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CHMP Recommends Approval of Cialis for the Treatment of Signs and Symptoms of Benign Prostatic Hyperplasia
Date:9/21/2012

INDIANAPOLIS, Sept. 21, 2012 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of Cialis® (tadalafil) tablets 5 mg for once a day use for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). The CHMP's opinion is now referred to the European Commission, which has the authority to approve medicines for the European Union (EU). The Commission usually issues a decision within one to two months following the CHMP opinion.

Tadalafil was approved for the treatment of erectile dysfunction in the EU in 2002. Tadalafil for once a day use was approved for the treatment of erectile dysfunction in the EU in 2007.

"If approved by the Commission, tadalafil will be the first and only medication approved in the EU to treat men with both erectile dysfunction and benign prostatic hyperplasia," said Kraig Kinchen, M.D., senior medical director at Lilly. "Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a significant therapeutic option for men and physicians."

The CHMP issued its opinion after reviewing safety and efficacy data from 1,500 patients in four clinical studies of BPH, including one study of BPH and ED. Additionally, safety data from the approved indication for erectile dysfunction were included in Lilly's submission. In the BPH and ED study, Cialis 5 mg for once a day use significantly improved scores on the International Prostate Symptom Score (IPSS), a questionnaire evaluating symptoms of BPH, and the International Index of Erectile Function-Erectile Function Domain (IIEF-EF), a questionnaire evaluating sexual function.

The most commonly reported adverse events in patients taking Cialis for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, indigestion, back pain and muscle pain. They were transient and generally mild or moderate.

BPH is a condition in which the prostate enlarges, which can cause urinary symptoms like needing to go urgently and frequently.

ED is a condition in which the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. Approximately 40 percent of men over 40 have ED.[1]

BPH and ED are conditions that may occur in the same patient. Several studies have shown that many men with ED also experience the symptoms of BPH.[2],[3],[4]

Tadalafil inhibits an enzyme called phosphodiesterase type 5 (PDE5). By inhibiting PDE5 in the penis, tadalafil helps produce vascular smooth muscle relaxation and increases blood flow. PDE5 enzymes are also found in the smooth muscle of the prostate and bladder. The mechanism for how tadalafil reduces BPH symptoms has not been fully established.   

About Tadalafil (Cialis)
Tadalafil is approved to treat erectile dysfunction (ED) in adult males throughout the world, including in the United States, Europe, Australia, Mexico and Canada. There are two different dosing options: tadalafil for once a day use (2.5 and 5 mg) or tadalafil for use as-needed, or 'on-demand' (10 mg and 20 mg).

Tadalafil on demand is a prescription only medicine licensed in the EU for the treatment of erectile dysfunction.

Tadalafil for once a day use is an ED treatment that is taken every day to help improve erectile function. When taken every day, it may help men be ready for sex anytime between doses or remove the need to plan the timing of sexual activity around taking a pill.

Tadalafil on demand may be taken at least 30 minutes  prior to sexual activity, with or without food, and may work for up to 36 hours following dosing.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world's most urgent medical needs.

This press release contains forward-looking statements about the potential of Cialis for the treatment of benign prostatic hyperplasia (BPH) and reflects Lilly's current beliefs.  However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review.  There is no guarantee that Cialis will receive additional regulatory approvals.  There is also no guarantee that Cialis will continue to be commercially successful.  For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission.  Lilly undertakes no duty to update forward-looking statements.

[1] Feldman HA et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994;151(1):54-61.
[2] Rosen R, Altwein J, Boyle P, Roger SK, Lukacs B, Meuleman E, et al. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Eur Urol. 2003;44(6):637-649.
[3] Brookes ST, Link CL, Donovan JL, and McKinlay JB.  Relationship between lower urinary tract symptoms and erectile dysfunction: results from the Boston Area community Health Survey. J Urol 2008;179:250-255.
[4] Gacci M, et al. Critical analysis of the relationship between sexual dysfunctions and lower urinary tract symptoms due to benign prostatic hyperplasia. Eur Urol 2011; 60:809-825.

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