PharmaMar and Chugai Agree to Terms for Early Termination of the License Agreement for Zepsyre® in Japan

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Jun 26, 2018, 01:13 ET

MADRID, June 26, 2018 /PRNewswire/ --

PharmaMar regains all its rights for Zepsyre^® in Japan with immediate effect and receives a payment of €3,000,000 from Chugai
PharmaMar progresses in the clinical development of Zepsyre^® in Japan while its ATLANTIS global registration trial in small-cell lung cancer continues
ATLANTIS trial has successfully passed two safety analyses by the IDMC after inclusion of 150 and 500 patients, respectively

On April 27^th, 2018 PharmaMar (MCE: PHM) reported to National Securities Market Commission that Chugai Pharmaceutical Co., Ltd. had exercised its right to terminate without cause the License, Development and Commercialization Agreement for Zepsyre^® in Japan entered on December 22^nd, 2016^[i], with an effective date of termination in April 2019. Today, PharmaMar announces that both Chugai and PharmaMar have entered into a mutual early termination agreement of this license agreement under which the termination of the license agreement is effective as of today and neither company shall have any further obligation to the other party thereafter. Consequently, under the terms of this early termination agreement, PharmaMar regains all its rights for Zepsyre^® in Japan with immediate effect and will receive a payment of €3,000,000 from Chugai in consideration for the early termination of the license agreement.

(Logo: http://mma.prnewswire.com/media/624563/PharmaMar_Logo.jpg )

PharmaMar continues with the clinical development of Zepsyre^® in Japan, while its global registration trial in small-cell lung cancer (ATLANTIS; n=600) is about to finalize recruitment in July 2018. This pivotal, randomized, Phase III trial assesses the efficacy of Zepsyre^® in combination with doxorubicin compared with the standard treatment for this indication.

ATLANTIS trial has successfully passed two safety analyses by the Independent Data Monitoring Committee (IDMC) after the inclusion of 150 and 500 patients. Results for the primary endpoint of overall survival are expected by the second half of 2019.

PharmaMar has begun discussions with new potential licensees for Japan during the recent annual meeting of ASCO (American Society of Clinical Oncology) in June, where the company has presented encouraging clinical data on the use of Zepsyre^® in small- cell lung cancer as a single agent, including an overall survival benefit of 11.8 months.

According to Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit, "we thank Chugai for the great relationship in the past. The mutual termination now offers PharmaMar the opportunity to engage in a new partnership for Japan, while Chugai can focus on its own pipeline."

About Zepsyre^®

Zepsyre^® (lurbinectedin, PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.

About small-cell lung cancer

SCLC is a very aggressive cancer that usually presents with distant metastases and has already spread at the time of diagnosis, thus limiting the role of traditional approaches and posing a worse prognosis compared to other lung cancer types. The 5-year survival rate is about 5%^[ii]. About 18% of all the lung cancer cases diagnosed are SCLC, and only in the US more than 34,000 new cases are recorded every year. This tumor is strongly associated with tobacco smoking, posing an important public health problem^[iii]. After failure to treatment with a platinum-based therapy in first line, the therapeutic alternatives are very limited, and the approval of the last drug for this disease took place 20 years ago.

About PharmaMar

Headquartered in Madrid, PharmaMar is a world-leading biopharmaceutical company in the discovery and development of innovative marine-derived anticancer drugs. The company has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar develops and commercializes YONDELIS^® in Europe and has other clinical-stage programs under development for several types of solid and hematological cancers, Zepsyre® (lurbinectedin, PM1183), plitidepsin, PM184 and PM14. PharmaMar is a global biopharmaceutical company with subsidiaries in Germany, Italy, France, Switzerland, United Kingdom, Belgium, Austria and the United States. PharmaMar fully owns other companies: GENOMICA, a leading molecular diagnostics company; Sylentis, dedicated to researching therapeutic applications of gene silencing (RNAi); and two other chemical enterprises, Zelnova Zeltia and Xylazel. To learn more about PharmaMar, please visit us http://www.pharmamar.com.

Disclaimer

This document is a press release, not a prospectus. This document does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the company. Moreover, no reliance should be placed upon this document for any investment decision or contract and it does not constitute a recommendation of any type with regard to the shares of the company.

i. https://www.pharmamar.com/wp-content/uploads/2018/04/HR-English-27.04.2018.pdf

ii. http://www.cancer.gov/types/lung/hp/small-cell-lung-treatment-pdq

iii. http://www.jnccn.org/content/11/1/78.full.pdf

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