Key Developments For Impax Laboratories, Inc.
Impax Laboratories, Inc. (IPXL.O) (Consolidated Issue listed on NASDAQ Global Market)
IMPAX Laboratories, Inc. Confirms Patent Challenge Relating To TRICOR 48mg And 145mg Tablets
IMPAX Laboratories, Inc. confirmed that it has initiated a challenge of the patents listed by Abbott Laboratories in connection with its TRICOR (fenofibrate) tablets, 48 mg and 145 mg. IMPAX Laboratories, Inc. filed its Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for a generic version of TRICOR with the U.S. Food & Drug Administration (FDA). Following receipt of the notice from the FDA that Impax`s ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owners of its Paragraph IV certification. On October 29, 2009, Abbott Laboratories and Laboratoires Fournier S.A. filed suit for patent infringement against Impax in the United States District Court for the District of New Jersey. This action formally initiates the patent challenge process under the Hatch-Waxman Act. Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax`s generic division, will commercialize the products.
IMPAX Laboratories, Inc.'s Impax Pharmaceuticals Initiates Second Phase III Trial of IPX066 in Parkinson`s Disease
Impax Pharmaceuticals,the brand products division of Impax Laboratories, Inc. announced that it has initiated a multinational Phase III trial of its late-stage drug candidate IPX066 in advanced Parkinson`s disease (PD) patients. IPX066 is an investigational extended release carbidopa-levodopa product intended to rapidly achieve and then sustain effective blood concentrations of levodopa, potentially improving PD clinical symptom management. This is the second of two Phase III studies designed to support marketing approval of IPX066 in Parkinson`s disease. Impax Pharmaceuticals previously reported in June the initiation of the first Phase III study of IPX066 in naïve PD patients. The ADVANCE-PD study, will evaluate the safety and efficacy of IPX066 versus immediate-release (IR) carbidopa-levodopa (CD-LD) in advanced PD patients with motor fluctuations. The trial is expected to enroll approximately 420 subjects who will be on treatment for approximately 22 weeks. The trial will be conducted at multiple sites in North America and Europe. The primary endpoint is percentage of off time during waking hours. Additional endpoints include total "off" time, total "on" time with no troublesome dyskinesias, Unified Parkinson`s Disease Rating Scale (UPDRS) and clinician and patient reported outcome measures, including quality of life scales.
IMPAX Laboratories, Inc. Settles Pending Litigation For FLOMAX
IMPAX Laboratories, Inc. announced that it has reached agreement with Astellas Pharma Inc. and Boehringer Ingelheim Pharmaceuticals, Inc. to settle pending U.S. litigation with regard to US Patent No. 4,703,063 for FLOMAX (generic name: tamsulosin hydrochloride) capsules through the entry of a consent judgment confirming the validity and infringement of the patent. FLOMAX is a treatment for the functional symptoms of benign prostatic hyperplasia. As a result of this settlement, the case will be terminated by the consent judgment. The settlement of the litigation provides Impax with the opportunity to launch a generic tamsulosin hydrochloride product on March 2, 2010, prior to the expiration of pediatric exclusivity. Further terms of the settlement will not be disclosed.
IMPAX Laboratories, Inc. Receives Tentative FDA Approval For Generic FLOMAX 0.4mg Capsules
IMPAX Laboratories, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company`s Abbreviated New Drug Application (ANDA) for generic version of FLOMAX (tamsulosin hydrochloride) 0.4mg capsules. Boehringer Ingelheim Pharmaceuticals, Inc. markets FLOMAX for the functional symptoms of benign prostatic hyperplasia.
IMPAX Laboratories, Inc. Announces Positive Results of Phase II Trial of IPX066
IMPAX Laboratories, Inc. announced the positive results from a recently completed Phase II trial of its late stage Parkinson's Disease drug candidate IPX066. In this cross over trial, IPX066 reduced subjects' off time during waking hours by 2 hours compared to Sinemet (3.8 hours of off time for IPX066 vs. 5.8 hours for Sinemet, P<0.0001), the standard of care in Parkinson's disease motor symptom management. A reduction in off time of two hours represents a substantial improvement for Parkinson's patients. The detailed results will be presented at the XVIII WFN World Congress on Parkinson's Disease and Related Disorders in Miami Beach, Florida, December 16 through December 19, 2009.
