Synthes and Lilly Sign Development and Collaboration Agreement (1)

WEST CHESTER, Pennsylvania and INDIANAPOLIS, June 9, 2011 /PRNewswire/ --

Synthes, Inc. (SIX: SYST.VX) and Eli Lilly and Company today announced the signing of an exclusive worldwide collaboration agreement to address the needs of patients who are cared for by orthopedic surgeons, including those with osteoporosis and those with bone fractures.

The agreement allows for the joint development and licensing of early stage compounds from Lilly to Synthes for use within orthopedic trauma, spine, craniomaxillofacial and reconstructive areas. These compounds have pre-clinical and in some cases clinical data packages and have the potential to aid in the local treatment and regeneration of the skeleton. The two companies will jointly develop site-specific osteoinductive (i.e. bone healing) products based on Synthes' biomaterials combined with Lilly's biologics or pharmaceuticals.

Within a second development program, Synthes and Lilly will jointly conduct and fund the evaluation of additional orthopedic uses for Lilly's osteoporosis drug Forteo(R) (teriparatide [rDNA origin] injection), marketed as Forsteo(R) in some countries outside of the United States). Building upon a Phase II study that Lilly has already completed, Lilly and Synthes will collaborate on additional clinical studies to evaluate potential future indications for Forteo, including fracture healing.

In addition to the development component of the agreement, the collaboration also includes the U.S. co-promotion of Forteo to orthopedic surgeons, an important segment of physicians who treat patients with a fracture due to osteoporosis. The companies will also co-promote Forteo in select countries and regions outside of the United States.

"I am very excited about this unique collaboration that will utilize the complementary clinical, development and operational strengths of each partner," said Michel Orsinger, president and CEO of Synthes. "Osteoporosis is one of the most significant unsolved clinical problems in orthopedics. Addressing the osteoporosis disease as well as the resulting fracture and bone defect is a significant strategic priority of both organizations," he continued. "Strategic collaborations between medtech and pharma companies represent a new and promising avenue to develop and market true innovations in a changing, dynamic market environment."

"We believe that patients worldwide will benefit from this collaboration because together we will be able to look for new ways to treat osteoporosis and bone fractures," said Bryce Carmine, executive vice president and president, Lilly Bio-Medicines, Eli Lilly and Company. "At Lilly, we are always exploring new opportunities to bring innovative medicines to people with unmet medical needs and improve outcomes for individual patients."

"Many orthopedic surgeons are in the position to diagnose and treat osteoporosis when their patients present with fractures, and we believe it is imperative to treat the underlying cause of the initial fracture," said Johnston Erwin, Bone/Muscle/Joint global development platform leader, Lilly Bio-Medicines, Eli Lilly and Company. "Our collaboration will also explore ways to treat fractures with Forteo in older patients and/or those who have osteoporosis and, longer term, will look for new ways to deliver medicine locally to the fracture site."

Financial terms of the agreement have not been disclosed.

Forteo, an FDA-approved osteoporosis therapy to help build new bone, is a treatment for postmenopausal women with osteoporosis who are at high risk for fracture(1) and to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.(2) Individuals at high risk for having broken bones include men and women with either a history of broken bones due to osteoporosis, who have several risk factors for fracture, or who cannot use other osteoporosis treatments.(1) Forteo is also approved to treat men and women with osteoporosis associated with sustained, systemic glucocorticoid therapy at high risk for fracture.(3) Forteo is a prescription medicine given as a 20 mcg once daily dose(4) available in a 2.4 mL prefilled delivery device for subcutaneous injection over 28 days.(5)

During the drug testing process, the medicine in Forteo caused some rats to develop osteosarcoma, which, in humans, is a serious but rare bone cancer. Osteosarcoma has been reported rarely in people who took Forteo, and it is unknown if people who take Forteo have a higher chance of getting the disease. Before patients take Forteo, patients should tell their healthcare provider if they have Paget's disease of bone, are a child or young adult whose bones are still growing or have had radiation therapy.(6) For more information about Forteo, please see the important safety information, including Boxed Warning regarding osteosarcoma, below.

About Eli Lilly and Company

Eli Lilly and Company, a leading innovation-driven company, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Information about Lilly is available at http://www.lilly.com.

Synthes: A leading medical device company

Synthes is a leading global medical device company, specialized in the development, manufacturing and marketing of instruments, implants and biomaterials for the surgical fixation, correction and regeneration of the human skeleton and its soft tissues.

Important Safety Information about FORTEO

What is the most important information I should know about FORTEO?

    
    WARNING: POTENTIAL RISK OF OSTEOSARCOMA
    During the drug testing process, the medicine in FORTEO caused some
    rats to develop a bone cancer called osteosarcoma. In people,
    osteosarcoma is a serious but rare cancer. Osteosarcoma has been
    reported rarely in people who took FORTEO. It is not known if people
    who take FORTEO have a higher chance of getting osteosarcoma. Before
    you take FORTEO, you should tell your healthcare provider if you
    have Paget's disease of bone, are a child or young adult whose bones
    are still growing, or have had radiation therapy

Who should not take FORTEO?

    
    - You should not take FORTEO for more than 2 years over your
      lifetime.
    - Do not use FORTEO if you are allergic to any of the ingredients in
      FORTEO. Serious allergic reactions have been reported.

What should I tell my healthcare provider before taking FORTEO?

    
    - Before you take FORTEO, you should tell your healthcare provider if
      you have a bone disease other than osteoporosis, have cancer in your
      bones, have trouble injecting yourself and do not have someone who
      can help you, have or have had kidney stones, have or have had too
      much calcium in your blood, take medications that contain digoxin
      (Digoxin, Lanoxicaps, Lanoxin), or have any other medical conditions.
    - You should also tell your healthcare provider, before you take FORTEO,
      if you are pregnant or thinking about becoming pregnant. It is not
      known if FORTEO will harm your unborn baby. If you are breastfeeding or
      plan to breastfeed, it is not known if FORTEO passes into your breast
      milk. You and your healthcare provider should decide if you will take
      FORTEO or breastfeed. You should not do both.

What are the possible side effects of FORTEO?

(CONTINUA)