Download Executive Summery Company Overview

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.
1
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.
2
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.
3
Executive Summery
Calibrated and tested drugs January 2013
Nr.
drug
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Cefotaxim
Ceftazidim
Cefuroxim
Clindamycin
Fortum
Garamycin
Nebcina
Privigen
Gentamycin
Meropenem
Morphin
Novorapid
Odansetron
Phenergan
Sandimmun
Vancomycin
Cisplatin
Epirubicin
Irinotecan
Carboplatin
Methotrexat
Vincristin
Docetaxel
Etoposid
Fluororacil
Doxorubicin
Concentration window (mg/ml)
50-200
50-200
50-200
3-24
50-200
2.5 -10
0.1-10.0
25-100
5-40
40-62.5
0.05 10
0.5-1.5
1.0-2.0
1.25-5.0
1.0-10.0
1.0-10.0
0.05-0.15
0.2 -0.6
0.7-2.0
0.4-1.3
0.5-22
0.0125-0.04
0.2-0.6
0.1-0.3
1.6-5.0
0.04-0.5
4
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.
5
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.
6
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.
7
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
8
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
1.
Report from clinical test of DrugLog
at the Pediatric Oncology, Akademiska Hospital.
2013-04-08
1.
Research/development grant of 3 MSEK
from The Foundation of Children with Cancer.
2013-04-15
1.
Product Release DrugLog 1.0
2013-05-06
2.
First customer contract for DrugLog 1.0
2013-06-15
3.
Partnership agreement
2013-07-01
4.
Share Issue program to raise 1.5 KEUR
2013-09-15
5.
First design of DrugLog integration to infusion pumps
2013-12-15
.
9
Executive Summery
DrugLog 1.0
10