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New facility for Ruconest production

2020-11-19T08:12:42+01:00November 19, 2020|HAEi News|

Pharming Group N.V. will be building a new facility to expand the company’s downstream processing capacity for its lead product, Ruconest (recombinant C1 esterase inhibitor (rhC1INH). The downstream processing facility will include the purification, filtration and concentration of the starting material. Construction is planned to begin mid-2021 at Pivot Park in Oss, the Netherlands. Pivot [...]

Data from compassionate use program of Ruconest in COVID-19 patients

2020-08-17T15:17:58+01:00August 17, 2020|HAEi News|

Pharming Group N.V. announces the publication of data in the peer-reviewed journal, Frontiers in Immunology, from a compassionate use programme of five patients with confirmed COVID-19 (SARS-CoV-2) infections hospitalized with related severe pneumonia that were treated with Ruconest (recombinant human C1 inhibitor, conestat alfa) at the University Hospital Basel, Switzerland. As reported on 21 April [...]

First patient enrolled in COVID-19 clinical trial with Ruconest

2020-08-10T16:46:23+01:00August 10, 2020|HAEi News|

The first patient has been enrolled in a randomized, controlled, investigator-initiated clinical trial in up to 150 patients for the treatment with Ruconest (recombinant human C1 inhibitor) of patients with confirmed COVID-19 (SARS-CoV-2) infections hospitalised with related severe pneumonia at the University Hospital Basel in Basel, Switzerland. In April 2020, Pharming Group N.V. reported encouraging results [...]

Encouraging results from use of Ruconest in COVID-19 patients

2020-04-21T08:15:57+01:00April 21, 2020|HAEi News|

Pharming Group N.V. sees encouraging results from five patients with confirmed COVID-19 infections hospitalized with related severe pneumonia that were treated with Ruconest (recombinant human C1 inhibitor) under a compassionate use program at the University Hospital Basel, Switzerland. Four male patients and one female patient (between 53-85 years of age) with COVID-19 and suffering from [...]

Ruconest recommended for acute treatment of children

2020-03-30T18:56:15+01:00March 29, 2020|HAEi News|

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has recommended approval of Ruconest for the treatment of acute angioedema attacks in children with HAE. This marketing authorization would expand the age range of Pharming Group N.V.‘s lead product, a recombinant analogue of the human C1 esterase inhibitor produced [...]

FDA approval of new facility for expanded Ruconest production

2020-03-10T17:23:13+01:00March 10, 2020|HAEi News|

The US Food and Drug Administration (FDA) has approved Pharming Group N.V.’s Prior Approval Supplement to add the new Netherlands production facility of starting material to the Biologics License Application (BLA) to support its lead product Ruconest. With the addition of this new facility for US supplies as well, Pharming can continue to expand sales [...]

EMA approval of new Ruconest facility

2020-01-21T16:18:30+01:00January 21, 2020|HAEi News|

Pharming Group N.V. has received European Medicines Agency (EMA) approval of a Type II Variation for a new production facility for the Ruconest. With the addition of this new facility, Pharming will significantly increase the production capacity of Ruconest as it becomes fully operational over the coming year. Pharming is now also able to release [...]

Pharming reacquires Ruconest-licensed territories

2020-01-03T13:58:17+01:00December 30, 2019|HAEi News|

Pharming Group N.V. has entered into a definitive agreement with Swedish Orphan Biovitrum AB (publ) (“Sobi”) to reacquire the commercial rights to Pharming’s product, Ruconest, in all remaining territories, which includes all remaining EU markets. Under the agreement, the license is being terminated with effect from 1 January 2020 in all 36 countries with a [...]

FDA Acceptance for Review of sBLA for Ruconest

2018-01-19T12:21:20+01:00January 19, 2018|HAEi News|

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 [...]

Positive data from paediatric clinical trial with Ruconest

2017-10-02T16:58:26+01:00October 2, 2017|HAEi News|

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) [...]

Conclusion of FDA End-of-Phase 2 interactions on Ruconest

2017-09-11T22:08:03+01:00September 11, 2017|HAEi News|

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 Lancet publicizes RUCONEST® prophylactic data

2017-07-26T17:41:20+01:00July 26, 2017|HAEi News|

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 [...]

European Commission amends Marketing Authorisation for Ruconest

2017-05-31T19:25:10+01:00January 17, 2017|HAEi News|

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 [...]

CHMP adopts positive opinion to include self-administration for Ruconest

2017-05-31T19:25:12+01:00November 11, 2016|HAEi News|

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 acquire all North American commercialization rights to Ruconest

2017-05-31T19:25:12+01:00August 9, 2016|HAEi News|

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 Announces Positive Results from Trial with Ruconest

2016-07-18T19:51:45+01:00July 18, 2016|HAEi News|

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 amends Ruconest Distribution Agreement with Sobi

2016-07-15T02:41:43+01:00July 15, 2016|HAEi News|

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, [...]

Change in Marketing Authorization Terms For Ruconest

2017-05-31T19:25:12+01:00April 8, 2016|HAEi News|

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 And Cytobioteck Announce Extension Of Distribution Agreement For Ruconest

2017-05-31T19:25:13+01:00February 9, 2016|HAEi News|

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 [...]

Completion Of Patient Enrolment In Clinical Study Of Ruconest

2016-01-06T21:14:09+01:00January 6, 2016|HAEi News|

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 [...]

South Korean Marketing Authorization For Ruconest

2017-05-31T19:25:13+01:00December 21, 2015|HAEi News|

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 [...]

EMA Reaffirms Important Health Benefits And Safety Of Ruconest

2015-12-07T21:42:34+01:00December 7, 2015|HAEi News|

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 [...]

More patients are using Ruconest®

2017-05-31T19:25:13+01:00October 28, 2015|HAEi News|

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 [...]

FDA Grants Ruconest Twelve-Year Reference Product Exclusivity

2017-05-31T19:25:13+01:00October 8, 2015|HAEi News|

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 [...]

Ruconest – HAEi Global Access Program

2017-05-31T19:25:05+01:00July 21, 2015|

Ruconest® brand of recombinant C1-inhibitor (conestat alpha). Ruconest® is approved by FDA and EMA and is delivered intravenously. Ruconest® is approved for self-administration. Company: Pharming Group NV The HAEi Global Access Program enables patients to gain access to Ruconest®--through an ethical and regulatory compliant “Named Patient Program” mechanism--in all countries where the drug is not commercially [...]

HAEi Global Access Program for RUCONEST® Now Live

2017-05-31T19:25:13+01:00July 21, 2015|HAEi News|

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 Announces Interim Results From The Ongoing Phase II Pediatric Clinical Trial Of Ruconest

2017-05-31T19:25:13+01:00June 1, 2015|HAEi News|

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 And Cytobioteck Announce Distribution Agreement For Ruconest

2015-05-25T19:24:59+01:00May 25, 2015|HAEi News|

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 [...]

Operational highlights from Pharming

2020-11-02T14:54:02+01:00October 29, 2020|HAEi News|

At the presentation of the financial report for the nine months and third quarter ended 30 September 2020 Pharming Group N.V. CEO Sijmen de Vries says: “We are pleased to announce continued growth, demonstrating consistent progress, despite the impact of the COVID-19 pandemic. We remain focused on, and are delivering against, our strategy for long-term growth. [...]

Pharming’s financial results for first quarter 2020

2020-05-14T21:08:38+01:00May 14, 2020|HAEi News|

At the presentation of Pharming Group N.V.’s financial report for the first quarter of the year ended 31 March 2020 CEO Sijmen de Vries says: “We received EMA and FDA approval of our new production facility for Ruconest, which will double our production capacity once fully operational later this year. In addition, approval from the [...]

EC approval for treatment of acute HAE attacks in children

2020-04-30T15:06:09+01:00April 30, 2020|HAEi News|

The European Commission has approved an extension in the indication of Ruconest’s (conestat alfa) Marketing Authorisation to include the treatment of acute angioedema attacks in children with HAE. This marketing authorisation expands the age range of Pharming Group N.V.’s  lead product, Ruconest, a recombinant analogue of human C1 esterase inhibitor. Ruconest was previously approved for [...]

News from South Africa

2020-01-03T13:19:18+01:00December 30, 2019|South Africa|

From President Adrienne de Jongh, HAE South Africa: The Global Access Program importing Ruconest is now running smoothly and proving to be very successful. There is a fair amount of administration involved though and we are grateful that the staff at the Lung Clinic at Groote Schuur Hospital have been so helpful. We have been busy with the legal work [...]

2019 HAEi Regional Workshop South Eastern Europe

2020-01-03T13:42:20+01:00December 30, 2019|Albania, Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus, Greece, Kosovo, Montenegro, North Macedonia, Romania, Serbia, Slovenia, Turkey|

By Natasa Angjeleska, Regional Patient Advocate for South Eastern Europe: We successfully managed to realize the fourth regional HAE International South Eastern Europe workshop at the Marriott Hotel in Skopje, North Macedonia 27-29 September 2019. We had 85 participants representing 11 countries from the region, including one guest physician coming from Belarus that expressed interest to join us. The composition of [...]

News from South Africa

2019-07-16T17:22:25+01:00July 16, 2019|South Africa|

A ‘one-of-a-kind’ medication access program from HAE International is now successfully delivering potentially life-saving medication to HAE-patients in South Africa. “As no modern medications have been commercially available in South Africa until now, HAE patients have been unable to access them. The HAE International Global Access Program offers a regulatory compliant process that allows healthcare [...]

Life-saving medication to South African HAE patients

2019-07-16T13:31:49+01:00July 8, 2019|HAEi News|

A ‘one-of-a-kind’ medication access program from HAE International is now successfully delivering potentially life-saving medication to HAE-patients in South Africa. “As no modern medications have been commercially available in South Africa until now, HAE patients have been unable to access them. The HAE International Global Access Program offers a regulatory compliant process that allows [...]

HAEi Global Access Program provides life-saving medication to South African HAE patients

2019-05-22T10:13:47+01:00May 16, 2019|HAEi News|

A ‘one-of-a-kind’ medication access program from HAE International (HAEi) is now successfully delivering potentially life-saving medication to patients in South Africa, who suffer from the rare genetic condition hereditary angioedema (HAE).HAE causes severe and unpredictable swelling (edema) in different areas of the body including the hands, feet, and face. Patients experience bouts of excruciating abdominal [...]

News from Puerto Rico

2019-07-16T18:27:03+01:00April 9, 2019|Puerto Rico|

In the second half of March, HAEA Puerto Rico held its Patient Summit 2019 in San Juan. The main speakers were Professor Sandra Christiansen from the US HAEA Angioedema Center at UCSD, Director Bruce Zuraw from the US HAEA Angioedema Center at UCSD, MD Rafael Zaragoza who is President of the Puerto Rican Association of [...]

Clinical trials

2020-10-05T08:42:20+01:00February 20, 2019|

Clinical Trials According to the International Clinical Trials Registry Platform under the World Health Organization (WHO) and clinicaltrials.gov under the U.S. National Institutes of Health the following trials should be recruiting at this moment (updated 30 September 2020): A Long-Term Safety Study of BCX7353 in HAE – [...]

Serving an important role in the management of HAE

2019-02-22T11:33:56+01:00January 23, 2019|HAEi News|

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: [...]

HAEi Central Eastern Europe Conference and Workshop 2018

2019-07-09T13:45:32+01:00January 14, 2019|Belarus, Czech Republic, Hungary, Kasakhstan, Poland, Russia, Ukraine|

The HAEi Central Eastern European region is a massive one consisting of 12 countries with a population close to 300 million people – and with only around 15 per cent of all HAE patients diagnosed. Therefore, this region requires an individual approach and hands-on assistance in activities related to advocacy, gaining access to and [...]

Favorable conclusion from study of acute HAE therapies

2018-12-07T09:51:06+01:00December 7, 2018|HAEi News|

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 [...]

Additional clinical trial data for prophylaxis of HAE requested

2018-09-26T17:37:26+01:00September 19, 2018|HAEi News|

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 [...]

Pharming’s Financial Results for first half of 2018

2018-07-27T11:38:20+01:00July 27, 2018|HAEi News|

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 [...]

The HAEi Global Access Program helps changing lives of HAE patients

2019-05-07T08:42:37+01:00April 14, 2018|HAEi News|

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, [...]

News from Austria

2019-07-16T21:39:46+01:00March 16, 2018|Austria|

The 2017 version of the HAE Austria patient meeting took place in Linz with the participation of more than 20 HAE patients. The HAE Austria President Adelheid Huemer gave an overview of the development over the last decade – from two members in 2006 to more than 50 today and from only Berinert for emergency [...]

Pharming’s Preliminary Financial Results for 2017

2018-03-07T12:04:55+01:00March 7, 2018|HAEi News|

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 [...]

Supplemental Biologics License Application to FDA

2017-11-28T00:15:52+01:00November 28, 2017|HAEi News|

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 [...]

On the right track

2017-10-27T17:41:40+01:00October 27, 2017|HAEi News|

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 [...]

Glossário

2017-11-23T20:58:55+01:00October 20, 2017|

Encontra nesta página, um glossário relacionado com AEH. Se não encontrar o que procura, por favor não hesite em nos enviar uma nota com o tópico que pretende. Uma breve explicação das palavras e termos em AEH (Clicar em + para expandir e ver as explicações para essa letra específica) [...]

Glosario

2017-10-26T22:40:40+01:00October 20, 2017|

En esta página encontrará un glosario de términos relacionados con el AEH. Si no encuentra lo que busca, no dude en enviarnos una nota preguntándonos. Breve explicación de palabras y términos difíciles relacionados con el AEH (Haga clic en + para ampliar y ver las explicaciones para esa letra específica) [...]

Глоссарий

2017-10-25T00:50:20+01:00October 20, 2017|

На этой странице представлен глоссарий терминов НАО. Если вы не найдете интересующий вас термин , пожалуйста, отправьте нам сообщение с вопросом. Краткое пояснение сложных трудных слов и терминов по НАО (Нажмите значок "+", чтобы развернуть пояснения слов на выбранную конкретную букву) Аденома печени Доброкачественная печеночно-клеточная опухоль. Адреналин Адреналин (эпинефрин) – [...]

Glossar

2017-11-03T00:19:22+01:00October 20, 2017|

Auf dieser Seite werden Begriffe erklärt, die im Zusammenhang mit dem Hereditären Angioödem (HAE) wichtig sind. Falls Sie einen bestimmten Begriff vermissen, können Sie uns gern einen Hinweis schicken. Wichtige Begriffe im Zusammenhang mit dem HAE (Klicken Sie auf das Pluszeichen, um die Erläuterungen einzublenden.) Abdomen Abdomen ist die fachmedizinische [...]

Glossaire

2017-11-23T00:48:37+01:00October 20, 2017|

Vous trouverez sur cette page un glossaire de termes liés à l'AOH. Si vous ne trouvez pas ce que vous cherchez, n'hésitez pas à nous envoyer un message avec votre question. Explication succincte des mots et termes difficiles liés à l’AOH (Cliquez sur + pour développer et voir les explications données [...]

Pharming and HAEi partners with Inceptua for Global Access Program

2017-09-26T18:55:38+01:00September 26, 2017|HAEi News|

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 [...]

Recommendations for Prophylaxis and Treatment of HAE Attacks

2017-09-18T03:48:07+01:00September 18, 2017|HAEi News|

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 Reports on Financial Results for the First Half of 2017

2017-07-27T16:38:29+01:00July 27, 2017|HAEi News|

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 [...]

Financial report 2016 from Pharming Group

2017-05-31T19:25:10+01:00March 10, 2017|HAEi News|

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 announces progress on financing

2017-05-31T19:25:12+01:00November 15, 2016|HAEi News|

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 [...]

Financial report from Pharming

2017-05-31T19:25:12+01:00October 28, 2016|HAEi News|

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 [...]

Change to Pharming strategy now bearing fruit

2017-05-31T19:25:12+01:00May 19, 2016|HAEi News|

From the Pharming Group N.V. financial report for the first quarter ended 31 March 2016: During the quarter we initiated sales of Ruconest in the countries which Pharming now commercializes directly, in Germany, Austria and the Netherlands . These countries had proved very difficult for our partner SOBI prior to 2015 when we agreed to take [...]

Pharming’s Report on Preliminary Financial Results 2015

2016-03-10T18:17:32+01:00March 10, 2016|HAEi News|

In the financial report for the full year that ended 31 December 2015 Sijmen de Vries, CEO and Chairman of the Board of Pharming Group N.V. writes (in extracts): 2015 was the year that Pharming started to move forward again, after years of consolidation and transition. Sales of Ruconest grew well in 2015. This was most strongly seen in [...]

Pharming Supports Rare Disease Day

2017-05-31T19:25:13+01:00March 1, 2016|HAEi News|

Pharming Group N.V. reiterates it commitment to the treatment of rare diseases on Rare Disease Day 2016, an annual global initiative committed to improving public understanding of rare diseases and highlighting the exceptional challenges facing patients and their carers. Nearly 7,000 different rare diseases have been identified to date, directly affecting the daily life of [...]

Committee for Medicinal Products for Human Use issues positive opinion to European Commission

2017-05-31T19:25:13+01:00February 27, 2016|HAEi News|

Following evaluation of a dossier submitted by Pharming Group N.V. last year, the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to the European Commission on the company's request to include the treatment of HAE attacks in adolescents with HAE and to remove the requirements for rabbit IgE testing that forms part [...]

Pharming reports on financial results first half year 2015

2017-05-31T19:25:13+01:00July 30, 2015|HAEi News|

  Biotech company Pharming Group N.V. has published its (unaudited) financial report for the six months ended 30 June 2015. From the operational highlights: Following the completed acquisition of our US partner, Salix Pharmaceuticals by Valeant Pharmaceuticals (VRX), the Ruconest US commercial infrastructure remains intact and commercialisation continues to be unaffected. A steady inflow of new [...]

Unique patient organization-driven program

2017-05-31T19:25:13+01:00July 21, 2015|HAEi News|

The global collaboration between Clinigen Group plc and Pharming Group N.V. to provide access to Pharming’s Ruconest (conestat alfa) is now live. The unique access program was initiated by HAEi, the International Patient Organization for C1- Inhibitor Deficiencies. Ruconest is a recombinant human C1- inhibitor, approved by the European Medicines Agency (EMA) and US Food [...]

Unique HAEi Global Access Program launched

2017-05-31T19:25:13+01:00May 16, 2015|HAEi News|

Landmark global program opens access to HAE medicine to rare disease sufferers for the first time Lausanne, Switzerland – 16 May 2015 – Thousands of patients suffering from a rare and potentially fatal genetic disease will have access to medicines for the first time, with the launch of the HAEi Global Access Program (HAEi [...]

HAEi Global Access Program

2019-08-23T03:00:25+01:00May 8, 2015|

HAEi GLOBAL ACCESS PROGRAM Thousands of patients suffering from HAE will have access to medicines for the first time, with the launch of the HAEi Global Access Program, a landmark medication access program. HAEi is proud to announce the HAEi Global Access Program (HAEi GAP). It [...]

Pharming Reports On Financial Results For Q1 2015

2017-05-31T19:25:13+01:00April 30, 2015|HAEi News|

Pharming Group N.V. has published its (unaudited) financial report for Q1 2015 ended 31 March 2015. From the financial highlights: Ruconest sales in the US amounted to 0.6 million EUR and sales by Sobi in the EU amounted to 0.4 million EUR. Alongside Pharming realised initial direct sales in Austria, Germany and the Netherlands. Product [...]

Glossario

2017-10-24T23:09:21+01:00April 16, 2015|

In questa pagina troverete un glossario sulla terminologia HAE. Se non troverete ciò che state cercando non esitate a contattarci inviandoci un messaggio sul vostro argomento. Breve spiegazione sulle parole ed i termini più difficili dell’HAE (Fare clic su + per espandere e visualizzare le rispettive spiegazioni sulla lettera specifica) [...]

Glossary

2019-02-18T10:53:07+01:00April 16, 2015|

GLOSSARY A brief explanation of difficult words and terms in HAE On this page you will find a HAE related glossary. If you don't locate what you are looking for do not hesitate to send us a note with your topic. Click to expand and see the [...]

Nominations to Pharming’s Board Of Supervisory Directors

2015-04-07T13:18:02+01:00March 19, 2015|HAEi News|

Pharming Group N.V. has nominated Paul Jai Sekhri and Jan Hendrik Egberts as members of the Board of Supervisory Directors. The nominations will be subject to shareholders’ approval at the upcoming Annual General Meeting of Shareholders, which will take place on 30 April 2015. Mr. Sekhri (1958) has over 28 years of operational experience in [...]

Pharming Reports On Preliminary Financial Results 2014

2017-05-31T19:25:13+01:00March 5, 2015|HAEi News|

Pharming Group N.V. has published its preliminary (unaudited) financial results for the year ended 31 December 2014. From the financial highlights: Revenues from operations increased to 21.2 million EUR (2013: 6.8 million EUR) as a result of higher license fees, including the receipt of a 20.0 million USD (16 million EUR) milestone from US partner [...]

HAE treatment

2020-07-15T14:24:38+01:00December 30, 2014|

WHAT IS HAE? Approved HAE Treatments Six products are currently approved and registered by the FDA (the United States Food and Drug Administration), the EMA (the European Medicines Agency) and a number of other countries to treat HAE: Approved by: FDA EMA Berinert® brand of plasma [...]