基加德科学公司周三宣布，已与亚洲及非洲北部地区的六家代工制药企业合作，将生产并销售抗艾滋病药物Lenacapavir，此药物是一种两年一次的注射剂，能为感染HIV提供近乎全面防护。这六家企业分别为印度、巴基斯坦和埃及的四间印度企业以及一家中国和埃及的企业，它们获准在120个国家销售该药，其中大部分是HIV病例高发的非洲国家。
基加德将不会向这些代工企业收取任何特许使用费，这一协议为快速且广泛地提供Lenacapavir药物铺平了道路。然而，该协议排除了许多中等收入和高等收入国家，如巴西、哥伦比亚、墨西哥、中国及俄罗斯等，它们共占据了全球大约20%的新HIV感染率。基加德将在这些国家以更高价格销售自有品牌药物。
据利物浦大学的研究人员指出，如果大量采购的话，此药物的生产成本可能仅需每年每人40美元左右，远低于基加德在美国为治疗HIV患者设定的价格：每年每人42,250美元。在预防HIV感染（简称PrEP）方面使用此药的具体价格尚不明确。
中国、俄罗斯等中高收入国家被排除在协议之外，而这些国家的HIV感染人数占全球总数的大约五分之一。基加德将按照世界银行的人均国民生产总值标准来决定谁能够获得药物。这导致了各国之间健康服务接入情况的日益差异，以及一种倾向：富裕和贫穷群体之间的隔离加剧。
对此发表评论的一名摩洛哥医生Othoman Mellouk表示：“对最受益于快速、广泛的药物提供的国家来说这是好消息，但随着新技术仅服务于最富有的国家和最贫困的国家，未来将越来越出现不平等的情况。”
此外，协议还存在一个特殊规定，禁止这六家代工企业向不在协定范围内的其他国家出口其产品。比如，巴西公共卫生系统将无法从印度公司购买廉价版本的药物。
基加德已经获得了巴西对Lenacapavir的专利权。但根据保守的贸易协定条款，国家有权颁发所谓“强制许可”，这一举措可超越知识产权保护。
即使巴西获得了此类许可并使用Lenacapavav，该六家代工企业仍被禁止向巴西卫生系统出售药品。
世界卫生组织已经为拉丁美洲国家批量购买药物以降低成本，但基加德的专利权也使巴西无法通过这一途径获得更经济的治疗选择。
一名与一家巴西艾滋病大型机构合作的知识产权律师Susana van der Ploeg将该规定称为“苛刻”。她预计仅剩下的一种可行选项是巴西科研人员逆向工程生产这种药物，本地化生产。她说：“我们将这样做，但需要时间，这将是挽救生命的时间。”
基加德在过去几年中排除了包括巴西在内的其他所有药物许可协议对象，这导致生活在贫困线以下的25%巴西人口受此影响。
此外，Gilead宣布会在年底之前向监管机构提交Lenacapavir上市申请，在自愿许可国家使用药品期间，其价格将为“零利润”。直至 generics 制药公司开始生产并获得监管审批。但基加德并未透露具体的价格或供应量。
据AVAC执行董事Mitchell Warren称，由于现有HIV预防措施如口服PrEP药物未被证明在最脆弱人群中有效降低新感染率，在全球需求迫切需要更有效的替代品的背景下，Lenacapavir的出现提供了希望。根据数据统计，2023年全球新HIV感染人数达到130万。
Gilead计划在低收入国家提供价格优惠至远低于美国水平（但仍旧高过巴西公共医疗系统能够承受的价格），同时确保美国富裕人群仍然可以选择购买原版药物。
基加德首席商务官Johanna Mercier表示，快速为Lenacapavir这一有可能颠覆性的新药签署许可协议是前所未有的行为。这标志着该公司致力于全球终止艾滋病流行的决心。
该generics版本的药物预计将在2027年晚期上市，在此之前，基加德将保持独家供应。全球HIV预防联盟和疟疾、肺结核及艾滋病基金将是最大的购买者之一，预计能够承担每人每年约100美元的价格。
Warren希望国际大型健康机构联手合作，以足够大的订单量使至少在2026年底有百万人开始使用Lenacapavir，从而向generics制造者传达市场潜力的信息。
新闻来源：www.nytimes.com
原文地址：Gilead Agrees to Allow Generic Version of Groundbreaking H.I.V. Shot in Poor Countries
新闻日期：2024-10-02
原文摘要：
The drugmaker Gilead Sciences on Wednesday announced a plan to allow six generic pharmaceutical companies in Asia and North Africa to make and sell at a lower price its groundbreaking drug lenacapavir, a twice-yearly injection that provides near-total protection from infection with H.I.V. Those companies will be permitted to sell the drug in 120 countries, including all the countries with the highest rates of H.I.V., which are in sub-Saharan Africa. Gilead will not charge the generic drugmakers for the licenses. Gilead says the deal, made just weeks after clinical trial results showed how well the drug works, will provide rapid and broad access to a medication that has the potential to end the decades-long H.I.V. pandemic. But the deal leaves out most middle- and high-income countries — including Brazil, Colombia, Mexico, China and Russia — that together account for about 20 percent of new H.I.V. infections. Gilead will sell its version of the drug in those countries at higher prices. The omission reflects a widening gulf in health care access that is increasingly isolating the people in the middle. Gilead charges $42,250 per patient per year for lenacapavir in the United States, where it is approved as a treatment for H.I.V. The company has said nothing about what lenacapavir will cost when used to prevent H.I.V. infections, a process called pre-exposure prophylaxis, or PrEP. The generics makers — four companies in India, one in Pakistan and one in Egypt — are expected to sell it for much less. Researchers at Liverpool University found the drug could profitably be produced for as little as $40 per patient per year, if it were being purchased in large volumes. The terms of the new deal are similar to agreements made in recent years by other large pharmaceutical companies for drugs to treat cancer, hepatitis, Covid and H.I.V. These agreements guarantee low-cost access in the poorest countries but exclude these large-population, middle-income countries, using World Bank national income-per-capita figures to decide who is included. Wealthy people living in these countries may be able to buy the brand-name drugs at the prices the drug companies set, said Dr. Othoman Mellouk, an expert in access to medicines with the health equity advocacy group ITPC Global who is based in Morocco. But most people cannot, and it is they who are most vulnerable to diseases such as H.I.V., he said. “It’s good for those countries who are included in the license, but we will see more and more inequality of access as new technologies are available for the richest and for the poorest — those who are going to struggle are those in-between,” Dr. Mellouk said. Melissa Barber, who studies access to medicines with the Yale Collaboration for Regulatory Rigor, Integrity and Transparency, said that the licensing deal shut out some of the countries that would most benefit from broad, swift access to lenacapavir, countries where H.I.V. is spreading among marginalized groups such as migrants, sex workers and injecting drug users, who are likely to be reached through public health systems. “The patient populations driving the epidemic are people very disconnected from the health system, people who are hard to get to: That’s the center of gravity of epidemic,” she said. Mitchell Warren, executive director of the H.I.V. prevention organization AVAC, said the exclusion of Brazil, Peru, Mexico and Argentina from the generics deal was shocking since the clinical trials that proved the drug worked were conducted in those countries. Gilead said it would provide the people who participated in the trial with lenacapavir “until it is available in their countries.” “Eight thousand people in a dozen countries participated in those two trials, but they didn’t do it alone, they did it with their communities,” Mr. Warren said. “Those trial sites were chosen because that’s where epidemics were the most serious.” The voluntary license has an unusual provision that prevents the generics makers from exporting their product to any country not covered in the deal — so, for example, Brazil’s public health system will not have the option of buying the cheap version of the drug from an Indian company. Gilead has patented lenacapavir in Brazil. But countries have the right, under even conservative trade agreements, to issue what are called compulsory licenses, which override intellectual property protections. However even if Brazil were to issue such a license for lenacapavir, the generics makers would be forbidden from selling to the Brazilian health system. The Pan American Health Organization buys drugs in bulk for Latin American countries in order to bring down prices, but the Gilead patent will also shut Brazil out of that avenue to a more affordable medication. Susana van der Ploeg, an intellectual property lawyer who works with a large Brazilian AIDS organization, called the provision “draconian.” The only remaining option is for Brazilian researchers to reverse-engineer the drug and set up production locally, she said. “And we will,” she said. “But it will take a long time, time when we could have been saving lives.” Brazil has been left out of all the other drug licensing deals in recent years, and the toll is paid by the 25 percent of its people who live below the poverty line, Ms. van der Ploeg said. “It’s not sustainable for us to give to people new forms of medicine,” she said. “We are a huge country with a public health system and huge inequalities and a lot of vulnerable people, including those with H.I.V.” A Gilead spokeswoman said the company was “exploring several innovative strategies to support access, including tiered pricing” to make the drug accessible as PrEP in Latin America. Ms. van der Ploeg said she expected the company would offer a price far below what it charges in the United States — but still far above what the Brazilian public health system could pay. There has been an urgent need for a more effective PrEP product because the existing H.I.V. prevention efforts, including oral PrEP drugs, have not proved effective at ending new infections among some of the most vulnerable groups. In 2023, there were 1.3 million new H.I.V. infections globally. The hope is that a discrete injection just twice a year may be more appealing for people still vulnerable to the virus. In late June, Gilead stopped a trial of lenacapavir early after a data review found that the drug had a stunning 100 percent efficacy rate. In a study of 5,300 cisgender women ages 16 to 25 in Uganda and South Africa, not a single one who received the injection contracted H.I.V. A second trial of the drug, among gay men and trans and non-binary people 16 and older, found similarly astounding results: In September, Gilead announced that among 3,200 trial participants in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States, there were just two H.I.V. infections among those who got the shots. “Signing these agreements so quickly for a new, potentially transformative product like lenacapavir, before any global regulatory submissions for PrEP, much less approval, is unprecedented in H.I.V.,” said Johanna Mercier, Gilead’s chief commercial officer. “It’s a clear symbol of our commitment to ending the epidemic for everyone, everywhere.” The generic version of the drug could be available by late 2027, Mr. Warren said. In theory, six different companies will then be competing for large orders, driving down the price. Until then, Gilead will be supplying the drug. The company said it would submit the drug to regulators for approval before the end of this year, and provide lenacapavir at a “no profit” price in the countries covered by the voluntary licenses until the generics makers have their manufacturing in operation and their versions are approved by regulators. Gilead would not say what that price would be or what volumes it would supply. The U.S. President’s Emergency Program for AIDS Relief and the Global Fund to Fight AIDS, Tuberculosis and Malaria are expected to be the two largest buyers of lenacapavir. They have indicated they can pay about $100 per patient per year. Mr. Warren said he hoped the major global health agencies would work together to place orders large enough to have at least a million people on lenacapavir by the end of 2026, which would help send a clear signal to generics makers about the potential market for the product.
