ERECTILE DYSFUNCTION

Overview Erectile dysfunction (ED) is defined as the inability to attain and maintain an erection sufficient to permit satisfactory sexual intercourse. Medical and Surgical Therapy of Erectile Dysfunction. Shindel A, Brant WO, Bochinski D, Bella AJ, Lue TF. In: De Groot LJ, Beck-Peccoz P, Chrousos G, Dungan K, Grossman A, Hershman JM, Koch C, McLachlan R, New M, Rebar R, Singer F, Vinik A, Weickert MO, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-2014 Accessed May 24 2015 http://www.ncbi.nlm.nih.gov/books/NBK278925/#med-surg-thrpy-ed.toc-8-1-physiology-of-erections

Overview 40% of men over the age of 40 ("40 over 40" rule) have ED. As a man gets older, ED is more common than having normal erectile function. In fact, after age 50-60, more men have ED than optimal (normal) erections. Medical and Surgical Therapy of Erectile Dysfunction. Shindel A, Brant WO, Bochinski D, Bella AJ, Lue TF. In: De Groot LJ, Beck-Peccoz P, Chrousos G, Dungan K, Grossman A, Hershman JM, Koch C, McLachlan R, New M, Rebar R, Singer F, Vinik A, Weickert MO, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-2014 Accessed May 24 2015 http://www.ncbi.nlm.nih.gov/books/NBK278925/#med-surg-thrpy-ed.toc-8-1-physiology-of-erections

Massachusetts Male Aging Study: Key Prevalence Study of ED Source: Massachusetts Male Aging Study: Key Prevalence Study of ED Men aged 40 to 70 years (N=1290) Review: Minimal ED 17% No ED 48% ED 52% Moderate ED 25% Reviewer Memo: Complete ED 10% Key point: In this US study, more than half of men aged 40-70 years had ED; 35% of all men in this age range had moderate to complete ED. Specific points: The Massachusetts Male Aging Study (MMAS) of 1290 men was conducted from 1987 to 1989 to determine ED prevalence and is widely regarded as one of the most comprehensive studies conducted to date in this area. Of the men reporting some degree of ED: 19% of the men with ED (10% of the total) had complete (severe) ED, 48% (25% of the total) had moderate ED and 33% (17% of the total) had minimal ED. Overall, 67% of men reporting ED in this study had moderate-to-complete ED. Definitions: Complete ED is defined as “unable to get and keep an erection.” Moderate ED is defined as “sometimes able to get and maintain an erection.” Minimal ED is defined as “usually able to get or keep an erection.” Feldman HA et al. J Urol. 1994;151:54-61. Minimal ED, “usually able to get or keep an erection.” Moderate ED, “sometimes able to get and maintain an erection.” Complete ED, “unable to get and keep an erection.” Source Material Feldman HA et al. J Urol. 1994;151:54-61. Slide Modified: Memo:

Overview 30 million men in the United States are estimated to have varying degrees of ED, with similar numbers in the EU. Fewer men in the EU obtain treatment compared to the Americas; cost of medications is the main barrier to care. Medical and Surgical Therapy of Erectile Dysfunction. Shindel A, Brant WO, Bochinski D, Bella AJ, Lue TF. In: De Groot LJ, Beck-Peccoz P, Chrousos G, Dungan K, Grossman A, Hershman JM, Koch C, McLachlan R, New M, Rebar R, Singer F, Vinik A, Weickert MO, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-2014 Accessed May 24 2015 http://www.ncbi.nlm.nih.gov/books/NBK278925/#med-surg-thrpy-ed.toc-8-1-physiology-of-erections

Overview 30 million men in the United States are estimated to have varying degrees of ED, with similar numbers in the EU. Fewer men in the EU obtain treatment compared to the Americas; cost is the main barrier to care. Figure from 2014-2018 Global Erectile Dysfunction Drugs Market. Research by Technavio Insights. Purchased by Biopharmcor.

Causes of Erectile Dysfunction Some common causes of ED are diabetes, cardiovascular disease, hypertension, abnormal cholesterol, smoking, obesity, lack of physical fitness and exercise, psychological issues, overuse of alcohol and the use of medications for other diseases (side-effect of medications such as blood pressure pills and anti-depressants). 2015 CUA Practice guidelines for erectile dysfunction. Bella AJ, Lee JC, Carrier S, Bénard F, Brock GB. Can Urol Assoc J. 2015 Jan-Feb;9(1-2):23-9. Access May 24 2015 at http://www.cua.org/en/guidelines

Impact of Erectile Dysfunction ED is a highly prevalent condition, which affects the physical and psychosocial (psychological) well-being and quality of life for thousands of men, their partners, and families around the world. ED leads to stress, anxiety and self-confidence issues, in addition to the physical inability to perform sexually. It is not surprising that the global market for ED medications was over $4.1 billion USD in 2013. 2015 CUA Practice guidelines for erectile dysfunction. Bella AJ, Lee JC, Carrier S, Bénard F, Brock GB. Can Urol Assoc J. 2015 Jan-Feb;9(1-2):23-9. Access May 24 2015 at http://www.cua.org/en/guidelines *Data from 2014-2018 Global Erectile Dysfunction Drugs Market. Research by Technavio Insights. Purchased by Biopharmcor.

Treatment of Erectile Dysfunction The treatment of ED in general was revolutionized by the introduction of the PDE5 inhibitor (PDE5I) class of medications. The first of these was sildenafil (Viagra®), followed by vardenafil (Levitra®/Staxyn®) and tadalafil (Cialis®). In April 2012 a fourth PDE5I, avanafil (Stendra®)*, received FDA approval. ED treatment is successful using pills (oral therapy) for the majority of men regardless of the underlying cause of ED. 2015 CUA Practice guidelines for erectile dysfunction. Bella AJ, Lee JC, Carrier S, Bénard F, Brock GB. Can Urol Assoc J. 2015 Jan-Feb;9(1-2):23-9. Access May 24 2015 at http://www.cua.org/en/guidelines *Data from 2014-2018 Global Erectile Dysfunction Drugs Market. Research by Technavio Insights. Purchased by Biopharmcor.

Treatment of Erectile Dysfunction 2015 CUA Practice guidelines for erectile dysfunction. Bella AJ, Lee JC, Carrier S, Bénard F, Brock GB. Can Urol Assoc J. 2015 Jan-Feb;9(1-2):23-9. Access May 24 2015 at http://www.cua.org/en/guidelines Full figure and article available for public review.

Treatment of Erectile Dysfunction The majority of men will have an excellent treatment response to PDE5Is. They will not require more invasive treatments. Second-line treatments for ED include intracavernous injections (needle delivery of medication into the penis), vacuum erection device, or intraurethral alprostadil (a small pellet inserted into the opening of the urinary passage). Third-line treatment includes surgical insertion of an internal penile prosthesis (pump). 2015 CUA Practice guidelines for erectile dysfunction. Bella AJ, Lee JC, Carrier S, Bénard F, Brock GB. Can Urol Assoc J. 2015 Jan-Feb;9(1-2):23-9. Access May 24 2015 at http://www.cua.org/en/guidelines

Summary Erectile dysfunction is common, occurs in more than half of men after age 50, and significantly impacts quality of life. Safe, effective oral drugs are available. The cost of these medications is the primary barrier for patient care. Opportunities exist for Biopharmcor to develop new generic medications to successfully treat men with ED.

Key Aspects of Erectile Dysfunction Point 1: ED rates are increasing globally. Point 2: Safe and effective oral treatments are available. Point 3: First-line treatment for EAU, AUA and CUA guidelines are PDE5Is (pills). Point 4: Cost is the main barrier to successful ED treatment. Development of generic medications offers a safe and effective option. EAU – European Association of Urology AUA – American Urological Association CUA – Canadian Urological Association

Further Information Please refer to the FAQ sections for Men’s Health and Erectile Dysfunction on the Biopharmcor website. European Association of Urology at http://patients.uroweb.org 3. American Urological Association patient care website at http://www.urologyhealth.org/ 4. 2015 Canadian Urological Association Guidelines for the Treatment of Erectile Dysfunction at: http://www.cua.org/themes/web/assets/files/guidelines/en/erectile_dysfunction_feb_2015.pdf.