Mature Biotech Outlook 2015: New Therapy Ventures Pave the Way for Success
All biotech companies - Gilead (GILD), Amgen (AMGN), Biogen Idec (BIIB) and Celgene (CELG), in past year, have given a positive return and hence increased the interest of biotech investors. These companies have been able to select therapy/niche indication where the high treatment cost justifies the need. While large pharma companies are active in M&A deals, the Mature biotech companies are sticking to its core expertise and venturing into unexplored/new therapy; e.g., GILD in anti-cancer and BIIB for hemophilia. Alike small molecule generics, biosimilar will also get easier and getting similar pace of recognition in coming years; where AMGN, BIIB already started investing in this space and can emerge as a big player in coming years.
REGN, ALXN, and VRTX have transformed into a large-cap mature biotech companies. Whether these three will be acquired or will remain independent and evolve in next giant is still a question, but both the cases present a good investment opportunity for those who willing to hold them for next five years.
GILD has announced the dividend payment and now all eyes will be on CELG and BIIB
REGN, ALXN, and VRTX have transformed into a large-cap mature biotech companies. Whether these three will be acquired or will remain independent and evolve in next giant is still a question, but both the cases present a good investment opportunity for those who willing to hold them for next five years.
GILD has announced the dividend payment and now all eyes will be on CELG and BIIB
1. ACORDA THERAPEUTICS – NEUROLOGICAL PIPELINE GETTING BIGGER
Key Pipeline Drugs
a. CVT -301 (PhIII, OFF episodes of Parkinson’s disease)
b. Dalfampridine (PhIII, post-stroke walking deficits)
c. rHIgM22 (Remyelinating mAb, PhI)
d. Glial Growth Factor 2 (neuregulin, PhI, GGF2)
Other Programs in the Pipeline – Future Uncertain
2. ALEXION PHARMA – PIPELINE MATURITY WILL WITNESS A STRONG 2015 FOR ALXN
Asfotase alfa (hypophosphatasia, HPP, R) on Track
Soliris in PNH and aHUS: Growth to Continue
SOLIRIS BEYOND PNH AND aHUS
Beyond Soliris
Other PhII Programs
Messenger RNA Therapeutics platform from Moderna
3. AMGEN – FOCUS ON NEW BIOLOGICS FOR LARGER MARKET AND EXPLOITING BIOLOGICS’ MANUFACTURING EXPERIENCE FOR BIOSIMILARS GAIN
Newly Marketed Product: Future Growth
a. Kyprolis
b. BLINCYTO
Key Pipeline Products and Development
a. Evolocumab (R, PCSK9 Inhibitor, CVD, SC)
b. Ivabradine (R, Chronic Heart Failure):
c. Talimogene laherparepvec
d. Brodalumab (PhIII, moderate-to-severe plaque psoriasis and psoriatic arthritis, PhII, Asthma)
e. Omecamtiv mecarbil (PhIIb, Heartfailure, licensed from Cytokinetics)
f. Romosozumab (PhIII, co-developed with UCB, Postmenopausal Osteoporosis, PMO)
g. AMG 334 (PhIIb, CGRP receptor mAb)
h. Trebananib (PhIII, Ovarian Cancer):
i. AMG 416 (PhIII, secondary hyperparathyroidism in pt with CKD, velcalcetide)
Failed in Clinical studies
Biosimilars in Development
AMGN’s Commercial Strategy
4. BIOGEN IDEC – GROWTH FROM NEWLY LAUNCHED PRODUCTS + CLINICAL MILESTONES OF NOVEL PIPELINE
Near-Term Key Pipeline Candidates to Watch
Hemophilia Franchise Offers Long-Term Opportunity
Anti-CD20 franchise Continues to Grow through Label Expansion of GAZYVA
NEUROLOGY: LEADERSHIP IN MS AND PORTFOLIO EXPANSION
5. CELGENE – INNOVATIVE STRATEGIES FOR LONG TERM GAINS
Development In Multiple Myeloma Franchise: Strengthening Pipeline
Other Oncology Drugs
Inflammation – Pipeline to start contributing to sales by 2015
Other Products in Early stage for Long Term Growth
6. GILEAD SCIENCES – POISED TO EMERGE AS A LEADER IN HCV TREATMENT
Sovaldi has made the way, Harvoni to take Lead
Pipeline: Anti-viral Franchise — HCV
Antiviral Franchise — HIV
Cardiovascular Program
Beyond Anti-Virals- Oncology
Acquisitions In Last Two Years
7. REGENERON – LATE-STAGE PIPELINE POTENTIAL – ACCELERATOR FOR FURTHER GROWTH
Label expansion of E ylea in DME, BRVO, and Myopic CNV indication
Late-Stage Pipeline
REGN-Sanofi Collaboration
8. VERTEX PHARMA – FROM LARGE VOLUME MARKET TO NICHE INDICATIONS – TRANSFORMATION HAS PAID
Cystic Fibrosis: Success in G551D mutation to Repeat in Larger Population of del508 Mutation
Small But Meaningful Addition in Other Mutations for KALYDECO monotherapy
CF BACKGROUND
Beyond CF Not a Priority
Key Pipeline Drugs
a. CVT -301 (PhIII, OFF episodes of Parkinson’s disease)
b. Dalfampridine (PhIII, post-stroke walking deficits)
c. rHIgM22 (Remyelinating mAb, PhI)
d. Glial Growth Factor 2 (neuregulin, PhI, GGF2)
Other Programs in the Pipeline – Future Uncertain
2. ALEXION PHARMA – PIPELINE MATURITY WILL WITNESS A STRONG 2015 FOR ALXN
Asfotase alfa (hypophosphatasia, HPP, R) on Track
Soliris in PNH and aHUS: Growth to Continue
SOLIRIS BEYOND PNH AND aHUS
Beyond Soliris
Other PhII Programs
Messenger RNA Therapeutics platform from Moderna
3. AMGEN – FOCUS ON NEW BIOLOGICS FOR LARGER MARKET AND EXPLOITING BIOLOGICS’ MANUFACTURING EXPERIENCE FOR BIOSIMILARS GAIN
Newly Marketed Product: Future Growth
a. Kyprolis
b. BLINCYTO
Key Pipeline Products and Development
a. Evolocumab (R, PCSK9 Inhibitor, CVD, SC)
b. Ivabradine (R, Chronic Heart Failure):
c. Talimogene laherparepvec
d. Brodalumab (PhIII, moderate-to-severe plaque psoriasis and psoriatic arthritis, PhII, Asthma)
e. Omecamtiv mecarbil (PhIIb, Heartfailure, licensed from Cytokinetics)
f. Romosozumab (PhIII, co-developed with UCB, Postmenopausal Osteoporosis, PMO)
g. AMG 334 (PhIIb, CGRP receptor mAb)
h. Trebananib (PhIII, Ovarian Cancer):
i. AMG 416 (PhIII, secondary hyperparathyroidism in pt with CKD, velcalcetide)
Failed in Clinical studies
Biosimilars in Development
AMGN’s Commercial Strategy
4. BIOGEN IDEC – GROWTH FROM NEWLY LAUNCHED PRODUCTS + CLINICAL MILESTONES OF NOVEL PIPELINE
Near-Term Key Pipeline Candidates to Watch
Hemophilia Franchise Offers Long-Term Opportunity
Anti-CD20 franchise Continues to Grow through Label Expansion of GAZYVA
NEUROLOGY: LEADERSHIP IN MS AND PORTFOLIO EXPANSION
5. CELGENE – INNOVATIVE STRATEGIES FOR LONG TERM GAINS
Development In Multiple Myeloma Franchise: Strengthening Pipeline
Other Oncology Drugs
Inflammation – Pipeline to start contributing to sales by 2015
Other Products in Early stage for Long Term Growth
6. GILEAD SCIENCES – POISED TO EMERGE AS A LEADER IN HCV TREATMENT
Sovaldi has made the way, Harvoni to take Lead
Pipeline: Anti-viral Franchise — HCV
Antiviral Franchise — HIV
Cardiovascular Program
Beyond Anti-Virals- Oncology
Acquisitions In Last Two Years
7. REGENERON – LATE-STAGE PIPELINE POTENTIAL – ACCELERATOR FOR FURTHER GROWTH
Label expansion of E ylea in DME, BRVO, and Myopic CNV indication
Late-Stage Pipeline
REGN-Sanofi Collaboration
8. VERTEX PHARMA – FROM LARGE VOLUME MARKET TO NICHE INDICATIONS – TRANSFORMATION HAS PAID
Cystic Fibrosis: Success in G551D mutation to Repeat in Larger Population of del508 Mutation
Small But Meaningful Addition in Other Mutations for KALYDECO monotherapy
CF BACKGROUND
Beyond CF Not a Priority
