Santhera Enters into License Agreement with Chiesi Group for Raxone® in LHON Valued at up to CHF 105 Million


2019-05-24 16:42:00 BioSpace


Santhera Pharmaceuticals announces that it has entered into an exclusive license agreement with Chiesi Farmaceutici, an international research-focused healthcare group , under which Chiesi Group will in-license Raxone® for the treatment of LHON for a total consideration of up to CHF 105 million , comprising an upfront cash payment of CHF 50 million and near- to mid-term sales milestone payments of up to CHF 55 million . Chiesi Group is in-licensing the rights to Raxone in LHON and all other ophthalmological indications worldwide except the US and Canada, where Santhera retains rights. In a second step, following the completion of certain reimbursement and post-regulatory commitments on the part of Santhera, Chiesi Group has the option to fully acquire Santhera’s Raxone business. The transaction enables Santhera to focus on the business areas core to its long-term growth strategy by advancing its clinical-stage neuromuscular and pulmonary programs. “Since the approval in 2015 we have successfully launched Raxone in Europe and reported strong year-on-year sales increases. In the past eighteen months we also strategically diversified our pipeline. This license agreement for Raxone in LHON, our sole neuro-ophthalmology asset, will allow us to create significant value for our shareholders as it provides financial resources enabling us to focus on delivering innovation to patients with neuromuscular and pulmonary diseases of great unmet medical need,” said Thomas Meier, PhD, Chief Executive Officer of Santhera. “We have built a strong portfolio in neuromuscular and pulmonary rare disease areas with last year’s acquisition of option-rights to vamorolone for Duchenne muscular dystrophy (DMD) and other inflammatory diseases, and the acquisition of POL6014 for cystic fibrosis and other pulmonary disorders. Major upcoming inflection points will be the decision on our marketing authorization application for Puldysa® in DMD in Europe, which we plan to submit shortly. Another milestone expected for next year are results of the pivotal trial with vamorolone in DMD. With positive results and upon exercising the option to acquire this asset, we could seek regulatory approvals in the US and Europe. We are delighted to be working with Chiesi Group, a global company with an established commercial infrastructure and a strong reputation for delivering innovation in rare diseases and areas of special care, including ophthalmology. We will work closely with Chiesi Group to ensure a smooth handover of the Raxone business and a seamless supply of this only approved medication for the treatment of this devastating form of vision loss to patients in need.”       “Chiesi Group has a strong commitment in the orphan diseases area, bringing innovative treatments forward to patients affected by rare or ultra-rare disorders and improving the quality of life of people with rare diseases is one of the most important goals. This strategic partnership reinforces this commitment with a therapeutic offer for patients affected by LHON, a neurodegenerative disease targeting the optic nerve and characterized by sudden vision loss”, commented Ugo Di Francesco, Chief Executive Officer, Chiesi Group. Santhera will license and transfer to Chiesi Group all of its rights for the development, commercialization and distribution of Raxone for the treatment of LHON and any other potential ophthalmological indications for all territories worldwide except the US and Canada. The closing of the transaction is subject to customary approvals and is currently expected to occur in the third quarter 2019. As of that date, the advance payment of CHF 50 million (EUR 44 million) will also become due. In an interim phase Santhera will continue to provide medical, technical, logistical and scientific support with regard to ongoing market authorization activities and/or market access undertakings for several months. In this context, the parties agreed that Santhera will continue to commercialize Raxone for LHON in France until ongoing pricing and reimbursement negotiations have been finalized. Santhera will also be responsible to complete the ongoing Post Authorization Measures, expected by 2021, in conjunction with the centralized European Marketing Authorization granted in 2015. Following the transaction, Santhera will focus its resources on advancing its late-stage clinical pipeline of products for the treatment of neuromuscular and pulmonary diseases. In particular, Santhera intends to fully exploit its strategic position in DMD therapy development, with ongoing programs to help all DMD patients irrespective of causative mutations, disease stage or age. Addressing the needs of advanced DMD patients experiencing respiratory dysfunction, Santhera plans to submit a conditional marketing authorization application (MAA) for Puldysa® (idebenone) to the EMA. Pivotal study data for vamoroloneas treatment of younger, still ambulatory DMD patients is expected in 2020. In addition, Santhera’s expertise in the respiratory area through its activities in the DMD space led to the acquisition of the promising clinical-stage asset POL6014, which has the potential to treat cystic fibrosis (CF) and other pulmonary diseases. Other pipeline elements include strategies to treat congenital muscular dystrophies. Centerview Partners acted as exclusive financial advisor to Santhera for this license agreement.
Santhera Pharmaceuticals 宣布已与专注于研究的国际医疗保健集团 Chiesi Farmacutii 签订独家许可协议,据此, Chiesi Group 将许可 Raxone ®用于治疗 LHON ,总对价最高为1.05亿瑞士法郎。包括预付现金5,000万瑞士法郎和近中期销售里程碑付款5,500万瑞士法郎。 除了美国和加拿大,奇西集团正在批准在 LHON 的拉索酮和世界范围内所有其他眼科适应症的权利。第二步,在完成 Santhera 的某些偿付和监管后承诺后, Chiesi 集团有权完全收购 Santhera 的 Raxone 业务。这笔交易使 Santhera 得以通过推进其临床阶段的神经肌肉和肺部项目,专注于其长期增长战略的核心业务领域。 “自2015年获得批准以来,我们在欧洲成功推出了拉索酮,并报告了强劲的同比销售增长。在过去的18个月里,我们也战略性地使我们的管道多样化.我们唯一的神经眼科资产 LHON 中的 Raxone 的许可协议将使我们能够为我们的股东创造重大价值,因为它提供了财政资源,使我们能够专注于为那些没有得到满足的医疗需求的神经肌肉和肺部疾病患者提供创新,” Thomas Meier 博士说,圣塔赫拉公司首席执行官。 “我们在神经肌肉和肺部罕见疾病领域建立了强大的投资组合,去年收购了 Duchenne 肌肉萎缩症( DMD )和其他炎症性疾病的 Vamorlone 选择权,收购了 POL6014用于囊性纤维化和其他肺部疾病。即将到来的主要拐点将是关于我们在欧洲 DMD 市场营销授权申请的决定,我们计划很快提交该申请。另一个里程碑,预计明年的结果关键审判与孤单在 DMD 。由于取得了积极的结果,并行使了收购该资产的选择权,我们可以在美国和欧洲寻求监管机构的批准。我们很高兴与 Chiesi 集团合作, Chiesi 集团是一家全球公司,拥有成熟的商业基础设施,在罕见病和特殊护理领域(包括眼科)提供创新的良好声誉。我们将与 Chiesi 集团密切合作,确保 Raxone 业务的平稳交接,并为需要的患者提供唯一批准的治疗这种破坏性视力丧失的药物。”这是一个很好的例子 “ Chiesi 集团在孤儿病领域做出了坚定的承诺,将创新的治疗方法应用于受罕见或极罕见疾病影响的患者,提高罕见病患者的生活质量是最重要的目标之一。Chiesi 集团首席执行官 Ugo Di Francesco 评论说,这一战略伙伴关系加强了这一承诺,向以视神经为靶点的神经退行性疾病 LHON 患者提供治疗。 Santhera 将许可 Chiesi Group 开发、商业化和经销 Raxone ,用于治疗 LHON 以及除美国和加拿大之外的全球所有地区的任何其他潜在眼科适应症,并将所有权利转让给 Chiesi Group 。 本次交易的交割尚需获得惯常的批准,目前预计将于2019年第三季度完成。截至该日,5000万瑞士法郎(4400万欧元)的预付款也将到期。 在临时阶段, Santhera 将在几个月内继续为正在进行的市场授权活动和/或市场准入活动提供医疗、技术、后勤和科学支助。在这方面,双方同意,在正在进行的定价和偿还谈判最终完成之前, Santhera 将继续将 Raxone 用于法国 LHON 的商业化。Santhera 还将负责与2015年授予的集中欧洲市场营销授权一起,完成预计到2021年实施的持续岗位授权措施。 交易完成后, Santhera 将集中资源推进其用于治疗神经肌肉和肺部疾病的后期临床产品管道。特别是, Santhera 打算充分利用其在 DMD 治疗发展中的战略地位,通过正在进行的项目来帮助所有 DMD 患者,而不论因果突变、疾病阶段或年龄。为满足患有呼吸功能障碍的先进 DMD 患者的需求, Santhera 计划向 EMA 提交有条件的 Pudysa ®( idebenone )上市许可申请( MAA )。预计到2020年,用于治疗年轻且仍在活动中的 DMD 患者的治疗的 Pivotal 研究数据。此外, Santhera 通过其在 DMD 领域的活动在呼吸领域的专业知识导致了有前景的临床阶段资产 POL6014的收购,该资产具有治疗囊性纤维化( CF )和其他肺部疾病的潜力。其他管道因素包括治疗先天性肌营养不良症的策略。