Avanir Pharmaceuticals Announces Diabetes Co-Promotion Agreement with Merck

ALISO VIEJO, Calif., Aug. 12, 2013 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced that it has entered into an exclusive, multi-year agreement with Merck (NYSE: MRK), known as MSD outside the United States and Canada, to co-promote Merck's type 2 diabetes therapies JANUVIA^® (sitagliptin) and the sitagliptin family of products in the long-term care institutional setting in the United States.

(Logo: http://photos.prnewswire.com/prnh/20130207/LA55901LOGO)

"As a company dedicated to the advancement of diabetes care, we are excited to partner with Avanir to help improve diabetes management and offer our type 2 diabetes therapies to this patient population," said Peter Alberti, U.S. marketing leader, Diabetes, Merck. "We believe that combining Merck's leadership in diabetes with Avanir's unique capabilities will help this growing population get the diabetes care they need."

Avanir's institutional sales force will promote the sitagliptin family of products to health care practitioners in the long-term care institutional setting beginning in October 2013. Under the terms of this agreement, Avanir will be compensated via a fixed fee plus an incentive-based payment. Merck will continue to remain responsible for the promotion of the sitagliptin family of products in all other settings and will remain responsible for all other aspects of research, manufacturing and marketing.

"We are extremely pleased to enter this agreement with Merck for its key diabetes therapies. This agreement will further advance our vision to become a leading specialty biopharmaceutical company and drive our commercial operations forward," said Rohan Palekar, chief commercial officer at Avanir. "Our sales force is well established within the institutional setting and should be able to expand the adoption of Merck's diabetes therapies based on their deep understanding of the treatment needs of these physician and patient populations."

About JANUVIA^® (sitagliptin) 25 mg, 50 mg, and 100 mg tablets

JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUVIA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUVIA.

Selected Important Risk Information About JANUVIA

JANUVIA is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.

There have been postmarketing reports of acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, in patients taking JANUVIA. After initiating JANUVIA, observe patients carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, promptly discontinue JANUVIA and initiate appropriate management. It is unknown whether patients with a history of pancreatitis are at increased risk of developing pancreatitis while taking JANUVIA.

Assessment of renal function is recommended prior to initiating JANUVIA^® (sitagliptin) and periodically thereafter. A dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with end-stage renal disease requiring hemodialysis or peritoneal dialysis. Caution should be used to ensure that the correct dose of JANUVIA is prescribed.

There have been postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis. A subset of these reports involved patients with renal insufficiency, some of whom were prescribed inappropriate doses of sitagliptin.

When JANUVIA was used in combination with a sulfonylurea or insulin, medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo. Therefore, a lower dose of sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.

The incidence (and rate) of hypoglycemia based on all reports of symptomatic hypoglycemia were: 12.2 percent (0.59 episodes per patient-year) for JANUVIA 100 mg in combination with glimepiride (with or without metformin), 1.8 percent (0.24 episodes per patient-year) for placebo in combination with glimepiride (with or without metformin), 15.5 percent (1.06 episodes per patient-year) for JANUVIA 100 mg in combination with insulin (with or without metformin), and 7.8 percent (0.51 episodes per patient-year) for placebo in combination with insulin (with or without metformin).

There have been postmarketing reports of serious hypersensitivity reactions in patients treated with JANUVIA, such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these reactions occurred within the first 3 months after initiation of treatment with JANUVIA, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue JANUVIA, assess for other potential causes for the event, and institute alternative treatment for diabetes.

Angioedema has also been reported with other dipeptidyl peptidase-4 (DPP-4) inhibitors. Use caution in a patient with a history of angioedema with another DPP-4 inhibitor because it is unknown whether such patients will be predisposed to angioedema with JANUVIA.

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with JANUVIA or with any other antidiabetic drug.

In clinical studies, the adverse reactions reported, regardless of investigator assessment of causality, in greater than or equal to 5 percent of patients treated with JANUVIA as monotherapy and in combination therapy and more commonly than in patients treated with placebo, were upper respiratory tract infection, nasopharyngitis, and headache.

No overall differences in safety or effectiveness were observed between subjects 65 years and over and younger subjects. While this and other reported clinical experience have not been identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.

This drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly, and it may be useful to assess renal function in these patients prior to initiating dosing and periodically thereafter.

About Avanir Pharmaceuticals, Inc.

Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.

AVANIR® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc. in the United States and other countries. JANUVIA® is a registered trademark of Merck Sharp and Dohme Corp., a subsidiary of Merck & Co., Inc.

©2013 Avanir Pharmaceuticals, Inc. All Rights Reserved.

Avanir Forward Looking Statements

Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Avanir's plans, potential opportunities, financial or other expectations, projections, goals objectives, milestones, strategies, market growth, timelines, legal matters, product pipeline, clinical studies, product development and the potential benefits of its commercialized products and products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with, the market demand for and acceptance of products promoted by Avanir, Avanir's promotional efforts, compliance with the terms, covenants and conditions of the agreement, likelihood of earning fixed fee and performance payments, advancement as a leading specialty biopharmaceutical company, advancing our commercial operations, and our ability to expand adoption of diabetes therapy, claims or concerns regarding the safety or efficacy of marketed products and integration of co-promotion activities and other risks detailed from time to time in the Company's most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

Avanir Media and Investor Relations:
Ian Clements, PhD: (949) 389-6700; [email protected]

Prescribing Information and Medication Guide for JANUVIA® (sitagliptin) are available at http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_pi.pdf and http://www.merck.com/product/usa/pi_circulars/j/januvia/januvia_mg.pdf.

SOURCE Avanir Pharmaceuticals, Inc.