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Jun. 30, 2015, 5:36 PM
Jun. 19, 2015, 5:36 PM
Jun. 16, 2015, 5:04 PM| Jun. 16, 2015, 5:04 PM | 11 Comments
May 27, 2015, 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%)
May 12, 2015, 8:57 AM
- Arena Pharmaceuticals (ARNA -2.1%) Q1 results: Revenues: $12.3M (+80.9%); COGS: $3.6M (+176.9%); R&D Expense: $22M (+4.8%); SG&A: $8.4M (+5.0%); Net Loss: ($24.3M) (+4.0%); Loss Per Share: ($0.10) (+16.7%); Quick Assets: $241M (+47.9%).
- No guidance given.
May 11, 2015, 4:11 PM
- Arena Pharmaceuticals (NASDAQ:ARNA): Q1 EPS of -$0.10 beats by $0.04.
- Revenue of $12.3M (+80.6% Y/Y) beats by $1.74M.
May 10, 2015, 5:35 PM
- AMBC, APEI, ARCW, ARNA, ASEI, ATHX, BDE, CALL, CHMI, CLNE, CYTX, DEPO, DRYS, DTSI, EAC, ELON, FF, FMC, FMI, FTEK, FXEN, GBDC, GTY, HALO, HI, IPAR, IPXL, JUNO, LPSN, MBI, MCC, MDR, MNTX, MODN, MR, MTZ, MVNR, OME, OMER, ONTY, OPK, ORIG, PAAS, PEIX, PINC, PVA, RAX, REN, SCLN, SF, SFXE, TCRD, TEP, TRQ, TTEC, UNXL, VRTU, XON, YY, ZGNX
Apr. 29, 2015, 9:17 AM
Apr. 22, 2015, 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%)
Apr. 10, 2015, 9:29 AM
- The USPTO issues a method-of-treatment patent to Arena Pharmaceuticals (NASDAQ:ARNA) for Belviq (lorcaserin HCl). Patent No. 8,999,970 describes a method for selecting appropriate patients based on renal function for Belviq. The patent extends Belviq's exclusivity to 2033.
- Separately, Eisai intends to restructure its U.S. operations, including a 25% workforce reduction. Its new Neurology Sales group will consist of 90 representatives who will promote Belviq and two other Eisai products. A shared contract sales force of 230 reps will promote Belviq on Eisai's behalf in addition to another product on behalf of another pharma firm. This represents nearly a 50% drop from the original 600-strong group promoting Belviq.
- Previously: Eisai Metabolic sales force now 600 (July 10, 2014)
- Previously: Arena says Eisai to increase size of Belviq sales force (Oct. 15, 2013)
Apr. 10, 2015, 8:48 AM
- Arena Pharmaceuticals (NASDAQ:ARNA) and commercialization partner Eisai (OTC:ESALF) (OTCPK:ESALY) announce the completion of two Phase 1 registration trials that they believe demonstrate the bioequivalence of an extended release formulation of Belviq (lorcaserin HCl) and the current twice-daily immediate release version. If approved, the new (expected) once-daily regimen will be marketed as Belviq XR.
- Each trial evaluated the safety, tolerability, pharmacokinetics and bioavailability of extended release lorcaserin in 36 healthy volunteers. They received either 10 mg twice per day or 20 mg once per day in a two-way crossover sequence.
- Arena President & CEO Jack Lief says, "This extended release formulation has the potential to offer once-daily dosing. We expect the results from these trials will allow us to submit a New Drug Application with the FDA for the treatment of weight management later this year and may also support our efforts to further pursue additional opportunities within our lorcaserin life cycle management portfolio."
- The FDA approved Belviq in June 2012 for chronic weight management, in addition to a reduced-calorie diet and exercise.
Mar. 24, 2015, 5:35 PM
Mar. 3, 2015, 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)
Mar. 3, 2015, 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%)
Mar. 2, 2015, 4:28 PM
- Arena Pharmaceuticals (NASDAQ:ARNA) Q4 results ($M): Total Revenues: 9.2 (+41.1%); Belviq: 3.8 (+62.1%); Operating Expenses: 37.0 (+31.2%); Net Loss: (32.1) (-36.7%); Loss Per Share: (0.15) (-36.4%); Quick Assets: 163.2 (-26.5%).
- Belviq subscriptions filled: 149K (+4.2% sequentially); Eisai net Belviq sales: $10.0M (-40.5% sequentially).
- The decline in Eisai's sales is due to the impact of the savings card program which enables patients without private insurance to obtain Belviq for no more than $75 per month.
- 2015 Guidance: Belviq forecast not provided; R&D Expense: $114M - 122M; SG&A Expense: $33M - 39M; CAPEX: $8M - 9M.
- ARNA is down 1% after hours on higher-than-normal volume.
Mar. 2, 2015, 4:02 PM
- Arena Pharmaceuticals (NASDAQ:ARNA): Q4 EPS of -$0.15 misses by $0.03.
- Revenue of $9.2M (+41.1% Y/Y) misses by $1.16M.
Arena Pharmaceuticals Inc is a biopharmaceutical company. The Company is engaged in discovering, developing and commercializing novel drugs that target G protein-coupled receptors, or GPCRs, to address unmet medical needs.
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