|Zogenix Provides Update on Zohydro(R) ER; Isis Pharma Earns $1M From GSK Hepatitis B Virus Program|
|By Staff and Wire Reports|
|Wednesday, 02 July 2014 18:20|
Zogenix, Inc. (ZGNX) announced an update on its development programs focused on the introduction of abuse deterrent formulations of Zohydro(R) ER (hydrocodone bitartrate) Extended-Release Capsules, CII. Zohydro ER is 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. The company has previously indicated that it is simultaneously developing two distinct approaches for abuse deterrent formulations of Zohydro ER. Following a recent meeting with the U.S. Food and Drug Administration (FDA), Zogenix expects to file a supplemental new drug application (sNDA) by October 2014 for a next-generation formulation of Zohydro ER Extended-Release Capsules designed to make it more difficult to abuse by injection or nasal administration.
If approved, this new formulation could be available to prescribers in early 2015. The company will continue to characterize the product's abuse deterrent properties with the goal of further amending the labeling for Zohydro ER Extended-Release Capsules in 2015 to include abuse deterrence claims consistent with the FDA's current draft Guidance for Industry, Abuse-Deterrent Opioids -- Evaluation and Labeling. As of today, only one of more than thirty extended-release/long-acting opioid analgesics has abuse deterrent properties described in FDA-approved labeling for making abuse via injection more difficult and reducing abuse via the nasal route based on the draft Guidance for Industry.
Zogenix also recently selected the final tablet formulation for clinical development in its collaboration with Altus Formulation. Like the next-generation formulation, this proprietary tablet technology is designed to meet FDA's stated goal of encouraging scientific and clinical research that will advance the development of abuse deterrent technologies to address opioid medication misuse and abuse. The innovative tablet formulation of Zohydro ER incorporates multiple features to maintain the extended-release property of the medication when crushed or chewed, reducing one of the ways in which opioids are abused through oral ingestion, as well other features to address abuse by injection or nasal administration.
The company is targeting a new drug application (NDA) submission for this tablet formulation during the first half of 2016, which will reference the approved NDA for Zohydro ER with respect to previous findings of safety and efficacy. The tablet formulation is designed to have the same hydrocodone release profile as the currently approved capsule formulation of Zohydro ER when used as intended, greatly simplifying its development program.
"We believe we have two strong technology options to deter misuse and abuse without affecting the established safety and efficacy profile of Zohydro ER, and look forward to submitting our data to the FDA with the goal of bringing these new options to patients," said Stephen Farr, Ph.D., President of Zogenix. "This dual approach will allow us to potentially launch our next generation of Zohydro ER Extended-Release Capsules in early 2015, followed by the tablet formulation with advanced proprietary abuse deterrent technology in 2016. We also continue to take part in comprehensive and collaborative efforts with prescribers, pharmacists and government officials to help ensure appropriate patients have access to the medications that will best support the management of their severe chronic pain."
In addition to working with FDA to integrate abuse deterrent properties into Zohydro ER, Zogenix strongly supports more comprehensive approaches to addressing the public health challenge of prescription drug abuse. Zogenix has taken extraordinary steps to support the appropriate use of Zohydro ER through a voluntary set of educational tools and safeguards to augment the FDA industry mandated class-wide Risk Evaluation Mitigation Strategy (REMS) for extended-release opioids. The company has implemented novel initiatives, such as providing Zohydro ER patients free locking pill bottle caps and discounts for safe-storage units to help prevent other people from gaining access to their medications. Prior to the availability of Zohydro ER, Zogenix established an independent External Safe Use Board to assess and make recommendations on surveillance programs and data collection related to misuse and diversion of the product.
Approved by the FDA in October 2013, Zohydro ER provides a potential solution to patients who could benefit from an extended-release hydrocodone for around-the clock management of severe chronic pain and who may be at risk for liver damage due to overexposure of acetaminophen, which can be fatal or require a liver transplant.
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced it has earned a $1 million payment from GlaxoSmithKline (GSK) related to the advancement of its program to develop antisense drugs to treat hepatitis B virus (HBV).
"Our collaboration with GSK has been very productive resulting in three novel antisense drugs in our pipeline. We look forward to continuing to advance these drugs and add additional new drugs to our pipeline with GSK," said B. Lynne Parshall, chief operating officer at Isis. "Including the $1 million announced today, we have earned $11 million in payments from GSK to discover and develop drugs for HBV."
"HBV infection is a serious health problem that can lead to significant and potentially fatal health conditions, including cirrhosis, liver failure and liver cancer. While chronic HBV is currently treated with oral antiviral agents or injectable interferons, these treatments do not clear HBV and do not effectively clear HBV antigens from these patients. This means that patients are unable to fully control HBV infection and achieve sustained disease remission. As such, more effective HBV agents that provide greater viral inhibition and permit greater immune system activity against the virus are needed. We believe that using our antisense approach we can develop a drug that has the potential to fill this patient need," said C. Frank Bennett, Ph.D., senior vice president, research at Isis.
As part of Isis' strategic alliance with GSK, Isis is discovering and developing drugs to treat HBV, which GSK has the exclusive option to in-license and further develop and commercialize after Isis completes the first clinical proof of concept study. Isis is eligible to earn pre-licensing payments from GSK as the HBV program advances in development. Isis is also eligible to receive double-digit royalties on sales from any product that GSK successfully commercializes under this strategic alliance with GSK, including those arising out of this HBV program.
Advaxis, Inc. (Nasdaq:ADXS), a biotechnology company developing cancer immunotherapies, announced that a product license from the United States Department of Agriculture (USDA) has been filed for ADXS-cHER2, its proprietary Her2/neu-directed cancer immunotherapy for the treatment of canine osteosarcoma and other HER2-overexpressing cancers.
Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced positive interim toxicology data for MANF in an ocular safety animal model, relevant to MANF development in Retinitis Pigmentosa.
American CryoStem Corporation (OTCQB:CRYO), a leading strategic developer, marketer and global licensor of patented adipose tissue-based cellular technologies for the Regenerative and Personalized Medicine industries, today announced that it has made a major step in establishing a global footprint for its cellular technology and laboratory processing platform by entering into an agreement to license its ATGRAFT™ adipose tissue (fat) processing and storage technologies with Health Innovative Technology Corporation Limited (HIT), a Hong Kong corporation.
Cerner (Nasdaq:CERN), a leading provider of health care information technology, recently announced the winners of the 2014 Cerner Advancing Clinical Excellence (ACE) Awards during a ceremony in Calgary.
Covisint Corporation (Nasdaq:COVS), a provider of a leading cloud engagement platform, today announced that CitiusTech, a leading provider of healthcare technology services and solutions has joined Covisint's Certified Service Partner Program.
Diversicare Healthcare Services Inc. (Nasdaq:DVCR), a premier provider of long-term care services, today announced the completion of its previously disclosed disposition of three skilled nursing centers in West Virginia effective July 1, 2014.
Foundation Healthcare, Inc. (OTC Markets:FDNH), which focuses on the development and management of surgical hospitals and related ancillary services, announced today the appointment of Mr. Hubert King to the position of Chief Financial Officer, effective July 1, 2014.
The Kroger Co. (NYSE:KR) and Vitacost.com, Inc. (Nasdaq:VITC), a leading online retailer of healthy living products, today announced a definitive merger agreement under which Kroger will purchase all outstanding shares of Vitacost.com for $8.00 per share in cash, or approximately $280 million.
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced the issuance of a broad U.S. patent relating to FZD-Fc soluble receptors, including OncoMed's clinical-stage candidate ipafricept (FZD8-Fc, OMP-54F28).
Pacific Biosciences of California, Inc. (Nasdaq:PACB) will hold its quarterly conference call to discuss its Second Quarter 2014 Financial Results on Thursday, July 24, 2014, at 4:30pm Eastern Time.
Zogenix, Inc. (Nasdaq:ZGNX) today announced an update on its development programs focused on the introduction of abuse deterrent formulations of Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII.