Search results for: ruconest

The U.S. Food and Drug Administration (FDA) has accepted for review Pharming Group N.V.'s supplemental Biologics License Application (sBLA) for Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with HAE. The FDA has indicated that the sBLA is sufficiently complete to permit a substantive [...]

Pharming Group N.V. announces positive data from a clinical trial with the use of Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for the treatment of HAE attacks in children. The open-label, single arm, Phase II clinical trial was designed in agreement with the European Medicines Agency (EMA) as part of a Paediatric Investigation Plan (PIP) [...]

Pharming Group N.V. has concluded its End-of-Phase 2 interactions with the U.S. Food and Drug Administration (FDA). As part of these interactions, Pharming provided the FDA with the results of two completed Phase 2 trials of Ruconest for the prophylaxis of HAE attacks; a randomized, double-blind, placebo-controlled trial and an open-label study. The two studies [...]

The weekly peer-reviewed general medical journal The Lancet has published data from a Phase II, double-blind, placebo-controlled, randomized clinical trial (NCT02247739) evaluating the efficacy and safety of RUCONEST (C1 esterase inhibitor [recombinant]) for the prevention of HAE attacks. As previously reported, in a study with 32 patients RUCONEST® 50 IU/kg (max 4200 IU) demonstrated a [...]

Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP), the European Commission has adopted the Commission Implementing Decision to amend the marketing authorisation for Ruconest to include self administration using the Ruconest Administration Kit. This decision allows for self-administration of Ruconest for acute HAE attacks by adolescents and adults with a new [...]

The Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the European Medicine Agency (EMA), has adopted a positive opinion recommending an extension to the terms of the marketing authorisation for Ruconest to the European Commission. This recommendation will allow self-administration of Ruconest for acute HAE attacks by adolescents and adults with [...]

Pharming Group N.V. has entered into a definitive agreement to acquire all North American commercialization rights to its own product Ruconest (recombinant human C1 esterase inhibitor), including all rights in the US, Mexico and Canada, from Valeant Pharmaceuticals International, Inc. Ruconest is an orphan drug designated therapy developed by Pharming, already approved for the treatment of [...]

Pharming Group N.V. has announced positive results from a Phase 2 clinical study of Ruconest (recombinant C1 esterase inhibitor, 50 IU/kg) for prophylaxis in patients with HAE. In the study, Ruconest showed a clinically relevant and statistically significant reduction in attack frequency for both the twice-weekly and once-weekly treatment regimens as compared with placebo. 32 HAE patients [...]

Pharming Group NV and Swedish Orphan Biovitrum AB (Sobi) has signed an amendment of their Ruconest distribution agreement from 2009. In addition to Austria, Germany and Netherlands, Pharming will market Ruconest directly into an additional 21 countries, effective 1 October 2016. These countries include Algeria, Andorra, Bahrain, Belgium, France, Ireland, Jordan, Kuwait, Lebanon, Luxembourg, Morocco, Oman, Portugal, [...]

The European Commission has adopted the CHMP recommendation to include the treatment of HAE attacks in adolescents with HAE and to remove the requirements for rabbit IgE testing that formed part of the EU label for Ruconest. The CHMP also noted that the importance of favorable effects of Ruconest is further supported by the continued availability [...]

Pharming Group N.V. has extended the exclusive distribution agreement with Cytobioteck S.A.S., a privately owned Bogota, Colombia based specialty healthcare company, for the distribution of Ruconest® (recombinant, non-blood derived human C1 inhibitor) for the treatment of acute attacks of HAE by adding countries in Central and South America. Pharming entered into the original exclusive distribution [...]

Pharming Group N.V. has completed the patient enrolment in the Phase 2 clinical study of Ruconest, (recombinant C1 esterase Inhibitor, 50 IU/kg), for prophylaxis in patients with HAE. Thirty HAE patients deficient in C1 esterase Inhibitor and with a history of at least four attacks per month have been enrolled in the randomized, double-blind study. The patients [...]

Pharming Group N.V.  and it's Seoul based South Korean specialty pharma partner Hyupjin have received the marketing authorization for Ruconest in South Korea. Ruconest is approved for the treatment of acute angioedema attacks in adult patients with HAE. Effectiveness was not established in HAE patients with laryngeal and oro-pharyngeal attacks. HyupJin will now seek reimbursement for Ruconest [...]

The European Medicines Agency (EMA) has recently renewed the marketing authorization for Ruconest for an unlimited period. Ruconest, the first and only recombinant (non-blood-derived) C1-esterase inhibitor replacement therapy, was first approved by the EMA in June 2010 for the treatment of acute attacks of HAE. Such initial marketing authorisation is normally issued initially for five years, and [...]

Pharming Group N.V. has presented its unaudited financial report for the first nine months ended 30 September 2015. CEO Sijmen De Vries comments (in extract): "During the third quarter, the number of prescriptions for our lead product Ruconest® increased by 29%, which indicates more patients are using Ruconest® to deal with their HAE attacks. We expect [...]

The U.S. Food and Drug Administration (FDA) has granted 12 years of exclusivity to Ruconest® (C1 esterase inhibitor [recombinant]) 50 IU/kg. The determination of exclusivity ensures that FDA will not approve before July 16, 2026 any applications for biosimilars of Ruconest— i.e. applications for recombinant C1 esterase inhibitors referencing Ruconest submitted under section 351(k) of the [...]

Unique patient organization-driven program is enabling people with HAE who cannot access effective treatments to receive medication for the first time Leiden, Netherlands and Burton-on-Trent, UK – 21 July 2015 – Pharming Group N.V. (“Pharming or the Company”), Euronext: PHARM) and Clinigen Group plc (‘Clinigen’ or the ‘Group’, AIM: CLIN) today announce that their global [...]

Pharming Group NV presented new results, supporting its EMA and FDA approved HAE therapy RUCONEST®, at the 9th C1- Inhibitor Deficiency Workshop that took place in Budapest, Hungary, 28-31 May 2015. Several abstracts, including two oral presentations, were presented, which demonstrate Pharming’s ongoing commitment to advance innovative science in HAE, with the goal of addressing [...]

Pharming Group NV has entered into an exclusive distribution agreement with Cytobioteck S.A.S., a privately owned Bogota, Colombia based specialty healthcare company, for the distribution of RUCONEST® (recombinant human C1 inhibitor) for the treatment of acute attacks of HAE in Colombia and Venezuela. Under the agreement, Cytobioteck will drive all regulatory processes and will purchase [...]

Following the presentation of two abstracts at the Western Society of Allergy, Asthma and Immunology (WSAAI) in Maui, Hawaii, USA, the Pharming Group N.V. COO Bruno Giannetti (MD, PhD) said: “This real-world evidence demonstrates that Ruconest continues to serve an important role in the management of HAE despite the availability of other therapeutic options.” The presentations are: [...]

A new study examines and compares re-dosing rates inter alia for human C1 esterase inhibitor in recombinant form (Ruconest®) and plasma-derived forms (Berinert®, Cinryze®) to icatibant (Firazyr®) in seven individual patients at risk of HAE attacks. A total of 69 attacks were recorded.  The study was led by Professor Dr Marcus Magerl of the Department [...]

Pharming Group N.V. has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the supplemental Biologics License Application (sBLA) for Ruconest [C1 Esterase Inhibitor (recombinant)] to expand the current indication to include prophylaxis in patients with HAE. In November 2017, following feedback from FDA on two completed trials of [...]

On the presentation of the Pharming Group N.V. financial report for the six months ended 30 June 2018 CEO Sijmen de Vries said: “We are delighted with the further progress we have made expanding the reach of Ruconest, allowing more patients to access the clinical benefits of our product. We have continued net profitability in the second [...]

Since announcing the appointment of Inceptua Medicines Access as the new HAEi Global Access Program (GAP) distribution partner last year, HAEi has been responding to a number of inquiries from those in countries where RUCONEST® is not commercially available. “HAEi is committed to helping the global HAE patient community obtain access to life-saving modern therapies, [...]

At the presentation of the Pharming Group N.V. preliminary (unaudited) financial report for the full year ended 31 December 2017 CEO Sijmen de Vries said: "The remarkable growth reported in 2017 was a direct result of our strategic decisions to reacquire the commercial rights to Ruconest in North America and implement direct marketing in the major [...]

Pharming Group N.V. has submitted a supplemental Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with HAE. The submission includes data from two completed trials of Ruconest for the prophylaxis of [...]

Pharming Group N.V. presents its (unaudited) financial report for the first nine months and the third quarter ended 30 September 2017. Operational highlights during the third quarter On September 11, following the conclusion of the End-of-Phase 2 interactions with the US Food and Drug Administration (FDA), Pharming announced that it will submit a supplemental Biologics [...]

Pharming Group N.V in association with HAEi announce the appointment of Inceptua Medicines Access as their new distribution partner for the “HAEi Global Access Program” (HAEi GAP) enabling patients in all countries where Pharming’s product RUCONEST is not commercially available to gain access to the drug through an ethical and regulatory compliant mechanism.  It is [...]

The Food and Drug Administration (FDA) has recently received reports from patients, physicians, and specialty pharmacies that they have been unable to obtain C1-Esterase Inhibitor (Human) Cinryze. Healthcare providers and patients may wish to consider alternate treatment options, including: For Prophylaxis: Haegarda was recently licensed for prophylaxis of HAE attacks. Haegarda is administered subcutaneously, twice [...]

Pharming Group N.V. presents its (unaudited) financial report for the six months ended 30 June 2017. CEO Sijmen de Vries comments: "Our strategic decision to reacquire the commercial rights to sell RUCONEST in North America has significantly increased revenue and profit generation for the first half of the year compared to the first half of [...]

Pharming Group N.V. has presented its (unaudited) financial report for the full year ended 31 December 2016. Sijmen de Vries, CEO and Chairman of the Board of Management, comments: 2016 was a major year for Pharming. During the year we achieved a number of positive milestones that culminated in December in the game-changing re-acquisition of [...]

Pharming Group N.V. has made significant progress with financing towards completion of the transaction with subsidiaries of Valeant Pharmaceuticals International, Inc. signed on 8 August 2016 for Pharming to acquire the commercialization rights to its own product Ruconest in North America. The company has signed a term sheet with a syndicate of debt providers. The documentation [...]

Pharming Group N.V. presents its financial report for the nine months ended 30 September 2016. From CEO Sijmen de Vries' comments: After a relatively modest start to sales of Ruconest® (recombinant C1 esterase inhibitor, 50 IU/kg) in 2016, revenue growth during the third quarter has significantly increased. Sales efforts in the US drove this growth. We [...]