We are a biopharmaceutical company focused on the development and commercialization of medically innovative therapies to treat serious diseases for which there are limited treatment options. We have one commercial product, XTANDI® (enzalutamide) capsules, or XTANDI, through our collaboration with Astellas Pharma Inc., or Astellas. XTANDI has received marketing approval in the United States, Europe and numerous other countries worldwide for the treatment of patients with metastatic castration-resistant prostate cancer, or mCRPC, and in Japan for the treatment of patients with castration-resistant prostate cancer, or CRPC. We and Astellas are also conducting investigational studies of enzalutamide in prostate cancer, advanced breast cancer, and hepatocellular carcinoma. Under our collaboration agreement with Astellas, we share equally with Astellas all profits (losses) related to U.S. net sales of XTANDI. We also receive royalties ranging from the low teens to the low twenties as a percentage of ex-U.S. XTANDI net sales. The collaboration also involved certain milestone payments from Astellas to us upon the achievement of defined development, regulatory and sales events, all of which have been achieved as of December 31, 2015. We seek to become a more fully-integrated biopharmaceutical company through the continued commercialization of XTANDI, the acquisition or in-license and development and commercialization of other product opportunities, and through the advancement of our own proprietary research and development programs. We expect that our future growth may come from both internal research efforts and third-party business development activities. In the fourth quarter of 2015, we acquired all worldwide rights to talazoparib (which we refer to as MDV3800), an orally available poly-ADP ribose polymerase, or PARP, inhibitor, from BioMarin Pharmaceutical Inc., or BioMarin. MDV3800 is currently in a Phase 3 clinical trial for the treatment of patients with germline BRCA, or gBRCA, mutated advanced breast cancer (i.e., advanced breast cancer in patients whose BRCA genes contain germline mutations). We are targeting a number of other indications in which to investigate MDV3800 including breast cancer (beyond gBRCA mutations), prostate cancer, small cell lung cancer, and ovarian cancer. In the fourth quarter of 2014, we licensed exclusive worldwide rights to pidilizumab (which we refer to as MDV9300), an antibody with immune-mediated anti-tumor effects for all potential indications from CureTech Ltd., or CureTech. Under the license agreement, we are responsible for all development, regulatory, manufacturing, and commercialization activities for MDV9300. We initiated a Phase 2 clinical trial evaluating MDV9300 in patients with relapsed or refractory diffuse large B-cell lymphoma in the fourth quarter of 2015, which is on partial clinical hold pending our revision of certain investigator brochure, protocols and informed consent documents. We submitted the revised documents to the FDA in early February 2016 and the FDA has 30 days thereafter to notify us if the partial hold is lifted. We also plan to develop MDV9300 in other hematologic malignancies such as multiple myeloma.
Company profile
Employees
Incorporated
Location
Fiscal year end
Industry (SIC)
Former names
Orion Acquisition Corp Ii
SEC CIK
Corporate docs
IRS number
133863260
Latest filings (excl ownership)
15-12B
Securities registration termination
11 Oct 16
25-NSE
Exchange delisting
28 Sep 16
8-K
Termination of a Material Definitive Agreement
28 Sep 16
S-8 POS
Registration of securities for employees (post-effective amendment)
28 Sep 16
S-8 POS
Registration of securities for employees (post-effective amendment)
28 Sep 16
S-8 POS
Registration of securities for employees (post-effective amendment)
28 Sep 16
S-8 POS
Registration of securities for employees (post-effective amendment)
28 Sep 16
S-8 POS
Registration of securities for employees (post-effective amendment)
28 Sep 16
S-8 POS
Registration of securities for employees (post-effective amendment)
28 Sep 16
S-8 POS
Registration of securities for employees (post-effective amendment)
28 Sep 16
Latest ownership filings