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Oncology Market Forecast To 2013

How do you uncover the threats and opportunities that your oncology drug will face this year, next year and each year after that? Our new report answers your questions with the most comprehensive forecast of the competitive oncology marketplace ever created. We’ve pulled together information over 130 drugs – from today’s blockbusters to tomorrow’s most promising breakthrough molecules. Our analysis provides key decision-making information such as: • what your competitors are aiming for • what you need to do to beat them • what market forces impact your Go/No-Go action • which indications to target

Oncology Market Forecast to 2013

What do you need to know to make strategic and tactical decisions about your drug’s success? Our research team analyzed sales performance, legal and regulatory changes, new product launches and recent changes in research strategy. We also studied likely trends, critical factors and hidden pitfalls for the next decade. No other resource gives you so much bedrock information on which to base your decision-making.

What factors are you already looking at and what else do you need to be aware of? Key oncology trends are easy to follow in the headlines. But what’s driving those trends? And what hidden factors are already shifting your competitors’ goals and strategy? This report looks at all the data to highlight what your team must do to be successful in 2009– 2013 and beyond.

Copyright 2008 Cutting Edge InformationCO

1000 Park Forty Plaza, Suite 440 Durham, NC 27713 www.cuttingedgeinfo.com

Oncology Brand Marketing 2


The report contains marketing analysis of over 130 drugs in a dozen drug classes and adjunct treatments including:

What’s currently approved and what are the upcoming new indications?What novel products are in development and what im-pact will they have on the market?What are the strategic market growth drivers?How are epidemiology and disease information impacting market size?

What are the U.S. and global outlooks for current and future leaders?What are the major market events, such as competitors’ new launches, that your team must be aware of?What new research strategies will change the direction of key companies’ pipelines?

With this level of comprehensive analysis, your team doesn’t have to guess when making decisions about how to fund and prioritize products and franchises. You will have everything you need to make good decisions today.

Copyright 2008 Cutting Edge InformationCOCopyright 2008 Cutting Edge InformationCO

1000 Park Forty Plaza, Suite 440 Durham, NC 27713 www.cuttingedgeinfo.com


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Copyright 2008 Cutting Edge InformationCO1000 Park Forty Plaza, Suite 440 Durham, NC 27713 www.cuttingedgeinfo.com


The report is structured for easy access to the oncology product data you need.

Chapter 1: Drug Class Analysis

Antineoplastics (79)

Alkylating Agents (9) Antimetabolites (8) Antimitotics (11) Cytotoxic Antibiotics (5) Hormones (10) Tyrosine Kinase Inhibitors (20) Monoclonal Antibodies (16)

Selected Table of Contents

Immunostimulants (9) Other Cancer Treatments (32) Adjunct Treatments (16)

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The report is structured for easy access to the oncology product data you need.

Chapter 2: Cancer Indication Market Analysis

• Breast Cancer • Colorectal Cancer • Leukemia • Lung Cancer • Prostate Cancer

Selected Table of Contents

• Amgen • AstraZeneca • BristolMyersSquibb • Celgene • Eli Lilly • GlaxoSmithKline • ImClone • Johnson & Johnson • Merck • Novartis • Pfizer • Roche • Sanofi-Aventis • Schering-Plough

Chapter 3: Company Profiles

1CHAPTER 1:cancer Brand prOfiles

CHAPTER

Cancer Brand ProfilesCutting Edge Information analyzed the market strengths and opportunities of 136 oncology brands and adjunct therapies. The following profiles include information about drugs’ competitive and strategic positions, market opportunities and growth, and patent or litigation information, when applicable. The brand profiles are organized by the following drug classes:

• Antineoplasticso Alkylating agentso Antimetaboliteso Antimitoticso Antibioticso Hormone therapieso Tyrosine kinase inhibitorso Monoclonal antibodies

• Immunostimulants• Other cancer treatments• Adjunct therapies

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ONCOLOGY BRAND PROFILES - 8

Alkeran (melphalan)Manufacturer/Partners: Celgene and GlaxoSmithKlineDrug Class: alkylating agentDelivery Mechanisms: injectable; oralLine of Treatment: third-line, palliative therapy

GlaxoSmithKline drug Alkeran was first approved in the US in July 1992. In April 2003, Celgene entered into a three-year licensing agreement with GlaxoSmithKline to distribute Alkeran under the Celgene label in the US. The agreement has been extended through March 31, 2009. The deal is automatically extendable for one year periods, unless either party alerts the other at least one year before the renewal date that it elects not to extend the agreement.

Alkeran is an important addition for Celgene because its palliative treatment of multiple myeloma coheres with Celgene’s incredibly successful second-line multiple myeloma treatment, Revlimid. It can also be used in combination with Celgene’s Thalomid for newly diagnosed cases of multiple myeloma. Additionally, it is used as a palliative treatment for carcinoma of the ovary. The combination of Revlimid, Thalomid and Alkeran has proven rather successful for Celgene. In 2007, Alkeran achieved sales of $73 million, complementing the $677 million Revlimid generated in the US market.

Clinical trials continue to strengthen Alkeran’s profile, as the treatment proves effective as a palliative option for a range of hematological diseases. Alkeran is also adaptable and convenient — it is available in both intravenous and tablet forms. Patients who cannot take the tablet form can instead have Alkeran administered via injection,

Development TableCompany Indication Description Development StageCelgene Corporation Myeloma Multiple Myeloma Approved

Alkeran Materiality

Competitive and Strategic Positioning

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ONCOLOGY BRAND PROFILES - 9

With Alkeran sales projected to remain in the $70 million range for the next five years, the agreement between GSK and Celgene has proved profitable for both. Sales of Alkeran are not projected to fall off because of Alkeran’s ability to be combined with other treatments. Because of the treatment’s complementary attributes to Revlimid — even though Alkeran’s US patent expires in November 2008 — Celgene will most likely try to maintain this agreement for a number of years. In addition, GSK and Celgene still hold the option to sue for the 30-month stay if any company decides to try to produce a generic. No competition appears to be readying for a generic, most likely due to Alkeran’s limited revenue in the US. GSK holds patents for Alkeran in Europe.

The US patent for Alkeran expires November 18, 2008. No patent litigation is pending at this time.

Alkeran Sales: 2003-2013 (in millions)

Patent InformationPatent # Expiration Date4997651 11/18/2008

Market Opportunities and Growth

Generic InformationManufacturer Generics AvailableNo generics available

Market ExclusivityReason Expiration DateNo data available

Patent and Litigation Information

3 CHAPTER 3:OncOlOgy drug Manufacturer prOfiles

CHAPTER 3Oncology Drug Manufacturer Profiles

The following oncology drug manufacturer profiles provide insight into company-specific strategies for their cancer drug pipelines. Cutting Edge Information’s analysts compiled research for 14 pharmaceutical and biotechnology drug manufacturers. These companies have either established oncology franchises or exciting development pipelines for new cancer compounds. Profiles companies include:

• Amgen• AstraZeneca• Celgene• Bristol-Myers Squibb• Eli Lilly• GlaxoSmithKline• ImClone• Johnson & Johnson• Merck• Novartis• Pfizer• Sanofi-Aventis• Schering-Plough

Each company profile provides information about the company’s competitive and strategic positioning, as well as the company’s performance and oncology development pipeline. The profiles are designed to inform readers about current trends in companies’ strategies toward the oncology market.

AstraZenecaOncology Ranking, 2007: #5Oncology Ranking, 2013: #11 (Projected)Industry Ranking, 2007: #5Oncology Blockbusters: 2 (Arimidex, Casodex)Oncology Products on Market: 4Oncology Products in Phase III Trials: 4

AstraZeneca is a top 10 pharmaceutical company and relied on oncology drugs for 12% of its revenue in 2007. Arimidex and Zoladex are AstraZeneca’s largest oncology drugs, together expected to grow to over $3 billion in sales by 2009. Both are indicated for breast cancer, as is Faslodex. Nolvadex was also indicated for breast cancer but sales were discontinued in 2006 due to declining sales, as its patent had expired.

Iressa, a once promising lung cancer drug, suffered a devastating setback when the FDA restricted sales in 2005 to patients who had already received the drug. Iressa seemed so promising in early-stage trials that it was approved prior to completing trials. Upon the completion of trials, however, the results were very disappointing, and the FDA changed the label to prevent new prescriptions.

While Iressa still has hundreds of millions of dollars of sales overseas, Genentech’s Tarveca has taken over the anti-EGFR market. AstraZeneca hopes to reclaim those sales with Zactima, an anti-EGFR drug in Phase III trials. Recentin and ZD4054, two other AstraZeneca drugs in trials for brain and prostate cancer respectively, are projected to be approved in 2009-2010 and have sales of nearly $300 million each by 2014.

AstraZeneca Oncology Market Share

ONCOLOGY MANUFACTURER PROFILES 12

Competitive and Strategic Positioning

Strengths:

• A top 10 pharma company, AstraZeneca can devote resources to promising drugs as needed.

• Zactima’s dual mechanism of action could potentially steal sales from both Tarceva and Avastin if it proves superior to those drugs in efficacy.

• Zactima is also in Phase II development for many different indications, which could boost sales dramatically as the drug matures.

Growth Areas:

• Recentin suffered a setback in recent trials results for the NSCLC indication, and its anticipated approval date was pushed back to 2010 as AstraZeneca focuses on the colorectal cancer indication instead.

• ZD4054, is currently only being tested for prostate cancer. Additional indications, if even possible, would take years after approval to earn.

• AstraZeneca is currently heavily reliant on breast cancer drugs in its oncology portfolio, and if new drug treatments change the breast cancer market, AstraZeneca’s oncology portfolio will suffer.

Competition:

• Arimidex is the best-selling aromatase inhibitor on the market. This first-line class of breast cancer drugs is projected to further increase its market share in the coming years.

• Casodex will be facing generic competition later this year, which will reduce its sales by over 50% in the next two years.

• After the failure of Iressa in the US market, AstraZeneca hopes to take reclaim lost market share from Tarceva with its Phase III anti-EGFR drug, Zactima.


AstraZeneca’s 2007 Oncology Revenue AstraZeneca’s 2013 Oncology Revenue

Company Performance

Arimidex has been FDA approved since December 1995 and has three hormone receptor-positive breast cancer indications for post-menopausal women. In 2007, final results from a study comparing Arimidex to tamoxifen therapy for breast cancer were announced – Arimidex beat tamoxifen in preventing the recurrence of breast cancer after five years of therapy. As a result, sales are expected to grow from the current $1.7 billion in annual sales to over $2 billion in 2009. Sales will then face a slow decline as a result of patent expirations.

Casodex is a prostate cancer treatment that has been on the market for over a decade.

Casodex reached its peak global sales in 2007, when it reaped about $1.3 billion worldwide. However, the brand’s sales are expected to be chopped in half in the next couple of years after its patent expires in October of 2008.

Faslodex is an estrogen receptor downregulator indicated for treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression. The highly restrictive indication for Faslodex also restricts its market share; in 2007 it had less than $200 million in sales. The primary growth potential for Faslodex is in additional cancer indications, which are currently in phase II studies. Its use in cancer is limited to estrogen-receptor positive cancer cells, and it is currently being tested in ovarian, prostate and lung cancers.

Iressa is a selective EGFR inhibitor that was FDA approved in 2003 for third-line treatment of non small cell lung cancer Iressa subsequently failed to show a survival benefit, and the FDA restricted access to the drug and allowed no new prescriptions. While Iressa has no future in the US or the EU for NSCLC, it is approved in many other countries, and continues to generate between $200 and $300 million in revenue for AstraZeneca.

Nolvadex , initially approved 1973, is a highly popular breast cancer drug that is just recently being supplanted by the aromatase inhibitors. After expiration of the last of its patents in the early 2000’s, generic competition has eaten away at Nolvadex’s sales. AstraZeneca discontinued sales of Nolvadex in the US in June of 2006, due to declining sales and the fact that generic versions of the drug are now widely available.

Zoladex is the second-largest selling LHRH agonist, for use in hormone-responsive cancers in the prostate and breast. It was first approved by the FDA in 1989 and its US patent has since expired. Worldwide sales continue to make this a blockbuster drug, and patents will not expire for years in many of the over 100 markets it serves. Analysts project a slow decline in global sales from the current $1 billion to $700 million by 2014.


Products

Recentin is an experimental treatment for non-small cell lung cancer and colorectal cancer. AstraZeneca anticipates filing an NDA for Recentin in 2010. In February of 2008, AstraZeneca announced the company will not move forward into Phase III trials to evaluate Recentin for non-small cell lung cancer, but is moving forward in the indication of colorectal cancer. According to early predictions, the drug will launch sometime in 2010 with $50 million in sales, and sales will peak at $281 million sometime after 2013.

Zactima is a VEGFR and EGFR inhibitor currently in Phase III trials for lung cancer. After positive Phase II results, AstraZeneca started their first Phase III trial in 2005, and has subsequently added three more. The FDA in 2005 also granted Orphan status to Zactima for its potential use in thyroid cancer. AstraZeneca plans to file for submission in 2008, and analysts project approval in 2009 and growth to nearly $300 million in sales by 2014.

ZD4054 is an endothelin A receptor antagonist currently in Phase III trials for hormone-refractory prostate cancer. AstraZeneca has been aggressively moving this drug towards FDA approval for prostate cancer indications, and has not initiated trials for any other indication. Analysts are projecting approval for this drug in 2010, and worldwide sales growth from $50 million to nearly $300 million by 2015.

ONCOLOGY BRAND PROFILES 15


Start using the report today. We designed this report to give every oncology product team the information they need to be as effective as possible. Whether you’re launching your company’s first cancer drug or adding to a thriving portfolio, you need to know your strengths and weaknesses.

To order your copy today, call Adam Bianchi at 919-433-0202 or write to [email protected].

Quick Summary

Chapter 1 – Analysis of Cancer Drugs by Classes

Chapter 2 – Analysis of Oncology Indications

Chapter 3 – Analysis of Top Companies’ Oncology Portfolios

REPORT LENGTH 350+ pages in PDF or hard copy format

METRICS AND CHARTS 1,000+ metrics

All leading oncology companies analyzed



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Oncology Market Forecast To 2013 - vpgcorp.com · Oncology Market Forecast To 2013 ... How are epidemiology and ... drugs in trials for brain and prostate cancer respectively,