Death of a business by opiophobic bureaucracy ?

Pernix Therapeutics Closes Acquisition of Zohydro ER Franchise

At least one Governor and numerous state Attorney Generals took this company to court over the introduction of this product. I guess between the opiate hysteria stirred up by all these groups hurt the sales of this product and the legal expenses incurred by the company… forced them to sell off the rights to this product and liquidate the company.

http://www.businesswire.com/news/home/20150424005748/en/Pernix-Therapeutics-Closes-Acquisition-Zohydro-ER-Franchise#.VTwig5Oui1x

MORRISTOWN, N.J.–(BUSINESS WIRE)–Pernix Therapeutics Holdings, Inc. (Nasdaq:PTX) (the “Company” or “Pernix”), a specialty pharmaceutical company, announced today that it has closed its acquisition of the Zohydro® ER (hydrocodone bitartrate) franchise, comprising three extended release hydrocodone products, including an abuse-deterrent pipeline and all related intellectual property. Pernix first announced the agreement with Zogenix, Inc. to acquire this franchise on March 10th.

“The Zohydro ER franchise is an excellent strategic fit with our focus on central nervous system disorders. These products address an extremely large and underserved market, affording us a significant opportunity for growth, both organically and through life cycle management”

“The Zohydro ER franchise is an excellent strategic fit with our focus on central nervous system disorders. These products address an extremely large and underserved market, affording us a significant opportunity for growth, both organically and through life cycle management,” stated Doug Drysdale, Chairman and Chief Executive Officer of Pernix.

“We look forward to launching Zohydro ER with BeadTek™ in May and advancing ZX-007, an innovative abuse-deterrent tablet formulation of hydrocodone ER, with the goal of submitting an NDA for this third-generation product mid-2016. We are also pleased to welcome the Zohydro ER sales team from Zogenix and certain other employees to Pernix. The new Pernix Pain Management Team will double our commercial footprint. Pernix today has three strategically promoted brands, each in large markets, with significant growth potential. Through a combination of sales execution and future acquisitions, we will look to strengthen our position as a leading player in the opioid pain market and build long-term value for our shareholders.” Drysdale concluded.

A transition to Zohydro ER with BeadTek is in process with the goal of no disruption to patients’ therapy, and all previous dosage strengths will be available in this new formulation. The original formulation will no longer be manufactured after May 4, 2015.

Terms of the agreement

Under terms of the agreement (as amended), Pernix, through its wholly-owned subsidiary, Ferrimill Limited (“Ferrimill”), has paid Zogenix $70 million in cash, issued to Zogenix 1,682,086 shares of Pernix common stock and deposited an additional $10 million in cash in escrow to fund potential indemnification claims for a period of 12 months following the closing. Pernix has also purchased certain Zohydro ER inventory as part of the transaction.

Ferrimill has also agreed to make certain payments conditioned on regulatory and commercial milestones of up to $283.5 million, including $12.5 million upon approval of ZX-007, a tablet formulation of extended-release hydrocodone with abuse-deterrent properties, and up to $271 million in potential sales milestones based on the achievement of pre-determined annual product sales milestones for Zohydro ER and ZX-007. Under the terms of the acquisition agreement, over 80% of the value of the sales milestones is tied to the achievement of net sales targets ranging from $500 million to $1 billion.

Pernix will purchase a pre-defined amount of Zohydro ER product inventory. Pernix will also seek to retain certain employees of Zogenix, including the field sales force of approximately 100 sales professionals and additional personnel related to the brand.

Jefferies LLC acted as financial advisor to Pernix. The Company’s legal advisers are Lowenstein Sandler LLP and Goodwin Procter LLP. Buchanan Ingersoll & Rooney PC acted as intellectual property counsel.

About Zohydro ER with BeadTek

Zohydro ER with BeadTek is an extended-release form of hydrocodone indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Zohydro ER with BeadTek does not contain acetaminophen, unlike many immediate-release hydrocodone products, such as Vicodin and Lortab, reducing the risk for potential liver toxicity due to overexposure of acetaminophen. The active ingredient, hydrocodone, is the most commonly prescribed opioid in the U.S., with over 114 million prescriptions in 2014. Zohydro ER with BeadTek is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate containing technology that contains an inactive ingredient that immediately forms a viscous gel when crushed and dissolved in liquids or solvents.

About BeadTek™

BeadTek was developed using safe, well-known excipients and proprietary manufacturing processes to create an inactive ingredient that immediately forms a viscous gel when crushed and dissolved in liquids or solvents. All of the beads within the medication capsule are indistinguishable in color, shape, density and size, and do not impact the drug release profile when taken as directed.

LIMITATIONS OF USE

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

2 Responses

  1. Methadone should be removed from the market.

  2. Zohydro has been unfairly tagged as a dangerous non abuse hydrocodone bitartrate type drug to be snorted, crushed, or a way of ingesting several hundred milligrams of the drug. They already do this with a big dose of acetaminophen to boot. Better the hydrocodone bitartrate alone . We used to buy compounded hydrocodone in a capsule of 15 Mg of hydrocodone with a mere 200 Mg. of APAP. This was before the Ryan-Haight Act. I was taking 120 Mg. of hydrocodone bitartrate with ONLY 1,200 Mg. of liver damaging Tylenol every 4-6 hours. Well under the amount of toxicity. The pain still wasn’t amaliarated, but 2 Mg of alprazolam with the hydrocodone assured that at least I was asleep. It took better than a week of this combination to allay the horrid pain in my bed of which I wasn’t going anywhere. Thank God the Ryan-Haight Act wasn’t enacted as of yet. I never the less stocked up for later usage post surgery. I’m glad I did. My hydroceles removed and my TURP required IRMS. The IRMS only mitigated the pain. The hydrocodone was a adjunct to the morphine. Still, without a dose of Tylenol. Unneeded and unwanted.

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