Impax files for approval of generic heartburn drug

Impax Laboratories Inc. is challenging the patents on a heartburn drug fromTakeda Pharmaceutical, just days after Takeda took the same action against Impax. The generic drugmaker said Monday that it filed for marketing approval of generic versions of 30-milligram and 60-milligram capsules of Dexilant. Impax said it believes it is the first company to file for approval of a generic version of Dexilant, also called dexlansoprazole. If so, it could get six months of marketing exclusivity for its generic. The company said U.S. sales of Dexilant 30-milligram capsules totaled $20 million in the 12 months ended January 2011, and sales of the 60-milligram capsules totaled $261 million. Takeda Pharmaceutical Co. sued Impax for patent infringement on Friday, Impax said. The lawsuit prevents the Food and Drug Administration from approving Impax's generic for 30 months after it filed for approval or until a court makes a ruling on the patents supporting Dexilant, whichever comes first. Dexilant was approved in January 2009, and the patents on the drug begin to expire in June 2020. Shares of Impax rose 58 cents, or 2.3 percent, to $26.20 in afternoon trading.

Impax Laboratories Confirms Patent Challenge Relating to DEXILANT® Delayed-Release Capsules, 30 mg and 60 mg

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Takeda Pharmaceutical Company, Ltd. in connection with DEXILANT® (dexlansoprazole) delayed-release capsules, 30 mg and 60 mg. Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of DEXILANT® 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 owner of its paragraph IV certification. On April 1, Takeda Pharmaceuticals Co. LTD, Takeda Pharmaceuticals North America Inc., Takeda Pharmaceuticals LLC and Takeda Pharmaceuticals America Inc. filed suit for patent infringement against Impax in Northern District of California. This action formally initiates the patent challenge process under the Hatch-Waxman Act. Based on the filing date of the ANDA, the Company believes that it is the first to file an ANDA with a paragraph IV certification on the 30 mg capsule, and expects to be entitled to 180 days of market exclusivity. Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s generic division, will commercialize the products. DEXILANT® is used to treat gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach). It is used to treat the symptoms of GERD, allow the esophagus to heal, and prevent further damage to the esophagus. DEXILANT® is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach. According to Wolters Kluwer Health, U.S. sales of DEXILANT® delayed-release capsules, 30 mg and 60 mg were approximately $20 million and $261 million, respectively, for the current 12 months ending January 2011.

Impax Pharmaceuticals Reports Positive Achievements on its Two Leading Brand Product Candidates IPX066 and IPX056

HAYWARD, Calif., Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (IPXL:

5.91, +0.46, +8.4%) today announced it has commenced a Phase III trial of IPX066 in Parkinson's Disease (PD) patients based on encouraging interim data collected from the Phase II study in PD patients. It also clarified the U.S. Food and Drug Administration (FDA) requirement for pediatric studies of its investigational medication IPX056.

Larry Hsu, Ph.D., president and chief executive officer of Impax Laboratories, said: "We are very pleased to report these recent achievements, which are important to our long term strategy of investing in developing branded pharmaceutical products. We believe this strategy will augment our generic business and propel our company to the next growth phase by providing longer-life-cycle products with significantly higher margin potential than our generic products."

IPX066 for Parkinson's Disease

Impax Pharmaceuticals has started enrolling patients in a Phase III trial of its late-stage drug candidate IPX066 in PD patients. IPX066 is an investigational extended release carbidopa levodopa product intended to produce a fast and sustained concentration of levodopa, potentially improving PD clinical symptom management.

Impax has completed multiple Phase I pharmacokinetic studies in healthy volunteers and will soon complete a open label and active-controlled Phase II study in PD patients. The interim results of this Phase II study have demonstrated consistent signals of superior clinical benefit in both extended pharmacokinetic profile and control of PD motor symptoms compared to conventional carbidopa levodopa.

Based on both confirmatory Phase I and compelling interim Phase II data, the company has commenced enrollment in the first Phase III study, also known as APEX-PD, in PD patients with mild symptoms of PD. The company is conducting this trial under a recent agreement with the FDA through a Special Protocol Assessment (SPA) for the Phase III clinical trial of IPX066 in PD patients.

Impax is planning to commence a second Phase III trial of IPX066 in patients with advanced PD patients later in 2009 or early 2010.

Michael Nestor, divisional president of Impax Pharmaceuticals said: "We are delighted with the efforts of our impressive team headed by Dr. Suneel Gupta which has rapidly advanced IPX066 from an Investigational New Drug (IND) filing (July 2008) to Phase III commencement under SPA in nine months. We are eager to continue the successful development of this product and bring the potential benefits of IPX066 to physicians who treat Parkinson's and their patients as quickly as possible. We continue to work towards our goal of filing a New Drug Application (NDA) in the fourth quarter of 2011."

Impax plans to submit the Phase II data for presentation at a future clinical meeting.

About the APEX-PD Phase III Study

-- The APEX-PD study is a Phase III randomized, double blind, placebo-controlled study to evaluate the safety and efficacy of IPX066 in subjects with PD. The study will evaluate three doses of IPX066 versus placebo in subjects with mild symptoms of PD.

-- The trial is expected to enroll approximately 350 subjects who will be randomized into one of four treatment groups.

-- The trial will be conducted at multiple sites in North America and Europe.

-- The agreed upon primary endpoint is change from baseline in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III. Additional endpoints include clinical and patient reported outcome measures.

IPX056 for Spasticity

Impax Pharmaceuticals recently held discussions with the FDA related to possible requirement for pediatric clinical studies as part of its potential NDA filing for IPX056. IPX056 is an investigational extended-release formulation of baclofen, the most widely prescribed drug in the treatment of spasticity, which has the potential to offer improved control of symptoms and dosing convenience.

Previously FDA had requested Impax to conduct a pediatric study as part of IPX056 NDA submission under the Pediatric Research Equity Act. In recent discussions with FDA on this issue, the Agency asked Impax to submit a proposed pediatric development plan for IPX056 with the NDA in order to avoid delaying the review and approval of IPX056 for adults. Impax plans to develop an appropriate pediatric development strategy in consultation with its advisors so the pediatric trial can be done independently of the adult indication approval process.

Mr. Nestor said: "We are pleased to have this timely input from the FDA, clarifying next steps in fulfilling the pediatric requirement for IPX056. Significantly, this allows our team to focus on the important work of finalizing the second Phase III trial in Multiple Sclerosis spasticity in adults, which we plan to start in late 2009 or early 2010. We continue to work towards our goal of filing a NDA in the first half of 2012."

About IPX066 and Parkinson's Disease

IPX066 is an investigational extended release carbidopa-levodopa product intended to produce a fast and sustained concentration of levodopa, potentially improving PD clinical symptom management. IPX066 has the potential to offer improved and more reliable control of PD symptoms, leading to clinically meaningful reductions in "off" time, a key objective in management of PD. In addition, IPX066 extended release formulation is designed to reduce dosing frequency, enhancing patient convenience.

Parkinson's Disease is a chronic neurodegenerative movement disorder affecting an estimated one million people in the U.S. About $1 billion per year is spent on medications to treat PD in the U.S.

About IPX056 and Spasticity

IPX056 is an extended-release formulation of baclofen, the most widely prescribed drug in the treatment of spasticity, which has the potential to offer improved control of symptoms and dosing convenience.

Spasticity is characterized by muscle stiffness and involuntary muscle spasms. It is reported in about two to three million patients in the U.S., occurring commonly in multiple sclerosis, stroke, spinal cord injury, traumatic brain injury and cerebral palsy.