VIVUS, Inc. (NASDAQ: VVUS) is indicated higher on news after it announced positive results from is Phase III study of Avanafil or TA-314. This is VIVUS’ investigational drug candidate for the treatment of erectile dysfunction.
The company reported that this study met all primary endpoints with improvement from baseline in erectile function as measured by the Sexual Encounter Profile (both SEP2 and SEP3) and improvements in the International Index of Erectile Function (IIEF). Patients treated with avanafil who attempted sexual intercourse (SEP3) within the first 15 minutes of dosing had success rates of 80%.
The open label study was in over 700 enrolled patients using avanafil as needed and at a dose of their choosing. The company noted that continues to anticipate the completion of the new drug application filing for avanafil in the second quarter of 2011.
Additional gains in the study were that 80% of sexual attempts among patients on avanafil had erections sufficient for intercourse. Some 67% of patients taking avanafil experienced successful intercourse, and successful intercourse was achieved as early as 15 minutes after dosing.
In the safety profile, Avanafil was well tolerated as evidenced by a low rate of discontinuations due to adverse events with only 2.8%. The most common side effects reported were headache (5.6%), flushing (3.5%), nasopharyngitis (3.4%) and nasal congestion (2.1%)
Lastly, there were no drug-related serious adverse events reported in the study.
VIVUS shares are indicated up around $7.15 right after 8:00 AM EST, a gain of about 4.1%. The 52-week trading range is $4.69 to $13.68.
JON C. OGG
When you hear the term ‘erectile dysfunction’ tied to the world of drugs and pharmaceuticals, chances are that the drugs that come to mind are VIAGRA and CIALIS. After all, Pfizer Inc. (NYSE: PFE) and Eli Lilly & Co. (NYSE: LLY) have spent billions combined and had untold efforts getting those ED drugs to be your first choice. VIAGRA broke records, then came ‘the weekender’ in Cialis.
But there is a second tier of ED treatments that never really caught on in the same manner. VIVUS, Inc. (NASDAQ: VVUS) has had its MUSE treatment on the market since 1997 and it has decided to sell off MUSE.
The company has entered into an asset purchase agreement with Meda for MUSE where Meda will acquire the MUSE assets (including the United States and foreign MUSE patents, existing inventory and the manufacturing facility located in Lakewood, New Jersey). Existing VIVUS employees that are MUSE dedicated are expected to join Meda and VIVUS will retain all of the liabilities associated with the pre-closing operations of the MUSE business.
VIVUS has already been business partners with Meda in Europe for MUSE since 2000, so it seems a natural fit here on the surface. VIVUS now plans to focus its efforts on the commercialization of QNEXA as a treatment against obesity and the development of avanafil for erectile dysfunction.
The terms of the deal call for an acquisition price of up to $23.5 million. the deal terms are for a cash payment of $22 million and VIVUS is eligible to receive a one-time milestone payment of $1.5 million based on future sales of MUSE.
MUSE has been on the market since 1997 as the first minimally invasive therapy for erectile dysfunction approved by the FDA. The drug is delivered locally to the erectile tissues and was meant to minimize chances of systemic interactions with other drugs or diseases.
VIVUS still has Qnexa and avanafil for erectile dysfunction under development stages today. Shareholders seem to not care about the transaction. VIVUS shares are down 0.45% at $6.55 in light volume trading.
JON C. OGG
NexMed, Inc. (NASDAQ: NEXMD) was up $1.15 (52%) to $3.42 in the midst of this mornings strong market rally. While no news has broken to explain this meteoric jump, NexMed did have some good news recently which contributed to investor confidence – the company received its first patent allowance on Vitaros (an erectile dysfunction treatment) in Japan.
NexMed, Inc. engages in designing and developing pharmaceutical products based on its patented NexACT drug delivery technology. It is based in San Diego, CA.
VIVUS Inc. (NASDAQ: VVUS) may soon have a new erectile dysfunction drug on the market if the test results lead to an FDA approval. Shares are trading higher this morning after it announced positive results in a phase 3 pivotal study evaluating the safety and efficacy of avanafil for the treatment of erectile dysfunction.
If everything is as solid as it sounds, it looks like Pfizer (NYSE: PFE) via Viagra and Eli Lilly & Co. (NYSE: LLY) via Cialis may have a new competitor.
The 646 patient study met the safety and efficacy enpoints of avanafil, with what may be some lower side effects than traditional ED drugs. The endpoints were also met across the three doses studied by demonstrating statistically significant improvement in erectile function as measured by the Sexual Encounter Profile and improvements in the International Index of Erectile Function score.
Nearly 80% of sexual attempts among patients on the 200 mg dose of avanafil had erections sufficient for intercourse. Full efficacy was reported by patients in 30 minutes or less, which is better than current ED drugs. Full efficacy was maintained for all doses across multiple time points beyond six hours.
The company also noted that all FDA-defined primary endpoints were met across all three doses of avanafil, and it was well tolerated as demonstrated by a high retention rate (85%). More importantly, there were no drug-related serious adverse events in the study and patients had low reports of common PDE5i side effects.
VIVUS shares are up 13% at $9.72 in pre-market trading and the 52-week trading range is $2.72 to $12.88.
JON C. OGG