[ad_1]
Deborah Kobeka, CEO of Evaluate, unveiled such a successful drug development strategy and business model through the K-Blockbuster Global Forum hosted by the Korea Biopharmaceutical Association on the 30th.
CEO Deborah said: “Pharmaceuticals with annual sales of $ 1 billion are called blockbusters. Unlike existing blockbusters that target 1 or 2 diseases, blockbusters with various indications are emerging. . ” It’s important, “he said.
He suggested that the first of the highly successful strategies is unmet demand and rare diseases. Executive Director Deborah explained: “Rare disease treatment can shorten product time to market through related policies and systems, and the barriers are low. Examples include Biogen Spinraza and Alexion Soliris.”
The second strategy is to increase the product approval indicators (indications). Currently, AbbVie’s Humira has 11 and MSD’s Kitruda has six approval indicators.
The third point is to protect the monopoly rights of the market and emphasize that the protection and management of “patents” has a very important relationship with profits. “There is a way to delay the entry of other products to the market to ensure market monopoly. Humira joined after obtaining approval for the drug and, at the same time, added 7 years of market monopoly.” After launch, we protect our patents by signing an exclusive license agreement with Watson. “
Alexion is the company that has adopted these three strategies with the greatest success. CEO Deborah said: “Solilis, a unique colon antibody, reached sales of $ 4 billion in 2020. This is 66% of the company’s (Alexion) total sales,” Deborah said. “Soliris is a rare disease, seizures nocturnal hemoglobinuria (PNH). It was used as an indication and through this we managed to maintain a high price range of $ 440,000 per person per year.”
Executive Director Deborah said: “Because PNH is a rare disease, the pool of specialists is very small. Therefore, it was possible to sell drugs with a small number of vendors. Thanks to the low trade barrier, we successfully entered the market without a partnership with a large pharmaceutical company, “he said. Along with this, it was emphasized that it became a very successful brand by conducting an awareness campaign about the PNH.
In addition to PNH, Alexion has expanded the indicators (indications) for four diseases, including atypical hemolytic uremic disease, general myasthenia gravis, and neuromyelitis optica, and currently has two additional indicators through research and development. Additionally, it is expanding its marketing space by launching a Soliris tracking product in 2019.
Additionally, Executive Director Deborah said: “Alexion succeeded in obtaining a patent extension for Soliris from the court.” He said.
“The blockbusters that occupy a high market share in the future will be next-generation treatments such as cell therapy and gene therapy that target rare diseases.” The scope is expected to gradually expand to small pharmaceutical companies and biotech companies. “
In addition, he said, “Because there are many potential candidates among many small pharmaceutical companies, the acquisition and licensing will be important to concern the market.” I look forward to a highly successful new drug being released that will be a growth engine for drugs based on the strategy of broadening the indicators by focusing on target diseases and vulnerable diseases, and guaranteeing exclusive rights. “
“Collaboration and acceleration are also essential”
To create a highly successful new drug, it is also necessary to advise that cooperation between industry, academia and research, acceleration and obtaining professional manpower are also necessary.
Tony Kujaris, Director of the Milner Institute, Cambridge University School of Medicine, UK, highlighted the University of Cambridge’s biomedical sciences ecosystem, which was formed around the Milner Institute of Medicine, and introduced strategies to reduce the gap between basic research and commercialization through industry-academia-research collaboration.
Tony said, “The Milner Institute serves as a hub for university researchers, hospitals and pharmaceutical companies. It is connected to 10 pharmaceutical companies and has investors in the startup field,” Tony said. “We opened the treatment symposium, the largest symposium in the university, and formed a network.” We are connecting projects, operating an accelerator, connecting startups and investors, and supporting active networking with pharmaceutical companies. “
Matthias Mullenbeck, general manager of Merck’s global business development division, said: “We signed 96 partnerships despite the Corona 19 pandemic last year and our goal is to reach a similar level this year. Through this, we are accelerating the innovation”. Emphasizing the importance of forms to create an innovation ecosystem.
Drawing on the importance of human resources and organizational competence for the development of innovative new drugs, Park Soo-hee, president of the Korean Pharmaceutical Association (KASBP), and Bang Young-joo, CEO of Bang & Ok Consulting (professor Emeritus at Seoul National University), are based on their experience of participating as a post-clinical member of Big Pharma, explaining the difficulties and strategies of success of the global challenge of phase 3.
“KIMCo, Korean Pharmaceutical Companies Also Joined For A Blockbuster … Megafund And Public-Private Partnerships Required”
Since national pharmaceutical companies have also established a consortium so that K-blockbusters can be launched, it is a position that it is necessary to form a public-private advisory body and create a mega-fund.
In presenting the theme of ‘Korean Blockbuster Development Model’, Kyung-Hwa Heo, CEO of Korea Innovative Medicines Consortium (KIMCo), raised the efficiency of domestic new medicine development, which was strong in exporting technologies in the early stages, but the global clinical and commercialization of new innovative drugs was insufficient, said it is necessary to seek structural changes in the market.
First, when the capital market for investment in new drug development is divided into three categories: ▲ government support ▲ private fund ▲ pharmaceutical biological company, most companies focus on R&D and investment portfolios. investment in the early stages or face limitations in investment in R&D in late clinical trials, he mentioned that it is a pattern that depends on the initial export technology. While the scale of investment is increasing, it is noted that late-stage investment, which requires the most funds to invest for highly successful development, is relatively insufficient.
To solve this problem, a private-private sector partnership (PPP) is required in the form of a partnership led by private companies and backed by the government, and it is emphasized that Korea should also create a ‘mega fund’ worth about 1 trillion. won that he can invest heavily in subsequent clinical trials. The world’s most famous PPP is the European Innovative Medicines Initiative (IMI), and Singapore’s TEMASEK sovereign fund and the Blackstone private fund that invests heavily in late clinical trials are representative examples of mega-fund construction.
CEO Heo Kyung-hwa said: “The mega-fund is not an option, it is essential.” “We have transformed the paradigm from early technology export to late clinical development and created a mega-fund, while selecting candidates based on technological innovation and commercial viability to select new drugs for national representatives. I have to do it.” He said.
He urged, “pharmaceutical bio-enterprise and biotechnology should form a consortium and form a consortium and create synergies in terms of technology and development capabilities.”
Hee-mok Won, President of the Pharmaceutical Association, said: “Although the national pharmaceutical bioindustry is equipped with sufficient capacities to challenge the development of new innovative drugs globally, it is a reality that we mainly choose the intermediate exit strategy. from abroad. technology export. “” Let us take up the challenge of creating a new blockbuster drug K with an optimized strategy. ”
