Biotecnología

BIOTECNOLOGIA IESE – 11 de marzo de 2010

BIOTECNOLOGÍA Toda aplicación tecnológica que utilice sistemas biológicos y organismos vivos o sus derivados para la creación o modificación de productos o procesos para usos específicos.

QUÉ SISTEMA BIOLÓGICO ? QUÉ ORGANISMO VIVO? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

CREACIÓN O MODIFICACIÓN DE PRODUCTOS O PROCESOS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],[object Object],[object Object],ENTENDIENDO LA VIDA. UN DOBLE HARDWARE

El DNA ES UNA SOPA DE LETRAS QUE ALMACENA TODA LA INFORMACION MEDIANTE UN SENCILLO ALFABETO DE 4 LETRAS (A,C,G,T,) ATGTTGACCTGATCGAAATGGATCCTCTCTCGACTATAACCA ATGATG GAAATGGATCATGTTGACCTGATC GATCCTCTCTCGACTTTGACCTGC ATGATGCCTAGCATGTTGACCTGATCGAAATGGATCCTCTCTCGACTA GGATCCTCTCTCGACTATAACCAATGATGCCTAGCACATGTTGACCTG CGACTATAACCAATGATGCCTAGCATGTTGACCTGATCGAAATGGATC CTAGCCAATGATGCCTAGCCAATGATGCCTAGCATGATGCCTAGCTTG TGGATCCTCTCTCGACTATAACCAATGATGCCTAGATGTTGACCTGAT GGATCCTCTCTCGACTATAACCAATGATGCCTAGCACATGTTGACCTG CCTGATCGAAATGGATCCTCTCTCGACTATAACCAATGATGCCTAGCA ATGTTGACCTGATCGAAATGGATCCTCTCTCGACTATAACCAATGATG CTAGCCAATGATGCCTAGCCAATGATGCCTAGCATGATGCCTAGCTTG GACTATAACC AATGATGCCTAGCACATGTTCTAGCCAAT GATGCACAT GTTCTAGCCCTAGCCAATGATGCCTAGCATGATGCCTAGCTTGTGATG

SÍNTESIS DE PROTEÍNAS CÓDIGO GENÉTICO . Es el conjunto de normas por las que la información codificada en el material genético (secuencias de ADN o ARN) se traduce en proteínas en las células vivas. El código define la relación entre secuencias de tres nucleótidos, llamadas codones, y los aminoácidos. La secuencia de codones determina la secuencia de una proteína en concreto, que tendrá una estructura y una función específicas

LOS GENES SON FRASES CON SIGNIFICADO FORMADAS POR PALABRAS DE TRES LETRAS ATGCCTACTT ATG CCA TTG ATTCCCAA aa1 aa2 aa3 PROTEINA

Genes Proteína Función Pérdida de función ENFERMEDAD Mutación

DNA P exón 1 exón 2 exón 3 Transcripción Splicing RNA proteína traducción LOS GENES ESTAN FRAGMENTADOS Intrón 1 Intrón 2

BIOTECNOLOGIA Y MEDICINA ,[object Object],[object Object],[object Object],[object Object],[object Object]

MODIFICANDO EL ADN ,[object Object],[object Object],[object Object]

EJEMPLOS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

REPARANDO EL ADN ,[object Object],[object Object],[object Object],[object Object]

EN QUÉ SE INVESTIGA ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],ARN

iRNA - PROBLEMAS Y OPORTUNIDADES ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

LA PRODUCCIÓN DE PROTEÍNAS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

LAS MEMBRANAS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

EVALUAR PROYECTOS Y COMPAÑIAS ,[object Object],[object Object],[object Object],[object Object]

ENFERMEDADES POR ORDEN DECRECIENTE DE PREVALENCIA

ORPHAN DRUG DEVELOPMENT AND APPROVAL TRENDS H12009= Q1 2009 + Q22009 Number of designated and approved orphan drugs in the US, 1993 – Q2 2009

ORPHAN DRUG DEVELOPMENT AND APPROVAL TRENDS H12009= Q1 2009 + Q22009 Number of designated, approved, withdrawn/suspended and refused orphan drugs in the EU, 2000 – Q2 2009

MARKET DEFINITION – Cancer Market Note : The L2A3 class comprises LHRH analogs but for the purpose of this report it will be defined as "LHRH agonists". LHRH antagonists are classified under the L2B9 class: other hormone antagonists. DNA = deoxyribonucleic acid; LHRH = luteinzing hormone-releasing hormone Source: Datamonitor

BUSINESS NEWS Biovitrum sells anti-obesity programme to AstraZeneca Astrazeneca is to pay biovitrum up to €186 million for its preclinical leptin. Novartis to pay up to $620 million for Corthera Novartis is to acquire the privately held US biopharmaceutical company Corthera for $120 million up front and up to $500 million in development and commercialisation milestones. Teva signs pact for OncoGenex’s cancer adjunct Teva is to pay $60 million up front and up to $370 million in milestones to access OncoGenex’s lead product, the cancer adjunct therapy candidate OGX-011. Novartis venture arm inks $200M deal with tiny Viamet Tiny Viamet Pharmaceuticals in Morrisville, NC has snared a $200 million licensing option deal with the venture arm of Swiss pharma giant Novartis.

TOP 20 BIOTECH VENTURE CAPITAL DEALS OF 2009 1. Clovis Oncology - $146.30 million 2. Zogenix - $70.96 million 3. BioVex Group - $70 million 4. Pacific Biosciences - $68 million 5. Hyperion Therapeutics - $68 million 6. Anacor Pharmaceuticals $50 million 6. Proteon Therapeutics $50 million 6. PTC Therapeutics $50 million 9. Virdante Pharmaceuticals - $47.75 million 10. Cempra Pharmaceuticals - $46 million 11. Complete Genomics - $45 million 11. SFJ Pharmaceuticals - $45 million 13. Amyris Biotechnologies - $41.75 million 14. Kolltan Pharmaceuticals - $40.50 million 15. Ironwood Pharmaceuticals - $40 million 15. Epizyme - $40 million 15. Adamas Pharmaceuticals - $40 million 15. Aileron Therapeutics - $40 million 15. Regado Biosciences - $40 million 20. GlycoMimetics - $38.98 million

Valuation approach and methods (I) ,[object Object],Current Competitors Target Population Future Competitors # Patients Treated Pharmaco- economics Benchmark Prices Product Price Cost Assumptions R&D Risks Revenue Projections Cash Flow Model Augmented NPV

Project values (including partnering scenarios) and company value ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Note: sum of project values may not add to 223 due to rounding errors.

Company value and comparables ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Mean = EUR 110 million  In summary, Bioscience Valuation believes that GP Pharm is fairly valued at about EUR 220 million. Note that this valuation does not consider drug sales in countries other than the EU5 and USA, nor does it fully consider all assets of GP Pharm (such as, e.g., land and facilities). Both factors tend to increase GP Pharm’s value beyond the EUR 223 million that results from Bioscience Valuation’s analysis.

Sarcodoxome ® - Assumptions Sarcodoxome ®

Product profile Source: Team meeting at GP Pharm ,[object Object],[object Object],[object Object],[object Object],Sarcodoxome ®

Decision tree Sarcodoxome ® ,[object Object],[object Object],Note: Scenario probabilities do not add up to 100% due to rounding effects.

Derivation of patients eligible for treatment - STS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2020 figures (USA, EU5) Total population USA: 330 million [1] EU5: 302 million [1] Patients receiving chemotherapy = patients eligible for Sarcodoxome ® Patients with soft tissue sarcoma (incidence) USA: 10,099 EU5: 8,705 USA: 10,782 EU5: 9,294 USA: 0.0031% [2] EU5: 0.0022% [3] USA: 7,574 EU5: 6,529 USA: 8,578 EU5: 7,349 STS patients excluding GIST Regional disease (prevalence) 75% [4] (70% - 75% - 80%, Pert) 25% [5] ( 19% - 25% - 31%, Pert) Adjusted for stage-specific 5-year survival rates [5] Distant disease (prevalence) 15% [5] ( 11% - 15% - 19%, Pert ) Adjusted for stage-specific 5-year survival rates [5] USA: 2,772 EU5: 2,390 95% [6] ( 90% - 95% - 100%, Pert ) Sarcodoxome ®

Pricing and patient share ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],2 3 4 5 6 1 Sarcodoxome ® 7

Competition - pipeline drugs for STS Sources: PJB Pharmaprojects, April 2007 Adis R&D Insight, April 2007 ,[object Object],Sarcodoxome ® * n.k. = development for STS is not mentioned * * * * * * * * ,[object Object]

Patient penetration ,[object Object],[object Object],Sarcodoxome ®

Commercial costs - promotional & sales force costs ,[object Object],Source: BSV benchmarks ,[object Object],[object Object],[object Object],Sales force costs ,[object Object],[object Object],Sarcodoxome ®

Commercial costs - sales representatives per territory ,[object Object],[object Object],Sarcodoxome ® Source: BSV benchmarks

Further assumptions for the project model - Sarcodoxome ® ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Total R&D costs: EUR 7.73 million Sources: GP Pharm Sarcodoxome ®

Sarcodoxome ® - Results Sarcodoxome ®

Sales forecast ,[object Object],Sarcodoxome ® Note: Sales per region might not add up sales for all countries due to rounding effects.

NPV results Sarcodoxome ® Note: total costs = R&D costs + commercial costs ,[object Object],[object Object],[object Object]

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