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, 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%)
Mon, Mar. 2, 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.
Mon, Mar. 2, 4:02 PM| Comment!
Sun, Mar. 1, 5:35 PM
Tue, Feb. 3, 9:34 AM
- South Korea's Ministry of Food and Drug Safety approves Arena Pharmaceuticals' (ARNA +3.9%) weight loss drug Belviq. The product will be marketed in-country by Ildong Pharmaceutical Co. Ltd.
- The approval triggers a $3M milestone payment to Arena from Ildong.
- Bevliq will be manufactured at Arena's Switzerland facility and sold to Ildong at 35% of its annual net sales. This will increase on a tiered basis up to 45% on the portion of net sales exceeding $15.0M.
Thu, Jan. 22, 3:26 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Novo Nordisk's (NVO -2.2%) Saxenda (liraglutide 3 mg) for the treatment of obesity, as an adjunct to a reduced-calorie diet and increased physical activity, in patients with an initial Body Mass Index (BMI) of >=30 kg/m2 (obese) or >=27 kg/m2 to <30 kg/m2 (overweight) who have at least one weight-related co-morbidity (e.g. hypertension, hypercholesterolemia, type 2 diabetes).
- A final decision by the European Commission usually takes ~60 days.
- The FDA approved Saxenda last month.
- Related tickers: (OREX +1.2%)(VVUS -4.6%)(ARNA -1.4%)
Wed, Jan. 21, 10:30 AM| Comment!
Wed, Jan. 21, 9:14 AM
Tue, Jan. 20, 5:38 PM
Tue, Jan. 20, 9:54 AM
- Arena Pharmaceuticals (ARNA -6.2%) heads south in early trading. In an 8-K filed this morning, the company disclosed that Belviq revenues in Q4 will be 35 - 45% below Q3's tally of $16.8M. The drop is due to the implementation of a savings card for eligible patients without commercial insurance coverage to pay no more than $75/month for the obesity medicine. The plan was implemented on January 1, but the company had to increase its estimated deductions from the gross sales amounts billed to distributors that remained in inventory in Q4 in addition to a reduced prescription growth rate believed to be associated with the seasonality of the obesity market.
- According to IMS Health Belviq prescriptions rose 4% sequentially. The company expects Belviq prescriptions in Q1 to be higher than Q4.
Tue, Jan. 20, 9:16 AM
Mon, Jan. 12, 4:40 PM
- Arena Pharmaceuticals (NASDAQ:ARNA) initiates a Phase 2 clinical trial evaluating ralinepag for the treatment of patients with pulmonary arterial hypertension. The 22-week randomized, double-blind study will assess the hemodynamic and exercise capacity effects, safety and tolerability of ralinepag in up to 60 patients with PAH. During the first nine weeks, subjects will be titrated to their individual tolerance level and then maintained at this level for the remainder of the study.
- Ralinepag an oral, non-prostanoid prostacyclin receptor agonist.
Wed, Jan. 7, 12:45 PM
Wed, Jan. 7, 10:41 AM
- Arena Pharmaceuticals (ARNA +33.4%) jumps on higher volume in early trading in response to its report of a dose-dependent effect on lymphocyte count lowering for APD334 in a Phase 1b trial.
- Mean decreases in lymphocyte count in blood from baseline were as high as 69%. Counts recovered from baseline, on average, within one week of cessation of dosing. Lymphocyte lowering has been shown to correlate with clinical efficacy in Phase 2 and 3 trials of other S1P1 modulators in multiple sclerosis, psoriasis and ulcerative colitis.
- APD334 is an oral drug that targets the sphingosine 1-phosphate subtype 1 (S1P1) receptor for the potential treatment of autoimmune diseases. The company plans to proceed to Phase 2 development.
- Related tickers: (OTCPK:ALIOF) (OTC:ALIOY) (NYSE:GSK) (OTCQX:RHHBY)
Wed, Jan. 7, 9:20 AM
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