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Orexigen Therapeutics, Inc. (OREX)

  • Fri, May 29, 5:41 PM
    • Orexigen Therapeutics (NASDAQ:OREX) enters into a supply agreement with Mallinckrodt (NYSE:MNK) for naltrexone, one of the active ingredients in its obesity pill Contrave. Orexigen will buy naltrexone at fixed prices, subject to certain limitations. The agreement will be effective through December 2018.
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  • Wed, May 27, 11:07 AM
    • Results from the SCALE Obesity and Prediabetes three-year extension study show that ongoing treatment with Novo Nordisk's (NVO +0.2%) Saxenda (liraglutide 3 mg), in combination with a reduced-calorie diet and increased physical activity, delayed the onset of type 2 diabetes in adults that were either obese or overweight with comorbidities and had prediabetes at baseline.
    • Over the course of the 160-week blinded Phase 3a trial, the time to onset of type 2 diabetes was 2.6x longer in the Saxenda cohort compared to placebo. The risk of developing type 2 diabetes was reduced by ~80%.
    • At week 160, patients receiving Saxenda experienced an average weight loss of 6.1% from baseline compared to 1.8% for placebo. Almost 50% of the Saxenda group (49.6%) achieved a clinically meaningful weight loss of at least 5% from baseline versus 23.4% for placebo. The proportion of patients in each group who lost at least 10% of their body weight compared to baseline was 24.3% and 9.4%, respectively.
    • The FDA approved Saxenda for the treatment of obesity in December 2014. The EMA approved it in March. It won't come cheap, though. In the U.S., it will cost over $1,000 per month.
    • Previously: Novo's obesity drug will cost U.S. patients over $1,000 per month (April 22)
    • Related tickers: (VVUS -1.2%)(ARNA -1.7%)(OREX -1.1%)
  • Wed, May 13, 9:15 AM
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  • Wed, May 13, 7:25 AM
    • Takeda Pharmaceutical (OTCPK:TKPHF) (OTCPK:TKPYY) sends Orexigen Therapeutics (NASDAQ:OREX) a dispute letter seeking termination of their collaboration agreement in response to cessation of The Light Study citing a material breach of the contract.
    • Apparently, Takeda wants Orexigen to pay the entire cost of the new CV outcomes trial which is slated to start later this year and run until 2022. According to RBC Capital Markets analyst Simos Simeonidis, the study will cost ~$200M. Under the terms of the agreement, the companies will split the costs. Also, Takeda has promised as much as $900M in milestone payments to Orexigen and has already committed $45M. The firms will now enter a dispute resolution process that may include arbitration.
    • Previously: Then, again, maybe Contrave doesn't prevent heart attacks (May 12)
    • Previously: Orexigen's Contrave data release may have not have been a good idea (March 3)
    • OREX is down 11% premarket on light volume.
  • Tue, May 12, 1:52 PM
    • Small cap Orexigen Therapeutics (OREX -7%) slumps on modestly higher volume on the news that the 9,000-patient clinical trial, The Light Study, evaluating its obesity drug Contrave's (buproprion/naltrexone) effects on cardiovascular (CV) outcomes has been terminated based on the recommendation of the Executive Steering Committee chaired by the Cleveland Clinic's Dr. Steven Nissen. The post-approval study was required to determine if a suspected 40% increase in CV risk in patients receiving Contrave could be ruled out.
    • The precise reason for stopping the trial is unknown, but there was a significant dust-up in March when Orexigen disclosed interim results based on only 25% of the expected data from the trial that showed Contrave may prevent heart attacks. The Cleveland Clinic, Takeda Pharmaceutical (Orexigen's marketing partner) and the FDA all cried foul saying that Orexigen not only violated the terms of the data access agreement but jeopardized the remainder of the trial.
    • To make matters worse, data at the 50% point, released by the Executive Committee, show that Contrave's CV benefit observed at the 25% juncture declined to the point where it was not longer statistically significant. Since Contrave elevates blood pressure, there was a real possibility that taking drug actually increased CV risk had the study gone to completion (allowing time for high blood pressure-related adverse events).
    • Orexigen says that a new CV outcomes trial will begin later this year. Interested parties will need to be patient. The target completion date is 2022.
    • Previously: Orexigen's Contrave data release may have not have been a good idea (March 3)
  • Fri, May 8, 7:06 AM
    • Orexigen Therapeutics (NASDAQ:OREX): Q1 EPS of -$0.14 in-line.
    • Revenue of $4.36M (+407.0% Y/Y) misses by $2.92M.
    • Press Release
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  • Wed, Apr. 22, 10:52 AM
    • Novo Nordisk (NVO -0.4%) launches its obesity drug Saxenda (liraglutide) today in the U.S. According to Reuters, it will cost $1,068 per month. Out-of-pocket costs for patients will depend, of course, on their insurance coverage.
    • The FDA approved Saxenda in late December.
    • Previously: FDA clears Novo weight management drug (Dec. 23, 2014)
    • Related tickers: (OREX -2.5%)(VVUS +0.2%)(ARNA +1.1%)
  • Fri, Mar. 27, 9:13 AM
  • Thu, Mar. 26, 4:54 PM
    • As expected, the European Commission approves Orexigen Therapeutics' (NASDAQ:OREX) Mysimba (naltrexone HCl/bupropion HCl prolonged release) as an adjunct to a reduced-calorie diet and increased physical activity in adult patients classified as obese (initial Body Mass Index (BMI) of 30 kg/m2) and overweight (BMI 27 kg/m2 - <30 kg/m2).
    • An estimated 20% of European adults is obese.
    • OREX is unchanged in after hours trading.
    • Previously: Europe advisory committee gives thumbs up to Orexigen obesity med (Dec. 19, 2014)
  • Fri, Mar. 6, 12:45 PM
  • Fri, Mar. 6, 9:15 AM
  • Wed, Mar. 4, 9:13 AM
  • Tue, Mar. 3, 4:55 PM
    • In a regulatory filing, Arena Pharmaceuticals (NASDAQ:ARNA) discloses that it expects commercial partner Eisai to refile the Marketing Authorization Application (MAA) in Europe for its obesity drug Belviq (lorcaserin HCl) by the end of the latter's fiscal year ending March 31, 2016.
    • Arena originally submitted the Belviq MAA in March 2012. In January 2013 it received a Day 180 List of Outstanding Issues from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The major objections preventing approval pertained to non-clinical and clinical issues including tumors in rats, valvuopathy and psychiatric events. CHMP requested that the benefit-risk balance of Belviq be further justified taking these issues into consideration. After a written response to the Day 180 List and an oral presentation to CHMP failed to assuage its concerns, the company withdrew the MAA in May 2013.
    • Related tickers: (NASDAQ:VVUS) (NASDAQ:OREX)
  • Tue, Mar. 3, 3:42 PM
    • Shareholders of Orexigen Therapeutics (OREX +30.4%) may be popping the corks about now considering their stock is the top gainer in the U.S. today on massive turnover of 81M. The party got started when the company filed an 8-K this morning detailing the results from an interim analysis of a long-term heart safety study of its obesity drug, Contrave (naltrexone HCl/bupropion HCl). Patients treated with Contrave showed a statistically significant reduction in major adverse cardiac events (MACE) compared to placebo.
    • The company has included claims in certain Contrave patents (No. 8,969,371) and provisional patent applications (61/913216, 61/914938 and 61/984580) about Contrave's positive effects on cardiovascular (CV) outcomes based on the data in this interim analysis.
    • What's not to like? Well, maybe a lot. Forbes reporter Matthew Herper says, per an agreement with the FDA, the interim results should not have been released publicly because it jeopardizes the conclusion of the study. Patients aware of Contrave's purported CV benefits may opt out of the trial in order to get access to drug instead of facing the 50% probability that they are receiving a placebo.
    • If the trial cannot be conducted to completion, then the expected FDA clearance of the CV benefit claim will be delayed indefinitely until such time as complete data can be submitted. How long would this be? Orexigen says that a second large, randomized, placebo-controlled study assessing Contrave's effect on CV outcomes should start later this year. The expected completion date? 2022.
    • Previously: Orexigen torpedoes shorts on news of Contrave's heart safety benefit (March 3)
  • Tue, Mar. 3, 1:03 PM
    • Orexigen Therapeutics (OREX +53%) short sellers are licking their wounds today. Shares are up on a whopping 22x surge in volume in response to the news that patients taking its obesity med Contrave (naltrexone HCl/bupropion HCl) may reduce their risk of having a heart attack by almost 50%.
    • The data behind the news comes from an interim analysis of the 9,000-patient LIGHT study which is being conducted to determine the heart-safety profile of the obesity med. The analysis showed patients receiving Contrave experienced 35 major adverse cardiac events (MACE) compared to 59 for those taking placebo. The benefit was statistically significant. A MACE is a heart attack, stroke or heart-related death.
    • The company will conduct a second interim analysis of the data at 50% of events, which should happen in the next several weeks. Orexigen is also required to run a second heart-safety study as a condition of its clearance by the FDA in September 2014.
    • Contrave is sold in the U.S. by Takeda Pharmaceutical Co. (OTCPK:TKPHF) (OTCPK:TKPYY).
    • According to Yahoo Finance, almost 42% of Orexigen's float (more than 38M shares) was sold short as of February 13.
    • Related tickers: (VVUS +4.3%)(ARNA -5.5%)
  • Tue, Mar. 3, 12:45 PM
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Company Description
Orexigen Therapeutics Inc is a biopharmaceutical company. The Company is engaged in development of pharmaceutical product candidates for the treatment of obesity. Its product candidate includes NB32 and Empatic.