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Lilly Granted Temporary Restraining Order to Halt Launch of Generic Raloxifene

Lilly Vows to Defend Intellectual Property Rights

INDIANAPOLIS, March 9 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) today issued the following statement after being granted a temporary restraining order to halt the launch of a generic version of Evista(R) (raloxifene HCl tablets) by Teva Pharmaceuticals. Teva had indicated it was prepared to launch the generic version prior to the resolution of outstanding patent litigation currently being heard by the U.S. District Court for the Southern District of Indiana.

"We appreciate the Court issuing the temporary restraining order and look forward to completing the trial and vindicating our patent rights," said Robert A. Armitage, senior vice president and general counsel for Lilly. "We believe Teva's challenges to Lilly's Evista patent are without merit and we expect to prevail in this litigation. We have taken and will continue to take all appropriate actions needed to protect our intellectual property rights as they relate to Evista.

"At Lilly, our mission is to discover and develop innovative new medicines for patients. Respect for our patents is critical to that mission, as is our ability to enforce our patents against those who violate them."

Evista is a breakthrough medicine indicated for the treatment and prevention of osteoporosis in postmenopausal women; and the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and the reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. The validity of the product's 2012, 2014 and 2017 patents have been challenged and are currently being heard in the case of Eli Lilly and Company v. Teva Pharmaceuticals Industries Ltd.


EVISTA(R), a selective estrogen receptor modulator (SERM), recently classified by the FDA as an estrogen agonist/antagonist, is indicated for the treatment and prevention of osteoporosis in postmenopausal women; and the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and the reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer.

Important Safety Information about EVISTA(R) (raloxifene HCl tablets)

EVISTA is not for everyone. Serious side effects can occur while taking EVISTA.

EVISTA may cause an increased risk of blood clots. You should not take EVISTA if you have had or are at risk for getting blood clots in the legs, lungs, or eyes. Stop taking EVISTA and call your doctor if you have swelling or feeling of warmth in your legs, chest pain, shortness of breath, coughing up blood or sudden changes in vision, as these may be signs of a blood clot. Being unable to move around for long periods may increase this risk. If you will need to be still for a long time, talk to your healthcare professional about ways to reduce the risk of blood clots.

In a study of women past menopause who were at high risk for heart attack, EVISTA increased the risk of dying from a stroke. However, EVISTA did not increase the risk of heart attack, stroke, or dying from other causes. Before taking EVISTA, tell your healthcare professional if you have had a stroke, mini-stroke, irregular heartbeat, high blood pressure, heart attack, history of smoking, or believe you have other risk factors for stroke or a heart attack.

You should not take EVISTA if you are nursing, pregnant, or may become pregnant, as it may harm your baby. If you have kidney or liver problems, you should talk to your healthcare professional about these conditions before taking EVISTA. Do not take EVISTA with estrogen in the form of pills, patches, or injections.

The most common side effects are hot flashes, leg cramps, swelling, flu-like symptoms, joint pain, and sweating. In clinical trials, side effects were usually mild enough that most women did not stop taking EVISTA. EVISTA does not reduce the risk of all forms of breast cancer. EVISTA does not treat breast cancer if you already have it or reduce the risk of it coming back if you had it in the past.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class 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. Additional information about Lilly is available at C-LLY

This release contains forward-looking statements regarding the U.S. Evista patent litigation. These statements are based on management's current expectations but actual results may differ materially. There can be no assurance that the company will prevail at trial or any appeal. Also, the company cannot predict whether generic raloxifene will be marketed prior to the resolution of this litigation. Other risk factors that may affect the company results can be found in company's Form 10-K dated February 2009.

Evista(R) (raloxifene, Lilly)


SOURCE Eli Lilly and Company
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