I wonder what bonuses they paid themselves in 2014. Of course they will be giving themselves a big bonus upon the refiling of Remoxy - should it ever get that far. The next problem will be that the patent expires before FDA approval.
Cash and investments were $40.6 million at December 31, 2014. In 2015, we expect net cash usage to be approximately $12 million.
"Our current priority is to work cooperatively with Pfizer on an orderly transfer of REMOXY", said Remi Barbier, Chairman, President & CEO. "We are excited by the prospect of regaining worldwide rights to REMOXY. In 2015 we plan to keenly focus on REMOXY, our main asset. A secondary goal for 2015 is to develop FENROCK, our proprietary abuse-deterrent pain patch. We believe we have the dedicated team in place to advance these two novel drug candidates and look forward to reporting potentially significant progress in the coming year."
In October 2014, Pfizer informed us of their intention to return to us full rights to REMOXY. We expect actual termination to become effective no later than six months thereafter, or April 2015, pursuant to the terms of our Collaboration & License Agreements with Pfizer. Upon termination, Pfizer is obligated to transfer to us data, records, materials and other assets related to REMOXY. Pending such termination, and after we receive and review the totality of data generated by Pfizer, we expect to report a target date for the potential re-filing of the REMOXY NDA.
Financial Highlights for 2014
At December 31, 2014, cash and investments were $40.6 million, compared to $49.8 million at December 31, 2013. We have no debt.
Net cash used in 2014 was $9.2 million.
Research and development expenses increased to $7.3 million in 2014 from $4.9 million in 2013, primarily due to increased investment in early stage drug assets. Research and development expenses included non-cash stock-related compensation costs of $1.6 million in 2014 and $1.3 million in 2013.
General and administrative expenses increased to $5.1 million in 2014 from $4.8 million in 2013, primarily due to increased non-cash stock-related compensation costs. General and administrative expenses included non-cash stock-related compensation costs of $2.1 million in 2014 and $1.8 million in 2013.
Our lead drug candidate, REMOXY Extended-Release Capsules CII, is an oral, twice-a-day formulation of oxycodone for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. We developed REMOXY to discourage certain common methods of tampering and misuse. We expect to regain worldwide rights to this drug candidate pending termination of the Collaboration Agreement and License Agreement with Pfizer.
FENROCK is a proprietary abuse-deterrent fentanyl pain patch in pre-IND stages of development. Our goal with FENROCK is to mitigate the abuse, misuse, overdose and death associated with currently marketed fentanyl patches. The active drug ingredient in the FENROCK transdermal pain patch is fentanyl (CII), a highly potent opioid typically used to manage severe cancer pain. We own worldwide rights to this pre-IND drug candidate.
About Abuse-deterrent Hydromorphone
This drug candidate is an oral QD (once-a-day) formulation of hydromorphone, a strong opioid for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. We are developing abuse-deterrent hydromorphone to discourage certain common methods of tampering and misuse. We own worldwide rights to this Phase I drug candiate.
Nice C&P Jimbo - so what do you think or are you so fed up with PTIE that you don't even profer any thoughts of your own these days. Clearly they are being royally screwed by PFE - but you can hardly blame PFE after the way Remi dissed them. I've been told that the junkie resistance of Remoxy is virtually non existent these days. Things have moved on in the last 7 years. The chances of Remoxy ever being approved are about as great as you quitting cross-dressing. Oh the days when you were Debs - or Icha - or Rod - and you used to chat to yourself on this Board. And you a well known Venture Capitalist from .... Those were the days eh!
Source: MedScape 3/16/15
Abuse-deterrent formulations (ADFs) of opioid analgesics can have the intended purpose of curtailing abuse, but their effectiveness has "clear limits," a new study confirms.
Theodore J. Cicero, PhD, and Matthew S. Ellis, MPE, from Washington University, in St. Louis, Missouri, found that introduction of ADF oxycodone (OxyContin, Purdue Pharma LP) led to an initial steep decline in abuse of this widely prescribed opioid, but this was followed by a plateau, resulting in "significant" levels of residual abuse.
The investigators also observed an uptick in heroin use after the introduction of ADF OxyContin, as has been observed previously.
"This change is a matter of considerable concern from a public health perspective given the toxicity of heroin in terms of overdose deaths, problems associated with injection and the transmission of infectious disease, crime, and so forth," the authors write.
The study was published online March 11 in JAMA Psychiatry.
Rise in Heroin Use
In 2010, as reported by Medscape Medical News at that time, the US Food and Drug Administration approved reformulated OxyContin to mitigate the risk for overdose. Instead of turning to a powder that can be injected, chewed, or snorted, the new formulation turns into a gummy gel when crushed.
To examine OxyContin abuse patterns and behaviors, Dr Cicero and Ellis surveyed 10,784 men and women in their early 40s who had opioid use disorder and who were entering one of 150 drug treatment programs across the United States. They also interviewed a subset of these individuals.
The investigators report that ADF OxyContin led to a significant decline in past-month abuse after its introduction (from 45% in January–June 2009 to 26.0% in July–December 2012, P
Pain Medicine News: 4/2/15
FDA Releases Final Guidance for Industry on Abuse-Deterrent Opioids
This guidance reflects the agency’s current thinking on how studies should be conducted and evaluated to determine if a given formulation has abuse-deterrent properties, according to the FDA. The 26-page document is geared toward helping drug makers to develop opioids with potential abuse-deterrent properties. It also contains recommendations for what labeling claims may be approved based on study results.
“Development of abuse-deterrent products is a priority for the FDA, and we hope this guidance will lead to more approved drugs with meaningful abuse-deterrent properties,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “While abuse-deterrent formulations do not make an opioid impossible to abuse and cannot wholly prevent overdose and death, they are an important part of the effort to reduce opioid misuse and abuse.”
The FDA said opioids could be abused and manipulated in a variety of ways to create a euphoric effect so abuse-deterrent technology should target known or expected routes of abuse. A draft guidance on abuse-deterrent opioids was first issued by the FDA in January 2013 and broke down abuse-deterrent technology into six categories:
1. Physical/chemical barrier
2. Agonist/antagonist combinations
5. Delivery system
6. Combination of two or more of the above
The final guidance contains a new category “novel approaches” that encompasses novel approaches or technology not captured in the previous categories.
The FDA said it intends to take a flexible, adaptive approach to evaluating and labeling potential products because the field of abuse deterrence is relatively new and the agency “expects that the market will foster iterative improvements in products.”
“The science of abuse-deterrent medication is rapidly evolving, and the FDA is eager to engage with manufacturers to help make these medications available to patients who need them,” said Margaret A. Hamburg, MD, former FDA commissioner. “We feel this is a key part of combating opioid abuse. We have to work hard with industry to support the development of new formulations that are difficult to abuse but are effective and available when needed.”
The guidance emphasized that any study designed to evaluate an opioid formulation’s abuse-deterrent properties should be “scientifically rigorous” and consider the following: appropriateness of positive controls and comparator drugs, outcome measures, data analyses to permit a meaningful statistical analysis and selection of study participants. The FDA recommended collecting data from each of the following premarket studies categories to obtain a full understanding of a product's abuse potential:
1. Laboratory-based in vitro manipulation and extraction studies (category 1)
2. Pharmacokinetic studies (category 2)
3. Clinical abuse potential studies (category 3)
The FDA noted that results from category 1 studies may affect the designs of the other two, and category 2 results may affect the design and need for category 3 studies. The guidance contains postmarket study recommendations for products that may be an exception to these criteria.
The FDA recommended that the labeling should include information on a product’s abuse-deterrent properties—which is supported by data—to better inform health care professionals, patients and the public about a product’s abuse potential. The label should also make it clear that abuse is still possible.
The agency said more research is needed at this time to develop better and safer opioids while reducing the risk for abuse and misuse. The FDA noted that this guidance does not apply to generic opioids and that this will be addressed in a future guidance.
Based on a press release from the FDA.
Man...I was really interested in this stock but if they're recommending it, I need to get out before the pump and dump