business development and its information needs jj owen, aveo pharmaceuticals bob bennett, merrimack...
TRANSCRIPT
Business Development And Its Information Needs
JJ Owen, AVEO PharmaceuticalsBob Bennett, Merrimack Pharmaceuticals
March 2007
Agenda
Introduction – Our Background
Business DevelopmentWho and What do they do?
Case Study: In-licensingOutputs and Sources
Creating Value: Beyond the Sources
Our Background
JJ Owen Bob Bennett
Years in Industry 7 9
Education Ph.D. Biology M.S. ChemistryM.B.A.
Work Experience Cell BiologistProteome/IncyteKnowledge MgmtSci & Comp AnalysisBus Dev
Organic ChemistSci & Comp AnalysisBus Dev
Company AVEO Pharmaceuticals Merrimack Pharmaceuticals
Position Business Development Business Development
Size of Company 80 60
Size of Bus Dev 3 3
Who is Business Development?
Small organization
Mostly MBA trained (some with science
backgrounds)
Typically marketing or finance backgrounds
Prior background - consultants
Intimately aware of several data sources
Unaware of a large majority
Time crunched deadlines is the norm
Attention span of a gnat
Job focus & data source needs constantly changing
Business Development – What do they do?
Traditional activities Non-traditional activities
Mergers &Acquisitions
Licensing Activity Competiti
ve Landscape
Financials
Market Analysi
s
Deal Negotiatio
n
Public Relation
s
Technical
WritingCompetitiv
e Intelligenc
e Project Manageme
nt
Case Study – In-licensing
In-licensing has been described as…
…Finding a needle in a haystack
In-licensing: Process Flow
Tracking database
Finding Leads
Conferences
Connections
Secondary Sources
Primary Sources
Target Sweeps
Making the Case
Company Profiles
Key Personnel
Pipeline snapshot
Financials
Deals
Competitor Pipelines
Clinical Trial Data
Commercial Profile
Market Data
Pursue Opportunity
Case Study – In-licensingFinding Leads
Finding Leads
Attend conferencesAACR, ASCO, CHI, SRI, EORTC, many, many others
ConnectionsWho do you know?
Secondary SourcesThomson Pharma, BioCentury, BioWorld, NewsFeeds,
WWW
Primary SourcesInvestors, SAB, BOD, Consultants
Target Sweeps
Company Drug Highest Dev. Status
ASTA Medica AG perifosine Phase 2 Clinical
Novartis AEE-788 Phase 1 Clinical
Rexahn RX-0201 Phase 1 Clinical
Abbott Laboratories AKT kinase inhibitors, Abbott Discovery
AEterna Zentaris Inc erucylphosphocholine Discovery
Amphora Discovery Akt1 inhibitors, Amphora Discovery
Berlex Biosciences BX-424 Discovery
Bristol-Myers Squibb BMS-536924 Discovery
Cellular Genomics Akt-1 inhibitors, Cellular Genomics Discovery
Consensus Pharmaceuticals anticancer agents, Consensus Discovery
Institute of Cancer Research UK PKB inhibitors, Astex/ ICR/ Cancer Research UK Discovery
Kinetek Pharmaceuticals protein kinase B (PKB/Akt) inhibitors, Kinetek Discovery
Merck Akt protein kinase inhibitors, Merck & Co Discovery
National Cancer Institute azoacridone anticancer agents, NCI Discovery
National Cancer Institute EM-12 Discovery
National Cancer Institute RTA-502 Discovery
NeoGenesis Pharmaceuticals Akt-1 inhibitors (cancer), NeoGenesis Discovery
Nerviano Medical Sciences Akt kinase inhibitors (cancer), Nerviano Discovery
SourcesThomson Pharma, Company Websites, Newsfeeds
Akt inhibitors
Case Study – In-licensingMaking the Case
Company Profiles - MGI Pharma
Drug Indications Stage
Aloxi Chemo-induced Nausea and vomiting Marketed
Salagen Dry mouth Marketed
Hexalen Ovarian Marketed
Dacogen MDS, Leukemia, Solid Tumors Registration
Irofulven Ovarian, Liver, Prostate, Pancreatic Phase 2
Saforis Mucositis Phase 3
ZYC101A Cervical dysplasia Phase 2/3
ZYC300 Cancer cells expressing CYP1B1 protein Phase 1/2
MG98 MDS, AML Phase 1
Overview• Headquarters: Bloomington, MN, Lexington, MA (MGI
Biologics)• Therapeutic Focus: Entities (small molecule or Biologics)
for cancer treatment and supportive care• Technology: BIOTOPE (targeted plasmid system) and
GENCAP (DNA protection)• Strategy: Acquisition of clinical stage development
compounds• Investors: Publicly traded on NASDAQ (MOGN)• Cash Position: $205.5M• Market Cap: $1.65 B ($1.65 B Enterprise Value)• Employees: 282
Recent News4/05: MGI PHARMA Reports First Quarter Results1/05: Dacogen NDA filing for MDS accepted by FDA 12/04: Dacogen P3 trial results in MDS reported at ASH10/04: Dacogen MAA filing for MDS accepted by EMEA 9/04: Begins promotion of Kadian to oncologists 9/04: Acquires WW marketing rights for Dacogen from
SuperGen9/04: Acquires Zycos for $50 M in cash9/04: Acquires Aesgen for $90 M in cash7/04: Kadian marketing agreement for oncology market with
Alpharma
Pipeline
--Aloxi (licensed NA rights from Helsinn SA)--Salagen (retains NA marketing rights)--Hexalen (retains WW rights)--Dacogen (Decitabine) (acquired WW rights from SuperGen)
•Small molecule, DNA methyltransferase inhibitor•P3 mono, MDS, 170 pts: RR 17% vs. 0% for supportive care
•P2 mono, Gleevec ref. CML, 27 pts: 17 hema. response --Irofulven (retains WW rights)
•Small molecule acylfulvene, breaks DNA strands•P2 mono, rel/ref Ovarian, 55 pts: 1 CR, 9 PR•P3 mono, ref Pancreatic: OS inferior to 5-FU•P2 with ERCC3 gene deficient pts underway•P2 mono, liver, 48 pts: 2 PR, 18 SD
--Saforis (retains WW rights), Phase III, mucositis--ZYC101a (acquired in purchase of ZYCOS )
•Antibody, completed Phase II, 161 pts, RR 43% vs. 27%, drug was well tolerated
--ZYC300 (acquired in purchase of ZYCOS)•Antibody, completed Phase I/II, 17 pts, ASCO 2003, drug was well tolerated and biologically active
--MG98 (licensed NA rights from Methylgene)•Antisense oligonucleotide, inhibits DNA methyltransferase-1
•P2 RCC, IFN combo: Initiated 10/04
Partnering Rationale
•Potential collaboration partner with our discovery platform and their therapeutic Antibody program•Aggressive late stage up and coming Oncology development company with cash and solid market cap
Sources--Thomson Pharma, Recap, Company website, Yahoo Finance, SEC
MGI Pharma
Key Officers
Leon O. Moulder, President and CEO
Prev at Eligix, Inc., Hoechst Marion Roussel (now Aventis), Marion Laboratories, and Marion Merrell Dow.
James C. Hawley, SVP, CFO Recently joined MGI Pharma, Prev. CFO and corporate secretary at CIMA LABS, principal with Manchester Companies, Inc., and Orthomet
Michael T. Cullen, CMO Prev at Searle/Pharmacia
Martin J. Duvall, SVP, Commercial Operations
Prev 18 yrs at Aventis
Mary Lynne Hedley, SVP, MGI Pharma Biologics
Cofounder of ZYCOS, Inc. and most recently served as president and chief executive officer
Personnel FinancialsIncome Statement (12/31/2004)Revenues $195.7 MCOGS 60.0 MR&D Expense 62.6 MSG&A Expense 73.8 M Acq. R&D Expense 83.1 MOperating Income (84.7 M)Interest Income 5.3 MInterest Expense (6.0 M) EBT (85.4 M)
Balance Sheet (12/31/04)Assets:Cash and Equivalents 205.5 MAccounts Receivable 122.3 MInventories 8.4 MOther Current Assets 5.8 MLT Investments 75.4 MProperty, Plant and Equipment 2.7 MIntangible Assets 8.0 MTotal Assets 436.3 M
Liabilities:Current Liabilities 58.8 MLong Term Debt 260.2 MOther Liabilities 2.8 MTotal Liabilities 321.8 MShareholders Equity:Net Shareholders Equity 114.5 MTotal Liabilities and SH Equity 436.3 M
Board of Directors
Andrew J. Ferrara President and CEO of Boston Healthcare, managing partner of Boston BioLicensing, L.L.C.
Gilla Kaplan Current head of the Laboratory of Mycobacterial Immunity and Pathogenesis, The Public Health Research Institute, Newark, NJ.
Edward W. Mehrer CFO of CyDex, a drug delivery company. Board member and audit committee chair of Novastar Financial
Hugh E. Miller Chairman, retired from ICI after a 22-year career
Lonnie Moulder See profile above
Lee Schroeder President and director of Lee Schroeder & Associates, Inc.
David B. Sharrock Director of Interneuron Pharmaceuticals Inc., Praecis Pharmaceuticals, Incara, Broadway, and The Ohio State University Foundation
Waneta C. Tuttle CEO, Southwest Medical Ventures, and CEO, Exagen Diagnostics, Inc.
Arthur L. Weaver Leading rheumatologist, serves as medical director of Arthritis Center of Nebraska
MGI Pharma
Deals
9/04: Acquires privately held Zycos for $50 M in cash•Acquires expertise in immunology and development of biologics•See Pipeline for clinical data
9/04: Acquires privately held Aesgen for $32 M in cash •Pays $32 M upfront, milestones of $33 M for approval and $25 M if annual sales exceed $50 M plus royalty of 5%
•Acquires Saforis, a P3 compound for oral mucositis9/04: Licenses WW rights to Dacogen from SuperGen
•P3 completed in MDS with an NDA expected 4Q04•Possible expansion into AML, CLL and solid tumor •Pays $40 M equity investment, up to $45 M in milestones, at least $15 M in development costs and royalty from 20-30%
7/04: Kadian marketing agreement with Alpharma•Kadian is a sustained release morphine marketed for pain relief•3 yr agreement for MGI to market Kadian to oncologists•Undisclosed profit sharing agreement
4/01: Licenses NA commercialization rights for Aloxi from Helsinn•Aloxi is a P3 product for chemotherapy induced nausea and vomiting•Pays $11 M upfront, undisclosed milestones and royalties•Helsinn funds development and responsible for manufacturing•4/03: Collaboration expanded to include post-operative nausea and vomiting indication and an oral formulation
•Pays $22.5 M upfront and up to $25 M in milestones1/01: US marketing rights for Mylocel from Barr Labs
•Mylocel (hydroxyurea) marketed for melanoma, CML and ovarian cancer•Barr receives undisclosed royalties
Competitive Landscape: Late Stage Breast Cancer Targeted Therapies
Drug MOA Current Phase
Latest Breast Cancer Trial Data Expected Filing Date
Lapatinib (GW2016)
Inhibits EGFR and Her2
Phase III Phase III combination trials, Lapatinib with:• Capcitebine, first line metastatic, on-going• Paclitaxel, first line metastatic, on-going• Letrozole , first line metastatic, hormone eligible patients, on-going, interim analysis – 35% RR
Late 2006
Early 2007
Avastin VEGF inhibitor Phase III Phase III trial for an Avastin-Capcitebine combination failed to meet primary endpoint
Phase III trial in comb w Paclitaxel, 700 pts, first line metastatic, 28% RR vs 14%, PFS 10.9 mo vs. 6.11 mo
Late 2006
Early 2007
ABX-EGFR Her2 antibody Phase II Phase II trials in solid tumors indicates solid data in several tumor types. Amgen/Abgenix appears to be targeting Colorectal cancer
Not applicable
Omnitarg (pertuzumab)
Her2 antibody Phase II Interim data from ASCO, open-label randomized trial, 79 patients, 2 cohorts, 2 PR, 32 SD
Not Applicable
Sources--Thomson Pharma--Clinicaltrials.gov, ASCO abstracts, DataMonitor
Market Analysis: Breast Cancer Epidemiology and Current Treatment Paradigm, 2004
Incidence Prevalence Mortality 1 yr survival 5 yr survival
412,894 2,714,400 121,197 97.5% 86.5%
Current Treatment Paradigm
Early Stage Late Stage
Surgery
Adjuvant Therapy*
Hormonal Therapy Chemotherapy
Tamoxifen AC (doxorubicin + cyclophosphamide)
Arimidex CMF (cyclophosphamide + methotrexate + fluoracil)
*depends on hormone receptor and menopausal status
Options dependent on status
Chemotherapy -Paclitaxel and Docetaxel
Hormonal Therapy-Tamoxifen or Arimidex
Targeted Therapy-Herceptin (Her2+ only, 25% of
patients)
Sources--DataMonitor, WWW, GloboCan, American Cancer society, NCI
Business Development Sources
Extremely limited resources, always looking for the
best “bang for your buck”
Choice of source is critical when one has money
Public sources, public sources, public sources
Current GapsSales projections
Analyst reports
Clinical trial data
Deal details
I Know How To Search For Information!
Of Course, You Know Better
Perception vs. Reality
Does Information Flow Freely?
Demand Supply
How Is Information & Analysis Delivered In Your Organization?
NewslettersLiterature AlertsConference ReportsInteractions with individualsMembership on project teams
On-line requestsJournal subscriptions Department webpage
Provide access to databases
Value Is Created In Each Step Of The Process
Greater breadth of information sourcesAccess
Timeliness
SubjectKnowledge
Delivery
Rapid access to information through knowledge, effective searching, and alerts
Cut through the noise, recognize critical info, provide analysis, deliver exec summaries
Multitude of delivery mechanismsReduce time to customer
How Would An Information Professional Assist Bus Dev?
Added Knowledge
Sources, limitations, and effective use
Focused Data
Quality, accuracy, completeness, analysis
Efficient Use Of Time
Division of labor
Assist In Budgeting
Able to forecast information needs as company matures
JJ Owen:AVEO Pharmaceuticals
[email protected] 617.299.5889
Bob Bennett:Merrimack [email protected]
617.441.1008
Thank you