2015年2月3日讯 /生物谷BIOON/ --仿制药巨头迈兰公司最近宣布已经和著名呼吸疾病药物开发商Theravance生物公司达成合作协议，共同开发Theravance公司处于临床二期的COPD药物TD-4208。而迈兰公司为此付出了高达2亿6千5百万美元的代价。协议规定，迈兰公司将向Theravance公司支付1500万美元的现金外加3000万美元的注入资本。此外还有高达2亿2千万美元的里程碑资金。
作为交换，迈兰公司将分享这种毒蕈碱拮抗剂类药物的版权。Theravance公司介绍说，不久前TD-4208已经完成了临床二期研究，并取得了令人满意的数据。公司目前正在着手进行临床三期研究的筹备工作。
目前市场上的类似药物如勃林格殷格翰公司的Spiriva大多是通过采用手持式设备进行给药，这给许多COPD患者带来了不便。调查显示，美国COPD患者中有超过9%的患者需要或者愿意选择喷雾形式的药物。Theravance公司表示，TD-4208一旦获批将是市面上首个同类型吸入式药物，并将有助于未来关于COPD联合疗法的开发。同时，这也是Theravance公司近两年来最大的一笔投资交易。
除了TD-4208之外，公司目前还开发有治疗阿片类药物肠胃副作用的TD-1211，
治疗慢性疼痛的TD-9855，治疗细菌感染的TD-1792和治疗胃肌轻瘫的药物TD-5108。
不过，值得注意的是，此次Theravance公司和迈兰公司的交易仅涉及喷雾剂型的TD-4208,公司仍保有定量雾化吸入器剂型和干粉吸入型COPD药物的全球专利。
详细英文报道：
Generics giant Mylan ($MYL) is shouldering its way into the blockbuster market for COPD treatments, signing a $265 million deal with the respiratory experts at Theravance Biopharma ($TBPH) to get its hands on a late-stage contender.
Under the agreement, Mylan will hand over a $15 million cash payment and make a $30 million equity investment in Theravance, promising $220 million more if the collaboration goes according to plan. In exchange, it will partner up on TD-4208, a once-daily long-acting muscarinic antagonist (LAMA) designed to relieve symptoms of COPD and other respiratory diseases. The drug posted positive top-line results in Phase II, Theravance said, and is on track to begin late-stage trials later this year. Per the deal, Theravance will pay its way through Phase III with Mylan reimbursing its costs up until an FDA filing.
The majority of once-a-day LAMA treatments, like Boehringer Ingelheim's Spiriva, are available only as handheld devices, Theravance said, creating an unmet need for the estimated 9% of American COPD patients who need or prefer the mist of a nebulizer. Mylan figures TD-4208 can fill that hole in the short term and, eventually, become part of a cocktail therapy with other bronchodilators.
The deal is Theravance's first major move since splitting in two last year, with one publicly traded company handling its revenue-generating drugs and the other leading the charge on R&D. The latter, Theravance Biopharma, is due 85% of the proceeds from its sibling's collaborations with GlaxoSmithKline ($GSK), a trio of marketed respiratory drugs with combined peak sales estimates north of $3.5 billion. That revenue stream will help it hit the gas on a pipeline of in-house treatments, and the Mylan deal fits in with Theravance's broad strategy, CEO Rick Winningham said.
"Funding of the Phase III registrational program by Mylan strengthens our company's capital position and enhances our financial flexibility to advance other high-value pipeline assets alongside TD-4208," Winningham said in a statement.
Beyond its lead asset, Theravance has four wholly owned Phase II treatments: TD-1211, designed to counteract the gastrointestinal side effects of opioid therapy; TD-9855, a norepinephrine and serotonin reuptake inhibitor with hopes of treating chronic pain; TD-1792, a treatment for bacterial infections; and TD-5108, a gastroparesis drug.
Theravance's deal with Mylan covers only a nebulized formulation of TD-4208, allowing the biotech to keep the global rights to metered dose inhaler or dry powder inhaler versions of the treatment. The biotech's shares jumped as much as 12% on news of the agreement Monday.