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Information Memorandum June 2012 Project Koenig. 2 Transaction Summary Company NameProject Koeing Year of Incorporation2003 in the US and 2005 in India.

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Presentation on theme: "Information Memorandum June 2012 Project Koenig. 2 Transaction Summary Company NameProject Koeing Year of Incorporation2003 in the US and 2005 in India."— Presentation transcript:

1 Information Memorandum June 2012 Project Koenig

2 2 Transaction Summary Company NameProject Koeing Year of Incorporation2003 in the US and 2005 in India Nature of BusinessMedical Device and Biotechnology PromotersProject Koeing US RequirementsThe Promoters are looking for private equity funding round of US$ 30 mn / Outright sale

3 3 Genesis of Project Koeing US: The Backdrop The Backdrop  Over last few decades, global Pharma companies experience rising competition and costs related to conducting research on patented molecules. Thus, they increasingly resort to outsourcing this research or acquiring commercially attractive and ready molecules, esp. Biotech product patents  During the last over 8-10 years, the price of biotech molecules grew substantially ranging between US$ bn. and several large transactions took place with Pharma companies buying or licensing out these molecules from biotech companies  However, the scientists responsible for developing these molecules were rarely sufficiently compensated, leading to a significant level of frustration in the scientist community, On the other hand, the biotech companies walked away with huge profits  Also, while the society was benefited with new innovative products, they came at a high cost Company’s Formation  Given his extensive experience in the Pharma and medical field, the key promoter of Project Koeing US (PK US), identified a unique opportunity of creating a ‘platform’ for research scientists wherein they could internally develop patented molecules at effective costs and reap financial rewards for their efforts  With this background, PK US was formed in year 2003  Many well renowned scientists from the U.S. and India joined PK US as equity holders in the Company and are currently on the Scientific Advisory Board, guiding the development of molecules they have themselves developed  The Company’s entire research team is not only fully dedicated to serving the society with their research contributions but is also focused on providing the same at more economical rates that would not have been possible otherwise

4 4 Project Koeing: A Snapshot  Project Koeing India (PKI) is the Indian subsidiary of PK US and is currently one of the fastest growing biotechnology companies in India  The Company’s vision is “ To improve the quality of human life by assisting in the detection and treatment of cancer and various abnormalities’  PKI has a unique business model of acting as an incubator of various molecules and technology platforms during their development process  The Company has already in-licensed patented molecules and technology platforms in 5 areas related to Cancer and other diseases in India. All these molecules or platforms are fully validated by important authentic agencies from the U.S. and India  Currently, the Company owns 65 patents  CAD: Ready for Market today The CAD based technology for diagnosis of breast cancer and other types soft tissue of cancers. It is a validated technology in the sense that the company has already received Bionexus status from the Malaysian Biotechnology Corporation Sdn. Bhd. And has been tested in over 400 cases in the US and proven to have an accuracy of 95%. Brief Description

5 5 The Company Structure Sub 1  The Company has been created for the commercialisation of Manufacturing technology platform for manufacture of recombinant protein Sub 3  The Company has been created for the commercialisation of A Immune system boosting cytokine technology for breast cancer Products Sub 2  The Company has been created for the commercialisation of a novel platform based on nucleic acid technology.  The 1 st product has already been shown to be safe and efficacious in cancer in Phase II human clinical trials and is all set for Phase3 studies with all approvals in place Project Koeing Sub 4 Malaysia  This division would undertake development of Biotechnology and Medical device projects In Malaysia – Currently a CAD Based Breast Cancer detection Project has been developed and is ready to market 100% equity 30% equity

6 6 In-house Value Add during the Development Process Licensing out/Sale of the Developed Molecules In-licensing of Molecules/Technology Platforms Typical Timeline – 3/4 Years  Project Koeing India licenses out new molecules or a technology platform from Pharma companies and takes over the remaining development process. The original creator (scientist) of the molecule typically takes an equity stake in Project Koeing India  Project Koeing India manages the entire development cycle of the molecule/platform in a more efficient & cost effective manner  The Company aims to:  Create cheaper and effective drugs to fight cancer. The Company is able to significant reduce the development costs of molecules as compared to Pharma Generic companies  Quick turnaround of the process  The Company enjoys the unique advantage of having various renowned scientists besides the original creator of the molecule/technology that provide extremely valuable insights during the development processes of these molecules/platforms  Once the development process is complete, Project Koeing India plans to license out or sell the developed molecules to global Pharma company that will launch these drugs into the market  Incase of licensing out, Project Koeing India will continue to hold all the patents related to the molecules/technologies, which can be further used to develop new technologies in related areas  The upfront payment received from the Pharma companies and the periodic royalties etc will be main revenue generators, which will be shared with the original creators of molecules/technologies Project Koeing India: A Unique Business Model Various Stages

7 7 The Technology Platform PKI’ various projects such as these have strong technological validates from institutions including US FDA, DCGI (India), Dept. of Science & Technology (Govt. of India), Malaysian Biotechnology Corp. etc  PKI currently has its four pillars of success in form of the following molecules:  A Platform technology for bio-manufacturing of recombinant proteins in yeast-based expression systems; Cost of production to be reduced to 20% of the current manufacturing cost  A Novel RNAi based Platform: Novel class award winning technology for the treatment of colorectal cancer; The product had already gone through Phase I / II studies in the US, and has been cleared by US FDA; Phase III studies to be conducted in India  Affinity based Drug delivery technology: Novel Class of molecules; The entire preclinical trials have been completed in US and application is being prepared for submission to the DCGI seeking approval to conduct Phase I/II clinical trials in India for liver cancer  Immunotherapy: A Cytokine Patent owned by the company and under further development in the Indian lab (at a preclinical stage); Very effective in Leukimia, Renal Cell carcinoma and other Cancers.  CAD: A Non invasive Medical device using AI based algorithms for detection of Breast cancer and automated biopsy plus drug delivery Five Technology Platforms Put together, these molecules have a market potential of over US$ 50 Bn.; PKI’ first exit of a Molecule/Platform is expected to take place in the next months; Prospective collaborators for these technologies include Merck, Roche, GSK, Pfizer etc Project Koeing is consistently working on creating its future pipeline of molecules/platforms etc and currently is in process of acquiring/licensing another 5-7 technologies

8 8 Five Key Projects in the Pipeline RNAi – 12 to 18 months A Phase III-stage clinical candidate that belongs to a novel class of molecules called ribozymes, which work by destroying mRNA molecules of target proteins; This is for the treatment of colorectal cancer Manufacturing Tech. – 6 months A platform technology for bio-manufacturing of recombinant proteins in yeast-based expression systems Affinity based drug delivery – 24 to 36 months An early clinical stage candidate that belongs to a novel class of molecules that work by organ targeted drug delivery; This is for the treatment of liver cancer Immuno-therapy – 60 months An early-stage program to discover and develop a Immuno Therapy based cytokine which will be able to help boost the immune response to fight against melanoma, Lymphoma and Rena cell carcinoma etc. Key Projects in the Pipeline CAD Tech – 3 Months A Medical Device platform technology for not only detection of various types of abnormalities like cancer but also automated Biopsy and drug delivery

9 9 Enhanced Protein Expression Technology – Manufacturing Tech. This is an interesting technology to increase the yield of fermented products and the yield is as much as times more in fermentation of recombinant proteins, leading to substantial decrease in production cost Description Platform for bio manufacturing of recombinant proteins in yeast based expression systems; Eventually the platform will also be extended to mammalian systems like CHO cells Technology Technology creator is SALK Institute for Biological Studies Dr. Martin, who had originally patented this technology, is also a shareholder in PKI Benefits This platform enables 5-10 fold increase in yield per unit, thus cost of production of proteins can be reduced to 20% of the current manufacturing cost It is also a platform which has varied applications Investors & Funding INR 45 mn has been awarded From World Bank Technology Development Funds through ICICI A total of around US$ 60 mn have been spent on the molecule so far Current Status In house work has shown and increase in Yeast cell productivity by a factor of 2 fold. Time to Market & Potential Time to market is around 1 year, with a total market potential of around US$ 30 bn

10 10 RNAi The DCGI has approved it for Phase III clinical trials in India at 20 cancer centers. RNAi based products will most likely be the first product to hit the market in the next months with a high success rate and huge market potential Description RNAi based products is a novel class prize winning technology for the treatment of colorectal cancer The mechanism of action of RNAi based products is mediated through Ribozyme; The result of RNAi based products in patients with high VegFr1 in colonic cancer patients are very high Technology 2 Major Biotech companies had initially worked on this molecule and invested over US$ 245 mn; KPI took over project when the the JV between the 2 companies split as a result of them being bought out by other major Pharma companie. Benefits Besides colorectal cancer, RNAi based products can also be used in the treatment of other types of cancer including breast cancer,and weight reduction Investors & Funding RNAi based products patent has been well acknowledged by the Govt. of India and thus has been granted US$ 4 mn from Dept. of Science & Technology for its development Current Status RNAi based products has already undergone Phase I & II trials in the U.S. and the Phase III are to begin in the next couple of months; the DCGI approval for the same has been received by PKI Time to Market & Potential Time to market is around months, with a total market potential of around US$ 15 bn Potential collaborators post the clinical trials include Pfizer, J&J and Otsuka, Aventis, Taiho etc. (Discussion have already been initiated with them.

11 11 Affinity based Drug delivery LIV1 is an early clinical stage candidate that belongs to a novel class of molecules that work by organ targeted drug delivery and is targeted at treating Liver related cancers Description The Ligand technology is a mechanism by which the active drug molecule can be delivered to the targeted organ depending on the nature of the disease The technology enables the specific Anti-Cancer drug needed to treat the tumor for focused delivery into the tumor Technology Technology creator was a Maryland based Biotech company under a JV with John Hopkins and as mentioned above, it has been validated by US FDA Benefits The first application targets liver cancer and comprises the cancer drug 5FdU linked to a second molecule that directs it selectively to the liver The FDA awarded Orphan Drug Status to the same that puts the drug on a fast track for approval Investors & Funding A total of around US$ 40 mn have been spent on the molecule so far Current Status An IND application has been prepared and is ready for submission to the DCGI seeking approval to conduct Phase I/II clinical trials of LIV-1 in India for liver cancer Time to Market & Potential Time to market is around 3 years, with potential market collaborators including Pfizer Market potential is around US$ 3 bn

12 12 Immuno Therapy Cytokine Technology is an early clinical stage gene therapy product that is targeted at treating Renal Cell Carcinoma, Myloma/ Lymphoma and other kinds of cancer Description The Immunotherapy, is an early- stage program to discover and develop a Cytokine based product for treating various immune based cancers like Myloma, Lymphoma and Renal Cell Carcinoma Technology Technology creator is researchers at NIH and PK US Benefits & Current Status While the product is at an early stage of development, it is believed to be very beneficial for breast and other kinds of cancers Investors & Funding The funding of INR 94 mn has been provided by grants and soft loan from the Department of Biotechnology, Government Of India How it works The tech works in three ways: –Blocking tumour angiogenesis (new blood vessel formation) –Inhibiting tumour cell proliferation by sequestering the growth factors –Limiting tumour metastasis by inhibiting tumour cell migration across semi-permeable barriers Time to Market & Potential Time to market is around 6 to 7 years, with a total market potential of around US$ 2 bn Potential collaborators include Novartis and GSK

13 13 CAD Technology Spacer for Inhalation CAD Ready for Market today Project Koeing has acquired an interesting technology for use in various asthmatic conditions. where the new spacers patented, developed, approved by US FDA can be of tremendous use in delivering much higher quantity of drug into the lungs as compared to the current traditional inhalers The CAD based technology for diagnosis of breast cancer and other types soft tissue of cancers. It is a validated technology in the sense that the company has already received Bionexus status from the Malaysian Biotechnology Corporation Sdn. Bhd. The Company in Malaysia will go into production as soon as funding can be obtained. In Studies involving over 400 patients the technology has shown to have an accuracy of 95% with less than 1 false positive in 4 films.

14 14 The Promoter Team Co Founder Founder Has spent over 40 years in the pharmaceutical industry Commenced at age 19 in Schering AG; Grew up to the level of All India No. 2, at the age of 27 Joined The UB Group as General Manager [Corporate Management div.]; Grew to the level of President Life Science Division, and was running 7 group companies in India and Africa Was a member of Hoechst AgrEvo board, Aventis AgrEvo, and several other UB Group companies Was responsible for bringing pain killer “Combiflam“in India, and several other successful brands of the group President Project Koeing India for last four years. Also Director, of a leading Neutraceutical company. Graduate in Engineering from the US Over 23 years of experience in Biotechnology- both in the US & India Founder and Executive Vice President of a CMO [worked in using Mammalian and Yeast Cell lines]. Subsequently, founded a BioInstruments company [Nasdaq quoted company], which was involved in the marketing of sophisticated equipments for Biotech R&D. Prior to this he was associated with a Medical device company- a CAD based diagnostic Tech company Founder, Managing Director of PK US and its associate companies in India and Malaysia

15 15 Senior Management Team ManagementQualifications & Experience Director Medical Affairs, Project Koeing India Was Director Medical Affairs, Hoechst, Aventis; Later, Vice President at Zydus Cadila Incharge – Regulatory AffairsWas previously working with Bharat Biotech Head, R&D Was professor in Texas Health centre. Director for Gene Transfer Technologies for Cancer Therapy & Research Center, Texas [USA] and was the Head-Biology Research for Reliance Life Sciences [Mumbai; Ph.D with Molecular Virology & Oncology, Wisconsin, U.S. Executive Vice President – Legal and Commercial Graduate from the University of Poona, pursued his Management Studies at the Jamanalal Bajaj Institute Mumbai & the Narsee Monjee Institute Bombay; Was previously a senior officer in Hoechst Marion Roussel and General Manager in Global Tele VP of New Projects Strategic Consultant by profession he is Looking after all the new projects of the company; Worked with Hitachi India, prior to joining Project Koeing India Executive Vice President = HRD & Materials Management Over 30 years of experience in Pharma and Liquor industry. Was Vice President UB Group CSO Has previously worked with Amgen, Genentech, Avasthagen etc; Was CSO of Project Koeing India for 3 years; Currently he has decided to move to San Francisco and will assist PK US operations in the US VP R&DWas previously working with Glenmark

16 16 Knowledge Quotient of the Team

17 17 Scientific Advisory Board NameAssociations Noriyuki Kasahara M.D., Ph.D. University of California at Los Angeles, CA Patrick Hwu, M.D.MD Anderson Cancer Center, Houston, TX Dr Mukund Joshi Ex President Indian Radiological & Imaging Association Chief Radiologist at Jaslok & Tata Hospital Dr. Om Tavri Ex President Indian Radiological & Imaging Association Chief Consultant Asian Cardiology Institute The Scientific Board plays a key role in maintaining a strong product pipeline for the Company by continuously searching for and acquiring new technologies/products for Project Koeing India to work upon in the future; Most of the Board members are part owners of the technologies/products, thus are shareholders in the Company

18 18 Clinical Advisory Board NameAssociations Alan Venook M.D.University of California at San Francisco, CA Malcolm Brenner M.B., Ch.B., Ph.D, F.R.C.P., F.R.C.Path. Baylor College of Medicine, TX Dr K C SaxenaFounder and CTO Stereometrix., San Jose, CA Dr. Eberhard Baltin MD & VC Hoechst Group MD Aventis Pharma Nassim Usmaan, Ph.DCEO, Catalyst Biosciences, San Francisco, CA Kim Margolin M.DFred Hutchinsons Cancer Center, Seattle, WA The Clinical Board plays an active role in the development and testing of products by guiding the entire process from acquisition till the clinical trials of the products

19 19 The R&D Lab at Mumbai Project Koeing India has an 18,000 sq ft Research and Development laboratories in Mumbai. This state of the art DSIR approved R&D labs will be used to develop products. A larger pilot plant and manufacturing center on 11 acres will be setup in Khapoli. Lab Facilities include 1.State of the art of Recombinant, Mammalian and Bacterial yeast based cGLP Laboratories 2.State of the art level 2t, Gene Therapy Labs with incineration at exhaust points to contain any virus spillage and positive pressure Corridors 3.Labs for development of cytokine based Immunotherapy 4.The common infrastructure is set aside with easy access for all labs 5.All the labs are in a clean zone environment and accessible only with appropriate access using electronic keys and electronic air lock system The lab facility at Mumbai is the cornerstone infrastructure for all the ongoing R&D efforts at PKI and is a state of the art facility serving all requirements of the various technologies/products under development

20 20 Key Features of the Lab Fermentation & Protein Purification Microbiology & Molecular Biology These labs are used for yeast fermentation and application of VFF2 technology to produce recombinant bio-therapeutic proteins such as human insulin, human growth hormone, G-CSF, etc. The major equipment here is as follows: Biocontainment hood Incubators Five-liter Fermentors Chiller and compressor units Bench-top refrigerated centrifuges and microfuges Floor model centrifuges PCR Thermocyclers Electrophoresis systems HPLC Chromatography systems (Radial and Axial) These labs are used for preparation of DNA, RNA and plasmids, banking of plasmids in E. coli bacteria, and analysis of DNA by restriction enzyme mapping, polymerase chain reaction (PCR) and gel electrophoresis. The major equipment here is as follows: Biocontainment hood Incubators Bench-top refrigerated centrifuges and microfuges PCR Thermocyclers Electrophoresis systems Gel documentation system (for electronic capture and recording of data)

21 21 Key Features of the Lab (contd.) Ancillary Labs Gene Therapy & RCL Assay They include labs for Media Preparation, Analytical and Cell Culture. The major equipment here is as follows: Water purification system Autoclaves Freezers: -80oC and -20oC UV/VIS Spectrophotometer ELISA Reader Biocontainment hoods CO2 Incubators These labs are used for discovery, production and analysis of lentiviral-based gene therapy products using MSP36. Since lenti-viruses can be pathogenic, the gene therapy lab has been specially designed to provide Level II containment with an independent HVAC system, negative pressure and burn-out unit. The major equipment here is as follows: Biocontainment hoods CO2 Incubators Microscope Two-way autoclave for biohazard waste decontamination Ultra-centrifuge

22 22 The Pilot Plant Pilot Plat for Recombinant Proteins Pilot Plant for Recombinant Proteins (being equipped): This has been built to be “almost” GMP specifications, incorporating separate HVAC systems, uni-directional flow of personnel, labs for QC/QA, Media Prep Room, and various suites for Fermentation, Clarification and Downstream. The major equipment here are as follows: 10- and 30-liter Fermentors Autoclaves Boiler (steam generation), chiller and compressor unit Floor model centrifuges Tangential flow filtration systems Low pressure and High Performance Chromatography systems Analytical lab instrumentation

23 23 SWOT Analysis StrengthsWeaknesses 1.Only company in India with a drug in Phase III stage 2.Owner of unique Manufacturing technology 3.High IPR value 4.Validated and recognized by International Research Institutes and Governments Agencies 5.Wide spectrum Of operations 6.High Precision Value Chain 1.Currently, an Indian Government subsidized organization, however with minimal incentive from the Govt. 2.Infancy stage of the biotech sector and the lack of significant awareness in India 3.Lack of super specialist manpower 4.Slightly complex legal structures OpportunitiesThreats 1.US$30 bn Orphan Drug Market to be tapped 2.Opportunity to generate very high networth worth US$100 bn worldwide 3.Huge Potential of value creation 4.Opportunity to generate higher IPR value 5.Opportunity to improve the quality of life by creating new improved treatments for cancer 6.Opportunity to improve Biotech research status in India & abroad 1.Brain Drain 2.Infringement of IPR 3.Sustention of Continuous R&D Investment 4.Technology obsolesce of the technical equipment used 5.Volatility of global economic conditions 6.High lead time in Infrastructure Development

24 24 Milestones Achieved & Road Ahead Achievements Till Date Expected Milestones Year 0-1Year 1-2Year 2-3 DCGI Approval for Phase III Trials for RNAi based products 18,000 sq.ft. R&D setup at Mumbai Acquired 5 acres of land for the new manufacturing plant More than US$ 10 mn invested by PKI in the current pipeline Govt. Permissions/R& D Plant setup Production & Approvals for RNAi based products Licensing/Sal e of RNAi based products (First Exit)

25 25 Key Focus Areas for Growth Key Focus areas for Project Koeing Create the planned Pilot manufacturing plant at Khopoli Complete the ongoing development of the current product pipeline on schedule Focus on acquiring new technologies /products to maintain a strong product pipeline Currently, Project Koeing requires US$ 30 mn to pursue its growth strategy, which primarily includes continuing development activities for its four key products and bring them to conclusion

26 26 Project Wise Fund Requirement The total fund requirement of US$ 30 mn is split across all the four key technologies/products with the Manufacturing and RNAi based products garnering the majority shares

27 27 Prospective Clients Upon Product Maturity Project Koeing has a large potential client base upon the maturity of its products/technologies Typical Exit  Revenue generation at PKI will take place at the exit of a product/technology, which will most likely take place in form of the licensing out of the technology/product once it is ready for commercialization  A typical licensing deal includes an upfront payment to the technology owner and royalties/periodic payments over next years  There could also be a sale of the technology/product for a large lump sum payment Potential Collaborators  All the major pharma companies in the world are prospective clients for Project Koeing, especially the ones doing significant research on cancer related drugs. Some such companies include Roche, GSK, Pfizer, J&J etc  Also, other companies such as UB Group, Shaw Wallace etc are also potential clients as they use fermentation technology as a basis of their operations

28 28 Biotechnology: The Next Sunshine Sector The Global Biotechnology Sector  The global biotechnology industry is over 30 years old and is generating almost US$ 100 bn in revenues. There are appr. 7,000 companies worldwide, less than 600 of which are public companies  There has also been a significant support from the Governments, given that almost US$ 150 bn worth Govt. funding has been granted to this sector  In last decade, the industry has made historic progress with strong product pipelines and product successes, record-breaking financing totals, unprecedented deal activity and impressive financial results. Further, according to an E&Y report, all the leading regions in the world have been recording a strong double digit growth  The sector is now beginning to understand disease 'globally' i.e., from a systems point of view, from gene or SNP to protein to networks to disease. In parallel, and conversely, the notion of 'one size fits all' is being replaced by medicine targeting the individual and the central tenet on which a huge biopharmaceutical industry has been built has to adjust to a new and evolving personalized medicine world The Indian Biotechnology Sector  The Biotechnology sector in India, although nascent at the present time and accounting for a mere 2% of the global Biotechnology market, is poised for exponential growth over the next 5 years with an expected global market share of 10%  The total revenues of this sector stand at around US$ 1 bn. With a market cap of around US$ 2.5 bn.  The Indian biotechnology industry is gathering momentum, by leveraging its low cost scientific skill base in an imitative manner with which to build its capPK USlities  Today, the Indian biotech sector has attained critical mass in manufacturing as well as research services and has slowly built a market for biotech products and services Indian Biotechnology is now poised to leverage its scientific skills and technical experience to make a global impact on a strong innovation led platform  A vibrant pharmaceutical industry, and fast developing clinical capPK USlities collectively points to a promising biotechnology sector and has placed India favourably in the global market.

29 29 Global Pharma Companies Focus on R&D RANKCOMPANY R&D SPEND (US$ BN.) As of March 2008 AS A %AGE OF SALES As of March Pfizer % 2Johnson & Johnson % 3GlaxoSmithKline % 4Sanofi-Aventis % 5Roche % 6Novartis % 7Merck & Co % 8Abbott % 9Astra Zeneca % 10Amgen % Global Pharma companies are increasingly spending more money on their R&D efforts, which indicates the significant focus from their end on developing new drugs and technologies. As a result, these companies have also been partnering with Biotech companies to fulfill their need for new drug discovery & development through various means

30 30 Deal Activity in Biotechnology Sector Companies Deal Value (US$ bn.) Novartis & Chiron5.1 Pfizer & Vicuron1.9 GSK & ID Biomedical1.4 Companies Deal Value (US$ bn.) Amgen & Immunex16.0 Biogen & Idec3.7 Amgen & Abgenix2.2 Shire & TKT1.6 OSI & Eyetech0.9 Quest & LabOne0.9 Pharma – Biotech Transactions Biotech – Biotech Transactions There has been significant deal activity in the Biotech sector in the past few years, indicating the various synergistic values both Pharma & Biotech companies are recognizing between themselves


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