Pharming released from CSL Behring court case

从杰特贝林(CSL Behring)法庭案件中释放的 Pharming

2019-10-26 09:03:31 BioSpace

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Pharming Group N.V. today announced that CSL Behring, a subsidiary of CSL Limited of Australia , has agreed to dismiss Pharming from its action against Pharming’s former employee, Dr. Joseph Chiao. Pharming has permanently terminated the employment of Dr. Chiao. CSL and Pharming have worked, and will continue to work, collaboratively through the issues central to CSL’s claims against Dr. Chiao. The parties continue to jointly conduct a forensic review, which we are confident will not uncover any evidence of confidential information, including personally identifiable information, being shared with Pharming by Dr. Chiao. Accordingly, the parties were able to reach mutual agreement for CSL voluntarily to dismiss Pharming from the case. As Pharming anticipated, after review, it became clear that Pharming did not encourage or induce Dr. Chiao’s alleged actions at issue in the case during his recruitment and hiring at Pharming. "The voluntary dismissal by CSL Behring of Pharming in this legal case confirms our previous statement that Pharming did not induce or encourage Dr. Chiao to breach any rules or contract terms or in any way to remove any data from his former employer, nor did Pharming or our colleague Dr. Anurag Relan receive any of CSL Behring’s confidential information from Dr. Chiao." Pharming is a specialty pharmaceutical company developing innovative products for the safe, effective treatment of rare diseases and unmet medical needs. Pharming’s lead product, RUCONEST® (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of acute Hereditary Angioedema (“HAE”) attacks in patients in Europe, the US, Israel and South Korea. The product is available on a named-patient basis in other territories where it has not yet obtained marketing authorization. RUCONEST® is distributed by Pharming in Austria, France, Germany, Luxembourg, the Netherlands, the United Kingdom and the United States of America. Pharming holds commercialisation rights in Algeria, Andorra, Bahrain, Belgium, Ireland, Jordan, Kuwait, Lebanon, Morocco, Oman, Portugal, Qatar, Syria, Spain, Switzerland, Tunisia, United Arab Emirates and Yemen. In some of these countries distribution is made in association with the HAEi Global Access Program (GAP). RUCONEST® is distributed by Swedish Orphan Biovitrum AB (publ) (SS: SOBI) in the other EU countries, and in Azerbaijan, Belarus, Georgia, Iceland, Kazakhstan, Liechtenstein, Norway, Russia, Serbia and Ukraine. RUCONEST® is distributed in Colombia, Costa Rica, the Dominican Republic, Panama, and Venezuela by Cytobioteck, in South Korea by HyupJin Corporation and in Israel by Kamada. RUCONEST® is also being examined for approval for the treatment of HAE in young children (2-13 years of age) and evaluated for various additional follow-on indications. Pharming’s technology platform includes a unique, GMP-compliant, validated process for the production of pure recombinant human proteins that has proven capable of producing industrial quantities of high quality recombinant human proteins in a more economical and less immunogenetic way compared with current cell-line based methods. Leads for enzyme replacement therapy (“ERT”) for Pompe and Fabry’s diseases are being optimized at present, with additional programs not involving ERT also being explored at an early stage at present. Leniolisib is in final stage clinical development for Activated Phosphoinositide 3-kinase Delta Syndrome (“APDS”). Leniolisib is a small molecule phosphoinositide 3-kinase delta (“PIK3δ”) inhibitor developed by Nopvartis. Global rights to the product were obtained from Novartis in August 2019. Development of the compound through its current registration-enabling trial will be continued by Novartis and Pharming in partnership. Pharming will commercialise the treatment if it obtains approval from regulators. Pharming’s technology platform includes a unique, GMP-compliant, validated process for the production of pure recombinant human proteins that has proven capable of producing industrial quantities of high quality recombinant human proteins in a more economical and less immunogenetic way compared with current cell-line based methods. Leads for enzyme replacement therapy (“ERT”) for Pompe and Fabry’s diseases are being optimized at present, with additional programs not involving ERT also being explored at an early stage at present. Pharming has a long-term partnership with the China State Institute of Pharmaceutical Industry (“CSIPI”), a Sinopharm company, for joint global development of new products, starting with recombinant human Factor VIII for the treatment of Haemophilia A. Pre-clinical development and manufacturing will take place to global standards at CSIPI and are funded by CSIPI. Clinical development will be shared between the partners with each partner taking the costs for their territories under the partnership. Additional information is available on the Pharming website: www.pharming.com This press release of Pharming Group N.V. and its subsidiaries (“Pharming”, the “Company” or the “Group”) may contain forward-looking statements including without limitation those regarding Pharming’s financial projections, market expectations, developments, partnerships, plans, strategies and capital expenditures. The Company cautions that such forward-looking statements may involve certain risks and uncertainties, and actual results may differ. Risks and uncertainties include without limitation the effect of competitive, political and economic factors, legal claims, the Company’s ability to protect intellectual property, fluctuations in exchange and interest rates, changes in taxation laws or rates, changes in legislation or accountancy practices and the Company’s ability to identify, develop and successfully commercialize new products, markets or technologies. As a result, the Company’s actual performance, position and financial results and statements may differ materially from the plans, goals and expectations set forth in such forward-looking statements. The Company assumes no obligation to update any forward-looking statements or information, which should be taken as of their respective dates of issue, unless required by laws or regulations. Sijmen de Vries, CEO Tel: +31 71 524 7400 Julia Phillips / Victoria Foster Mitchell / Brett Pollard Tel: +44 203 727 1136 Leon Melens Tel: +31 6 53 81 64 27
Pharming Group N.V .今天宣布,杰特贝林(CSL Behring)(澳大利亚 CSL 有限公司的子公司)已同意驳回 Pharming 对 Pharming 前雇员 Joseph Chiao 博士的诉讼。药明博士已永久终止聘用赵博士。CSL 和 Pharming 已经并将继续通过 CSL 对 Chiao 博士的索赔的核心问题进行合作。双方继续共同进行法证审查,我们有信心将不会发现任何机密信息的证据,包括个人识别信息,由 Chiao 博士与 Pharming 分享。因此,双方能够就 CSL 自愿驳回 Pharming 的案件达成一致。 正如 Pharming 所预料的那样,经过审查后,很明显,在他在 Pharming 的招聘和招聘过程中, Pharming 没有鼓励或诱使 Chiao 博士在此案中提出指控。 “杰特贝林(CSL Behring) of Pharming 在这一法律案件中自愿解雇,证实了我们之前的声明,即 Pharming 没有诱使或鼓励 Chiao 博士违反任何规则或合同条款,或以任何方式从他的前雇主处删除任何数据,Pharming 和我们的同事 Anurag Relen 博士也没有从 Chiao 博士那里收到任何杰特贝林(CSL Behring)的机密信息。” 药明医药是一家专业医药公司,为罕见病的安全、有效治疗和未满足的医疗需求开发创新产品。Pharming 的主导产品 RUCONEST ®( conestat alfa )是一种重组人 C1酯酶抑制剂,用于治疗欧洲、美国、以色列和韩国的急性遗传性血管水肿( HAE )发作。该产品在其他尚未获得营销授权的地区以指定患者为基础提供。 RUCONEST ®由 Pharming 在奥地利、法国、德国、卢森堡、荷兰、英国和美利坚合众国发行。Pharming 在阿尔及利亚、安道尔、巴林、比利时、爱尔兰、约旦、科威特、黎巴嫩、摩洛哥、阿曼、葡萄牙、卡塔尔、叙利亚、西班牙、瑞士、突尼斯、阿拉伯联合酋长国和也门拥有商业化权利。在这些国家中的一些国家,分配是与 HAMI 全球访问计划( GAP )相关联的。 RUCONEST ®由瑞典孤儿 Biovitrum AB ( pull )( SS : SOBI )在其他欧盟国家和阿塞拜疆、白俄罗斯、佐治亚、冰岛、哈萨克斯坦、列支敦士登、挪威、俄罗斯、塞尔维亚和乌克兰发行。 RUCONEST ®由 Cytobieck 在哥伦比亚、哥斯达黎加、多米尼加共和国、巴拿马和委内瑞拉发行,在韩国由 HyupJin 公司发行,在以色列由 Kamada 发行。 RUCONEST ®也正在进行审批,以批准治疗年轻儿童(2-13岁)的港机工程,并对各种附加的后续适应症进行评估。 Pharming 的技术平台包括一种独特的、符合 GMP 要求的、经过验证的纯重组人蛋白生产工艺,与目前基于细胞系的方法相比,该工艺已证明能够以更经济、更少免疫遗传学的方式生产出大量高质量的重组人蛋白。目前正在优化庞贝和法布里疾病的酶替代治疗(“ ERT ”)方向,目前还在探索不涉及 ERT 的其他方案。 Leniolisib 处于活化磷酸肌醇3-激酶 Delta 综合征( APDS )的临床开发的最后阶段。Leniolisib 是由 Nopvartis 开发的一种小分子磷酸肌醇3-激酶δ(“ PIK3δ”)抑制剂。该产品的全球权利于2019年8月从诺华(Novartis)公司获得。诺华(Novartis)公司和药明公司将通过目前的注册授权试验继续开发该化合物。如果获得监管机构的批准,药明将把这种疗法商业化。 Pharming 的技术平台包括一种独特的、符合 GMP 要求的、经过验证的纯重组人蛋白生产工艺,与目前基于细胞系的方法相比,该工艺已证明能够以更经济、更少免疫遗传学的方式生产出大量高质量的重组人蛋白。目前正在优化庞贝和法布里疾病的酶替代治疗(“ ERT ”)方向,目前还在探索不涉及 ERT 的其他方案。 Pharming 与国药(Sinopharm)一致下属的中国医药工业国家研究所(“ CSPI ”)建立长期合作关系,共同开发新产品。从治疗血友病 A 的重组人凝血因子 VIII 开始。临床前的开发和制造将按照 CSPI 的全球标准进行,并由 CSPI 提供资金。临床开发将由合作伙伴与每个合作伙伴共同承担各自区域在合作伙伴关系下的费用。 更多信息请访问 Pharming 网站:\160; www.pharming.com 本 Pharming Group N.V .及其子公司(“ Pharming ”、“本公司”或“本集团”)的新闻稿可能包含前瞻性陈述,包括但不限于有关 Pharming 的财务预测、市场预期、发展、合作伙伴关系、计划、战略和资本支出的声明。 本公司提醒,该等前瞻性陈述可能涉及一定的风险和不确定性,实际结果可能存在差异。风险和不确定性包括但不限于竞争、政治和经济因素的影响、法律主张、公司保护知识产权的能力、汇率和利率的波动、税法或税率的变化、立法或会计惯例的变化和公司识别能力,开发并成功地将新产品、市场或技术商业化。 因此,公司的实际业绩、状况以及财务业绩和报表可能与这些前瞻性陈述中规定的计划、目标和预期存在重大差异。除非法律或法规要求,公司不承担更新任何前瞻性陈述或信息的义务,这些陈述或信息应在各自发布之日起生效。 Sijmen de Vries ,首席执行官 电话:+31715247400 Julia Phillips / Victoria Foster Mitchell / Brett Pollard 电话:+44237271136 Leon Melens 电话:+31653816427

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