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Mar. 1, 2015, 5:35 PM
Feb. 3, 2015, 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.
Jan. 22, 2015, 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%)
Jan. 21, 2015, 10:30 AM
- Arena Pharmaceuticals (ARNA -9.6%) completes the sale of 21M shares of common stock to its underwriters for an undisclosed price, who also have an over-allotment option for an additional 3M shares. Net proceeds will fund its clinical and preclinical activities, R&D and general corporate purposes.
Jan. 21, 2015, 9:14 AM
Jan. 20, 2015, 5:38 PM
Jan. 20, 2015, 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.
Jan. 20, 2015, 9:16 AM
Jan. 12, 2015, 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.
Jan. 7, 2015, 12:45 PM
Jan. 7, 2015, 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)
Jan. 7, 2015, 9:20 AM
Dec. 23, 2014, 4:05 PM
- The FDA approves Novo Nordisk's (NYSE:NVO) Saxenda (liraglutide [rDNA origin] injection) for the treatment of chronic weight management in addition to a reduced-calorie diet and physical activity in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related co-morbidity such as hypertension, type 2 diabetes or high cholesterol.
- Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist in the same class as the company's glucose management medicine Victoza.
- Weight management drug-related tickers: (NASDAQ:OREX) (NASDAQ:VVUS) (NASDAQ:ARNA)
Dec. 15, 2014, 7:43 AM
- Zafgen (NASDAQ:ZFGN) initiates a Phase 2b study in Australia evaluating its lead product candidate, beloranib, for the treatment of patients with both severe obesity and type 2 diabetes. The trial will enroll ~150 subjects. Its primary objective is to demonstrate weight loss over a 6 - 12-month period along with glycemic control.
- The primary endpoint is the change on total body weight from baseline at the end of randomized treatment.
- Beloranib, a MetAP2 inhibitor, is an injectable small molecule therapy that reduces hunger while stimulating the use of stored fat as an energy source.
- The company licensed beloranib from South Korean firm Chong Kun Dang Pharmaceutical Corp.
- Related tickers: (NASDAQ:VVUS) (NASDAQ:OREX) (NASDAQ:ARNA)
Dec. 3, 2014, 3:36 PM
- Actelion Ltd (OTCPK:ALIOF) (OTC:ALIOY) submits a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Uptravi (selexipag) for the treatment of patients with pulmonary arterial hypertension (PAH).
- Selexipag is selective IP prostacyclin receptor agonist. Prostacyclin activates the IP receptor inducing vasodilation and inhibiting proliferation of vascular smooth muscle cells. If approved, it will be the first such drug cleared for use in PAH.
- In April 2008, the company signed a license agreement with Nippon Shinyaku under which Actelion has global development and commercialization rights to selexipag outside of Japan. The firms will be partners in Japan.
- Actelion plans to submit an NDA to the FDA shortly.
- PAH-related tickers: (GSK -0.8%)(GILD -1.9%)(MSTX -1.5%)(ARNA +1.7%)(OTCPK:BAYRY -1.8%)(UTHR -1.2%)
Nov. 25, 2014, 11:28 AM
- The USPTO awards U.S. Patent No. 8,895,776 entitled "Modulators of the Prostacyclin Receptor Useful for the Treatment of Disorders Related Thereto" covering Arena Pharmaceuticals' (ARNA -1.7%) ralinepag, an orally available prostacyclin receptor agonist.
- The company is developing ralinepag for the treatment of vasospastic diseases such as pulmonary arterial hypertension.
- Patent applications related to ralinepag have been filed in 19 jurisdictions including the U.S., Europe, Japan and China.
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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