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Tadalafil

February 12, 2011 by staff 

Tadalafil, Tadalafil is a PDE5 inhibitor, currently marketed as tablets to treat erectile dysfunction (ED) under the name Cialis, and under the name ADCIRCA for the treatment of pulmonary arterial hypertension. It was originally developed by the biotechnology company ICOS, and then again developed and marketed worldwide by Lilly ICOS LLC, a joint venture of ICOS Corporation and Eli Lilly and Company. Cialis tablets, 5 mg, 10 mg and 20 mg are yellow, film coated and almond shaped. The recommended dose for pulmonary hypertension is 40 mg (two 20 mg tablets) once daily.

Tadalafil is also manufactured and sold under the name Tadacip by the Indian company Cipla pharmaceutical doses of 10 mg and 20 mg.

On November 21, 2003, the Food and Drug Administration approved tadalafil (Cialis) for sale in the U.S. as the third pill prescription ED drugs (after sildenafil citrate (Viagra) and vardenafil (Levitra)). Effectiveness of 36 hours Cialis earned the nickname “The Weekend Pill”, as sildenafil and vardenafil, tadalafil is recommended as a drug “as needed”. Cialis is the only one of three that is also proposed as a drug once a day.

In addition, tadalafil was approved in May 2009 the United States for the treatment of pulmonary hypertension and is currently under regulatory review in other regions for this condition. In late November 2008, Eli Lilly sold the exclusive rights to market tadalafil pulmonary hypertension in the United States at United Therapeutics to an upfront payment of $ 150 million.

The FDA approval of Viagra, March 27, 1998 was an innovative commercial event for the treatment of erectile dysfunction, with sales exceeding one billion dollars. Subsequently, the FDA approved Levitra (vardenafil) August 19, 2003, and Cialis (tadalafil), November 21, 2003.

Cialis was discovered by Glaxo Wellcome (now GlaxoSmithKline) in the partnership between Glaxo and ICOS to develop new drugs that began in August 1991. In 1993, the Bothell, Washington, biotechnology company ICOS Corporation began studying compound IC351, a phosphodiesterase type 5 (PDE5) enzyme inhibitor. In 1994, Pfizer scientists discovered that sildenafil, which also inhibits the PDE5 enzyme, caused penile erection in men participating in a clinical study of a heart medicine. Although the ICOS scientists were not testing compound IC351 for emergency treatment, they recognized its potential usefulness for the treatment of this disorder. Soon, in 1994, ICOS received a patent for compound IC351 (unlike the structure of sildenafil and vardenafil), and Phase 1 clinical trials began in 1995. In 1997, Phase 2 clinical trials have been launched for men with ED, and then progressed to Phase 3 trials that supported approval of the drug by the FDA. Although Glaxo had entered into an agreement with ICOS share the profits 50/50 for medicinal products derived from this partnership, Glaxo let the agreement expire in 1996 that drugs are not developed in the major markets of the company.

In 1998, ICOS Corporation and Eli Lilly and Company formed the Lilly ICOS LLC, a joint venture to develop and commercialize tadalafil as a treatment against erectile dysfunction. Two years later, Lilly ICOS LLC, filed a New Drug Application with the FDA for compound IC351 (under the generic name tadalafil and the brand name Cialis). In May 2002, Lilly ICOS reported to the American Urological Association that clinical trials have demonstrated that tadalafil was effective up to 36 hours, and a year later, the FDA approved tadalafil. One advantage Cialis has over Viagra and Levitra is the half-life of 17.5 hours (and thus Cialis is advertised to work up to 36 hours, after which it remains about 25 percent of the dose absorbed in the body) compared the four half-hour-life of sildenafil (Viagra).

In 2007, Eli Lilly and Company purchased the company ICOS for $ 2.3 billion. Consequently, Eli Lilly owned Cialis and then closed the ICOS operations, ending the joint venture and firing most of ICOS approximately 500 employees, except for the 127 employees of the ICOS biologics facility, which was then bought by CMC Biopharmaceuticals A / S (CMC).

Persons surnamed “Cialis” objected to Eli Lilly and Company to the naming of the drug, but the company argued that the name for the drug is not related to the family.

United States, the FDA relaxed the rules on marketing of prescription drugs in 1997, enabling targeted advertising directly to consumers. Lilly ICOS-hired agency Grey Worldwide in New York, part of Grey Global Group, to lead the advertising campaign Cialis. Cialis ads were softer and warmer than its competitors’ ads to reflect the longer duration of the drug, allowing a more relaxed approach. Iconic themes in the ads for Cialis include couples in bathtubs and the slogan “When the time comes, will you be ready?” Cialis ads were unique among the pills citing characteristics of the drug. Accordingly, the Cialis ads were also the first to describe the side effects in advertising, the FDA requires that advertisements with details to mention the side effects. One of Cialis ads aired in the 2004 Super Bowl. A few weeks before the Super Bowl The FDA has required more side effects can be included in advertising, including priapism. Although many parents opposed the Cialis ad be aired during the Super Bowl, “clothing malfunctions” of Janet Jackson halftime Cialis eclipsed. In January 2006, Cialis ads were tweaked, adding a physician to screen for side effects and describe the ad, where over 90 percent of the audience are adults, thereby end Super Bowl ads. In 2004, Lilly ICOS, Pfizer, GlaxoSmithKline and spent a combined 373.1 million and announced Cialis, Viagra, Levitra and respectively. Cialis has sponsored many golf events including the America’s Cup and the PGA Tour once is the title sponsor of the PGA Tour Western Open.
[via wikipedia and online sources]

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