The European Academy of Allergy and Clinical Immunology, EAACI, is a non-profit organisation active in the field of allergic and immunologic diseases such as asthma, rhinitis, eczema, occupational allergy, food and drug allergy and anaphylaxis. EAACI was founded in 1956 in Florence and has become the largest medical association in Europe in the field of allergy and clinical immunology. It includes over 7,800 members from 121 countries, as well as 42 National Allergy Societies.
The World Allergy Organization (WAO) is an international alliance of 92 regional and national allergy, asthma and clinical immunology societies. Through collaboration with the Member Societies, WAO provides a wide range of educational and outreach programs, symposia, and lectureships to allergists/immunologists around the globe and conducts initiatives relating to clinical practice, service provision, and physician training in order to better understand and address the challenges facing allergists/immunologists worldwide.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of unmet medical needs. RUCONEST
is a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum. RUCONEST
is partnered with Santarus, Inc. (NASDAQ: SNTS) in North America and a Biologics License Application for RUCONEST is under review by the U.S. Food and Drug Administration. The product is also being evaluated for various follow-on indications. Pharming has a unique GMP compliant, validated platform for the production of recombinant human proteins that has proven capable of producing industrial volumes of high quality recombinant human protein in a more economical way compared to current cell based technologies. Pharming now plans to utilise this platform for the development of rhFVIII for the treatment of Haemophilia A. Additional information is available on the Pharming website,
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company's current commercial efforts are focused on five products.
(budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis and
(omeprazole/sodium bicarbonate) for the treatment of certain upper gastrointestinal disorders are promoted to gastroenterologists.
(metformin hydrochloride extended release tablets) and
(bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes, and
(fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol, are promoted to endocrinologists and other physicians who treat patients with type 2 diabetes. Full prescribing and safety information for Santarus’ products is available at
or by contacting Santarus at 1-888-778-0887.
Santarus’ product development pipeline includes the investigational drug RUCONEST
(recombinant human C1 esterase inhibitor). A Biologics License Application for RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema is under review by the U.S. Food and Drug Administration with a response expected in April 2014. Santarus is also developing rifamycin SV MMX
, which is in Phase III clinical testing for the treatment of travelers’ diarrhea. In addition, the company has completed a Phase I clinical program with SAN-300, an investigational monoclonal antibody. More information about Santarus is available at
Santarus and Pharming caution you that statements included in this press release that are not a description of historical facts are forward-looking statements.
The inclusion of forward-looking statements should not be regarded as a representation by Santarus or Pharming that any of its plans or objectives will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus and Pharming's businesses, including, without limitation:
whether the FDA will approve the RUCONEST BLA in a timely manner or at all; whether the FDA will concur with the clinical interpretation of the Phase III study results or the conduct of the study; whether the FDA ultimately will require additional clinical studies or other development programs before approving RUCONEST; risks related to Santarus’ dependence on Pharming for many functions related to RUCONEST, and Pharming’s ability to continue to perform these functions based on its limited financial resources; risks related to the license and supply arrangements between Santarus and Pharming, including the potential for termination of the arrangements; other difficulties or delays in development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus and Pharming’s products; and other risks detailed in prior press releases as well as in public periodic filings with the Securities and Exchange Commission, including Santarus’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2013.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and neither Santarus nor Pharming undertakes any obligation to revise or update this news release to reflect events or circumstances after the date hereof, except as may be required by law. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
, and ZEGERID
are registered trademarks of Santarus, Inc. GLUMETZA
is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET
is a trademark of VeroScience LLC. MMX
is a trademark of Cosmo Technologies Limited. RUCONEST
is a trademark of Pharming Group N.V.