Regeneron Pharmaceuticals Inc (REGN)

[surf1944]

4:08PM Regeneron Pharms announces that it intends to offer, $400 million aggregate principal amount of convertible senior notes due 2016 in a private placement (REGN) 64.63 +0.68 : Co announces it intends to offer, subject to market and other conditions, $400 mlnaggregate principal amount of convertible senior notes due 2016 in a private placement. The co also intends to grant to the initial purchaser a 13-day option to purchase up to an additional $60 mln aggregate principal amount of notes on the same terms and conditions. The co intends to use a portion of the proceeds of the offering, together with the proceeds from the warrant transactions, to fund the cost of the convertible note hedge transactions in connection with the offering. The co intends to use the remaining net proceeds for general corporate purposes.

[surf1944]

Regeneron Pharmaceuticals Inc., a biopharmaceutical company focused on the treatment of serious medical conditions, is likely to see FDA approval for its EYLEA on its November 18th PDUFA date, according to Roth Capital. And after Roche’s Avastin caused at least 16 serious eye infections, the drug could have a larger-than-expected end market.

shorted at $67, seems to be overbought

The infections from Roche’s Avastin have left many patients blind, while a study by John Hopkins University found that patients given Avastin to treat AMD were 11% more likely to die and 57% more likely to suffer a stroke than those treated with the more expensive Lucentis. With these problems in the market, a potential approval for EYLEA could help the drug into a very ready marketplace.

Investors interested in gaining exposure to this opportunity may want to consider at-the-money February 2012 calls trading with a premium of $11.30. With a breakeven point of $71.30, any more beyond this would have a cost basis of just $11.30 per share, making the upside potential very significant and the upfront capital requirements relatively modest.

http://seekingalpha.com/article/291187-3-analyst-healthcare-picks-ready-to-break-out?source=yahoo

[DewDiligence]

A little additional color on that story: #msg-65120671. Regards, Dew

[surf1944]

Regeneron rheumatoid arthritis drug meets goal
Regeneron Pharma and Sanofi say rheumatoid arthritis drug sarilumab met mid-stage study goal

Chart for Regeneron Pharmaceuticals, Inc.
On Wednesday July 13, 2011, 10:18 am EDT

NEW YORK (AP) -- Regeneron Pharmaceuticals Inc. and Sanofi said a clinical trial showed their drug candidate sarilumab reduced symptoms of moderate to severe rheumatoid arthritis.

The companies said late Tuesday that they are discussing the doses of the drug that will be tested in a late-stage clinical trial. In a mid-stage trial, the companies said patients who were treated with sarilumab and methotrexate improved more than patients who were treated with methotrexate and a placebo.

Sanofi shares rose 50 cents, or 1.3 percent, to $38.59 in morning trading and Regeneron added 23 cents to $57.38.

The study compared five different doses of the drug to placebo. Regeneron and Sanofi said 49 percent of patients who were treated with the lowest dose had their symptoms improve by at least 20 percent, while 72 percent of the patients in the highest-dose group met that benchmark. They said 46.2 percent of the methotrexate and placebo patients had the same improvement. Sarilumab patients were also more likely to have improvements of 50 percent and 70 percent, and also did better on a separate measurement of symptoms.

The most common side effects of sarilumab included infections, low white blood cell count, and liver function test abnormalities. The results are from a 12-week study involving 306 patients who were not helped by previous treatment with methotrexate. The study will continue for 12 more weeks.

The companies said a separate study showed sarilumab did not work better than a placebo as a treatment for ankylosing spondylitis, a painful, progressive form of spinal arthritis.

Citi Investment Research analyst Yaron Werber said it is too soon to tell how well sarilumab compares to Roche's rheumatoid arthritis drug Acemtra, which is already on the market. However he said the data on side effects looks encouraging. Werber said the results show the depth of the Tarrytown, N.Y., company's collaboration with Sanofi. The most advanced drug in that collaboration is the cancer treatment aflibercept, but it also includes treatments for high lipid levels and pain.

[Percysixstargazer]

Trading in Regeneron Common Stock Halted

Last update: 6/17/2011 7:05:00 AM

Advisory Committee of the U.S. Food and Drug Administration Discussing EYLEA(TM) (aflibercept ophthalmic solution) Biologics License Application

TARRYTOWN, N.Y., June 17, 2011 /PRNewswire via COMTEX/ -- Regeneron Pharmaceuticals, Inc. (REGN) announced that NASDAQ has halted trading of the company's common stock today. The Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is meeting today to discuss the company's Biologics License Application (BLA) for EYLEA(TM), also known as VEGF Trap-Eye, for the treatment of the neovascular form of age-related macular degeneration (wet AMD).

Regeneron submitted a BLA for marketing approval in wet AMD in the U.S. in February 2011 and received a Priority Review designation. Under Priority Review, the target date for an FDA decision on the EYLEA BLA is August 20, 2011.

About EYLEA

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs. However, in certain diseases, such as age-related macular degeneration, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit vascular permeability and lead to edema.

EYLEA (aflibercept ophthalmic solution), also known as VEGF Trap-Eye, is a fully human fusion protein, consisting of portions of VEGF receptors 1 and 2, that binds all forms of VEGF-A along with the related Placental Growth Factor (PlGF). EYLEA is a specific and highly potent blocker of these growth factors. EYLEA is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.

Regeneron and Bayer HealthCare are collaborating on the global development of EYLEA for the treatment of the neovascular form of age-related macular degeneration (wet AMD), central retinal vein occlusion (CRVO), diabetic macular edema (DME), and other eye diseases and disorders. Bayer submitted an application for marketing authorization in Europe in wet AMD in June 2011.

Bayer HealthCare will market EYLEA(TM) outside the United States, where the companies will share equally the profits from any future sales of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States.

[surf1944]

Regeneron Eye Drug to Rival Lucentis Works in U.S. Review
By Catherine Larkin and Anna Edney - Jun 15, 2011 10:00 AM ET

Regeneron Pharmaceuticals Inc. (REGN)’s experimental treatment for a common cause of blindness prevents vision loss, U.S. regulators said, suggesting they may soon approve the competitor to Roche Holding AG (ROG)’s Lucentis.

The new medicine, known as VEGF Trap-Eye or aflibercept, worked as well as Lucentis when injected into the eye every month or other month in patients with wet age-related macular degeneration, or AMD, Food and Drug Administration staff said in a report released today. Lucentis, a $1.4 billion-a-year product for Basel, Switzerland-based Roche, is given monthly.

Less frequent dosing may help Tarrytown, New York-based Regeneron capture at least 15 percent of the U.S. market from Lucentis if it’s approved, said Robyn Karnauskas, a Deutsche Bank analyst in New York. Most patients will still be treated with Avastin, a Roche cancer drug that’s cheaper than Lucentis though not FDA approved for treating the eye disease, she said.

“VEGF Trap-Eye doesn’t need to take a lot of the market for it to mean something to Regeneron,” Karnauskas said in a telephone interview. She estimates the medicine will generate global sales of $2 billion in 2018.

Outside advisers to the FDA will meet June 17 in Adelphi, Maryland, to consider the data on Regeneron’s drug and recommend whether it should be approved. The agency is scheduled to take action by Aug. 20 under a six-month priority review program for medicines that represent a major advance in treatment.
‘Very Favorable’

The FDA asked its advisers to consider whether patients on the new medicine should be monitored every month even if recommended dosing of the drug is every two months. The advisory panel will also consider draft labeling for the product, which was “very favorable for Regeneron,” Karnauskas said.

“We think the FDA is likely to approve Trap-Eye with a dosing regimen that would make it competitive to both Lucentis & Avastin,” Karnauskas said today in a note to clients.

Regeneron rose $3.50, or 6.4 percent, to $58.53 in Nasdaq Stock Market composite trading at 9:57 a.m. New York time, the biggest intraday percentage gain since May 6. The shares had increased 68 percent this year before today, outperforming the 9.2 percent gain among 20 stocks in the AMEX Biotechnology Index. Paris-based Sanofi-Aventis SA (SAN) is the company’s biggest investor with an 18 percent stake as of Oct. 13, according to data compiled by Bloomberg.

AMD is a leading cause of blindness in Americans age 60 and older, according to the National Eye Institute. About 15 percent of patients have the more advanced “wet” form of the disease tied to abnormal blood vessels that grow under the macula, the part of the retina responsible for seeing in fine detail. Blood and fluid leaked from the vessels can result in vision loss.

1.5 Million Patients

Regeneron estimates that about 1.5 million people have wet AMD with 200,000 new cases diagnosed each year.

Regeneron proposed the brand name Eylea to the FDA. Bayer AG (BAYN), of Leverkusen, Germany, has rights to market VEGF Trap-Eye outside the U.S. and this month submitted an application in Europe for use in wet AMD.

Lucentis is sold outside the U.S. by Novartis AG (NOVN), also based in Basel, Switzerland. The drugmaker reported Lucentis sales of $1.5 billion last year.

To contact the reporter on this story: Catherine Larkin in Washington at [e-mail]; Anna Edney in Washington at [e-mail].

http://www.bloomberg.com/news/2011-06-15/regeneron-eye-drug-to-rival-lucentis-works-in-u-s-review-1-.html?cmpid=yhoo

[surf1944]

Regeneron Pharms REGN Needham Buy $49 » $60

Read more: http://www.briefing.com/Investor/Public/Calendars/UpgradesDowngrades.htm#ixzz1LrW9iAEE

[surf1944]

Regeneron Pharms REGN RBC Capital Mkts Outperform $48 » $70

Read more: http://www.briefing.com/Investor/Public/Calendars/UpgradesDowngrades.htm#ixzz1Kp7fRJSb

[surf1944]

Regeneron Pharms REGN Boenning & Scattergood Outperform $58

Regeneron Pharms REGN Brean Murray Buy $57 » $67

Read more: http://www.briefing.com/Investor/Public/Calendars/UpgradesDowngrades.htm#ixzz1KjHvft00

[surf1944]

7:31AM Regeneron Pharms FDA grants Priority Review for VEGF Trap-Eye for the treatment of wet age-related macular degeneration (REGN) 453.84 : Co announces that the U.S. Food and Drug Administration has accepted for review the Company's Biologics License Application for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration. The FDA also granted the Company's request for priority review of its BLA. A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Under priority review, the target date for an FDA decision on the VEGF Trap-Eye BLA is August 20, 2011.

[surf1944]

7:33AM Regeneron Pharms reports ARCALYST meets primary and all secondary endpoints in second Phase 3 Trial for prevention of gout flares in patients initiating uric acid-lowering therapy (REGN) 37.00 : Co announces that in a second Phase 3 study in gout patients initiating allopurinol therapy, ARCALYST met the primary and all secondary study endpoints. Patients who received ARCALYST at a weekly, self-administered, subcutaneous dose of either 160 mg or 80 mg had a 72% decrease in mean number of gout flares compared to the placebo group. These results were consistent with those previously reported in the first, identical Phase 3 efficacy study. Compared to placebo, treatment with ARCALYST reduced the proportion of patients who experienced at least one gout flare during the study period by 63% for ARCALYST 160mg and by 54% for ARCALYST 80 mg. Compared to placebo, treatment with ARCALYST reduced the proportion of patients who experienced two or more flares by 82% for ARCALYST 160 mg and by 74% for ARCALYST 80 mg. ARCALYST was generally well tolerated with the incidence of serious adverse events generally well-balanced across the placebo and ARCALYST groups. Injection site reactions, usually considered mild, were reported more commonly with ARCALYST than with placebo. Co plans to submit supplemental Biologics License Application in mid-2011.

[americano]

Thanks Surf, regn sure a good one over the years, I use to own it , but been a long time, since I held it.

[surf1944]

There has been a large amount of short covering taking place in the biotech sector, also just a lack of longs giving in with any major selling.

Avg Vol (3 month)3: 581,878
Avg Vol (10 day)3: 258,157
Shares Outstanding5: 82.11M
Float: 57.38M
% Held by Insiders6: 28.43%
% Held by Institutions6: 75.80%
Shares Short (as of Aug 31, 2010)3: 5.28M
Short Ratio (as of Aug 31, 2010)3: 17.30
Short % of Float (as of Aug 31, 2010)3: 8.50%
Shares Short (prior month)3: 5.42M

[americano]

REGN one of the best I have seen over the years.

[surf1944]

Rigel Announces Second Quarter 2010 Financial Results

http://finance.yahoo.com/news/Rigel-Announces-Second-prnews-1589415505.html?x=0&.v=1

[surf1944]

6:21AM Regeneron Pharms: Astellas to pay $295 mln to extend license of Regeneron's VelocImmune antibody technology through 2023 (REGN) 24.61 : The co and Astellas Pharma announced that Astellas has extended through 2023 the non-exclusive license agreement that allows Astellas to utilize Regeneron's VelocImmune technology in its internal research programs to discover fully human monoclonal antibody product candidates. Astellas will pay $165 mln upfront and another $130 mln in June 2018 unless it terminates the agreement prior to that date. Upon commercialization of any antibody products discovered utilizing VelocImmune, Astellas will pay a mid-single-digit royalty on product sales. In March 2007, Astellas and Regeneron entered into a six-year VelocImmune license agreement pursuant to which Astellas made license payments of $20 million per year in 2007 through 2010. This amendment supersedes the original agreement and as such, Astellas will no longer make annual license payments in 2011 and 2012.

[surf1944]

http://investor.regeneron.com/

[surf1944]

The Pharma Initiative: Three Stock Picks (REGN)

http://seekingalpha.com/article/205540-the-pharma-initiative-three-stock-picks

[surf1944]

Regeneron Announces Presentation at the Bank of America Merrill Lynch 2010 Healthcare Conference

Press Release Source: Regeneron Pharmaceuticals, Inc. On Friday May 7, 2010, 9:30 am EDT
TARRYTOWN, N.Y., May 7 /PRNewswire-FirstCall/ -- Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN - News) will webcast its presentation at the Bank of America Merrill Lynch 2010 Healthcare Conference on Thursday, May 13, 2010. The presentation is scheduled for 1:00 p.m. Eastern Time. The session may be accessed through the Company's web site, http://www.regeneron.com/, on the Investor Relations page. An archived version of the presentation will be available after the live webcast through May 28, 2010.

Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST® (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in Phase 3 clinical trials for the potential treatment of gout, diseases of the eye (wet age-related macular degeneration and central retinal vein occlusion), and certain cancers. Additional therapeutic candidates are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information about Regeneron and recent news releases are available on Regeneron's web site at http://www.regeneron.com/.

Contact Information:

Michael Aberman, M.D.
Peter Dworkin

Investor Relations
Corporate Communications

914.345.7799
914.345.7640

[e-mail]
[e-mail]

[surf1944]

UPDATE 3-Regeneron shares jump after CEO touts drugs
Tue Mar 23, 2010 6:45pm EDTStocks
Regeneron Pharmaceuticals, Inc.

* Expects aflibercept colon, lung cancer data next year

* Says aflibercept has best chance against colon cancer

* Says drug may have less blood-clot risk than Avastin

* Shares close up 5.6 pct (Adds CEO quotes from interview, details on drugs)

By Ransdell Pierson

NEW YORK, March 23 (Reuters) - The CEO of Regeneron Inc (REGN.O) said on Tuesday his company expects late-stage data by the first half of 2011 on its experimental drug for colorectal and lung cancer, and that it could show a safety advantage over Roche Holding AG's (ROG.VX) blockbuster Avastin.

Shares of Tarrytown, New York-based Regeneron closed up 5.6 percent at $25.72 Tuesday on the Nasdaq, after Chief Executive Leonard Schleifer put the spotlight on aflibercept and other company drugs now winding their way through late-stage trials.

Partner Sanofi-Aventis (SASY.PA) is paying all costs of developing the oncology product, aflibercept, which is also being tested against prostate cancer. Interim data from late-stage trials for that cancer are expected in mid-2011.

But Schleifer said aflibercept probably has the best chance of succeeding against colorectal cancer. He noted it works through a similar mechanism as Avastin, which is one of the leading approved treatments for that cancer.

Aflibercept and Avastin both block a protein called VEGF that tumors use to build blood vessels capable of supplying themselves nutrients.

But Avastin and other anti-VEGF drugs cause blood clots, presumably by causing sticky blood cells called platelets to clump together, Schleifer said in a presentation at the annual Barclays Capital Global Healthcare Conference in Miami.

"There is reason to expect our drug doesn't activate platelets," providing a possible safety advantage over rival anti-VEGF drugs, Schleifer said.

Regeneron is also conducting late-stage trials of drugs meant to treat gout and macular degeneration, a leading cause of blindness.

Schleifer said the company expects late-stage data in the the second quarter on use of its drug, Arcalyst (rilonacept), to prevent gout flares and to treat acute gout -- an intensely painful form of arthritis.

He said Regeneron expects late-state data in the second half of this year on its medicine for macular degeneration, called VEGF-TRAP, whose active ingredient is aflibercept.

By developing an eye drug with its VEGF-inhibitor, Regeneron is following a trail blazed by Roche. The Swiss drugmaker also sells a treatment for macular degeneration, Lucentis, whose active ingredient is very similar to Avastin.

Regeneron also hopes to receive "proof-of-concept" data in the second quarter from an early-stage human trial of an experimental drug that cut "bad" LDL cholesterol 70 percent in primate studies. It works by blocking a protein called PCSK9.

"It's one of the most exciting new targets in biotechnology," Schleifer told Reuters in an interview, noting the drug is among a handful of monoclonal antibodies being tested in human trials under a 3-year-old deal with Sanofi.

Regeneron aims to begin trials of 30 to 40 other antibodies in the next eight years, under the Sanofi partnership.

"This is a year chock full of data for us and the depth and breadth of our pipeline, with eight biologics in development, is really just beginning to be appreciated," Schleifer said.

"I would aspire over time to achieve what some of the larger and more successful biotechnology companies have done, such as Genentech and Amgen," he said, adding that success will be measured by how many significant drugs Regeneron launches.

Sanofi provides Regeneron $160 million a year that it uses to discover new antibodies, and pays 100 percent of later costs to test the experimental drugs in clinical trials. In return, Schleifer said Regeneron will be entitled to very hefty royalties on drugs that succeed in trials and are approved.

Sanofi's funding represents a "substantial" percentage of the $750 million Regeneron will spend this year on research and development, Schleifer said, a strong endorsement of the company by far-larger Sanofi.

"It's also a big vote of confidence of us in Sanofi because we hooked up with them," said Schleifer. "And I feel strongly about that." (Reporting by Ransdell Pierson; editing by Matthew Lewis, Bernard Orr)


http://www.reuters.com/article/idCNN233742320100323?rpc=44

[surf1944]

Regeneron Pharms REGN RBC Capital Mkts Sector Perform $20 to $25

[surf1944]

7:02AM Regeneron Pharms reports VEGF trap-eye shows positive results in a Phase 2 study in patients with diabetic macular edema (REGN) 30.46 : The co and Bayer HealthCare AG today announced that VEGF Trap-Eye showed positive results in a Phase 2 study in patients with diabetic macular edema (DME). The primary endpoint of the study, a statistically significant improvement in visual acuity over 24 weeks compared to the standard of care in DME, macular laser therapy, was met. Visual acuity improvement was measured by the mean number of letters gained over the initial 24 weeks of the study. Patients in each of the four dosing groups receiving VEGF Trap-Eye achieved statistically significantly greater mean improvements in visual acuity (8.5 to 11.4 letters of vision gained) compared to patients receiving macular laser therapy (2.5 letters gained) at week 24 (p< 0.01 for each VEGF Trap-Eye group versus laser). VEGF Trap-Eye was generally well tolerated, and there were no drug-related serious adverse events.

[surf1944]

Regeneron Pharms REGN Roth Capital started with a Buy $35

[surf1944]

Regeneron Pharms REGN Roth Capital started with a Buy $35

[CHA$E]

Pharm's working their magic ~ Regeneron Announces Conference Call to Discuss Expanded Antibody Collaboration with Sanofi-aventis 11/10

[surf1944]

Regeneron Pharms REGN RBC Capital Mkts Outperform to Sector Perform

[nightstocker]

HI hodginsjkp welcome to ihub.

[hodginsjkp]

Tomorrows ask price is indicating further rises tomorrow even if Nasdaq futures are down.