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Ligand Pharmaceuticals宣布推出Pelthos Therapeutics,以加速ZELSUVMI™的商业化

Ligand Pharmaceuticals Announces Launch of Pelthos Therapeutics to Accelerate Commercialization of ZELSUVMI™

businesswire 等信源发布 2024-04-03 19:00

可切换为仅中文


JUPITER, Fla. & DURHAM, N.C.--(BUSINESS WIRE)--Ligand Pharmaceuticals (Nasdaq: LGND) today announced the launch of Pelthos Therapeutics (Pelthos), a biopharmaceutical company, and the appointment of seasoned industry executive Scott Plesha to the role of Chief Executive Officer.

佛罗里达州朱庇特(JUPITER)和北卡罗来纳州达勒姆(BUSINESS WIRE)--配体制药(Nasdaq:LGND)今天宣布推出生物制药公司Pelthos Therapeutics(Pelthos),并任命经验丰富的行业高管斯科特·普莱莎(ScottPlesha)担任首席执行官。

Pelthos is committed to commercializing innovative, safe, and efficacious therapeutic products to help patients impacted by diseases with limited treatment options. The company’s lead product is ZELSUVMI™ (berdazimer) topical gel, 10.3%, for the treatment of molluscum contagiosum (molluscum) in adults and pediatric patients one year of age and older.1 ZELSUVMI has received a Novel Drug designation from the U.S.

Pelthos致力于将创新,安全和有效的治疗产品商业化,以帮助受治疗选择有限的疾病影响的患者。该公司的主导产品是ZELSUVMI™(berdazimer)局部凝胶,占10.3%,用于治疗成人和一岁及以上儿科患者的传染性软体动物(软体动物)。1 ZELSUVMI已获得美国的新药名称。

Food and Drug Administration and is the first and only approved topical prescription medication that can be applied by patients, parents, or caregivers at home, outside of a physician's office, or other medical setting to treat this highly contagious viral skin infection. The product was developed using Pelthos’ proprietary nitric oxide-based technology platform, NITRICIL™.

美国食品和药物管理局(Food and Drug Administration)是第一种也是唯一一种经批准的局部处方药,可供患者、父母或护理人员在家中、医生办公室外或其他医疗环境中使用,以治疗这种高度传染性的病毒性皮肤感染。该产品是使用Pelthos专有的基于一氧化氮的技术平台NITRICIL™开发的。

ZELSUVMI is expected to be available in the United States in late 2024..

ZELSUVMI预计将于2024年末在美国上市。。

Ligand acquired the rights to ZELSUVMI and all the assets related to the NITRICIL technology platform from Novan, Inc. in September 2023.

Ligand于2023年9月从Novan,Inc.获得了ZELSUVMI的权利以及与腈腈技术平台相关的所有资产。

“ZELSUVMI is a highly differentiated product that we believe will bring significant improvements to the lives of patients living with tremendous unmet needs,” said Todd Davis, CEO of Ligand. “We are excited for the launch of Pelthos, the commercialization of ZELSUVMI, and the advancement of the company under Scott’s leadership.”.

Ligand首席执行官托德·戴维斯(ToddDavis)表示:“ZELSUVMI是一种高度分化的产品,我们相信它将极大地改善生活在巨大未满足需求的患者的生活。”。“我们对Pelthos的推出、ZELSUVMI的商业化以及Scott领导下公司的发展感到兴奋。”。

Mr. Plesha brings to his role more than 30 years of experience in the pharmaceutical industry, including two decades building and leading specialty pharmaceutical commercial organizations. Prior to joining Pelthos, Mr. Plesha was President and Chief Commercial Officer at BioDelivery Sciences (BDSI) until it was acquired by Collegium Pharmaceutical in 2022.

普莱夏先生在制药行业拥有30多年的经验,包括20多年建立和领导专业制药商业组织的经验。在加入Pelthos之前,Plesha先生曾任生物传递科学(BDSI)总裁兼首席商务官,直到2022年被Collegium Pharmaceutical收购。

Under Mr. Plesha’s leadership, BDSI sales grew from $5 million to $160 million. He previously served as Senior Vice President of Gastrointestinal Sales at Salix Pharmaceuticals. During his fifteen-year tenure at Salix, Mr. Plesha led a nationwide salesforce that grew product sales to more than $1.5 billion annually.

在普莱夏先生的领导下,BDSI的销售额从500万美元增长到1.6亿美元。他曾担任Salix Pharmaceuticals胃肠道销售高级副总裁。在Salix任职的15年中,普莱夏领导了一支全国性的销售队伍,产品销售额每年增长到15亿美元以上。

Before Salix, Mr. Plesha was a Regional Sales Manager for Oclassen Dermatologics, a division of Watson Laboratories, and in commercial roles of increasing responsibility at Solvay Pharmaceuticals..

在Salix之前,Plesha先生是Watson Laboratories部门Oclassen Dermatologics的区域销售经理,并在Solvay Pharmaceuticals担任越来越重要的商业角色。。

“I am excited to assume the leadership of Pelthos as we prepare to offer the first at-home therapy for the many patients who are completely untreated today or who need a more suitable option,” said Scott Plesha. “This is a company that has several meaningful milestones on the horizon and a team that is ready to execute to meet the needs of patients.”.

斯科特·普莱夏说:“我很高兴担任佩尔索斯的领导,因为我们准备为许多今天完全未经治疗或需要更合适选择的患者提供第一次家庭治疗。”。“这是一家即将实现几个有意义的里程碑的公司,一支随时准备执行以满足患者需求的团队。”。

Ligand intends to commercialize ZELSUVMI in partnership with a capital provider and/or strategic partner. This is consistent with Ligand’s strategy to reposition and maximize the value of highly differentiated and promising pharmaceutical assets by combining premier management teams and outside funding sources in return for significant equity and royalty rights in the newly formed entities.

Ligand打算与资本提供商和/或战略合作伙伴合作,将ZELSUVMI商业化。这与Ligand的战略是一致的,即通过将卓越理财团队和外部资金来源相结合,重新定位和最大化高度分化和有前途的制药资产的价值,以换取新成立实体的重大股权和特许权使用权。

To date, Ligand has created three companies utilizing this strategy: Viking Therapeutics, Primrose Bio, and OmniAb®..

迄今为止,Ligand已经创建了三家利用这一策略的公司:Viking Therapeutics、Primrose Bio和OmniAb®。。

Pelthos is a wholly owned subsidiary of Ligand.

Pelthos是Ligand的全资子公司。

About ZELSUVMI™ (berdazimer) topical gel, 10.3%

关于ZELSUVMI™(berdazimer)局部凝胶,10.3%

ZELSUVMI (berdazimer) topical gel, 10.3% is a nitric oxide (NO) releasing agent indicated for the topical treatment of molluscum contagiosum in adults and pediatric patients one year of age and older. Complete prescribing information is available at www.zelsuvmi.com.

ZELSUVMI(berdazimer)局部凝胶,10.3%是一种一氧化氮(NO)释放剂,适用于成人和一岁及以上儿科患者的传染性软体动物局部治疗。有关完整的处方信息,请访问www.zelsuvmi.com。

About Ligand Pharmaceuticals

关于配体药物

Ligand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing our technologies or both. Our business model seeks to generate value for stockholders by creating a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure.

Ligand是一家生物制药公司,通过支持高价值药物的临床开发实现科学进步。配体通过提供资金、许可我们的技术或两者来实现这一目标。我们的商业模式旨在通过创建由高效和低公司成本结构支持的生物技术和医药产品收入流的多元化组合,为股东创造价值。

Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable and diversified manner. Our business model is based on funding programs in mid- to late-stage drug development in return for economic rights and licensing our technology to help partners discover and develop medicines.

我们的目标是为投资者提供一个机会,以盈利和多样化的方式参与生物技术行业的承诺。我们的商业模式基于中晚期药物开发的资助计划,以换取经济权利,并授权我们的技术来帮助合作伙伴发现和开发药物。

We partner with other pharmaceutical companies to attempt to leverage what they do best (late-stage development, regulatory management and commercialization) in order to generate our revenue. Our Captisol® platform technology is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs.

我们与其他制药公司合作,试图利用他们最擅长的(后期开发,监管管理和商业化)来产生收入。我们的Captisol®平台技术是一种化学修饰的环糊精,其结构旨在优化药物的溶解度和稳定性。

We have established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Takeda, Gilead Sciences and Baxter International. For more information, please visit www.ligand.com. Follow Ligand on X @Ligand_LGND..

我们与世界领先的制药公司建立了多个联盟、许可证和其他业务关系,包括安进、默克、辉瑞、爵士、武田、吉利德科学和百特国际。有关更多信息,请访问www.ligand.com。关注X@ligand\u LGND上的配体。。

We use our investor relations website and X as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Investors should monitor our website and our X account, in addition to following our press releases, SEC filings, public conference calls and webcasts..

我们使用我们的投资者关系网站和X作为披露重大非公开信息的手段,并遵守FD条例规定的披露义务。投资者除了关注我们的新闻稿、SEC文件、公开电话会议和网络广播外,还应监控我们的网站和X账户。。

About Pelthos Therapeutics

关于Pelthos Therapeutics

Pelthos Therapeutics is a biopharmaceutical company committed to commercializing innovative, safe, and efficacious therapeutic products to help patients with unmet treatment burdens. Our lead product ZELSUVMI™ (berdazimer) topical gel, 10.3%, for the treatment of molluscum contagiosum is now approved by the U.S.

Pelthos Therapeutics是一家生物制药公司,致力于将创新,安全和有效的治疗产品商业化,以帮助未满足治疗负担的患者。我们的主导产品ZELSUVMI™(berdazimer)局部凝胶,10.3%,用于治疗传染性软体动物,现已获得美国批准。

Food and Drug Administration. In addition to ZELSUVMI, Pelthos has a pipeline of potential product candidates that utilize our proprietary nitric oxide-based technology platform, NITRICIL™. More information is available at www.pelthos.com. Follow Pelthos on LinkedIn and X..

食品和药物管理局。除了ZELSUVMI之外,Pelthos还有一系列潜在的候选产品,这些产品利用了我们专有的基于一氧化氮的技术平台NITRICIL™。有关更多信息,请访问www.pelthos.com。在LinkedIn和X上关注pelthos。。

Forward-Looking Statements

前瞻性声明

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements.

本新闻稿包含配体的前瞻性声明,涉及风险和不确定性,并反映了配体截至本新闻稿发布之日的判断。诸如“计划”、“相信”、“期望”、“预期”和“意愿”等词语以及类似的表达,旨在识别前瞻性陈述。

These forward-looking statements include: the timing of commercial launch of ZELSUVMI; the potential that ZELSUVMI could avoid surgical removal or more intensive therapies in some patients; and the possibility that Ligand’s strategy to maximize value through the creation of Pelthos Therapeutics will be successful.

这些前瞻性声明包括:ZELSUVMI商业推出的时间;ZELSUVMI可以避免某些患者的手术切除或更强化的治疗;配体通过创建Pelthos疗法实现价值最大化的策略将获得成功。

Actual events or results may differ from Ligand's expectations due to risks and uncertainties inherent in Ligand’s business, including, without limitation: the risk that Ligand and Pelthos may not commercially launch ZELSUVMI in late 2024 or at all; Ligand and Pelthos may not be able to successfully commercialize ZELSUVMI which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; the market size for ZELSUVMI may be smaller than estimated; Ligand’s dependence on third parties in connection with product manufacturing and distribution of ZELSUVMI; Ligand may not be able to protect its intellectual property and patents covering ZELSUVMI which may be challenged or invalidated; and other risks described in Ligand’s prior press releases and filings with the Securities and Exchange Commission available at www.sec.gov.

由于配体业务固有的风险和不确定性,实际事件或结果可能与配体的预期不同,包括但不限于:配体和佩尔索斯可能在2024年底或根本不在商业上推出ZELSUVMI的风险;Ligand和Pelthos可能无法成功地将ZELSUVMI商业化,这将取决于许多因素,包括政府当局和健康保险公司的覆盖率和报销水平以及医疗保健提供者的市场接受程度;ZELSUVMI的市场规模可能比估计的要小;配体在ZELSUVMI产品制造和分销方面对第三方的依赖;配体可能无法保护其知识产权和涵盖ZELSUVMI的专利,这些专利可能会受到质疑或无效;以及Ligand之前的新闻稿和提交给证券交易委员会的文件中描述的其他风险,请访问www.sec.gov。

Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Ac.

配体否认在本发布日期之后更新这些前瞻性声明的任何意图或义务。这一警告是根据私人证券诉讼改革委员会的安全港规定作出的。

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1 ZELSUVMI Package Insert. LNHC Inc. 2023.

1 ZELSUVMI包装插页。LNHC公司,2023年。