SA News • Tue, Dec. 9
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Tue, Dec. 9, 12:38 PM
- RedHill Biopharma Ltd. (RDHL +12.2%) submits a Marketing Authorization Application (MAA) to the UK Medicines and Healthcare Products Regulatory Agency and several other member states seeking approval for the 5-HT3 receptor Bekinda (ondansetron) (formerly RHB-102) for the treatment of cancer therapy-induced nausea and vomiting.
- The MAA has been submitted under the European Mutual Recognition Procedure with the UK as the reference European member state.
- The 5-HT3 market is estimated at ~$940M worldwide with Europe representing ~1/3 of the total.
- CINV-related tickers: (OTC:ESALF) (OTCPK:ESALY -3%) (OPK +1.1%)(GALE +1.8%)(INSY +0.7%)(HRTX +1.3%)(TSRO +2.9%)(GWPH +4.5%)
Fri, Oct. 10, 10:50 AM
- The FDA approves Akynzeo (netupitant and palonsetron) for the treatment of nausea and vomiting in patients undergoing cancer chemotherapy. Akynzeo is a combination of two drugs. Oral palonosetron, approved in 2008, prevents nausea and vomiting in the acute phase (24 hours) after the start of chemo. Netupitant, a new drug, prevents nausea and vomiting during both the acute phase and delayed phase (25 - 120 hours) after the start of chemo.
- Akynzeo is distributed in the U.S. by Eisai (OTC:ESALF)(OTCPK:ESALY -0.2%) under license from Lugano, Switzerland-based Helsinn Healthcare S.A.
- Related tickers: (OPK -1.6%)(GALE -6.1%)(INSY -1.9%)(HRTX -2.7%)(RDHL)(TSRO -0.8%)(GWPH -4.6%)
Wed, Mar. 5, 8:46 AM
- Biogen Idec (BIIB) has purchased the rights to two experimental treatments for Alzheimer's disease from Japan's Eisai.
- Biogen will pay Eisai an unspecified amount upfront and milestones. If the drugs, called E2609 and BAN2401, are commercialized, the companies will share the profits.
- Eisai (ESALF) will lead the development of the therapies and pursue regulatory authorization, although both companies will co-promote the drugs in the U.S., Europe and other markets.
- "Eisai's candidates have demonstrated compelling early data and complement our Alzheimer's disease research while extending our pipeline in this critical area," says Biogen CEO George Scangos.
Mon, Feb. 3, 7:44 AM
Nov. 7, 2013, 4:29 PM
- Arena Pharmaceuticals (ARNA) expands its Belviq marketing agreement with Eisai (ESALF).
- Eisai now has commercialization rights "for all countries worldwide, except for South Korea, Taiwan, Australia, Israel, and New Zealand."
- ARNA gets $60M upfront and is eligible for up to $176.5M in milestone payments and up to $1.56B in one-time purchase price adjustment payments.
- ARNA will still recognize 31.5% of North American sales and 30.75% of sales in South America. Rates under new agreement: Europe, China, and Japan, 27.5%; 30.75% elsewhere. Rates may rise as high as 35% in Europe, China, and Asia on sales over $500M.
- The companies also say they plan to "investigate the potential of Belviq in new areas, such as smoking cessation, a once-daily formulation, a fixed-dose combination with phentermine, as well as explore Belviq's impact on diabetes and cardiovascular outcomes." (PR)
- See also: ARNA Q3 results
Nov. 1, 2013, 8:03 AM
Oct. 16, 2013, 9:08 AM
- "Based on the ratio of NRx/TRx, refill rates appear to be low," Needham's Alan Carr says, referring to Arena's (ARNA) Belviq.
- The shares rallied sharply Tuesday, after marketing partner Eisai (ESALF.PK) said it will double its sales force for the weight-loss drug.
- Nevertheless, Carr says "Belviq patient awareness [is] low." The analyst also calls single-agent efficacy "modest."
- Hold rating reiterated.
- ARNA +1.3% premarket.
Oct. 15, 2013, 9:31 AM
- Arena Pharmaceuticals (ARNA +5%) says Belviq marketing partner Eisai (ESALF.PK) is set to double the size of its sales force for the weight-loss drug by December.
- The move will "will enable Eisai to reach approximately 65K physicians in the U.S.," ARNA notes.
- Eisai says the expansion "demonstrates the success ... gained in discussing the [drug's] potential value within the payor community, and the subsequent agreements ... reached with many ... payor partners." (PR)
- Worth noting: In a bearish note late last month, Credit Suisse predicted Eisai would need to hire additional reps in order for the companies to hit the bank's (lowered) Belviq estimates.
Oct. 1, 2013, 1:12 PM
- Piper Jaffray cuts its price target on Arena Pharmaceuticals (ARNA -6.8%) to $10 from $11.50, which was exactly what the stock did not need on the heels of Monday's Credit Suisse bear call.
- According to market chatter, Edward Tenthoff has cut Q3 Belviq sales estimates to $1/4M versus $4/14M previously.
Sep. 30, 2013, 10:11 AM
- A downbeat note out of Credit Suisse hits shares of Arena Pharmaceuticals (ARNA -6.6%) hard in early trading.
- CS slashes Belviq estimates for Q4, FY14, and FY15 to $12M (from $36M), $157M, and $325M, noting that although "these are substantial cuts ... getting to [the] new numbers will still require exponential growth [and] will require Eisai (ESALF.PK) to hire additional reps."
- Other (decisively bearish) takeaways: Profitability is now forecast for 2017 (versus 2016 previously), "slower ramp results in lower royalties and also defers the timing of milestone payments," the company "may need to do another round of financing next year."
- Price target cut to $4 from $5.
- Also lower: VVUS
Sep. 16, 2013, 8:34 AM
- Arena (ARNA) updates investors on partner Eisai's (ESALF.PK) Belviq marketing initiatives.
- ARNA says full-page ads will begin running this month in The Oprah Magazine, so the weight-loss drug has got that going for it.
- Also mentioned is Eisai's program to provide "support and savings" for Belviq patients. (PR)
- For more on Belviq's advertising campaign see SA contributor Spencer Osborne's latest article here
- Also: Belviq weekly TRx
- ARNA +3% premarket. Competitor VVUS +2.4% premarket
Aug. 30, 2013, 11:39 AM
- Astex Pharmaceuticals (ASTX -4.1%) is notably weak today after running up ~25% on Wednesday following topline data from a Phase 2 trial of SGI-110.
- Not helping the stock's cause is an article from theStreet's Adam Feuerstein who takes issue with RBC analyst Michael Yee's bullish thesis.
- "Concluding that SGI-110 is better than Dacogen [another ASTX product which is licensed to Eisai (ESALF.PK)] based on an interim look at just 17 patients is silly," Feuerstein says, adding that the observed 53% response rate in the cohort of elderly patients with treatment-naive AML "will not hold up once the cohort ... reaches full enrollment."
- Ultimately, Feuerstein thinks it's "premature to say much of anything about SGI-110's activity in AML relative to Dacogen based on the paltry and incomplete data released ... on Wednesday."
- For the record, the company says it released interim results because "the data was material and ASH just cleared [the company] for top-line data release without violating the embargo."
Aug. 28, 2013, 9:05 AM
- RBC's Michael Yee reiterates an Outperform rating on Astex Pharmaceuticals (ASTX) following topline data from an ongoing trial of SGI-110.
- Yee thinks the shares have significant room to run even after the 18% gain the stock has posted premarket — price target is $9.
- RBC likes SGI-110 compared to Eisai's (ESALF.PK) Dacogen (indicated for Myelodysplastic syndrome).
Aug. 1, 2013, 8:41 AM
- Arena Pharmaceuticals (ARNA) and Belviq partner Eisai (ESALY.PK) report quarterly results, giving investors a look at Belviq sales figures.
- Belviq sales come in at $4.13M. ARNA recognizes $1.3M of the net product sales. Scripts filled between June 11 and July 19: 12,500.
- ARNA on the call: "Too early to provide sales guidance." (webcast)
- ARNA received $65M in milestone payments for the quarter. (PR)
- ARNA +2.5% premarket. Eisai PR.
Jun. 7, 2013, 8:47 AM
Jun. 5, 2013, 2:47 PM
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ESALF vs. ETF Alternatives
Eisai Co. and its subsidiaries are engaged in the manufacture and sale of pharmaceuticals, consumer health care products, diagnostic products, chemicals and food additives, and animal health products. Co.'s products include antiallergy agent, osteoporosis treatment, gastritis/gastric ulcer... More
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