARK, President & CEO of Dong-A PharmTech, stated, "We congratulate
Dong-A Pharmaceutical Co., Ltd. for this approval and we look forward to
working closely with our sister company in further development for this
unique compound."
Dong-A PharmTech Co., Ltd.'s clinical development program for Zydena is
ongoing in the USA and is expected to move into Phase 3 clinicals in
2006.
Zydena (Udenafil), a New Erectile Dysfunction (ED) Drug,
Receives Marketing Approval in Korea
Product Market Launch Set for December, 2005
SEOUL, KOREA -- November 30, 2005 -- Dong-A Pharmaceutical Co., Ltd.,
announced today that they received marketing approval from the Korean
Food and Drug Administration (KFDA) for udenafil, their new
phosphodiesterase type 5 (PDE5) inhibitor for erectile dysfunction (ED).
Udenafil will be marketed in Korea under the brand name Zydena in 100 mg
and 200 mg tablet strengths.
Dong-A Pharmaceutical Co., Ltd.'s new oral tablet for ED will compete
with Viagra (sildenafil, Pfizer), Cialis (tadalafil, Lilly/ICOS), and
Levitra (vardenafil, Bayer/GSK) for a share of the estimated 100 million
dollar ED market in Korea. Various Phase 2 and 3 clinical studies have
shown that udenafil produced highly significant improvement in erectile
function after 12 weeks of drug therapy with up to a 92% vaginal
penetration success rate compared to 53% for the placebo group and up to
76% intercourse completion rate compared to 15% for the placebo group.
Additionally, 48% of the patients in Phase 3 clinical studies at the
high dose level returned to normal function after 12 weeks on drug
compared to only 4% on placebo. The overall patient satisfaction as
measured by the standard global assessment question (GAQ) was up to 89%
in the high dose treatment group compared to 26% in the placebo group.
The most frequently noted side effects were mild to moderate facial
flushing and headache which are expected for this class of drug.
Previous Phase 1 studies have shown that udenafil has a unique
pharmacokinetic profile (Tmax of 1.0-1.5 hours and a half-life of 11-13
hours) suggesting that the drug could have a relatively rapid onset and
sufficiently long duration to make it effective for up to 24 hours.
In a separate study involving more than 100 subjects to confirm
udenafil's long duration, the drug was shown to be efficacious in 55% of
the ED patients after 8 to 12 hours. Prior studies have also
demonstrated a selectivity profile for udenafil that is similar to
sildenafil but unlike tadalafil, it does not significantly inhibit the
PDE11 isozyme and thus is not expected to produce significant myalgia.
No myalgia, back pain, or leg pain was observed in the Phase 3 studies
for udenafil.
Zydena to Compete Against Viagra
Industry watchers say that there is a sizable black market for
anti-erectile dysfunction drugs that could add to this official market,
adding that the market has an excellent potential for growth in coming
years.
The three multinational firms showed signs of being alarmed by prospects
of competing with the local brand.
It is said that the multinationals had raised an issue over the safety
of Zydena, claiming that Donga didn't submit crucial data to authorities
backing its claim that it wouldn't cause cancer. The Korea Food and Drug
Administration delayed its approval of Zydena, thwarting Donga's plan to
market its drug on Aug. 15. Donga now plans to begin the sale on the
company anniversary, Dec. 1 st .
Zydena is coming into the market at a time when there could be a lot of
changes. Bayer is trying to keep its stronghold with Viagra, maintaining
its marketing concept of being the first and best among the
anti-erectile dysfunction drugs.
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During sex, your heart works harder. Therefore sexual activity may not
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VIAGRA enables many men with erectile dysfunction to respond to sexual
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