By Narrative Science Analysts expect Arena Pharmaceuticals to rally after a loss of 12 cents a year ago. Profits for the company, which will report its second quarter earnings on Thursday, August 1, 2013, are expected to come in at 12 cents per share. …read more
Source: FULL ARTICLE at Forbes Markets
By Max Macaluso, Ph.D., The Motley Fool
Filed under: Investing
Last summer, the Food and Drug Administration approved two new medications for the treatment of obesity. VIVUS‘ Qsymia has already reached the market, while Arena Pharmaceuticals‘ Belviq will be launched by its commercialization partner Eisai once the drug clears DEA scheduling. A third player, Orexigen Therapeutics , is still developing its drug Contrave. The fact that obesity affects more than a third of American adults today has attracted many biotech investors to these stocks, but many may not fully understand how physicians approach treatment for this disease. For instance, are exercise and diet all patients really need to manage their weight?
To help clarify this complex topic, Motley Fool health-care analyst Max Macaluso spoke with Dr. Domenica Rubino, a weight-management expert and representative of The Obesity Society. In the following segment from their discussion, Dr. Rubino discusses the role that drugs play in treating obesity. A transcript follows the video.
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The relevant video segment can be found between 5:20 and 8:17.
Max Macaluso: Let’s pivot the discussion to drugs and treatment now. Arena recently got Belviq approved. It’s not on the market yet. Vivus got Qsymia approved, and Orexigen is still developing Contrave. What role do drugs really play in treatment?
Dr. Domenica Rubino: A fundamental thing to understand is that the physiology of obesity is actually very complicated. Just as I was saying there are multiple causes of obesity, there are multiple factors that protect weight.
What people don’t really understand is that the body is totally focused on holding onto weight, at all costs. People like to say, “Well, you just eat less, move more.” It’s not as simple as that, because when we do lose weight — and countless people who struggle with this lose weight — there are a lot of mechanisms that kick in.
There are endocrine signals coming from the fat cells, muscle cells, the GI tract, all to the brain to say, “Hold onto that weight.”
What happens to that person is they get hungrier, they don’t really want to move, certain foods look much more appealing, certain parts of the brain are lighting up, thinking, “Oh, I want that.”
What else can happen is that people start to lose their sense of portion. The same subject, before weight loss and after weight loss, will not be able to estimate that portion anymore. Your body is in full-court press to regain weight.
That’s where these medications can be really helpful. They augment our toolbox, as physicians, because primarily what we work with is helping people make lifestyle changes, identifying those factors that I was talking about.
Do they have sleep apnea? …read more
Source: FULL ARTICLE at DailyFinance
By Max Macaluso, Ph.D., The Motley Fool
Filed under: Investing
The obesity crisis in America is a hotly debated topic. According to the Centers for Disease Control and Prevention, more than 35% of adults in the U.S. are considered to be obese, and this disease can lead to chronic health problems such as diabetes. The need for new ways to fight this disease has led VIVUS , Arena Pharmaceuticals , and Orexigen Therapeutics to develop medications for the treatment of obesity. VIVUS‘ drug Qsymia is already on the U.S. market, though sales have not impressed investors so far, Arena is nearing the launch of its medicine Belviq, and Orexigen’s drug is in late-stage clinical trials.
As investors assess the merits of each stock, many may not fully understand the complexities of treating this disease. For instance, what role do drugs actually play in treatment? Are lifestyle changes more important? Is obesity even considered to be a disease?
To help demistify these topics, Motley Fool health care analyst Max Macaluso spoke with Dr. Domenica Rubino, a weight-management expert and representative of The Obesity Society. In the following segment from their discussion, Dr. Rubino discusses how physicians actually diagnose obesity. A transcript follows the video.
Who will win the obesity drug market?
Can VIVUS pick up its lagging sales and fend off the competition, or will Arena Pharmaceuticals reign supreme in the obesity space? If you’re in the dark, grab copies of The Motley Fool‘s premium research reports on VIVUS and Arena Pharmaceuticals to stay up to date. Senior biotech analyst Brian Orelli gives investors the must-know information, including an in-depth look at the obesity market and reasons to buy and sell both stocks. Click now for an exclusive look at Arena and VIVUS — complete with a full year of free updates — today.
var FoolAnalyticsData = FoolAnalyticsData || []; FoolAnalyticsData.push({ eventType: “TickerReportPitch”, contentByline: “Max Macaluso, Ph.D.”, contentId: “cms.26043”, …read more
Source: FULL ARTICLE at DailyFinance
By Keith Speights, The Motley Fool
Filed under: Investing
Do you know someone who needs to lose weight? Helping them do so could end up saving you money over the long run. What’s more, even helping a total stranger lose weight could save you money as well. How can this be true? We first need to take a look at Medicare.
Nearly 1.5% of every dollar you make goes to the federal health care program. If you’re self-employed, you kick in twice as much because you must pay the employer’s portion also. And if you fit in Obamacare’s high income classification, you’ll tack on another 0.9%.
But you’re really paying even more for Medicare. Of the $530 billion received by the federal program in 2011, $223 billion came from the general Treasury fund and only around $196 billion derived from payroll taxes. The government actually spent $550 billion — more than it received. That total amounts to a little over $12,000 spent per enrollee.
As Medicare spending grows, more money will be needed. Guess who’s going to pay up? All of us. However, if the spending could somehow be controlled, taxpayers should be able to hang on to more of their hard-earned dollars. That’s where a new study comes into play.
Dr. Kenneth Thorpe — a former Deputy Assistant Secretary for the U.S. Department of Health and Human Services and current chair of the Department of Health Policy and Management at Emory University’s Rollins School of Public Health — led the research team that conducted a study published recently in Health Economics Review. This study found that more than $12,000 per patient could be saved over a 10-year period by helping Medicare beneficiaries lose weight. That comes to as much as $144 billion.
The problem is in actually achieving that weight loss. Bariatric surgery can cost at least $18,000. That wipes out all of the estimated savings. Intensive behavioral therapy, or IBT, for weight loss is much less expensive, but it isn’t enough for many obese individuals. Is there another option? Thorpe and his colleagues suggest that combining IBT with new weight-loss drugs could hold the key to helping Medicare beneficiaries lose weight and thereby reducing spending.
Currently, two weight-loss drugs have been approved by the Food and Drug Administration. VIVUS markets Qsymia. Arena Pharmaceuticals stands ready to begin selling Belviq once the Drug Enforcement Administration finalizes scheduling of the obesity drug. Another company, Orexigen Therapeutics , hopes to receive approval for Contrave and launch the drug commercially in 2014. The problem for those who think one or more of these drugs could help with lowering Medicare costs is that the program doesn’t reimburse patients for taking any of them. Not a dime.
The FDA agreed that Qsymia and Belviq are safe enough for the public. Clinical studies found both drugs to be effective in helping patients lose weight. Even one of the studies that the government used as a basis for its decision to reimburse for IBT concluded that combining weight-loss drugs with …read more
Source: FULL ARTICLE at DailyFinance
By Brian Orelli, The Motley Fool
Filed under: Investing
If you invested in Arena Pharmaceuticals a year ago, you’re sitting on some pretty solid gains; shares are up about 150% since last March. The Nasdaq over that timeframe is up only about 4%, while the Dow is doing a little better, up 10%, but still nowhere near the returns the biotech has seen.
The gains, of course, are thanks to getting its first product approved. If you bought a year ago and sold just after the approval of its obesity drug Belviq, you could have pocketed nearly a five-bagger.
Zoom out the chart a little more, though — let’s say five years — and the investment doesn’t look so good. Buying a Nasdaq index fund would have produced double a return over holding shares for that long.
Delays are costly
That spike up and down in 2010 was when the company produced positive data showing that its drug helped patients lose weight, and then the FDA advisory committee voted 9-5 recommending against approval. The agency subsequently followed suit, rejecting Belviq and asking for more safety data.
Before that, Arena was your typical biotech with multiple shots on goal. There was APD125 to treat insomnia, APD791 for arterial thrombosis, and a collaboration with Johnson & Johnson to develop a diabetes drug codenamed APD597, which the pharma handed back to Arena in 2010. None of them turned out to be as potentially lucrative as Belviq.
Despite not much gain in the share price over the past five years, Arena’s valuation has grown substantially.
ARNA Market Cap data by YCharts.
The share price hasn’t risen by nearly as much because Arena has had to sell additional shares to raise capital. Drug development isn’t cheap. Over the past five years, share count has more than tripled. The pie is bigger, but each share constitutes a much smaller slice.
But what about the next five years?
No point in dwelling — too much — in the past; it’s the future that counts.
Clearly, most of Arena’s current valuation is locked up in Belviq. The drug should launch shortly, as soon as the Drug Enforcement Agency makes a final decision about the its potential level of abuse. Belviq will be marketed by Arena’s partner Eisai.
Based on how VIVUS‘ competing drug Qsymia has done, I wouldn’t expect a fast launch for Belviq. Arena and Eisai still have a lot of work to do convincing payers that it’s worth covering the drug; otherwise it’s too expensive for many patients to bother with.
The companies also have to alleviate doctors’ worries about the safety. Wyeth’s fen-phen and Abbott Labs‘ Meridia, which were both pulled from the market for safety reasons, have doctors questioning the risk-benefit ratio for new drugs. It’ll take some time for doctors to get comfortable with Qsymia and Belviq and prescribe them for …read more
Source: FULL ARTICLE at DailyFinance
By Keith Speights, The Motley Fool
Filed under: Investing
“Wait” seems to be the operative word for the obesity drug industry these days. Investors in VIVUS are still waiting to see if Qsymia can attain the levels of commercial success that they anticipated. Arena Pharmaceuticals anxiously awaits finalization of scheduling for Belviq by the slow-moving U.S. Drug Enforcement Administration. But the biggest wait of all belongs to Orexigen Therapeutics . Here’s the latest on the waiting game for the third potential weight-loss drug to hit the market — Orexigen’s Contrave.
In a hurry
After the initial New Drug Application, or NDA, for Contrave was not approved by the U.S. Food and Drug Administration, Orexigen hurried to move forward with the cardiovascular study needed to satisfy the FDA. The company launched this additional research, called the Light Study, in June. By early July, Orexigen announced that enrollment was going much faster than initially expected and could wrap up in first quarter of 2013 — taking around half the time originally anticipated.
That outlook actually proved to be pessimistic. Orexigen completed screening for the Light Study by mid-December, enrolling around 9,000 patients to participate in the study and cutting off more than a year from the initial timetable. The next major milestone for the research will be an interim analysis. That analysis can’t occur until 87 or so major adverse cardiovascular events, or MACE, occur with the patients. After the herculean efforts to get the study going so rapidly, Orexigen must now essentially wait for bad things to happen.
In January, the company announced that the resubmission process for the Contrave NDA could be hurried along somewhat. The FDA will allow a summary report from the Light Study interim analysis to be used with the NDA in lieu of a complete report. While the complete clinical study report will be required within 60 days of the resubmission, this decision cuts time out of the process.
How long will the waiting game take? Orexigen says that plans are to submit the NDA again by the end of this year. However, company executives have hedged in recent comments, stating that this time frame could be pushed back to early 2014 if the MACE rate is on the low end of the target 1% to 2% range.
Late to the game?
A key question for investors looking at Orexigen relates to how successful Contrave can be as a late entrant to the obesity drug market. With Qsymia already on the market and Belviq likely to launch in the U.S. any day now, will Contrave be too late to the game? The answer is: “It depends.”
If Arena and VIVUS manage to achieve tremendous success and develop great patient and prescriber loyalty for their drugs, Contrave could face an uphill battle to gain a foothold. VIVUS recently introduced promotions that appear to be designed to attract and hold on to customers in anticipation of near-term competition from Belviq. With the earliest possible commercial launch of Contrave still over a …read more
Source: FULL ARTICLE at DailyFinance
By Max Macaluso, Ph.D., The Motley Fool
Filed under: Investing
With Arena Pharmaceuticals and Eisai still waiting for their obesity drug Belviq to complete DEA scheduling, it was their chief rival VIVUS that made news today. All eyes were on VIVUS‘ decision to take out a loan that could amount to $110 million.
But why is this necessary at all? Does the company need more capital to enhance its marketing strategy for the obesity drug Qsymia, or is this a signal that VIVUS is currently in a difficult financial situation? Health-care analyst Max Macaluso sheds light on this news in the following video.
Is now the time to sell VIVUS?
VIVUS‘ shares were clobbered after Qsymia’s dismal launch. Investors everywhere are wondering whether the tide will turn for this fledgling drugmaker or if now is the perfect time to sell. In a new premium research report, the Fool’s top health-care contributor breaks down this complex story and explains the details VIVUS investors must know — including reasons to buy and sell. To find out more about this premium report click here now.
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Source: FULL ARTICLE at DailyFinance
By Max Macaluso, Ph.D., The Motley Fool
Filed under: Investing
Obesity-drug makers Arena Pharmaceuticals , VIVUS , and Orexigen Therapeutics are three of the mostly hotly debated stocks in the biotech space. The fact that obesity afflicts more than 35% of American adults today defines the massive market opportunity these three companies have, but investors may not completely understand the nuances of this complex disease. For instance, how do clinicians approach the treatment of obesity? Are medications an integral part of treatment, or are lifestyle changes more important? Can obesity be cured?
To shed light on these topics, Motley Fool health-care analyst Max Macaluso spoke with Dr. Domenica Rubino, a weight-management expert and representative of The Obesity Society. In the following video segment from their discussion, Dr. Rubino discusses what can cause obesity in addition to a poor diet. A transcript follows the video.
Who will win the obesity drug market?
Can VIVUS pick up its lagging sales and fend off the competition, or will Arena Pharmaceuticals reign supreme in the obesity space? If you’re in the dark, grab copies of The Motley Fool’s premium research reports on VIVUS and Arena Pharmaceuticals to stay up to date. Senior biotech analyst Brian Orelli gives investors the must-know information, including an in-depth look at the obesity market and reasons to buy and sell both stocks. Click now for an exclusive look at Arena and VIVUS — complete with a full year of free updates — today.
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Source: FULL ARTICLE at DailyFinance
By Max Macaluso, Ph.D., The Motley Fool
Filed under: Investing
Obesity drugmakers Arena Pharmaceuticals , VIVUS , and Orexigen Therapeutics are three of the mostly hotly debated stocks in the biotech space. The fact that obesity afflicts more than 35% of American adults today defines these companies’ massive market opportunity. Investors may not completely understand the nuances of this complex disease, however. For instance, how do clinicians approach the treatment of obesity? Are medications actually an integral part of treatment, or are lifestyle changes more important? Can obesity be cured?
In order to shed light on these topics, Motley Fool health-care analyst Max Macaluso spoke with Dr. Domenica Rubino, a weight management expert and representative of The Obesity Society. In the following segment from their discussion, Dr. Rubino discusses how clinicians define obesity and what other conditions it can lead to.
The relevant video segment can be found between 0:00 and 1:24.
Max Macaluso: Hi, welcome to The Motley Fool. I’m Max Macaluso and today I’m joined by Dr. Domenica Rubino. Welcome.
Dr. Domenica Rubino: Hi, Max. Thank you.
Max: Dr. Rubino is a board-certified physician in obesity medicine, endocrinology, diabetes and metabolism, and internal medicine.
Dr. Rubino: Absolutely.
Max: Today you’re here as a representative of The Obesity Society.
Dr. Rubino: Yes. Thank you.
Max: Dr. Rubino, three of the most popular stocks that our audience follows are Arena, Vivus, and Orexigen. These are three companies that are either developing drugs for the treatment of obesity or already have FDA approved drugs. You’ve also been involved in some of the trials as a clinical investigator.
Today let’s start with a general question. What is obesity?
Dr. Rubino: Obesity is a condition in which we have excess fat — excess fat cells. The concern about obesity is actually the fat that’s deposited around the abdominal organs, which is reflected in an increase in abdominal waist circumference.
That abdominal obesity actually is what causes problems and diseases. It contributes to heart disease, diabetes, high blood pressure, cholesterol, sleep apnea.
Max: Cancer as well.
Dr. Rubino: Cancer as well, osteoarthritis, liver disease, infertility issues… so it is actually a major health risk to have this excess abdominal weight.
Who will win the obesity drug market?
Can VIVUS pick up its lagging sales and fend off the competition, or will Arena Pharmaceuticals reign supreme in the obesity space? If you’re in the dark, grab copies of The Motley Fool‘s premium research reports on VIVUS and Arena Pharmaceuticals to stay up to date. Senior biotech analyst Brian Orelli gives investors the must-know information, including an in-depth look at the obesity market and reasons to buy and sell both stocks. Click now for an exclusive look at Arena and VIVUS — complete with a full year of free updates — today.
By Dan Carroll, The Motley Fool
Filed under: Investing
You can’t find a hotter topic in health care than obesity. From its impact on public health and quality of life to its long-term costs to advanced economies, rising obesity rates across the world are one of the most polarizing trends for the future. It’s no surprise then that Arena Pharmaceuticals and VIVUS — rivals squaring off with their FDA-approved obesity drugs Belviq and Qsymia, respectively — capture the hearts and opinions of investors everywhere.
While the FDA has been happy to welcome Belviq and Qsymia to the market, Europe hasn’t been so kind. The European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, rejected VIVUS’ appeal for approval last month and has also raised questions this year about Belviq’s approval. While Arena’s European fate hasn’t been decided yet, what are these companies missing out on if Europe rejects both obesity drugs? Let’s go inside the obesity crisis across the Atlantic to see just how damaging a rejection could be.
Lower obesity rates, but no less a crisis
It’s easy to point to the U.S. as the capital of the obesity revolution, but Europe’s not at all skinny by comparison. The U.K.’s Academy of Medical Royal Colleges has raised concerns that Britain’s obesity crisis could soon become “unresolvable,” and rates are on the rise across the continent.
According to the World Health Organization, between 2% an 8% of all health care costs can be attributed to obesity in Europe, depending on country and region. That’s considerably less than the U.S., where 17% of all health care costs come back to obesity; then again, European obesity rates are considerably less than in America.
15% of French citizens were obese as of 2012, according to a study sponsored by ObEpi-Roche — while Romania reported obesity rates of just 8% in women and 7.6% in men. The U.K. reported the top obesity rate among European women at 24%, while Malta reported the highest male rate at 22%. Both are still considerably less than the U.S.’s astronomical 35.7% adult obesity rate in 2012, as measured by the CDC.
That’s not to say that obesity drug companies like Arena don’t have an opportunity in Europe. Obesity rates have been rising fast — France’s 2012 statistic included a 35% increase in obesity in 18 to 24 year-olds in just the prior three years. By comparison, only 11.2% of French citizens were obese in 2008; total obesity rates for the nation climbed almost 34% between 2008 and 2012. Europe’s problem is growing fast, but America’s obesity crisis still tops the charts among advanced economies.
However, with health care budgets under attack in Europe due to the continent’s ongoing fiscal crisis, Europe’s ability to pay for obesity drugs is under fire.
Budgets under fire
France’s 2012 obesity study showed that poorer people had a higher likelihood of being obese than their wealthier counterparts. While Arena’s Belviq isn’t a very expensive drug by pharmaceutical standards — the company set …read more
Source: FULL ARTICLE at DailyFinance
By Max Macaluso, Ph.D., The Motley Fool
Filed under: Investing
Arena Pharmaceuticals and VIVUS are the two stocks most typically associated with obesity drugs, but diabetes-drug maker Novo Nordisk is also trying to enter this space. The company is completing phase 3 clinical trials in an attempt to get Victoza approved as a weight-loss drug for obese and overweight patients with type 2 diabetes.
After reporting data from a clinical study today, shares of Novo Nordisk fell almost 5%. In the following video, health-care analyst Max Macaluso discusses what this news means for investors and how this drug fits into the obesity-drug market.
Who will win the obesity-drug market?
Can VIVUS pick up its lagging sales and fend off the competition, or will Arena Pharmaceuticals reign supreme in the obesity space? If you’re in the dark, grab copies of The Motley Fool’s premium research reports on VIVUS and Arena Pharmaceuticals to stay up to date. Senior biotech analyst Brian Orelli gives investors the must-know information, including an in-depth look at the obesity market and reasons to buy and sell both stocks. Click now for an exclusive look at Arena and VIVUS — complete with a full year of free updates — today.
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Source: FULL ARTICLE at DailyFinance
By Max Macaluso, Ph.D., The Motley Fool
Filed under: Investing
Obesity has become one of the most prevalent diseases in the United States. According to the Centers for Disease Control and Prevention, more than 35% of American adults are considered obese today, and rates of this disease among children are also increasing. VIVUS‘ Qsymia, an obesity drug that became available to physicians last September, and Arena Pharmaceuticals‘ Belviq, another FDA-approved drug for the treatment of obesity that should be launched in the coming weeks, are two new medications that can be prescribed in the fight against this disease. Both drugs are indicated for patients who are either obese, or overweight (i.e., BMI more than 27) and also suffer from hypertension, diabetes, or high levels of cholesterol in their bloodstream.
This may not be a surprise, since obesity is commonly associated with heart problems and cholesterol, but did you know that obesity can also lead to specific types of cancer? The World Cancer Research Fund states that overweight or obese patients can be at increased risk of developing colorectal, pancreatic, kidney, and breast cancers. Whether obesity-fighting drugs will be able to play a direct role in mitigating this risk going forward is debatable, but preventing and treating this disease in the future is one component in the fight against cancer.
Dr. Margaret I. Cuomo, author of the book A World Without Cancer, discusses this topic with Motley Fool analyst Max Macaluso in the following video. A transcript is provided below the video.
Opportunities and risks in the obesity drug market
Biotech companies focusing on treatments for obesity may have massive opportunities, but they also face a number of risks. Can VIVUS pick up its lagging sales and fend off the competition, or will Arena Pharmaceuticals reign supreme in this space? If you’re in the dark, grab copies of The Motley Fool‘s premium research reports on VIVUS and Arena Pharmaceuticals to stay up to date. Senior biotech analyst Brian Orelli gives investors the must-know information, including an in-depth look at the obesity market and reasons to buy and sell both stocks. Click now for an exclusive look at Arena and VIVUS — complete with a full year of free updates — today.
var FoolAnalyticsData = FoolAnalyticsData || []; FoolAnalyticsData.push({ eventType: “TickerReportPitch”, contentByline: “Max …read more
Source: FULL ARTICLE at DailyFinance
By Brian Orelli, The Motley Fool
Filed under: Investing
The message from Orexigen Therapeutics during its fourth-quarter conference call yesterday was clear: Everything is proceeding as planned.
The corollary to that message is that it’s going to be awhile before the biotech is able to launch its obesity drug, Contrave.
The Food and Drug Administration made the company run a clinical trial to confirm that there weren’t any heart-related complications with Contrave. The trial is now fully enrolled and is on track for an interim look in the second half of the year. At least, as best the biotech can tell.
The interim look will happen after the occurrence of a certain number of cardiovascular events, such as heart attacks or strokes. As the trial progresses, the committee should have a better idea of whether the trial will fall in the estimated 1% to 2% event rate. If it’s low — closer to 1% — the interim peek will be later, potentially pushing resubmission into early 2014. Orexigen won’t know the event rate, but the data monitoring committee will let the company know if it’s on track to finish later this year.
Orexigen and marketing partner Takeda could be a year or more behind the launch of obesity drugs from VIVUS and Arena Pharmaceuticals . But I’m not sure that’s the worst thing in the world.
VIVUS is off to a slow start. Despite the large number of obese Americans, doctors aren’t prescribing Qsymia in mass. Patients aren’t clamoring for the drug in part because of high out-of-pocket expenses. It’s going to take education of doctors and insurers to get sales up. That education will be more about the obesity space in general than specific drugs, so Orexigen will benefit from VIVUS‘ and Arena’s efforts.
Takeda is the best marketing partner. VIVUS doesn’t even have one. Arena has Eisai, but I think Takeda is likely to be more effective since it sells diabetes drugs Actos and Nesina. The former is off patent, but Nesina was just approved, giving Takeda sales reps two drugs to hock to the doctor once Contrave gets approved.
Of course, first the cardiovascular study has to come back clean. Tick tock. Tick tock.
Who will win the obesity drug market?
Can VIVUS pick up its lagging sales and fend off the competition, or will Arena Pharmaceuticals reign supreme in the obesity space? If you’re in the dark, grab copies of The Motley Fool’s premium research reports on VIVUS and Arena Pharmaceuticals to stay up to date. Senior biotech analyst Brian Orelli gives investors the must-know information, including an in-depth look at the obesity market and reasons to buy and sell both stocks. Click now for an exclusive look at Arena and VIVUS — complete with a full year of free updates — today.
The article Tick Tock Goes the Obesity Clock originally appeared on Fool.com.
Fool contributor Brian Orelli has no position in any stocks mentioned. The …read more
Source: FULL ARTICLE at DailyFinance
By Keith Speights, The Motley Fool
Filed under: Investing
The early bird gets the worm. Business gurus might not use that old phrase, but many of them tout the principle behind it. They tell anyone who will listen that getting to market first provides significant advantages. Customers will gain familiarity with the first product on the market and be much less likely to switch to another product later. That’s what the gurus say, but is it true?
One biotech that certainly hopes they’re right is VIVUS . The company’s weight loss drug Qsymia gained FDA approval last July. VIVUS quickly moved to launch the drug, with Qsymia reaching the market in September.
However, Arena Pharmaceuticals is nipping at its heels. Arena’s Belviq actually gained FDA approval a few weeks earlier than Qsymia. The company hasn’t been able to launch the drug commercially, though, as it awaits scheduling by the Drug Enforcement Agency.
Will VIVUS be able to benefit from a first-mover advantage? Or is this concept really not applicable to biotech?
Birds of a different feather
If history is a guide from a different area of biotech, VIVUS might be in for a challenge. Way back in 1998, Amgen‘s Enbrel became the first TNF inhibitor to receive FDA approval for treating rheumatoid arthritis. Regulatory approval for other indications followed over the next few years.
By any measure, Enbrel was a huge success. But another TNF inhibitor followed closely in its footsteps. Johnson & Johnson’s Remicade gained FDA approval for treating rheumatoid arthritis in 1999. The two drugs battled it out by themselves until 2002, when the FDA approved AbbVie’s Humira.
So, how well did Amgen’s first-mover advantage hold up? If we fast forward the clock to 2012, the sales for the three drugs tell the story. Amgen made $4.2 billion from Enbrel. Add to that figure another $3.7 billion from Pfizer‘s sales of Enbrel outside the U.S. That gives Enbrel a total of $7.9 billion in 2012 sales.
Second-to-market Remicade trailed Enbrel with $6.1 billion in sales. AbbVie’s 2012 sales for Humira totaled $9.3 billion, making it the world’s top-selling drug. While Enbrel and Remicade also rank in the top five drugs in terms of worldwide sales, the laggard in getting to market became the leader.
One slippery worm
Of course, second or even third place isn’t all that bad, even for a first-mover, when sales are great for everyone. So far, though, VIVUS is finding that the market for weight loss drugs isn’t as easy to crack as it had hoped.
U.S. sales for Qsymia have been disappointing — only around $2 million in 2012. VIVUS also has faced challenges in gaining approval for reimbursement for the drug, although the company has made progress on that front.
Europe has proved to be even more difficult. The Committee for Medicinal Products for Human Use, or CHMP, rejected Qsymia (known in Europe as Qsiva) in October. VIVUS appealed the decision, but CHMP stood by its earlier negative decision. Another clinical trial focusing on cardiovascular …read more
Source: FULL ARTICLE at DailyFinance
By Max Macaluso, Ph.D., The Motley Fool
Filed under: Investing
Drugmaker VIVUS has struggled to ramp up sales of its recently approved obesity medication Qsymia. With competition from Arena Pharmaceuticals and its partner Eisai looming once their drug Belviq clears DEA scheduling, VIVUS has launched the Save Now! program. In this video, health care analyst Max Macaluso discusses how this new program will impact VIVUS‘ business and how it might affect the competitive landscape of the obesity market.
Who will win the obesity drug market?
Can VIVUS pick up its lagging sales and fend off the competition, or will Arena Pharmaceuticals reign supreme in the obesity space? If you’re in the dark, grab copies of The Motley Fool’s premium research reports on VIVUS and Arena Pharmaceuticals to stay up to date. Senior biotech analyst Brian Orelli gives investors the must-know information, including an in-depth look at the obesity market and reasons to buy and sell both stocks. Click now for an exclusive look at Arena and VIVUS — complete with a full year of free updates — today.
Editor’s note: This video was filmed on March 5, 2013.
The article Will This Obesity Biotech’s Latest Scheme Boost Sales? originally appeared on Fool.com.
Max Macaluso, Ph.D. has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
Copyright © 1995 – 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.
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