Wow, that was the Pharma headline news this morning, after the excitement of last night's announcement that Medivation are hosting a conference call at 8.30am to announce a partnership deal.
I was expecting a big Pharma oncology company to have bitten, not a Japanese company known for it's cardiology and immunology franchise. Granted they have urology products such as Flomax, but this is a cancer drug for late stage prostate cancer. It will likely compete with Cougar Biotech/J&J's abiraterone, if both make it to the market. Interesting. That shakes up the prostate cancer landscape a little bit.
More details will follow at the 8.30am conference call, so I'll update this post with more information then.
The details of the deal can be found on Medivation's website here.
Basically, $MDVN gets $110m in up front payment, followed by $655m in milestones. The two companies will the share costs and profits in US. I should add a big caveat here – MDV3100 is currently being evaluated in the Phase 3 AFFIRM clinical
trial in men with castration-resistant prostate cancer who were
previously treated with docetaxel-based chemotherapy. The results are as yet unknown.
Medivation announced this morning that they made a competitive decision to choose Astellas as a partner for MDV3100 based on 5 key factors:
1) Global reach in development and commercialisation: Astellas has over $10B in sales globally
2) Expanding use into early stage prostate cancer through urologists: Astellas has a urology franchise (via Flomax)
3) Expand the clinical development program: earlier stage trials after hormone (and possibly before) therapies
4) High priority product: Astellas wants to build an oncology franchise around MDV3100
5) Terms offer compelling value to MDVN and shareholders: ($110M up front, $655M milestone payments, co-development and commercialisation in the US, Astellas exclusivity ex-US with royalty payments to Medivation.
Astellas management declined to provide any details of the proposed clinical development plan, were a little defensive about the market size of the initial indication after failure of docetaxel, which is also treated by medical oncologists not urologists, there were vague mumblings about 'we intend to fast track to the drug market and then develop and expand into earlier opportunities' kind of approach.
Note, it's an oral drug so yes, it would be attractive to urologists but only with data and that will be a long time coming in even the hormone refractory setting. There are no guarantees that MDV3100 in the chemo refractory trial that started accruing in September will work in that late stage setting (we should all remember the ghost of GPC's satraplatin there), although it might be effective in the hormone sensitive- early refractoriness setting before metastases sets in. There are some early preclinical data showing it was superior to bicalutamide (Casodex) based on my preliminary search.
All in all – it's a very big leap of faith and a long term strategic play that is very risky indeed. My suspicion is that Astellas won't want to be outdone by Takeda in the Japanese and Asian markets, so their new strategic focus looks like it will be building an oncology franchise from scratch while possibly leveraging their expertise in urology in the medium term.