Alto, a pharmacy start-up, just raised $250 million from SoftBank’s Vision Fund 2 and others

CNBC: | January 30, 2020

Alto Pharmacy has raised $250 million from investors including SoftBank’s second Vision Fund, three people familiar with the matter told CNBC. The investment has already been approved by the Vision Fund’s investment committee, meaning it’s a done deal, the sources said. It also marks one of the first handful of known bets from the SoftBank’s new fund. The deal values the company at more than $700 million, according to one of the people. SoftBank’s Vision Fund has already done just over half a dozen deals in the health and life sciences sector, including 10x Genomics, which subsequently went public, and employer health-focused Collective Health. It has several venture partners dedicated to the space, with Silicon Valley-based Deep Nishar taking the most active interest in health care.

Spotlight

A five day executive course on Quality by Design (QbD). QbD is at the very heart of modern pharmaceutical development. The implementation of QbD principles provides a cost-efficient approach to delivering high quality medicines for patients. Regulatory authorities, both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), are placing great emphasis on the QbD component as a part.

Spotlight

A five day executive course on Quality by Design (QbD). QbD is at the very heart of modern pharmaceutical development. The implementation of QbD principles provides a cost-efficient approach to delivering high quality medicines for patients. Regulatory authorities, both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), are placing great emphasis on the QbD component as a part.

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PHARMA TECH

Iktos Announces Deployment of Their AI for Drug Design Software Makya™ by Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Iktos | December 09, 2021

Iktos, a company specialized in Artificial Intelligence for new drug design today announced recent collaboration agreement in AI for new drug design with Jiangsu Hengrui Pharmaceuticals Co., Ltd., a leading global pharmaceutical company based in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Under the agreement, Iktos’ de novo generative design software Makya™ will be used by Hengrui scientists to facilitate rapid and cost-effective design of novel compounds and accelerate hit-to-lead/lead optimisation for undisclosed Hengrui Pharma’s drug discovery programmes. Iktos has released Makya™, a generative AI-driven de novo design software for Multi-Parametric Optimization (MPO), available either as a SaaS platform or for implementation on customer premises or in the customer’s Virtual Private Cloud (VPC). Makya’s user-friendly interface enables it to be used by medicinal or computational chemists. Makya™ can also be operated as a Python package through a Jupyter notebook interface. Iktos’ AI technology, based on deep generative models, helps bring speed and efficiency to the drug discovery process, by automatically designing virtual novel molecules that have desired activities for treating a given disease. This tackles one of the key challenges in drug design: rapid identification of molecules which simultaneously satisfy multiple bioactivity and drug-like criteria for drug discovery and development. “Innovation is the core development strategy. Hengrui has a strong interest in exploring and utilizing enabling technologies, such as AI, to transform and accelerate the discovery of innovative medicines. We are excited about the opportunity to use Iktos’ proprietary AI platform to beef up our drug design and discovery capability to better address unmet clinical needs”. Dr. Weikang Tao, Vice President of Hengrui Pharma and CEO of R&D Centers "We are very pleased to collaborate with Hengrui Pharma, a leading global pharmaceutical company based in China. We are excited and proud to announce our first collaboration deal in China pharma sector and to have Hengrui Pharma scientists use our software in their early discovery programs", said Yann Gaston-Mathé, Co-founder and CEO of Iktos. "It is our ultimate goal to facilitate our technology usage by expert drug discovery scientists, who have deep knowledge and understanding of their discovery programs. This way, the promise of AI to dramatically improve drug discovery will have a better chance to be realized and impact therapeutic development. At Iktos, we strive to build an innovative technology platform capable of improving the efficiency of drug discovery by combining our powerful algorithmic technology, our know-how derived from the experience of the many collaborations we have established to date, and an intuitive and user-friendly user interface which is essential to an optimal user experience.” About Iktos Incorporated in October 2016, Iktos is a start-up company specializing in the development of artificial intelligence solutions applied to chemical research, more specifically medicinal chemistry and new drug design. Iktos is developing a proprietary and innovative solution based on deep learning generative models, which enables, using existing data, the design of molecules that are optimized in silico to meet all the success criteria of a small molecule discovery project. The use of Iktos technology enables major productivity gains in upstream pharmaceutical R&D. Iktos offers its technology both as professional services and as a SaaS software platform, Makya™. Iktos is also developing Spaya™, a synthesis planning software based upon Iktos’s proprietary AI technology for retrosynthesis. About Jiangsu Hengrui Pharmaceuticals Co., Ltd. Jiangsu Hengrui Pharmaceuticals Co., Ltd. is a leading global pharmaceutical company based in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui Pharma has 8 innovative products marketed and more than 50 clinical-stage innovative candidates, of which 20 are currently under global clinical development. Hengrui Pharma ranked 21st among the top 1,000 global pharma companies announced by Torreya in 2020. Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.

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RESEARCH

Regeneron, following in Lilly's footsteps, wins FDA emergency nod for COVID-19 antibody cocktail

Regeneron | November 24, 2020

Covid-19 Regeneron antibody cocktail, one of the drugs of President Donald Trump was given after he was infected with the SARS-COV-02 virus, had been cleaned for emergency use by the FDA. And, despite the towering vaccine slide, one analyst still sees therapy as a $ 1 billion-plus business. Authorization of Emergency Use (EUA) for Regn-COV2, a combination of monoclonal antibodies Kasarivimab and IMdevimab, marked the second for antibody therapy. The first to go to Bamlanivimab Eli Lilly, who was given EUA a few days ago. In addition to the difference between Regn-COV2 is a concoction of several drugs, while Lilly's maintenance contains only one drug, both EUU is almost identical; The two of them for Covid-19 patients were light to medium for a minimum of 12 years old who were not hospitalized but at high risk to advance to Covid-19. “The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement. FDA fact sheet detail the criteria for determining "high-risk" patients. These include obese people with more than 35 body mass index, older patients in or more than 65 years, or people with fundamental conditions such as chronic kidney disease, diabetes, cardiovascular disease or breathing conditions, among others. Data from a phase 1/2 study in 799 patients showed the cocktail could reduce viral load significantly better than placebo did. More importantly, there were lower rates of hospital visits among REGN-COV2-treated patients within 28 days. “This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors,” George Yancopoulos, M.D., Ph.D., Regeneron’s chief scientific officer, said in a statement Saturday. Through a $450 million agreement signed in July with the Trump administration’s Operation Warp Speed, Regeneron could provide up to 300,000 treatment doses of REGN-COV2 to the federal government for distribution. The company plans to have the single-dose therapy available to about 80,000 patients by this month and hit the 300,000 mark by the end of January. The U.S. government has a separate $375 million pact with Lilly for 300,000 doses of bamlanivimab. Antibody drugs are hard to produce, and 300,000 doses are dwarfed in comparison by the 2 million treatment courses Gilead Sciences has pledged to produce of its small-molecule therapy Veklury (remdesivir) by the end of this year. With that limited initial supply, Regeneron CEO Len Schleifer, M.D., Ph.D. warned that demand of REGN-COV2 may exceed supply during the early days.

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PHARMACY MARKET

Tarsier Pharma Raises Capital to Execute Phase-3 Clinical Trial

Tarsier Pharma | August 28, 2021

Tarsier Pharma, a late clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat patients with blinding ocular diseases, today announced it raised capital to execute a phase-3 clinical trial of its TRS01 program in the US and Europe. Strategic and new investors alongside existing investors participated in this transaction. Following a successful End of Phase II meeting with the FDA, the Company obtained all necessary regulatory approvals to execute phase 3 and has recruited leading uveitis experts as principal investigators. Tarsier plans to enroll the first patient in Q4 of 2021. Tarsier's technology, TRS, is a novel immunomodulator molecule that showed, in a dose-ranging, randomized, double-masked phase I\II trial in the target indication, a prompt and statistically significant improvement in signs and symptoms of uveitis. "We are excited to have the support of our existing and new investors, as we continue our clinical development of TRS01 in advanced stages," said Dr. Haim Langford, CEO of Tarsier. "Looking ahead, we are eager to bring our lead product to market and simultaneously progress our development of important pipeline projects for other back-of -the-eye blinding diseases, and plan to raise additional capital to realize these as well." About Tarsier Pharma Tarsier Pharma is a late clinical stage pharmaceutical company, phase-3 ready, focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ocular blinding diseases. TRS is a breakthrough proprietary technology platform, based on a new bio-inspired chemical entity, with novel mechanism of action and demonstrated safety and efficacy in a rare debilitating and blinding indication. Lead product candidate for uveitic glaucoma Non-infectious uveitis is an autoimmune blinding ocular inflammation, considered the third leading cause of blindness in the developed world. Tarsier's TRS01 is a potent fast-acting immunomodulator, delivered as eye drops, for the treatment of non-infectious anterior uveitis in patients with uveitic glaucoma – considered an end-stage condition of uveitis. Once a uveitis patient has also developed glaucoma (uveitic glaucoma), the only available treatments for active inflammation, which are steroids, should be avoided, due to their negative side effects in expediting glaucoma and vision loss. Thus, TRS01 has the potential to become the standard of care for uveitic glaucoma.

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