Regeneron (Nasdaq: REGN) climbs after raising Eylea sales outlook

Northern, WI 2/13/12 (StreetBeat) – Shares of Regeneron Pharmaceuticals Inc. (Nasdaq: REGN) jumped Monday after the company predicted much stronger sales of its eye drug Eylea.

Regeneron launched Eylea in November and said sales during the fourth quarter totaled $24.8 million. It now expects $250 million to $300 million in U.S. sales of the drug in 2012, up from its previous forecast of $140 million to $160 million.

Regeneron stock jumped $11.18, or 11.percent, to $113.26 in morning trading.

The Food and Drug Administration approved Eylea on Nov. 18 as a treatment for "wet" age-related macular degeneration, or wet AMD, which is a common cause of blindness. Eylea was the first drug approved to treat the disease since Roche's drug Lucentis in 2006. Patients who take Eylea don't have to see their doctor as often as patients who take Lucentis, and patients who take Eylea may not need to use it as often. One clinical study indicated that Eylea was more effective than Lucentis after a year of treatment.

Regeneron has asked the FDA to approve Eylea as a treatment for a second eye condition, central retinal vein occlusion, and its partner Bayer HealthCare is seeking approval to market Eylea in Japan and the European Union.

In the fourth quarter, Regeneron lost $53.4 million, or 58 cents per share. A year earlier it took a loss of $14.6 million, or 17 cents per share. Revenue fell 8 percent to $123 million from $133.7 million, because of a decrease in revenue from collaborations with other drugmakers.

Analysts expected the company to report a loss of 60 cents per share and $132 million in revenue, according to FactSet.

After the approval of Eylea, Regeneron's product sales climbed to $29.8 million from $5.3 million. The company also sells Arcalyst, which is used to treat a group of rare, inherited auto-inflammatory conditions called CAPS. It is trying to get Arcalyst approved as a treatment for gout. Revenue from a partnership with Sanofi of France fell to $77 million from $82.1 million, and revenue from other collaborations dropped to $9.4 million from $34.9 million.

In 2011, Regeneron lost $221.8 million, or $2.45 per share, compared with a 2010 loss of $104.5 million, or $1.26 per share. Annual revenue fell 3 percent to $445.8 million from $459.1 million.

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Regeneron Shares Fall as Eye Drug Fails to Show Benefit Over

Tallahassee, FL (StreetBeat) -- Regeneron Pharmaceuticals (Nasdaq:REGN.O) said its recently approved eye drug failed to show meaningful advantage over rival Roche Holding's (ROG.VX) Lucentis after two years of treatment, sending Regeneron's shares down 8 percent before the bell.

Regeneron reported data from a late-stage trial testing its drug Eylea in patients with age-related macular degeneration for two years against patients who received Lucentis for the same period.

Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly. Some 11 million Americans have signs of AMD.

Patients taking Eylea gained an average of 7.6 letters on an eye chart with 4.2 injections during the second year compared with Lucentis' patients who gained 7.9 letters with 4.7 injections.

"We view this as a negative for Regeneron as Eylea appears to offer no meaningful advantage in efficacy or dosing post-Yr 1 at an uncompetitive price, translating to increased challenges against gaining market share from Lucentis/Avastin," Jefferies & Co analyst Biren Amin wrote in a note.

Regeneron shares were down $4.79 at $53.49 before the bell. They had closed at $58.28 on Friday on Nasdaq.

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Regeneron Wins FDA Approval for Macular-Degeneration Drug

Austin, TX 11/21/11 (StreetBeat) --The folks at Regeneron Pharmaceuticals (Nasdaq: REGN) are going to have a happy weekend right before they settle down for Thanksgiving.

Tarrytown, N.Y.-based Regeneron said yesterday it has gotten clearance from the FDA to start selling afilbercept (Eylea) as a new treatment for the "wet" form of age-related macular degeneration. The drug, also known scientifically as VEGF Trap-Eye to signify its intended biological target, is designed to stop the formation of abnormal blood vessels that can often cloud the vision and ultimately lead to blindness in elderly people.

The regulatory approval puts Regeneron in position to compete with products that have transformed the treatment of macular degeneration over the past five years -- Genentech's ranibizumab (Lucentis) and bevacizumab (Avastin). The new Regeneron drug is given as a once-monthly injection in the first three months, and then a lower dose is given every two months. Regeneron said it will charge about $16,000 a year for the new product, compared with $29,000 for its direct rival, Genentech's Lucentis. The other Genentech drug, Avastin, however, is much cheaper -- although its use is more controversial because it was developed as a cancer drug. Avastin isn't approved by the FDA as a macular-degeneration treatment, but doctors prescribe it anyway because it has been found to be effective in low doses, which cost less.

"The approval of Eylea offers a much-needed new treatment option for patients with wet AMD," said Jeffrey Heier, an assistant professor of ophthalmology at Tufts School of Medicine, in a Regeneron statement. "Eylea offers the potential of achieving the efficacy we've come to expect from current anti-VEGF agents, but with less frequent injections and no monitoring requirements. This may reduce the need for costly and time-consuming monthly office visits for patients and their caregivers."

Any new treatment for age-related macular degeneration is tapping into a potentially big pool of patients, as the baby boomers get older. More than 1.7 million people in the U.S. are thought to have the disease, and incidence is continuing to climb.

Regeneron's application to the FDA was based on clinical trials of 2,412 patients who were randomly assigned to get the new drug or the standard product, Genentech's Lucentis. The studies showed the Regeneron drug was as effective as the standard treatment at improving visual clarity after one year. The side effects included eye pain, blood at the injection site, clouding of the eye lens, and an increase in eye pressure, according to a statement from the FDA.

"Eylea is an important new treatment option for adults with wet AMD," said Edward Cox, director of the Office of Antimicrobial Products in FDA's Center for Drug Evaluation and Research, in a statement.

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