Partnering Strategy:
 
PharmaMar’s business strategy for its pipeline compounds is to find co-development partners who can successfully contribute to a joint development effort between Europe, the US, and Japan. In this arrangement, PharmaMar will retain commercialization rights for Europe while granting licenses for all territories outside of Europe. This strategy is reflected in our partnership with Centocor Ortho Biotech (Johnson & Johnson) on our lead product, Yondelis^®, for which Centocor Ortho Biotech holds commercialization rights for all territories outside of Europe and Japan. In March 2009, PharmaMar entered into a partnership with Taiho Pharmaceutical granting Taiho the Japanese rights on Yondelis^®.

 

Compounds that show activity in therapeutic areas other than oncology are generally out-licensed on a worldwide basis, as exemplified by agreements reached with Marinomed Biotechnologie GmbH (Vienna, Austria) in March 2009 concerning analogs of Kahalalide F, and in June 2009 with Medimetriks Pharmaceuticals, Inc. (Fairfield, NJ), who will develop Kahalalide F for dermatological disorders.
 
Out-licensing:
 
PharmaMar is currently open to discussions on co-development and commercialization partnerships for the following pipeline compounds:
 
Aplidin^® (plitidepsin): After receiving favorable phase II results against multiple myeloma and peripheral T-cell lymphoma, PharmaMar is now seeking a co-development partner with a US-focus to join us in conducting pivotal trials in these indications. In addition, a phase II trial in myelofibrosis is to be initiated shortly, based on preclinical evidence of Aplidin’s marked activity in this setting.
 
Irvalec^® (PM02734): This novel cyclic depsipeptide from the Kahalalide family demonstrates compelling in vitro and in vivo synergism with EGFR-targeting agents. Phase I program results show, Irvalec^® has a promising safety profile and preliminary evidence of efficacy as monotherapy, exemplified by one ongoing complete response in metastatic esophageal carcinoma after 40+ cycles and a number of patients with SD for more than 3 months. A phase I/II trial in combination with erlotinib (Tarceva^®) and a phase II trial in non-small cell lung cancer (NSCLC) as monotherapy are in progress. A phase II trial in esophageal and gastric cancer is to start in due course.

 

Zalypsis^® (PM00104): This compound, originally isolated from Jorunna funebris (the polka-dot nudibranch), is a novel, synthetic, minor-groove DNA binding compound with cytotoxic activity in the single-digit nanomolar range. In a number of in vivo models it shows activity both as monotherapy as well as in combination with established cytotoxic and novel-targeted agents. The results of the phase I program suggest a safe profile with preliminary evidence of clinical activity. A phase I study in combination with carboplatin as well as phase II studies in endometrial and cervical cancer will be initiated shortly. A phase I/II study in multiple myeloma is in preparation.

 

Anti-HIV compounds: Certain compounds identified in PharmaMar’s discovery program have shown anti-HIV activity and display the following features in vitro:

PharmaMar seeks a licensing partner to take on this project at an early preclinical stage, ultimately to develop and commercialize these compounds either alone or through a sublicense.
 
Research & Discovery:
 
PharmaMar has established an extensive worldwide collaborative network including more than 60 centres of marine biology, chemistry, and cancer biology research. We continue seeking to establish collaborations with local governments and institutions for the exploration of local biodiversity and establishing joint drug discovery programs for novel marine-derived anticancer compounds.
 
Contact:
 
For any enquiries regarding in- or out-licensing opportunities, please contact our Business Development & Licensing Department at: bdl@pharmamar.com or call +34 918 234 518 (Jörg Landwehr, Director, Business Development & Licensing).