Getting hit in AH - Medicare Review of its coverage - down 18% in AH trading
I wish I had something to say about OGXI. Not much. All things considered, holding up in view of general market, low risk tolerance, and quiet time for the company. Not to mention rebalancing after last week and removal from Russell 3000.
Hope something gives the company some traction until phase III gets market interested.
Roche's Avastin takes a hit at FDA panel. Advisers vote 12-1 to recommend FDA revoke approval of the drug for breast cancer.
It's a good step to saving healthcare cost by removing those costly drugs that don't work.
Here is the example I cited: Avastin for MBC, no survival benefit, cost as much as Provenge. Reason no one objected as much as Provenge for HRPC is Avastin is used with chemotherapy while Provenge is used alone. This is the beneath the surface battle between chemo vs biologic.
Both INCY and AMAG deals took a long time. And incidentally, both deals were signed after the companies agreed with EMEA regarding pivotal trial design. Provenge will need new trial to get approved at EU most likely.
Thanks jq, you're probably right, though I remain a little skeptical about how competitive big pharmas are. DNDN has been looking for an EU partner for over a year now, ever since Provenge met its P3 endpoint, and they even hired Goldman Sachs to help in their search, yet they've come up empty. Maybe it has less to do with the behemoths insisting on getting a cut of the US market than with their doubts that Provenge can get EU regulatory approvals. Since DNDN now says it will work with the EU regulators on its own, if it succeeds in winning them over I guess we'll find out if that also lands it a partner.
Yes, both INCY and AMAG drugs are projected billion dollar drugs. This has become more and more common now. The reason is very simple, big pharma are desparate for new blockbuster drugs. There are so few high quality drug candidates out there. If you have a high quality drug that has huge potential, you hold the card, not the big pharma. If one doesn't give you the term you want, someone else will step in.
The other reason, to less degree, is big pharma more and more looking beyond US market now than they used to.
Some DNDN analyst are going into hyper pump. One just PR'ed that cost/benefit is not something investors should worry about.
Looks like OGXI will do fine if they have to compete with the latest $75,000 a year treatments.
I think CMS/Medicare's decision to review whether and to what extent
it will reimburse for Provenge, and to take a year doing it, is probably depressing the whole oncology sector somewhat. In the end I'm sure they will reimburse; at worst DNDN may feel it needs to reduce the price of Provenge and/or Medicare will refuse to cover off-label use. If the latter happens, it would actually benefit OGXI since Provenge's label is for asymptomatic prostate cancer, i.e. cancer which isn't yet causing bone pain and doesn't require chemo. So there would be no overlap with the intended use of OGX-O11 (although the P2 trial of OGX-427 seems intended for the same population as Provenge).
There has also been concern that Don Berwick, the guy Obama just appointed to head CMS, has expressed admiration for the British National Health Service's practice of weighing the price of a drug against its benefit. But I'm convinced there's no way Obama will let Medicare follow in the footsteps of the NHS, which has refused to cover Nexavar, for example, because it costs too much for a drug that extends life for only a few months. For one thing, Obama received a ton of money from big pharma in his campaign, and they make most of their money in the U.S., which is the only major market where the government doesn't negotiate drug prices so prices are higher here than anywhere else. Early on in the U.S. healthcare debate, Obama cut a deal with big pharma whereby he agreed that any healthcare reform would not provide for the government to negotiate drug prices. Second, virtually no cancer drugs extend life by more than a few months, so if the NHS approach were carried to its extreme -- which even the NHS doesn't do -- the government wouldn't reimburse for any cancer drugs.
I think DNDN blundered by refusing to include U.S. rights when it was trying to partner ex-U.S. rights with a big pharma. No big pharma would want to set a precedent that a small biotech could keep the lucrative U.S. market to itself. The consequence of DNDN's strategy has been that it hasn't found an ex-U.S. partner and doesn't have a pharmaceutical giant in its corner in its dealings with CMS. There have even been rumors that a big pharma may have initiated the request that CMS do a review of Provenge.
Fortunately OGXI has Teva, which while not quite a big pharma is close enough, since it has plenty of clout in Washington. If the OGX-011 trials succeed, I don't think there will be any problem getting reimbursement. (Of course, OGX-011 is also a lot cheaper than Provenge, though it does require medical personnel to administer more doses than for chemo alone.)