|Tuesday, 03 March 2009 06:56|
Orexigen Therapeutics (OREX) will report additional Phase 3 results for Contrave around mid-year and hopes to file a NDA by year-end. Arena Pharma (ARNA) is expected to report Phase 3 results for lorcaserin by the end of this month. Vivus expects to post Phase 3 results around mid-year for Qnexa with a NDA filing planned before year-end.
Nearly two-thirds or 65% of U.S. population is classified as obese or overweight with a three-fold increase in adolescent obesity rates over the past three decades. Obesity is the second leading cause of preventable deaths behind smoking and weight loss is proven to decrease mortality while also improving blood sugar control in diabetics. Over one-third (35%) of people in the U.S. have a lifetime of developing Type 2 diabetes and the trend is clearly increasing as a result of obesity rates, especially in the younger population.
Qnexa is a once-daily, combination drug (phentermine 15 mg immediate-release + topiramate 92 mg controlled-release) in Phase 3 clinical development for weight loss in obese patients and improving blood sugar control in diabetics. Phentermine is the most widely prescribed prescription weight loss drug which is available in generic forms and has a database of 1.8 million patient years of usage.
Topiramate is better known as Topamax (patent expires this month), which has 5.8 million patient years of use and was originally developed as a seizure drug and is also used for the prevention of migraine headaches. While both components of Qnexa will be available in generic forms, topiramate is not indicated for weight loss and the dosages being evaluated in clinical trials would make dosing difficult using the two drugs individually.
Also, Vivus holds composition of matter and method of use patents for Qnexa as a combination treatment for obesity in the unique dosage forms being evaluated in Phase 3 clinical trials, with more than 4,500 patients currently enrolled in late-stage studies for weight loss and Type 2 diabetes control. Last year, Vivus reported results for Qnexa from the 28-week EQUATE Phase 3 clinical trial which met its primary endpoint by demonstrating superior weight loss with both the full-dose and mid-dose of Qnexa, as compared to the drugs used individually and placebo.
Subjects treated with full-dose and mid-dose Qnexa had an average weight loss of 9.2% and 8.5% respectively, as compared to weight loss of 1.7% reported in the placebo group (p<0.0001). Average weight loss was 19.8 pounds and 18.2 pounds in the treatment arms as compared to 3.3 pounds in the placebo group. Qnexa was well-tolerated, with no drug-related serious adverse events in the study.
The first pivotal Phase three trial in the general population for the Company's other late-stage drug candidate, avanafil, were initiated last December with topline results possible by year-end. Last month, a Phase 3 trial was initiated (REVIVE-Diabetes) to evaluate avanafil in diabetics. Avanafil is in the same class as erectile dysfunction (ED) drugs such as Pfizer's (PFE) Viagra, Lilly's (LLY) Cialis, and Glaxo's (GSK) Levitra, which represents a large market with over $3B in sales.
Avanafil is being developed through a low-risk $30M funding agreement with Deerfield Management ($20M royalty/funding agreement + $10M in Vivus common stock) as a next-generation, fast-acting oral PDE5 inhibitor. Avanafil is differentiated from what is a crowded market for ED drugs based on its faster onset of action (35 minutes) and better safety profile (shorter half life of 90 minutes means the drug is metabolized quicker with less chance for side effects or drug interactions).
Recent market volatility presents an excellent buying opportunity for shares of Vivus, which ended last year with a projected cash balance of $180M - compared to market cap of $218M and negligible debt of $8.7M. Vivus offers investors two late-stage Phase 3 drug candidates in Qnexa and Avanafil, with results expected at mid-year and year-end, respectively. Vivus also plans to file a NDA for Qnexa by year-end, pending the outcome of the two pivotal Phase 3 trials at mid-year.
Big pharma companies in search of new products and late-stage pipeline candidates will be watching closely as ARNA, OREX, and Vivus report their pivotal weight loss study results over the next few months and a major licensing deal or acquisition will likely follow for the company posting the best results in terms of safety and efficacy.
My bet is on Vivus and with the most recent leg of the market meltdown, the stock is trading at multi-year lows around three bucks - representing a steep discount to the timely $65M registered common stock offering last August at $7.77 per share and within the range of the previous two option grant prices to officers and directors at $2.69 and $3.75 per share.