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ROUNDTABLE DISCUSSION: Reformulating Opioids to Deter Abuse - See more at
http://www.drug-dev.com/Main/Back-Issues/ROUNDTABLE-DISCUSSION-Reformulating-Opioids-to-Det-648.aspx
In this exclusive Drug Development & Delivery magazine roundtable discussion, several Specialty Pharmaceutical company executives were asked to share their thoughts about FDA’s labeling requirements, describe their company’s formulation technologies, and explain their vision for where they think the opioid market is headed. Participants are: Ted Andrew, Product Manager-Rx Softgel, Catalent Pharma Solutions; Nasrat A. Hakim, President & Chief Executive Officer, Elite Pharmaceuticals Inc.; Bob Radie, President and CEO, Egalet Ltd.; and Anthony Soscia, President, Atlantic Pharmaceuticals.
Q: The FDA “limitation of use” labeling language suggests that extended-release opioid-containing products should only be used when other alternatives have not been successful. Do you think that this may eventually drive physicians to further prescribe immediate-release opioids and non-opioids as an alternative for chronic analgesic therapy?
Mr. Soscia: The labeling changes for ER/LA opioids were primarily intended to address the Physicians for Responsible Opioid Prescribing (“PROP”) Citizen’s petition filed in July 2012, which requested changes to the approved labeling of all Extended-Release/Long-Acting (ER/LA) opioid analgesics, quantity, and day limits, and that ER/LA dosing be limited when prescribed for non-cancer pain. The current language deletes the reference to moderate pain and adds the requirement that the prescriber has explored other treatment options. This change is intended to encourage prescribing decisions based on an individualized assessment, which is necessary for any patient on ER/LA opioids.
I do not believe it is FDA’s intention to push prescriptions one way or the other but there may be a prescribing shift to immediate-release (IR) opioids and non-opioid treatments as there are certain patients taking ER/LA therapy who may be better served by IR opioids or non-opioid therapy. In addition, there are several side effect trends being observed with the chronic use of opioids in certain populations. These include hyperalgesia and alterations in hormonal production such as testosterone. In certain cases, an acute, immediate-release product may be more appropriate. The FDA will most likely be following these trends very closely.
Mr. Andrew: The FDA has taken a proactive approach to addressing the growing epidemic of prescription drug abuse by narrowing the scope of extended-release labeling to a second level therapy, only after immediate-release, faster-acting opioids and non-opioid treatments are exhausted or not applicable.
The “limitation of use” labeling is an effective step that will, at a minimum, serve to educate the patient and physician, which in turn, can foster a more substantive dialog about the risks and other treatment options available. However, ultimately, this is a physician-patient decision so I do not feel like the movement to more immediate-release prescriptions at the expense of extended release will be significant.
Mr. Hakim: I do not believe the “limitation of use” labeling language will drive physicians to switch from extended-release opioids to immediate-release opioids. I believe the vast majority of physicians already understand both the benefits and shortcomings of extended-release and immediate-release opioids and prescribing will continue to be driven by what is best for the patient. Given all considerations, I believe extended-release opioids will continue to be the primary choice for chronic pain.
Q: There are several types of technologies being evaluated for abuse deterrence i.e. physical, aversive, antagonist, and prodrug. How do technologies in the same class differentiate themselves from other technologies and from generics that may pursue competitors’ technologies?
Mr. Andrew: As the public and regulatory pressure for effective abuse-deterrent opioids increase, the technology available continues to expand. The abuse market continues to develop to address new trends in abuse. This creates an environment where an effective abuse-deterrent technology will need to continually evolve and/or be multi-level to be effective in the longer term.
While different abuse-deterrence technologies have strengths and weaknesses, a successful approach needs to balance therapeutic effectiveness, level of abuse deterrence, and cost considerations. For example, while incorporating an aversion or antagonist adds complexity to the formulation to prevent abuse, it could potentially impact patients taking the medicine as directed. Physical deterrence is another method that has shown some initial promise making it more difficult to abuse, however, can be readily abused by adding manipulation steps.
Mr. Hakim: Key factors that will differentiate these products include safety, which includes product attributes such as robustness and stability. For example, within the antagonist category, there was an abuse-deterrent product pulled from the market due to stability issues. Companies developing new products will want to avoid such issues.
Intellectual property is also a differentiator. The area of opioid abuse resistance has the interest of many companies and this has led to a large number of patents for abuse-resistant technologies. To be successful, companies will not only have to develop a product to address the market and regulatory needs, but the product will need to have patent protection. Any company introducing a new abuse-resistant product can expect to be challenged in the courts by competitors.
Finally, with regard to epidemiological data, the FDA would like to see a number of years of epidemiological data to determine what technologies work and, given time, this data will differentiate technologies and products.
Mr. Soscia: Differentiation within and between classes is an important question with regard to establishing the market longevity of the branded products containing abuse-deterrent technologies. The abuse-deterrent product’s market life is a key metric to observe meaningful changes in abuse deterrence before generic penetration. It remains to be seen how the FDA is going to allow generic competition to technologies in the same class. Questions include issues of abuse-deterrent matching or equivalence on the category and tier abuse deterrent labeling. What constitutes abuse-deterrence equivalence? Will a generic have to match an innovator product with Phase 4 studies that may be included on the innovator label?
Other questions and issues arise relative to incremental increases in abuse-deterrence in the same category. For instance, if a new technology exhibits statistically significant improvements in drug extraction resistance or in nasal liking compared to a currently marketed abuse-deterrent platform, will the FDA grant the new entry a branded status and remove the former abuse-deterrent product? How about other classes of drugs that are known to exhibit safety issues if accidentally or intentionally abused? Can those be reformulated and will the FDA force or agree to removal of the reference listed drug? This is certainly only the beginning of myriad of questions that will evolve in this space. The FDA labeling changes should encourage current and future development of these products but not be used in a way to stifle long-term competition or more advanced technologies.
Q: Describe your abuse-deterrent formulation technology and how it works to deter abuse yet maintain patient effectiveness.
Mr. Soscia: Our patented abuse-deterrent drug delivery technology is called SMART/Script™ (SMART/Simple, controllable, resistant, insoluble, physical trap). The Atlantic technology is unique amongst physical technologies in that when a moderate amount of physical force, such as that incurred by chewing or grinding with a coffee mill, is applied to the product, the drug contained is sequestered and reduced from dose dumping. This decrease in release may be permanent depending on the circumstances. When taken intact however, the drug will release as intended. The sequestering action does not require an external solvent to activate (a.k.a. gelling agents). It can be applied to both immediate- and sustained-release drug candidates whereas most platforms take either an immediate-release or sustained-release abuse-deterrent approach.
Mr. Hakim: Elite’s proprietary abuse-deterrence technology uses an antagonist approach and is a multi-particulate formulation in a capsule. It uses a two-bead system consisting of the opioid agonist and the opioid antagonist, naltrexone. Both bead populations are the same size, shape, weight, density, etc., so the bead population cannot be differentiated between the two. When our product is taken as intended, the opioid will release and the opioid antagonist will pass through the body unreleased, giving the patient the desired therapeutic effect. If the product is tampered with, the naltrexone will preferentially bind to the same receptors in the brain that the opioid would target, rendering the opioid useless.
Mr. Radie: Egalet has created two drug delivery systems, each with abuse-deterrent features and the ability to control the release profile of the active pharmaceutical ingredient. Our one-component system is used to produce tablets, such as Egalet-001, that consist of a hard matrix that is difficult to crush, grind or dissolve and that also controls the release of the API. The matrix, which contains the API as well as inactive agents, erodes over time in the GI tract, releasing the API.
Our two-component system is used to produce tablets, such as Egalet-002, that consist of a matrix similar to the matrix that is a part of our one-component system, but that is surrounded by a water-impermeable, non-eroding, hard shell made of polylactic acid that creates a cylinder, with the API-containing matrix exposed at both ends. The shell serves to limit the portion of the matrix’s surface area that is exposed to the GI tract, which allows us to tailor the release rate of the API and makes it even more difficult to crush or grind the tablet, thereby enhancing its abuse-deterrent properties. We use an injection molding technology to create the matrix and shell.
Mr. Andrew: Catalent OptiGel Lock™ technology incorporates multi-level abuse deterrence in a softgel dose form. First, because it is in a softgel form, it cannot be ground, grated or blended to create microparticles for both inhalation and further diversion. Second, numerous formulations can potentially be developed that may reduce the syringeability and render the remaining API unavailable for misuse. In addition, the same technology serves as a barrier to heat and solvent extraction and concentration of the formulated opioid.
Q: How does your technology satisfy the FDA’s proposed abuse-deterrent labeling requirements and still promote patient safety?
Mr. Radie: Using our proprietary technology platform, we have developed a pipeline of clinical-stage, opioid-based product candidates in tablet form that are specifically designed to deter abuse by physical and chemical manipulation while also providing the ability to tailor the release of the API. In addition to our planned clinical trials for Egalet-001 and Egalet-002, we are currently conducting abuse-deterrence studies with both product candidates in accordance with the FDA draft guidance, with the goal of obtaining abuse-deterrent claims in our product labels.
We believe that our systems offer several advantages. For example, with regard to abuse deterrence, abusers often seek to accelerate the absorption of opioids into the bloodstream by crushing in order to swallow, snort or smoke, or dissolving in order to inject the drug. Tablets produced using our systems have physical and chemical barriers intended to deter these common methods of abuse.
Additionally, we can tailor the release. In our tablets, the API is integrated into the matrix, which makes it difficult for abusers to extract quickly. However, when the tablet is exposed to GI fluids, the matrix erodes, thereby releasing the API. Using our technology, we can change the amount and composition of the polymer used to create the matrix formulation and can vary the surface area of the matrix exposed to the GI
tract. By varying the matrix composition and surface area, we can control the rate of erosion of the matrix and the rate of release of the API, which allows us to develop products with immediate-release, extended-release, and sustained-release profiles.
Mr. Soscia: A product formulated with SMART/Script™ will satisfy the premarketing Tiers and Categories in the recently released FDA guideline regarding abuse-deterrent labeling. If the Smart/Script product is taken as directed, the drug will release in the same manner as the currently marketed products.
Mr. Hakim: Our formulations, when intact and taken as intended, provide the delivery of the drug in the same manner as the current extended-release formulations. The products will have the same safety and efficacy profile as current products on the market. If the drug is crushed, then our technology will release an antagonist, which will reduce the euphoria level achievable through whichever route of administration the abuser might want to use.
Q: What do you see as the pros and cons of immediate-release vs. extended-release opioid formulations as they relate to abuse deterrence?
Mr. Hakim: The objective of the industry is to create abuse-resistant technologies that are effective for both immediate-release and extended-release products. The technologies that work for each type of product may be different or maybe not, but the key is simply that they are effective. If the industry can achieve that, then the choice of using IR or ER will be driven by the patient needs and not by any external factors. This is where I believe the market is heading.
Mr. Andrew: Immediate-release products tend to be over prescribed for acute pain and give a more euphoric feeling compared to extended-release products. Thus, there is a view that immediate-release formulations may more readily lead to addiction.
While extended-release products potentially offer pain management with a lower potential for addiction, the danger occurs when these products are manipulated through crushing or extraction to convert to an immediate-release form. Having a higher concentration of active ingredient than the immediate-release version, the risk of overdose is greater.
Abuse-deterrence technology, in order to be effective, should be applicable across formulations. While the mechanism of abuse can vary, the overall top line methods should be addressed: oral (dose dumping with alcohol), nasal (crushing), injection (extraction), rectal, and smoking.
Mr. Soscia: I believe abuse-deterrent formulations need to be applied to the entire category otherwise you just push abuse to another non-abuse deterrent product (i.e. the pushing down on one side of a balloon to see the other side rise). That theory has been borne out with the reformulation and removal of the previously marketed form of OxyContin. While the epidemiological data is still being collected and analyzed, there was an early observed shift in abuse from the newly reformulated “hardened” OxyContin to other molecules, primarily to immediate release oxycodone products. Empirically this makes sense, as abuse would be driven to the molecule that can be most easily acquired and manipulated. Currently, the number of prescriptions in the U.S. dispensed for immediate-release opioid greatly outnumbers those for extended or long-acting formulations and I believe that trend will continue. In addition, as a 30-mg IR oxycodone contains the same amount of API as an ER 30-mg oxycodone product there should be a matching abuse-deterrent immediate-release dosage form to compliment the latter. The majority of abuse-deterrent technologies are focused on the extended-release market while the immediate-release market has very few technologies. I believe it is possible to rebrand the generic immediate-release space using Atlantic’s technology and further focus on branded products such as an immediate-release, single-ingredient hydrocodone. This product in particular is a priority due to the hepatoxicity, ototoxicity and high abuse rates of hydrcodone:acetaminophen IR combinations.
Q: Is there anything you’d like to add or comment on that is not discussed above?
Mr. Hakim: The barriers to abuse are very different between physical versus pharmacological approaches. While no approach is perfect, we believe the barrier to prevent abuse is higher with the pharmacological approach. In other words, the difficulty in using either crushing or extraction to convert the opioid product into an abusable form is greater with a pharmacological approach, and we believe prescribers will understand this as more products become available.
References
1. Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: National Academies of Science; 2011. www.iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-fortransforming-Prevention-Care-Education-Research.aspx. Accessed June 19, 2013.
2. Manchikanti L, Fellows B, Ailinani H, et al. Therapeutic use, abuse, and non-medical use of opioids: a ten-year perspective. Pain Physician. 2010;13:401-435.
3. Toblin RL, Paulozzi LJ, Logan JE, et al. Mental illness and psychotropic drug use among prescription drug overdose deaths: a medical examiner chart review. J Clin Psychiatry. 2010;71:491-496.
4. Joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting opioid analgesics. July 22-23, 2010.www.fda.gov/downloads/AdvisoryCommit tees/CommitteesMeetingMaterials/Drugs/AnestheticAndLifeSupportDrugsAdvisoryCommittee/UCM217510.pdf.
5. Paulozzi LJ, Budnitz DS, Xi Y. Increasing deaths from opioid analgesics in the United States. Pharmacoepidemiol Drug Saf. 2006;15:618-627.
6. Kuehn BM. Opioid prescriptions soar:increase in legitimate use as well as abuse. JAMA. 2007;297:249-251.
7. Ng Kimberly Erin, et. al. PharmDLegislative Initiatives and Review of Abuse-Deterrent Opioid Formulations. US Pharm. 2013;38(10):21-26. Oct. 18,2013. http://www.uspharmacist.com/content/c/44472/.
8. FDA announces safety labeling changes and post market study requirements for extended-release and long-acting opioid analgesics. FDA news release. September 10, 2013. www.fda.gov/NewsEvents/ Newsroom/PressAnnouncements/ ucm367726.htm. Accessed September 23, 2013.
- See more at: http://www.drug-dev.com/Main/Back-Issues/ROUNDTABLE-DISCUSSION-Reformulating-Opioids-to-Det-648.aspx#sthash.7GLBagxP.dpuf
Yes. Anticipate Elite to announce first shipment of generic Isradapine on Wed 12/10 or Wed 12/17.
Have you been following Elite for 10 years?
The study, initiated in July of 2014, demonstrated Elite’s product is bioequivalent to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) as measured for opioid blood plasma levels. The study was a single dose, open label, randomized, cross-over study in healthy volunteers with 34 subjects conducted under fasted conditions Final findings of bioequivalence are dependent upon FDA review.
Oxycontin (Oxycodone Hydrochloride) - Description and Clinical Pharmacology: http://www.druglib.com/druginfo/oxycontin/description_pharmacology/
See: "PHARMACOKINETICS AND METABOLISM"
I recommend anyone looking to understand what Elite is currently doing with Camargo read the FDA's Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products.
Why they went with Camargo?
The 505(b)(2) pathway allows companies to get out of the competitive environment of generics while still enjoying a development process that eliminates most preclinical studies as well as extensive safety and efficacy tests, dramatically reducing costs and time to market.
About Section 505(b)(2)
The Company plans to file an NDA for this product based on the provisions of section 505(b)(2) of the U.S. Food, Drug & Cosmetic Act. Section 505(b)(2) allows the FDA to approve a drug on the basis of data in the scientific literature or data previously cited by the FDA as the basis for the approval of related drugs. This procedure makes it easier and potentially faster for drug developers to obtain approval of new formulations of drugs based, in part, on proprietary data of the developer of the original drug.
http://www.camargopharma.com/Userfiles/white-paper/Cmrgo_WhitePaperApprovalPthwy_VFb.pdf
"Done properly, these studies allow a company to reference the safety and efficacy information that is already known for the original drug and proceed directly to NDA submissions.""
Pfizer has no pipeline and they are losing patent protected drugs left and right. Coming off patent this year is Celebrex and Zyvox, Viagra in 2017, and Lyrica in 2018. That's a combined revenue of $11 billion. They lost Lipitor in 2011 and have made ill-fated acquisitions in the pain sector for billions in losses. They can continue to throw money at the problem via acquisition -- though the track record thus far is bad -- but long-term it's not sustainable.
There is precedent here for fast track priority review. Evzio (naloxone hydrochloride injection) got that last spring. The FDA reviewed Evzio under the agency’s priority review program which provides an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.
Fast-track designation, a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf
These formulations will remain Sched II regardless of ADT.
No his name is Nasrat. Not NasRAT.
Nasrat Hakim. Not NasRAT.
I thought Embeda was fine? What's the problem?
On October 20, 2014, the Company hired Dr. G. Kenneth Smith as its Vice President of Legal. The position of Vice President of Legal duties includes providing senior management with effective advice on legal strategies and negotiating critical business contracts. The Vice President of Legal reports to and receives direction from the CEO and shall perform such functions and duties as are required by the Company’s CEO.
Dr. Smith has a Ph.D. in Biochemistry from the University of Houston (1997) and a J.D. from the University of Houston (1994). Prior to joining, Elite, Dr. Smith served as Chief Intellectual Property Counsel for Alpharma Inc and Head of North American Intellectual Property for Sanofi Aventis. In both positions, Dr. Smith had global responsibility for all intellectual property issues related to multiple business units involved in various technologies including branded products, animal health products, active pharmaceutical ingredients (API), generic drugs, and vaccines. He has managed and participated in international intellectual property litigation, including European and Japanese oppositions as well as patent litigation in Canada and France. Dr. Smith has also been involved in trademark issues, and many licensing and acquisition negotiations. Dr. Smith also has an MBA with a concentration in entrepreneurship from Lehigh University (2007), an MS in Biochemistry from the University of Illinois (1989) and a B.S. in Chemistry and Psychology from the College of William and Mary (1978).
The company also announced the appointments of Dr. Jason LePree as Vice President of Scientific Affairs and Dr. Sophy Abraham as Head of Regulatory Affairs.
Dr. LePree joins Elite with a wealth of experience in formulations and analytical research and development having most recently served as the Principal Scientist, Formulations Research and Development for Capsugel. Dr. LePree also held previous positions in research and development with Abon Pharmaceuticals, Penwest Pharmaceuticals, Novartis, and Hoffman-LaRoche. Dr. LePree has a B.S. in Pharmacy from Rutgers University and a Ph.D. in Pharmacy from the University of Wisconsin. He is also an Adjunct Professor of Pharmacy at Long Island University.
Dr. Abraham brings to Elite extensive regulatory and analytical experience having worked for over 20 years at Teva Pharmaceuticals. Her most recent position at Teva was Senior Regulatory Associate. Dr. Abraham has B.S. in Zoology, Botany, and Chemistry from the University of Kerala, India and a Ph.D. in Zoology from the University of Baroda, India.
A copy of the press release is being finished with this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.
Embeda's approval bodes well for Elite and any other company developing ADT/ART. Also, what is lost in all of this, is that a small amount of companies are going to own this space. Billions to share. And Elite is one of them.
That's not true. I have one in my contract. If we were to merge with another hospital within 10 years of my contract and I lose chairman level I get a buyout. This happens in contracts all the time.
A golden parachute. Happens all the time in contracts.
Sure it would. It's a chess game. This shows a potential partner if you don't give us the $$$ we are looking for we can go it on our own. Hence the LPC funding, hence the hires, hence Camrago etc. etc.
I would disagree that they are midlevel.
Elite's new Vice President of Legal, Dr. Kenneth Smith, was Chief Intellectual Property Counsel for Alpharma. King Pharmaceuticals acquired Alpharma to get the patents on Flector and Embeda.
Austin, TX -- International law firm Dewey & LeBoeuf LLP, announced today that G. Kenneth Smith has joined the firm as counsel in the intellectual property practice in the Austin office.
Commenting on Mr. Smith’s arrival, Mike Stenglein managing partner of the firm’s Austin office said, "We are very excited and fortunate to have Ken join Dewey & LeBoeuf’s Austin office. Ken's extensive experience in the pharmaceutical industry will enhance our ability to serve clients not only in Texas, but throughout the nation and in foreign jurisdictions."
Mr. Smith’s practice focuses on intellectual property issues, including patent, trademark, trade secret, copyright and litigation, with an emphasis on pharmaceutical and biochemical matters. He joins Dewey & LeBoeuf from Alpharma Inc. where he was the vice-president, chief patent counsel and head of business development for the branddivision. Mr. Smith was responsible for identifying, selecting and negotiating licensing agreements, product and company acquisitions for Alpharma Branded Product Division Inc. and patent litigation. He was also in charge of rebuilding the intellectual property department after divestiture of the generics business unit and developing a company-widetrade secret policy, publication policy and document retention policy.
Mr. Smith received a B.S. in chemistry and psychology from the College of William and Mary, a M.S. in biochemistry from the University of Illinois, a J.D. and PhD cum laude in Biochemistry from the University of Houston and a Masters of Business Administration from Lehigh University. Mr. Smith is a member of the Illinois and Massachusetts Bars and a member of the United States and Canadian Patent and Trademark Bars.
http://www.iptoday.com/news-archived-article.asp?id=1331&type=
Probably with a competitive cash salary and stock options like most pharma companies. They make money, we make money. A lot of money.
Dr. Jason LePree
Director, Preformulation and Non-solids Formulation
Penwest Pharmaceuticals/Endo Pharmaceuticals Post Acquisition
July 2007 – April 2011 (3 years 10 months)Patterson, NY
I am responsible for physical characterization of new chemical entities, including pKa determination, solid state stability, stability in solution, and solubility determinations and intrinsic dissolution testing using techniques such as HPLC and UV spectrophotometry and solid state characterization using modulated DSC, TGA and cross polarized hot stage light microscopy. In addition, I support all non-solids formulation development and manufacture for preclinical and clinical studies.
Key skills and accomplishments:
•Used lipolysis testing and other in-vitro tests to formulate and select lipid-based dosage formulations for preclinical studies, Phase I and Phase II studies for drug candidate, A0001. Became in-house expert in manufacture of liquid-filled hard gelatin and HPMC capsules.
•CMC team leader for drug development candidate and led a team of scientists including representatives from Analytical Sciences, Quality Assurance, Formulations, Non-solids, Quality Control, and a contract research organization to ensure drug substance and drug product were available for pre-clinical and clinical trials.
•Wrote the drug product and drug substance sections for the Phase I and Phase II INDs and Phase II IMPDs.
•Developed creams, ointments, and emulsions for development candidates for dermatological and rectal use. Verified physical and chemical stability of the topicals through stability studies.
https://www.linkedin.com/profile/view?id=44043009&authType=NAME_SEARCH&authToken=HkCr&locale=en_US&srchid=176009441414162434214&srchindex=1&srchtotal=1&trk=vsrp_people_res_name&trkInfo=VSRPsearchId%3A176009441414162434214%2CVSRPtargetId%3A44043009%2CVSRPcmpt%3Aprimary
Dr. Jason LePree, Elite's new Vice President of Scientific Affairs worked at Penwest Pharmaceuticals. Anyone remember them? They were bought out by Endo for their patents (OPANA).
http://www.prnewswire.com/news-releases/endo-pharmaceuticals-agrees-to-acquire-penwest-pharmaceuticals-and-submits-nda-for-new-formulation-of-long-acting-oxymorphone-designed-to-be-crush-resistant-100285584.html
Austin, TX -- International law firm Dewey & LeBoeuf LLP, announced today that G. Kenneth Smith has joined the firm as counsel in the intellectual property practice in the Austin office.
Commenting on Mr. Smith’s arrival, Mike Stenglein managing partner of the firm’s Austin office said, "We are very excited and fortunate to have Ken join Dewey & LeBoeuf’s Austin office. Ken's extensive experience in the pharmaceutical industry will enhance our ability to serve clients not only in Texas, but throughout the nation and in foreign jurisdictions."
Mr. Smith’s practice focuses on intellectual property issues, including patent, trademark, trade secret, copyright and litigation, with an emphasis on pharmaceutical and biochemical matters. He joins Dewey & LeBoeuf from Alpharma Inc. where he was the vice-president, chief patent counsel and head of business development for the brand division. Mr. Smith was responsible for identifying, selecting and negotiating licensing agreements, product and company acquisitions for Alpharma Branded Product Division Inc. and patent litigation. He was also in charge of rebuilding the intellectual property department after divestiture of the generics business unit and developing a company-wide trade secret policy, publication policy and document retention policy.
Mr. Smith received a B.S. in chemistry and psychology from the College of William and Mary, a M.S. in biochemistry from the University of Illinois, a J.D. and PhD cum laude in Biochemistry from the University of Houston and a Masters of Business Administration from Lehigh University. Mr. Smith is a member of the Illinois and Massachusetts Bars and a member of the United States and Canadian Patent and Trademark Bars.
http://www.iptoday.com/news-archived-article.asp?id=1331&type=
So Elite's new Vice President of Legal, Dr. Kenneth Smith, was Chief Intellectual Property Counsel for Alpharma. King Pharmaceuticals acquired Alpharma to get the patents on Flector and Embeda.
Mimi Park's Elite's Head of Quality Assurance and Compliance came from Purdue Pharma. She spent almost ten years (95-05) at Purdue. Oxy was approved/launched by Purdue in '95.
Nasrat Hakim, before going to Actavis, was Global Vice President of Compliance for Alpharma, where he was employed from 2004 to 2007. I forgot to mention earlier that King Pharmaceuticals acquired Alpharma Pharmaceutical in 2008. And, two years later was acquired by Pfizer?
But, nothing going on here. Elite is going nowhere...
And then in 2010, 11, 12, 13 & 14...
Years. Bought in 2004.
2015 will be 11 years for me in ELI-ELTP. Looking forward to it.
I suggest that anyone interested in making a lot of money buy shares of ELTP.
I would like to see some data though. Oh wait. This happened: http://www.elitepharma.com/investor_relations.asp?goto=387
ELITE PHARMACEUTICALS RELEASES POSITIVE TOP LINE HUMAN ABUSE LIABILITY DATA FOR ELI-200, AN OPIOID ABUSE DETERRENT PRODUCT
HAL study compared subjective effects of drug liking, drug high and good drug effects between ELI-200 and the comparator formulation in non-dependent recreational drug users
Northvale, New Jersey, Tuesday, September 09, 2014: Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (OTCBB: ELTP) today reported top line results from a Human Abuse Liability (HAL) study for the ELI-200 product. ELI-200 is an undisclosed abuse deterrent opioid product for pain.
The study results demonstrated statistically significant (p <.0001) lower measures of drug liking, drug high and good drug effects for Elite’s manipulated (crushed) ELI-200 when compared to the manipulated (crushed) drug listed comparator product and found 91.9% of the subjects experienced increased drug liking with the comparator product compared to ELI-200 in non-dependent recreational drug users when administered intranasally. The study also found 80.6% of the subjects experienced a decrease in drug liking with the intranasal crushed ELI-200 in comparison to the administration of oral intact ELI-200.
The data will be presented at the 16th Annual Rodman and Renshaw Global Investment Conference in New York City on September 9, 2014.
“We could not be more pleased with the top line result from the Human Abuse Liability Study for ELI-200 which confirms the effectiveness of our abuse deterrent technology,” said Nasrat Hakim, President and CEO of Elite Pharmaceuticals. “This successful technology will be the platform for an entire line of opioid products utilizing our proprietary technology. We remain on track to file our first new drug application for ELI-200 by December 2014.”
HAL Study Details
The HAL study was a single-center, randomized, double-blind, double-dummy, active- and placebo-controlled, single-dose, five-way crossover to evaluate the relative bioavailability, abuse potential and safety of crushed intranasal ELI-200 capsules compared to the crushed intranasal comparator product, oral intact ELI-200, and placebo in 37 healthy male and female non-dependent recreational opioid users with intranasal experience. The primary objective was to assess the abuse potential of ground ELI-200 relative to the crushed comparator product when administered intranasally to non-dependent, recreational opioid users with intranasal experience.
The secondary objectives were:
• To assess the abuse potential of crushed intranasal ELI-200 relative to placebo (intranasal and oral) in non-dependent, recreational opioid users with intranasal experience.
• To assess the abuse potential of oral intact ELI-200 relative to crushed intranasal ELI-200, crushed intranasal comparator, and placebo (oral and intranasal) in non-dependent, recreational opioid users with intranasal experience.
• To assess the relative bioavailability of the opioid in plasma from crushed intranasal and oral intact ELI 200 compared with one another and crushed comparator when administered intranasally in non-dependent, recreational opioid users with intranasal experience.
• To assess the safety of crushed intranasal and oral intact ELI-200 compared with crushed intranasal comparator and placebo (intranasal and oral) in non-dependent, recreational opioid users with intranasal experience.
The full report from the HAL studies is expected in October.
HAL studies are included in the FDA’s Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling (January 2013). These studies are an important tool for the FDA to assess the relative abuse potential of a new drug. For drugs with abuse-deterrent properties, a HAL study assesses the impact of the potentially abuse-deterrent formulation on measures that predict how probable it is that the medication will be attractive to abusers. The industry guidance recommends that a Visual Analog Scale (VAS) be used to measure drug liking, drug high, good drug effects and other qualities.
Update on Other Development Programs
In addition, the Company also reports results from pivotal and pilot bioequivalence studies for ELI-202. The study results from the pivotal study for ELI-202 demonstrated Elite’s product, both the lowest strength and the highest strength, were bioequivalent for the opioid to the branded drug based on pharmacokinetic measures including peak concentration (Cmax) and area under the curve (AUC) for opioid blood plasma levels. ELI-202 is combination drug that contains a second drug and the study results for the second drug showed bioequivalence for AUC, but a lower Cmax. No food effect was seen with either drug. The study was a single dose, open label, partially randomized, three-way cross over study in healthy volunteers with 32 subjects under fasted conditions and under fed conditions.
Prior to receiving the complete and final report for this study, Elite initiated a pilot study to understand and address the lower Cmax for the combination drug. Two formulations were dosed in the pilot study and both formulations demonstrated that a repeat bioequivalence study with 32 subjects or more would be expected to be bioequivalent for the measured parameters. The pilot study was a single dose, open label, randomized, three period, crossover study in 8 healthy volunteers per arm under fasted conditions. A repeat bioequivalence study for ELI-202 is scheduled to begin in early October.
The formulations utilized Elite’s proprietary pharmacological abuse deterrent technology with the opioid antagonist naltrexone. Levels of sequestration of naltrexone were also evaluated and dosing of Elite’s intact formulation resulted in almost no exposure levels to naltrexone (LOQ of 4 pg/mL) and its metabolite 6-?-naltrexol (LOQ of 10 pg/mL) as intended.
“Our technology continues to perform as expected with positive outcomes,” continued Mr. Hakim. “There will be no impact on our target filing for ELI-202 in Q4 2015.”
We clearly disagree on the value that Elite's patents and formulas hold. I will take my cues from the FDA this Oct.
I did.
But they did not have the patent protection and modular tech that Elite has. Elite's tech very well could become the best practice in delivery system.
A lot...
Who paid $3,000,000,000, for a drug company that makes a drug that no one wants?
http://online.wsj.com/news/articles/SB10001424052748703440004575547802833881486
Yes it does. There is a planned suite of these ART products. Starting with ELI200 - ELI2??.
Promise is interesting word... I think a quote or reference to that would be appropriate.
Elite is about to come out publicly with positive data for ELI200 that will forever change the future of the company. That is the only thing that matters right now and the rest is just noise.
They are doing a very good job on the communication front. What confusions reality is the misinformation on message boards and blogs.
That change actually makes the product line more logical. With the modular tech you can have ELI200, ELI201, ELI202...ELI215 etc.
I know many people on this board who have said when to sell at x and buy at y and they seem to make out well. I am not here for that but have no issue with it occurring,
No I meant I could have sold at .40 numerous times and have 4 million shares right now instead of 2 million.
I sold a small position in the .80s to recoup some losses but have accumulated over 2 millions shares which I have not touched once. I don't know the first thing about trading and if I did could probably own double the shares I do right now. That said,I take solace in the fact I know what I own, know where it is going and can't wait to reap the bounty of the end result.
I agree. Data is key. I have known for other reasons professionally and personally that Elite's approach was solid. I also think it is telling when the likes of Nasrat Hakim and Doug Plassche signed on (and when Hakim said he looked at preliminary data in his introductory CC) that this was about to happen.