美国及EU的制药企业展望 2015年:First-in-Class创新及成本最佳化在大型制药企业的商务形成中发挥重要作用

Global Pharma US & EU Outlook 2015 : First -In- Class Innovations and Cost Optimization Plays Major Role In Shaping Up Business for Large Cap Pharmaceutical Companies

出版商 MP Advisors 商品编码 296608
出版日期 内容资讯 英文 63 Pages
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美国及EU的制药企业展望 2015年:First-in-Class创新及成本最佳化在大型制药企业的商务形成中发挥重要作用 Global Pharma US & EU Outlook 2015 : First -In- Class Innovations and Cost Optimization Plays Major Role In Shaping Up Business for Large Cap Pharmaceutical Companies
出版日期: 2015年01月26日内容资讯: 英文 63 Pages







Merck KGaA:新兴市场及抗PD1抗体使前景向上;收购Sigma-Aldrich稳定产业成长


Novo Nordisk:由于糖尿病的价格及竞争压力抑制产业成长

Product Code: 4478

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.

AstraZeneca: Late Stage Pipeline maturing; Focused development on Respiratory, Psoriasis and anti-PD1 will support long term growth

  • Late stage development is positive but near term pressure immense
  • R&D Strategy
  • Long-term CV study and R&D Updates
  • Brilinta preferred over Plavix in NSTE-ACS patients in the US
  • Strengthening Business in Diabetes: Acquisition from BMY
  • Late Stage Development Program
    • Selumetinib (PhIII, NSCLC, MEK inhibitor, Array Pharma)
    • Lesinurad (PhIII, URAT1 inhibitor/Hyperuricemia in Gout): did not reduce gout flares but biomarker uric acid level met the end point for approval
    • Immunotherapy such as anti CTLA and anti-PD1 will strengthen the franchise long-term
    • Olaparib (PARP Inh, Ovarian cancer)- FDA approval
    • AZD9291 (once daily, oral Tyrosine kinase inhibitor, second-line NSCLC)
    • Inflammation pipeline: Benralizumab (IL-5R antibody, severe asthma and COPD)
    • Competitive landscape of cytokine targeted therapies (Tralokinumab, Dupilumab, Lebrikizumab, Mepolizumab
    • Brodalumab (IL-17RA antibody, Psoriasis, Psoriatic arthritis, Ph III)
    • Outlook of respiratory franchise going forward: Symbicort, Pearl and Almirall
    • Anti-infective franchise update (AZD0914)
  • Nexium OTC approved and generic entry in 2015
  • The impact of competition on Faslodex
  • Key milestones
  • Table 1: Competitive Landscape of Biologics in Severe Asthma

GlaxoSmithKline: Reliance On Low Margin Consumer Health And Vaccines; Unable To Revive Respiratory Franchise

  • Respiratory business competitive and large outcome trials became futile
  • Cost savings to keep up the operating margins and Potential ViiV IPO to fund NVS JV buy-out
  • Our views on the recently approved drugs from GSK
  • Eperzan/Tanezeum (Albiglutide): Superior efficacy, better tolerability, ease of administration and compliance benefit should position Albiglutide better than competition in earlier lines of treatment
  • Mepolizumab (IL-5 inhibitor, UR, once monthly, severe eosinophilic asthma)
  • Competitive Landscape in severe asthma
  • Advair Generics
  • Key milestones
  • Tables:
  • Table 1: Bydureon, albiglutide & Victoza Clinical data comparison

Merck: Anti-PD1 and HCV will remain growth drivers going forward!!

  • IMPROVE-IT Outcome data positive, boosted confidence on other aggressive LDL reducing antibodies therapy
  • TECOS should help DPP-IV expand their share in a fast growing but highly genericized diabetes market
  • Acquisition of Cubist for $9.1b will fortify MRK's anti-infective acute hospital care franchise
  • Collaboration with Bayer for novel cardiovascular assets ($1b+)
  • Ebola Vaccine acquisition and development
  • Keytruda Potential
  • HCV Therapy (grazoprevir/elbasvir, PhIII): targeted for patients who do not tolerate market leading Sovaldi
  • Regulatory Developments - Gardasil, Belsomra, Grass and Ragweed sublingual allergy tablets, Sugammadex, Odanacatib
  • Isentress and anti-retroviral development
  • Diabetes Franchise - Ertugliflozin, Januvia/Janumet, Omarigliptin
  • Keytruda in Second-line NSCLC: Potential additional indications -breast cancer
  • Remicade Biosimilar impact in Europe: patent expiry in major EU countries in Feb 2015
  • Key milestones
  • Tables:
  • Table 1: Keytruda: List of on-going combination studies
  • Table 2: On-going Phase III clinical trials for HCV combo
  • Table 3: On-going clinical trials of Keytruda
  • Table 4: Competitive Landscape of Anti-PD1

Merck KGaA: Emerging market and anti-PD1 to lift the outlook; Acquisition of Sigma-Aldrich to stabilize business growth

  • Acquisition of Sigma-Aldrich for $17b would add over $2.1b in topline
  • Strategic alliances with PFE to develop Immuno-oncology pipeline- anti-PD1
  • Erbitux in first line CRC
  • Erbitux Biosimilar threat is limited due to different manufacturing process in EU/US
  • Gonal-F- Biosimilar competition
  • Performance materials
  • Merck Millipore in life sciences tool market (€2.6b)
  • Consumer Health (€472m - ~4% of total sales)
  • Emerging market continues to support the company growth going forward (€1.8b)
  • Key Milestones
  • Tables & Charts
  • Table 1: Merck Serono PhII and PhIII pipeline assets
  • Chart 1: Merck KGaA - Revenue Contribution By Strategic Divisions In 2013
  • Chart 2: Geographic contribution based on 2013 sales

Novartis: Strengthening Position In Oncology: Heart Failure And Psoriasis Therapy Will Find New Blockbusters

  • LCZ696 (valsartan with neprilysin inhibitor; twice daily; 8442 patients study) in chronic heart failure patients: Superiority can command higher prices and reimbursement
  • Rationale for fixed dose combination and Paradigm HF
  • Patent expiry pressure immense
  • Targeted and cellular therapy approach in Oncology
  • CART Technology
  • Gilenya in Multiple Sclerosis continues to be key growth driver but market ramp up of Tecfidera (BiogenIdec) is extraordinary despite PML issue
  • Lemtrada was effective but disease progressed after discontinuation
  • SERELAXIN (RLX-030) in Acute Heart Failure - Unmet need but FDA rejected the approval for more efficacy data
  • Signifor LAR - Approved in Cushing's disease and in acromegaly: 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
  • Secukinumab (Cosentyx) in Plaque Psoriasis - Trying To Be Different in a Crowded Space
  • Current treatments of psoriasis and psoriatic arthritis
  • Long term safety data is the key for gaining acceptance by Dermatologist
  • Panobinostat (UR, multiple myeloma, oral HDAC inhibitor) - negative recommendation from FDA and safety concerns coupled with no improvement in overall survival
  • Patent expiry impact and potential drivers
  • Sandoz growth to be driven by biosimilars and respiratory generics
  • Key milestones
  • Tables:
  • Table 1: Efficacy data of LCZ696 in PARADIGM-HF
  • Table 2: Competition in Acromegaly
  • Table 3: PASSPORT-Efficacy and Safety Comparison: SIGNIFOR LAR VS. SANDOSTATIN LAR
  • Table 4: Select Late- & Mid-stage pipeline: Plaque Psoriasis
  • Table 5: PHIII Clinical Data on Plaque Psoriasis of marketed products
  • Table 6: Patent Expiry Impact Through 2019
  • Table 7: Sandoz Biosimilar Pipeline Status

Novo Nordisk: Business growth is limited by pricing and competitive pressures in Diabetes

  • Xultophy made the entry in Europe-US filing delayed
  • Competitive pressures on Victoza: Semaglutide needs to show at least comparable efficacy to Trulicity
  • Dulaglutide Phase III data non-inferior to Victoza suggests slightly better efficacy with once weekly advantage
  • Dulaglutide Efficacy and safety data comparison based on ADA conference vs. Victoza (AWARD-6)
  • Insulin Franchise: Bio-similar insulin's and Novel Insulin's impact cannot be neglected
  • Liraglutide 3mg obesity (Saxenda): FDA advisory committee voted in favor (14-1)
  • Clinical safety and Efficacy from SCALE study vs. Contrave
  • Pricing and Safety likely to hamper the market reimbursement and uptake, but delayed progression to pre-diabetes may help
  • Regulatory concerns of pancreatitis, thyroid cancer & CV risk for high dose regimen in obesity
  • Haemostasis franchise - Turoctocog (NovoEight), NovoThirteen (Cartridecacog), N8-GP
  • Haemophilia A market size and competition - Novoeight competing long-acting pipeline product from Biogen Idec / Sobi, but may score with a first mover advantage in Hemophilia A Key milestones
  • Tables:
  • Table 1: Clinical data comparison of weekly GLP-1 Vs Victoza
  • Table 2: Obesity - Efficacy data comparison vs. marketed drugs