International Finance Corporation Ltd. (Israel)

Biovac hauled in a $108.3 million financing package that will allow the South African pharma company to build the continent’s first end-to-end, multi-vaccine production plant. Biovac has secured a $108.3 million financing package that will allow the South African pharma company to build the continent’s first end-to-end, multi-vaccine production plant.The financial backing comes from the International Finance Corporation (IFC), the European Investment Bank (EIB) Group, and the European Commission in the form of a $20 million loan, plus a €75 million ($88.3 million) investment from EIB Group, the company said in an April 16 press release.The latter tranche, dubbed a “quasi-equity” investment, is a form of long-term financing to provide flexible capital for growth while sharing risk, according to the release. It’s being provided under the Human Development Accelerator guarantee program backed by the European Commission and administered by the EIP Group in partnership with the Gates Foundation.“Expanding local vaccine development and end-to-end manufacturing on African soil for global supply has always been Biovac’s vision, and this funding enables us to accelerate it,” Morena Makhoana, Biovac’s chief executive, said in the release. “The new facility will ensure a reliable supply of life-saving vaccines for Africa and expand our role in building skills, advancing technology transfer and driving vaccine innovation that will benefit generations to come.”The project—located at Biovac’s Cape Town manufacturing site—is expected to be completed by 2028 and will churn out oral cholera vaccines. Eventually, the site will produce vaccines for polio, pneumonia and meningitis.When fully operating, the facility will have the capacity to produce up to 40 million doses a year, the company said.That would address roughly 40% of the global cholera vaccine supply gap and support regional markets served by UNICEF and Gavi, the Vaccine Alliance, according to the release. The project will also generate more than 340 skilled jobs and an estimated 7,000 indirect jobs.Biovac inked a deal back in 2024 with Sanofi and EuBiologics to produce and distribute critical vaccines on the continent. The collaboration with Sanofi involved making inactivated polio vaccines.That same year, Moderna withdrew its pledge to build a $500 million manufacturing facility in Kenya because it hadn’t received any vaccine orders from the African continent since 2022. Moderna’s decision was blasted by the African CDC, which said Moderna was shifting blame for its backpedal.

Teva wins appeal in migraine patent fight with LillyICER suggests reworks to accelerated approvalBiovac brings in more than $100M to expand vaccine production facility Teva wins appeal in migraine patent fight with LillyA US appeals court has revived a patent lawsuit filed by Teva against Eli Lilly over their rival migraine drugs, reversing a prior ruling in the case. The US Court of Appeals for the Federal Circuit found that Teva's Ajovy (fremanezumab) patents were valid.The dispute dates back to 2018, when Teva alleged that Lilly's rival CGRP inhibitor Emgality (galcanezumab) infringed patents related to Ajovy. A jury agreed in 2022, awarding Teva $176.5 million in damages.But the victory proved short-lived. In 2023, a US district judge in Massachusetts threw out the verdict, ruling instead that Teva's patents — concerning the use of humanised anti-CGRP antagonist antibodies to treat headache — were invalid for lack of written description and enablement. Now that Teva has won its appeal, the case now heads back to Massachusetts federal court. Lilly disagrees with the decision and is "evaluating all ⁠available options," a company spokesman told Reuters, adding that the ruling doesn't affect its ability to provide Emgality to patients.-Anna BratulicICER suggests reworks to accelerated approvalThe Institute for Clinical and Economic Review (ICER) released a white paper on Thursday that offered ways the FDA can improve its accelerated approval pathway, including improving transparency so patients and their physicians understand the risks and benefits of taking a drug cleared via the speedy programme. "We can point to several successes where patients have benefited from expedited access to transformative medications," said ICER president and CEO Sarah K. Emond. "However, there are also many instances of regulatory inconsistency, lagged development of confirmatory trial data, and access restrictions that have limited patient use." ICER recommended that trials designed to support accelerated approval use endpoints that "matter most to patients," while encouraging the FDA to begin differentiating between surrogate endpoints that are most likely to predict a drug's success in a confirmatory trial. For those post-marketing studies, the organisation advised that drugmakers adopt an informed consent requirement for patient recruitment. The group also suggested that the US regulator implement procedures to re-review or rescind accelerated approvals if a confirmatory trial fails. -Elizabeth EatonBiovac brings in more than $100M to expand vaccine production facilityThe European Investment Bank and the International Finance Corp chipped in a €75 million ($88 million) "quasi-equity" investment and a $20-million loan, respectively, for the Biovac Institute to build out its vaccine facility in Cape Town, South Africa, according to a report from Bloomberg.Construction on the site is expected to finish by 2028. Once complete, the facility will be able to produce more than 400 million doses of multiple vaccines, from start to finish, without needing active pharmaceutical ingredients (APIs) from overseas. It will initially be focused on oral cholera vaccine production, followed by vaccines for polio, meningitis and pneumonia.The site expansion is projected to create more than 340 direct positions and 7000 indirect jobs.-Elizabeth Eaton

Biovac’s new vaccine factory in Cape Town, which is expected to make up to 400 million vaccines per year, has secured financing from the European Investment Bank, the European Commission and the International Finance Corporation. The total cost of the facility will be $180 million, Biovac’s CEO Morena Makhoana told Endpoints News in an email. The factory will be located at Biovac’s campus in Pinelands, Cape Town. The facility will initially make oral cholera vaccines and will expand into polio, pneumonia and meningitis vaccines. Once completed, the site will produce between 30 and 40 million cholera vaccine doses per year, which will address around 40% of the global cholera vaccine supply gap. Of the total building cost, around $108.5 million will be funded by the EIB and IFC. Biovac is set to receive €75 million ($88.5 million) “quasi‑equity” investment from the EIB and a $20 million senior loan provided by the IFC, according to a Thursday press release by the European Union. The EIB’s quasi‑equity investment is a long-term fund provided under the Human Development Accelerator program, which is backed by the EC and implemented by the EIB and the Gates Foundation. Construction of the factory is expected to be completed by 2028 and around 340 new jobs will be created. The EU has made efforts to support vaccine manufacturing in Africa. In 2024, it pledged €750 million ($885 million) to help launch the African Vaccine Manufacturing Accelerator. As a part of that launch, Biovac partnered with Sanofi to manufacture inactivated forms of polio vaccines for over 40 African countries. Biovac was founded in partnership with the South African government in 2003 to build up the country’s local vaccine manufacturing and supply. Endpoints is fielding the next Biopharma Sentiment Index (BPSI) — a concise, three-minute survey that distills thousands of industry views into a clear quarterly benchmark. This year is pivotal for biopharma, and we need your perspective on where things are going. Take the survey here. Editor’s note: This story was updated to correct the number of vaccines in paragraph one and the number of cholera vaccines in paragraph three.