PHARMA TECH

BeiGene-Novartis PD-1 deal; Sinovac vaccine; Celltrion antibody COVID-19 data

Novartis | January 19, 2021

Novartis plunked down up to $2.2 billion for BeiGene's China-approved PD-1 drug tislelizumab to complement its own checkpoint inhibitor. Hear what BeiGene CEO John Oyler has to say about tislelizumab's position in and outside China. Sinovac's COVID-19 vaccine reported confusing data from Brazil, raising doubt about its true efficacy. Celltron's anti-SARS-CoV-2 antibody improved patients' outcomes in a phase 2/3 trial. And more.

Novartis paid $650 million upfront and committed up to $1.55 billion in milestones to license certain rights to BeiGene’s PD-1 inhibitor tislelizumab in major markets outside China. The Swiss pharma is not abandoning its own checkpoint inhibitor spartalizumab despite a recent phase 3 trial failure; instead, it views the two PD-1s as “complementary.”

BeiGene retains the right to co-market tislelizumab in North America. The Novartis deal gives the Chinese biotech a chance to get help “learning how to commercialize and build some capabilities” beyond China, BeiGene CEO John Oyler said in an interview. He believes the drug could compete in Asian-prevalent cancer types and its value in large indications will show over time. The CEO also believes the PD-1/L1 class has reached a pricing sweet spot in China where additional major price cuts aren’t likely.

Brazilian researchers first said Sinovac’s COVID-19 vaccine, CoronaVac, was 78% effective in a local phase 3 trial. But then, a few days ago, they released new data of just 50.4% efficacy. The gap was caused by the omission of “very mild” infections in the previous data. The misstep led to criticism of the trial organization, Brazil’s Butantan biomedical center, as well as suspicion about CoronaVac’s true efficacy. Turkey just authorized the shot for emergency use based on a reported 91.25% efficacy in an interim analysis of its local trial.

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PHARMA TECH

BIOCORP and Merck KGaA, Darmstadt, Germany, Sign a New Partnership for Smart Drug Delivery

BIOCORP and Merck KGaA, Darmstadt, Germany | October 11, 2022

BIOCORP a French company specialized in the design, development, and manufacturing of innovative medical devices, and Merck KGaA, Darmstadt, Germany, a leading science, and technology company, have entered into an agreement for the development and supply of a specific version of Mallya device as an accessory for one of Merck KGaA, Darmstadt, Germany's drug delivery devices. Manufactured in Clermont-Ferrand Mallya is a Bluetooth enabled clip-on device for pen injectors that collects dose and time of each injection and transfers information in real time to a companion software. Mallya is the first in its category to receive the CE-mark and commercial versions for insulin pen injectors are already available and distributed in Europe and other geographies. Major agreements have already been signed by BIOCORP with Sanofi, Novo Nordisk and Merck KGaA, Darmstadt, Germany, to develop specific versions of the technology in the field of Insulin and Human Growth Hormone (HGH). Healthcare companies BIOCORP and Merck KGaA, Darmstadt, Germany, will develop a new version of Mallya to help patients monitor their injection during their treatment. The device will automatically keep track of doses injected with timestamp and indicate that the product is administered properly, aiming to support patients with self-injections and to provide reassurance to patients. Financial details of the partnership include payments from Merck KGaA, Darmstadt, Germany, up to 5 million € for the development of the product within the first three years of the collaboration. Additional revenues are estimated to reach up to 8 million € during the first 5 years after launch depending on commercial milestones and adoption of Mallya devices by Merck KGaA, Darmstadt, Germany patients with further upside potential in the subsequent years. "We are delighted with this new partnership with Merck KGaA, Darmstadt, Germany, extending our collaboration to additional therapeutic areas. We had already announced that there is a great opportunity for our connected device Mallya in various therapeutic areas. As in diabetes, Mallya aims to reduce patients' stress and improve compliance with their treatments to optimize and secure the results “, Éric Dessertenne, CEO of BIOCORP ABOUT BIOCORP Recognized for its expertise in the development and manufacture of medical devices and delivery systems, BIOCORP has today acquired a leading position in the connected medical device market thanks to Mallya. This smart sensor for insulin injection pens allows reliable monitoring of injected doses and thus offers better compliance in the treatment of patients with diabetes. Available for sale from 2020, Mallya spearheads BIOCORP's product portfolio of innovative connected solutions. The company has 74 employees. BIOCORP is listed on Euronext since July 2015.

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PHARMACY MARKET

Jacobio Pharma to Collaborate with Merck on Clinical Trial of JAB-21822 in Combination with Cetuximab

Jacobio Pharma | October 13, 2022

Jaco Jacobio announced it has entered into a clinical trial collaboration agreement with Merck on clinical study of combination therapy between Jacobio's KRAS G12C inhibitor JAB-21822 and Merck's epidermal growth factor receptor inhibitor Erbitux®. This clinical study aims to evaluate the efficacy of JAB-21822 in combination with cetuximab in patients with KRAS G12C-mutated colorectal cancer. Jacobio is the sponsor of the combination study, and Merck will provide cetuximab for clinical trials in China and Europe under the collaboration agreement. "Our preclinical studies have shown that the combination of JAB-21822 and cetuximab can enhance the anti-tumor activity of JAB-21822 inhibitors in colorectal cancer tumor models, regressing tumors and delaying tumor regrowth after drug discontinuation. We look forward to new treatment options for patients through our collaboration with Merck," Dr. WANG Yinxiang, Chairman and Chief Executive Officer of Jacobio About JAB-21822 JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer first-line treatment; combination therapy with SHP2 inhibitor, PD-1 monoclonal antibody and cetuximab. About ERBITUX®. ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells. ERBITUX has obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998. About Jacobio Jacobio Pharma is committed to developing and providing new and innovative products and solutions to improve people's health. Our pipeline revolves around novel molecular targets on six major signalling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim for our key projects to be among the top three in the world. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. Jacobio has R&D centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug Discovery Platform (IADDP) and our iADC Platform.

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BUSINESS INSIGHTS

NeuroBo Pharmaceuticals, Inc. and Dong-A ST Co. Ltd. Announce Strategic Collaboration

NeuroBo Pharmaceuticals, Inc. | September 16, 2022

NeuroBo Pharmaceuticals, Inc. and Dong-A ST Co., Ltd. announced that they have entered into a conditional exclusive license agreement for NeuroBo to develop and commercialize DA-1241 and DA-1726, which are currently being evaluated for the treatment of nonalcoholic steatohepatitis obesity and type 2 diabetes. DA-1241 is a novel G-Protein-Coupled Receptor 119 agonist, which promotes the release of key gut peptides GLP-1, GIP and PYY, which, in turn, play an important role in glucose metabolism, lipid metabolism and weight loss. DA-1241 is a synthetic, selective small molecule, suitable for oral administration and has been shown to be well tolerated in phase 1 studies. Further, its multimodal mechanism appears to induce strong anti-NASH effects, supported by potential best-in-class efficacy, as demonstrated in pre-clinical studies. DA-1726 is a novel oxyntomodulin analogue functioning as a glucagon-like peptide-1 receptor and glucagon receptor dual agonist. OXM is a naturally-occurring, 37-amino acid peptide hormone that is released from the gut after ingestion of a meal, activating both the GLP-1 and glucagon receptors, prompting reduced food intake as well as an increase in energy expenditure, potentially resulting in superior body weight loss compared to selective GLP-1 receptor agonists. The beneficial effects of this dual mechanism of DA-1726 on weight loss compared to selective GLP-1 activity has been demonstrated in animal models. Additionally, DA-1726 has shown the ability to improve hepatic steatosis, inflammation and fibrosis when compared to the GLP-1 agonist, semaglutide in these same models. Under the license agreement, NeuroBo will be responsible for global development, regulatory and commercial activities other than for certain Asian-Pacific geographies. Dong-A will manufacture clinical supplies and initial commercial supplies of the product at its manufacturing facility in Korea. "The acquisition of these two cardiometabolic assets marks a seismic shift for NeuroBo, providing us with a highly promising, diversified pipeline with several upcoming value inflection points in the NASH and obesity space -- areas with enormous market opportunity," stated Gil Price, M.D., President and Chief Executive Officer of NeuroBo. "Through this agreement, Dong-A, one of our largest shareholders, has reaffirmed its commitment to remain a long-term strategic partner of NeuroBo. Dong-A is dedicated to our success and we are grateful it has also committed to provide continued support to facilitate the clinical development of the licensed assets. Once the transaction has closed, which is contingent upon certain closing conditions, we will be uniquely positioned to initiate a phase 2a study of DA-1241 in NASH in the first half of 2023, with data expected in the second half of 2024. We also intend to initiate a phase 1a safety study of DA-1726 in the first half of 2023, for which data is expected in the second half of 2023. We are truly excited about the prospects of NeuroBo as we transition to a cardiometabolic company across the large and growing markets of obesity and NASH." "We are highly enthusiastic about this opportunity to accelerate development of our novel treatments in partnership with NeuroBo. Dong-A plans to continue to strengthen its R&D capability and to seek additional collaboration opportunities to establish ourselves in the US market", Min Young Kim, Chief Executive Officer of Dong-A About the Proposed Licensing Transaction Under the terms of the license agreement, Dong-A will receive an upfront payment of $22 million in Series A convertible preferred stock, which will automatically convert into common stock upon receipt of requisite stockholder approval, and will be eligible to receive commercial- and regulatory-based milestone payments, dependent upon the achievement of specific regulatory and commercial developments. Dong-A will also be entitled to single digit royalties on net sales of the two assets. Dong-A has also agreed to commit $15,000,000 toward financing the assets, subject to NeuroBo's ability to obtain additional financing under the terms of the license agreement. The license agreement has been approved by the board of directors of NeuroBo. The transaction is expected to close in the third quarter of 2022, subject to obtaining third party financing for development of the assets and other customary closing conditions. About NeuroBo Pharmaceuticals NeuroBo Pharmaceuticals, Inc., is a clinical-stage biotechnology company historically focused on therapies for neurodegenerative, infectious, and, upon closing of the license agreement, cardiometabolic diseases. Its therapeutics programs currently include ANA001, an oral niclosamide formulation, which is in Phase 2/3 clinical trials to treat patients with moderate coronavirus disease (COVID-19); NB-01 for the treatment of painful diabetic neuropathy; NB-02 for the treatment of symptoms of cognitive impairment and to modify the progression of neurodegenerative diseases associated with the malfunction of tau protein; and gemcabene currently being assessed as an acute treatment for COVID-19 in combination with ANA001. NeuroBo Pharmaceuticals, Inc. is headquartered in Boston, Massachusetts. About Dong-A Dong-A ST Co. is a leading healthcare company in South Korea with a business focus on developing, manufacturing and distributing pharmaceutical products and medical devices worldwide. Dong-A has successfully developed and marketed several products globally and continues to develop prospective clinical candidates. Dong-A also provides licensed-in and licensed-out drugs, and medical devices, including high-technology medical devices, custom-made products, and sets of artificial cardiac circuits for use in open-heart surgery. Dong-A has over 5,500 employees including 2,300 in the pharmaceutical sector. Dong-A was founded in 1932 and is headquartered in Seoul, South Korea.

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