Wed, Mar. 25, 7:51 AM
- The FDA approves Emergent BioSolutions' (NYSE:EBS) Anthrasil [Anthrax Immune Globulin Intravenous (Human)] for treatment of inhalational anthrax in combination with appropriate antibacterial drugs. The milestone triggers a $7M payment to the company from the Biomedical Advanced Research and Development Authority (BARDA). Also, its Orphan Drug status provides a seven-year period of market exclusivity for the indication.
- Anthrasil is a sterile solution of purified human immune globulin G (IgG) that contains polyclonal antibodies that target the anthrax toxins of Bacillus anthracis. It is prepared using plasma collected from healthy, screened donors who have been immunized with Emergent's BioThrax (Anthrax Vaccine Adsorbed) vaccine, the only FDA-licensed vaccine for the prevention of anthrax disease.
Mon, Mar. 16, 8:58 AM
- Under agreements with the University of Oxford, GlaxoSmithKline (NYSE:GSK) and the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID), Emergent BioSolutions (NYSE:EBS) has manufactured a modified vaccinia Ankara (MVA) Ebola Zaire vaccine candidate (MVA EBOZ) that will be use in a Phase 1 trial to be conducted in the U.K. to assess the safety of MVA EBOZ as a heterologous boost to Glaxo's Chimp Adenovirus type 3 (ChAd3) Ebola vaccine candidate.
- Emergent performed proof-of-concept work and manufactured the MVA EBOZ vaccine candidate at a 200L scale in an avian cell line, which eliminates the requirement of eggs in the manufacturing process. The scalable process has the potential to meet the demand for multi-million doses in a few months.
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Thu, Mar. 5, 1:41 PM| Comment!
Wed, Mar. 4, 5:35 PM
Sun, Jan. 11, 3:14 PM
- Emergent BioSolutions (NYSE:EBS) announces preliminary results for Q4: Revenues: $445M - 450M, BioThrax Sales: ~$246M; Net Income: $36M - 38M; non-GAAP Net Income: $53M - 55M; Quick Assets: ~$280M.
- 2015 Guidance: Revenues: $510M - 540M, BioThrax Sales: $270M - 285M; Net Income: $50M - 60M; non-GAAP Net Income: $60M - 70M.
- Q1 Guidance: Revenues: $90M - 105M.
Nov. 6, 2014, 5:33 PM| Comment!
Nov. 5, 2014, 5:35 PM
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Oct. 9, 2014, 7:47 AM
Oct. 7, 2014, 4:51 PM
- Emergent BioSolutions (EBS -3.7%) restructures its business to increase efficiencies, reduce costs and drive earnings. The action items are:
- The Munich, Germany product development facility will be closed while retaining the MVAtor IP.
- The Henlow Bay facility in Winnipeg, Canada and the Human Growth Hormone Product program will be sold to Belrose Pharma for a undisclosed sum. The transaction should close in 60 days.
- Management plans to complete the initiatives by the end of 2014 and does not expect them to impact 2014 financial performance. It does expect to save $7M - 9M per year beginning in 2015. The savings will result from consolidated operations, streamlined product development and reduced headcount.
Oct. 3, 2014, 1:53 PM
- The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee voted against recommending regulatory approval of SonaCare Medical's Sonablate 450 for the treatment of recurrent prostate cancer in patients previously treated with external beam radiation therapy. The device utilizes high intensity focused ultrasound (HIFU) to ablate tissue.
- The panel's rejection was due to the fact that Sonacare's clinical trial data were based on an interim analysis of the first 100 patients in a planned 200-patient study. The company obviously believed the data were compelling enough to proceed with its submission prior to the conclusion of the study but the reviewers felt otherwise.
- The panel voted 7-3 against (1 abstention) recommending that the treatment was safe if used as intended; 9-2 against recommending that the treatment was effective if used as intended and 10-0 against recommending that the benefits outweigh the risks.
- Briefing docs
- Prostate cancer therapy-related tickers:(TKAI -2.1%)(MDVN +1.2%)(NYMX +4.8%)(EXEL -0.3%)(PGNX +2.8%)(MRK +1.8%)(ADXS +2.7%)(EBS +1.8%)(EDAP +3%)(ISIS +2.1%)(NVGN)(DNDN +0.7%)(ISR +1.4%)(OGXI +0.4%)
Sep. 8, 2014, 3:26 PM
- Emergent BioSolutions (EBS -1.3%) closes a contract with NIH's National Institute of Allergy and Infectious Diseases (NIAID) to develop an dry formulation of NuThrax (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant). The five-year contract provides up to $29M for manufacturing and non-clinical activities through the preparation of an IND to the FDA.
- The dry formulation is expected to increase the stability of the vaccine candidate at ambient and higher temperatures and hopefully eliminate the need for cold chain during shipping and storage.
Aug. 20, 2014, 9:26 AM
- Emergent BioSolutions (NYSE:EBS) and MorphoSys AG enter into an agreement to jointly develop and commercialize Emergent's bi-specific antibody, ES414, for the treatment of prostate cancer. Under the terms of the contract, Emergent will receive an upfront payment of $20M and milestone payments of up to $163M. MorphoSys will bear 64% of ES414's development costs and Emergent will bear 36%. Emergent will retain commercialization rights in the U.S. and Canada and pay MorphoSys royalties from mid-single-digit up to 20%. MorphoSys will own commercialization rights for the rest of the world and pay Emergent low-single-digit royalties.
Aug. 8, 2014, 8:32 AM
- The Centers for Disease Control and Prevention exercises its option for the supply of Vaccinia Immune Globulin IV (VIGIV) into the U.S. Strategic National Stockpile. VIGIV, manufactured by Emergent BioSolutions (NYSE:EBS), is a therapeutic for the treatment of complications from smallpox vaccination.
- The contract option is valued at $18.9M over three years, bringing the total contract value up to $36.6M.
Aug. 7, 2014, 5:49 PM
Aug. 7, 2014, 5:02 PM
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