Another "multibillion-dollar opportunity" is how Medivation Inc. CEO David Hung framed talazoparib, the company's late-stage PARP inhibitor, in an investor call late Wednesday. During an event RBC Capital Markets analyst Simos Simeonidis subtitled "why our PARP is worth a lot more than $3/share," Hung outlined what's new and compelling about the drug, a potential prize for Sanofi SA (bearer of a $3/share contingent value right alongside its $58 per share bid for Medivation) or other acquisitive parties.
Touting possible "best-in-class" performance due to what he said is a superior ability to trap PARP protein on DNA, Hung suggested the company might even take an earlier-than-expected look at its pivotal trial in BRCA-positive breast cancer, called EMBRACA, by reducing the target number of events required for completion of the study. The trial is currently expected to complete enrollment this year, ahead of a top-line readout that has been expected in the first half of 2017. Though not committing to a timeline for any future reveals, Hung said an earlier readout is "something that we are exploring very seriously."
Seriousness also drove new openness to engaging in dialogue around a potential transaction with Sanofi. Momentum for a potential tie-up took wing Wednesday with the establishment of a confidentiality agreement between the two companies. A data room was set to be opened and management meetings scheduled "in the near term," Sanofi said. The détente even killed a consent solicitation Sanofi had launched seeking to remove and replace Medivation's board.
Pfizer Inc.,of New York, and Celgene Corp., of Summit, N.J., have also expressed interest in acquiring Medivation, according to Reuters.
While Hung refused to take questions about possible transactions on Wednesday's call, the company "definitely got their message across," Simeonidis wrote following the 100-minute tour-de-talazoparib.
The presentation ended with an estimate pegging talazoparib's addressable U.S. and European market at greater than $30 billion across six tumor types. But Simeonidis posed an obvious question asked by fellow Medivation watchers: "With EMBRACA phase III data within a year, if MDVN is as confident as they sound, why would they even consider selling?"
For one, despite Medivation's optimism, not everyone is convinced of talazoparib's rosy future. "While talazoparib's in vitro data are encouraging, we believe more clinical data are necessary to establish safety/efficacy as well as potential differentiation," wrote Cowen and Co. analyst Eric Schmidt. Despite Medivation's assertion that talazoparib's DNA trapping potency will translate into favorable clinical activity, he added, "we find it difficult to extrapolate from the in vitro experience to the clinical setting given potential differences in dosing, PK/PD profiles, off-target effects, and clinical trial designs."
Some analysts also voiced concern about slowing demand trends for the company's sole commercial product, Xtandi (enzalutamide). The drug is approved in the U.S., Europe and Japan for the treatment of metastatic castration-resistant prostate cancer (mCRPC), and Medivation splits U.S. profits 50-50 with Astellas Pharma Inc. It's also entitled to royalties ranging from the low teens to the low twenties as a percentage of ex-U.S. Xtandi net sales. However, a potential U.S label update for Xtandi, based on readouts of the TERRAIN and STRIVE trials, as well as a positive opinion recommending inclusion of data from the head-to-head TERRAIN trial of Xtandi vs. Casodex (bicalutamide, Astrazeneca plc), could change that.
As speculation over a potential Medivation takeover rumbles on, at least one higher bid from Sanofi and perhaps better offers from other suitors seems to still be expected. "If and when a much improved offer comes," Simeonidis concludes, Medivation "will be a lot more realistic than they may appear to be on the surface."