LEIDEN, THE NETHERLANDS--(Marketwire - Jul 16, 2012) - Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today announces that a
randomized, cross-over double blind, placebo controlled study in healthy
volunteers has shown that Pharming's recombinant human Lactoferrin (rhLF)
safe, based on the assessment of clinical data, gastro-intestinal tolerance
adverse event reporting.
Twenty-four healthy subjects with an age-range of 25 to 49 years
the study. These volunteers consumed recombinant human Lactoferrin at a
dose of 0, 300 or 1000 mg, in combination with 10 grams of skimmed milk
Each treatment was consumed for a period of two weeks. There was no
between treatment and placebo and it was concluded that consumption of rhLF
safe. The study was supported by a grant from the Dutch Food and Nutrition
(FND). These results are consistent with a previous clinical study,
Pharming in 2002 under a pharmaceutical development plan, in which
use of rhLF was tested to a dose of 60 mg/kg in healthy volunteers.
safety studies showed that doses up to 2000 mg/kg/day were safe.
Human Lactoferrin is a natural protein that helps to fight and prevent
infections. The protein is present in substantial quantities in mother's
and plays an important role in the defense system of infants. The protein
also present in various body fluids and continues to play an important role
against a wide range of bacterial, fungal and viral pathogens in adults.
Out-licensing discussions aimed at finding partners interested in further
developing the Lactoferrin franchise are ongoing.
Bruno Giannetti, COO of Pharming said: "With this study in human volunteers
now complete an extensive dossier of safety studies on Pharming's
human Lactoferrin. We conclude that these latest results confirm previous
findings and together provide a very good basis to use rhLF as a food
and support for our ongoing discussions with potential partners and buyers
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of
medical needs. RUCONEST® is a recombinant human C1 inhibitor approved
treatment of angioedema attacks in patients with HAE in all 27 EU countries
Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish
Orphan Biovitrum (OMX: SOBI). RUCONEST® is partnered with Santarus,
(NASDAQ: SNTS) in North America where the drug is undergoing Phase III
development. The product is also being evaluated for follow-on indications
the areas of transplantation and reperfusion injury. The advanced
of the Company include innovative and validated platforms for the
protein therapeutics, technology and processes for the purification and
formulation of these products. A feasibility study, using the validated
transgenic rabbit platform, aimed at the development of recombinant Factor
for the treatment of Haemophilia A is underway with partner, Renova Life,
Additional information is available on the Pharming website,
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Source: Pharming Group N.V. via Thomson Reuters ONE