Partnership with KVK, One of the Better Manufacturers of Controlled Substances in the U.S., Opens the Aperture for Bartering Barrage of APADAZ with PBMs and MCOs
KemPharm to Host a Appointment Alarm Today, Tuesday, October 30, 2018 at 4:30 p.m. ET to Altercate the Collaboration
CORALVILLE, Iowa, Oct. 30, 2018 (GLOBE NEWSWIRE) — KemPharm, Inc. (NASDAQ: KMPH), a specialty biologic aggregation affianced in the analysis and development of proprietary prodrugs today appear its admission into a absolute accord and authorization acceding with KVK Tech, Inc. for the U.S. bartering rights of its FDA-approved prodrug product, APADAZ (benzhydrocodone and acetaminophen tablets).
Under the acceding of the agreement, KemPharm is acceptable to accept up to an estimated $3.4 actor in pre-launch payments and assertive amount reimbursements, including a $2.0 actor acquittal aloft accomplishment of a defined anniversary accompanying to the antecedent blueprint acceptance of APADAZ, as able-bodied as an accumulated of up to $53 actor in anniversary payments angry to specific net sales levels. In addition, net profits will be aggregate amid KemPharm and KVK up to 50% based on accomplishing defined net sales levels. KVK has the absolute adapted for all commercial, manufacturing, packaging and administration activities for APADAZ in the U.S. and will be amenable for all authoritative and commercialization-related expenses. In addition, assertive pre-launch expenses, including the costs of API and added abstracts for manufacturing, validation batches, account investments and added launch-specific costs will be confused from KemPharm to KVK. Pre-launch activities that KemPharm and KVK will abide to coact on accommodate beat and plan acceptance by pharmacy account managers (PBM’s) and managed affliction organizations (MCO’s) for the absolute appliance of APADAZ as an another to currently attainable hydrocodone/acetaminophen products.
As one of the better controlled actuality manufacturers in the U.S., KVK Tech has an all-embracing accommodation to aftermath added than 3.5 billion tablets annually, with an alive plan for amplification of accommodation to aftermath over 15 billion tablets by 2020. Currently, the hydrocodone/acetaminophen bazaar represents about 5 billion tablets dispensed annually in the U.S.
“Securing this acceding with KVK is an important footfall advanced against the bartering barrage of APADAZ, a artefact which we accept offers a differentiated analysis advantage for the concise administration of astute pain,” said Travis C. Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “We accept APADAZ is now well-positioned for bartering barrage back this acceding puts cogent accomplishment and administration capabilities in abode and opens the aperture to added discussions with payers apropos the appliance of APADAZ in their bloom plans.”
“As one would expect, KVK undertook all-encompassing due activity and conducted its own bazaar analysis apropos KemPharm’s proposed bartering plan for APADAZ through its absolute relationships with assorted PBM’s and MCO’s. We both accede there appears to be a abundant bazaar befalling for the backup of accepted hydrocodone/acetaminophen articles with APADAZ,” added Mickle. “Additionally, as a aftereffect of our collaboration, KemPharm has the befalling to accretion greater banking adaptability because of the pre-launch payments, cost-sharing, reimbursements and abeyant acquirement beck from both sales milestones and accumulation allotment on a go-forward basis. We are acutely admiring with this befalling to accomplice with KVK for the bartering barrage of APADAZ.”
“Since our founding, KVK Tech has strived to become a trusted baton in generics accomplishment and distribution,” said Anthony Tabasso, President and Chief Executive Officer of KVK Tech. “Our business aesthetics is congenital on a charge to arete with a focus on three amount values: Safety, GMP Compliance, and Productivity. We accept congenital a acceptability of accouterment affection articles on-time, alike back added manufacturers acquaintance accumulation disruptions. APADAZ represents an accomplished befalling to accommodate physicians and patients with a added differentiated artefact than currently attainable on the bazaar today, and we attending advanced to application our expertise, calm with KemPharm, to auspiciously barrage APADAZ.”
Aquilo Partners, L.P. served as KemPharm’s banking adviser on the transaction.
Conference Alarm Information:
KemPharm will host a appointment alarm and alive audio webcast with accelerate presentation today, Tuesday, October 30, 2018, at 4:30 p.m. ET, to altercate its accord with KVK. Interested participants and investors may admission the appointment alarm by dialing either:
An audio webcast with accelerate presentation will be attainable via the Investor Relations area of the KemPharm website http://investors.kempharm.com/. An annal of the webcast and presentation will abide attainable for 90 canicule alpha after today, October 30, 2018, at about 5:30 p.m. ET.
KemPharm is a specialty biologic aggregation focused on the analysis and development of proprietary prodrugs to amusement austere medical altitude through its proprietary LATTM (Ligand Activated Therapy) technology. KemPharm utilizes its proprietary LAT technology to accomplish bigger prodrug versions of FDA-approved drugs as able-bodied as to accomplish prodrug versions of absolute compounds that may accept applications for new ache indications. KemPharm’s artefact activity is focused on the aerial charge areas of ADHD, affliction and added axial afraid arrangement disorders, and its co-lead analytic development candidates, KP415 and KP484, are both based on a prodrug of d-methylphenidate, but with differing extended-release/effect profiles, and are advised for the analysis of ADHD. In addition, KemPharm has accustomed FDA approval for APADAZ®, an immediate-release aggregate artefact absolute benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. For added advice on KemPharm and its activity of prodrug artefact candidates appointment www.kempharm.com or affix with us on Twitter, LinkedIn, Facebook and YouTube.
Founded in 2004, KVK has fast become a trusted baton in generics. KVK’s business aesthetics is congenital on a charge to arete with a focus on three amount values: Safety, GMP Compliance, and Productivity. KVK focuses on acceptable advance through connected advance and account for its customers, employees, and community. KVK is focused on convalescent the way it does business by alert to all the bodies who are circuitous in authoritative healthcare decisions, from patients to healthcare providers.
KVK’s committed aggregation is comprised of individuals with the technical, analytic and business ability that is all-important for accession that after-effects in the development of a assorted ambit of life-changing medicines for patients of all socio-economic levels.
All of KVK’s articles are fabricated in the U.S. in a advanced ability in Newtown, PA. Currently, KVK is architecture a antiseptic injectable bulb adjacent and is on the border of commutual the antecedent accoutrement of the above Lockheed-Martin circuitous in Newtown. KVK is committed to advancement its absolute business operations in America, and it continues to body strong, abiding relationships with the nation’s better pharmacy chains, wholesalers and distributors.
APADAZ® (benzhydrocodone and acetaminophen tablets) was developed from KemPharm’s proprietary LAT (Ligand Activated Therapy) technology and is advised for the concise (no added than 14 days) administration of astute affliction astringent abundant to crave an opioid analgesic and for which another treatments are inadequate. APADAZ is different amid decree opioids in that it contains a prodrug that is chemically inert, or inactive, on its own. Back ingested, enzymes in the gastrointestinal amplitude carve the ligand from the prodrug (benzhydrocodone) and absolution the ancestor biologic (hydrocodone), which can again apply its ameliorative effect. The final accustomed artefact labeling for APADAZ includes these and added abstracts credibility but concludes that the all-embracing after-effects of the analytic affairs did not authenticate abuse-deterrence by accepted altitude standards.
The approval of APADAZ via the 505(b)(2) alleyway was based in allotment on pharmacokinetic studies with Vicoprofen®, Ultracet®, and Norco® in which APADAZ accustomed acknowledgment to hydrocodone and acetaminophen (APAP) that is accepted to aftereffect in ameliorative furnishings agnate to currently accustomed immediate-release hydrocodone/APAP aggregate articles back administered orally as intended.
Indication:APADAZ contains an opioid agonist and acetaminophen and is adumbrated for the concise (no added than 14 days) administration of astute affliction astringent abundant to crave an opioid analgesic and for which another treatments are inadequate.
Limitations of Use:Because of the risks of addiction, abuse, and abusage with opioids, alike at recommended doses, assets APADAZ for use in patients for whom another analysis options [e.g., non-opioid analgesics] accept not been or are not accepted tolerated, or accept not provided able analgesia, or are not accepted to accommodate able analgesia.
Important Assurance Information:APADAZ is contraindicated in patients with: cogent respiratory depression; astute or astringent bronchial asthma in an unmonitored ambience or in absence of resuscitative equipment; accepted or doubtable gastrointestinal obstruction, including diplegic ileus; and hypersensitivity to hydrocodone or acetaminophen.
APADAZ contains benzhydrocodone, a Schedule II controlled substance. APADAZ can be abused and is accountable to misuse, addiction, and bent diversion.
Potential risks associated with APADAZ accommodate addiction, abuse, and misuse, life-threatening respiratory depression, neonatal opioid abandonment syndrome, risks of accessory use or cessation of cytochrome P450 CYP3A4 inhibitors and inducers, acetaminophen hepatotoxicity risks from accessory use with benzodiazepines or added axial afraid arrangement (CNS) depressants, accident of life-threatening respiratory abasement in patients with abiding pulmonary ache or in elderly, cachectic, or debilitated patients, adrenal insufficiency, astringent hypotension, austere bark reactions, risks of use in patients with added intracranial pressure, academician tumors, arch injury, or broken consciousness, hypersensitivity/anaphylaxis, risks of use in patients with gastrointestinal conditions, accident of use in patients with access disorders, and withdrawal, risks of active and operating machinery.
Potential biologic interactions with APADAZ include:
Most accepted adverse reactions (>5%) are nausea, somnolence, ing, constipation, pruritus, dizziness, and headache.
The Abounding Prescribing Advice for APADAZ contains the afterward Boxed Warning:
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
Addiction, Abuse, and Misuse: APADAZ exposes patients and added users to the risks of opioid addiction, abuse, and misuse, which can advance to balance and death. Assess anniversary patient’s accident above-mentioned to prescribing APADAZ and adviser all patients consistently for the development of these behaviors and conditions.
Opioid Analgesic Accident Evaluation and Mitigation Strategy (REMS):To ensure that the allowances of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Biologic Administration (FDA) has adapted a REMS for these products. Beneath the requirements of the REMS, biologic companies with accustomed opioid analgesic articles charge accomplish REMS-compliant apprenticeship programs attainable to healthcare providers. Healthcare providers are acerb encouraged to
Life-Threatening Respiratory Depression: Serious, life-threatening, or baleful respiratory abasement may action with use of APADAZ. Adviser for respiratory depression, abnormally during admission of APADAZ or afterward a dosage increase.
Accidental Ingestion: Accidental assimilation of alike one dosage of APADAZ, abnormally by children, can aftereffect in a baleful balance of hydrocodone.
Neonatal Opioid Abandonment Syndrome: Abiding use of APADAZ during abundance can aftereffect in neonatal opioid abandonment syndrome, which may be life-threatening if not accustomed and treated, and requires administration according to protocols developed by neonatology experts. If abiding opioid use is adapted in a abundant woman, admonish the accommodating of the accident of neonatal opioid abandonment affection and ensure that adapted analysis will be available.
Cytochrome P450 3A4 Interaction: The accessory use of APADAZ with all cytochrome P450 3A4 inhibitors may aftereffect in an access in hydrocodone claret concentrations, which could access or prolong adverse reactions and may account potentially baleful respiratory depression. In addition, cessation of a accordingly acclimated cytochrome P450 3A4 inducer may aftereffect in an access in hydrocodone claret concentration. Adviser patients accepting APADAZ and any CYP3A4 inhibitor or inducer.
Hepatotoxicity:APADAZ contains acetaminophen. Acetaminophen has been associated with cases of astute alarmist failure, at times consistent in alarmist displace and death. Most of the cases of alarmist abrasion are associated with the use of acetaminophen at doses that beat 4000 milligrams per day, and generally absorb added than one acetaminophen-containing product.
Risks From Accessory Use With Benzodiazepines Or Added CNS Depressants: Accessory use of opioids with benzodiazepines or added CNS depressants, including alcohol, may aftereffect in abstruse sedation, respiratory depression, coma, and death.
For Important Assurance Advice including abounding prescribing information, visit: www.kempharm.com.
Caution Apropos Advanced Looking Statements:
This columnist absolution may accommodate advanced statements fabricated in assurance aloft the safe anchorage accoutrement of Area 27A of the Securities Act of 1933, as amended, and Area 21E of the Securities Exchange Act of 1934, as amended. Advanced statements accommodate all statements that do not chronicle alone to actual or accepted facts, and can be articular by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the abrogating versions of those words or added commensurable words. These advanced statements include, after limitation, statements apropos the abeyant accomplishment of any milestones beneath the authorization and accord agreement, any accompanying anniversary payments, and the abeyant commercialization of APADAZ. Advanced statements are not guarantees of approaching accomplishments or performance. These advanced statements are based on advice currently attainable to KemPharm and its accepted affairs or expectations and are accountable to a cardinal of uncertainties and risks that could decidedly affect accepted plans. Risks apropos KemPharm’s business are declared in detail in KemPharm’s Annual Report on Form 10-K for the year concluded December 31, 2017, and KemPharm’s added Periodic and Accepted Reports filed with the Securities and Exchange Commission. KemPharm is beneath no obligation to (and especially disclaims any such obligation to) amend or adapt its advanced statements, whether as a aftereffect of new information, approaching contest or otherwise.
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