Healthcare Industry News:  C1 inhibitor 


 News Release - September 13, 2010

Pharming signs commercialization agreement with Santarus for Rhucin(R) in North America

LEIDEN, NETHERLANDS, Sept. 13 --(Healthcare Sales & Marketing Network) - Biotech company Pharming Group NV ("Pharming") (NYSE Euronext: PHARM) today announced that it has entered into an agreement with specialty biopharmaceutical company Santarus, Inc ("Santarus") (NASDAQ:SNTS ) for the commercialization of Rhucin® (recombinant human C1 inhibitor; Ruconest™ in Europe) in North America (the United States, Canada and Mexico) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE) and other future indications.

Under the agreement, Santarus will pay Pharming a USD 15 million upfront fee upon signing. Furthermore, Santarus will pay a USD 5 million milestone payment upon acceptance of the Rhucin Biologic License Application (BLA) by the US Food and Drug Administration (FDA). Additional payments are payable upon completing clinical and commercial milestones. Santarus will purchase its commercial supply of Rhucin from Pharming at a tiered supply price, based on a percentage of net sales of Rhucin.

Pharming is responsible under the agreement for the clinical development of Rhucin for HAE and all HAE related regulatory activities in the US, whereas Santarus will be responsible for regulatory approval in Canada and Mexico. In addition, Santarus and Pharming will share responsibility and costs for the clinical development of Rhucin for the treatment or prevention of renal transplantation rejection. Santarus will be responsible for related regulatory activities in North America.

Sijmen de Vries, CEO of Pharming commented, "We are excited to have taken a significant step closer to making Rhucin, an innovative, highly effective and safe replacement therapy, available for HAE patients in North Amercia. In Santarus we have a commercialization partner with a proven track record in clinical development and commercialization of high value pharmaceutical products. We are confident that they will provide a sound commercialisation platform for Rhucin in North America. We also look forward to working with Santarus on developing Rhucin in its next indication .

Rhucin® (recombinant human C1 esterase inhibitor, Ruconest in Europe) is a human protein developed through Pharming's proprietary technology where the human protein is expressed in milk of transgenic rabbits. Pharming is developing Rhucin/Ruconest for treatment of patients with acute attacks of Hereditary Angioedema (HAE). HAE is a human genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1-inhibitor, resulting in an overreaction of the immune system. The disease is characterized by unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway, which may last up to five days when untreated. In addition to the life-threatening nature of the disease in case of laryngeal attacks, quality of life for individuals with the disease may be seriously impaired. Approximately one in 30,000 individuals (1:10,000 - 1:50,000) suffers from HAE with an average of approximately eight acute attacks per year.

Conference call information Pharming has scheduled a conference call regarding this announcement for analysts at 9:30 am CET and for press at 11:00 am CET. To participate, please call one of the following numbers:

Analyst call (conference ID 4364219):

* From the Netherlands: 0800 265 8543 (toll-free) or +31 (0)45 631 6902

* From the UK: 0800 358 0886 (toll-free) or +44 207 153 2027

* From the US: +1 877 941 2930 (toll-free) or +1 480 629 9726

Press call (conference ID 4364227):

* From the Netherlands: 0800 265 8543 (toll-free) or +31 (0)45 631 6902

* From the UK: 0800 358 0886 (toll-free) or +44 207 153 2027

* From the US: +1 877 941 2928 (toll-free) or +1 480 629 9725

An audio cast of the conference calls will be available on Pharming's website shortly thereafter.

About Santarus, Inc

Santarus, Inc is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists, endocrinologists and other physicians. The company's current commercial efforts are focused on GLUMETZA(®)(metformin hydrochloride extended release tablets) and CYCLOSET(®) (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes. Santarus is also developing two late-stage GI product candidates, budesonide MMX(®) and rifamycin SV MMX(®), for the US market. Budesonide MMX is being investigated in a Phase III clinical program for the induction of remission of mild or moderate active ulcerative colitis. Santarus began Phase III clinical testing of rifamycin SV MMX in patients with travelers' diarrhea in the second quarter of 2010. More information about Santarus is available on the company's website at

About Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of genetic disorders, specialty products for surgical indications, and nutritional products. On June 24, the European Medicines Agency adopted a positive opinion for Ruconest™ (Rhucin® in non-EU territories) for the treatment of angioedema attacks. Market Authorization in the European Economic Area is therefore expected imminently with an anticipated market launch in the fourth quarter 2010. The product is also under development for follow-on indications, i.e. antibody-mediated rejection (AMR) and delayed graft function (DGF) following kidney transplantation. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products. In July, the partial spin-off of DNage was completed. Additional information is available on the Pharming website,

This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements.

Contact: Ms. Marjolein van Helmond, Manager Corporate Communications, T: +31(0)715247431 or +31(0)610929954

Source: Pharming Group

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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