Monitoring International Trends posted January 2015

Market structure and company news

The NBA’s business intelligence follows company profitability, business forecasts, capital raisings or returns, mergers and takeovers, arrangements for joint research and/or development, contracts for supply of manufacturing inputs, and marketing agreements. Companies considered include suppliers, potential suppliers and developers of products which may be of interest.

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   Novo Nordisk is seeking a new CEO, to replace Lars Rebien Soerensen who has led the company for 14 years but is not expected to remain until his contract runs out in 2019.
   
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   Baxter’s spin-off of its pharmaceutical business as Baxalta is on track for mid-2015 and the company says it will enhance shareholder value.
   
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   Baxter’s recombinant factor eight, Advate, has in the short term been retaining market share better than some analysts expected in the face of competition from the first of the long-acting products coming on the market.
   
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   Baxter agreed to sell its proprietary Vero cell technology and related assets, including its production facility in Bohumil, Czech Republic, to Nanotherapeutics. The Vero cell platform is a cell-based technology for vaccines production. The agreement includes related vaccines for H5N1, H1N1 and seasonal influenza and investigational vaccine programs for Ross River virus, chikungunya and West Nile virus. Baxter had previously sold its commercial vaccines business and related traditional manufacturing facilities to Pfizer. President of Baxter BioScience, Ludwig Hantson, said ''The divestiture of the vaccines franchise will allow Baxter BioScience to enhance focus in core therapeutic areas of hematology, oncology and immunology, as it prepares to become an independent biopharmaceutical company. In addition, these transactions provide flexibility to direct resources toward strategic priorities that will drive future growth.''
   
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   CSL employs 120 staff in China, across five major cities. In 2013-14, CSL earned $US 300 million through albumin sales in China, a 29 per cent increase on the previous year.
   
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   CSL Behring has significant manufacturing capacity in Switzerland, and its market capitalisation fell in December when the Swiss government lifted its cap on the Swiss franc.
   
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   ProMetic Life Sciences has contracted with Generium Pharmaceuticals for various plasma-derived biopharmaceuticals to be manufactured and commercialized in Russia and the Commonwealth of Independent States (CIS). The agreement includes the co-development and global commercialization of two plasma-derived coagulation factors. The Generium plasma purification facility will be able to process up to 600,000 litres of plasma annually. The design will be based on ProMetic's Laval facility. Construction has begun and is expected to be completed by 2017. Of the US $17 million fees to be paid by Generium, US $6 million is to be paid up front, with US $11 million of staged payments at defined milestones.
   
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   Isis and Alnylam, leaders in RNA-targeted therapeutics, have entered into a new agreement, extending their existing strategic partnership (formed in 2004) to lead the development and commercialization of RNA therapeutics. The new agreement includes a cross-license of intellectual property (IP) on four disease targets, with each company having exclusive RNA therapeutic licence rights for two programs. There is also a non-exclusive technology IP cross-license, providing each company rights to some of each other's technology advances for RNA therapeutics through to April 2019. Alnylam is currently developing an investigational RNAi therapeutic targeting antithrombin (AT) for the treatment of haemophilia and rare bleeding disorders. ALN-AT3 is in a Phase 1 clinical trial enrolling haemophilia patients.
   
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   ADMA Biologics received a $US 5 million tranche from Hercules Technology Growth Capital, Inc. The $5 million was based upon ADMA achieving clinical endpoints of a Phase III clinical study of RI-002 as a treatment for Primary Immunodeficiency Disease (PIDD), under its existing loan and security agreement.
   
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    Sangamo BioSciences president and CEO Edward Lanphier presented an update on the company's clinical and preclinical ZFP Therapeutic programs and an overview of business strategy at the J.P. Morgan Healthcare Conference in San Francisco. He mentioned
    
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       the initiation in the first half of 2015 of a Phase I clinical trial of the zinc finger nuclease (ZFN)-modified hematopoietic stem cell approach for the possible cure of beta-thalassemia. The company also expects to file an investigational new drug application for this approach in sickle cell disease by the end of the year. Both programs are partnered with Biogen Idec.
       
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       the initiation In the first half of 2015 of a Phase I clinical trial of the company’s ZFP Therapeutic, SB-728, in stem cells, which is designed to enable functional control of HIV. All subjects have been accrued in an ongoing Phase II trial (SB-728-1401) of this approach in T-cells, and initial data are expected from this study by the end of 2015.
       
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       continued attempts to expand delivery capabilities and potential therapeutic applications of Sangamo's ZFP technology, including the recently announced initiative to develop in vivo RNA delivery of ZFNs to address in vivo gene knockout targets in the liver. The potential to dose patients with ZFNs in several treatments provides the opportunity to "dose to effect" or to administer the ZFNs until a sufficient level of permanent modification is obtained to provide a life-long therapeutic outcome.
       
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       Sangamo Biosciences has in-licensed nanoparticle technology to enable systemic messenger RNA (mRNA) delivery of Sangamo's proprietary zinc finger nucleases (ZFNs). mRNA delivery of ZFNs is being used in the development of the next generation of Sangamo's ZFP Therapeutics. Edward Lanphier, Sangamo's president and CEO, said "Specifically, this strategy opens up an entirely new set of therapeutic genome-editing targets; mRNA delivery could enable progressive and permanent knock out of a gene at the DNA level versus repressing its expression using continued and chronic administration of antisense or RNAi therapeutics."
       
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    Cerus Corporation announced the pricing of an underwritten public offering of 12,727,273 shares of its common stock offered at a price to the public of $US 5.50 per share for expected gross proceeds of $70.0 million. Cerus said it would use the net proceeds from the offering for continued development activities related to the Intercept Blood System, to fund commercialization efforts for the INTERCEPT Blood System in the US and elsewhere and for other general corporate purposes including regulatory activity, selling, general and administrative expenses, and working capital.
    
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    Cohera Medical signed an exclusive sales and marketing distribution agreement with B. Braun for its TissuGlu Surgical Adhesive in Germany, Spain and Portugal. B. Braun Surgical, S.A. will exclusively market and sell TissuGlu in the territories of Germany, Spain and Portugal through its existing Closure Technologies commercial teams.
    

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