Thu, Mar. 26, 8:08 AM
- The Japanese Ministry of Health, Labour and Welfare approves Actelion's (OTCPK:ALIOF) (OTCPK:ALIOY) Opsumit (macitentan) for the treatment of pulmonary arterial hypertension (PAH). The approval was based on the results in the SERAPHIN Phase 3 trial that showed patients treated with macitentan 10 mg per day experienced a 45% risk reduction (p<0.0001) of the composite morbidity-mortality endpoint compared to placebo.
- The company will co-promote Opsumit in Japan with Nippon Shinyaku.
- Opsumit was cleared by the FDA in October 2013 and by the European Commission (EC) in December 2013.
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)
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. 24, 2014, 8:40 AM
- Tetraphase Pharmaceuticals (NASDAQ:TTPH) is reportedly considering selling itself after being approached by interested suitors. Sources say the acquirer could be Acetelion (OTCPK:ALIOF) (OTC:ALIOY) or Roche (OTCQX:RHHBY).
- The attraction is Tetraphase's antibiotic eravacycline, currently in Phase 3 development. Both oral and IV formulations of the drug have demonstrated higher dose response rates than Johnson & Johnson's (NYSE:JNJ) Levaquin (levofloxacin) for the treatment of complicated urinary tract infections. In the Ignite-2 study, patients receiving 200 mg eravacycline IV-to-oral doses achieved a response rate of 70.8% while patients receiving 250 mg IV-to-oral doses achieved 64.3%, both significantly ahead of Levaquin's 52.2% response rate.
- A trial comparing eravacycline to Merck's (NYSE:MRK) Invanz (ertapenem) for the treatment of complicated intra-abdominal infections is underway.
- TTPH is up 18% premarket on light volume.
- Previously: Tetraphase completes eravacycline Phase 3 enrollment
Aug. 13, 2014, 1:25 PM
- Shares of InterMune (ITMN +14.3%) spike on a 2x surge in volume in response to rumors that Roche (OTCQX:RHHBY +0.4%), Sanofi (SNY +0.7%), Glaxo (GSK -0.1%) and Actelion (OTCPK:ALIOF) (OTC:ACIOY) are preparing offers. Trading in ITMN shares was halted briefly at 1:00 pm EDT due to abnormal volatility.
Apr. 29, 2014, 8:00 AM
- Intermune (ITMN) is the latest pharmaceutical company to be linked with merger news, with the Betaville blog reporting that the firm is the subject of takeover interest from Actelion (ALIOF) and Sanofi (SNY).
- Actelion has apparently lined up $3-4B in financing from several banks, including JPMorgan.
- Intermune shares are +1.8% premarket; its market cap is $3.02B as of yesterday's close.
Dec. 24, 2013, 12:12 PM| Comment!
Nov. 21, 2013, 7:48 AM
- AstraZeneca (AZN) may be interested in buying Actelion (ALIOF), Citi says, in a note that sent shares of the Swiss biotech surging in overseas trade.
- Here's the actual quote (via Reuters): "Creative corporate finance
... coupled with 'long runway' acquisitions such as Actelion could provide a useful bridge to organically fueled growth."
- Citi thinks the deal would boost operating profits by double-digits for AZN.
Oct. 18, 2013, 4:21 PM
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