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This went down do to the FDA not approving their new drug under 'non-abusive'. I made some money on it and kept some shares that have lost 80% of the price. But hanging in there hoping for a miracle.
dumping 42000 shares after market close. Hope this rebounds but I only have 29 shares. Didn't see this coming.
compare ETLP to KMPH: ETLP on OTC, KMPH on Nasdaq. ETLP is working on a compound that deters abuse, KMPH is modifying the oxy molecule to stop the potential for modifying the pill for abuse. I recently got a prescription for 10 mg hydrocodozone for 2 months and didn't get hooked and it did work great at stopping the pain. For someone with constant pain I can see how they can get hooked on something like this. The market dictates the price of a share of stock and it appears that in 17 years ETLP hasn't been able to produce a sellable product and investors have lost interest in the company. Good luck with ETLP. I got in on the IPO day for KMPH and have traded it many times and made some money on the daily noise.
KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, announced today that its president and chief executive officer, Travis C. Mickle, Ph.D., will present at the RBC Capital Markets 2016 Healthcare Conference being held in New York, NY, February 23-24, 2016. Dr. Mickle will also present at the Cowen & Co. 36th Annual Health Care Conference 2016 being held in Boston, MA, March 7-9, 2016.
Details of KemPharm's presentations are as follows:
RBC Capital Markets 2016 Healthcare Conference
Date: Tuesday, February 23, 2016
Time: 3:35 PM (ET)
Location: The New York Palace Hotel in New York, NY
Cowen & Co. 36th Annual Health Care Conference 2016
Date: Monday, March 7, 2016
Time: 4:40 PM (ET)
Location: The Boston Marriott Copley Place in Boston, MA
The presentations will be webcast and available on the Investor Relations section of KemPharm's website at http://investors.kempharm.com/.
KemPharm designed KP201/APAP to deter tampering and abuse by selecting a molecular structure that prevents the release of the opioid upon crushing, physical manipulation and the application of other commonly employed extraction techniques. This approach to abuse-deterrence at the molecular level contrasts with other abuse-deterrent technologies, which are formulation-based, combining the opioid drug with another drug or in an abuse-deterrent capsule or physical matrix.
We believe our molecular-based approach to abuse-deterrence may be more effective than many formulation-based approaches as we believe the KP201 prodrug does not release hydrocodone effectively upon intranasal administration and has very poor solubility in blood, water and other solvents, thus rendering it unsuitable for IV administration.
KP511/ER also utilizes KemPharm’s LAT platform technology to create its abuse-deterrent properties at the molecular level, which we believe may enable abuse-deterrent characteristics similar to KP201/APAP.
Additionally, based on the molecular structure of KP511, KemPharm believes it may be possible that the metabolic processes of releasing hydromorphone from the prodrug become saturated at excessively large oral doses. If confirmed by further studies, this could potentially mean that KP511 and KP511/ER may reduce the risk of oral overdosing by a unique mechanism that is inherent in the prodrug molecule itself.
ADHD medication
KP415 is a NME prodrug of methylphenidate, which KemPharm is developing for the treatment of ADHD. The ADHD market is largely served by the stimulant products methylphenidate and amphetamine, and KP415 is designed to be a controlled release (CR) abuse-deterrent methylphenidate product.
KemPharm currently anticipates human proof-of-concept data for KP415 in 2016 and plans to seek approval of KP415 under the 505(b)(2) NDA pathway.
Key Product Features of KP415
Based on our preclinical data, KemPharm believes KP415, if approved by the FDA, may have valuable product features and provide significant benefits to patients, physicians, and society when compared to other FDA-approved and widely prescribed methylphenidate products:
Molecular-based abuse-deterrent technology. KP415 utilizes its LAT platform technology to create its abuse-deterrent properties at the molecular level, and the company believes it will have abuse-deterrent characteristics similar to KP201/APAP.
Once-daily dosing. Pharmacokinetic data from preclinical studies show that the time to maximum plasma concentration of methylphenidate after oral administration of KP415 is approximately three times longer than that after oral administration of currently marketed IR methylphenidate. KemPharm believes this inherent CR attribute of KP415’s molecular structure may allow for convenient, once-daily dosing.
Amenable to patient-friendly formulations. Although KemPharm believes KP415 possesses abuse-deterrent properties at the molecular level similar to KP201, its preclinical data shows that KP415 is highly water soluble, and we believe it could ultimately be used in a variety of patient-friendly dosage forms such as oral thin film, orally dissolving tablets, chewable tablets and liquids as a means of increasing patient convenience and compliance.
Improved drug properties. KemPharm seeks to develop NME prodrugs with improved attributes over FDA-approved drugs, such as reduced susceptibility to abuse, enhanced bioavailability and increased safety. For example, the molecular structure of KP201/APAP is resistant to tampering and deters abuse.
Composition-of-matter patent protection. KemPharm’s prodrugs combine an FDA-approved parent drug with one or more ligands to create NMEs and may be eligible for patent protection as novel compositions of matter, provided that all other applicable requirements are met. Our strategy is to seek patent protection not only for our NME prodrug product candidates, but also for related compounds with the intention of creating heightened barriers to market entry.
505(b)(2) NDA pathway. KemPharm’s LAT platform technology allows the company to develop NME prodrugs that may be eligible to use the 505(b)(2) NDA pathway. Under that regulatory pathway, if we are able to demonstrate the bioequivalence of one of its product candidates to an appropriate approved drug, we will then be able to reference the FDA's previous findings of safety and effectiveness for the approved drug in our 505(b)(2) NDA submissions. This may allow us to avoid the significant time and expense of conducting large clinical trials and eliminate the need for some preclinical activities.
We use our LAT platform technology to create NME prodrugs by chemically attaching one or more molecules, or ligands, to an FDA-approved parent drug. When combined with the parent drug, our ligands create prodrugs designed to have improved drug attributes while maintaining efficacy equivalent to the parent drug. Once administered, targeted human metabolic processes, such as those in the GI tract, separate the ligand from the prodrug and release the parent drug, which can then exert its therapeutic effect.
The ligands that we typically use have been demonstrated to be safe in toxicological studies or have been granted Generally Recognized as Safe (GRAS) status by the FDA. Further, since our prodrugs are chemical successors of the parent drugs, they are considered to be NMEs and thus may be eligible for protection by composition-of-matter patents.
KemPharm has employed its LAT prodrug platform to create a portfolio of product candidates that we believe will offer significant improvements over FDA-approved and widely prescribed drugs.
Our most advanced product candidate, KP201/APAP, is an immediate release (IR) combination of KP201, our prodrug of hydrocodone, and APAP (acetaminophen). We are developing KP201/APAP for the treatment of acute moderate to moderately severe pain.
KP201/APAP is designed to be an abuse-deterrent opioid product that offers equivalent efficacy to the existing standard-of-care, IR hydrocodone/APAP combination products such as Vicodin, Norco and Lortab. KP201 combines hydrocodone with the ligand benzoic acid and is designed not to release its hydrocodone component until it is metabolized in the GI tract following oral administration.
We designed KP201/APAP to deter tampering and abuse by selecting a molecular structure that prevents the release of the opioid upon crushing, physical manipulation and the application of other commonly employed extraction techniques. This approach to abuse-deterrence at the molecular level contrasts with other abuse-deterrent technologies, which are formulation-based, combining the opioid drug with another drug or in an abuse-deterrent capsule or physical matrix.
We believe our molecular-based approach to abuse-deterrence may be more effective than many formulation-based approaches as we believe the KP201 prodrug does not release hydrocodone effectively upon intranasal administration and has very poor solubility in blood, water and other solvents, thus rendering it unsuitable for intravenous (IV) administration.
Key Product Features of KP201/APAP
If approved by the FDA, KemPharm believes KP201/APAP may have many valuable product features and may provide significant benefits to patients, physicians and society, compared to other FDA-approved and widely prescribed IR hydrocodone/APAP combination products:
Molecular-based abuse-deterrent technology. Unlike formulation-based opioid abuse-deterrent approaches, KP201/APAP incorporates KemPharm’s LAT platform technology to create its abuse-deterrent properties at the molecular level. This may provide a higher barrier against attempted abuse than many existing formulation-based approaches.
No generic equivalent product. KP201 is a new molecular entity (NME) prodrug with a new chemical name, benzhydrocodone, and if approved, KemPharm expects it will have a lower prescribed milligram strength than the therapeutic equivalent amount of hydrocodone bitrate used in existing IR hydrocodone/APAP combination products. These differences will mean there will be no generic equivalent product for KP201/APAP in most states, making substitution difficult at the pharmacy.
Composition-of-matter patent protection. KP201/APAP is protected by a U.S. composition-of-matter patent on KP201 that will expire, after utilizing all appropriate patent term adjustments but excluding possible patent term extensions, in 2031.
KP201/APAP Human Abuse Liability Program Design and Data Review
The KP201/APAP human abuse liability program was designed by KemPharm to assess key abuse-deterrence criteria as specified by the FDA. The program included three clinical trials, KP201.A01, KP201.A02 and KP201.A03, as well as three distinct trials designed to evaluate the tamper-resistant properties of KP201/APAP.
Results from the KP201.A01 oral human abuse liability trial, which was designed to measure hydrocodone exposure, drug likability and the safety of KP201/APAP, as compared to Norco®, when taken orally at 4, 8 and 12 tablet dosages, indicated that KP201/APAP resulted in lower exposure to hydrocodone at the two highest dose levels for the trial, as well as lower incidence of hypoxia across the same dosage levels, in each case compared to Norco®, suggesting the potential for improved safety.
Results from the KP201.A02 intranasal human abuse liability trial, which was designed to determine the relative bioavailability, abuse potential, and safety of equivalent doses of crushed and intact KP201/APAP as compared to Norco®, indicated that KP201/APAP, when insufflated, reduces peak hydrocodone exposure (Cmax), delays the time to achieve peak exposure (Tmax), and significantly decreases in exposure to hydrocodone (AUC0-2h) at early time points typically associated with an increased safety risk.
Data from the KP201.A03 intranasal human abuse liability trial, which was designed to compare the amount of hydrocodone released from KP201 and from hydrocodone bitartrate (HB) (both without APAP) after insufflation, demonstrated a statistically significant reduction in Cmax, a delay in Tmax, and a significant decrease in total exposure to hydrocodone especially at early time points typically associated with increased drug liking, abuse and safety. Secondary endpoints related to drug liking, pupillometry and ease of snorting also showed significant differences between KP201 and HB, with KP201 demonstrating lower drug liking, less pupil dilation and higher difficulty of snorting than HB.
Lastly, results from three distinct trials designed to evaluate the tamper-resistant properties of KP201/APAP indicated that KP201 remains mostly intact in its inactive prodrug form when being subjected to various chemical manipulation techniques used commonly by opioid abusers. The trials demonstrated that efforts to extract and hydrolyze KP201/APAP were less efficient compared to HB/APAP tablets. Under the more than 1,000 conditions tested, KP201/APAP released less hydrocodone compared to the hydrocodone released from the HB/APAP tablets in every case, usually only yielding the inactive prodrug, KP201. Additionally, KP201/APAP is difficult to prepare for injection and it does not appear to be possible to smoke either KP201 or KP201/APAP.
KP201/IR
KP201/IR is an acetaminophen (APAP)-free formulation of its immediate release (IR) hydrocodone product, KP201. We expect this highly differentiated product candidate to feature the same abuse-deterrent properties demonstrated by KP201/APAP, our most advanced product candidate.
Based on current development timelines, KemPharm anticipates a potential New Drug Application (NDA) filing for acetaminophen-free KP201 in 2017. KP201/IR would be the first IR, acetaminophen-free hydrocodone option available to physicians.
KP511/ER
KP511/ER is an extended release (ER) formulation of KP511, KemPharm’s NME prodrug of hydromorphone, which the company is developing for the treatment of moderate to severe pain. KP511/ER is designed to be an abuse-deterrent opioid product that offers equivalent efficacy to approved ER hydromorphone products.
KemPharm’s prodrug, KP511, combines hydromorphone with one or more ligands and can be formulated in both IR and ER dosage forms. KP511 is designed not to release its hydromorphone component until it is metabolized in the GI tract following oral administration. We believe KP511 is highly tamper-resistant and is stable under conditions that can potentially defeat many formulation-based abuse-deterrent technologies.
KemPharm plans to seek approval of KP511/ER under the 505(b)(2) NDA pathway. Based on preclinical data, we believe that KP511 may release hydromorphone after oral administration in humans in a manner that is comparable to the appropriate approved hydromorphone drug.
Key Product Features of KP511/ER
Based on our preclinical data, KemPharm believes KP511/ER, if approved by the FDA, may have valuable product features and provide significant benefits to patients, physicians and society when compared to FDA-approved hydromorphone products:
Molecular-based abuse-deterrent technology. KP511/ER utilizes KemPharm’s LAT platform technology to create its abuse-deterrent properties at the molecular level, and the company believes it may have abuse-deterrent characteristics similar to KP201/APAP.
Oral overdose protection. In preclinical studies, KemPharm observed that hydromorphone blood levels in rats increased more slowly and to a lesser extent after oral administration of increasing excessively large doses of KP511, as compared to increasing equimolar oral doses of hydromorphone hydrochloride. We also observed that the study animals began dying from the increasing excessively large oral doses of hydromorphone hydrochloride, but never died from an equimolar oral dose of KP511. Based on the molecular structure of KP511, KemPharm believes it may be possible that the metabolic processes of releasing hydromorphone from the prodrug become saturated at excessively large oral doses. If confirmed by further studies, this could potentially mean that KP511 and KP511/ER may reduce the risk of oral overdosing by a unique mechanism that is inherent in the prodrug molecule itself.
KP606/IR
KP606/IR is an immediate release (IR) formulation of KP606, KemPharm’s NME prodrug of oxycodone, which the company is developing for the treatment of moderate to severe pain.
KP606/IR is designed to be an IR abuse-deterrent opioid product that offers equivalent efficacy to approved oxycodone products KP606 combines oxycodone with one or more ligands. We have currently formulated an IR dosage of KP606 and plan to develop an ER dosage.
KemPharm currently anticipates human proof-of-concept data for KP606/IR in 2017 and plans to seek approval of KP606/IR under the 505(b)(2) FDA pathway.
KP746
KP746, KemPharm’s NME prodrug of oxymorphone, is designed to be an abuse-deterrent opioid product that offers equivalent efficacy to approved oxymorphone products.
Based on preclinical studies of KP746, KemPharm believes that the prodrug may offer enhanced bioavailability at typical therapeutic doses and abuse-deterrent features in comparison to standard oxymorphone. Specifically, based on preclinical studies, KemPharm believes KP746 may be highly tamper-resistant and may be stable under conditions that can potentially defeat many other abuse-deterrent technologies, suggesting greatly reduced intranasal bioavailability and minimal to no release of oxymorphone when administered intravenously.
KP746 applies KemPharm’s Ligand Activated Therapy (LAT) platform technology and has the potential to be the first approved prodrug of oxymorphone.
KemPharm
We employ our Ligand Activated Therapy (LAT) platform technology to create prodrugs in order to improve one or more of the attributes of approved drugs, such as susceptibility to abuse, bioavailability and safety.
Our most advanced product candidate, KP201/APAP, consists of KP201, our prodrug of hydrocodone, formulated in combination with acetaminophen (APAP). We are developing KP201/APAP as an immediate release (IR) product candidate for the treatment of acute moderate to moderately severe pain.
KP201/APAP was designed with abuse-deterrent properties to address the epidemic of opioid abuse in the United States. We designed KP201/APAP to deter tampering and abuse by selecting a molecular structure that prevents the release of the opioid upon crushing, physical manipulation and other commonly employed extraction techniques. We believe this approach to abuse-deterrence at the molecular level may be more effective than many formulation-based abuse-deterrence technologies, which combine the opioid drug with another drug or use an abuse-deterrent capsule or physical matrix.
In addition to KP201/APAP, KemPharm is building a pipeline of prodrug product candidates that target large market opportunities in pain, attention deficit hyperactivity disorder (ADHD) and other central nervous system indications.
The price of silver is less than it's selling price. Least productive mines closing down and most silver produced is a byproduct of copper or another metal being worked. Time to buy real silver and hold. Just my opinion.
tem 7.01 Regulation FD Disclosure.
On February 10, 2016, KemPharm, Inc., a Delaware corporation, or KemPharm, issued a press release announcing that its new drug application, or NDA, for KP201/APAP, its investigational drug candidate for the short-term management of acute pain, has been accepted and granted priority review by the U.S. Food and Drug Administration, or the FDA. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01 and contained in the press release furnished as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and is not incorporated by reference into any of KemPharm’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
Item 8.01 Other Events.
As described above, on February 10, 2016, KemPharm announced that its NDA for KP201/APAP has been accepted and granted priority review by the FDA. In addition, the FDA has set a target action date under the Prescription Drug User Fee Act of June 9, 2016.
KemPharm Reports Positive Data Demonstrating Tamper-Resistant Properties of KP201/APAP
Results Indicate that Prodrug Design of KP201/APAP Significantly Hinders Traditional Means of Abuse, Including Extraction, Injection and Smoking
Coralville, IA – September 30, 2015 – KemPharm, Inc. (NASDAQ: KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today reported positive results from three distinct studies designed to evaluate the tamper-resistant properties of its lead opioid prodrug KP201/APAP, KemPharm’s prodrug of hydrocodone in combination with acetaminophen (APAP) compared to a generic hydrocodone bitartrate/APAP product (HB/APAP). The studies were designed based on feedback from the U.S. Food and Drug Administration (FDA). KemPharm believes that, together with the positive data from KemPharm’s previous human abuse liability trials, these results may support FDA Category 1 abuse-deterrent language in the KP201/APAP product label, if approved by the FDA.
Highlights from the Tampering Studies:
·
Under all conditions tested (over 1,000 conditions examined), the amount of hydrocodone released from KP201, the active pharmaceutical ingredient (API) of KP201/APAP, was less than the amount of hydrocodone released from HB/APAP tablets.
·
Extraction from KP201/APAP yielded mostly inactive KP201, while hydrocodone was efficiently extracted from HB/APAP under the same conditions.
·
Greater than 90% of all conditions tested for extraction yielded no hydrocodone released from KP201/APAP.
·
Conditions that led to any release of hydrocodone from KP201/APAP required harsh chemicals and usually heat; by comparison, hydrocodone was extracted from HB/APAP tablets with only water.
·
Traditional means of preparing a drug for injection were not suitable for KP201/APAP, yielding only inactive KP201, while up to 100% of hydrocodone could be extracted from HB/APAP by the same process.
·
Cold water extraction yielded no free hydrocodone from KP201/APAP.
·
Smoking or freebasing of KP201/APAP tablets was not possible.
·
Smoking of the KP201 API itself after extraction yielded no hydrocodone; by comparison, it was possible to smoke the hydrocodone API.
Travis C. Mickle, Ph.D., President and CEO of KemPharm, stated, “These results demonstrate the unique characteristics of our prodrug technology, showing that KP201 appears to remain intact in its inactive prodrug form even when being subjected to various chemical manipulation techniques used commonly by opioid abusers. Importantly, we believe these results may support favorable product labeling for KP201/APAP, if approved by the FDA. KP201 has demonstrated intranasal, and KP201/APAP has demonstrated oral, abuse-deterrent and safety properties that we believe further differentiates our product candidate when compared to the immediate-release opioid products currently available.”
The first study, KP201.T01, evaluated KP201/APAP for the possibility and potential for individuals to extract the KP201 prodrug from its tablet formulation and convert the extracted KP201 API into active hydrocodone, following a protocol that KemPharm developed with input from the FDA. The study evaluated how the abuse-deterrent properties of KP201 could be defeated or compromised, as compared to HB/APAP tablets. The results showed that efforts to extract and hydrolyze KP201/APAP were less efficient compared to HB/APAP tablets. Under the more than 1,000 conditions tested, KP201/APAP released less hydrocodone compared to the hydrocodone released from the HB/APAP tablets in every case, usually only yielding the inactive prodrug, KP201.
A second study, KP201.T02, was designed to determine the properties of KP201 that reduce the likelihood of intravenous (IV) abuse of KP201/APAP as compared to HB/APAP, based again on a protocol developed by KemPharm with input from the FDA. The study evaluated the amount of KP201, APAP and hydrocodone detected in an extract derived from KP201/APAP tablets that would be suitable for IV abuse. The results showed the traditional means used to prepare a drug for injection were likely not suitable for KP201/APAP. In each condition employed, only inactive KP201 was extracted, if anything at all, while up to 100% of the hydrocodone from HB/APAP tablets could be extracted for injection. Cold water extraction methods typically used to “enrich” or “purify” the hydrocodone from HB/APAP also yielded only inactive KP201 with no release of hydrocodone from the prodrug. As expected, hydrocodone was readily extracted from HB/APAP tablets by this method.
The final study, KP201.T03, examined the potential to abuse KP201/APAP by smoking. The results demonstrated that KP201/APAP could not be smoked in either tablet or API form. The results also showed that freebasing KP201/APAP was not possible. By contrast, HB/APAP can be prepared as a freebase and also smoked as the API.
Dr. Mickle also noted, “KemPharm is on track to report data from the second intranasal abuse study of KP201/APAP (KP201.A02) in the coming weeks. We look forward to reporting the results of this study and to filing an NDA for KP201/APAP utilizing the 505(b)(2) pathway as anticipated in the fourth quarter of 2015.”
About KemPharm
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of prodrugs to treat serious medical conditions through its Ligand Activated Therapy (LAT) platform technology. KemPharm utilizes its LAT platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, ADHD and other CNS disorders.
Caution Concerning Forward Looking Statements
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. These forward-looking statements are not guarantees of future actions or performance. These forward-looking statements are based on information currently available to KemPharm and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: KemPharm's financial resources and whether they will be sufficient to meet KemPharm's business objectives and operational requirements; results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by KemPharm's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. KemPharm's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning KemPharm’s business are described in additional detail in KemPharm's Registration Statement on Form S-1 (Registration No. 333-202660) declared effective April 15, 2015, and KemPharm's other Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
This is a loser stock. It isn't going anywhere but down. Expect it to reverse split AGAIN so it can lose more. China is going into a downturn and steel is suffering.
One day left in June. Tomorrow perhaps?
In at $11.80 just ended at $19.56 today. Anyone else notice this gem? Loving the ride.
North Liberty, IA and Las Vegas, NV – Sept. 4, 2013 – KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, today announced the advancement of a new pain therapy program, KP606, a first-in-class oral prodrug of oxycodone. KP606 adds to the Company's franchise of abuse-deterrent prodrugs, which includes KP201 (hydrocodone) and KP511 (hydromorphone).
KemPharm announced the discovery of KP606 at PAINWeek 2013, the nation's largest pain conference for frontline clinicians with an interest in pain management.
In preclinical studies, KP606 exhibited superior pharmacological characteristics that suggest an improved safety profile compared to currently marketed oxycodone products, possibly reducing or preventing symptoms of constipation and limiting abuse potential. KP606 also features tamper resistant properties that make it difficult to extract oxycodone from the prodrug, which is not active until cleaved in the body.
Travis C. Mickle, Ph.D., President and CEO of KemPharm, commented, "With the discovery of KP606, KemPharm now has the most complete – and advanced – pipeline of abuse-deterrent opioid prodrugs in development. Oxycodone, along with hydrocodone and hydromorphone, are not only the most prescribed opioid-based pain medications, but are three of the most prescribed drugs in the entire world. As we continue towards an NDA filing for KP201 in the second quarter of 2014, KemPharm's goal is to re-define the pain management market by developing a franchise of therapeutics that offer unique physicochemical and pharmacological attributes that may deliver additional patient benefits, including reduced potential for abuse and reduction or elimination of opioid-induced constipation."
KemPharm is a biopharmaceutical company focused on the discovery and development of new chemical entities (NCEs) to treat serious medical conditions through its proprietary and broadly applicable Ligand Activated Therapy (LAT) approach. The company utilizes its LAT technology to generate improved prodrug versions of FDA approved drugs in the high needs areas of pain, ADHD and other CNS diseases. KemPharm's lead clinical candidate, KP201, is in development for the treatment of acute, moderate to moderately severe pain with a new drug application (NDA) expected to be filed in the second quarter of 2014. Composed of hydrocodone chemically bound to a ligand, KP201 offers unique physicochemical and pharmacological attributes that may deliver additional patient benefits, including reduced potential for abuse and reduction or elimination of opioid-induced constipation (OIC). KemPharm's pipeline is also highlighted by KP511, its hydromorphone prodrug for pain, KP606, its oxycodone prodrug for pain, and KP415, a prodrug of methylphenidate for the treatment of ADHD. For more information on KemPharm, please visit the company's website at www.kempharm.com
KemPharm, Inc. (Nasdaq:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary new molecular entity ("NME") prodrugs, announced today that its Executive Vice President of Research and Development, Sven Guenther, Ph.D., will present a review of the current status of scientific research in the field of pain therapeutics including a case study on the development of the Company's novel pain drug candidate, KP201/APAP, at the Abuse Deterrent Formulations Summit being held May 19-20, 2015, in Washington, DC.
Dr. Guenther's case study, titled, "The Search for New Pain Therapeutics with Low Inherent Abuse Potential—A Case for Prodrugs," will be presented on the second day of the ADF Summit, Wednesday, May 20, 2015. The presentation will provide an overview of the successes and failures in the scientific community of finding new pharmaceuticals for the treatment of pain and discuss the potential benefits that prodrugs, such as KP201, may bring to reducing the potential for abuse.
KP201/APAP is KemPharm's most advanced product candidate in development for the treatment of acute moderate to moderately severe pain. Consisting of KP201, KemPharm's NME prodrug of hydrocodone, formulated in combination with acetaminophen, KP201/APAP is designed to deter tampering and abuse.
Dr. Guenther commented, "There is a movement across the country within the pharmaceutical industry and regulatory agencies to combat the epidemic of prescription drug abuse in the U.S., leading to growing demand for better opioid-based medications. We believe that KP201/APAP is at the forefront of this movement, possessing a unique abuse-deterrent chemical structure which ensures that the drug becomes active only when exposed to enzymes in the digestive system. We are pleased to contribute to the refinement of industry best practices for developing abuse-resistant therapeutics."
Hello all. KPMH is local to me and the ipo came and went. Bought in at $11.80 and watching it oscillate. Any thoughts about this new Nasdaq company?
th..th..th..th..that's all, folks.
It's back. Watch for silver to rise now.
What else is he going to say, sitting on billions in silver? That the world is doing OK and silver should go back to $8? But in reality creating money by borrowing it out of thin air and spending like a drunken Kennedy can't last forever. The world is running out of silver so stack up while paper keeps physical cheap.
How's that shorting silver going for you lately?
don't.... stop.... posting.....
I love they picture.
What happens is the stock gets locked out of buying or selling and then goes to zero. Stockholders get nothing.
Zing! Now that's what the silver chart should increase for the next 30 days.
I'm so glad Ameritrade didn't let me buy in at $.45 It would have been a huge mistake.
Silver is HOT today!
No, no and no.
Silver has bottomed. See you back at $50+ an oz for silver.
Headlines will read: America fails. Women and minorities hardest hit.
SOME Americans have become this way but most of us aren't on welfare or SSI disability. Maybe those you write about should just move to Europe where they would fit in nicely. That would leave the rest of the country for us workers.
A friend of mine just bought her first 20 silver eagles. She has money and looking forward to stacking. Her husband has a nice Morgan 1921 silver dollar but he's like you, doesn't believe that silver is worth scrap price, has no value and anyone is stupid to stack. But then again, his parents were farmers and he will inherit a lot of land and they just built a new house. He works hard and is well off but doesn't understand the concept of money.
This is America. Anyone can open a store and overpay their help! Can I work for you since you believe in paying for full time workers and full benefits?
They took the product and ran.
Don't worry, if food gets scarce I won't eat you.
Actually if the world went to hell and the dollar went the way of Zimbabwe economy and their trillion dollar bills then silver dimes and quarters would be worth far more than paper bills of any denomination. But then again it would be worse than a zombie apocalypse movie.
Preppers might last a few days or a year longer than most but what kind of a life would it be?
About 2 years too late. They should have declared bankruptcy a long long time ago.
Where did you get the idea I 'believe the end of the world is coming'? I am not a 'prepper' and have never claimed to be.
What planet is silver dropping another $7 to 10 per oz?