Medivation's Board of Directors Unanimously Rejects Sanofi's Unsolicited Proposal - Seite 2
- Talazoparib represents another blockbuster opportunity as a potentially best-in-class PARP inhibitor targeting a wide range of oncology indications.
- Top-line data from the Phase 3 EMBRACA trial in germline BRCA mutated advanced breast cancer is expected in the first half of 2017.
- Recent data reported at AACR demonstrate talazoparib's potential in tumors with defects in DNA repair beyond BRCA deficiency and possibly in patients without evidence of homologous recombination deficiency when used in combination with low dose chemotherapy.
- The company is preparing to initiate several clinical trials in 2016, including in breast cancer beyond germline BRCA mutations, prostate cancer, ovarian cancer and small cell lung cancer, including potentially registrational trials.
- Medivation recently met with the FDA to discuss clinical trial design and a potential accelerated approval pathway in prostate cancer.
- Talazoparib is highly synergistic with our existing development and commercial infrastructure.
- Additional clinical data demonstrating talazoparib's potent activity is expected to be presented at a medical meeting later in the year.
- Pidilizumab has the potential to be a novel immuno-oncology candidate supported by clinical efficacy and a strong safety profile in several hematological malignancies.
The execution of Medivation's business plan will deliver value to its stockholders that is far superior to Sanofi's proposal.
- Medivation has an exceptional track record for execution.
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- XTANDI has achieved all development and sales milestones under Medivation's collaboration with Astellas.
- Medivation's track record for delivering value to our stockholders is exemplified by XTANDI, which was in-licensed as a pre-clinical asset in 2005, received full FDA approval in seven years (better than industry average), and achieved $2.2 billion in worldwide annual net sales on a run rate basis in less than four years.
- The company has generated a 1,440%+ total shareholder return for its stockholders since 2009.
- Medivation has already achieved two years of profitability, despite only launching XTANDI in late 2012, and the company has pursued minimal, dilutive capital raises.
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Sanofi's timing is designed to benefit Sanofi - not Medivation's stockholders.
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