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ARNA > SEC Filings for ARNA > Form 8-K on 21-Jul-2014All Recent SEC Filings

Show all filings for ARENA PHARMACEUTICALS INC

Form 8-K for ARENA PHARMACEUTICALS INC


21-Jul-2014

Other Events


Item 8.01 Other Events.

On July 21, 2014, we announced that our wholly owned subsidiary, Arena Pharmaceuticals GmbH, has entered into an exclusive marketing and supply agreement for BELVIQ® (lorcaserin HCl) with Teva Pharmaceutical Industries Ltd.'s local Israeli subsidiary, Abic Marketing Limited. Under the agreement, we granted Abic the rights to market and distribute BELVIQ in Israel for weight loss or weight management in obese and overweight patients, subject to regulatory approval by the State of Israel Ministry of Health.

Abic is responsible for regulatory approval and, ultimately, marketing and distribution of BELVIQ in Israel, including related costs and expenses. We will manufacture finished drug product at our facility in Switzerland, which we will sell to Abic at a purchase price equal to a percentage of Abic's annual net sales of BELVIQ. In addition, we will receive an upfront payment, and are eligible to receive milestone payments upon regulatory submission and regulatory approval of BELVIQ as well as one-time purchase price adjustment payments based on Abic's annual net sales.

Forward-Looking Statements

Certain statements in this Form 8-K are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the advancement, therapeutic indication, use, safety, efficacy, and potential of BELVIQ or lorcaserin; rights and obligations under the marketing and supply agreement with Abic and the significance of such agreement; and expectations and future activities related to such agreement, including the regulatory submission, review and approval of BELVIQ, manufacture and sale of finished drug product, upfront, milestone and other payments, and commercialization of BELVIQ in Israel. For such statements, we claim the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from our expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the following: dependence on collaborators, including risks related to the implementation and continuation of the marketing and supply agreement with Abic; 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; our 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 our 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 our 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 us 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 our research and development may not meet regulatory requirements or otherwise be sufficient for (or we or a collaborator may not pursue)


further research and development, regulatory review or approval or continued marketing; our ability to obtain and defend patents; the timing, success and cost of our 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 our forward-looking statements are disclosed in our filings with the Securities and Exchange Commission. These forward-looking statements represent our judgment as of the time of the filing of this Form 8-K. We disclaim any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

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