VIVUS Tapping ED Hurdles (VVUS, PFE, LLY)
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
Bad Arena (ARNA) News Good For Orexigen (OREX) And Vivus (VVUS)
Arena Pharmaceuticals (ARNA) disappointing news about diappointing trial results for its obesity treatment lorcaserin.
The news, however, is pushing the firms two competitor higher in early trading as they are perceived to benefit from ARNA’s failure. Vivus (VVUS) is trading up 7% to $11.35 on heavy volume. Orexigen (OREX) started the session higher by now trades a little below flat at $9.14
Douglas A. McIntyre
VIVUS Becomes THE New Weight Loss Target (VVUS, OREX, ARNA)
Emerging drug player VIVUS Inc. (NASDAQ: VVUS) is soaring to new heights on what is already exponential trading volume on its key weight loss study results. The company’s interim update showed that two studies covering more than 3,750 patients may become the new weight loss target of all weight loss drugs, and therefore which could be used for diabetes and heart disease patients in some or many cases.
Those taking Qnexa reduced their weight by up to 14.7% on average in one trial, and the drug also showed improvement in blood pressure and diabetes symptoms and risk factors. Vivus’ second study showed an average weight loss of about 13.2%.
Those taking the placebo lost only about 2.5% of their weight in the first study and about 2.4% in the second study. Vivus indicated that it will seek FDA approval by year end.
Vivus reported that the side effects included dry mouth, tingling, constipation, altered taste and insomnia. Some reported drug-related instances of depression and depressed mood and adverse events of moderate to severe nature were observed in less than 2% and were actually similar to that seen in the placebo group. Unfortunately, these mood and depression instances are very common instances in those trying to lose significant weight.
There is an important aspect here, and that is that it puts two other drug companies in the hot seat. Orexigen Therapeutics Inc. (NASDAQ: OREX) met its weight loss targets in late stage studies and it has previously given an early-2010 for when it seeks FDA approval. Arena Pharmaceuticals Inc. (NASDAQ: ARNA) is also developing a weight loss treatment which it said earlier this year met endpoints.
This new study result has shares of VIVUS up over 50% to $10.60 in pre-market trading and at 9:50 AM EST there has already been 4.15 million shares trading hands. More importantly, this takes the stock to highs of this entire decade now.
Orexigen Therapeutics is also up almost 4% at $8.50 on the news, while Arena Pharmaceuticals is up almost 7% at $4.94.
This and other studies in the war against diabetes and obesity was mentioned in a much broader and much larger piece including stocks: NVO, AMLN, LLY, MNKD, PFE, SPEX, VVUS, GNBT, BMY, AZN, ARNA, GERN, STEM, OREX, HDIX, PODD
JON C. OGG
Diabetes Drug War Heats Up (NVO, AMLN, LLY, MNKD, PFE, SPEX, VVUS, GNBT, BMY, AZN, ARNA, GERN, STEM, OREX, HDIX, PODD)
Over the last couple of weeks, there has been quite a bit of new data in the drug war in the fight against diabetes. New studies have been updated, earnings projections have been made, FDA dates have been telegraphed and more. While these are still far short of ultimate cures, the war against diabetes may have many new or improved treatments out sooner rather than later. We originally discussed one or two of the key upcoming treatments pending for the eight major diseases and conditions as “the next $170 billion opportunity” and this is a much deeper dig into that broad initiation. We have included many of the recent developments in the potential treatments for obesity as well, considering that Type II diabetes and obesity are frequently conditions tied directly to each other.
According to the Journal of Health Affairs, the figure on obesity for Americans is a whopping $147 billion per year in total medical costs. This comes to 10% of all healthcare spending. The figure from the U.S. Centers for Disease Control was some $116 billion spent domestically on treating diabetes in 2007. As this is a lengthy bit, we have not included some of the other treatments that have been in use or that were recently flagged because of reports of higher chances of cancer rates associated by the long-term use of these.
FDA & IMMEDIATE ACTION
There is a new diabetes hopeful that is supposed to be coming sooner rather than later. Novo Nordisk (NYSE: NVO) reported a 21% gain in earnings in the last week and said that it expects the FDA to make a decision on its next-generation diabetes drug Victoza (liraglutide) in a matter of weeks. The company’s CFO and CEO both indicated that the Danish company does expects a positive response from the FDA and we heard a August to September expectation. Novo Nordisk has already launched Victoza in England, Germany and Denmark last month and expects to release it in other European Union countries throughout 2009 and into 2010. The benefit is that this one doesn’t risk pushing blood glucose levels to counts which are dangerously low and it also helps users lose weight. Novo Nordisk said it has priced Victoza competitively with Byetta from Amylin Pharmaceutical, Inc. (NASDAQ: AMLN) and Eli Lilly (NYSE: LLY). After the earnings and after shares were still close to 52-week highs, we saw analyst downgrades on Friday for Novo Nordisk by both UBS and by J.P. Morgan.
The drug still expected the next big new release with Blockbuster potential is an inhalable insulin from MannKind Corp. (NASDAQ: MNKD). Afresa is to be its name. Despite past woes of inhalable insulin, MannKind shares were hitting 52-week highs in June and its shares are still up 20% from three months ago. A late-stage study showed that Afresa’s performance was similar to injectable insulin. The company recently sold a 7.4 million shares secondary offering to raise cash for this launch, and its CEO took 1 million shares of the offering. The thought was that MannKind would secure a partner for marketing and development, but the recent stock offering gives it more internal options ahead of what is believed to be a Spring-2010 FDA approval action. Pfizer Inc (NYSE: PFE) has been thought of as a partner as it moved Exubera inhaled-insulin patients to MannKind’s experimental product. The two companies had been partners until Pfizer pulled Exubera from the market in 2007.
There is also a huge opportunity for the once per week dosing. We are not yet convinced that this can be a universal next generation treatment, however this might be fine for many of the lower grade cases if you can refer to any diabetes cases as lower grade. Amylin Pharmaceuticals, Inc. (NASDAQ: AMLN), Eli Lilly (NYSE: LLY) and Alkermes Inc. (NASDAQ: ALKS) have had a recent New Drug Application accepted by the FDA for review. Exenatide is an investigational sustained release medication for type 2 diabetes that would be injected once per week and is the active ingredient in BYETTA. We are not alone in this thought, but Amylin is a company which many have thought would be acquired for years now when considering the link of diabetes and obesity.
VIVUS, Inc. (NASDAQ: VVUS) has a substantial shot here with Qnexa, its Type 2 diabetes treatment through weight loss assistance. The stock recently came off on worries of its risk factor language that may have to be disclosed, but it showed a 9.4% weight loss or over 20 pounds observed in patients. The DM-230 study was a 56-week study assessing the impact of Qnexa on glycemic management in 130 obese patients. The 10-site study was comprised of 90 females and 40 males with an average age of 50 who had Type 2 diabetes, and a majority of the patients had been diagnosed with diabetes for more the five years and were taking two or more oral diabetes medications. In the phase II and phase III clinical trials, Qnexa demonstrated glycemic control, significant weight loss, and an improvement in cardiovascular risk factors. VIVUS is also presenting data at a brokerage firm conference this coming Thursday. The company’s market cap is still just under $500 million and its most recent balance sheet had north of $144 million in cash and equivalents with very little long term debt.
Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca (NYSE: AZN) have recently received FDA approval for Onglyza as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. This Onglyza is a once-daily dipeptidyl peptidase-4 (DPP4) inhibitor that can be used in combination with commonly prescribed anti-diabetic medications or on a standalone basis as a monotherapy to significantly reduce glycosylated hemoglobin levels.
MORE OBESITY CANDIDATES COMING
Several biotechnology companies are working on the next wave of obesity candidates, as noted above in VIVUS’s Qnexa. Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) has Lorcaserin, Orexigen Therapeutics, Inc. (NASDAQ: OREX) has Contrave, and Amylin Pharmaceuticals Inc. (NASDAQ: AMLN) has pramlintide. Orexigen’s Contrave has completed phase III trials and our time line for when the company will file for approval is in early 2010. The company is presenting data this Thursday at the Canaccord Adams Global Growth Conference. VIVUS’s Qnexa is currently in two phase III programs with a new drug application expected around the middle of 2010. Amylin’s pramlintide and metreleptin are currently in phase IIb.
We have the expectation that Arena will have a first-mover advantage with an NDA planned before the end of 2009. Certainly, any delays or advances could change the status of the front-runner category leadership. Arena’s near-term catalyst is the release of the phase III BLOSSOM data out in September 2009, which will be used as part of a supplemental NDA in late 2009 or into 2010. This still leaves a year or more for final FDA action from now. Arena shares surged in late-July after reporting that its obesity results met the three endpoints.
STEM CELLS
Stem Cell therapy offers a huge promise, but so far that looks to be years out and the promise is actually more of a hope for the time being. Geron Corporation (NASDAQ: GERN) is in the research stage of using stem cells in evaluation of Type 1 diabetes. The exact level of this study is not as far as along as some of its cancer and spinal studies, but this is one of the few stem cell companies that have dedicated part of their mission to diabetes. StemCells Inc. (NASDAQ: STEM) also has a Pancreatic Program concentrating its efforts on Type-I diabetes. Its goals are to identify, isolate, and culture pancreatic stem and progenitor cells, and to test their therapeutic potential.
While we at BioHealthInvestor would love to hold hope and promise for stem cells, we would not be hoping for stem cell treatments any time in the near future. While some positive notions have been noted in the stem cell sector, the National Institute of Health noted, “Over the past several years, doctors have attempted to cure diabetes by injecting patients with pancreatic islet cells—the cells of the pancreas that secrete insulin and other hormones. However, the requirement for steroid immunosuppressant therapy to prevent rejection of the cells increases the metabolic demand on insulin-producing cells and eventually they may exhaust their capacity to produce insulin. The deleterious effect of steroids is greater for islet cell transplants than for whole-organ transplants. As a result, less than 8 percent of islet cell transplants performed before last year had been successful.”
Vivus' Qnexa: Better for Diabetes, or Better for Weight Loss? (VVUS)
Vivus Inc. (NASDAQ: VVUS) issued its awaited results on its mid-stage trial of its experimental drug Qnexa, showing that it lowered blood sugar levels and led to weight loss in patients with Type II diabetes.
The results are from its 28-week trial involving 206 subjects, and Vivus said that patients on Qnexa achieved a 1.2% reduction in the key blood sugar measurement hemoglobin A1c compared to a drop of -0.6% for those who received only the placebo.
Qnexa is also being developed for obesity, and the disclosed amount was a loss of approximately 8% of the patients’ starting body weigh. The placebo group reported a loss of 1.2% of their starting body weight.
Vivus also reported that Qnexa trial patients also had significant improvement in cardiovascular risk factors including blood pressure, triglyceride levels and waist circumference.
Qnexa is potentially not going to go entirely unchallenged or at least might not escape without at least some controversy, particularly considering the history of the company and the history of the compounds. It is a combination of phentermine from “fen-phen” and an epilepsy drug Topamax (generic as topiramate).
Shares have been mixed today despite this being reported as and being perceived as positive news. Shares are up less than 1% at $7.05 after 90 minutes of being open, although shares have traded in a $6.81 to $7.22 trading range today alone.
Jon Ogg
June 10, 2008
Analyst Research Calls Impacting Biotechs (ALXN, OSCI, SGMO, VVUS, CRA)
There were some research calls that are affecting many shares of biotech stocks this morning, as follows:
- Alexion Pharmaceuticals (NASDAQ: ALXN) started as Buy at Piper Jaffray, shares up almost 2%.
- Oscient Pharmaceuticals (NASDAQ: OSCI) started as Neutral at Piper Jaffray; shares flat as a thin volume stock.
- Sangamo Biosciences (NASDAQ: SGMO) Started as Sell at Brean Murray; shares down 11%
- Vivus (NASDAQ: VVUS) Cut to Market Perform from Outperform at Wachovia; shares down some 4%.
Elsewhere, Celera Genomics (NYSE: CRA) was started with a “Perform” rating at Oppenheimer. While Celera is a molecular diagnostic company, they are involved in the identification and validation of diagnostic markers using their own proprietary genomics and proteomics discovery platforms.
Jon Ogg
May 29, 2008
