Lilly + ImClone Systems merge

7 Oct 2008

Global leader in oncology biopharmaceuticals created in $6.5 billion transaction reports on boost to oncology pipeline with up to three promising targeted therapies in phase III in 2009:


"Eli Lilly and ImClone Systems yesterday announced that the boards of directors of both companies have approved a definitive merger agreement under which Lilly will acquire ImClone through an all cash tender offer of $70.00 per share, or approximately $6.5 billion.

This strategic combination will create one of the leading oncology franchises in the biopharmaceutical industry, offering both targeted therapies and oncolytic agents along with a pipeline spanning all phases of clinical development. The combined oncology portfolio will target a broader array of solid tumor types including lung, breast, ovarian, colorectal, head and neck, and pancreatic, positioning Lilly to pursue treatments of multiple cancers. Combining with ImClone will further strengthen Lilly's growing portfolio of first-in-class and best-in-class pharmaceutical products, enabling Lilly to better support oncologists, with the ultimate goal of delivering better outcomes for cancer patients. Importantly, the combination also expands Lilly's biotechnology capabilities. ImClone's state-of-the-art development and commercial manufacturing facility will provide significant flexibility to develop and manufacture complex biomolecules.

"We think very highly of ImClone's ground-breaking work in oncology, particularly its success with ERBITUX(R), a blockbuster targeted cancer therapy, and its ability to advance promising biotech molecules in its pipeline," said John C. Lechleiter, Ph.D., Lilly's president and chief executive officer. "We are excited about the possibilities of improving outcomes for individual patients and building value for shareholders. This transaction will broaden our portfolio of marketed cancer therapies and boost Lilly's oncology pipeline with up to three promising targeted therapies in Phase III in 2009. By bringing together ImClone's and Lilly's marketed oncology products, pipelines, and biotech capabilities, we are taking a very important step forward in addressing the challenges of patent expirations we will face early in the next decade. We look forward to working with the ImClone team and their partners to ensure a smooth transition."

John H. Johnson, ImClone's chief executive officer, said "We believe this is an important step forward in ImClone's and Lilly's shared goal of addressing the medical needs of cancer patients around the world. The significant progress ImClone has made over the last few years is a direct result of the important contributions of our employees, and joining forces at this stage of our growth will allow us to leverage Lilly's global capabilities and make even greater advancements in our proprietary pipeline."

ERBITUX is marketed by ImClone's two partners, Merck KGaA and Bristol- Myers Squibb, and ImClone co-promotes ERBITUX in North America together with BMS. ERBITUX is indicated as both a single agent and with chemotherapy for certain types of colorectal cancers and as a single agent or in combination with radiation therapy for head and neck cancers. In 2007, worldwide sales of ERBITUX grew 18 percent to approximately $1.3 billion.

Benefits of the Transaction

A key strategic priority for Lilly is increasing the flow of high-quality, innovative new therapies. Today, Lilly has approximately 50 molecules in clinical development and the strongest mid-stage pipeline in its history. The company continues to evaluate and execute on opportunities to help bolster its pipeline, including the in-licensing of promising molecules and targeted acquisitions. The acquisition of ImClone adds late-stage assets, early- and mid-stage prospects, and the opportunity to generate additional value from ERBITUX. Importantly, it also supports the company's strategy to further increase its focus on biotechnology by increasing the proportion of its pipeline represented by biologics.

-- Broadens Lilly's current oncology product portfolio. The transaction will immediately enable Lilly to offer physicians and their patients a complementary portfolio of leading oncolytic agents and targeted therapies including GEMZAR(R), ALIMTA(R) and ERBITUX.

-- Strengthens Lilly's oncology pipeline and biotech capabilities. Lilly has a rich history and deep expertise in oncology which will be augmented by ImClone's culture of discovery. ImClone's pipeline adds several molecules in mid-to late-stage clinical development targeting virtually all major solid tumor types. These targeted therapies, three of which have the potential to be in Phase III in 2009, add to Lilly's own oncology pipeline of 13 compounds in clinical development. Lilly's biotech capabilities will be complemented and enhanced by ImClone's expertise in the scale-up and manufacturing of biologics. In addition, ImClone's state-of-the-art development and commercial manufacturing facility will offer additional capacity for antibodies in development from both companies.

-- Provides important source of growth beginning in period of patent expirations. The acquisition of ImClone will help Lilly meet the challenge posed by patent expirations on several currently marketed products in the middle of the next decade. ERBITUX has significant future growth opportunities, including from potential new indications in first-line head and neck, colorectal and non-small cell lung cancer. Given that three of ImClone's pipeline assets have the potential to be in Phase III testing in 2009, they could also contribute significantly to Lilly's revenue growth during this period, while ImClone's earlier stage assets should help bolster Lilly's late-stage pipeline.

Promising ImClone Pipeline Molecules

-- IMC-1121B is a fully-human monoclonal antibody that targets the VEGF receptor to deprive tumor blood vessels of the nutrients they need for further growth. Phase II studies are underway for metastatic melanoma, renal, liver, ovarian and prostate cancers. Metastatic breast cancer is in Phase III testing, while Phase III testing in gastric cancer may begin in 2009.

-- IMC-A12 is a fully-human monoclonal antibody that targets the insulin- like growth factor-1 receptor (IGF-1R). Phase II testing is underway in breast, prostate, pancreatic, colon, liver and head and neck cancers, as well as sarcoma, with Phase III trials planned in 2009. IMC-A12 has the potential to work with a variety of other targeted agents.


-- IMC-11F8 is a potent, fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFR), the same receptor targeted by ERBITUX. It is currently in Phase II studies for metastatic colorectal cancer with one or more Phase III trials planned in 2009.