Welcome
Buyer Community> Trade Intelligence> Chemicals> UPDATE 2-New Regeneron/Bayer eye drug matches Lucentis
Source: Reuters

UPDATE 2-New Regeneron/Bayer eye drug matches Lucentis

Published: 22 Nov 2010 02:11:32 PST

* Given once every 2 months, matches once-monthly Lucentis

* Safety of Regeneron drug, Lucentis similar in studies

* Researcher: drug could become top choice for patients

(Adds Bayer sales forecast, analyst comment, paragraphs 9-11)

NEW YORK, Nov 22 - Regeneron Pharmaceuticals Inc's treatment for the leading cause of blindness in the elderly was as effective and safe in two late-stage trials as Roche Holding AG's blockbuster Lucentis, with half the number of eye injections.

Regeneron's drug maintained or improved patient vision as well when injected into the eye every two months as Lucentis, which is injected once a month -- a potential boon in convenience and comfort to patients that could translate into big sales if the experimental drug is approved.

Lucentis, for which analysts expect sales of some $3 billion this year, is sold outside the U.S. by Novartis AG.

"In my mind this becomes the obvious first choice for patients because a drug requiring half as many injections would be a significant advantage to these elderly patients, their families and clinicians," Dr. Jeffrey Heier, an ophthalmologist at Ophthalmic Consultants of Boston, said in an interview.

He helped lead one of the pivotal studies, conducted in the United States and Canada.

The tiny U.S. biotechnology company and its European partner, Bayer AG, on Monday said they would seek approvals of their medicine, called VEGF Trap-Eye, in the United States and Europe in the first half of 2011 based upon its similar performance to Lucentis in maintaining or improving vision of patients with the "wet" form of macular degeneration.

Regeneron Chief Executive Leonard Schleifer declined to predict peak sales of his medicine, if it is approved, or whether it could leapfrog Lucentis as the standard treatment.

"But we would hope our drug proves to be the best in class," he said. "We would hope that the best in class, which delivers the best value to patients, could be the biggest seller."

Bayer confirmed its peak sales forecast for the drug of 250-500 million euros ($342-684 million) a year. Bayer has ex-U.S. marketing rights, splitting profits with Regeneron.

Deutsche Bank analyst Tim Race said VEGF Trap-Eye could lift Bayer's 2015 earnings before interest, tax, depreciation and amortisation by around 2 percent, if it captures 50 percent of the ex-U.S. market.

For Novartis and Roche, he estimated Lucentis would make up 5 percent and 8 respectively of 2010 operating profit.

In wet macular degeneration, swelling caused by leaking blood vessels damages the macula, which is the center of the retina and the visual field. It is the leading cause of blindness for people aged 65 or older in the U.S. and Europe.

DIFFERENT METHOD

Like Lucentis, but using a different method, Regeneron's drug works by blocking a protein called vascular endothelial growth factor (VEGF) involved in creation of blood vessels.

It met its main goal of matching Lucentis in two Phase III trials over a 52-week period. The 1,217-patient North American study was conducted by Regeneron, while Bayer conducted a trial of 1,240 patients in Europe, Asia and Latin America.

In the North American study, vision with the Regeneron drug was maintained or improved in 96 percent of patients receiving a monthly 0.5 milligram injection and in 95 percent of those receiving a 2 milligram dose once or twice a month. That compared with 94 percent of patients receiving a standard 0.5 milligram dose of Lucentis every month.

Similar results were seen in the companion overseas study conducted by Bayer. Vision with VEGF Trap-Eye was maintained in 96 percent of patients receiving a monthly 0.5-milligram injection, and also in those receiving a 2 milligram dose either monthly or twice a month. That compared with preserved or improved vision in 94 percent of those taking the standard once-monthly dose of Lucentis.

The drug was statistically better than Lucentis on a secondary measure. Patients in the North American trial receiving a monthly 2 milligram dose on average were able to read an additional 10.9 letters of an eye chart after one year, compared with an extra 8.1 letters for those receiving Lucentis.

The companies said a "generally favorable safety profile" was seen for both drugs and in both trials, with the most frequent ocular adverse events related to the injection itself, as well as eye pain and retinal hemorrhage.

Lucentis is a genetically altered version of a naturally occurring monoclonal antibody, designed to interfere with VEGF and thereby limit formation of blood vessels in the eye.

The Regeneron drug, invented by the company research chief George Yancopoulos, is instead made from components of two receptors to the VEGF protein that have been fused together.

Regeneron is testing another formulation of the drug, whose chemical name is aflibercept, in colon, lung and prostate cancer and expects data next year from those trials. (Additional reporting by Ben Hirschler in London and Ludwig Burger in Frankfurt; Editing by Bernard Orr and Jane Merriman)

Related Article
Most Popular