SYS-CON MEDIA Authors: Roberto Medrano, Dmitriy Stepanov, Gilad Parann-Nissany, Srinivasan Sundara Rajan, Sean Houghton

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Global Pharmaceutical & Biotechnology Outlook 2014: Major US and EU

NEW YORK, Feb. 12, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Global Pharmaceutical & Biotechnology Outlook 2014: Major US and EU
http://www.reportlinker.com/p02013807/Global-Pharmaceutical--Biotechnology-Outlook-2014-Major-US-and-EU.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

Strategy Diversification Divested: Productivity measurements, Divestment of non-core assets resulting in healthy Cash position- Will accelerate Next wave of targeted acquisitionIn 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

Table of contents

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-defined- More focus on early development to improve late stage success
• Recent Restructuring efforts of Major Pharma companies
• Cost efficiency 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 re?ected in revenues
• The impact of competition on Faslodex
• Late stage development program update:
i) Selumitinib
ii) Lesinurad
iii) Olaparib
iv) Benralizumab
v) Brodalumab
vi) Moxetumomab
vii) Trolokinumab
viii) 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 signi?cance limited
• Late Stage Assets Review: PEG-Lispro, LY2963016, Dulaglutide, Empagliflozin, 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): Efficacy and safety data in Asthma and COPD
• Eperzan (Albiglutide): Superior ef?cacy, better tolerability, ease of administration and compliance bene?ts 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, 7

5. Merck: Restructuring Impact And Targeted Focus On Oncology And HCV Will Drive Growth!!
• Detailed data on Odanacatib – Upside lies in the safety pro?les 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. Pfizer: 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 (Peak sales $2.5b)
• 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
• Bococizumab (RN316 (PF-04950615), PCSK9 inhibitor, PhIII, Hypercholesterolemia) –Third entrant will lose its relevance if others succeed
• Advantages and Risks vs. Competitor in anti-PCSK9 area
• Key Milestones

Table 1: Xeljanz: Efficacy 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 Tec?dera (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-Efficacy 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 ef?cacy 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 filing
Table 2: Efficacy 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: Efficacy target profile of Gazyva in clinical studies
Table 6: Clinical data of BRAF inhibitor in metastatic melanoma

10. Sanofi: 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 24
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

Companies Mentioned

AstraZeneca,Bristol-Myers Squibb, Eli Lilly, Merck,Novo Nordisk, Novartis, Pfizer, Roche,GlaxoSmithKline

To order this report: Global Pharmaceutical & Biotechnology Outlook 2014: Major US and EU
http://www.reportlinker.com/p02013807/Global-Pharmaceutical--Biotechnology-Outlook-2014-Major-US-and-EU.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

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