Global Pharmaceutical & Biotechnology Outlook 2014: Major US and EU
Strategy Diversification Divested: Productivity measurements, Divestment of non-core assets resulting in healthy Cash position- Will accelerate Next wave of targeted acquisition
In the recent years several new therapies have been approved in the area of diabetes (SGLT-2, GLP-1 agonists), Multiple Sclerosis, HCV, melanoma and breast cancer from major pharmaceutical companies. Many of them are expected to reach multibillion dollars peak sales in the near-term which is likely to compensate the patent expiry loss in top-line revenue. Novel mechanisms like anti-PD1, anti-PCSK9 and CDK inhibitors have also got exclusive attention by large cap Pharma companies. Most companies are in race to acquire assets in these hot therapy areas. Companies who already have these assets are investing heavily in clinical development programs. The interest in pursuing opportunities in Oncology therapy is unhindered for all major Pharma companies. Research investments in oncology likely to continue for several more years due to the significant unmet need exist in this area.
But for a few companies, patent expiry impact continues to haunt the top-line and they are finding it difficult to replace declining sales with Proprietary pipeline products. Beyond 2013, the impact of patent loss will further aggravate the revenue decline. They have chosen strategies of prioritization pipeline assets, cost efficiency measures, divestment of non-core assets which yield poor margins and increase focus on therapy areas where they have already proven its mettle. Increase in dividend payout and share repurchase are some near term measures where they are actively participating. Gain in financial strength through divestment of non-core assets (OTC, Animal Health, Consumer health, Diagnostics) will be utilized in pursuing opportunities in high margin therapy areas. At the same time it has becoming more difficult to find such lucrative assets because they are scarce and if available are trading at very high premium in speculation of getting acquired (ex. Roche-Alexion). Going forward, Economies of Scale will also play a major role in swapping the non-core business among major pharma including Vaccines, OTC and animal health to improve margins.
Global Pharma continues to remain attractive due to management efforts on the restructuring of entire business model, cost efficiency measures, de-consolidation, acquisition of high value targeted assets, share repurchase program and dividend policy.
Global Biopharmaceutical Outlook 2014-Global Pharma, released by MP Advisors provides analyses of individual large cap companies, promising drug candidates in their late stage pipelines, competitive landscape, and important therapy areas where new innovation will create leadership, forecast for major marketed drugs where competition/ regulatory scenario will change the dynamics, and the potential impact of several important upcoming milestones on the industry
In the recent years several new therapies have been approved in the area of diabetes (SGLT-2, GLP-1 agonists), Multiple Sclerosis, HCV, melanoma and breast cancer from major pharmaceutical companies. Many of them are expected to reach multibillion dollars peak sales in the near-term which is likely to compensate the patent expiry loss in top-line revenue. Novel mechanisms like anti-PD1, anti-PCSK9 and CDK inhibitors have also got exclusive attention by large cap Pharma companies. Most companies are in race to acquire assets in these hot therapy areas. Companies who already have these assets are investing heavily in clinical development programs. The interest in pursuing opportunities in Oncology therapy is unhindered for all major Pharma companies. Research investments in oncology likely to continue for several more years due to the significant unmet need exist in this area.
But for a few companies, patent expiry impact continues to haunt the top-line and they are finding it difficult to replace declining sales with Proprietary pipeline products. Beyond 2013, the impact of patent loss will further aggravate the revenue decline. They have chosen strategies of prioritization pipeline assets, cost efficiency measures, divestment of non-core assets which yield poor margins and increase focus on therapy areas where they have already proven its mettle. Increase in dividend payout and share repurchase are some near term measures where they are actively participating. Gain in financial strength through divestment of non-core assets (OTC, Animal Health, Consumer health, Diagnostics) will be utilized in pursuing opportunities in high margin therapy areas. At the same time it has becoming more difficult to find such lucrative assets because they are scarce and if available are trading at very high premium in speculation of getting acquired (ex. Roche-Alexion). Going forward, Economies of Scale will also play a major role in swapping the non-core business among major pharma including Vaccines, OTC and animal health to improve margins.
Global Pharma continues to remain attractive due to management efforts on the restructuring of entire business model, cost efficiency measures, de-consolidation, acquisition of high value targeted assets, share repurchase program and dividend policy.
Global Biopharmaceutical Outlook 2014-Global Pharma, released by MP Advisors provides analyses of individual large cap companies, promising drug candidates in their late stage pipelines, competitive landscape, and important therapy areas where new innovation will create leadership, forecast for major marketed drugs where competition/ regulatory scenario will change the dynamics, and the potential impact of several important upcoming milestones on the industry
Macro Analysis: Strategy Diversification Divested: Productivity measurements, Divestment of non-core assets resulting in healthy cash position- Will accelerate Next wave of Targeted
ACQUISITIONS
New Drug Filing Declining but compensated by faster approval with Break through
DESIGNATION
FDA Break through designation allowed faster market reach
R&D strategy re-dened- More focus on early development to improve late stage success
Recent Restructuring efforts of Major Pharma companies
Cost efciency measures and divestments
Financial Environment favourable for the Next Wave of acquisition
Table 1: Pharma Pipeline allocation changes: 2010-2013
Table 2: Global Pharma –Head count reduction & Share repurchase program
Table 3. Cash, Debt and Mkt Cap Of Global Pharma/ Biotech Companies
Table 4: Cash, Debt and EV of Rising star companies
Chart 1: CASH AND DEBT OF GLOBAL PHARMA/ BIOTECH COMPANIES
COMPANY ANALYSIS:
1. ASTRAZENECA: EARLY STAGE PIPELINE STRONG; BOLD INITIATIVES OFFER SOME RELIEF BUT ARE NOT
Enough To Hold Pressure
Long term clinical studies and R&D outlook
Strengthening business in diabetes: Acquisition from BMY
Outlook of respiratory franchise going forward: Symbicort and PT003
Brilinta/Brilique –Prescription Trend and formulary adoption improving but not reected in revenues
The impact of competition on Faslodex
Late stage development program update: I) Selumitinibii) Lesinuradiii) Olaparibiv) Benralizumabv) Brodalumabvi) Moxetumomabvii) Trolokinumabviii) MEDI4736 (anti-PDL1)ix) AMP-514
KEY MILESTONE Table
Table 1: PhIIb combo data of lesinurad in gout pts – allopurinol-inadequate responders
Table 2: Recent acquisition /partnership deals done in 2013
Table 3: Generic exposure thru 2018
Chart 1: CHINESE MARKET GROWTH: GLOBAL PHARMA IN 2013
2. BRISTOL-MYERS SQUIBB: SPECIALTY BIOPHARMA WITH ONCOLOGY FOCUS CAN GIVE RETURNS:
Nivolumab and Eliquis Success Important
Snapshots Review on Late stage pipeline assets
Divestment of diabetes business to AZN – Deal review
Eliquis Ramp up would be central to BMY’s stock price performance in 2014
Yervoy’s potential could be limited by emerging competition Ipilimumab status in other indications
Anti-PD1 antibody (Nivolumab, BMS-936558, PhIII) Immunotherapy (NSCLC, Melanoma)
Other key Pipeline assets: Elotuzumab
Impact of generization in topline revenue
KEY MILESTONES
Table: 1: Anti PD-1 pipeline molecules
Table 2: Ongoing PhIII clinical studies on Anti-PD1
Table 3: Peak sale potential of future blockbusters
Table: 4: Generic exposure thru 2018
3. ELI LILLY: PATENT PRESSURES AGGRAVATED WITH UNDIFFERENTIATED PIPELINE ASSETS BUT
Supporting Diabetes Market Offers a sigh of Relief
Necitumumab offers sigh of relief but commercial signicance limited
Late Stage Assets Review: PEG-Lispro, LY2963016, Dulaglutide, Empagliozin,
SGLT2 + DPP4 FDC, Solanezumab, Baricitinib, Ixekizumab, Cixutumumab, Ramucirumab
Litigation of marketed products update: Evista and Alimta
KEY MILESTONES
Table: 1: Competitive landscape – GLP-1 agonist
Table 2: SGLT2 inhibitors- competitive landscape
Table 3: Ongoing PhIII clinical studies of Ramucirumab
Table 4: Patent expiry impact through 2018
4. GLAXOSMITHKLINE: BASE BUSINESS PROVIDES SUSTAINABILITY; SEVERAL BLOCK BUSTER’S WILL OFFER GROWTH!
Multiple blockbusters emerging in Melanoma, Respiratory and HIV
MAGE-A3 vaccine in NSCLC
Anoro (Umeclidinium/Vilanterol, LABA/LAMA FDC-Ellipta device) positioning becomes stronger than LABA+ICS or LABA or LAMA mono in COPD
Relvar/Breo Ellipta (Vilanterol/Fluticasone FDC): Efcacy and safety data in
Asthma and COPD
Eperzan (Albiglutide): Superior efcacy, better tolerability, ease of administration and compliance benets should position Albiglutide better than competition in earlier lines of treatment
KEY MILESTONES
Table 1: Clinical data of BRAF Inhibitor in Metastatic Melanoma
Table 2: Bydureon, Albiglutide & Victoza- DURATION 6 vs. HARMONY 6,
5. MERCK: RESTRUCTURING IMPACT AND TARGETED FOCUS ON ONCOLOGY AND HCV WILL DRIVE GROWTH!!
Detailed data on Odanacatib – Upside lies in the safety proles of this drug
Completion of Mega-trials should ensure R&D cost savings to the tune of $1billion
R&D Pipeline Update: HCV combo, Lambrolizumab and Corporate Restructuring
PROGRAM
Growing evidence base on CV safety of DPP-IV inhibitors
TECOS should help DPP-IV expand their share in a fast growing but highly genericized diabetes market
Once weekly DPP-IV - MK-3102 should help Merck carve a share in the rst line setting in type 2 diabetes
HCV Therapy: MK-5172 and MK-8742 combo, Once daily
Lambrolizumab (MK-3475, anti-PD1) in Second-line NSCLC; Potential additional
Indications for anti-PD1
Merck restructuring Impact going forward is positive for Investor
Januvia franchise - Reason for de-growth in the US and outlook for the DPP-IV market –Emerging competition from SGLP-2 inhibitors
Impact of Gardasil and V503: JP Govt. scheduled to review the withheld decision of Gardasil in early 2014
View on Remicade Biosimilar approval in Europe
Key Milestone
Table 1: Ongoing clinical trials of Lambrolizumab
Table 2: Competitive landscape of anti-PD1
Chart 1: Late stage pipeline in HCV therapy
6. PZER: DEPENDENT ON PALBOCICLIB AND PREVNAR-13 IN ADULTS TO SUSTAIN BUSINESS!
Restructuring: Three Major Business Segments
Xeljanz (tofacitinib)-RA broader label but slower uptake: Limited Opportunity for
Xeljanz and forecast $1.2b in peak sales with competition Following
Prevnar 13 US growth will be driven by approval in adults and outcome of the
CAPiTA study data is the key
Eliquis Superiority claim in Stroke will give an edge over competitor
Palbociclib (CDK4/6 cell cycle inhibitor, PhIII, ER positive and HER2 negative
Breast cancer) - Blockbuster potential -PFE leading the race: Competitors are 1.5 y behind in development
Dacomitinib (PhIII, secondline NSCLC) –Low potential
Hypercholesterolemia) – Third entrant will lose its relevance if others succeed
Advantages and Risks vs. Competitor in anti-PCSK9 area
KEY MILESTONES
Table 1: Xeljanz: Efcacy comparison with baricitinib
Table 2: Select oral RA drugs in development
Table 3: Ongoing clinical trials: CDK inh.-Palbociclib
7. NOVARTIS: PIPELINE STRENGTHENING : DE-CONSOLIDATION WILL PROVIDE TARGETED FOCUS
Respiratory sales ramp to drive sales; Patent expiry pressure immense
Oncology targeted and cellular therapy approach
Divestment of blood transfusion unit to Grifols
String of Pearls- LDK378, Serelaxin followed by breakthrough designation for BYM338 (bimagrumab)
Gilenya ramp up in Multiple Sclerosis much faster than expected but market ramp up Tecdera (BiogenIdec) is extraordinary
SERELAXIN (RLX-030) in Acute Heart Failure – Unmet need would allow an approval-FDA breakthrough designation granted - LCZ696 in chronic heart failure
Secukinumab in Plaque Psoriasis - Trying To Be Different in a Crowded Space
Competitive Scenario in Plaque Psoriasis
PASPORT-Cushings Head to Head Study positive: Sandostatin LAR Replacement ready in active acromegaly
Signifor/ Pasireotide will penetrate in patients inadequately controlled on Sandostatin. Signifor
LAR will take up market share from Sandostatin LAR before the patent expiry in 2017
Panobinostat in RRMM
Sandoz growth to be driven by biosimilars and respiratory generics
KEY MILESTONE Table
Table 1: Competition in Acromegaly
Table 2: PASPORT-Efcacy and safety comparison: Signifor LAR vs. Sandostatin LAR
Table 3: Select late- & mid-stage pipeline: Plaque Psoriasis
Table 4: PhIII Clinical data on Plaque Psoriasis of marketed products
8. NOVO NORDISK: GLP-1 AND INSULIN MARKET BECOMING TOO COMPETITIVE; RELIEF SHOULD
Come From Victoza in Obesity
Novothirteen targets rare, autosomal, niche market
Competitive pressures on Victoza
Dulaglutide Phase III data suggests slightly better efcacy with once weekly advantage over Victoza
Levemir under threat from SAN's U300
Bio-similar insulins impact cannot be neglected
Liraglutide 3mg obesity regulatory overhang persists
Regulatory concerns of pancreatitis, thyroid cancer & CV risk for high dose regimen in obesity
Haemostasis Franchise
Key Milestone Table
9. ROCHE: PRICING POWER WITH STRONG FOOT HOLD IN ONCOLOGY WILL DRIVE GROWTH
Strong late stage pipeline will offer potential sustainability and growth
Superiority of Gazyva against Rituxan in CLL
Ramp up of Kadcyla in second-line advanced breast cancer patients
Perjeta -First approved therapy in preoperative, early stage, and rst-line HER2 positive breast cancer strengthening its breast cancer franchise
Further Indication expansion for Perjeta
RoActemra monotherapy Superior to Humira: ADACTA Study
Kadcyla: MARIANNE, EMILIA AND APHINITY trials will lend sustainable growth to breast cancer franchise
Roche to retain all of its current Herceptin sales beyond Patent Expiry in US and
EU; Rituxan Biosimilar threat is negligible
Etrolizumab ( Ulcerative colitis and Crohn's Disease)
Avastin outlook - 2014 onwards
Bitopertin (Schizophrenia-negative symptoms)
Onartuzumab (MetMab, MET positive NSCLC (2nd and 3rd line) and triple negative breast cancer)
Zelboraf ramp up to get impacted by competition from GSK MPDL3280A (anti-PDL1 mAB, PhIII, NSCLC, Melanoma)
KEY MILESTONE Table
Table 1: Major pipeline molecules with expected ling
Table 2: Efcacy and safety comparison of Kadcyla vs. trastuzumab+docetaxel in rstline BC (PhII)
Table 3: Ongoing important clinical studies of Kadcyla in late stage HER 2 positive cancer
Table 4: Ongoing clinical trials on biosimilar rituxan
Table 5: Efcacy target prole of Gazyva in clinical studies
Table 6: Clinical data of BRAF inhibitor in metastatic melanoma
10. SANO: SUSTAINABLE BUSINESS BUT INNOVATIVE PIPELINE NOT IMPRESSIVE
R&D Pipeline: Upside limited due to Strong Competition; but orphan indication approval to improve the top-line growth
Anti-PCSK9 antibody and Dengue Vaccine are potential mega blockbuster candidates, and could make all the difference for SAN's investor but it will take long to deliver
Lemtrada ramp up in Europe (CR received in the US)
Lyxumia (Lixisenatide) –US ling withdrawn due to want of CV outcome data from FDA and ELIXA outcome and head to head Victoza data
New Lantus formulation (Insulin U300)
Lantus/Lixisenatide combination update
Patent Expiry Impact to continue in 2014
Aubagio: Except for oral administration and lower discontinuations, there is no differentiation for Aubagio vs. existing treatment options
Sarilumab ( anti-IL-6R mAB, Rheumatoid arthritis)
Dengue Vaccine (PhIII)
Alirocumab anti-PCSK6, Hypercholesterolemia) –CV outcome study will push the ling in 2018
KEY MILESTONE
Table 1: Sarilumab ACR results at week
Table 2: Alicromumab PhIII ODYSSY Program
Annexure I: Clinical and Regulatory Milestones In 2014
Annexure II: Global Pharma- PhII and PhIII Pipeline Candidates
Annexure III: Pipeline Peak Sale Potential Thru 2018
Annexure IV: Impact of Patent Expiry Thro 2018
Annexure V: Drugs Losing Patent Protection By 2018
ACQUISITIONS
New Drug Filing Declining but compensated by faster approval with Break through
DESIGNATION
FDA Break through designation allowed faster market reach
R&D strategy re-dened- More focus on early development to improve late stage success
Recent Restructuring efforts of Major Pharma companies
Cost efciency measures and divestments
Financial Environment favourable for the Next Wave of acquisition
Table 1: Pharma Pipeline allocation changes: 2010-2013
Table 2: Global Pharma –Head count reduction & Share repurchase program
Table 3. Cash, Debt and Mkt Cap Of Global Pharma/ Biotech Companies
Table 4: Cash, Debt and EV of Rising star companies
Chart 1: CASH AND DEBT OF GLOBAL PHARMA/ BIOTECH COMPANIES
COMPANY ANALYSIS:
1. ASTRAZENECA: EARLY STAGE PIPELINE STRONG; BOLD INITIATIVES OFFER SOME RELIEF BUT ARE NOT
Enough To Hold Pressure
Long term clinical studies and R&D outlook
Strengthening business in diabetes: Acquisition from BMY
Outlook of respiratory franchise going forward: Symbicort and PT003
Brilinta/Brilique –Prescription Trend and formulary adoption improving but not reected in revenues
The impact of competition on Faslodex
Late stage development program update: I) Selumitinibii) Lesinuradiii) Olaparibiv) Benralizumabv) Brodalumabvi) Moxetumomabvii) Trolokinumabviii) MEDI4736 (anti-PDL1)ix) AMP-514
KEY MILESTONE Table
Table 1: PhIIb combo data of lesinurad in gout pts – allopurinol-inadequate responders
Table 2: Recent acquisition /partnership deals done in 2013
Table 3: Generic exposure thru 2018
Chart 1: CHINESE MARKET GROWTH: GLOBAL PHARMA IN 2013
2. BRISTOL-MYERS SQUIBB: SPECIALTY BIOPHARMA WITH ONCOLOGY FOCUS CAN GIVE RETURNS:
Nivolumab and Eliquis Success Important
Snapshots Review on Late stage pipeline assets
Divestment of diabetes business to AZN – Deal review
Eliquis Ramp up would be central to BMY’s stock price performance in 2014
Yervoy’s potential could be limited by emerging competition Ipilimumab status in other indications
Anti-PD1 antibody (Nivolumab, BMS-936558, PhIII) Immunotherapy (NSCLC, Melanoma)
Other key Pipeline assets: Elotuzumab
Impact of generization in topline revenue
KEY MILESTONES
Table: 1: Anti PD-1 pipeline molecules
Table 2: Ongoing PhIII clinical studies on Anti-PD1
Table 3: Peak sale potential of future blockbusters
Table: 4: Generic exposure thru 2018
3. ELI LILLY: PATENT PRESSURES AGGRAVATED WITH UNDIFFERENTIATED PIPELINE ASSETS BUT
Supporting Diabetes Market Offers a sigh of Relief
Necitumumab offers sigh of relief but commercial signicance limited
Late Stage Assets Review: PEG-Lispro, LY2963016, Dulaglutide, Empagliozin,
SGLT2 + DPP4 FDC, Solanezumab, Baricitinib, Ixekizumab, Cixutumumab, Ramucirumab
Litigation of marketed products update: Evista and Alimta
KEY MILESTONES
Table: 1: Competitive landscape – GLP-1 agonist
Table 2: SGLT2 inhibitors- competitive landscape
Table 3: Ongoing PhIII clinical studies of Ramucirumab
Table 4: Patent expiry impact through 2018
4. GLAXOSMITHKLINE: BASE BUSINESS PROVIDES SUSTAINABILITY; SEVERAL BLOCK BUSTER’S WILL OFFER GROWTH!
Multiple blockbusters emerging in Melanoma, Respiratory and HIV
MAGE-A3 vaccine in NSCLC
Anoro (Umeclidinium/Vilanterol, LABA/LAMA FDC-Ellipta device) positioning becomes stronger than LABA+ICS or LABA or LAMA mono in COPD
Relvar/Breo Ellipta (Vilanterol/Fluticasone FDC): Efcacy and safety data in
Asthma and COPD
Eperzan (Albiglutide): Superior efcacy, better tolerability, ease of administration and compliance benets should position Albiglutide better than competition in earlier lines of treatment
KEY MILESTONES
Table 1: Clinical data of BRAF Inhibitor in Metastatic Melanoma
Table 2: Bydureon, Albiglutide & Victoza- DURATION 6 vs. HARMONY 6,
5. MERCK: RESTRUCTURING IMPACT AND TARGETED FOCUS ON ONCOLOGY AND HCV WILL DRIVE GROWTH!!
Detailed data on Odanacatib – Upside lies in the safety proles of this drug
Completion of Mega-trials should ensure R&D cost savings to the tune of $1billion
R&D Pipeline Update: HCV combo, Lambrolizumab and Corporate Restructuring
PROGRAM
Growing evidence base on CV safety of DPP-IV inhibitors
TECOS should help DPP-IV expand their share in a fast growing but highly genericized diabetes market
Once weekly DPP-IV - MK-3102 should help Merck carve a share in the rst line setting in type 2 diabetes
HCV Therapy: MK-5172 and MK-8742 combo, Once daily
Lambrolizumab (MK-3475, anti-PD1) in Second-line NSCLC; Potential additional
Indications for anti-PD1
Merck restructuring Impact going forward is positive for Investor
Januvia franchise - Reason for de-growth in the US and outlook for the DPP-IV market –Emerging competition from SGLP-2 inhibitors
Impact of Gardasil and V503: JP Govt. scheduled to review the withheld decision of Gardasil in early 2014
View on Remicade Biosimilar approval in Europe
Key Milestone
Table 1: Ongoing clinical trials of Lambrolizumab
Table 2: Competitive landscape of anti-PD1
Chart 1: Late stage pipeline in HCV therapy
6. PZER: DEPENDENT ON PALBOCICLIB AND PREVNAR-13 IN ADULTS TO SUSTAIN BUSINESS!
Restructuring: Three Major Business Segments
Xeljanz (tofacitinib)-RA broader label but slower uptake: Limited Opportunity for
Xeljanz and forecast $1.2b in peak sales with competition Following
Prevnar 13 US growth will be driven by approval in adults and outcome of the
CAPiTA study data is the key
Eliquis Superiority claim in Stroke will give an edge over competitor
Palbociclib (CDK4/6 cell cycle inhibitor, PhIII, ER positive and HER2 negative
Breast cancer) - Blockbuster potential -PFE leading the race: Competitors are 1.5 y behind in development
Dacomitinib (PhIII, secondline NSCLC) –Low potential
Hypercholesterolemia) – Third entrant will lose its relevance if others succeed
Advantages and Risks vs. Competitor in anti-PCSK9 area
KEY MILESTONES
Table 1: Xeljanz: Efcacy comparison with baricitinib
Table 2: Select oral RA drugs in development
Table 3: Ongoing clinical trials: CDK inh.-Palbociclib
7. NOVARTIS: PIPELINE STRENGTHENING : DE-CONSOLIDATION WILL PROVIDE TARGETED FOCUS
Respiratory sales ramp to drive sales; Patent expiry pressure immense
Oncology targeted and cellular therapy approach
Divestment of blood transfusion unit to Grifols
String of Pearls- LDK378, Serelaxin followed by breakthrough designation for BYM338 (bimagrumab)
Gilenya ramp up in Multiple Sclerosis much faster than expected but market ramp up Tecdera (BiogenIdec) is extraordinary
SERELAXIN (RLX-030) in Acute Heart Failure – Unmet need would allow an approval-FDA breakthrough designation granted - LCZ696 in chronic heart failure
Secukinumab in Plaque Psoriasis - Trying To Be Different in a Crowded Space
Competitive Scenario in Plaque Psoriasis
PASPORT-Cushings Head to Head Study positive: Sandostatin LAR Replacement ready in active acromegaly
Signifor/ Pasireotide will penetrate in patients inadequately controlled on Sandostatin. Signifor
LAR will take up market share from Sandostatin LAR before the patent expiry in 2017
Panobinostat in RRMM
Sandoz growth to be driven by biosimilars and respiratory generics
KEY MILESTONE Table
Table 1: Competition in Acromegaly
Table 2: PASPORT-Efcacy and safety comparison: Signifor LAR vs. Sandostatin LAR
Table 3: Select late- & mid-stage pipeline: Plaque Psoriasis
Table 4: PhIII Clinical data on Plaque Psoriasis of marketed products
8. NOVO NORDISK: GLP-1 AND INSULIN MARKET BECOMING TOO COMPETITIVE; RELIEF SHOULD
Come From Victoza in Obesity
Novothirteen targets rare, autosomal, niche market
Competitive pressures on Victoza
Dulaglutide Phase III data suggests slightly better efcacy with once weekly advantage over Victoza
Levemir under threat from SAN's U300
Bio-similar insulins impact cannot be neglected
Liraglutide 3mg obesity regulatory overhang persists
Regulatory concerns of pancreatitis, thyroid cancer & CV risk for high dose regimen in obesity
Haemostasis Franchise
Key Milestone Table
9. ROCHE: PRICING POWER WITH STRONG FOOT HOLD IN ONCOLOGY WILL DRIVE GROWTH
Strong late stage pipeline will offer potential sustainability and growth
Superiority of Gazyva against Rituxan in CLL
Ramp up of Kadcyla in second-line advanced breast cancer patients
Perjeta -First approved therapy in preoperative, early stage, and rst-line HER2 positive breast cancer strengthening its breast cancer franchise
Further Indication expansion for Perjeta
RoActemra monotherapy Superior to Humira: ADACTA Study
Kadcyla: MARIANNE, EMILIA AND APHINITY trials will lend sustainable growth to breast cancer franchise
Roche to retain all of its current Herceptin sales beyond Patent Expiry in US and
EU; Rituxan Biosimilar threat is negligible
Etrolizumab ( Ulcerative colitis and Crohn's Disease)
Avastin outlook - 2014 onwards
Bitopertin (Schizophrenia-negative symptoms)
Onartuzumab (MetMab, MET positive NSCLC (2nd and 3rd line) and triple negative breast cancer)
Zelboraf ramp up to get impacted by competition from GSK MPDL3280A (anti-PDL1 mAB, PhIII, NSCLC, Melanoma)
KEY MILESTONE Table
Table 1: Major pipeline molecules with expected ling
Table 2: Efcacy and safety comparison of Kadcyla vs. trastuzumab+docetaxel in rstline BC (PhII)
Table 3: Ongoing important clinical studies of Kadcyla in late stage HER 2 positive cancer
Table 4: Ongoing clinical trials on biosimilar rituxan
Table 5: Efcacy target prole of Gazyva in clinical studies
Table 6: Clinical data of BRAF inhibitor in metastatic melanoma
10. SANO: SUSTAINABLE BUSINESS BUT INNOVATIVE PIPELINE NOT IMPRESSIVE
R&D Pipeline: Upside limited due to Strong Competition; but orphan indication approval to improve the top-line growth
Anti-PCSK9 antibody and Dengue Vaccine are potential mega blockbuster candidates, and could make all the difference for SAN's investor but it will take long to deliver
Lemtrada ramp up in Europe (CR received in the US)
Lyxumia (Lixisenatide) –US ling withdrawn due to want of CV outcome data from FDA and ELIXA outcome and head to head Victoza data
New Lantus formulation (Insulin U300)
Lantus/Lixisenatide combination update
Patent Expiry Impact to continue in 2014
Aubagio: Except for oral administration and lower discontinuations, there is no differentiation for Aubagio vs. existing treatment options
Sarilumab ( anti-IL-6R mAB, Rheumatoid arthritis)
Dengue Vaccine (PhIII)
Alirocumab anti-PCSK6, Hypercholesterolemia) –CV outcome study will push the ling in 2018
KEY MILESTONE
Table 1: Sarilumab ACR results at week
Table 2: Alicromumab PhIII ODYSSY Program
Annexure I: Clinical and Regulatory Milestones In 2014
Annexure II: Global Pharma- PhII and PhIII Pipeline Candidates
Annexure III: Pipeline Peak Sale Potential Thru 2018
Annexure IV: Impact of Patent Expiry Thro 2018
Annexure V: Drugs Losing Patent Protection By 2018
