Orexigen (Nasdaq: OREX) rallies after FDA approves competing obesity drug

Northern, WI 6/28/12 (StreetBeat) -- Anti-obesity drug maker Orexigen (Nasdaq:OREX) is climbing after another company, Arena Pharmaceuticals (Nasdaq:ARNA), received FDA approval for its anti-obesity drug, Lorcaserin, yesterday afternoon. In a note to investors earlier this morning, research firm JMP Securities wrote that the FDA's approval of Lorcaserin suggests that the agency sees the need for an effective anti-obesity drug. The FDA's position on this matter could benefit Orexigen, said the firm, which thinks that the company offers the best value in the anti-obesity space.

The firm reiterated an $8 price target and Outperform rating on Orexigen. Meanwhile, JP Morgan reacted to the FDA's approval of Arena's Lorcaserin by upgrading shares of Orexigen this morning to Overweight from Neutral with a $10 target. In early trading Orexigen jumped 67c, or 13.62%, to $5.59.

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Diet Pill Maker Arena Pharmaceuticals (Nasdaq: ARNA) Wins Backing of FDA Advisers

Orlando, FL 5/11/12 (StreetBeat) -- In a stunning turn of events in less than two years, diet pill maker Arena Pharmaceuticals (Nasdaq: ARNA) won the backing of a panel of government advisers to sell what may be the first new weight-loss treatment in the US in more than a decade. The company’s shares rose 80% in early trading Friday after advisers voted 18-4 in favor of approving Arena’s drug, lorcaserin.

Arena is the second company to win such an endorsement for a diet drug this year after Vivus (Nasdaq: VVUS) was recommended by Food and Drug Administration advisers in February. The FDA delayed a decision on Vivus’ Qnexa, moving a potential approval date later than one set for Arena. If the FDA doesn’t adjust its dates, it will decide on Arena’s drug, lorcaserin, by June 27, and on Vivus’ Qnexa by July 17.

After a pair of overwhelmingly positive panel recommendations from advisers, it’s beginning to look like there may be two near-term approvals for diet drugs. That seemed unthinkable a little more than a year ago after Orexigen Therapeutics (Nasdaq: OREX) followed Arena and Vivus in being rejected by the US agency because of safety concerns.

Shares of Arena rose to $6.59 in morning trading. Vivus was up 4% to $23.57 and Orexigen, which is the farthest away from any potential approval, jumped 7% to $3.57.

Safety has been the killer for these new diet pills. The FDA is very cautious about approving another product that could pose health risks to people taking them. Abbott Laboratories (NYSE: ABT) withdrew its drug Meridia from the market in 2010 after fears of heart attack and stroke. The drug cocktail fen phen was withdrawn from the market in 1997 after evidence of heart valve damage. Those drugs were sold by American Home Products, which was later renamed Wyeth and is now part of Pfizer (NYSE: PFE).

In April, Vivus said the FDA was extending its deadline for an approval ruling on Qnexa because the agency needed more time to review a company plan on mitigating risks for patients. Arena, which is partnered with Japanese drug maker Eisai to sell lorcaserin, has responded to FDA worries about safety, including heart valve problems. However, Arena hasn’t yet discussed a risk plan -- a so-called a risk evaluation and mitigation strategy -- or a post-approval safety study with the FDA, company executives said on a conference call Friday. Eisai would pay 90% of any post-approval safety analysis. No decision has been made yet on a price for the pill.

Arena, Vivus and Orexigen argue that obesity is an epidemic in the US, leading to health problems such as heart disease, diabetes and other conditions.

Please contact www.thestreetbeat.com for interest in our latest investor relations platform the “CEO Interview Series” with its host Steve Kanaval. The package includes a one-on-one interview with a seasoned industry professional; published segment to our web site with embedded audio/video file; and a compressed file that can be easily e-mailed out to your current and/or potential investors. Please e-mail bflautt@gmail.com or call (662) 392-0740 for pricing and scheduling.

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Vivus (Nasdaq: VVUS), Arena (Nasdaq: ARNA) Unlikely to Be Affected by FDA Obesity Panel

Chicago, IL 3/30/12 (StreetBeat) – Arena Pharmaceuticals Inc. (Nasdaq: ARNA) and Vivus Inc. (Nasdaq: VVUS), competing to win U.S. regulatory approval for weight-loss treatments, probably won’t be affected by an advisory panel’s recommendation for heart-risk studies, a Food and Drug Administration spokeswoman said.

The panel voted 17-6 yesterday in Silver Spring, Maryland, to recommend that companies developing weight-loss therapies should conduct clinical trials to assess heart danger or review pre-approval human trial data on heart attacks and strokes. The panel’s goal was to help the agency update guidelines for bringing obesity treatments to market, Erica Jefferson, a spokeswoman for the FDA, said in an e-mail today.

“It’s unlikely that the discussions over the past couple days will impact any existing applications,” Jefferson said.

Vivus, Arena and a third California-based company, Orexigen Therapeutics Inc. (Nasdaq: OREX), are racing to bring the first weight-loss pill to market in 13 years. The fen-phen appetite-suppression drug combination was pulled from pharmacies 15 years ago when it was linked to heart-valve abnormalities.

Vivus rose 7.5 percent to $22.88 at 9:43 a.m. New York time. Arena increased 1.6 percent to $3.09 and Orexigen fell 3.5 percent to $4.38.

The FDA is set to make a decision on Mountain View, California-based Vivus’s drug Qnexa by April 17. San Diego-based Arena’s treatment lorcaserin faces an advisory panel May 10, with the agency expected to make a decision by June 27.

Orexigen agreed in September with the FDA to conduct a two- year study of heart risks for the drug Contrave. The La Jolla, California-based company is a partner with Takeda Pharmaceutical Co. (4502), based in Osaka, Japan.

Two-Tiered Studies

Panel members agreed studies should be two tiered: pre- and post-approval. Companies should rule out a certain degree of risk during pre-approval and further prove the drugs don’t cause excessive heart harm after the medicines are on the market, advisers said during discussion. The FDA isn’t required to follow the panel’s guidance.

The panel voted Feb. 22 that Qnexa’s benefits outweigh its risks. Sanjay Kaul, a professor in the David Geffen School of Medicine at UCLA Cedar Sinai Medical Center and a panel member, said the treatment works the best to help patients lose weight, giving it a good chance of the FDA requiring post-approval studies on heart risk instead of additional ones before.

The last obesity drug the FDA approved was Roche Holding AG (Pinksheets: RHHBY)’s Xenical in 1999.Abbott Laboratories (NYSE: ABT) withdrew its obesity treatment Meridia in 2010 after a post-market trial revealed a 16 percent increase in risk of heart attack or stroke in those taking the product over those using a placebo and little difference in weight loss.

Arena is studying its compound lorcaserin to assess cancer risks. The company is in a partnership with Tokyo’s Eisai Co. (4523)

The FDA previously has rejected all three drugs, asking for more data on safety risks, including the likelihood of birth defects associated with Qnexa.

More than 78 million U.S. adults are obese, according to the Centers for Disease Control and Prevention in Atlanta. Obesity raises the risks of diabetes, heart attacks and stroke, and costs the U.S. economy an estimated $147 billion a year in medical expenses and lost productivity, according to the CDC.

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Orexigen® (Nasdaq: OREX) Announces FDA Agreement on a Special Protocol Assessment for the Contrave® Outcomes Trial

Palm Beach, FL 2/6/12 (StreetBeat) -- Orexigen®Therapeutics, Inc. (Nasdaq: OREX) today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the Contrave® outcomes trial. On January 31, 2011, the Company received a Complete Response Letter to its New Drug Application (NDA) noting a single approval deficiency related to cardiovascular safety, requiring Orexigen to conduct a randomized, double-blind, placebo-controlled cardiovascular outcomes trial prior to approval. The objective of the trial is to demonstrate that Contrave does not unacceptably increase the risk of major adverse cardiovascular events (MACE). The Company plans to initiate the Contrave outcomes trial late in the second quarter of 2012.

"We are pleased to receive agreement on the SPA from the FDA after just one cycle of review," said Michael Narachi, President and CEO of Orexigen. "A few months ago, we received detailed written correspondence from the FDA's Director of the Office of New Drugs that identified a clear and feasible path forward for this important potential obesity therapy. We believe the rapid progress we have since made with the FDA's Division of Metabolic and Endocrinologic Products on the detailed protocol and plans for analysis is further indication of the alignment we have reached within the FDA on the requirements for resubmission of the Contrave NDA."

As previously outlined, approximately 10,000 patients will be enrolled in this streamlined trial which is focused on capturing infrequent MACE events. An interim analysis and NDA resubmission is planned once approximately 87 MACE events have occurred, which is anticipated to be less than two years from the start of the trial. If marketing approval is received for Contrave, the trial will continue toward the final analysis in the post-approval setting.

The Company plans to provide more details on the trial design and protocol on its fourth-quarter and year-end 2011 conference call in early March.

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Stocks to Watch Today

Home Depot, the No. 1 home-improvement retailer, said Wednesday it expects fiscal-year sales to rise 2.3% with earnings from continuing operations up 27% to $1.97 a share.Shares of the company were a tad lower at $33.46, down 0.3% in premarket trading.

Costco said fiscal first-quarter earnings rose 17% as sales at its warehouse stores jumped 11%. Shares of Costco were 0.2% lower to $69.49 in premarket trading Wednesday.

Texas Instruments tightened its fiscal fourth-quarter outlook after Tuesday's closing bell saying it now sees earnings of 61 cent sto 65 cents a share on revenue ranging from $3.43 billion to $3.57 billion. Texas Instruments shares fell 0.8% to $33.15 in premarket trading.

Fortune Brands on Wednesday confirmed reports it will break itself into three separate companies. The company, whose products include Maker's Mark bourbon whisky and Titleist golf products, said it will spin off its home and security division to shareholders, try to sell or spin off its golf products business, and continue as a public liquor company. Shares were rising in the premarket by $3.35, or 5.48%, to $64.50.

The U.S. Treasury has reached terms on the sale of the remainder of its stake in Citigroup, pricing the final 2.4 billion common shares at $4.35 each. Citigroup shares were down 0.2% to $4.61.

Men's Wearhouse, the Houston-based men's apparel retailer, forecast a much wider than expected loss for the current quarter, citing increased costs from bonus payments and medical expenses. There were no premarket quotes for Men's Wearhouse. The stock settled 0.4% higher at $28.74 Tuesday, but tumbled 8.7% to $26.24 in after-hours trading.

Netflix said Chief Financial Officer Brian McCarthy is leaving. McCarthy's departure is effective Friday, making for a rather abrupt transition for replacement David Wells, who most recently served as vice president of financial planning and analysis. Shares of the company were down 3.7% to $182.80 in premarket trading.

Orexigen Therapeutics' Contrave, the weight loss drug, has been recommended for approval by a Food and Drug Administration panel. Shares of Orexigen surged 139.7% to $11.41. Other companies also working on diet drugs include Vivus and Arena Pharmaceuticals. The stocks rose 15.4% to $9 and 11.4% to $1.57, respectively.

H&R Block posted weaker-than-expected quarterly financial results after the closing bell Tuesday. There were no premarket quotes for the stock. It settled 4.1% higher at $13.55 on Tuesday.

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