Overview

Executive Summary


In-licensing occurs when a company buys the rights either to develop and market
a compound another company has discovered, or to market a compound that
another company has discovered and developed. Biotech companies fit the bill,
becoming the R&D goldmines of the industry as pharma firms acquire, or in-
license the rights to promising new drugs.
Biotechnology companies often have on their books promising compounds for
which they lack the resources to develop in-house, and many of the big pharmas
are choosing to develop these attractive and strategic in-licensed products rather
than non-core in-house alternatives.
Recent research estimates that 40% of pharma industry revenues will be derived
from in-licensed products by the end of 2002, and that biotechnology and
pharmaceutical companies will spend up to $15 billion a year on those licensing
deals. It is estimated that this year Big pharmas will be turning to 3,000 or so
biotechnology companies for help infilling their product pipelines.
As the trend to in licensing grows, biotech companies with promising products
increasingly enjoy a seller’s market as pharma giants prowl for prospects. In late-
stage deals especially, competition is fierce. For the pharma companies, speed
of acquisition is therefore essential to maintain competitive advantage.
This report gives an overview of the market, the trends and major players
engaged in in-licensing. It further analyses the in-market and pipeline products of
the top 10 pharma companies to ascertain the in-licensing initiative undertaken
by these companies. Details of particular drugs and the corresponding in-
licensees are also provided and give an idea of the proportion of their marketed
drugs and pipeline made up of products that have been licensed in from other
companies.
Table Of Contents
Overview

In-Licensing In The Changing Research And Development Environment

The scenario of research and development practices in the pharmaceutical industry is changing
rapidly. Advances in genomic and organic compound research have exploded the number of
potential drug targets and the compounds. These new targets are niche oriented with attendant
financial implications. When internal R&D organisations are unable to fill their product pipelines,
companies often look to external sources to supplement their portfolios. Biotech companies are
fitting the bill, becoming the R&D goldmines of the industry as pharma firms acquire, or in-license
the rights to promising new drugs.
To capitalise on the market potential of any in-licensed product, pharma companies must apply
an integrated process – from discovery, to launch, through to ongoing management of their in-
licensed products. If the operational aspects of in-licensing are ignored, companies will suffer
from the inefficiencies of high inventory, high scrap and, crucially, delayed launch of new
products. In-licensing opportunities can come at any stage of development and therefore specific
capabilities are required to link in-licensed products within the organisation and manage the
effects on the overall supply chain.

Managing The Trend

As the practice of in-licensing accelerates, pharma companies are developing dedicated internal
management structures to oversee integration. The most effective of these approaches employs
an experienced, cross-functional management team to direct the process of acquiring a new
product and integrating it into the overall supply chain.
The team approach helps spread accountability across all functions involved. The in-licensing
process is cyclical in nature, tied to the life cycles of the various products involved. A company’s
in-licensing management team should therefore participate in the corporation’s strategic planning
process and have a voice in the management of the product portfolio.

Three-Phase Process

The process of in-licensing products, and ensuring operational alignment, can be divided into
three phases: evaluation, project management and line management. At the junction of each
phase, a senior management team review the progress of the core team running the in-licensing
initiative and make a ‘go,’ ‘no go,’ or ‘re-assess’ decision. Finance, sales and marketing,
operations, registration, and medical functions is involved from the start. The in-licensee, together
with functional heads of the biotech company, communicates at an early stage to prevent an
operational ‘bullwhip’ effect as the project progresses. If they do, problems solved early won’t
become major problems down the road.
In the evaluation phase, finance ensures that the in-licensing opportunities have a favorable
potential return. The status of the licensor is also assessed to assure competency and financial
solidity. As the process continues, functional interconnectivity within corporations is paramount.
The operational needs of both parties have to be captured, communicated and agreed. Ideally, a
comprehensive service-level agreement should be executed prior to the Commercial launch of
the product.
The in-licensor needs to examine the warehouse capacity, packaging and labelling capacity, and
distribution logistics. Both parties need to agree their requirements and capabilities. Factors such
as lead-time, order size, frequency of order and the method of replenishment must all be
addressed. Once the product is launched, communication between functions in both companies
remains vital. If market demand fluctuates, that information must be immediately shared among
the companies, otherwise too much product could be moved into channels with the resulting high
inventory eating up capital and producing scrap.
Speed And Accuracy

The dynamics of in-licensing are hardly secret. Some of the most lucrative deals on the market
today originated from in-licensed drugs. Pfizer and Warner Lambert’s co-marketed cholesterol-
lowering drug Lipitor is perhaps the most successful example. As the trend to in-licensing grows,
biotech companies with promising products increasingly enjoy a seller’s market as pharma giants
prowl for prospects. In late-stage deals especially, competition is fierce. For the pharma
companies, speed of acquisition is therefore essential to maintain competitive advantage.
In this race, winning companies will use an efficient, expeditious process for both identifying
potential products and evaluating the operational implications of in-licensing various products.
While the physiological impact of a new drug is clearly pre-eminent, ignoring the operational
elements of in-licensing can severely limit the financial return of each investment.
Source:
Licensing Deals: Global Figure

According to IMS HEALTH's Pharmaceutical Company Profiles, the number of licensing deals
entered into annually by the world's leading pharmaceutical companies increased steadily in the
period 1996-2001.
Percentage Revenues From In-Licensed Pharmaceutical Products

In-licensed products generate increasing proportion of revenues. IMS HEALTH MIDAS data for
the period 1996-2001 shows the revenue generated for the ten largest global pharmaceutical
firms by in-licensed products has grown from an average of 19% in 1996 to 22% in 2001. The
data show that Abbott generates the largest proportion of its revenues from in-licensed products.
The Companies that rely least on in-licensed products for revenue are Novartis (9% of 2001 revenues were generated by such products) and GlaxoSmithKline (14%). This statistic is likely to change, however, as more and more valuable intellectual property is created in the biotech sphere, particularly given the recent advances in pharmacogenomics and pharmacogenetics. GSK in-licensed a record nine products during 2000, while Novartis will funnel 30% of its research investment into external collaborations in 2001. There are certainly signs that the multinational pharmaceutical companies are spending an increasing proportion of their research budgets on external collaborations; Pharmacia, for instance, now deploys over 20% of its R&D expenditure on external collaborations, up from just 4% when the company was formed in 1995. The company's top R&D priority is now the licensing-in of potential anticancer compounds. AstraZeneca spends a similar proportion of its R&D investment externally. Commenting on the need for external collaborations at the recent Financial Times World Pharmaceutical Conference, Novartis' Head of Research, Dr Paul Herrling, said, "Not even the largest pharmaceutical companies can satisfy all of their research innovation needs in-house." Sources: AstraZeneca

Company Profile

AstraZeneca was formed on April 6, 1999, and combines the better of two companies, Zeneca
Group Plc and Astra AB, both with a track record of innovation and a documented ability to
develop new concepts in medicine. Astral Zeneca is a globally managed research organization
with 10,000 staff at nine sites in the UK, US, Sweden, Canada and India. Major focus being on
advanced enabling science and technology methods, such as informatics and genetics and
commitment to improving productivity in drug discovery and development. Continued emphasis of
the company is on the formation of strategic research partnerships with academic and
commercial partners to complement in-house skills.
AstraZeneca has a world-leading R&D organization and one of the best pipelines in the industry.
They spend over $8 million each working day on R&D and have 10,000 people dedicated to the
discovery and development of innovative new medicines that meet the needs of patients
worldwide with Annual investment of over $2.6 billion to improve the quality and efficiency of the
discovery process and ensure a flow of high potential candidates for development as new
products.

In-Licensing Arrangements For Marketed Products

As one of the world's leading pharmaceutical companies, successful collaborations and the in-
licensing of innovative products and technologies play a key role in strengthening AstraZeneca
portfolio.
Licensor Product
Category

In-Licensing Arrangements For Products In Pipeline

Licensor Product
Aventis
Company Profile
Aventis Pharma AG is the pharmaceutical company of Aventis. Aventis Pharma is dedicated to
treating and preventing human disease through the discovery, development, manufacture and
sale of innovative pharmaceutical products aimed at satisfying unmet medical needs.
Aventis is investing over 20 percent of its R&D budget in external alliances. By partnering and in-
licensing products, Aventis is leveraging it’s development and marketing strengths. Networking
and alliances are becoming major elements of Aventis’ Drug Innovation & Approval strategy.
Aventis R&D investments in 2000 of approximately € 2.7 billion were among the highest in the
pharmaceutical industry worldwide. Aventis has a very interesting pipeline with nearly 50 new
chemical entities, new vaccines, and more than 20 line extensions in development including
several major products to satisfy unmet medical needs.

In-Licensing Arrangements For Marketed Products

S. No. Product
Licensors/Developers
Category
Source: Annual Report 2000
In-Licensing Arrangements For Products In Pipeline

S.No. Product Manufacturer/Licensor
Category
Bristol-Myers Squibb (BMS)
Company Profile

Bristol-Myers Squibb, from its beginnings in upstate New York in 1887, is today a diversified
health and personal care company headquartered in New York City, NY, that develops,
manufactures and markets prescription pharmaceuticals, consumer medicines, nutritional and
medical devices and beauty care products worldwide. Its mission is to extend and enhance
human life by providing the highest-quality health and personal care products.
BMS' Pharmaceutical Research Institute (BMS-PRI) is a global research and development
organisation dedicated to discovering and developing innovative, best in class, cost-effective
medicines that improve health and quality of life for people worldwide. Headquartered in
Princeton, New Jersey, the PRI has a workforce of about 4,000 scientific and administrative
personnel worldwide dedicated to R&D. Discovery research efforts are focused on the following
therapeutic areas: oncology, cardiovascular and metabolics, anti-infectives, neurosciences,
immunology and inflammation, dermatology, and pain management.
Source:
In-Licensing Arrangements For Marketed Products

Product Licensor/Developer
Category
Metastatic cancer, gastric passage, breast Source:
In-Licensing Arrangements for Products in Pipeline

Product Licensor/Developer
Category
Eli Lilly & Company

Company Profile

Eli Lilly & Company is a leading manufacturer of prescription and over-the-counter
pharmaceutical products. The Company also manufactures and sells animal health products, and
manufactures and distributes its products through owned or leased facilities in the United States,
Puerto Rico and 30 other countries. Eli Lilly directs its research efforts primarily toward the search
for products to diagnose, prevent and treat human diseases. The Company also conducts
research to find products to treat diseases in animals, and to increase the efficiency of animal
food production. The company employs more than 31,000 people worldwide and markets its
medicines in 179 countries.
Lilly Research Laboratories (LRL) is responsible for the discovery, development, and clinical
evaluation of Lilly’s pharmaceutical products and for providing ongoing scientific support for
marketed products. LRL comprises more than 6,000 people from a wide variety of scientific
disciplines who work in laboratories in the United States and at other locations around the world.
Research and development locations in the U.S. include four sites in Indiana (Indianapolis,
Greenfield, West Lafayette, and Clinton). Outside the United States, Lilly operate research
facilities in Belgium, Canada, England, Germany, Japan, and Spain. In addition, they conduct
clinical research in approximately 70 countries around the world.
In 1999, Lilly spent approximately $1.8 billion in the quest to discover and develop innovative
medicines-18 percent of their sales. By contrast, only three years earlier, Lilly’s R&D budget was
just over $1.2 billion. In 2000, it hit the $2 billion mark (approx.) in R&D spending.
Lilly’s internal research efforts are primarily focused on five therapeutic areas:
In recent years, Lilly has introduced important new drugs for the treatment of cancer,
schizophrenia, osteoporosis, diabetes, cardiovascular complications, and other urgent medical
needs. In 1994, Lilly acquired Sphinx Laboratories, a division of LRL headquartered in Research
Triangle Park, North Carolina. Sphinx's novel approach to drug discovery and development has
provided with cutting-edge research tools to identify and optimise promising drug candidates
more quickly and efficiently. Lilly is currently involved in more than 140 research and
development collaborations with leading companies and universities.
Source:
In-Licensing Arrangements For Marketed Products

S.No. Product
Manufacturer/Licensor
Category
Takeda Chemical Industries, Diabetes -- Type 2 (non-insulin Solvay Pharmaceuticals, Inc. Congestive heart failure Hypertension Centocor, Johnson & Johnson diseaseStroke/traumatic brain injury Johnson & Johnson, Centocor angioplasty/bypassRestenosis
In-Licensing Arrangements For Products In Pipeline

Licensors/
S.NO. Product
Category Current
Developers
GlaxoSmithKline

Company Profile

GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company with a
powerful combination of skills and resources meeting the healthcare needs of people around the
world. By doing so, GSK delivers strong growth in today's rapidly changing business
environment.
GlaxoSmithKline was formed in January 2001 as a result of merger between GlaxoWellcome and
SmithKline Beecham. Headquartered in the UK and with operations based in the US, the new
company is one of the industry leaders, with an estimated seven per cent of the world's
pharmaceutical market.
GlaxoSmithKline is a leader in four major therapeutic areas:
In addition, it is a leader in the increasingly important area of vaccines. The company also has a Consumer Healthcare portfolio comprising over-the-counter (OTC) medicines; oral care products and nutritional healthcare drinks, all of which are among the market leaders. GSK is among the top three companies worldwide in both OTC medicines and oral healthcare products, with ten oral healthcare and nutritional healthcare brands with sales of $100
million. The company has market-leading products in analgesics, nicotine replacement therapy,
gastro-intestinal and respiratory tract consumer medicines; and in nutritional, dermatology and
natural wellness. Consequently, GSK has household name brands in 130 countries.
In-Licensing Arrangements For Marketed Products

Licensor Product

In-Licensing Arrangements For Products In Pipeline

Licensor Product
Johnson & Johnson

Company Profile

Johnson & Johnson, employing approximately 100,000 people worldwide, is engaged in the
manufacture and sale of a broad range of products in the health care field in many countries of
the world. Johnson & Johnson was organized in the State of New Jersey in 1887. It is organized
on the principles of decentralized management.
Johnson & Johnson's pharmaceutical business is one of the most diverse in the country and in
the world. The company sells over 90 drugs. With the help of drugs, Johnson & Johnson has
been improving margins every year, a trend that is expected to continue. Johnson & Johnson is
the world’s most comprehensive and broadly based manufacturer of health care products, as well
as a provider of related services, for the consumer, pharmaceutical and professional markets.
Research activities represent a significant part of the Company’s business. These expenditures
relate to the development of new products, improvement of existing products, technical support of
products and compliance with governmental regulations for the protection of the consumer.
In 2001, Johnson & Johnson invested $3.6 billion or 10.9% of sales in research and
development, recognizing the importance of on-going development of new and differentiated
products and services. Research expense as a percent of sales for the Pharmaceutical segment
was 16.6% for 2001, 16.4% for 2000 and 15.7% for 1999.
Source: Annual Report 2001
In-Licensing Arrangements for Products in Pipeline

Product Manufacturer/Licensor
Category
Source: Johnson & Johnson Pharmaceuticals in late stage US development or registration (July 2002)
In-Licensing Arrangements for Marketed Products
Product Co-Promoter/Developer
Cholesterol 1,2,3
Shire Pharmaceuticals Group PLC, Janssen ZymoGenetics, Ortho-McNeil Pharmaceutical Merck & Co., Inc.

Company Profile

Merck & Co., Inc. is a global research-driven pharmaceutical company that discovers, develops,
manufactures and markets a broad range of human and animal health products, directly and
through its joint ventures through Merck-Medco Managed Care, L.L.C. (Merck-Medco). Although
the company is known largely as a drug maker, prescription benefits management subsidiary
Merck-Medco accounts for more than half of its sales. With some of its top sellers nearing patent
expiration, Merck is pushing new products through its pipeline. With more than 69,000
employees, Merck conducts research at 11 major research centers in the United States, Europe,
and Japan, manufactures products in 32 facilities and sells products in approximately 150
countries. Merck continues to invest heavily in research and development with an estimated $2.6
billion in R&D spending in 2001. Merck have invested more than $15 billion in R&D over the past
10 years.
The strategy for Growth at Merck is based on breakthrough research and demonstrating the
value of their medicines to patients, payers and providers. Worldwide sales in 2000, including
Merck-Medco, were more than $40 billion. Pharmaceutical benefit services accounted for 54% of
2000 revenues; therapeutic agents, 43% and non-reportable human and animal health products,
3%. For the fiscal year ended 12/31/01, sales of Merck & Co. Inc had rose 18% to $47.72 billion.
Net income rose 7% to $7.28 billion. Results reflect strong growth in worldwide human health
sales and other established products, partially offset by higher materials and production costs.
For the 3 months ended 12/31/2001, revenues were 12,558,000; after tax earnings were
1,860,900. (In thousands of dollars)
In-Licensing Arrangement For Marketed Products

Manufacturer/Licensor Category

In-Licensing Arrangement For Products In Pipeline

Product Description
Internal
Licensor/Alliance
PFIZER INC.

Company Profile

Pfizer Inc is a research-based global pharmaceutical company. Their products are available in
more than 150 countries. It is a global pharmaceutical and consumer Products Company, which
discovers, develops, manufactures and markets innovative medicines for humans and animals.
Pfizer has 12,000 skilled researchers working at R&D facilities in more than 20 countries around
the world. The company has R&D budget of $4.7 billion for the year 2001, the highest in the
pharmaceutical industry and the third highest among all companies. It has more than 130 new
product candidates in development to treat diseases and conditions affecting hundreds of millions
of people—everything from cancer to the common cold.
The company has three business segments: Source:
In-Licensing Arrangements For Marketed Products
Product
Licensor/Developer
Category
Current Phase
technology
Source:
In-Licensing Arrangements For Products In Pipeline
Licensors/
S.No Product
Category Current
Developers


Pharmacia
Company Profile

Pharmacia Corporation is one of the world's fastest-growing pharmaceutical companies with a strong portfolio of products, a robust pipeline of new drugs in development and a commitment to improving health and wellness for people around the world. Pharmacia Corporation, invest more than $2 billion each year to discover and develop medicines that improve the health of people around the world. Major R&D activities are focused in the areas of cancer, arthritis/inflammation, infectious S.No. Product
Manufacturer/Licensor
Category
Anadys’GATE Anadys Pharmaceuticals, Inc.
diseases and disorders of the central nervous system. It also has a presence in ophthalmology,
urology and women's health. Pharmacia's cutting-edge R&D organization is responsible for an
ever-increasing portfolio of new therapeutic compounds and medicines.
At the same time, Pharmacia has become a world leader in its ability to forge strategic
partnerships, further enhancing R&D activities and strengthening product offerings. Pharmacia's
strong internal innovation and smart external partnering have resulted in the development of
products such as Celebrex, the world's leading treatment for arthritis, Xalatan, the world's leading
therapy for glaucoma, and Zyvox, the first of the world's newest family of antibiotics in 35 years.
In-Licensing Arrangements Of Marketed Products
Licensor Product
Category



In-Licensing Arrangements Of Products In Pipeline

S.No. Product
Manufacturer/Licensor
Category
Current Phase
Anadys’GATE Anadys Pharmaceuticals, Inc.

Sources:



Roche Group
Company Profile
Roche has more than 140 subsidiaries worldwide devoted to drugs, vitamins, and diagnostic
products. Its pharmaceuticals (more than 60% of sales) include antibiotic Rocephin; obesity
treatment Xenical; AIDS drug Invirase; acne treatment Roaccutan/Accutane; and Tamiflu, which
is used for prevention and treatment of influenza. OTC products include vitamins, the analgesic
Aleve, and antacid Rennie. Roche is a leading maker of vitamins; owns 58% of biotech giant
Genentech; is buying a majority stake in Japan's Chugai; and is the world's no.1 diagnostics
company. The company spun off fragrances and flavours unit Givaudan and a biotech division,
which is now called BASILEA Pharmaceutica.
For the first half of 2002, investments by Roche Group in research and development totaled 1.9
billion Swiss francs, or 14% of sales. Research and development costs as a percentage of sales
on Group level declined from 14.9% to 14.3%. For Pharmaceuticals, which accounts for more
than 80% of the Group’s research and development expenses, they decreased from 17.0% to
16.4%. With a total of 136 projects in research and 76 projects in development – including 35
new molecular entities (NMEs) – Roche has increased the size and quality of its pharmaceuticals
pipeline. Roche expects its new products to provide genuine added value for patients, healthcare
professionals and payers. In all, they currently have 48 NMEs in their pipeline.
Source: Half Year Repor
In-Licensing Arrangements for Marketed Products

Licensor Products
Sanofi-Synthelabo Philippines
Roche markets Genetech products in Canada.
In-Licensing Arrangements for Products in Pipeline

Products Partners
Category
Phase
Marketed (Except
Wyeth
Company Profile

Wyeth (WYE), formerly known as American Home Products Corporation (AHP) is engaged in the
discovery, development, manufacture, distribution and sale of a diversified line of products in two
primary businesses: Pharmaceuticals and Consumer Health Care. Pharmaceuticals include
branded and generic human ethical pharmaceuticals, biologicals, nutritionals, and animal
biologicals and pharmaceuticals. Consumer Health Care products include analgesics,
cough/cold/allergy remedies, nutritional supplements, herbal products, and hemorrhoidal,
antacid, asthma and other relief items sold over-the-counter.
Wyeth is a research-based, global pharmaceutical company responsible for the discovery and
development of some of today's most innovative medicines. Their products are sold in more than
140 countries, and their product portfolio includes innovative treatments across a wide range of
therapeutic areas. Their worldwide resources include more than 52,000 employees,
manufacturing facilities on five continents, and a discovery and development platform
encompassing pharmaceuticals, vaccines and biotechnology.
In 2001, Wyeth spent approximately $1.9 billion on research and development, with an emphasis
on pharmaceutical, vaccine, and biotechnology products. In 2002, the company expects to invest
more than $2 billion on research and development. This level of spending places Wyeth among
the world's leading pharmaceutical companies in terms of research and development
commitment.
Source:

In-Licensing Arrangements For Products In Pipeline

Product Manufacturer/Licensor
Category

In-Licensing Arrangements For Marketed Products
Product Co-Promoter/Developer
Altace
Schering-Plough
Company Profile
Schering-Plough incorporated in 1970, is a worldwide pharmaceutical company committed to
discovering, developing and marketing new therapies and treatment programs. The Company is
a renowned leader in biotechnology, genomics and gene therapy. Company’s Core product
groups are: Allergy and respiratory, anti-infective and anticancer, cardiovascular and
dermatological. Schering-Plough also has a global animal health business as well as leading
consumer brands of foot care; over-the counter and sun care products.
Schering-Plough’s Research and Development spending decreased 2%, representing 13.4% of
sales in 2001. Research and development expenses grew 12% to $1.3 billion and represented
13.6% of sales in 2000. The changes in spending in both years reflect the timing of the
Company’s funding of both internal research efforts and research collaborations with various
partners to discover and develop a steady flow of innovative products.
Source: Annual Report 2001
In-Licensing Arrangements For Marketed Products

Product Manufacturer/Developer
Avonex
IMPAX Laboratories, Inc. Drug Royalty Corporation Inc., Tanabe Seiyaku Company Drug Royalty Corporation Inc., Cambridge Antibody Technology Group Drug Royalty Corporation Inc., Amgen Inc.

Company Profile

Amgen founded in 1980, is the world's largest independent biotechnology company. The
Company discovers, develops, manufactures and markets human therapeutics based on
advances in cellular and molecular biology. The company focuses its resources on developing
proteins, antibodies and small molecules to treat conditions associated with kidney disease,
cancer, inflammation and neurologic and metabolic disorders.
The Company has research facilities in the United States, and has clinical development staff in
the United States, the European Union, Canada, Australia and Japan. In July 2002, Amgen
acquired Immunex Corporation, a biopharmaceutical company dedicated to developing immune
system science to protect human health.
Research and development expenses of Amgen Inc. have increased at a compound annual
growth rate of 21.7% over the past ten years. Research & Development expenses rose from
$845 million in 2000 to $865 million in 2001.
Amgen's in-licensing efforts, focusing on both industry and academia, are an important part of our
ongoing search for innovative products and technologies. They are known for their collaborative
approach, extensive research capabilities, quality science, clinical expertise, worldwide sales
operations, and manufacturing capabilities. The combination of these factors makes Amgen the
number one choice for those searching to develop their technologies effectively.
Source: Annual Report 2001
In-Licensing Arrangements For Marketed Products

Product Manufacturer/Developer
Novantrone Immunex
Liposome Company, Inc., Elan Corporation PLC

Source: http://www.canbiotech.com/UserResourcesCB/1RSInlicensing.pdf