Profile: Impax Laboratories Inc (IPXL.O)
14 Mar 2014
Impax Laboratories Inc., incorporated on March 23, 1995, is a specialty pharmaceutical company. The Company is engaged in the development, manufacture and marketing of bioequivalent pharmaceutical products, referred to as generics, in addition to the development and marketing of branded products. The Company operates in two segments: Global Pharmaceuticals Division (Global Division) and the Impax Pharmaceuticals Division (Impax Division). The Global Division concentrates its efforts on the development, manufacture, sale and distribution of the Company's generic products, which are the pharmaceutical and therapeutic equivalents of brand-name drug products and are usually marketed under their established drug names. The Impax Division is engaged in the development of brand pharmaceutical products for the treatment of central nervous system (CNS) disorders. The Impax Division is also engaged in the sale and distribution of Zomig (zolmitriptan) products. As of February 8, 2013, the Company had 66 abbreviated new drug applications (ANDAs) approved by the Food and Drug Administration (FDA), which include generic versions of brand name pharmaceuticals, such as Brethine, Florinef, Minocin, Claritin-D 12-hour, Claritin-D 24-hour, Wellbutrin SR, Wellbutrin XL, Ditropan XL, Depakote ER and Prilosec.
In the generic pharmaceutical market, the Company focuses its efforts on developing, manufacturing, selling and distributing controlled-release generic versions of selected brand-name pharmaceuticals covering a range of therapeutic areas. It employs its technologies and formulation to develop generic products, which reproduce brand-name products’ physiological characteristics. Generic products contain the same active ingredient and are of the same route of administration, dosage form, strength and indication(s) as brand-name products already approved for use in the United States by the FDA. It also develops, manufactures, sells and distributes specialty generic pharmaceuticals. Its Global Division also generates revenues from research and development services provided under a joint development agreement with an unrelated third-party pharmaceutical entity.
The Company sells and distributes generic pharmaceutical products through four sales channels: the Global Product sales channel, which include generic pharmaceutical prescription products it sells directly to wholesalers, retail drug chains, and others; the Rx Partner sales channel, which include generic prescription products sold through unrelated third-party pharmaceutical entities pursuant to alliance and collaboration agreements; the Private Label sales channel, which include generic pharmaceutical over-the-counter (OTC) and prescription products it sells to unrelated third parties who in-turn sell the product under their own label, and the OTC Partner sales channel, which include sales of generic pharmaceutical OTC products sold through unrelated third-party pharmaceutical entities pursuant to alliance and collaboration agreements.
As of February 8, 2013, it marketed 124 generic pharmaceutical products representing dosage variations of 37 different pharmaceutical compounds through its Global Division, and 14 other generic pharmaceutical products, representing dosage variations of four different pharmaceutical compounds, through its alliance and collaboration agreement partners. As of February 8, 2013, it had 50 applications pending at the FDA.
The Impax Division is focused on developing pharmaceuticals products for the treatment of CNS disorders, which include epilepsy, migraine, multiple sclerosis, Parkinson’s disease, and the promotion of branded pharmaceutical products through its specialty sales force. Its branded pharmaceutical product portfolio consists of commercial CNS products and development stage projects. In February 2012, it licensed from AstraZeneca the exclusive the United States commercial rights to Zomig (zolmitriptan) tablet, orally disintegrating tablet, and nasal spray formulations. As part of a Distribution, License, Development and Supply Agreement, it also has non-exclusive rights to develop new products containing zolmitriptan and to commercialize these products in the United States in connection with the Zomig brand.
In the development of the Company’s pipeline products, it applies formulation and development to develop controlled-release versions of drug substances, which are marketed either in the United States or outside the United States. As of February 2012, it had one late-stage branded pharmaceutical product candidate, RYTARY, for which an NDA for the treatment of idiopathic Parkinson’s disease (PD) was accepted for filing by the FDA. The Company's Phase III clinical program for RYTARY included the APEX-PD clinical trial. RYTARY is an extended release capsule formulation of CD-LD, which is intended to maintain consistent plasma concentration of levodopa for a longer duration versus immediate release levodopa, which may have an impact on fluctuations in clinical response. RYTARY is being developed in collaboration with GSK for territories outside the United States and Taiwan.
The Company competes with Teva Pharmaceutical Industries Ltd., Actavis, Inc., Mylan Inc., Ranbaxy Laboratories Ltd., Lannett Company, Inc., Sandoz, Inc., and Par Pharmaceutical Companies, Inc.
Impax Laboratories Inc
30831 Huntwood Avenue
HAYWARD CA 94544