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Executive Summery. Company Overview Pharmacolog I Uppsala AB is a medical device company based in Uppsala, Sweden. The company specializes in providing quality assurance solutions for safe administration of medications.
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Executive Summery Company Overview Pharmacolog I Uppsala AB is a medical device company based in Uppsala, Sweden. The company specializes in providing quality assurance solutions for safe administration of medications. The company was established in 2007 by Hans Dahlin and Kjell Westerlund as a spin off from ONCOlog medical QA AB. The company's lead product, DrugLog, focuses on the quality assurance of the preparation of drugs in the clinical setting. The company is owned by several national and international small companies and private persons. The CEO of the company is Hans Dahlin, how has clinical and company leadership background in cancer care since more than 30 years.
Executive Summery • Preparation and Administration of Drugs • In most hospitals the reconstitution and preparation of drugs takes place in central units, typically in a controlled environment with experienced staff. When prepping medications there are key elements that need to be taken into account • Accurate dosing • Sterility • Stability • Operator safety • Verification and quality assurance • Adhering to guidelines and recommendations is important, but may not be sufficient. The preparation and administration of drugs in certain situations, for example pediatrics, oncology, etc., is sometimes more complex and the risk of errors or system failures could result in catastrophic outcomes for a patient. The prevalence of these errors is not exactly known, but serious incidences are reported in the press and our own studies indicate that it is significant. DrugLog offers the opportunity to introduce a Quality Control check, prior to the injection or infusion of the drug.
Executive Summery DrugLog Technology The core technology is based on absorption spectroscopy in the ultraviolet (UV) spectral range from 200 nm to 800 nm. Existing (off the shelf) mini spectrometers and UV lamps are used in the system. In order to identify the drug to be tested a broad band spectral analysis of the liquid sample is made and matched against stored reference spectral data for calibrated drugs. For each set up at a drug preparation unit, selected drugs from different manufactures are calibrated and stored in the system as a reference drug spectral database. In this way generic drugs that show differences in spectral response can be identified, which automatically can identify potential counterfeits. Currently there are a total of 26 drugs tested and calibrated for full range of clinically used concentrations in the DrugLog database. Concentrations of drugs are based on an adapted interpolation analysis.
Executive Summery Calibrated and tested drugs January 2013 Nr. drug Concentration window (mg/ml) 1 Cefotaxim 50-200 2 Ceftazidim 50-200 3 Cefuroxim 50-200 4 Clindamycin 3-24 5 Fortum 50-200 6 Garamycin 2.5 -10 7 Nebcina 0.1-10.0 8 Privigen 25-100 9 Gentamycin 5-40 10 Meropenem 40-62.5 11 Morphin 0.05 10 12 Novorapid 0.5-1.5 13 Odansetron 1.0-2.0 14 Phenergan 1.25-5.0 15 Sandimmun 1.0-10.0 16 Vancomycin 1.0-10.0 17 Cisplatin 0.05-0.15 18 Epirubicin 0.2 -0.6 19 Irinotecan 0.7-2.0 20 Carboplatin 0.4-1.3 21 Methotrexat 0.5-22 22 Vincristin 0.0125-0.04 23 Docetaxel 0.2-0.6 24 Etoposid 0.1-0.3 25 Fluororacil 1.6-5.0 26 Doxorubicin 0.04-0.5
Executive Summery DrugLog in an integrated network environment DrugLog has a built in computer that can be connected to local networks for integrating with existing patient, treatment, drug prescription records, and other related databases. DrugLog has been tested and verified at the hospital pharmacy preparing cytostatic at the university hospitals in Gent, Belgium and Uppsala, Sweden, as well as at the Pediatric Oncology Department at the University Hospital in Uppsala.
Executive Summery Potential Market Size Based on the IMS report from 2008, the Market value for a product like DrugLog focused on cancer care would be about 100 MEUR with a price point of 2 EUR per infusion and a 5% market. penetration. Further market development for other compound drugs for use in Infusion Pumps is considerable.
Executive Summery Intellectual Property The company has a strong patent position for the DrugLog covering the European and the US markets. The patent covers test of liquid drugs for intravenous treatment with spectroscopic technology (like absorption, emission, Raman etc.) in health care.
Executive Summery • Strategic Partnership • The business model for Pharmacolog is to build partnership for broadens the clinical use of DrugLog with a global marketplace. • Pharmacology will provide: • the manufacture of pre-production prototypes • development of the software to appropriate standard • testing of drugs and different situations • clinical evaluation with publication of results • preparation of quality system and filing for CE mark and FDA registration • Partners will provide • support on intellectual property protection • input on final product configuration and design • development of disposable/single use component • marketing/commercialization plan • FDA regulatory pathway • In addition, the selected partners will receive licenses to IP rights and DrugLog technology for production and sales within their own legal environments. • Pharmacolog will continue to develop the functionality of the software in close co-operation with the partners • Pharmacolog will receive revenue from royalty for each unit produced and/or each use
Executive Summery Financial goals The share capital of Pharmacolog is held by small companies and private persons. Pharmacolog plans to development further capital in the range 1-2 million EUR in 2013 for an aggressive marketing and sales during 2014. Milestones 2013 Report from clinical test of DrugLog 2013-04-08 at the Pediatric Oncology, Akademiska Hospital. Research/development grant of 3 MSEK 2013-04-15 from The Foundation of Children with Cancer. Product Release DrugLog 1.0 2013-05-06 First customer contract for DrugLog 1.02013-06-15 Partnership agreement .2013-07-01 Share Issue program to raise 1.5 KEUR2013-09-15 First design of DrugLog integration to infusion pumps2013-12-15
Executive Summery DrugLog 1.0