Wow, that's profound. The Q3 &Q4 catalysts haven't even started to materialize. You're short and getting a spanking. Ouch. Just today.....ouch!
Here we go again. Like I said...."It's all about the money". Hernando (aka..the smartest guy in the room) swears Avastin won't be pursued by Roche for ophthalmic applications. Maybe countries will just bypass the rig'em roll and approve the use independently , without Roche
having too much to say about it. I've said it all along, whether Roche wants Avastin to be used, it's going to get used in ophthalmology.......to save money by payers.:
In June, the Italian government said it would pay for Roche's ($RHBBY) cancer drug Avastin to be used to treat a blinding eye disease, in place of the company's far more expensive eye drug Lucentis. Now, France is following Italy's lead.
The French legislature has introduced an amendment to its social security budget bill that would green-light the use of Avastin in age-related macular degeneration (AMD), even though the drug is not approved for that use. Lawmakers will vote on the measure next week. The move would affect both Roche and its Lucentis marketing partner in Europe, Novartis ($NVS).
And it's backed up by some compelling economic arguments. Gerard Bapt, one of France's socialist legislators, estimates that Avastin is 30 times less expensive than Lucentis in that country. A positive vote on the measure could save France at least #$%$200 million ($273 million) a year, Bapt estimates, according to Reuters.
Nobody's dumping anything. This sale your referring too was planned long ago. I checked in with Beverly at IR, she confirmed small sales of these had to be planned long ago. Insiders are always at risk of being accused of trading on insider info; not the case here. Check it out for yourself through Beverly.
Tide, I believe it does tip the scales in favor of approval. I actually think Hernando was right in his statement regarding how the FDA wanted the anti-vegfs approved first for the DME indication. Now Allergan has a DME approval in its Dexamethasone drug for a 4-6 month delivery. Doesn't 3 years sound better? So, Iluvien will be approved this September with labeling discussions already initiated with the FDA. It sure does seem the EU is much more flexible with regulatory issues. The FDA is archaic and Iluvien is the poster child of their flip flopping.
Spre, Noticed the volume at the end of the day and after hours. We'll see in the coming days if they were insiders. They have to show a form 4 if they did. Figures that the FDA would be the last to move on Iluvien.
Yeah maybe, but I like to read his creative comments. With ELON in the toilet and no sign of a contract anywhere, one is able to laugh a bit instead of crying over the lack of company direction.
Kool. I'm still hoping that PSDV starts to show data on their sustained release implant with PFE. We've all been waiting for years. Until then, AERI looks like their eye drop is going to be a big improvement over latanoprost . Still have PIII trial pending. Good stuff.
Just following up on the drop idea. Paul Ashton said "drops don't get to the back of the eye".....seems he was right again.
New out this morning.
June 24 (Reuters) - Ohr Pharmaceutical Inc said its experimental eye drop did not show any significant benefit over a placebo in reducing the number of injections of another drug directly into the eye.
Ohr's drug, Squalamine, was being tested in a mid-stage trial in patients with age-related macular degeneration, the leading cause of blindness among the elderly.
An interim analysis of trial data showed patients getting Squalamine needed an average of 6.2 eye injections, while those on placebo needed 6.4.
The main goal of the trial was to reduce the number of required injections.
My whole point is one that you constantly seem to miss, there is mounting pressure on big pharma due to costs. Payers are trying to find ways to save money and Lucentis is the poster child. If off label Avastin is available for ophthalmology, off label, then compounding pharmacies are going to see increased activity. Either way, PSDV will have a future, and a big one. You fail to understand, payers are going to ultimately demand a less expensive version of a drug if it has similar efficacy; FDA approved or not. I do agree that Iluvien fits nicely into this niche for CDME. However, the powers that be love vegf's for obvious reasons, with the exception of the payers, the costs are mounting. Avastin will be the poster child for PSDV sustained delivery, period. It will happen much sooner than you think. Now, go back to the ALIM MB and twiddle your thumbs.
REGN took a big hit today on news that payers are getting tired of the high costs of Ophthalmic treatments of large molecules. Perfect timing:..
Whatever its motivation, Roche has done everything it can to limit the use of Avastin outside of cancer, said Robert Deuson, a health economist with the Santa Monica-based Milken Institute.
“The combination of legal threats, safety concerns and financial incentives to use ranibuzimab (the generic name for Lucentis) has maintained the more expensive drug’s lucrative market,” Deuson said.
Sales of Lucentis may have reached their peak, according to a report from Karen Anderson, an analyst who covers Roche for the research firm Morningstar. A new drug, Eylea, is providing “intense” competition, Anderson wrote in a Feb. 27 report.
Eylea is slightly less expensive than Lucentis, about $1,850 per dose. But its real advantage is that Eylea is given less frequently than the monthly Lucentis injections. Eylea is injected once a month for the first three months, then once every two months.
But even given at that reduced frequency, Eylea costs about 18 times as much as Avastin.
Avastin was approved in 2004 for colon cancer. Lucentis was approved for age-related macular degeneration in 2006. In between those approvals, eye doctors got access to Avastin, and found it greatly effective in treating AMD in patients who would otherwise go blind.
In 2012, Lucentis was approved for diabetic macular edema; Avastin is also used off-label for that disease.
Off-label use is a common and legitimate medical practice, said Dr. William Freeman of UC San Diego’s Shiley Eye Center. The high cost of clinical trials may discourage some drugmakers for applying to sell for some legitimate potential uses, said Freeman, director of the Jacobs Retina Center at Shiley.
Freeman said he favors Avastin, but also uses Lucentis and Eylea.
So, cost effective? What would be more cost effective than a sustained release version with similar efficacy and one sixth the application frequency? Big pharma is going to have to do something and quickly to satisfy the payers. JMO, naturally. But isn't that what Paul Ashton has been preaching for years?
Here is some more good read regarding the ophthalmic drug issue, medicare and how doc's have the incentive not to save the system money. Can you see the writing on the wall yet? Hence, PSDV sustained biologic platforms to the rescue?
Perverse incentives. The newly released data also flesh out an old story: that many features of fee-for-service Medicare reflect perverse incentives that influence care. For example, many drugs and biologics administered by physicians in office or hospital outpatient settings are paid for under Part B, and thus are included in these data as payments to physician practices. Because of the way doctors are reimbursed for supplying these drugs—at the drugs’ so-called “average sales price” plus 6 percent—physicians may be encouraged to buy and use more expensive drugs within the same class.
A case in point: ophthalmology practices that use the very similar drugs Avastin and Lucentis, both made by Genentech, to treat age-related macular degeneration. A federally funded clinical trial showed that the two drugs produce equivalent results, but annual treatment costs are $650 for Avastin (which is used “off-label,” since the FDA hasn’t approved it for this use) compared with $50,000 with Lucentis.
Needless to say, 6 percent of a higher priced drug is a larger payout than 6 percent of a lower-priced one. Although opthalmologists who use Lucentis typically insist that the higher reimbursement isn’t a factor, it’s hard to explain otherwise why there is so much variation in the drugs’ use. This dynamic is why government officials would like to test more “bundled payment” arrangements, in which providers would be paid an overall fee for a care episode, and would thus be incentivized to provide only the most cost-effective care.
Very interesting that it came up today with REGN down 4% on the news. Jim Birchenough of BMO Capital reported news that payers are getting concerned over swelling ophthalmology costs in the nations medicare bill. I don't know, isn't this what we've been talking about on this MB for the last couple of weeks. Now, if pharma is forced to address the "swelling" cost issue by payers...........I don't know.....6 month sustained release that has similar efficacy?
Will the Medicare 'data dump' re-ignite the Lucentis/Avastin debate?
With drug pricing already in the US spotlight, this week's release of previously-confidential Medicare physician-billing data could once again sharpen the debate around the cost of different therapies used for the treatment of wet age-related macular degeneration (AMD).
Taking a step back, the Medicare data unveiled a number of fascinating trends, such as the top 10 'biggest billers' receiving a combined $121 million in Medicare payments. Subsequent headlines – and the data – have been distorted, argue some of the prominently featured physicians, and once again the price of drugs are to blame.
What is particularly noticeable, however, is the prominent position of ophthalmologists on the Medicare billing list, which could well reignite debate around the use of compounded Avastin as an alternative to Lucentis for the treatment of AMD.
Bringing the story full circle, some have put Regeneron Pharmaceuticals' success in the AMD market down to the reduced pricing of its later entrant Eylea, which could act as a potential inspiration for hepatitis C developers looking to take a chunk out of Gilead's market share.