Healthcare Industry News:  Bayer HealthCare 

Biopharmaceuticals

 News Release - March 25, 2008

ARCALYST(TM) (rilonacept), First and Only FDA-approved Treatment for Cryopyrin-Associated Periodic Syndromes (CAPS), Now Available in the United States

Regeneron Introduces the ARCALYST Resource Center to Enable Patient Access to Therapy for a Rare Inherited Inflammatory Condition

TARRYTOWN, N.Y.--(HSMN NewsFeed)--Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced ARCALYST™ (rilonacept) Injection for Subcutaneous Use is now available for prescription in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. Regeneron was granted marketing approval for ARCALYST by the U.S. Food and Drug Administration in February 2008, making it the only therapy approved for patients with CAPS, a group of rare, inherited, auto-inflammatory conditions characterized by life-long symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli. To avoid triggers that cause flares, patients often adopt a compromised lifestyle with limitations on everyday activities.

“Recognizing the painful, isolated lives experienced by patients with CAPS, we are pleased that we can offer these patients an FDA-approved therapy that helps control its debilitating symptoms,” said Leonard S. Schleifer, M.D., Ph.D., Regeneron's president and chief executive officer.“ Just as we were dedicated to developing a therapy for this condition with a large unmet medical need, we are also fully committed to assisting CAPS patients in gaining access to ARCALYST treatment. We have developed a comprehensive support program for CAPS patients and their physicians to help fulfill this goal.”

Regeneron has introduced the Regeneron ARC (ARCALYST Resource Center), which provides assistance to:
  • help CAPS patients find appropriate medical care from trained healthcare providers
  • prepare CAPS physicians to diagnose and appropriately treat these rare conditions
  • aid CAPS patients in securing insurance authorization
  • refer CAPS patients to company-sponsored and third-party financial assistance programs, when appropriate
ARCALYST is being distributed through two specialty pharmacies, which will directly mail patients a monthly shipment of ARCALYST and the supplies needed for self-injection. The pharmacies will also provide access to self-injection training and adherence counseling to patients who need those services.

More information about ARCALYST and the Regeneron ARC is available to patients and physicians through a toll-free number at 1-877-REGN777 (1-877-734-6777).

About Cryopyrin-Associated Periodic Syndromes (CAPS)

Recently, medical researchers have identified and described a group of rare, inherited, auto-inflammatory disorders, known as Cryopyrin-Associated Periodic Syndromes or CAPS. Three related conditions make up the broader disease known as CAPS: Familial Cold Auto-inflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), and Neonatal-Onset Multisystem Inflammatory Disease (NOMID). ARCALYST is not indicated for use in, and has not been studied in, patients with NOMID.

CAPS are characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli.

CAPS are generally caused by autosomal-dominant mutations (changes) in the NLRP-3 (previously known as CIAS1) gene and resultant alterations in the protein, cryopyrin, which it encodes. Cryopyrin, active in circulating, infection-fighting, white blood cells, controls the production of a protein called interleukin-1 (IL-1). As part of the body’s infection-fighting defense system, IL-1 circulates throughout the body and can trigger inflammatory reactions when it binds to inflammatory cells. Researchers have found that alterations in the cryopyrin protein lead to over-production of IL-1, resulting in an inflammatory response and the symptoms of CAPS. Most, but not all, patients with CAPS have the NLRP-3 gene mutation.

The incidence of CAPS has been reported to be approximately 1 in 1,000,000 people in the United States.

About ARCALYST™ (rilonacept)

ARCALYST is a targeted inhibitor of interleukin-1 (IL-1), the key driver of inflammation in Cryopyrin-Associated Periodic Syndromes (CAPS). In the pivotal clinical development program for ARCALYST, change in disease activity was measured using a composite symptom score composed of a daily evaluation of rash, feelings of fever/chills, joint pain, eye redness/pain, and fatigue. Patients treated with ARCALYST experienced an improvement in overall symptom scores as compared with patients treated with placebo. These improvements were noted within several days of initiation of ARCALYST therapy in most patients and were sustained over time with continued treatment with ARCALYST. The most commonly reported adverse reactions with ARCALYST were injection-site reaction and upper respiratory tract infection.

ARCALYST is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. IL-1 blockade may interfere with immune response to infections. Serious, life-threatening infections have been reported in patients taking ARCALYST. ARCALYST should be discontinued if a patient develops a serious infection. Taking ARCALYST with tumor necrosis factor inhibitors is not recommended because this may increase the risk of serious infections. Treatment with ARCALYST should not be initiated in patients with active or chronic infections. Patients should not receive a live vaccine while taking ARCALYST™ (rilonacept). It is recommended that patients receive all recommended vaccinations prior to initiation of treatment with ARCALYST. Patients should be monitored for changes in their lipid profiles and provided with medical treatment if warranted. Hypersensitivity reactions associated with ARCALYST administration have been rare. Please see the full Prescribing Information for ARCALYST, available online at www.regeneron.com/ARCALYST-fpi.pdf

About Regeneron Pharmaceuticals, Inc.

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 clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. Additional information about Regeneron and recent news releases are available on Regeneron's Web site at www.regeneron.com

Forward Looking Statement

This news release discusses historical information and includes forward-looking statements about Regeneron and its products, development programs, finances, and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical development of Regeneron’s drug candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize its product and drug candidates, competing drugs that are superior to Regeneron’s product and drug candidates, uncertainty of market acceptance of Regeneron’s product and drug candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement, including Regeneron’s agreements with the sanofi-aventis Group and Bayer HealthCare, to be canceled or to terminate without any product success, risks associated with third party intellectual property, and other material risks. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission (SEC), including its Form 10-K for the year ended December 31, 2007. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise unless required by law.


Source: Regeneron Pharmaceuticals

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