UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 21, 2015
MEDIVATION, INC.
(Exact
name of registrant as specified in its charter)
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Delaware |
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001-32836 |
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13-3863260 |
(State or other jurisdiction
of incorporation) |
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(Commission
File No.) |
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(IRS Employer
Identification No.) |
525 Market Street, 36th Floor
San Francisco, California 94105
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (415) 543-3470
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 1.01 |
Entry into a Material Definitive Agreement. |
On August 21, 2015, Medivation, Inc.
(Medivation) entered into an Asset Purchase Agreement (the Agreement) with BioMarin Pharmaceutical Inc. (BioMarin), under which Medivation will acquire from BioMarin all rights to talazoparib (formerly referred to
as BMN 673), an orally-available poly ADP-ribose polymerase (PARP) inhibitor, and related assets including all patents, data, know-how, third party agreements, regulatory materials, and inventories.
Under the terms of the Agreement, Medivation will pay BioMarin $410 million upfront, up to an additional $160 million upon the achievement of
regulatory and sales-based milestones, and mid-single digit royalties on net sales of products that contain talazoparib during the royalty term specified in the Agreement. Medivation will also assume certain liabilities related to the acquired
assets to the extent they arise after the closing, including liabilities for the ongoing clinical trials of talazoparib, liabilities under certain agreements previously entered into by BioMarin and assigned to Medivation in the transaction, and
certain of BioMarins obligations pursuant to its Stock Purchase Agreement with LEAD Therapeutics, Inc., dated February 4, 2010, as amended, the agreement under which BioMarin initially acquired BMN 673.
Furthermore, for a certain period of time after the closing of the transaction contemplated by the Agreement, neither BioMarin nor any of its
affiliates will engage in or assist a third party in the clinical development or commercialization of any PARP inhibitor except in certain specified circumstances. The consummation of the transaction is subject to the satisfaction of customary
closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. The Agreement contains customary representations and warranties, covenants,
indemnification, termination and other provisions customary for transactions of this nature.
In connection with the transaction, the
parties will also enter into a Transition Services Agreement at the closing to facilitate the transition of the research and development activities relating to talazoparib from BioMarin to Medivation, including responsibility for the ongoing
clinical studies.
The foregoing is only a brief description of the material terms of the Agreement, does not purport to be a complete
description of the Agreement or the transaction contemplated thereby and is qualified in its entirety by reference to the Agreement, a copy of which will be filed as an exhibit to Medivations quarterly report on Form 10-Q for the quarter
ending September 30, 2015. Medivation intends to seek confidential treatment for certain portions of the Agreement pursuant to a confidential treatment request that it intends to submit to the Securities and Exchange Commission pursuant to Rule
24b-2 under the Securities Exchange Act of 1934, as amended (the Exchange Act).
Item 7.01 |
Regulation FD Disclosure. |
On August 24, 2015, Medivation and BioMarin issued a
joint press release announcing the entry into the Agreement. A copy of the joint press release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.
The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed filed for purposes of
Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall such information be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933,
as amended, or the Exchange Act, except as otherwise stated in such filing.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits.
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99.1 |
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Press release, dated August 24, 2015, entitled Medivation to Expand Global Oncology Franchise with the Acquisition of All Worldwide Rights to Talazoparib (BMN 673), a potent PARP inhibitor, from BioMarin |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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MEDIVATION, INC. |
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Dated: August 23, 2015 |
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By: |
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/s/ Richard A. Bierly |
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Richard A. Bierly |
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Chief Financial Officer (Principal Financial
and Accounting Officer) |
EXHIBIT INDEX
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99.1 |
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Press release, dated August 24, 2015, entitled Medivation to Expand Global Oncology Franchise with the Acquisition of All Worldwide Rights to Talazoparib (BMN 673), a potent PARP inhibitor, from BioMarin |
Exhibit 99.1
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Medivation Contact |
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BioMarin Pharmaceutical Contacts |
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Anne Bowdidge |
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Investors: |
(650) 218-6900 |
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Traci McCarty |
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(415) 455-7558 |
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Media: |
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Debra Charlesworth |
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(415) 455-7451 |
Medivation to Expand Global Oncology Franchise with the Acquisition of All Worldwide Rights to Talazoparib
(BMN 673), a potent PARP inhibitor, from BioMarin
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Talazoparib is a Highly-Potent PARP Inhibitor in Phase 3 Development for the Treatment of BRCA-Mutated Breast Cancer |
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Clinical Activity Observed in Multiple Oncology Opportunities with Potential for monotherapy or Combination therapy with Standard of Care Oncology Treatments |
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Transaction Price of $410 Million Upfront, Up to $160 Million in Milestones and Mid-Single Digit Royalties |
San Francisco and San Rafael, Calif., Aug 24, 2015 Medivation, Inc. (Nasdaq: MDVN) and BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that
they have entered into an asset purchase agreement under which Medivation will acquire all worldwide rights to talazoparib (formerly referred to as BMN 673), a highly-potent, orally-available poly ADP ribose polymerase (PARP) inhibitor currently in
a Phase 3 study for the treatment of patients with deleterious germline BRCA 1 or BRCA 2 mutations and locally advanced and/or metastatic breast cancer. Under the agreement, Medivation will be responsible for all research, development, regulatory
and commercialization activities for all indications on a global basis.
Acquiring all worldwide rights to talazoparib provides Medivation with a
transformational opportunity to diversify and expand our proprietary portfolio and global oncology franchise. PARP inhibitors are an exciting class of oncology therapeutics that have been associated with promising activity across multiple tumor
types, including breast and prostate cancer. These latter two disease indications are areas in which Medivation has proven expertise and development capabilities and in the case of prostate cancer, an established and successful commercial
presence, said David Hung, M.D., President and Chief Executive Officer of Medivation. Talazoparibs potential to act alone or augment the effects of a wide array of tumor DNA-damaging oncology therapies and its high potency and
level of activity in various cancers make talazoparib a great strategic fit for Medivations oncology portfolio, building on existing strengths as well as potentially allowing Medivation to expand into new oncology indications.
We believe that Medivation is an outstanding company to drive the future development of talazoparib and ensure it reaches its full therapeutic
potential, said Hank Fuchs, M.D., Chief Medical Officer at BioMarin. Medivations expertise and track record in oncology clinical development and commercialization has been well demonstrated by the Companys success to date.
Placing talazoparib in their capable hands allows us to optimize our portfolio and focus our resources on established areas of expertise developing novel products to treat rare and ultra-rare genetic diseases.
Under the terms of the agreement, Medivation will pay BioMarin $410 million upfront, up to an additional $160
million upon the achievement of regulatory and sales-based milestones and mid-single digit royalties for talazoparib. At the closing of the transaction, Medivation will assume all financial obligations associated with the development and
commercialization of talazoparib.
The closing of the transaction is conditioned on the expiration or termination of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act. The transaction is anticipated to close in 2015.
About Talazoparib
Talazoparib is a highly-potent, orally available PARP inhibitor, a class of molecules that has shown clinical activity against cancers involving defects in DNA
repair, under investigation for the treatment of certain cancers.
Talazoparib is currently in the Phase 3 EMBRACA trial in patients with germline BRCA
mutated breast cancer. The pivotal study is a two-arm study randomizing patients with germline BRCA mutated locally advanced and/or metastatic breast cancer 2:1 to talazoparib or the protocol-specified physicians choice of chemotherapy.
Patients may have received no more than two prior chemotherapy regimens for metastatic disease. The primary objective of the study is to compare progression-free survival of patients treated with monotherapy talazoparib relative to those
treated with protocol-specified physicians choice single-agent chemotherapy. Radiographic progression will be determined by blinded independent central radiology review. Talazoparib is also being studied in a single arm Phase 2 ABRAZO trial
evaluating overall response rates in patients with germline BRCA mutated breast cancer, and in multiple investigator-sponsored trials across multiple tumor types.
About Medivation
Medivation, Inc. is a biopharmaceutical
company focused on the development and commercialization of medically innovative therapies to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to
critically ill patients and their families. For more information, please visit us at http://www.medivation.com
About BioMarin
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The companys product portfolio comprises
five approved products and multiple clinical and pre-clinical product candidates. Approved products include Vimizim® (elosulfase alfa) for MPS IVA, a product wholly developed and
commercialized by BioMarin; Naglazyme® (galsulfase) for MPS VI, a product wholly developed and commercialized by BioMarin; Aldurazyme®
(laronidase) for MPS I, a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; Kuvan® (sapropterin dihydrochloride) Powder for Oral Solution and Tablets,
for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany and Firdapse® (amifampridine), which has been approved by the European
Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS). Product candidates include drisapersen, an exon skipping oligonucleotide, for which a marketing application has been submitted to FDA and EMA for the treatment of patients
with Duchenne muscular dystrophy (DMD) with mutations in the dystrophin gene that are amenable to treatment with exon 51 skipping, pegvaliase (formerly referred to as BMN 165 or PEG PAL), PEGylated recombinant phenylalanine ammonia lyase, which is
currently in Phase 3 clinical development for the treatment of PKU, reveglucosidase alfa (formerly referred to as BMN 701), a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase 3
clinical development for the treatment of Pompe disease, vosoritide (formerly referred to as BMN 111), a modified C-natriuretic peptide, which is currently in Phase 2 clinical development for the treatment of achondroplasia, BMN 044, BMN 045 and BMN
053, exon skipping oligonucleotides, which are currently in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (exons 44, 45 and 53), cerliponase alfa (formerly referred to as BMN 190), a recombinant human tripeptidyl
peptidase-1 (rhTPP1) for the treatment of CLN2 disease, a form of Batten disease, which is currently in Phase 1, BMN 270, an AAV-factor VIII vector, for the treatment
of hemophilia A and BMN 250, a novel fusion of alpha-N-acetyglucosaminidase (NAGLU) with a peptide derived from insulin-like growth factor 2 (IGF2), for the treatment of MPS IIIB. For more
information, please visit us at http://www.BMRN.com
Forward-Looking Statement Disclaimer
The forward looking statements in this press release are based on information currently known to Medivation and BioMarin, and are subject to risks and
uncertainties. Actual results may differ substantially for a number of reasons, including, but not limited to: failure to satisfy the conditions to complete the acquisition; risk that Medivation will not be able to advance the talazoparib research
program; risk that Medivation will not be able to reproduce the results of earlier studies in the on-going studies or in later studies; other challenges inherent in product development, including ability to obtain regulatory approvals, competition
and challenges to intellectual property; and other risks detailed in Medivations and BioMarins filings with the Securities and Exchange Commission, or SEC, including their respective quarterly reports on Form 10-Q for the quarter ended
June 30, 2015. Neither BioMarin nor Medivation undertake any obligation to update these forward-looking statements other than as required by law.
Legal advisors were Sidley Austin LLP (Medivation) and Cooley LLP (BioMarin).
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