Strong data for pegylated interferon lambda, Eiger Biopharmaceuticals Inc.’s COVID-19 treatment, boosted the company stock (NASDAQ:EIGR) by more than 40% at midday as the company continues to seek global regulatory approval. The path is blocked as interferon lambda is not currently approved by the U.S. FDA for any use. In October, the company said it would not submit emergency authorization use request after feedback from the FDA. Phase III data from the TOGETHER study in patients with mild to moderate COVID-19, published Feb. 9 in The New England Journal of Medicine, showed that among predominantly vaccinated participants, a single dose of peginterferon lambda significantly decreased clinical events.
BIO CEO 2023: Money low, need high, among pain and addiction companies, BIO report finds
The Biotechnology Innovation Organization (BIO) found in a new study that 77% of clinical programs focused on pain therapeutics five years ago are no longer active and that financings of companies working in the space are flat. Meanwhile, oncology companies, targeting an overall smaller market, have raised huge sums of money, $9.7 billion in 2021 vs. pain and addiction companies’ $228 million. There are more than 100 million people living with pain or addiction in the U.S., and about 50 million people have chronic pain, according to the U.S. CDC. Those with cancer numbered about 16.6 million in 2019, according to the National Cancer Institute. The indirect costs of pain and addiction in the U.S., including the opioid crisis, is between $3 trillion and $4 trillion, said David Thomas, vice president of industry research for BIO, who is the co-author of the State of Innovation in Pain and Addiction Therapeutics 2017-2022. Thomas presented his findings during a panel session at the BIO CEO 2023 conference in New York on Feb. 7.
TVM invests $25M in new IgE-directed antibody allergy play
TVM Capital Life Science has invested $25 million in Lamab Biologics Inc., which is taking forward a new twist on an old story in tackling allergic conditions. The asset-centric virtual company is developing a novel monoclonal antibody directed at immunoglobulin E (IgE) antibodies, which are responsible for mediating allergic responses. It is all of 20 years since Xolair (omalizumab), an earlier anti-IgE antibody, gained its first U.S. FDA approval, for treating moderate to severe asthma. Munich-based TVM has not disclosed the academic team behind Lamab’s antibody, but they are U.S.-based and were also involved in the development of Xolair.
GSK to commercialize Zhimeng’s new hepatitis drug
Zhimeng Biopharma Inc. found a global partner for its hepatitis B virus (HBV) program, licensing rights to GSK plc for CB-06, an oral small-molecule Toll-like receptor 8 agonist. Pending positive data from an ongoing phase I study, GSK will gain rights to develop, manufacture and commercialize the drug for chronic HBV infection, either for use in combination or as a sequential treatment with bepirovirsen.
Lots of changes coming to China IP scene, but improvement slow
With China taking steps to enact or propose amendments to more than 60 intellectual property (IP)-related laws and regulations over the past few years, drug and device companies doing business in the country need to keep abreast of the changes. Despite those changes, most of the participants in today’s U.S. Patent and Trademark Office’s quarterly China IP webinar indicated in a pre-webinar survey that they have yet to see much of an improvement in China’s enforcement and regulation of IP rights.
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Aligos, Alpha Cognition, Annovis, Appili, Asieris, Astria, Atyr, Bayer, Cassava, Century, Creative Medical Technology, Evotec, Halucenex, Indivior, Leo, Lirum, Nectin, Neurosense, Opiant, Oramed, Pierre Fabre, Related Sciences, Revir, Santhera, Seres, Spexis, Spruce, UCB