Pernix Therapeutics Holdings, Inc. (NASDAQ GM: PTX) (“Pernix” or the “Company”), a specialty pharmaceutical company, today announced that it has signed an agreement with Osmotica Pharmaceuticals Corp (“Osmotica”) to market and sell KHEDEZLA™ (desvenlafaxine) Extended-Release (ER) Tablets, 50 mg and 100 mg. The sales and marketing of KHEDEZLA will be supported by Pernix’s team of approximately 90 sales professionals, promoting the product to high desvenlafaxine prescribing physicians. The New Drug Application (NDA) for KHEDEZLA Tablets was approved by the U.S. Food and Drug Administration pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act in July 2013. KHEDEZLA is indicated for the treatment of major depressive disorder (MDD). “We are pleased to add KHEDEZLA to the Pernix product portfolio,” said Doug Drysdale, Chairman and CEO of Pernix. “KHEDEZLA provides Pernix with an opportunity to leverage its greatest asset – our team of 90 professional sales men and women and represents the first step in our transformation to specialist promotion. KHEDEZLA has excellent promotional synergy with our sleep maintenance product, SILENOR. We believe that the ability to promote SILENOR and KHEDEZLA side by side provides a valuable product offering to Pernix’s target physicians.” The KHEDEZLA NDA included comparative bioequivalence testing against Pfizer’s PRISTIQ® (desvenlafaxine) Extended-Release Tablets. According to IMS Health data, annual U.S. sales of PRISTIQ are approximately $614 million. Under terms of its agreement with Osmotica, Pernix will market, sell and distribute KHEDEZLA in the United States. Pernix and Osmotica will share profits from the sales of the product. The transaction was completed without the use of any proceeds from Pernix’s recently closed Senior Notes 2019 offering. Important Information about KHEDEZLA ER Tablets A black box warning is associated with this product regarding increased risk of suicidal thoughts and behaviors in children, adolescents and young adults taking antidepressants. All persons taking KHEDEZLA should be monitored for worsening and emergence of suicidal thoughts and behaviors. KHEDEZLA is not approved for use in pediatric patients. Refer to full prescribing information for complete boxed warning.
KHEDEZLA (desvenlafaxine) Extended-release Tablets are contraindicated in patients who are hypersensitive to desvenlafaxine succinate, venlafaxine hydrochloride or to any component of the product. Angioedema has been reported in patients treated with desvenlafaxine. The use of MAOIs intended to treat psychiatric disorders with KHEDEZLA or within 7 days of stopping treatment with KHEDEZLA is contraindicated because of an increased risk of serotonin syndrome. The use of KHEDEZLA within 14 days of stopping a MAOI intended to treat psychiatric disorders is also contraindicated. Starting KHEDEZLA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.About Pernix Therapeutics Holdings, Inc. Pernix Therapeutics is a specialty pharmaceutical company primarily focused on the sales, marketing, manufacturing and development of branded pharmaceutical products. The Company markets a portfolio of branded products, including: CEDAX®, an antibiotic for middle ear infections and a number of treatments for cough and cold conditions including ZUTRIPRO®, REZIRA® and VITUZ®. The Company also markets SILENOR, a non-narcotic product for the treatment of insomnia. The Company promotes its branded products to physicians through its Pernix sales force and markets its generic portfolio through its wholly owned subsidiaries, Cypress Pharmaceuticals and Macoven Pharmaceuticals. The Company’s wholly owned subsidiary, Pernix Manufacturing, manufactures and packages products for the pharmaceutical industry in a wide range of dosage forms. Founded in 1996, the Company is based in Houston, TX. Additional information about Pernix is available on the Company’s website located at www.pernixtx.com. About Osmotica Pharmaceutical Corp. Osmotica Pharmaceutical is a global specialty pharmaceutical company with a proven history of developing commercially successful pharmaceutical products. The company uses its proprietary osmotic technology platform and with strategic partners develops and commercializes high quality pharmaceutical products. In addition to the products currently on the market, the company’s pipeline includes numerous ANDA programs and several innovative neurology-based NDA programs.
Osmotica Pharmaceutical and its related companies form an international group of companies with principal operations located in the United States, Argentina and Hungary.For more information on the Company, please visit Osmotica’s website at www.osmotica.com. Cautionary Notice Regarding 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 “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “target” or similar expressions are forward-looking statements. Because these statements reflect the Company’s 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 our 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 the Company’s future financial results and could cause actual results to differ materially from those expressed in forward-looking statements contained in the Company’s 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. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.