BEL projekt Projekt ModPro AB Uppsala Science Park Uppsala Kontakt: Prof. Lars Baltzer Tel:

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1 BEL projekt 2008 Market analysis and technology assessment of in situ proximity ligation for high throughput drug candidate screening Olink Bioscience Dag Hammarskjölds väg 54A Uppsala Tel: Kontakt: Simon Fredriksson and Björn Ekström Market value of cancer diagnostic biomarkers Atlas Antibodies AB AlbaNova University Center Stockholm Tel: Kontakt: Dr. Marianne Hansson, CEO Försäljningsstrategi för ny produkt Peviva AB Kontakt: Richard Herrmann Gunnar Asplunds allé 24, hus C Tel: Mobil: Projekt ModPro AB Uppsala Science Park Uppsala Kontakt: Prof. Lars Baltzer Lars.Baltzer@modpro.se Tel:

2 Market analysis and technology assessment of in situ proximity ligation for high throughput drug candidate screening Olink Bioscience Supervisor: Simon Fredriksson and Björn Ekström Olink has developed an enabling method for studying protein interactions, which is currently commercialized under the Duolink product name. The product targets customers studying intracellular signaling pathways in academia and the pharmaceutical industry. It is the only method capable of analyzing protein interactions in unmodified single cells providing localized single molecule detection and quantification. When screening at high throughput for new drug candidates to potentially disrupt a cellular pathway to for example halt cancer growth, one desires an assay system as close to an in vivo environment as possible. It is anticipated that improved screening procedures with lower false lead generation could greatly enhance the currently very slow and costly drug discovery process by excluding non-performers at an earlier stage. Several molecular biology methods are today in use for interaction measurements in cells during high throughput screening procedures but all of these require over-expression of non-native proteins by tagging these with reporter proteins. These conventional procedures perturb the intracellular system at times causing artefactual results and more importantly, can never be used to study efficacy at a molecular level in clinical trials. In contrast, the Duolink technology enables measurement of interactions directly in native cells from either cell cultures (high throughput screening) or tissue materials (clinical trials). A unique opportunity then presents itself for using the same technology when screening drug candidates in cell culture systems as when analyzing efficacy directly in tissue during the pre-clinical and clinical trials. This project will aim to assess the overall market potential for such a drug screening system and also define the unique selling points of this technology by among other activites, interviewing potential users in the pharmaceutical and biotech industry.

3 PROJECT: Market value of cancer diagnostic biomarkers Atlas Antibodies AB Atlas Antibodies is a biotech company, founded in 2006 by researchers at the Royal Institute of Technology (KTH) in Stockholm and the Rudbeck Laboratory, Uppsala University in Uppsala, Sweden. Atlas Antibodies is active in the field of biomarker discovery, by evaluating clinically interesting biomarkers discovered by the Human Protein Atlas (HPA) program. The antibodies produced by HPA are analyzed in immunohistochemistry (IHC) staining of 48 normal human tissues in triplicates and in 20 different cancer tissues, from 12 patients in duplicates. Several potential cancer protein markers have been discovered in these IHC analyses. Atlas Antibodies owns the rights to patent new biomarkers identified in the HPA program. Evaluation of the market value of cancer diagnostic biomarkers The biomarker discovery business will generate value through out-licensing of rights to biotechnology, diagnostic or pharmaceutical companies, via collaboration with adequate companies, and/or by in-house development of diagnostic products. Out-licensing of rights to protected biomarkers can for example be (i) biomarker by biomarker, (ii) include a cancer area, e.g. all markers for breast cancer and/or (iii) by application, e.g. cancer diagnostics. In order to define the best strategy to out license protected biomarkers it is important to estimate the value of unique biomarkers and a set of biomarkers in a specific cancer area. Who are the market leaders in cancer diagnostics? What is the market size for cancer diagnostic products in general and specifically antibody based cancer diagnostic products? What does the future cancer diagnostic market look like (products, technology, trends, size, development)? What type of deals has been made in the biomarker discovery area based on application/disease areas (diagnostics, therapy, cancer, metabolism, Alzheimer, etc.)? What type of deal structures are the most common (upfront payment, milestone payment, research cover, royalties)? What is the value of entered deals (upfront payment, milestone payment, research payment, royalties)? What companies has entered into such deals? What has the outcome been from these deals? Market and deal analysis The methods for conducting this analysis will include: Searches on the internet Discussions with key persons in the field Dr. Marianne Hansson, CEO and Mr. Mikael Johnsson, Board member will be representing Atlas Antibodies

4 Samarbete mellan KTH och Peviva AB inom kursen Bioteknik Ekonomi Ledarskap, vårterminen 2008 Förslag till uppgiftsbeskrivning Utgångsläget Peviva AB är ett litet bioteknikföretag som tillverkar analysprodukter för kvantifiering av celldöd (apoptos respektive nekros) genom mätningar i blodserum. I dagsläget har företaget två produkter: M30-Apoptosense ELISA (mätning av apoptos) M65 ELISA (mätning av total celldöd, dvs nekros och apoptos) Därutöver säljer företaget antikroppar för immunohistokemi i samma ämnesområde. Peviva AB har under året 2007 utvecklat en ny produkt för en marknad i vilken företagets insikt är begränsad och som genom sin utformning och prissättning vänder sig till en ny möjlig kundkrets. Även denna produkt, CytoDeath ELISA, mäter apoptos, men är inte användbar på blodserum utan endast på in-vitro-material som används inom forskningen. Den nya produkten är färdigutvecklat och klar för produktion. Uppgiftsbeskrivningen Uppgiften är att inhämta data och analysera företagets situation samt utifrån denna skriva en plan för introduktion och försäljningsstrategi för den nya produkten. Analysen och datainhämtningen kan bestå av identifikation av kunder och kundgrupper undersökning av kunders behov, agerande och antaganden konkurrerande produkter på marknaden och konkurrerande producenters produktsortiment och uppträdande på marknaden prisbilden på marknaden teknisk jämförelse mellan konkurrerande produkter och tekniker möjliga distributionskanaler och deras ekonomiska ramar kunders inköpsprocedurer andra aspekter som utgår ifrån studenternas idéer och det aktuella informationsunderlaget I första steget ska studenterna sätta sig in i företagets situation och därefter avgränsa uppgiften. I detta sammanhang skrivs en arbetsplan, där studenterna väljer några av ovanstående punkter som de ska bearbeta och rangordnar dessa. Arbetet framförs för företaget i form av en skriftlig rapport och en presentation. Kontakt Richard Herrmann Peviva AB Gunnar Asplunds allé 24, hus C Telefon: Mobil: E-post: richard.herrmann@peviva.se

5 Project ModPro AB. ModPro AB ( is a small but rapidly growing biotech company specializing in the design and synthesis of a new type of molecules that bind proteins specifically, and with high affinity. The recognition of proteins is the key to clinical diagnostics and drug development and biotech and pharmaceutical companies have so far most often taken advantage of the properties of antibodies to quantify proteins on chip or to bind proteins in vivo. While antibodies remain the industrial golden standard for protein binding, they are associated with many problems, and Modpro has developed an improved concept that is now being brought to the market. The potential for such molecules is considerable in view of the fact that the clinical diagnostics market is huge, and growing, and in view of the fact that more than 300 candidate antibody drugs are in clinical trials today. Binders for proteins that can compete favourably with antibodies can in principle invade both of these markets successfully. Modpro produces designed polypeptides with around 40 amino acids, where one or maximum two amino acid side chains have been modified to form more complex residues. Surprisingly, these simple manipulations have dramatic effects on affinity and specificity, and increase polypeptide affinities by six orders of magnitude or more, while providing selectivities that rival those of antibodies. The binders have molecular weights that are 1/30 of those of antibodies, do not denature upon heating, are robust and show no batch to batch variation as they are chromatographically pure. They are prepared by chemical synthesis that requires relatively modest investments in infrastructure, and they are thus cost effective in production. The use of chemical methodology for the preparation of these molecules makes it easy to specificially introduce further functions such as fluorophores, handles for immobilization and handles for cargo, e.g. radiometal chelates, active transporters for membrane penetration and combinations of all of the above. They are conveniently stored and transported as lyophilized powders. All of these properties make them attractive as key components in clinical diagnostics tests and as protein drugs. Modpro is the only company in the world to pursue this concept today, and has a competitive edge, at least for the time being. It is a Swedish invention. Modpro AB was founded in 2002 and it has taken Modpro several years to define its products and what to sell. At this stage it is crystal clear that the products are binders for proteins for a variety of applications and the first product has now reached the market, with more products on order and under development or under evaluation. So far, all binders have been made on demand. Although several orders have been received and generated revenue due to downpayments, it takes time before the binders generate cashflow from royalties and production. It is therefore important to define the strategic goals and identify what products are of interest to the biotech and pharmaceutical markets and begin to build a portfolio of binders to be offered ready-made to customers to bring in revenue faster. The research market is only of marginal interest, the main goal is to put the Modpro binders into clinical diagnostic tests and to develop new pharmaceuticals.

6 In this project the students should carry out a market analysis and identify the clinically important protein targets of commercial importance where Modpro binders should be of interest, either because there are major problems with existing binders, which is not unusual, or because no binder has yet been developed, or for reasons of IPR. The markets should be those of diagnostics and pharmaceuticals, but reports of unexpected and surprising needs from the industry would be an added bonus from this investigation. The market analysis could for example include interviews with companies and clinicians, and reading of articles from of financial and clinical journals. It is important to know that companies are disinclined to reveal problems with current products, or products under development, so questions could e.g. be directed to end users as well as to vendours. Students are normally expected to be good at extracting hot information in clever ways. Contact person ModPro AB: Lars Baltzer President Lars.Baltzer@modpro.se