Replies to post #116341 on Biotech Values

[masterlongevity]

yes, they would still run the trial. they are a scientific company, and there is no way to predict the exact outcome of a blinded trial.

[DewDiligence]

…it seems like Roche is in a good position to know the positives and negatives of each drug, yet they chose to run expensive trials for the DME indication for Lucentis.

Roche is doing what any sensible company would do in this circumstance: get as many approved indications as possible for Lucentis and hope for the best in the head-to-head study with Avastin.

[DewDiligence]

Lucentis phase-3 ‘RIDE’ study in DME hits primary endpoint:

http://finance.yahoo.com/news/Second-Lucentis-Phase-III-bw-796863806.html?x=0&.v=1

At 24 months, 33.6 percent of patients (42/125) who received 0.3 mg Lucentis and 45.7 percent of patients (58/127) who received 0.5 mg Lucentis were able to read at least 15 more letters on the eye chart than they were at baseline, compared to 12.3 percent of patients (16/130) who received sham injections. The difference between each Lucentis dose group and the sham injection group was statistically significant. The study was not designed to compare the Lucentis doses with each other.

Combined with the positive results from the phase-3 study in DME called RISE, a clone of RIDE that reported data two weeks ago (#msg-60818771), Lucentis for DME should be a shoo-in for FDA approval in this indication.

Lucentis is already approved for DME in the EU based on trials conducted by NVS (#msg-58523789).

[DewDiligence]

This could be the big break Roche and NVS have been seeking
to bolster the argument for (expensive) Lucentis in place of
(dirt cheap) Avastin for AMD and other retinal diseases. The
study in question is observational, however, and the research
was supported by the two companies. Still, if the data from the
NIH’s head-to-head study turn out ambiguous, the Hopkins/
Medicare analysis described here could be consequential.

http://online.wsj.com/article/SB10001424052748703806304576242233381703032.html

›Analysis Flags Fears Over Avastin

APRIL 4, 2011, 1:43 P.M. ET
By GORAN MIJUK

ZURICH—A soon to be published analysis comparing Roche Holding AG's cancer medicine Avastin and Novartis AG's and Roche's eye drug Lucentis in treating an eye disease could create some safety concerns over Avastin's off-label use and potentially cushion a feared drop in Lucentis sales in the U.S.

According to an abstract of an analysis of the Medicare patient claims database by the Johns Hopkins University, scheduled to be presented in early May at a meeting of the Association for Research in Vision and Ophthalmology, or ARVO, in Fort Lauderdale, Fla., the off-label use of Avastin showed a statistically significant increased risk for mortality and hemorrhagic stroke compared to Lucentis.

The abstract indicated that the use of Avastin showed an 11% higher risk in overall mortality and a 57% higher risk of hemorrhagic cerebrovascular accident. "Data from this Medicare claims analysis suggest differences in the safety profile of Avastin versus Lucentis," the researchers concluded. But they cautioned that the analysis, involving 78,000 patients, was limited by incomplete information on some important confounding factors such as smoking, and lipid and blood pressure levels, which would be able to further clarify the relative safety of the treatments.

Some of the researchers have commercial relations with Roche biotech unit Genentech and Novartis eye-care unit Alcon, the abstract said, while Genentech was mentioned in the abstract as having provided support. Roche said the analysis is an independent study conducted by the Johns Hopkins University, but that the university received funding from Genentech and Novartis to support the study.

The abstract, which was published on ARVO's website, raised Roche's and Novartis's hopes that they can protect Lucentis sales. But analysts cautioned that the full data needs to be studied before a final verdict about the drug's prospects, especially those in the U.S., can be made. The analysis is scheduled to be presented May 3.

Avastin is one of Roche's best-selling cancer products, with more than $6 billion in annual sales. Lucentis, which nets more than $2 billion in revenue for Roche and Novartis, is marketed by Roche in the U.S. and elsewhere by crosstown rival Novartis.

The drugs work in the same way and their composition is closely related. Avastin was developed to treat various forms of cancer but many eye doctors say it is just as effective as Lucentis when used in age-related macular degeneration. Avastin is also considerably cheaper than Lucentis, costing about $50 for one treatment when used in the eye, versus about $1,500 per injection for Lucentis. To save money, many physicians in the U.S. have started to give patients Avastin rather than Lucentis for the treatment of the eye disease. Doctors are allowed to prescribe drugs for uses not approved by the Food and Drug Administration, a practice known as off-label prescribing.

The price difference is a particular concern for Medicare, which one study says could save more than $500 million annually by using Avastin rather than Lucentis in the eye disease. The National Eye Institute, part of the National Institutes of Health, is expected to soon publish the results of a head-to-head study that compares the efficacy and safety of the two drugs when used in the eye disease. That trial, involving 1,200 patients, is considered important for shaping physician opinion about which drug to use.

If more doctors and payers back Avastin's off-label use, that would hurt Lucentis sales, especially those of Roche in the U.S., where the off-label use has been more widespread than elsewhere. Novartis' sales outside the U.S. could also be hurt.

JP Morgan issued a word of caution, reflecting the researchers' conclusion, that the data may be too limited for a final verdict.

Novartis said it felt that the Johns Hopkins analysis will help support Lucentis sales. "I predict less off-label use of Avastin as this body of evidence comes to light," Novartis chief executive Joe Jimenez said in an interview.

Roche said the Johns Hopkins "results ... support [Roche's] belief that Lucentis is the most appropriate treatment for wet age-related macular degeneration," adding that the data available in the abstract "suggest there may be differences in the safety profile of Lucentis and Avastin when used in the eye."‹

[DewDiligence]

Roche reports detailed Lucentis/DME data from US phase-3 studies:

http://finance.yahoo.com/news/Two-Pivotal-Phase-III-bw-202584487.html?x=0&.v=1

Curiously for two identical studies, RIDE showed a dose response, but RISE did not:


The top-line data from these studies were reported in Mar 2011 (#msg-60818771, #msg-61386067). FDA approval of Lucentis in DME should be a shoo-in; ever since Lucentis first showed efficacy in AMD many years ago, there has been little doubt that it would work in DME also. Lucentis is already approved for DME in the EU based on trials conducted by NVS (#msg-58523789).