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VIVUS, Inc. Announces License Agreement for the Marketing Rights to STENDRA in the
United States and Canada
MOUNTAIN VIEW, Calif., Oct. 11, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced the signing of an agreement providing Auxilium Pharmaceuticals, Inc. (Nasdaq:AUXL) the exclusive rights to market STENDRA™ (avanafil) in the United States and Canada. The parties also simultaneously signed a Commercial Supply Agreement pursuant to which VIVUS will be responsible for the manufacture and supply of STENDRA to Auxilium for a mutually agreed term. STENDRA is an oral therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of erectile dysfunction (ED). Under the license agreement, VIVUS is eligible to receive up to $300 million based on certain regulatory and sales milestones, including an upfront licensing fee of $30 million and a $15 million payment contingent upon a potential label amendment regarding onset-of-action, in addition to royalties on product sales. "Auxilium is the ideal partner for STENDRA, with an established sales force and excellent relationships with physicians responsible for men's health," stated Seth H.Z. Fischer, CEO of VIVUS. "We look forward to working with Auxilium as they prepare for launch later this year." It is estimated that more than 50 percent of men over 40 years of age experience some degree of EDi. Prevalence of the condition increases with age and can be caused by a variety of factors, including medications (anti-hypertensives, histamine receptor antagonists); lifestyle (tobacco, alcohol use); diseases (diabetes, cardiovascular conditions, prostate cancer); prostatectomy, and spinal cord injuries. The market opportunity for ED medical treatments continues to grow, with U.S. sales exceeding $2.9 billion in 2012ii. About one half of men being treated with currently available PDE5 inhibitors are dissatisfied with the results of that treatment and tend to switch among the products in pursuit of better efficacy or less side effectsiii. "We believe STENDRA complements our current portfolio of testosterone replacement therapy and ED products, further broadening our men's health care franchise in a very large market segment consisting of patients that tend to switch among products," said Adrian Adams, chief executive officer and president of Auxilium. "The rapid onset of action of STENDRA and its favorable side effect profile make it an exciting new entrant into the category." Auxilium expects to begin its commercial launch of STENDRA by the end of 2013, first with shipments of STENDRA in December 2013, followed by promotional activities in early January 2014 with its PRIMERA sales force, which consists of 150 representatives currently devoted to strategic targeting of urologists, endocrinologists, and certain high prescribing primary care physicians. Auxilium will also leverage digital media to reach a broader audience online.
"The Agreement with Auxilium in the U.S. and Canada, along with the previously-announced license agreement with Menarini for Europe and abroad, fulfills significantly our objective of monetizing avanafil," stated Timothy E. Morris, senior vice president, finance and global commercial development, chief financial officer for VIVUS. "Both deals combined have the potential to generate over $95 million in cash to VIVUS within the first year, in addition to royalties earned on sales of avanafil." VIVUS will continue to be responsible for the product's post-approval requirements in the U.S., including a potential label amendment based on the results of the TA-501 study designed to assess the efficacy of STENDRA in approximately 15 minutes. In the study, STENDRA patients achieved statistically significant improvement over placebo, in the mean proportion of attempts that resulted in erections sufficient for successful intercourse, as early as 10 minutes for the 200 mg dose and 12 minutes for the 100 mg dose after being taken.
Aquilo Partners, L.P. acted as the exclusive advisor to VIVUS on the transaction.
About Avanafil
STENDRA (avanafil) is approved in the U.S. by the FDA for the treatment of erectile dysfunction. Auxilium Pharmaceuticals, Inc. has exclusive marketing rights to STENDRA in the U.S. and Canada.
STENDRA will be available through retail and mail order pharmacies. Auxilium plans to offer programs that will help patients with out-of-pocket costs. SPEDRA, the trade name for avanafil in the EU, is approved by the EMA for the treatment of erectile dysfunction in the EU. VIVUS has granted an exclusive license to the Menarini Group through its subsidiary Berlin-Chemie AG to commercialize and promote SPEDRA for the treatment of erectile dysfunction in over 40 European countries plus Australia and New Zealand.
Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian-Pacific Rim countries. VIVUS is in discussions with other parties for the commercialization rights to its remaining territories.
Important Safety Information
STENDRA™ (avanafil) is prescribed to treat erectile dysfunction (ED).
Do not take STENDRA if you take nitrates, often prescribed for chest pain, as this may cause a sudden, unsafe drop in blood pressure.
Discuss your general health status with your healthcare provider to ensure that you are healthy enough to engage in sexual activity. If you experience chest pain, nausea, or any other discomforts during sex, seek immediate medical help.
STENDRA may affect the way other medicines work. Tell your healthcare provider if you take any of the following; medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir (Crixivan®), saquinavir (Fortavase® or Invirase®) or atazanavir (Reyataz®); some types of oral antifungal medicines, such as ketoconazole (Nizoral®), and itraconazole (Sporanox®); or some types of antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin. In the rare event of an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including STENDRA) reported a sudden decrease or loss of vision. It is not possible to determine whether these events are related directly to these medicines or to other factors. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including STENDRA, and call a doctor right away.
Sudden decrease or loss of hearing has been rarely reported in people taking PDE5 inhibitors, including STENDRA. It is not possible to determine whether these events are related directly to the PDE5 inhibitors or to other factors. If you experience sudden decrease or loss of hearing, stop taking STENDRA and contact a doctor right away. If you have prostate problems or high blood pressure for which you take medicines called alpha blockers or other anti-hypertensives, your doctor may start you on a lower dose of STENDRA.
Drinking too much alcohol when taking STENDRA may lead to headache, dizziness, and lower blood pressure.
STENDRA in combination with other treatments for ED is not recommended.
STENDRA does not protect against sexually transmitted diseases, including HIV.
The most common side effects of STENDRA are headache, flushing, runny nose and congestion.
Please see full patient prescribing information for STENDRA (50 mg, 100 mg, 200 mg) tablets.
About VIVUS
VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health. For more information about VIVUS, please visit Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks, uncertainties and other factors, including risks and uncertainties related to regulatory approval of certain avanafil claims within the Auxilium exclusive territories and the timing, strategy, tactics and success of avanafil commercialization by Auxilium in the U.S. or Canada These risks and uncertainties could cause actual results to differ materially from those referred to in these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Investors should read the risk factors set forth in VIVUS's Form 10-K for the year ending December 31, 2012, as amended by the Form 10-K/A filed on April 30, 2013, and as amended by the Form 10-K/A filed on June 12, 2013, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements. iii 1- Impact CR Consumer Segmentation, Feb 2013; Qualitative Market Interviews (n= 722) 2- HCP Research, Primary Interviews; LSSG, LLC n= 64 VIVUS Announces Avanafil Partnership With Menarini
Menarini to Launch and Market SPEDRA in 40 Countries in Europe and Abroad
VIVUS to Receive Upfront Payment Plus Milestones and Royalties Over the Term of the Agreement
MOUNTAIN VIEW, Calif., July 9, 2013 - VIVUS, Inc. (NASDAQ: VVUS) today announced that it has entered into a License and
Commercialization Agreement and a Supply Agreement with Menarini and its wholly-owned subsidiary BERLIN-CHEMIE
AG/MENARINI, to commercialize and promote SPEDRA™ (avanafil) in over 40 European countries plus Australia and New
Zealand. SPEDRA is a new phosphodiesterase-5 inhibitor (PDE5-i) approved under the trade name STENDRA™ by the U.S.
FDA in April 2012 and by the European Commission (EC) in June 2013 for the treatment of erectile dysfunction (ED).
The Menarini Group is the leading Italian pharmaceutical company in the world with over 125 years of history. Menarini, a private company headquartered in Florence, Italy, has a 2012 turnover of more than €3.2 billion ($4.2 billion) and has over 16,000 employees worldwide. In the EU, Menarini expects to field a sales force of 1,350 representatives to promote SPEDRA. "Menarini will be an excellent partner for SPEDRA," stated Timothy E. Morris, senior vice president, global corporate
development and finance and CFO of VIVUS, Inc. "Menarini has tremendous know how and marketing capabilities
throughout Europe and has already established a presence in men's health with the acquisition last year of Priligy®
(Dapoxetine) for treatment of premature ejaculation (PE). The licensing process was competitive and Menarini was chosen for
their extensive presence in their territories and their history of successful drug launches across Europe. We look forward to a
long and productive collaboration with Menarini."
VIVUS will receive an upfront payment and various approval and sales milestones plus royalties on SPEDRA sales. Within the first year, VIVUS is expected to receive approximately €39 million (or approximately $51 million at current exchange rates) including upfront payments totaling €16 million (or approximately $21 million at current exchange rates). Menarini will also reimburse VIVUS for payment made to cover various obligations to Mitsubishi Tanabe Pharma Corporation (MTPC) during the term of the agreement. VIVUS is eligible to receive up to €79 million (or approximately $102 million at current exchange rates) in milestones and other payments over the life of the agreement in addition to royalties. The agreement will continue on a country-by-country basis in the Menarini Territory, until the latest of: expiration of the last-to-expire valid MTPC patent covering SPEDRA; data protection covering SPEDRA; or ten (10) years after the SPEDRA product launch. VIVUS and Menarini also entered into a supply agreement whereby VIVUS will supply Menarini with commercial product.
"SPEDRA is an important addition into our commercial portfolio. The rapid onset of action and unique profile make SPEDRA an
important treatment option for men with ED," stated Alberto Giovanni Aleotti, vice chairman of Menarini Group. "We are
eagerly preparing for the launch of SPEDRA, which we expect to occur in the major EU countries early next year".
Aquilo Partners, L.P. acted as the exclusive advisor to VIVUS on the Menarini transaction.
Priligy® (Dapoxetine) is the first oral medication approved for "on-demand" treatment of PE. ED is considered a disease of vascular origins in many patients and affects approximately 52 percent of men between the ages of 40 and 70. Prevalence increases with age and can be caused by a variety of factors, including medications (anti-hypertensives, histamine receptor antagonists); lifestyle (tobacco, alcohol use, drug use); diseases (diabetes, vascular conditions, metabolic syndrome, obesity), and spinal cord injuries. Left untreated, ED can negatively impact relationships and self-esteem, causing feelings of embarrassment and guilt. However, about half of men being treated with currently available PDE5 inhibitors are dissatisfied with treatment. The market opportunity for ED medical treatments continues to grow, with worldwide sales exceeding $5.5 billion in 2012.
About Avanafil
SPEDRA™, the trade name for avanafil in the EU, has just been approved by the EMA for the treatment of erectile dysfunction in the EU.
STENDRA is approved by the FDA for the treatment of erectile dysfunction in the U.S. VIVUS, through collaboration arrangements with third parties, intends to market and sell STENDRA in the U.S. and under the trade name SPEDRA in the EU and other territories outside the U.S. Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian-Pacific Rim countries. VIVUS is currently in discussions with potential partners to commercialize STENDRA in the U.S. and other territories throughout the world.
Currently, it is recommended that STENDRA should be taken approximately 30 minutes before sexual activity. STENDRA should not be taken more than once per day. For more information about STENDRA, please visit . About VIVUS
VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health. For more information about the company, please visit Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks, uncertainties and other factors, including risks and uncertainties related the launch and commercialization of SPEDRA in the EU, Australia and New Zealand. These risks and uncertainties could cause actual results to differ materially from those referred to in these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Investors should read the risk factors set forth in VIVUS's Form 10-K for the year ending December 31, 2012, as amended by the Form 10-K/A filed on April 30, 2013 and by the Form 10-K/A filed on June 12, 2013, and periodic reports filed with the Securities and Exchange Commission. VIVUS does not undertake an obligation to update or revise any forward-looking statements. About the MENARINI GROUP
Menarini is an international pharmaceutical company with over 16,000 employees worldwide and a presence in more than 100 countries in Europe, Asia, Latin America, Africa and the Middle East, and has a 2012 turnover of more than €3.2 billion ($4.2 billion). Research and internationalization represent the main areas of strategic development for its future. The Group has 14 manufacturing sites located in Italy and abroad where over 545 million packages/year are produced and distributed throughout the five continents; thus, allowing Menarini to contribute to the health of patients all over the world with its high quality standards.
Menarini Group- Valeria Speroni Cardi, Head of Menarini Group Press office - Menarini GROUP
Valeria Speroni Cardi
Head of Press office

VIVUS, Inc.
Timothy E. Morris
Chief Financial Officer
650-934-5200
Investor Relations: The Trout Group
Brian Korb
646-378-2923

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