Elite Pharmaceuticals Profile
Elite Pharmaceuticals, Inc. (Elite), a specialty pharmaceutical company, engages in the development and manufacture of oral, controlled-release products and the manufacture of generic pharmaceuticals.
Segments
The company operates through two segments, which are products whose marketing approvals were secured via an Abbreviated New Drug Application (ANDA) and products whose marketing approvals were secured via the New Drug Application (NDA). ANDA products are referred to as generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals.
Commercial Products
Phentermine 37.5mg
The approved ANDA for Phentermine 37.5mg was acquired pursuant to an asset purchase agreement with Epic Pharma LLC (Epic) dated September 10, 2010 (the ‘Phentermine Purchase Agreement’).
Sales and marketing rights for Phentermine 37.5mg are included in the licensing agreement between the company and Precision Dose Inc. (Precision Dose) dated September 10, 2010 (the ‘Precision Dose License Agreement’). Phentermine 37.5mg is being manufactured by the company and distributed by TAGI Pharma (TAGI) under the Precision Dose License Agreement.
Phendimetrazine Tartrate 35mg
The ANDA for Phendimetrazine was acquired by the company in 2013. Phendimetrazine 35mg is a commercial product being manufactured at the Northvale Facility and distributed by the company.
Phentermine 15mg and Phentermine 30mg
Phentermine 15mg capsules and Phentermine 30mg capsules were developed by the company, with the company receiving approval from the United States Food and Drug Administration (FDA) of the related ANDA in September 2012.
Sales and marketing rights for Phentermine 15mg and Phentermine 30mg are included in the Precision Dose License Agreement. Phentermine 15mg and Phentermine 30mg are being manufactured by the company and distributed by TAGI under the Precision Dose License Agreement.
Naltrexone 50mg
The ANDA for Naltrexone 50mg was acquired by the company in 2010.
Sales and marketing rights for Naltrexone 50mg are included in the Precision Dose License Agreement. Naltrexone 50mg is being manufactured by the company and distributed by TAGI under the Precision Dose License Agreement.
Isradipine 2.5mg and Isradipine 5mg
The approved ANDAs for Isradipine 2.5mg and Isradipine 5mg were acquired by the company in 2013.
Isradipine 2.5mg and Isradipine 5mg are a commercial product being manufactured by the company at the Northvale Facility and distributed by Epic, on an exclusive basis.
Oxycodone 5mg, Oxycodone 10mg, Oxycodone 15mg, Oxycodone 20mg and Oxycodone 30mg (‘Oxy IR’)
This product was an Identified IR Product in the Epic Strategic Alliance Agreement Dated March 18, 2009 (the ‘Epic Strategic Alliance’). Methods used by Epic in the manufacture of Oxy IR were developed at the Northvale Facility pursuant to the Epic Strategic Alliance, in which the company is entitled to a Product Fee of 15% of Profits through March 2026, as defined in the Epic Strategic Alliance. The first commercial sale of Oxy IR occurred in March 2016.
Trimipramine 25mg, Trimipramine 50mg and Trimipramine 100mg
The approved ANDA for Trimipramine was acquired by the company in 2017.
Trimipramine 25mg, Trimipramine 50mg and Trimipramine 100mg are a commercial product being manufactured by the company at the Northvale Facility and distributed by Epic, on an exclusive basis.
Amphetamine IR Tablets
In December 2018, the company received approval from the FDA for Amphetamine IR Tablets, a generic version of Adderall, an immediate-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate) with strengths of 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg tablets. The product is a central nervous system stimulant and is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
Amphetamine IR Tablets are a commercial product being manufactured by the company and distributed by Lannett Company Inc. (Lannett), on an exclusive basis.
Dantrolene Capsules
The approved ANDAs for Dantrolene 25mg, Dantrolene 50mg and Dantrolene 100mg were acquired by the company in 2013. Dantrolene Capsules are a commercial product being manufactured by the company at the Northvale Facility and distributed by Lannett, on an exclusive basis.
Amphetamine ER Capsules
In December 2019, the company received approval from the FDA for Amphetamine ER Capsules, a generic version of Adderall XR, an extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate) with strengths of 5mg, 10mg, 15mg, 20mg, 25mg, and 30 mg tablets. The product is a central nervous system stimulant and is indicated for the treatment of ADHD and Narcolepsy.
Amphetamine ER Capsules are a commercial product being manufactured by the company and distributed by Lannett, on an exclusive basis.
Loxapine Capsules
The approved ANDA for Loxapine was acquired by the company in 2013. Loxapine Succinate 5, 10, 25 and 50 mg are commercial products being manufactured by the company at the Northvale Facility, launched commercially in May 2021 and distributed by Burel Pharmaceuticals, Inc, an affiliate of Prasco, LLC, on an exclusive basis.
Products Under the United States Food and Drug Administration (FDA) Review
SequestOx - Immediate Release Oxycodone with sequestered Naltrexone
SequestOx is the company’s abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. SequestOx is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone, which incorporates 5mg, 10mg, 15mg, 20mg and 30mg doses of oxycodone into capsules.
In January 2016, the company submitted a 505(b)(2) NDA for SequestOx. In March 2016, the company received notification of the FDA’s acceptance of this filing and that such filing has been granted priority review by the FDA with a target action under the Prescription Drug User Fee Act of July 14, 2016.
In July 2016, the FDA issued a Complete Response Letter (CRL) regarding the NDA. The CRL stated that the review cycle for the SequestOx NDA is complete and the application is not ready for approval in its present form.
In July 2017, the company reported topline results from a pivotal bioequivalence fed study for or SequestOx. In January 2018, the company reported positive topline results from a pilot study conducted for a modified SequestOx wherein, based on the results of this pilot study, the modified SequestOx formulation is expected to achieve bioequivalence with a Tmax range equivalent to the reference product when conducted in a pivotal trial under fed conditions. The company has provided the pilot data to the FDA, requesting clarification as to the requirements for resubmission of the NDA. The FDA has provided guidance for repeated bio-equivalence studies to bridge the new formulation to the original SequestOx studies and also extended its filing fee waiver until July 2023.
Oxycodone Hydrochloride Extended Release (generic version of Oxycontin)
In September 2017, the company filed an ANDA with the FDA for generic version of Oxycontin (extended release Oxycodone Hydrochloride). OxyContin is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The FDA requested additional information relating to this filing, compliance with which would require significant resources. Development of this product has been reinitiated with a target filing in Q1 2023.
Approved Products Not Yet Commercialized
Acetaminophen and Codeine Phosphate
The company received approval from the FDA of an ANDA for a generic version of Tylenol with Codeine (acetaminophen and codeine phosphate) 300mg/7.5mg, 300mg/15mg, 300mg/30mg and 300mg/60mg tablets. Acetaminophen with codeine is a combination medication indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate. The company is not pursuing licensing deals for any opioids at this time until the market changes. The company will wait for the market to stabilize before pursuing these opportunities.
Generic Version of an Antibiotic Product
In January 2019, the company filed an ANDA with the FDA for a generic version of an antibiotic product. The product is jointly owned by the company and Praxgen Pharmaceuticals LLC. The product was approved in April 2022.
Discontinued and Transferred Products
As part of standard operating practices, the company, from time to time, as relevant, conducts evaluations of all ANDAs owned, including, without limitation, of ANDAs acquired or approved prior to the year ended March 31, 2022 (Fiscal 2022) and ANDAs acquired or approved during the Fiscal 2022.
Strategy
The company’s strategy includes developing the generic versions of controlled-release drug products with high barriers to entry.
Licensing, Manufacturing and Development Agreements
Precision Dose License Agreement
In September 2010, the company executed a License Agreement with Precision Dose (the ‘Precision Dose License Agreement’) to market and distribute Phentermine 37.5mg, Phentermine 15mg, Phentermine 30mg, Hydromorphone 8mg, Naltrexone 50mg, and certain additional products that require approval from the FDA, through its wholly-owned subsidiary, TAGI Pharma (TAGI), in the United States, Puerto Rico and Canada. Phentermine 37.5mg was launched in April 2011. Hydromorphone 8mg was launched in March 2012. Phentermine 15mg and Phentermine 30mg were launched in April 2013. Naltrexone 50mg was launched in September 2013. Precision Dose will have the exclusive right to market these products in the United States and Puerto Rico and a non-exclusive right to market the products in Canada.
Pursuant to the Precision Dose License Agreement, the company will receive a license fee and milestone payments. The term of the Precision Dose License Agreement is 15 years and may be extended for 3 successive terms, each of 5 years.
Marketing License with Epic Pharma LLC
In November 2020, the company entered into a license, manufacturing and supply agreement with Epic Pharma LLC (Epic) to market the two company generic products in the United States (the ‘Epic Pharma License’).
As of May 23, 2021 and continuing until the agreement terminates, Epic has exclusive marketing rights to Trimipramine Capsules and Isradipine Capsules. The products are manufactured by the company for Epic on a cost plus basis.
Marketing License with Prasco, LLC and Burel Pharmaceuticals, Inc.
On February 14, 2020, and as amended on July 30, 2020, the company entered into a license, manufacturing and supply agreement with Prasco, LLC and its affiliate Burel Pharmaceuticals, Inc. (Burel) to market generic Loxapine Succinate capsules in the United States (the ‘Burel License’). Burel sales for the product began in May 2021.
Under the agreement, Burel has exclusive marketing rights to Loxapine. The product is manufactured by the company, and the company receives manufacturing fees and license fees of 50% of gross profits or greater, with such being defined as net sales less the price paid to the company for the products, distribution fees of less than 10% and shipping costs. The term of the agreement is three years from the execution date of the agreement and will automatically renew for one year periods unless one of the parties gives prior written notice.
Strategic Marketing Alliances with Lannett Company Inc.
The company has entered into two separate license, supply and distribution agreements with Lannett Company Inc. (Lannett). The first agreement, dated March 6, 2019, relates to products that were co-developed with Praxgen (the ‘Lannett- Praxgen Product Alliance’). The second agreement, dated April 9, 2019, relates to products that were solely developed by the company (the ‘Lannett-Elite Product Alliance’). Both agreements are collectively and individually referred to as the ‘Lannett Alliance’).
Pursuant to Lannett- Praxgen Product Alliance with Lannett, Lannett will be the exclusive U.S. distributor for Amphetamine IR Tablets and Amphetamine ER Capsules. The company manufactures these products, which are purchased, marketed and distributed by Lannett under the Lannett label.
The first commercial shipment of Amphetamine IR Tablets, a generic version of Adderall, with strengths of 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg, pursuant to the Lannett- Praxgen Product Alliance occurred in April 2019.
The first commercial shipment of Amphetamine ER Capsules, a generic version of Adderall XR, with strengths of 5mg, 10mg, 15mg, 20mg, 25mg and 30mg, pursuant to the Lannett- Praxgen Product Alliance occurred in March 2020.
Pursuant to the Lannett-Elite Product Alliance, Lannett will be the exclusive U.S. distributor for Dantrolene Capsules. The first commercial shipment of Dantrolene Capsules, with strengths of 25mg, 50mg and 100mg occurred in June 2019.
Pursuant to the Lannett Company, Inc. and/or its affiliates (Lannett)-Elite Product Alliance, the company manufactures for Lannett’s purchase, marketing, and distribution of Dantrolene Capsules under the Lannett label.
Products Under Development
The company’s research and development activities include developing its proprietary abuse deterrent technology and the development of a range of abuse deterrent opioid products that utilize this technology or other approaches to abuse deterrence.
The company’s proprietary abuse-deterrent technology utilizes the pharmacological approach to abuse deterrence and consists of a multi-particulate capsule, which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence and opioid dependence.
The company filed an NDA for the first product to utilize its abuse deterrent technology, Immediate Release Oxycodone 5mg, 10mg, 15mg, 20mg and 30mg with sequestered Naltrexone (collectively and individually referred to as ‘SequestOx’), on January 14, 2016.
Abuse-Deterrent and Sustained Release Opioids
The abuse-deterrent opioid products utilize the company’s patented abuse-deterrent technology that is based on a pharmacological approach. These products are combinations of a narcotic agonist formulation intended for use in patients with pain, and an antagonist, formulated to deter abuse of the drug. Both, agonist, and antagonist, have been on the market for a number of years and sold separately in various dose strengths.
The company is not selling opioids and is evaluating the market place when deciding to proceed with the above listed filed applications.
Patents
The company has secured various patents, of which two have been assigned for a fee to another pharmaceutical company. The company’s patents include U.S. patent 8,182,836, which expires in March 2024; U.S. patent 8,425,933, which expires in March 2025; U.S. patent 8,703,186, which expires in March 2025; Canadian patent 2,521,655, which expires in April 2023; Canadian patent 2,541,371, which expires in April 2024; U.S. patent 9,056,054, which expires in June 2030; and U.S. patent 10213388, which expires in June 2030.
Trademarks
SequestOx is a trademark owned by the company.
Research and Development
For the year ended March 31, 2022, the company’s research and development costs were $4.1 million.
Regulation
The design, development, manufacturing, and marketing of pharmaceutical compounds, on which the company’s success depends, are intensely regulated by governmental regulatory agencies, in particular the FDA and DEA (the United States Drug Enforcement Administration or any successor entity).
The company is a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and is required to be independent with respect to the company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
The company’s activities are subject to various federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute, the federal civil False Claims Act, and laws and regulations pertaining to limitations on and reporting of healthcare provider payments (physician sunshine laws).
History
Elite Pharmaceuticals, Inc. was incorporated in 1997 under the laws of the state of Delaware. The company was reincorporated under the laws of the state of Nevada in 2012.
