SAN DIEGO, CA and WOODCLIFF LAKE, NJ, November 7, 2013 – Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) and Eisai Inc. announced today the expansion of the BELVIQ® (lorcaserin HCl) marketing and supply agreement between Arena Pharmaceuticals, Inc.’s wholly owned subsidiary, Arena Pharmaceuticals GmbH, and Eisai Inc. along with its parent company Eisai Co., Ltd. The expanded agreement provides Eisai with exclusive commercialization rights for all countries worldwide, except for South Korea, Taiwan, Australia, Israel and New Zealand. This agreement amends and restates the previous agreement that granted Eisai rights to commercialize BELVIQ in most of North and South America. Eisai’s commercialization rights are subject to applicable regulatory approval.
“This new agreement not only expands Eisai’s territory for commercialization, but it also prioritizes our global development program for BELVIQ,” said Jack Lief, Arena’s President and Chief Executive Officer. “Expanding our collaboration with Eisai provides the potential to make BELVIQ available to physicians and patients worldwide for weight management and creates a powerful platform to investigate this novel compound for possible new indications by leveraging our combined drug development and regulatory expertise.”
Lonnel Coats, Eisai Inc.’s President and Chief Executive Officer, added, “Our expanded commitment to BELVIQ reflects the company’s human health care mission to bring new, innovative therapies to patients. Our belief in this product is strengthened by the feedback we have received from patients, physicians and payers since the US launch of BELVIQ. We have a strong foundation on which Eisai and Arena can build a global franchise for BELVIQ.”
Under the terms of the agreement, Arena will receive from Eisai an upfront payment of $60 million and is eligible to receive up to a total of $176.5 million in regulatory and development milestone payments. The total for milestone payments represents an increase of $123 million from the amount remaining available under the previous agreement.
Arena will continue to sell BELVIQ to Eisai for commercialization in the US and in the other territories in North and South America for a purchase price starting at 31.5% and 30.75% of Eisai’s net sales, respectively. With respect to the new territories added under the amended agreement, the purchase price starts at 27.5% of Eisai’s net sales in Europe, China and Japan, and at 30.75% of Eisai’s net sales in all other territories. The purchase price will increase on a tiered basis in the US and the other territories, other than Europe, China and Japan, to as high as 36.5% and 35.75%, respectively, on the portion of Eisai’s annual net sales exceeding $750 million. The purchase price will increase to 35% in Europe, China and Japan on the portion of Eisai’s annual net sales exceeding $500 million.
Arena is also eligible to receive a total of $1.56 billion in one-time purchase price adjustment payments based on sales in the territories covered by the agreement. The total for purchase price adjustment payments represents an increase of $185 million from the amount available under the previous agreement.
In addition to pursuing regulatory approval for weight management in the expanded territory, under the terms of the agreement, Eisai and Arena plan to investigate the potential of BELVIQ in new areas, such as smoking cessation, a once-daily formulation, a fixed-dose combination with phentermine, as well as explore BELVIQ’s impact on diabetes and cardiovascular outcomes.
About BELVIQ® (lorcaserin HCl)
BELVIQ is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. The exact mechanism of action of BELVIQ is not known.
BELVIQ® (lorcaserin HCl) CIV is Approved by the US Food and Drug Administration (FDA)
BELVIQ is indicated in the United States as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of:
- 30 kg/m2 or greater (obese), or
- 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes).
Limitations of Use:
- 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.
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 (e.g., cabergoline). In clinical trials, 2.4% of patients taking BELVIQ and 2.0% of patients taking placebo developed valvular regurgitation: none of these patients was 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 (e.g., sickle cell anemia, multiple myeloma, or leukemia), or in men with anatomical deformation of the penis (e.g., 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.
In addition to granting exclusive marketing and distribution rights to Eisai for most territories worldwide, Arena has granted rights for BELVIQ to Ildong Pharmaceutical Co., Ltd., for South Korea, and to CY Biotech Company Limited for Taiwan. Arena plans to enter into additional collaborations to commercialize BELVIQ outside of these territories.
About Arena Pharmaceuticals
Arena is a biopharmaceutical company focused on discovering, developing and commercializing novel drugs that target G protein-coupled receptors, or GPCRs, to address unmet medical needs. BELVIQ® (lorcaserin HCl), Arena’s internally discovered drug, is approved in the United States, and is under review for regulatory approval in additional territories. 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® is a registered trademark of Arena Pharmaceuticals GmbH.
About Eisai Inc.
At Eisai Inc., human health care is the goal. Eisai gives its first thoughts to patients and their families, and helping to increase the benefits health care provides. As the US pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., Eisai’s passionate commitment to patient care is the driving force behind its efforts to help address unmet medical needs. Eisai is a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Eisai’s 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 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.
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 advancement, therapeutic indication and use, safety, efficacy, mechanism of action, regulatory review and approval, and potential of BELVIQ or lorcaserin; the expanded agreement with Eisai, the significance of such agreement and related expectations and plans, including payments, leveraging of expertise, product development (including potential indications and formulations), registration and commercialization; prioritization of the BELVIQ global development program; the building of a global franchise for BELVIQ and potential to make BELVIQ available worldwide; Eisai’s commitment; plans to enter into additional collaborations and the commercialization of BELVIQ in additional territories; 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: risks related to the implementation and continuation of the Second Amended Agreement and dependence on collaborators; the timing and receipt of payments and fees, if any, from collaborators; risks related to commercializing drugs, including regulatory, manufacturing and supply issues and the availability and use of BELVIQ; cash and revenues generated from BELVIQ, including the impact of competition; Arena’s revenues will be 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 when expected or ever 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; 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 further research and development, regulatory review or approval or continued marketing; Arena’s ability to obtain and defend patents; 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.|
|Alex Scott||Lynn Kenney|
|Contact: Arena Pharmaceuticals, Inc.|
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|Cindy McGee, Vice President||David Schull, President|
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Type Press Release
Date Released November 07, 2013