VIVUS, Inc. (NASDAQ:VVUS), Arena Pharmaceuticals, Inc.(NASDAQ:ARNA) Rebound After Earlier Losses

Drug-maker VIVUS, Inc.(NASDAQ:VVUS), on Thursday reported higher than expected losses leading to one-fifth depreciation in its stock price.

The company, which makes the anti-obesity drug Qsymia, said that net loss for the quarter widened to $40.4 million, or 40 cents a share, from $8.6 million, or 10 cents, a year earlier.

Analysts had expected a loss of 32 cents.

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Revenue was $41,000, the amount received from pharmacies that had delivered the drug to patients, Vivus said.

Qsymia was approved y the US Food and Drug Administration in July this year, one of the two obesity drugs to be approved in the country in more than a decade.

However, according to Vivus, patients are abandoning prescriptions at the pharmacy on discovering they must pay a large portion of the cost out-of-pocket.

Vivus has taken the unusual strategy of getting the drug prescribed by speciality doctors rather than primary-care general physicians.

Shares of VVUS were down about 7% in yesterday’s session and now up 3.50%.

Meanwhile Arena Pharmaceuticals, Inc.(NASDAQ:ARNA), which has launched rival anti-obesity drug Belviq, reported lower-than-estimated losses for the third quarter benefiting from lower research and development costs.

Arena reported losses of $15.5 million, or 7 cents per share, for the three months ended Sept. 30. In the third quarter of 2011 Arena lost $22.7 million, or 16 cents per share.

Its revenue declined to $1.5 million from $3.5 million, but most costs declined and the company booked a gain on revaluing derivatives and recorded interest income.

Analysts were forecasting a larger loss of 9 cents per share and $2.4 million in revenue.

Shares of the company are up 6% in today’s session, paring all its losses earlier this week.

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Vivus Inc, Express Scripts Holding Slump On Earnings Miss – VVUS, ESRX

Shares of VIVUS, Inc.(NASDAQ:VVUS) fell by $3.16 or 21.14% to $11.79 in the morning session as the company posted a wider than estimated loss in the Q3.

Vivus posted a net loss of $40.40 million or $0.40 cents per share in comparison to $8.63 million 0r $0.10 cents per share for the last year.

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The biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, primarily attributed increased selling, general and administrative expenses related to pre-commercialization and commercialization activities for Qsymia to be the reasons for increase in net loss.

The start-up costs associated with the post-approval studies for Qsymia and STENDRA led to increase in research and development expenses.

Prescriptions shipped from certified pharmacies to patients helped the company to recognize net product revenue of $41 thousand for the third quarter.

Stocks of Express Scripts Holding Company(NASDAQ:ESRX) fell by $8.70 or 13.84% to $54.18 in the morning session as the company deemed the analyst forecast for year 2013 as "overly aggressive," which casted doubts as to how well the company is integrating its $29 billion purchase of Medco Health Solutions Inc.

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Excluding special items the third quarter earnings were $1.02, arise by 29% in comparison to last year, which beats analyst expectation of 99 cents per share according to Thomson Reuters I/B/E/S.

Further net income rose by 21% to $391.4 million as compared to last year. Revenue increased by 133% to $27 billion. Claims rose 116 percent to 398.6 million.

Raising the lower end of its forecast range for 2012 earnings by 5 cents Express Scripts projects full-year profit this year of $3.65 to $3.75 a share.

Analyst projects $4.49 a share in 2013, according to Thomson Reuters I/B/E/S. But the company said the analyst forecast to be too aggressive.

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VIVUS Inc. (NASDAQ:VVUS): Analyst Predicts Low Sales of Qsymia, Share Slumps

Shares of drug maker VIVUS, Inc.(NASDAQ:VVUS) declined 5.56% to $21.06 on Thursday, after Credit Suisse analyst Lee Kalowski, stated that Wall Street might be exceeding their estimates regarding the initial sales of the company’s obesity treatment Qsymia. His estimates are around $12 million in Q4 revenue, which is almost half of the predictions made by others.

Kalowski, who gave an “Outperform” rating on the company stock, elaborated that sales of Qsymia might be less due it being released with a comparatively small number of sales representatives, not being marketed to consumers directly, and being accessible via mail order only. Wholesalers and pharmacies are not in the picture as of now. Qsymia was launched in the USlast month and it is the first long-term prescription weight loss drug available in the market after 1999. This is also the only approved drug of Vivus.

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There is scope for the market to expand. A body of advisers to the European Union’s health agency is in the process of analyzing the drug, even though Vivus is not too sure if the EU advisory board will approve. A request has been made to US regulators so that the drug can be made available in medical shops.

However, Qsymia will need to take on rivals in the weight-loss drug market because the FDA has given a green light to Arena Pharmaceuticals’ Belviq, even though Qsymia is perceived as being the most effective among the two. Belviq will be available for sale in early 2013. 

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VIVUS, Inc. (NASDAQ:VVUS) wants to make the anti-obesity medicine more widely procurable for customers

VIVUS, Inc.(NASDAQ:VVUS) has called for a reconsideration of, and an amendment of the Risk Evaluation and Mitigation Strategy requirement. The FDA had asked the company to get REMS for their new anti-obesity drug, which the pharmaceutical now wants to be looked into, again. Qsymia, which is the drug, is not widely available at present due to the Risk Evaluation and Mitigation Strategy. But if the FDA does look into it, and agree to the reconsideration, then the drug can be made more widely available to many more consumers.

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The FDA had approved the drug, but they had put the REMS clause in place. This was done in July, this year. Under the strategy, the prescription for the anti-obesity drug would have to be mail order pharmacies which were qualified enough. Training from healthcare provider, Medication guide, educational tools ad well as patient brochure were the other specifications which the FDA placed. Vivus had made a deal with the pharmacy chain of Express Scripts with regards to the prescriptions clause. REMS requirements may not be very stringent, but they do restrict the widespread availability of the drug. Vivus, keeping in mind the greater distribution of the medicine, has called for the reevaluation. After it got approved by the FDA with the clause in July, the medicine was launched to the public in September, around the middle of the month.

The company may have been selling Qsymia only for about a month now, but they have already managed to get themselves a distribution deal, and they want their medicine to be more widely available, to increase sales and popularity, hence the bold demand from the FDA. Vivus, however, has not been there on the news for all the good reasons. The company’s negligence to get approval from Europe has been talked about, a fair amount. The market is also waiting to get proof of the results of Qsymia. If the drug manages to sell well enough, then Vivus equity might grow quite a lot. About ten percent of growth is the average anticipated rate. 

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VIVUS Inc. (NASDAQ:VVUS) Shares Rallied Sharply On Positive News

VIVUS Inc. (NASDAQ:VVUS), which is expecting the European Medicines Agency to reject approval for its anti-obesity drug Qsymia, saw its shares spike on Monday.

The spike came after the company put out a release saying that the largest domestic pharmacy benefit manager, Express Scripts, has joined VVUS in its mail-only delivery network for Qsymia.

This is a big boost for Vivus, which has already obtained U.S. FDA approval for its anti-obesity drug and is looking for a huge sales push.

Its closest competitor Arena Pharmaceuticals has also obtained approval for its competing anti-obesity drug Belviq.  These are the two drugs in this category that have been approved by the U.S. FDA in more than a decade.

Seeking Alpha observed, "While we aren't expecting sales figures that could immediately justify the ~$2 billion valuation of Vivus as a company, this is a somewhat bullish hint for the prescription obesity drug market as a whole. VVUS is moving up especially fast today, because its shareholders also want to see signs of Qsymia getting a head start on the upcoming competition from Arena Pharmaceuticals, Inc.(NASDAQ:ARNA)’s Belviq (lorcaserin)."

On September 21, shares in Vivus tanked 12 percent and has since moved to $18 a share.

On Monday it rallied more than 10%.

Part of it also stems from the fact that Belviq cannot be put into the market until it gets clearance from the DE, which leaves the field clear for Qsymia.

Shares of ARNA also rose 1.50% to $8.76.

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VIVUS, Inc. (NASDAQ:VVUS) shares Extend Friday’s Fall, Down 15% In 2 Session - Arena Pharmaceuticals (ARNA)

Shares of VIVUS, Inc.(NASDAQ:VVUS) dropped another 9% at $19.07 after falling 5% in Friday’s session, after it announced that its obesity drug, the first diet pill released in US in more than 10 years, might not be approved by a European regulatory committee. There have been safety issues with obesity drugs before like the infamous "fen-phen" diet-drug combo, which is why regulatory committees have become more stringent.

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Cowen and Co analyst Simos Simeonidis states that an approval in the future by the European Union is unlikely due to the numerous issues that have been raised by them, such as the lack of comfort with phentermine in Europe. Vivus's Qsiva has phentermine, which suppresses the appetite, along with the anti-seizure drug topiramate. An obesity pill was released in Europecalled Acomplia, but was taken off the market due to enhanced suicide risks.

The final decision about Qsiva from the European Medicines Agency's Committee for Medicinal Products for Human Use will be pending till October. If the results are negative, Vivus will re-evaluate their marketing application later and submit it again or opt for a review via an appeal. Simeonidis said that Vivus will be able to eliminate a part of the acquisition premium assigned by some investors.

The U.S. Food and Drug Administration in July had given the green signal to Vivus’s drug with the name Qsymia. Arena Pharmaceuticals’s Belviq was also approved by them and it is the first diet pill to be given the go-ahead in 13 years. Belviq is likely to be released next year, whereas Vivus has unveiled their product in September. 

Shares of Arena Pharmaceuticals, Inc.(NASDAQ:ARNA) are down 4.50%.

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