Lead Products

Lead Products

Our LCM product candidates seek to add value to drugs that are expected to go off-patent by integrating off-patent active pharmaceutical ingredients, or APIs, with our formulations, resulting in a new final combinations.

Our LCM products are new, proprietary forms of marketed drugs which we believe may offer advantages over existing formulations, such as improved patient compliance and reduced side effects and allow extended patent protection and regulatory exclusivity due to different formulations of product components. Our LCM product candidates seek to improve patients’ disease management and to increase their treatment adherence as well as to add value to drugs that are expected to go off-patent by integrating off-patent active pharmaceutical ingredients, or APIs, with our proprietary formulations, resulting in a new proprietary final combinations.

Our lead product candidate is Glatiramer Acetate Depot, a once-monthly injection for the treatment of patients with multiple sclerosis. GA Depot is currently undergoing clinical studies for both relapsing forms of MS (RRMS) and primary progressive MS (PPMS). We have completed a 24-patient, prospective one-year, open-label Phase II clinical trial in RRMS patient in Israel, with an ongoing extension for the patients for more than 5 years enabling long-term safety evaluation. We currently conducting an FDA IND Phase III a single pivotal clinical trial to support a marketing application under the 505(b)(2) regulatory pathway. In addition to the on-going open-label phase II study in RRMS patients, we are executing a prospective, multi-center, Phase IIa clinical trial for the evaluation of the safety and efficacy of Glatiramer Acetate Depot in patients suffering from PPMS.

We are developing other LCM products targeting large markets. We are developing Pregabalin ER, an extended release oral form of Lyrica®, Pfizer, Inc.’s Pregabalin-based drug, for the treatment of neuropathic pain. We are also developing long acting GLP-1 Depots for treating diabetes. We plan to develop and seek approval for each of our LCM product candidates either as Qualitative and Quantitative (QQ) composition version or under the 505(b)(2) regulatory pathway in the United States. We are also developing Paliperidone Palmitate long acting injections and Buspirone ER tablets for CNS indications.
Depot systems seek to overcome several well-recognized challenges often associated with conventional digestive delivery such as variations in drug plasma levels between doses that can lead to adverse effects or compromised efficacy, poor patient compliance due to frequent dosing, and difficulty localizing exposures to the target organ or tissue.
Depot delivery systems are non-digestive formulations containing multiple doses of a drug that are designed to release the drug over a specified, often prolonged, period of time. Depot formulations come in many forms, designed for several different administration routes, including injections and implantations.

Pipeline

502(b)(2) Pathway Compound (Brand)

  • Indication
  • R&D/IP
  • Human PK
  • Phase II
  • Phase III & Registration

GA Depot (Copaxone®)

Indication: RRMS
  • R&D/IP
  • Human PK
  • Phase II
  • Global Licensing
  • Phase III & Registration
  • 2022

GA Depot (Copaxone®)

Indication: PPMS
  • R&D/IP
  • Human PK
  • Phase II
  • Promising open study results
  • Phase III & Registration
  • Phase III 2022

Pregabalin ER (Lyrica®)

Indication: Neuropathic Pain
  • R&D/IP
  • Human PK
  • Phase II
  • Nhwa Regional Agreement
  • Phase III & Registration
  • 2020

GLP-1 Depot

Indication: Diabetes
  • R&D/IP
  • Human PK
  • Phase II
  • Regional Agreement
  • Phase III & Registration

Buspirone ER (BuSpar®)

Indication: CNS
  • R&D/IP
  • Human PK
  • Phase II
  • Nhwa Regional Agreement
  • Phase III & Registration

ANDA Pathway Compound (Brand)

  • Indication
  • R&D/IP
  • Human PK
  • Registration
  • Marketing

Fingolimod (Gilenya®)

Indication: RRMS
  • R&D/IP
  • Human PK
  • Registration
  • IL/EU/LATAM Marketing Agreement
  • Approved IL May 2017
  • Marketing
  • Sales & Marketing IL/EU 2019-2020

Apremilast (Otezla®)

Indication: Psoriasis
  • R&D/IP
  • Human PK
  • Registration
  • Marketing
  • Sales & Marketing IL 2021

gCopaxone (Copaxone®)

Indication: RRMS
  • R&D/IP
  • Human PK
  • Registration
  • DMF 2020
  • ANDA 2021
  • Marketing

Paliperidone (once a month)

Indication: Schizophrenia
  • R&D/IP
  • Human PK
  • Registration
  • Regional Agreement
  • Marketing

Paliperidone (every 3 months)

Indication: Schizophrenia
  • R&D/IP
  • Human PK
  • Registration
  • Marketing

Aripiprazole (Ability Maintena)

Indication: Schizophrenia
  • R&D/IP
  • Human PK
  • Registration
  • Marketing