ISIN number NL 0000377018
Common code 15661178
Bloomberg symbol PHAR NA
Reuters symbol PHAR.AS
O/S 06/07/2012 724,248,676 http://www.pharming.com/index.php
Immunology 2011 Annual Meeting
- Specialty biopharmaceutical company Santarus, Inc. (NASDAQ: SNTS) and biotech company Pharming Group NV (NYSE Euronext: PHARM) today announced new data on 62 patients with Hereditary Angioedema (HAE) who received repeat treatment with the investigational drug RHUCIN® (recombinant human C1 inhibitor) for 168 acute angioedema attacks. The median time to beginning of relief of symptoms across treatments for repeat attacks was approximately 60 minutes with response rates that were consistently 90% or greater. This open-label study was an extension of the randomized, double-blind, placebo-controlled study conducted by Pharming in North America. The findings were presented Sunday, March 20, 2011 in a poster session at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2011 Annual Meeting in San Francisco.
Specialty biopharmaceutical company Santarus, Inc. (NASDAQ: SNTS) and biotech company Pharming Group NV (NYSE Euronext: PHARM) today announced the receipt of a "refusal to file" letter from the U.S. Food and Drug Administration (FDA) for the RHUCIN® (recombinant human C1 inhibitor) Biologics License Application (BLA) submitted by Pharming. In the letter the FDA indicated that the BLA was not sufficiently complete to enable a critical medical review.
December 03, 2010
Pharming Announces Euro 16.1 Million Investment From Socius Capital Group
Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced the Company has entered into a definitive agreement with Socius CG II, Ltd, a subsidiary of Socius Capital Group, LLC ("Socius"), a Delaware limited liability company. Socius, based in New York and Los Angeles, has completed financings with numerous life sciences and other emerging growth companies in the United States and Europe. Pharming will receive €16.1 million gross proceeds in cash in return for non-convertible debt notes and equity if Socius exercises its investment rights.
October 28, 2010
Pharming's Ruconest™ For HAE Granted European Marketing Authorization
Biotech company Pharming Group NV (Pharming or "the Company") (NYSE Euronext: PHARM) and Swedish Orphan Biovitrum (Sobi) (STO: SOBI) today announced that the European Commission has granted Pharming Marketing Authorization for its lead product Ruconest™ for the treatment of acute attacks of Hereditary Angioedema (HAE). Pharming will now receive a €5 million milestone payment from marketing and distribution partner Sobi.
September 13, 2010
Pharming Signs Commercialization Agreement With Santarus For Rhucin® In North America
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
August 25, 2010
Pharming Plans Submission Rhucin BLA To Us FDA End 2010
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that it intends to submit the Biologic License Application (BLA) to the US Food and Drug Administration (FDA) to obtain marketing approval for Rhucin® for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE). Following pre-BLA discussions with the FDA, Pharming is preparing the BLA dossier for submission towards the end of this year but no later than January 2011.
Ruconest is a novel biotech alternative to plasma derived C1inh for the
treatment of HAE attacks
- Identical amino acid sequence
- Differences in glycosylation profile
- Highly purified
• Approved at a higher dose (50U/kg) achieving optimal efficacy
- Similar affinity to target proteases
- Functional units are directly comparable (1vial of Ruconest> 4 vials of plasma product)
- Dose is more important driver of efficacy than half-life
- No relapse
• Reassuring safety profile
- No pharmacological AEs
- No induction of allergies observed
- No induction of neutralizing antibodies
- Contraindicated in pts with rabbit allergy
The Rabbit in the Hat; Initiating Coverage with a Buy Rating
We are initiating coverage of Pharming with a Buy rating and a $0.35 price target. The key investment driver for Pharming is its innovative transgenic animal platform for production of complex recombinant proteins for therapeutic use. With an E.U.-approved product and late stage development in the U.S. and several international partners, Pharming represents a potentially significant value proposition, in our view.