FDA Approves Aveed

FDA Approves Aveed (testosterone undecanoate) Injectable Testosterone Replacement Therapy

DUBLIN, March 6, 2014 /PRNewswire/ -- Endo International plc announced today that its operating company Endo Pharmaceuticals Inc. received U.S. Food and Drug Administration (FDA) approval of Aveed (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. Aveed is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750 mg) intramuscular injection given once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter. It is expected to be available in early March.

"Today's FDA approval of Aveed is a significant milestone for Endo. Aveed expands our branded portfolio of men's health products and highlights our passion and commitment to providing high quality therapies that improve patient care," said Rajiv De Silva, president and chief executive officer of Endo. "With Aveed, Endo can now offer men living with hypogonadism different treatment options to raise testosterone levels. We are focused on getting Aveed to market to ensure that appropriate patients have access to it."

The approval of Aveed is based on data from an 84-week Phase 3 trial of hypogonadal men in the U.S. Men enrolled in the study had an average age of 54 years and a serum total testosterone level of less than 300 ng/dL. In the Phase 3 study, Aveed increased mean serum testosterone levels, maintaining them for up to 10 weeks at steady state (between weeks 14-24). Aveed is approved with a Risk Evaluation and Mitigation System (REMS) requiring prescriber education and certification as well as restricted product distribution.

"Physicians have prescribed FDA-approved testosterone replacement therapies for many years to help treat men diagnosed with testosterone deficiency, or hypogonadism. Aveed is an important new option that may be suitable for some men given its dosing schedule and administration," said Martin Miner, M.D., co-director of the Men's Health Center at Miriam Hospital and a clinical associate professor of Family Medicine and Urology at Brown University's Warren Alpert School of Medicine, Providence. "As with any prescription therapy, hypogonadal men should talk to their doctor about the potential risks and benefits of testosterone replacement therapy so they can make an informed treatment decision."

"Men's Health Network is pleased to see the FDA approval of a new treatment for hypogonadism as we believe men with this condition should have access to a broad range of treatment options," said Ana Fadich, MPH, vice president of the national non-profit organization Men's Health Network. "Men diagnosed with hypogonadism and their partners need to have an open discussion, with each other and the man's doctor, about the condition and ways to manage it so they can find the right treatment that best suits their individual needs."

About Aveed (testosterone undecanoate)

Aveed injection is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). Aveed has a Boxed Warning for serious pulmonary oil microembolism (POME) reactions and anaphylaxis. It should be used in patients who require therapy and in whom the benefits of the product outweigh the serious risks of POME and severe allergic reaction (anaphylaxis).

Aveed is available as a single-use vial. Dosage titration is not necessary. Following the first intramuscular injection of 3 mL of Aveed (750 mg), a second 3 mL dose is injected 4 weeks later, and then 3 mL is injected every 10 weeks thereafter. Aveed is prescribed and administered by trained healthcare providers in a doctor's office, clinic, or hospital.

Aveed contains testosterone undecanoate, which Endo licensed through its subsidiary Endo Pharmaceuticals Solutions Inc. from Bayer Pharma AG. Outside the U.S., Bayer Pharma AG and its subsidiaries have been marketing testosterone undecanoate injections since 2003.

Additional safety data for testosterone undecanoate injections are available from 18 clinical trials conducted worldwide in 3,556 subjects treated outside the U.S.

About Endo International plc

Endo International plc is a global specialty healthcare company focused on improving patients' lives while creating shareholder value. Endo develops, manufactures, markets, and distributes quality branded pharmaceutical, generic and device products through its operating companies. Endo has global headquarters in Dublin, Ireland and US headquarters in Malvern, PA. Learn more at www.endo.com.

About Endo Pharmaceuticals Inc.

Endo Pharmaceuticals Inc., headquartered in Malvern, PA, is focused on developing and delivering high-value branded pharmaceutical products that meet the unmet needs of patients. Endo Pharmaceuticals is an operating company of Endo International plc (NASDAQ: ENDP) (TSX: ENL), a global specialty healthcare company focused on improving patients' lives while creating shareholder value. Learn more at www.endo.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in Endo's Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect Endo's future financial results and could cause Endo's actual results to differ materially from those expressed in forward-looking statements contained in our Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

SOURCE Endo Pharmaceuticals

Posted: March 2014

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