For J&J Prostate Cancer Is PARP For The Course

| About: Johnson & (JNJ)

Johnson & Johnson (NYSE:JNJ) addressed two issues with one relatively small $35m payment: its position in prostate cancer and absence from PARP inhibition. The big pharma group locked up one of just two unpartnered assets in this rejuvenated class and has chosen to focus its work in prostate cancer, where Zytiga might soon run out of market exclusivity.

The project in question is niraparib, and J&J is not hanging around to find out if Tesaro (NASDAQ:TSRO) reports positive Phase III data in ovarian cancer in the coming weeks. It will take some work to catch up with AstraZeneca’s (NYSE:AZN) Lynparza in prostate disease, but with a dosing trial underway that will also measure response and survival, niraparib could be competitive.

Virgin ground

In Phase III, inhibition of poly (ADP-ribose) polymerase has been primarily tested in ovarian cancer – as of 2014, Lynparza is the only approved agent here – and breast cancer, with some trials underway in non-small cell lung, gastric and pancreatic cancers (Therapy focus – PARP inhibitor class set to come of age in 2016, March 1, 2016).

However, an investigator-led, open-label Phase II trial is testing Lynparza in prostate disease, with early data reported at last year’s AACR meeting.

Tesaro has Phase III trials in ovarian and breast cancers, with the former expected to read out in the second quarter of 2016. Either J&J has no interest in these disease areas – its two big oncology products are in haematological and prostate cancer – or Tesaro made a strategic decision to reserve niraparib rights in the most advanced indications.

In any case, what the Massachusetts-based biotech got for its efforts was a deal worth a total of $415m in milestones in addition to the $35m upfront fee, a $50m investment from J&J’s venture fund, and the larger partner funding all development in prostate cancer.

These sums should top up its cash pile as it launches the chemotherapy anti-emetic Varubi and seeks to advance other R&D assets, including the immuno-oncology agent TSR-042. Tesaro ended 2015 with $230m in cash, and raised $155m in a private share placement in March.

J&J will probably be eager to expand the prostate cancer programme beyond the current Phase I dosing trial, in which niraparib is tested in combination with Xtandi.

Fixing a hole

The reason for urgency is that although Zytiga has been on the market just five years, it faces loss of exclusivity as early as next year, depending on whether Mylan (NASDAQ:MYL) can win a challenge to patents that expire in 2027. UK researchers filed the first patents related to Zytiga in 1992.

Zytiga’s sales are forecast to hit $2.3bn this year, according to EvaluatePharma’s consensus, making it J&J’s third-biggest seller after Remicade and Stelara – the former of these has exclusivity issues of its own as the FDA this week approved a biosimilar.

Part of the J&J's prostate cancer puzzle has been solved by JNJ-927/ARN-509, which like Zytiga is a hormone therapy. Given that niraparib is so far being tested with another androgen deprivation agent, Xtandi, J&J might view it as an effective complement to Zytiga or JNJ-927.

J&J’s choice of niraparib leaves Clovis Oncology’s (NASDAQ:CLVS) rucaparib as the only PARP inhibitor not in the hands of a commercial-stage company. With its lead candidate rociletinib likely facing a tough reception at an FDA advisory committee next week, partnering news for rucaparib could be the group’s main positive catalyst for 2016 – and indeed, the only news in PARP inhibition outside of clinical development.