Jimbers
9 años hace
Expanding the around globe!
Pharming And Cytobioteck Announce Extension Of Distribution Agreement For Ruconest®
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Leiden, The Netherlands, 09 February 2016: Pharming Group N.V. (“Pharming” or “the Company”) (Euronext: PHARM) announced today that it has extended the exclusive distribution agreement with Cytobioteck S.A.S. (“Cytobioteck”), 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 Hereditary Angioedema (HAE) by adding countries in Central and South America.
Pharming entered into the original exclusive distribution agreement with Cytobioteck in May 2015 for the distribution of RUCONEST® in Colombia and Venezuela. Under the extended agreement, Cytobioteck will also exclusively distribute RUCONEST® in Argentina, Costa Rica, the Dominican Republic and Panama. Cytobioteck will continue to drive all regulatory processes and purchase its commercial supplies of RUCONEST® from Pharming at a fixed transfer price.
Sijmen de Vries, Pharming’s CEO, commented: “We are very pleased that we have been able to extend the agreement with Cytobioteck for the distribution of RUCONEST® in Central and South America. Over the past year Cytobioteck have made good progress with the regulatory processes in Colombia and Venezuela and several emergency treatments have already been provided to HAE patients in these countries in accordance with local regulations.”
Cytobioteck’s CEO, Dr. Osvaldo Piñeros, commented: “We look forward to being able to provide HAE patients with RUCONEST® in Argentina, Costa Rica, the Dominican Republic and Panama, in addition to Colombia and Venezuela. Our role is to deliver the best therapies available for our patients and we believe RUCONEST® provides a significant treatment option for HAE patients as the one and only recombinant, non-blood derived C1-esterase inhibitor replacement therapy with a proven and consistent efficacy and safety profile.”
plumo
10 años hace
Pharming Confirms Receipt Of US$20 Million Milestone Payment From Salix Pharmaceuticals
Leiden, 04 November 2014 - Biotech company Pharming Group NV (“Pharming” or “the Company”) (EURONEXT: PHARM), today announced the receipt of a US$20 million milestone payment from Salix Pharmaceuticals (“Salix”). The milestone was paid according to the terms and conditions of the Ruconest® commercialization agreement between Salix and Pharming.
Sijmen de Vries, Pharming CEO, commented, “The US launch of Ruconest®, as announced yesterday, and the receipt of the US$20 million milestone from Salix, mark what we perceive as the beginning of a new era for Pharming. The receipt of this milestone payment strengthens our debt-free balance sheet to more than €38 million as of today. From this solid basis, as result of future receipts of 30% of US net sales, up to $100 million annu
al sales, increasing stepwise up to 40% for annual US sales in excess of US$100 million for the supply of Ruconest® to Salix and in addition growing revenues from EU sales, both from our own direct commercialization and by Sobi, we are now aiming for our goal of achieving financial sustainability of the Company.
plumo
10 años hace
Salix & Pharming Announce the Launch of RUCONEST® in the U.S. for the Treatment of Acute Angioedema Attacks in Patients with...
Today : Monday 3 November .
RUCONEST® (C1 Esterase Inhibitor [Recombinant]) 50 IU/Kg is the First and Only Recombinant Treatment Option Available in the U.S. for Adult and Adolescent Patients Suffering from HAE
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Pharming Group NV (EURONEXT: PHARM) today announced the launch of RUCONEST® (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg in the United States for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). Effectiveness in clinical studies was not established in HAE patients with laryngeal attacks. Today’s announcement follows the July approval of the drug by the Food and Drug Administration.
“We’re excited to offer the only recombinant C1 esterase inhibitor therapy for HAE in the United States,” said Carolyn J. Logan, President and Chief Executive Officer of Salix. “RUCONEST treats the root cause of HAE attacks, which has been shown to raise C1 inhibitor levels to within the normal range. RUCONEST can be self-administered by appropriately trained patients and is effective at stopping most HAE attacks in one dose.”
RUCONEST, a recombinant C1 esterase inhibitor, can be administered by the patient after receiving training by a healthcare provider. RUCONEST is over 98 percent pure, and because it is not made from human plasma, it does not carry any known risk of passing on viruses that can be found in human blood.
HAE is a rare genetic condition that affects between 1 in 10,000 to 1 in 50,000 people. It causes episodes of swelling in various parts of the body, including the hands, feet, abdomen and face. Patients with abdominal swelling often experience severe pain, nausea and vomiting. HAE attacks stem from a deficiency of the C1 inhibitor protein in the blood. The disease is often misdiagnosed, as the symptoms of an attack can mirror someone experiencing an allergic reaction. Severe, painful swelling can occur at any time, which means most people suffering from HAE deal with the constant fear of when their next attack might surface and how that might impair their lives and those around them.
“HAE is an especially challenging disease for patients to manage,” said Anthony Castaldo, President of the Hereditary Angioedema Association (US HAEA), a non-profit patient services and research organization with a membership of over 5,000 HAE patients in the United States. “If left untreated, patients can experience attacks that are incredibly painful and, because of its unpredictability, HAE interferes with daily life. We’re pleased HAE patients now have another treatment option available to them.”
RUCONEST is available by prescription across the United States through RUCONEST SOLUTIONS and comes with comprehensive patient support services. For more information, including an opportunity for a free trial of RUCONEST, visit Ruconest.com or call RUCONEST® SOLUTIONS at (855) 613-4HAE.
RUCONEST is manufactured by Pharming Group NV in the Netherlands. Salix has licensed exclusive rights from Pharming to commercialize RUCONEST® in North America and market RUCONEST for the treatment of acute HAE attack symptoms.
“RUCONEST’s availability in the United States marks a significant milestone for Pharming,” said Sijmen de Vries, CEO of Pharming. “RUCONEST has helped patients in other countries around the world and we look forward to seeing the difference it will make in the lives of HAE patients in the U.S.”
Indication:
RUCONEST® is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Effectiveness in clinical studies was not established in HAE patients with laryngeal attacks.
Important Safety Information for RUCONEST
RUCONEST® (C1 esterase inhibitor [recombinant]) is contraindicated in patients with a history of allergy to rabbits or rabbit-derived products, and patients with a history of life-threatening immediate hypersensitivity reactions to C1 esterase inhibitor preparations, including anaphylaxis.
Severe hypersensitivity reactions may occur. The signs and symptoms of hypersensitivity reactions may include hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and/or anaphylaxis during or after injection of RUCONEST. Should symptoms occur, discontinue RUCONEST and administer appropriate treatment. Because hypersensitivity reactions may have symptoms similar to HAE attacks, treatment methods should be carefully considered.
Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of plasma derived C1 esterase inhibitor products in patients with risk factors. Risk factors may include the presence of an indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, and immobility. Monitor patients with known risk factors for TE events during and after RUCONEST administration.
RUCONEST has not been studied in pregnant women; therefore, it should only be used during pregnancy if clearly needed.
The most common adverse reactions (incidence =2%) were headache, nausea, and diarrhea. The serious adverse reaction in clinical studies of RUCONEST was anaphylaxis.
Please see complete Prescribing Information for RUCONEST.
About RUCONEST®
RUCONEST® (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg is an injectable medicine that is used to treat acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). HAE is caused by a deficiency of the C1 esterase inhibitor protein, which is present in blood and helps control inflammation (swelling) and parts of the immune system. A shortage of C1 esterase inhibitor can lead to repeated attacks of swelling, pain in the abdomen, difficulty breathing and other symptoms. RUCONEST® contains C1 esterase inhibitor at 50 IU/kg.
When administered at the onset of HAE attack symptoms at the recommended dose, RUCONEST works to return a patient’s C1-INH levels to normal range and quickly begins to relieve the symptoms of an HAE attack with a low recurrence of symptoms.
RUCONEST is the first and only plasma-free, recombinant C1-INH approval from the U.S. Food and Drug Administration (FDA) and was approved in July 2014.
RUCONEST has been granted Orphan Drug designation by the FDA for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE). With RUCONEST now approved by the FDA, Salix believes this designation should provide seven years of marketing exclusivity in the United States.
biginvestors
10 años hace
LEIDEN (Reuters) - The Leiden biotechnology company Pharming takes some possessions of the bankrupt French counterpart TRM SASU. That made the Leiden company announced on Tuesday. The sale is a sum of 500,000 euros.
Pharming receives as a result of the acquisition access to five new product development, including for the treatment of Pompe disease, disease Farby and Gaucher disease. Pharming has access to knowledge regarding transgenic rabbits developed by TRM.
Pharming has deliberately chosen to take over. Only part of the activities of the French counterpart ,, Pharming is particularly interested in the developments related to the complex proteins, "confirmed CEO Sijmen de Vries, Pharming.,, We will be in Paris to continue looking for drugs for rare and life-threatening genetic diseases."
According to De Vries, it is too early to speak. Already possible results ,, We now further optimize research, "he.,, Continued Only after you decide on whether or not pre-clinical research and further steps. So really concrete results as a result of the acquisition to still take some time."
LEIDEN (AFN) - Het Leidse biotechnologiebedrijf Pharming neemt een aantal bezittingen over van de failliete Franse branchegenoot TRM SASU. Dat maakte het Leidse bedrijf dinsdag bekend. Met de koop is een bedrag van 500.000 euro gemoeid.
Pharming krijgt als gevolg van de acquisitie toegang tot vijf nieuwe productontwikkelingen, onder meer voor de behandeling van de ziekte van Pompe, de ziekte van Farby en de ziekte van Gaucher. Daarnaast heeft Pharming toegang gekregen tot kennis met betrekking tot transgene konijnen die is ontwikkeld door TRM.
Pharming heeft er bewust voor gekozen om slechts een deel van de activiteiten van de Franse branchegenoot over te nemen. ,,Pharming is vooral geïnteresseerd in de ontwikkelingen met betrekking tot de gecompliceerde eiwitten", bevestigde topman Sijmen de Vries van Pharming. ,,Wij zullen in Parijs verder zoeken naar medicijnen voor de zeldzame en levensbedreigende genetische ziekten."
Volgens De Vries is het te vroeg om al over eventuele resultaten te spreken. ,,Wij gaan nu onderzoek verder optimaliseren", vervolgde hij. ,,Pas daarna beslis je over al dan niet preklinisch onderzoek en verdere stappen. Dus echt concrete resultaten als gevolg van de overname laten nog wel even op zich wachten."
plumo
12 años hace
Santarus and Pharming Announce Submission of RUCONEST Biologics License Application to FDA
SAN DIEGO & LEIDEN, Netherlands--(BUSINESS WIRE)-- Santarus, Inc. (NASDAQ: SNTS) and Pharming Group NV (NYSE Euronext: PHARM) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RUCONEST® (recombinant human C1 esterase inhibitor) 50 U/kg, an investigational drug for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE).
The safety and efficacy of RUCONEST for the treatment of HAE attacks were evaluated in a clinical program that included a Phase III randomized placebo-controlled study conducted under a Special Protocol Assessment agreement with the FDA. The pivotal Phase III clinical study showed statistically significant and clinically relevant improvement in the primary endpoint of time to beginning of relief of symptoms for RUCONEST compared with placebo. The RUCONEST clinical program also included two additional randomized placebo-controlled studies and four open label treatment studies. In total, the BLA dossier includes ten clinical studies covering 940 administrations in 236 subjects.
Santarus licensed certain exclusive rights from Pharming to commercialize RUCONEST in North America for the treatment of acute attacks of HAE as well as other potential future indications. Under the terms of the license agreement, a $5 million milestone is payable to Pharming upon FDA acceptance for review of the BLA for RUCONEST.
About RUCONEST and Hereditary Angioedema
RUCONEST (INN conestat alfa) is a recombinant version of the human protein C1 esterase inhibitor, and is produced with Pharming's proprietary transgenic technology. RUCONEST is approved in Europe for the treatment of acute angioedema attacks in patients with HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 esterase inhibitor, resulting in unpredictable and debilitating episodes of intense swelling. The swelling may occur in one or more anatomical areas, including the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals. RUCONEST is an investigational drug in the U.S. and has been granted orphan drug designation by the FDA both for the treatment of acute attacks of HAE and for prophylactic treatment of HAE.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of unmet medical needs. RUCONEST® is a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum. RUCONEST® is partnered with Santarus, Inc. (NASDAQ: SNTS) in North America and a BLA for RUCONEST was submitted to the FDA in April 2013. The product is also being evaluated for various follow-on indications. Pharming has a unique GMP compliant, validated platform for the production of recombinant human proteins that has proven capable of producing industrial volumes of high quality recombinant human protein in a more economical way compared to current cell based technologies. Pharming now plans to utilise this platform for the development of rhFVIII for the treatment of Haemophilia A. Additional information is available on the Pharming website, www.pharming.com.
About Santarus
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company's current commercial efforts are focused on five products. UCERIS™ (budesonide) extended release tablets for the induction of remission in patients with active, mild to moderate ulcerative colitis and ZEGERID® (omeprazole/sodium bicarbonate) for the treatment of certain upper gastrointestinal disorders are promoted to gastroenterologists. 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, and FENOGLIDE® (fenofibrate) tablets, which is indicated as an adjunct to diet to reduce high cholesterol, are promoted to endocrinologists and other physicians who treat patients with type 2 diabetes. Full prescribing and safety information for Santarus' products is available at www.santarus.com.
Santarus' product development pipeline includes the investigational drug RUCONEST® (recombinant human C1 esterase inhibitor). A BLA for RUCONEST was submitted to the FDA in April 2013 for the treatment of acute angioedema attacks in patients with HAE. Santarus is also developing rifamycin SV MMX®, which is in Phase III clinical testing for treatment of travelers' diarrhea. In addition, the company has completed a Phase I clinical program with SAN-300, an investigational monoclonal antibody. More information about Santarus is available at www.santarus.com.
Santarus and Pharming caution you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus or Pharming that any of its plans or objectives will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus and Pharming's businesses, including, without limitation: whether the FDA will accept the RUCONEST BLA for review following submission and ultimately approve it; whether the FDA will concur with the clinical interpretation of the Phase III study results or the conduct of the study; whether the FDA ultimately will require additional clinical studies or other development programs before accepting the RUCONEST BLA or approving RUCONEST; risks related to Santarus' dependence on Pharming for many functions related to RUCONEST, and Pharming's ability to continue to perform these functions based on its limited financial resources; risks related to the license and supply arrangements between Santarus and Pharming, including the potential for termination of the arrangements; other difficulties or delays in development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus and Pharming's products; and other risks detailed in prior press releases as well as in public periodic filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and neither Santarus nor Pharming undertakes any obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Santarus®, FENOGLIDE®, UCERIS™, and ZEGERID® are trademarks of Santarus, Inc. GLUMETZA® is a trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET® is a trademark of VeroScience LLC. MMX® is a trademark of Cosmo Technologies Limited. RUCONEST® is a trademark of Pharming Group N.V.
plumo
12 años hace
Directorate Change
Leiden, The Netherlands, August 3, 2012.Biotech company Pharming Group NV (?Pharming? or ?the Company?) (NYSE Euronext: PHARM) today announces that Karl Keegan, Chief Financial Officer, is leaving the Company in order to pursue a position based in the UK. Karl will step down from his role as CFO and resign from the Board of Management and the Company as of end of August. In view of the recently announced downsizing of the organization and Karl?s upcoming departure, the future size of the Board of Management will also be evaluated. Following Karl?s departure, his responsibilities as CFO will be assigned to Sijmen de Vries, Chief Executive Officer.
Sijmen de Vries, Pharming CEO, said: ?On behalf of Pharming I would like to thank Karl for his hard work and significant contribution since joining the Company two years ago, particularly his efforts in securing financing for the Company in the face of challenging funding conditions for biotechs. We wish Karl all the best in his future endeavours.?
plumo
12 años hace
Pharming Announces Restructuring Plan
Leiden, The Netherlands, August 2, 2012. Biotech company Pharming Group NV (?Pharming? or ?the Company?) (NYSE Euronext: PHARM) today announced a strategic restructuring plan of its Dutch operations designed to accelerate the Company's path to sustainability and future profitability. The proposed plan, which necessitates a request for ?collective redundancies?, was filed with the Dutch authorities (UWV Werkbedrijf, in accordance with the ?Wet Melding Collectief Ontslag?). The process entails a formal procedure, required when there is a need for downsizing of an organisation by 20 staff or more. The plan continues the restructuring initiated in June by the closure and subsequent sale of Pharming?s US facility.
Post the completion of this restructuring, the organisation will have maintained full capabilities to execute tec hnology transfers of platform technology and product processes as well as retaining all product development associated know-how. Furthermore, Pharming will continue to participate in existing collaborative product development and to pursue potential partnerships in the future.
The Company will thus maintain sufficient personnel to achieve these strategic objectives by aligning the staffing resources and potential partnering requirements of the organisation with its strategic needs post the anticipated finish of Study 1310 (our US pivotal trial) and submission of the Ruconest BLA to the FDA .
As a result of the restructuring, the Company aims to reduce costs by approximately ? 3.5-5 million annually over the coming 12-18 months. The timing of the plan will be influenced by external (e.g. authorities and business development activities) and internal influences (operational deliverables).
Pharming's Works Council has yet to advise on the restructuring plan, according to the Works Councils Act art 25. Following the decision of the authorities and the advice of the Works Council, the plan will be implemented.
?This restructuring will allow Pharming to implement the next steps in its business strategy: transitioning from a mainly internal research driven model to a market driven, externally focused, collaborative research and development model?, said Sijmen de Vries, CEO. ?It is clear that Pharming must adopt a leaner, more cash efficient business model if it is to survive in the longer term and we firmly believe that these actions will help to re-position Pharming to create value for our stakeholders.?
plumo
12 años hace
Pharming Secures €10 Million Working Capital Facility From Existing Investors
Leiden, The Netherlands, August 1, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announces that it has secured an equity working capital facility of up to €10 million for a two year term, with Kingsbrook Opportunities Master Fund LP as lead investor and other institutional investors (“the Investors”).
The working capital facility should enable Pharming’s cash runway to reach the anticipated read out of Study 1310 for Ruconest in the US and the associated US$10 million milestone payment (upon successful read out of the study) and a further US$5 million upon acceptance of the BLA by the FDA from US partner, Santarus, Inc.
Pharming will have the option to draw from the working capital facility in tranches in exchange for ordina ry shares in the capital of the Company. Pharming will retain control of the timing and amount of any funds draw down. Pharming must give notice to the Investors (a “Draw Down Notice”) prior to drawing down funds. Each Draw Down Notice will state the number of ordinary shares Pharming wishes to sell to the Investors (“the Draw Down Amount”). The Investors have the option to purchase up to 600% of the Draw Down Amount.
On signing, the Investors will receive warrants to purchase up to an aggregate of 16,500,000 ordinary shares in the capital of the Company. When draw downs have exceeded a total of €2,500,000 and for every subsequent €2,500,000 drawn, the Investors will receive additional warrants to purchase up to an additional 16,500,000 ordinary shares. The warrants have an exercise period of five years and are exercisable at a strike price equal to 110% of the average of the volume weighted average price of the ordinary shares o n the market for the 10 trading days prior to the signing of this agreement.
Sijmen de Vries, CEO, said “Pharming is very pleased to have secured this facility against a backdrop of extremely difficult conditions in the capital markets. The facility can be used at Pharming’s option and should enable Pharming to reach the unblinding of Study 1310. This financing has been achieved as part of the ongoing strategic review and is a key component of strengthening the Company’s cash position”.
Roth Capital Partners LLC acted as sole placement agent in this transaction.
plumo
12 años hace
Pharming Confirms Safety Profile Of Recombinant Human Lactoferrin In A Food Safety Study In Healthy Human Volunteers
Leiden, The Netherlands, July 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) is safe, based on the assessment of clinical data, gastro-intestinal tolerance and adverse event reporting.
Twenty-four healthy subjects with an age-range of 25 to 49 years participated in the study. These volunteers consumed recombinant human Lactoferrin at a daily dose of 0, 300 or 1000 mg, in combination with 10 grams of skimmed milk powder. Each treatment was consumed for a period of two weeks. There was no difference between treatment and placebo and it was concluded that con sumption of rhLF is safe. The study was supported by a grant from the Dutch Food and Nutrition Delta (FND).These results are consistent with a previous clinical study, undertaken by Pharming in 2002 under a pharmaceutical development plan, in which intravenous use of rhLF was tested to a dose of 60 mg/kg in healthy volunteers. Pre-clinical 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 milk and plays an important role in the defense system of infants. The protein is 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: &ldq uo;With this study in human volunteers we now complete an extensive dossier of safety studies on Pharming’s recombinant human Lactoferrin. We conclude that these latest results confirm previous findings and together provide a very good basis to use rhLF as a food ingredient and support for our ongoing discussions with potential partners and buyers for the project.”
plumo
12 años hace
Pharming Updates On Shares In Issue
Leiden, The Netherlands, July 6, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) announced today that it issued the final amount of shares due to bondholders.
As announced in Pharming’s press release dated December 23, 2011; under the €8.4 million private bond, which has now been redeemed in shares in full, a top- up payment in shares caused by the drop in share price over the last month has become due. Therefore 35,256,025 shares will be issued to the bondholders. This is the final payment under the terms and conditions of the bond.
As of today, the number of outstanding shares has increased from 688,992,651 to 724,248,676.
plumo
12 años hace
Pharming Completes Recruitment Of Ruconest® US Pivotal Phase III StudyLeiden, The Netherlands, July 05, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announces that it has reached full recruitment of its ongoing US pivotal Phase III clinical study (Study 1310) evaluating the investigational drug RUCONEST® (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE). 75 randomized patients are in the study and no further patients will be entered.
Study 1310 will now continue until such time that either all of the treated patients have received an open label treatment for a subsequent HAE attack, or until 90 days have lapsed since their randomized attack. This will be followed by the analysis of the results. Positive results of the study will trigger a US$ 10 million m ilestone payment to Pharming from its US partner Santarus Inc.
Currently 53 of the 75 patients have experienced a repeat attack or achieved a 90 day attack free period.
Bruno Giannetti, COO of Pharming, said, “Completion of recruitment into this clinical study is an important milestone for Pharming. As previously stated, the final step to completion of the trial consists of an additional follow up period of up to 90 days, depending on when patients experience a subsequent attack.
However, it is a generally accepted assumption that approximately one to two attacks occur per month in otherwise untreated HAE patients, suggesting that those individuals in our study may typically experience a subsequent attack significantly sooner than 90 days post their randomized attack.”
plumo
12 años hace
Pharming Announces Sale Of US Facilities
Leiden, The Netherlands, July 03, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) announced today that it had signed an agreement to sell the tangible assets of its US operations. Following the announcement of the closure of the US based cattle platform research operations, a swift process has lead to the sale of the tangible assets; the farm buildings and surrounding land in Wisconsin, to Sexing Technologies, a private company based in Navasota, Texas. Sexing Technologies Inc. specializes in the genetic improvement and reproductive services and export of livestock, primarily through the production and commercialization of sexed sorted semen and embryos, around the globe (http://www.sexingtechnologies.com/). Please refer to our press release of 25 June 2012 for more deta ils on the closing of the US based research facilities.
Further discussions concerning the sale of some of the legacy projects that were primarily located in the US operation are ongoing.
plumo
12 años hace
Effects of C1 Inhibitor on Tissue Damage in a Porcine Model of Controlled HemorrhageDalle Lucca, Jurandir J.*; Li, Yansong*; Simovic, Milomir*; Pusateri, Anthony E.†; Falabella, Michael*; Dubick, Michael A.‡; Tsokos, George C.§
AbstractABSTRACT: Activation of the complement system has been associated with tissue injury after hemorrhage and resuscitation in animals. We investigated whether administration of recombinant human C1-esterase inhibitor (rhC1-INH), a regulator of complement and contact activation systems, reduces tissue damage and cytokine release and improves metabolic acidosis in a porcine model of hemorrhagic shock. Male Yorkshire swine were assigned to experimental groups and subjected to controlled, isobaric hemorrhage to a target mean arterial pressure of 35 mmHg. Hypotension was maintained for 20 min followed by a bolus intravenous injection of rhC1-INH or vehicle; animals were then observed for 3 h. Blood chemistry and physiologic parameters were recorded. Lung and small intestine tissue samples were subjected to histopathologic evaluation and immunohistochemistry to determine the extent of injury and deposition of complement proteins. Cytokine levels and quantitative assessment of renal and hepatic function were measured via enzyme-linked immunosorbent assay and chemistry analyzer, respectively. Pharmacokinetics of rhC1-INH revealed dose proportionality for maximum concentration, half-life, and the time span in which the functional C1-INH level was greater than 1 IU/mL. Recombinant human C1-INH significantly reduced renal, intestinal, and lung tissue damage in a dose-dependent manner (100 and 250 IU/kg). In addition, rhC1-INH (250 IU/kg) markedly improved hemorrhage-induced metabolic acidosis and circulating tumor necrosis factor a. The tissue-protective effects of rhC1-INH appear to be related to its ability to reduce tissue complement activation and deposition. Recombinant human C1-INH decreased tissue complement activation and deposition in hemorrhaged animals, improved metabolic acidosis, reduced circulating tumor necrosis factor a, and attenuated tissue damage in this model. The observed beneficial effects of rhC1-INH treatment on tissue injury 20 min into severe hypotension present an attractive model of low-volume resuscitation, particularly in situations with a restrictive medical logistical footprint.
plumo
12 años hace
New Data Published On Ruconest’s Protective Effects After Severe Blood Loss
Leiden, The Netherlands, July 02, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) announced today that recombinant human C1 inhibitor (rhC1INH; RUCONEST®) has been shown to have a protective effect in a preclinical animal model of severe blood loss designed to simulate battlefield injuries.
These results can be found online here and will be published in print in July 2012 in Shock issue 38:1.
Dr Dalle Lucca et al. found that rhC1INH reduced tissue damage in this pig based model of severe hemorrhage, the tissue damage, following hemorrhage, strongly resembles that of ischemia-reperfusion injury (IRI). These findings further suppo rt the application of rhC1INH in the prevention of IRI such as that found after transplantation, myocardial infarction, major vascular surgery and trauma. Pharming and its partners continue to be interested in the broad therapeutic area of IRI and are reviewing several of these indications for potential future clinical development.
This study was funded by the US Army Medical Research and Materiel Command.
plumo
12 años hace
Pharming Announces Presentation Of New Ruconest® Clinical Data
Leiden, The Netherlands, June 18, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today presented clinical safety and efficacy data for Ruconest® (recombinant human C1 inhibitor, or rhC1INH) at the annual meeting of the European Academy of Allergy and Clinical Immunology (EAACI), Geneva, Switzerland, 16 to 20 June 2012.
The new data covers a number of aspects that are relevant to the increasing number of physicians that use Ruconest in the day-to-day treatment of HAE patients in the European Union: Efficacy and safety data for Ruconest in the treatment of adolescents suffering from acute attacks of HAE; underpinning a potential extension of the European labeling of Ruconest and “real- life” experience by French physicians; building confidence in Ruconest by successf ul treatment with Ruconest of a HAE patient that previously failed various other treatments.
In addition an analysis of a previously reported open- label study to explore potential benefits of Ruconest in prophylaxis of HAE, potentially an additional indication that could be explored.
The headlines and authors of the poster presentations are:
Toubi et al: “Safety and Efficacy evaluation of rhC1INH for the treatment of HAE attacks in adolescent patients”. This analysis reviewed data from 16 adolescent HAE patients who were treated for a total of 50 angioedema attacks with Ruconest. Patients were treated up to 7 times for HAE attacks at all locations. Median times to onset of symptom relief for successive attacks ranged from 19 to 123 minutes. Median times to minimal symptoms ranged from 120 to 650 minutes. Ninety percent of the attacks responded within 4 hours after treatment, and none of the attacks relapsed. The most frequentl y reported adverse event was headache. No hypersensitivity reactions and no drug-related serious adverse events were observed. No treatment-emergent antibodies developed in these patients.
Bouillet et al: The case of a type III HAE patient who failed several therapies and was successfully treated with Ruconest.
Reshef et al: “Safety and Efficacy of a weekly infusion of Recombinant Human C1 Inhibitor (rhC1INH) for Prophylaxis of Hereditary Angioedema (HAE) attacks”. This was an open label study on the prophylactic effect of once-weekly administration of Ruconest in 25 HAE patients. Patients included in this study had a history of frequent HAE attacks, with a significant impact on their quality of life. The frequency of HAE attacks during the 8 week treatment period was reduced by approximately 50 percent, from a median of 0.6 attacks per week to 0.3. The repeated administrations were generally safe and well-tolerated.
A bout the EAACI Annual Meeting
The EAACI Congress 2012 will attract around 7000 international clinicians, researchers and allied health professionals. This is the most important professional meeting for advances in research, treatment and prevention of allergic and immunologic diseases (such as asthma, rhinitis, eczema and occupational allergy, food and drug allergy, severe anaphylactic reactions, rheumatic and autoimmune diseases, AIDS). More information on the congress can be found on www.eaaci2012.com.
RUCONEST® Phase III Study
Pharming is conducting a Phase III clinical study with RUCONEST® under a Special Protocol Assessment (SPA) that is intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). RUCONEST is being evaluated for the treatment of acute attacks of angioedema in patients with HAE in an international, multicenter, randomized, placebo-contro lled Phase III study at a dosage of 50 U/kg with a primary endpoint of time to beginning of relief of symptoms. Santarus has licensed certain exclusive rights from Pharming to commercialize RUCONEST in North America for the treatment of acute attacks of HAE and other future indications. Under the terms of the license agreement, a $10 million milestone is payable to Pharming upon successful achievement of the primary endpoint of the Phase III clinical study. The study is expected to be completed in Q3 2012.
plumo
12 años hace
Pharming Updates On Study 1310 And Shares In Issue
Leiden, The Netherlands, June 15, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today provides a short update from its press release dated June 12, 2012.
Study 1310, the Phase III clinical study with RUCONEST® that is intended to support the submission of a Biologics License Application (BLA) to the US FDA, continues to recruit with additional patients enrolled this week. Currently 70 of the 75 patients required for the completion of Study 1310 have been treated.
In addition, as announced in Pharming’s press release dated December 23, 2011; under the €8.4 million private bond, which has now been redeemed in shares in full, a top- up payment in shares caused by the drop in share price over the last month has become due. Therefore 18,330,106 shares will be issued to the bondholders under the terms and conditions of the bond.
As of today, the number of outstanding shares has increased from 670,662,545 to 688,992,651.
plumo
12 años hace
Pharming Undertakes Review Of Strategic Options
Roth Capital Partners and Nomura Code to assist in exploring strategic alternatives
Leiden, The Netherlands, June 12, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announces that it has engaged Roth Capital Partners and Nomura Code to assist it in exploring strategic alternatives and provides an update on Study 1310 for Ruconest.
As the European capital markets continue to be challenging for Life Science companies, Pharming’s Board and management team have engaged Nomura Code alongside long term advisor, Roth Capital Partners, to assist in a review of strategic options which could include a merger, equity investment or sale. No decision has been made to enter into any specific transaction at this time and there is no certainty that Pharming will enter into a transaction in the future. Th is review will be accompanied by additional cost containment measures and the ongoing discussions on platform technology collaborations. We expect to be able to update the market in Q3, 2012. Recruitment for Pharming's Study 1310, the US pivotal trial for Ruconest is ongoing (68 patients recruited to date) and it is expected that full enrollment (75 patients) could be achieved within the next few weeks, in line with expectations. However, an internal oversight has recently come to our attention that could potentially delay the unblinding of the top-line data by up to three months in order to complete the statistical package required by the FDA. This matter is currently being investigated.
The potential delay relates to the final step to completion of the trial consists of an additional blinded follow up period of up to 90 days, depending on when patients experience a subsequent attack. Once the last patient has completed the blinded follow-up period (expe rienced an attack or reached the 90 day mark), the data base will be locked and data analysis will begin. Our experience with this trial is that participating patients are typically having a subsequent attack significantly sooner than 90 days, which means that locking of the data base and top-line results would still become available in Q3, 2012, however if the last patient entering the trial takes the full 90 days then top line results will be in Q4 2012.
Completion of Study 1310 and read-out of the top-line results will, if positive, trigger a US$10 million milestone payment from Pharming's US partner Santarus Inc.
plumo
13 años hace
Pharming Reports Financial Results First Quarter 2012
Leiden, The Netherlands, April 26, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today published its financial report for the first quarter ended March 31, 2012.
FINANCIAL HIGHLIGHTS
Revenues and other income increased to €1.0 million (Q1 2011: €0.7 million)
Operating costs from continuing operations increased to €5.2 million (Q1 2011: €4.9 million). Total net loss from continuing operations increased to €6.5 million (Q1 2011: €4.2 million), mainly as a result of the costs associated with the December 2011 €8.4 million convertible bond
Cash outflows from operations decreased to €3.5 million (Q1 2011: €4.5 million)
Cash increased to €8.8 million (2011 year end: €5.1 million) The negati ve equity position of €1.2 million at year end 2011 increased by €2.4 million to €3.6 million
OPERATIONAL HIGHLIGHTS
The ongoing pivotal clinical trial Study 1310 remains on track and is expected to readout by the third quarter of 2012
New agreements signed for the commercialization of Ruconest® with Transmedic Pte Ltd. (for the territories of Brunei, Indonesia, Malaysia, Philippines, Singapore, and Thailand) and Hyupjin Corporation for the Republic of Korea
Commenced an open-label Phase II clinical study evaluating Ruconest® for the treatment of acute attacks of angioedema in pediatric patients with HAE
Positive study results published in peer-reviewed journal Biodrugs demonstrated that recombinant human C1 inhibitor was not observed to have a prothombotic effect when used to treat acute HAE attacks
Sijmen de Vries, CEO, commented: "The first three months of 2012 has seen us de livering on extending the geographical coverage for Pharming’s C1 inhibitor franchise, and this remains a key goal. We are also pleased to report that recruitment into our ongoing pivotal clinical trial Study 1310 remains on track and we look forward to updating on further progress."
FINANCIAL RESULTS
In the three months to March 31, 2012 the Company generated revenue and other income from continuing operations of €1.0 million (Q1 2011: €0.7 million). This increase comes, in part, from Ruconest® sales of €0.4 million (up from €0.15 million in Q1 2011) and increased income from grants of €0.1 million. Costs associated with the revenues and other income amounted to €0.4 million (Q1 2011: €0.1 million).
Total operating costs from continuing operations increased by €0.3 million from €4.9 million in the first quarter of 2011 to €5.2 million in the same quarter of 2012. Th e increase reflects the Company’s activities in relation to Study 1310 required for US regulatory approval for Rhucin®. Successful completion of this study, which is anticipated to readout by the third quarter of 2012, will trigger a US$10.0 million milestone payment by Santarus. In addition, the Company anticipates submitting a BLA filing approximately three months thereafter with another US$5.0 million due from Santarus as and when the U.S. Food and Drug Administration accepts the BLA filing for review.
Early in 2012 the Company finalized a transaction announced in December 2011 under which it issued €8.4 million convertible bonds plus 38,717,484 warrants. The bonds have to be repaid in six monthly instalments and can be settled in cash and/or in shares. To date four of the six payments have been made. If the Company elects to pay in shares the instalment amount plus interest is converted to a number of shares based on the share price (average of volume weighted average price over the period and to which a discount is applied). With regards to these pay- backs in shares, the Company issued a total of 67,437,000 shares until the end of the first quarter of 2012. These items largely accounted for a net loss in financial income and expense of €1.9 million as compared to a €0.1 million net profit on financial income and expenses in the comparative quarter of 2011.
As a result of the above items, net loss from continuing operations increased by €2.3 million to €6.5 million in Q1 2012 (Q1 2011: €4.2 million). Due to a one-time €0.6 million profit on discontinued operations in the first quarter of 2011, which followed liquidation and deconsolidation of the DNage business early in 2011, total net loss increased from €3.6 million to €6.5 million. The net loss per share for the first quarter of both 2011 and 2012 amounted to €0.01.
FINANCIAL POSITION
Total cash and cash equivalents (including restricted cash) increased by €3.7 million from €5.1 million at year end 2011 to €8.8 million at the end of the first quarter 2012.
As explained in the financial results section, the Company anticipates receiving US$10.0 million from Santarus upon the successful completion of Ruconest®’s Study 1310 in Q3 2012 and another US$5.0 million as and when the U.S. Food and Drug Administration accepts the BLA filing for review. Receipts of these milestones are expected to significantly improve the Company’s cash and equity position.
NEGATIVE EQUITY
In December 2011 the Company announced that it had entered negative equity. This negative equity position of €1.2 million at year end 2011, as expected, increased by €2.4 million to €3.6 million and reflects the €6.5 million net loss for the first quarter, net of €4.1 millio n posted for shares issued as a repayment of convertible bonds (€3.8 million) and other share-based payments (€0.3 million).
The negative equity position has in itself no immediate impact on the execution of Pharming’s business plan, nor does it imply that the Company is legally required to issue new share capital. However, the Company is considering various options in order to reduce the negative equity and return to a positive equity position.
Pharming is continuously reviewing its financial and liquidity position and has various options to improve its equity standing under International Financial Reporting Standards (IFRS). Notably, the Company reports that the negative equity position was mainly caused by the inability to recognize the €19.7 million upfront payments and milestones received from Sobi and Santarus as equity (at March 31, 2012 the deferred license fees income amounted to €16.9 million; if release to the stat ement of income would have been permitted under IFRS, the Company would have reported a positive equity position of €13.3 million). Anticipated receipt of the two development milestones associated with the successful readout of Study 1310 (US$10.0 million) and acceptance of the BLA filing by the FDA (US$5.0 million) will, under IFRS, be recognized immediately and thus augment the equity position.
As a result of the negative equity position announced in December 2011, the Company committed to comply with Euronext Amsterdam Notice 2011-001 paragraph 3 requirements, which include the publication of quarterly financial statements within two months after the end of the quarter in compliance with International Accounting Standard 34 (Interim Financial Reporting). Therefore, the condensed consolidated interim financial statements for the quarter ended March 31, 2012 can be found on Pharming’s website as of today.
RHUCIN Phase III Study
Pharming is conducting a Phase III clinical study with RHUCIN under a Special Protocol Assessment (SPA) that is intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). RHUCIN is being evaluated for the treatment of acute attacks of angioedema in patients with HAE in an international, multicenter, randomized, placebo-controlled Phase III study at a dosage strength of 50 U/kg with a primary endpoint of time to beginning of relief of symptoms. Santarus has licensed certain exclusive rights from Pharming to commercialize RHUCIN in North America for the treatment of acute attacks of HAE and other future indications. Under the terms of the license agreement, a $10 million milestone is payable to Pharming upon successful achievement of the primary endpoint of the Phase III clinical study. The study is expected to be completed by the third quarter of 2012.
About RUCONEST® (RHUCIN&re g; in non-European territories) and Hereditary Angioedema
RUCONEST® (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH). RUCONEST is produced through Pharming’s proprietary technology in milk of transgenic rabbits and in Europe is approved under the name RUCONEST for treatment of acute angioedema attacks in patients with HAE. RHUCIN® is an investigational drug in the U.S. and has been granted orphan drug designation for the treatment of acute attacks of HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the U.S. Hereditary Angioedema A ssociation, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals
plumo
13 años hace
Pharming Redeems Fourth Tranche Of Convertible Bond
Leiden, The Netherlands, April 11, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announced that it has redeemed the fourth tranche of its €8.4 million convertible bond. A total of 22,051,282 shares were issued to the bondholders under the terms and conditions of the bond, serving as a pre-installment for the May 15, 2012 redemption and interest payment.
As announced in our press release on December 23, 2011, Pharming will redeem the bond on a month by month basis in six equal monthly tranches of €1.4 million and the interest payable, such that the bond will be redeemed in full on July 15, 2012. Pharming can decide at its discretion to redeem the bond and pay the interest due, by means of monthly equity tranches or cash payments.
As of today, the number of outstanding shares has increased from 561,503,681 to 583,554,963.
plumo
13 años hace
Pharming and Hyupjin Corporation announce commercialisation agreement for RUCONEST in Korea
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that it has entered into an agreement with Hyupjin Corporation, a Seoul based Korean specialty pharma company, to commercialise RUCONEST® (recombinant human C1 inhibitor) for the treatment of acute attacks of Hereditary Angioedema (HAE) in the Republic of Korea.
Under the agreement, Hyupjin will drive the regulatory approval in Korea and purchase its commercial supplies of RUCONEST from Pharming at a fixed transfer price.
"The collaboration with a well-established company such as Hyupjin Corporation, as part of our ongoing efforts to extend the commercialisation of RUCONEST is very exciting for us" said Sijmen de Vries, CEO of Pharming. "We are very much looking forward to having RUCONEST distributed by such an experienced partner in Korea. With this agreement with Hyupjin Corporation, we now have two strong partners in Asia for the distribution of RUCONEST, whilst discussions continue with potential partners for other territories."
Mr. Macsan Cho, General Manager of Hyupjin Corporation, said: "In our continuous effort to bring the most innovative therapeutics to patients, this agreement to distribute RUCONEST will now enable us to provide the Korean HAE patients access to this most innovative way to treat their disease. Given our long established relationships in immunology, we feel that RUCONEST complements our existing product portfolio very well and we look forward to getting started
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10 años hace
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