Innovative and improved drugs therapies developed through novel target discovery and technology platforms have originated from the backyards of small research focused companies (Rising Stars, RS, non-profitable biotech companies). The universe continues to grow despite the high risk and the wait to transform into a successful profitable Mature Biotech is long.
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Innovative and improved drugs therapies developed through
novel target discovery and technology platforms have originated
from the backyards of small research focused companies (Rising
Stars, RS, non-profitable biotech companies). The universe
continues to grow despite the high risk and the wait to transform
into a successful profitable Mature Biotech is long.
3. Brief SummaryBrief Summary
Reports Cornerwww.reportscorner.com
Innovative and improved drugs therapies developed through
novel target discovery and technology platforms have originated
from the backyards of small research focused companies (Rising
Stars, RS, non-profitable biotech companies). The universe
continues to grow despite the high risk and the wait to transform
into a successful profitable Mature Biotech is long. 2012 saw new
drugs approvals for unmet needs, first in class drugs for Anti-
obesity, Myelofibrosis, cancers and better drug options for HCV,
RA, MS, psoriasis, HCC, dyslipidemia etc. We expect approval of
"better drugs for bad bugs", targeted therapies for cancer,
Alzheimer's, antivirals and orphan diseases in the next five years.
Despite negative outcome of pivotal clinical trials or ruling by the
FDA, no one (investors and large pharma/biotech companies)
have given up on innovation which is reflected in the healthy cash
position within the sector. Hope of resurrection will prevail in the
next five years and successful commercialization of anti-obesity,
dyslipidemia etc. could boost the RS sector.
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The expectation bar of investors for M&A is on the rise and with
several RS companies accepting the challenge of marketing drugs
on their own. Coming years will witness a mix of both-
acquisitions as well as entering the Mature Biotech club. The race
in innovations is killing newly launched novel drugs (ex. INCIVEK
protease inhibitor for HCV) and patents do not offer protection
from competition by better drugs in development. Diversified
strategies will be essential both for the small and big players to
mitigate these challenges as the life cycle of new drugs may be
shorter than before in some therapy areas.
The New Avatar's of Microbes is a growing threat world wide and
we expect "GAINS" for companies focused in the anti-infective
therapy class. "Pill vs. Prick"- is gaining popularity as new oral
options are entering the market for RA, Psoriasis, MS etc. Pricing
and experience of patients and physicians will drive compliance
and define market opportunity of these drugs.
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Orphan disease focus will continue to remain attractive and
success of Eteplirsen (PhII, Sarepta) for the treatment of
Duchenne muscular dystrophy (DMD) and other antisense, RNAi
drugs in the pipeline could see the final maturing of
oligonucleotide based drug therapies.
Global Biopharmaceutical Outlook 2013 of the Rising Stars sector
released by MP Advisors provides an in depth analyses of biotech
companies and their drug pipeline amidst competition and
dynamic regulatory environment. The report discusses the
competitive landscape of the targeted therapy areas and the
innovative strategy each company is deploying to surmount
challenges and remain attractive for acquisitions, partnerships or
march toward profitability. Sum of parts valuations of drugs in the
pipeline are included after factoring clinical development risks
and competition.
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Risk reward analyses of important upcoming milestones of the
companies are included which should help fund managers as well
as pharma company management to make critical decisions.
The detailed 109 pages report contains:
Macro Analysis
Report Card of MP Advisors Recommendation of 2012
Top Picks for 2013
Select Drug Approval in 2011-12 and Drug Launches in 2013-14
Select Mid To Late Stage Drug Disappointments
Cash Balance of Select RS Companies
Challenges and Unmet Need of Innovators - Launched and
Pipeline Unpartnered Compounds
Resisting resistance – Emergence of Bad Bugs – GAIN Act
New Targets And Drugs For Bad Bugs
Select Mid To Late Stage Anti-Infective Pipeline For Serious
Hospital Infections
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Retrograde Evolution- Where Innovation is Killed by Innovators
Oral vs. Injectables - Select Oral RA Drugs in Development.
In-depth Company Analysis and Reports on
Top Picks
Cempra – GAIN from Drugs for Bad Bugs
Galapagos - GLPG0634 Excels vs. all JAK Inhibitors for RA.
Incyte - JAKAFI/ JAKAVI Approved for Myelofibrosis and Drugs in
Pipeline –Drivers of Growth
Morphosys - Maturing Pipeline and Partnering/Acquisition in the
Offing
Outperforms
ArQule - Failure in NSCLC – Disappointing but Not "The End" for
Tivantinib
Basilea - Ceftobiprole + Early Stage Pipeline Remains A Free
Option!
Medivir - Simeprevir in the HCV Race - Value Un-Appreciated!
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Rigel - Be in SyK (for RA)– Positives Coming Ahead
SymBio - Novel Oncology Drug Portfolio Available as a Free Call
Option!
Trius - Partnering or Buy Out on the Cards.
Vivus - Marketing Anti-obesity Drugs -Where Being First Has not
Helped
Market Performs
Amarin - VASCEPA – Left to Fend on its Own!
Aveo - Tivozanib – Wait May be Longer!
Halozyme - rHuPH20 Benefits for Chronic Use - Still Under
Scrutiny
Immunomedics - Lack of Catalysts in Near Term
ISIS - What More is Left Beyond KYNAMRO?
Industry Tables
Drug Clinical Milestones
Drug Launch Table- 2013
NPV Valuation
9. Table of ContentsTable of Contents
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Macro Analysis
• Report Card of MP Advisors Recommendation of 2012
• Top Picks for 2013
• Select Drug Approval in 2011-12 and Drug Launches in 2013-14
• Select Mid To Late Stage Drug Disappointments
• Cash Balance of Select RS Companies
• Challenges and Unmet Need of Innovators - Launched and Pipeline Unpartnered
Compounds
• Resisting resistance – Emergence of Bad Bugs – GAIN Act
• New Targets And Drugs For Bad Bugs
• Select Mid To Late Stage Anti-Infective Pipeline For Serious Hospital Infections
• Retrograde Evolution- Where Innovation is Killed by Innovators
• Oral vs. Injectables – Select Oral RA Drugs in Development.
In-depth Company Analysis – Top Picks
10. Table of ContentsTable of Contents
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1. Cempra (CEMP)
1.1. Investment Drivers – Solithromycin, TAKSTA
1.2. Unmet Need For Next Generation Macrolides
1.3. Why Will Physicians Prescribe Solithromycin?
1.4. Background
1.5. Spectrum Of Activity Against Cabp Bacteria
1.6. Clinical Updates – Solithromycin, TAKSTA
1.7. Clinical Success Rates – Comparison With Linezolid Of Taksta
1.8. Market Opportunity
2. Galapagos (GLPG)
2.1. Investment drivers
2.2. unpartnered programs - GLPG0974, GLPG0187, CAM-1
2.3. Partnered programs - GLPG0778 / GLPG0555
2.4. Clinical Data Comparison – Select Oral RA Drugs
3. Incyte (INCY)
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3.1. Investment drivers – JAKAFI/JAKAVI
3.2. JAKAFI – Label Expansion
3.3. Competition to JAKAFI/ JAKAVI
3.4. JAK's Potential in Autoimmune / Inflammation therapy area
3.5. Other Mid- to Early-stage Pipeline
3.6. Competitive Landscape: Myelofibrosis
3.7. Clinical Data Comparison: Myelofibrosis
3.8. Baricitinib: PhIII Studies' Detail
4. Morphosys (MOR)
4.1. Investment drivers
4.2. Latest development in pipeline products (unpartnered) – MOR103, MOR208,
MOR202
4.3. Latest development in pipeline products (partnered) – Gantenerumab, BHQ880,
CNTO888
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Company analysis
Outperforms
1. ArQule (ARQL)
1.1. Major Setback for Tivantinib in NSCLC
1.2. Clinical Data – HCC, Other solid tumors
1.3. Other Pipeline Products – ARQ736, ARQ621, ARQ087
1.4. PhI Studies In Solid Tumors – Tivantinib
2. Basilea (BSLN)
2.1. Isavuconazole – Next Key Driver
2.2. Ceftobiprole and Early Stage Programs – A Free Option
2.3. Partnered Programs – Toctino, Isavuconazole
2.4. Comparative Pharmacokinetics Of The Triazoles
2.5. Competitive Landscape For Anti-Fungals
2.6. Early-stage Pipeline
2.7. Ceftobiprole – Chronology of events with FDA and MAA/CHMP
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3. Medivir (MVIR)
3.1. Positive on Approval of Simeprevir+IFN/RBV Combination
3.2. Key Products In Pipeline: IFN-Free Combination
3.3. Simeprevir – Ongoing PhIII Trials
4. Rigel (RIGL)
4.1. Investment driver – Fostamatinib
4.2. Fostamatinib: OSKIRA – PhIII Clinical Trials Designs
4.3. Select Oral RA Drugs In Development
4.4. Other Compounds in DevelopmenT – R343, R333, R548, R348
4.5. Clinical Data Comparison – Select Oral RA Drugs
5. SymBio (4582 JP)
5.1. Upside from SymBio's portfolio – TREAKISYM
5.2. Pipeline – Rigosertib, Anti-emetic Transdermal Patch
5.3. Symbio Product Portfolio
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5.4. Background
5.5. Competition From Key Marketed Drugs in CLL, MDS AND NHL
5.6. Competition From Drugs in the Pipeline For CLL, NHL and RRMM in
JAPAN/ASIA
5.7. PI3K Inhibitors in Development
5.8. Data Presented At ASH 12 of Bendamustine
5.9. Data Presented At ASH 12 of Regosertib
6. Trius (TSRX)
6.1. Market Opportunity of Tedizolid in ABBBSI
6.2. Other Indications – Tedizolid
6.3. Clinical Updates – Tedizolid
6.4. MRSA Infection – Competitive Landscape
6.5. Clinical Data in ABSSSI/ cSSSI of Select Antibiotics
6.6. Top-Line Data From the TR701-112 Trial in ABSSSI
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6.7. Collaborations
7. Vivus (VVUS)
7.1. Reimbursement Strategies Are Slowly Falling in Place – Qnexa
7.2. Stendra – Wait for a Marketing Partner May Be Rewarded Soon
7.3. Qysmia in patients with moderate to severe Obstructive Sleep Apnea (OSA)
7.4. Weight Loss And Safety Profile Comparison
Market Performs
1. Amarin (AMRN)
1.1. Clean Label Highlights Clinical Benefits
1.2. Strong IP has not been able to neutralize the concern around NCE/NME decision
1.3. Commercializing strategy
1.4. Manufacturing and Global Supply Chain
1.5. Competitive Analysis: VASCEPA vs. LOVAZA & EPANOVA
1.6. Clinical Data Comparison in Hypertriglyceridemia – VASCEPA vs. LOVAZA &
EPANOVA
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2. Aveo (AVEO)
2.1. Updated data at European Society for Medical Oncology (ESMO '12)
2.2. Data presented from TIVO-1 study at ASCO '12
2.3. Ongoing Trials for Tivozanib
2.4. Competitive Landscape: Advanced Renal Cell Carcinoma
3. Halozyme (HALO)
3.1. Baxter and CSL Have Competing SC Versions of Immunoglobulins
3.2. 2nd Generation Herceptin Could Limit the Opportunity for Herceptin SC
3.3. Biosimilar and Biobetters Could Stem MabThera SC (Rituxan) Opportunity
3.4. Upside from Unpartnered Products: Limited Opportunity
3.5. Biosimilars in Development
4. Immunomedics (IMMU)
4.1. Key Pipeline Products – Epratuzumab, 90YClivatuzumab+gemcitabine,
Veltuzumab
4.2. Antibody-Drug Conjugate (ADC) Programs
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4.3. Product Pipeline
4.4. Technology Platforms
4.5. Competitive Landscape: Lupus
5. ISIS (ISIS)
5.1. KYNAMRO – Negative CHMP and Risk Highlighted by EMDAC
5.2. Partnership – AZN, BIIB, GSK
5.3. Other Late-/ Mid-stage Programs - OncogeneX/ Teva's OGX-011/TV-1011,
OncogeneX's OGX-427, ISIS' ISIS-EIF4ERx,
5.4. Competitive Landscape: Familial Hypercholesterolemia
Industry Tables
1. Drug Clinical Milestones
2. Drug Launch Table- 2013
3. NPV Valuation
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https://www.reportscorner.com/reports/10016/Global-Pharmaceutical-&-
Biotechnology-Outlook-2013:-Rising-Stars/
