-- New Drug Application for once-daily formulation of lorcaserin expected to be submitted to the FDA later this year --
WOODCLIFF LAKE, N.J. and SAN DIEGO, Calif., April 10, 2015 /PRNewswire/ -- Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced the completion of two Phase 1 registrational clinical trials that Eisai and Arena believe demonstrate bioequivalence of an investigational once-daily extended release formulation of lorcaserin, as compared to the twice-daily immediate release formulation approved by the US Food and Drug Administration (FDA) and marketed as BELVIQ®. If approved, the extended release formulation is expected to be marketed as BELVIQ XR, which is the brand name conditionally approved by the FDA.
"This extended release formulation has the potential to offer once-daily dosing," said Jack Lief, Arena's President and Chief Executive Officer. "We expect the results from these trials will allow us to submit a New Drug Application with the FDA for the treatment of weight management later this year and may also support our efforts to further pursue additional opportunities within our lorcaserin lifecycle management portfolio."
Each of the two randomized, crossover trials evaluated the safety, tolerability, pharmacokinetics and bioavailability of an extended release formulation of lorcaserin in 36 healthy adult subjects. Patients in each trial were divided into two treatment groups and received both doses in a two-way crossover sequence. Patients in the first study were dosed under fasted conditions either 10 mg twice-daily (BID) immediate release or 20 mg once-daily (QD) extended release. Patients in the second study were dosed either 20 mg QD extended release in the fasted state or 20 mg QD extended release in the fed state.
The most common treatment-emergent adverse events were similar to those seen in the Phase 3 clinical trials of BELVIQ, and included mild or moderate headache, constipation, dizziness and nausea. There were no discontinuations for adverse events, and no serious adverse events were observed.
Lorcaserin extended release formulation is investigational and not approved by any regulatory agency.
About BELVIQ® (lorcaserin HCl) CIV
Immediate-release lorcaserin is approved under the brand name BELVIQ for weight management by the FDA and the Ministry of Food and Drug Substances in South Korea. Eisai Inc. and Ildong Pharmaceutical Co., Ltd., market and distribute BELVIQ in the United States and South Korea, respectively, and Arena manufactures and supplies the finished commercial product from its facility in Switzerland.
BELVIQ is a serotonin 2C receptor agonist indicated in the United States as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of 30 kg/m2 or greater (obese), or BMI of 27 kg/m2 or greater (overweight) with at least one weight-related medical condition, such as high blood pressure, high cholesterol, or type 2 diabetes. The safety and efficacy of coadministration of BELVIQ with other products intended for weight loss, including prescription drugs (e.g., phentermine), over-the-counter drugs, and herbal preparations, have not been established. The effect of BELVIQ on cardiovascular morbidity and mortality has not been established.
For more information about BELVIQ, click here for the full US FDA-approved Product Information or visit www.BELVIQ.com.
Important Safety Information
BELVIQ should not be taken during pregnancy or by women who are planning to become pregnant.
Warnings and Precautions
BELVIQ is a serotonergic drug. The development of potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported during use of serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors, and selective serotonin reuptake inhibitors, tricyclic antidepressants, bupropion, triptans, dietary supplements such as St. John's Wort and tryptophan, drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors), dextromethorphan, lithium, tramadol, antipsychotics or other dopamine antagonists, particularly when used in combination. Patients should be monitored for the emergence of serotonin syndrome symptoms or NMS-like reactions, including agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea, and muscle rigidity. Treatment with BELVIQ and any concomitant serotonergic or antidopaminergic agents should be discontinued immediately if the above events occur, and supportive symptomatic treatment should be initiated.
Patients should not take BELVIQ in combination with drugs that have been associated with valvular heart disease (eg, cabergoline). In clinical trials, 2.4% of patients taking BELVIQ and 2.0% of patients taking placebo developed valvular regurgitation: none of these patients were symptomatic. BELVIQ should be used with caution in patients with congestive heart failure (CHF). Patients who develop signs and symptoms of valvular heart disease, including dyspnea, dependent edema, CHF, or a new cardiac murmur, should be evaluated and discontinuation of BELVIQ should be considered.
Impairment in attention, memory, somnolence, confusion, and fatigue have been reported in patients taking BELVIQ. Patients should not drive a car or operate heavy machinery until they know how BELVIQ affects them.
The recommended dose of 10 mg twice daily should not be exceeded, as higher doses may cause euphoria, hallucination, and dissociation. Monitor patients for the development or worsening of depression, suicidal thoughts or behaviors, and/or any changes in mood. Discontinue BELVIQ in patients who develop suicidal thoughts or behaviors.
Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus who are being treated with antidiabetic medications, so measurement of blood sugar levels before and during treatment with BELVIQ is recommended. Decreases in doses of antidiabetic medications or changes in medication regimen should be considered.
Men who experience priapism should immediately discontinue BELVIQ and seek emergency medical attention. BELVIQ should be used with caution with erectile dysfunction medications. BELVIQ should be used with caution in men who have conditions that might predispose them to priapism (eg, sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (eg, angulation, cavernosal fibrosis, or Peyronie's disease).
Because BELVIQ may cause a slow heartbeat, it should be used with caution in patients with a history of bradycardia or heart block greater than first degree.
Consider monitoring for CBC changes, prolactin excess, and pulmonary hypertension.
Most Common Adverse Reactions
In patients without diabetes: headache (17%), dizziness (9%), fatigue (7%), nausea (8%), dry mouth (5%), and constipation (6%).
In patients with diabetes: hypoglycemia (29%), headache (15%), back pain (12%), cough (8%), and fatigue (7%).
BELVIQ should not be taken by women who are nursing.
BELVIQ® is a federally controlled substance that may lead to abuse or dependence.
About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
About Arena Pharmaceuticals
Arena is embracing the challenge of improving health by seeking to bring innovative medicines targeting G protein-coupled receptors to patients. Arena's focus is discovering, developing and commercializing drugs to address unmet medical needs, and BELVIQ® (lorcaserin HCl) is Arena's first internally discovered drug approved for marketing. Arena's US operations are located in San Diego, California, and its operations outside of the United States, including its commercial manufacturing facility, are located in Zofingen, Switzerland. For more information, visit Arena's website at www.arenapharm.com.
Arena Pharmaceuticals® and Arena® are registered service marks of Arena Pharmaceuticals, Inc. BELVIQ® and BELVIQ XR® are registered trademarks of Arena Pharmaceuticals GmbH.
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the therapeutic indication, use, safety, efficacy and potential of BELVIQ and BELVIQ XR, including the potential of BELVIQ XR to offer once-daily dosing; submission of a New Drug Application for BELVIQ XR, including related timing; the potential approval and marketing of the extended release formulation of lorcaserin, including under the brand name BELVIQ XR; the results of the registrational trials of BELVIQ XR, including their significance, demonstrating bioequivalence, allowing the submission of a New Drug Application with the FDA and supporting efforts to pursue additional opportunities; pursuing additional opportunities within the lorcaserin lifecycle management portfolio; the collaborations with Eisai and Ildong and related activities and expectations; embracing the challenge of improving health; seeking to bring innovative medicines to patients; and Arena's focus, plans, goals, strategy, expectations, research and development programs, and ability to discover and develop compounds and commercialize drugs. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Arena's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: we may determine not to submit a regulatory application for BELVIQ XR or the FDA (or any other regulatory agency) may not accept any such application, agree that bioequivalence has been established or ever approve any such application; risks related to commercializing drugs, including regulatory, manufacturing, supply and marketing issues and the availability and use of BELVIQ; cash and revenues generated from BELVIQ, including the impact of competition; the risk that Arena's revenues are based in part on estimates, judgment and accounting policies, and incorrect estimates or disagreement regarding estimates or accounting policies may result in changes to Arena's guidance or previously reported results; the timing and outcome of regulatory review is uncertain, and BELVIQ may not be approved for marketing in combination with another drug, for another indication or using a different formulation or in any other territory for any indication; regulatory decisions in one territory may impact other regulatory decisions and Arena's business prospects; government and commercial reimbursement and pricing decisions; risks related to relying on collaborative arrangements; the timing and receipt of payments and fees, if any, from collaborators; the entry into or modification or termination of collaborative arrangements; unexpected or unfavorable new data; nonclinical and clinical data is voluminous and detailed, and regulatory agencies may interpret or weigh the importance of data differently and reach different conclusions than Arena or others, request additional information, have additional recommendations or change their guidance or requirements before or after approval; data and other information related to any of Arena's research and development may not meet regulatory requirements or otherwise be sufficient for (or Arena or a collaborator may not pursue) further research and development, regulatory review or approval or continued marketing; Arena's and third parties' intellectual property rights; the timing, success and cost of Arena's research and development; results of clinical trials and other studies are subject to different interpretations and may not be predictive of future results; clinical trials and other studies may not proceed at the time or in the manner expected or at all; having adequate funds; and satisfactory resolution of litigation or other disagreements with others. Additional factors that could cause actual results to differ materially from those stated or implied by Arena's forward-looking statements are disclosed in Arena's filings with the Securities and Exchange Commission. These forward-looking statements represent Arena's judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.
Contacts: Eisai Inc.
Contact: Arena Pharmaceuticals, Inc.
Media Contact: Russo Partners