According to a recent study published by Grand View Research (http://nnw.fm/RKlb7), the global therapeutics market for liver diseases – which range from hepatitis (an inflammatory condition typically caused by a virus) and liver cancer, to non-alcoholic fatty liver disease and cirrhosis – is on track to grow to just over $12 billion by 2020, a nearly 60 percent increase compared to 2014’s figure. A concomitance of factors is at play here, with everything from a geriatric population that is likely to increase by 86 percent through 2050 (National Institute of Aging) to an increasing prevalence of hepatitis and hepatocellular carcinomas helping to drive the therapeutics market to new highs. Technavio’s analysts even recently estimated the global liver disease therapeutic market’s CAGR somewhere around 15.61 percent for the period from 2015 to 2019 (http://nnw.fm/6v6Sx).
This highly charged market environment is what makes the recent licensing announcement by biopharma developer Ligand Pharmaceuticals (NASDAQ: LGND) so interesting. The licensing of its proprietary, broad-spectrum LTP Technology™ (Liver Targeting Prodrug) platform to Nucorion Pharmaceuticals – the U.S. based biotech that was actually co-founded by the company and Dr. Zucai Suo, professor of chemistry and biochemistry at Ohio State University – grants Ligand and Nucorion premium access to one of the most fiercely contested liver disease therapy growth markets on earth, China. Ligand’s LTP technology uses an activation mechanism that is essentially the next generation of its HepDirect™ approach, which uses a chemical modification to make a given API (Active Pharmaceutical Ingredient) biologically inactive until trigged by a liver-specific enzyme (and may therefore improve efficacy/safety of some drugs and can be applied to existing or new drug products). This similar but broader-acting activation mechanism allows LTP technology to be effectively used with many chemical classes of drugs or chemistry strategies, and even bypass cancer cell resistance mechanisms in the Nucorion implementation.
Nucorion is well positioned to serve the Chinese liver disease drug market, where the rapid rise in the number of hepatitis C and alcoholic liver patients already drove the space up to RMB 43 billion (~$6.5 billion) back in 2013 (http://nnw.fm/yZR0x) as well as the other major global pharmaceutical markets. This deal to fully exploit Ligand’s LTP technology significantly enhances Nucorion’s foothold in China, as the technology allows for selective delivery of a wide range of active pharmaceutical agents directly to the liver, presenting a variety of pharmacokinetic advantages, such as increased possible drug concentrations and efficacies in the liver, with a simultaneous reduction in off-target drug toxicities and side-effects from whatever drug is being utilized.
Nucorion’s preclinical pipeline programs under the aforementioned license agreement represent an approach to the market as broad as the applicability of Ligand’s delivery technology. Nucorion’s LTP technology-enabled analogs, NUC-404 (HBV Nucleotide), NUC-202 (Gemcitabine), and NUC-101 (HCV Nucleotide), ably cover all the requisite bases, from hepatocellular carcinoma to hepatitis B virus (HBV) and hepatitis C virus (HCV).
According to the latest official WHO data (http://nnw.fm/A3qB8), there are over 90 million chronic HBV carriers in China, or nearly one-third of all cases worldwide, and by 2030 an estimated 10 million will die mostly avoidable deaths. Because LTP is also the only known prodrug technology to take advantage of the liver-specific CYP3A4 activation enzyme methodology, and LTP technology has been previously validated in both the U.S. and China (including four clinical stage programs, of which Pradefovir Phase 2b is the most advanced), the potential upside here should be abundantly clear.
Ligand is the ideal mother ship for Nucorion, too, given the prowess of this biopharma heavyweight, which is focused on developing or acquiring the technologies needed to not only help pharma companies advance their new medicines, but drive its own shareholder value to new highs in the process. Even a cursory glance at some of LGND’s featured market products and associated affiliations tells investors a great deal. Whether we are talking about the company’s (4.7 to 9.4 percent royalty) partnership with Novartis (NYSE: NVS) on orally-administered platelet enhancer Promacta (Anemia, HepC, ITP, Oncology), or relapsed/refractory blood cancer injection Kyprolis® (1.5 to 3 percent royalty), of which Amgen (NASDAQ: AMGN) is the licensee – the case is clear: Ligand is the kind of heavy-hitter Nucorion needs to maximize its opportunity in China.
Ligand enjoys the enviable position of having an extremely robust portfolio of technologies under its belt, over 85 partners and licensees, and established alliances with some of the biggest names in biopharma today, including AstraZeneca (NYSE: AZN), Bristol-Myers Squibb (NYSE: BMY), GlaxoSmithKline (NYSE: GSK), Merck (NYSE: MRK), Pfizer (NYSE: PFE), and Sanofi (NYSE: SNY). CEO of LGND, John Higgins, was clearly proud when news of the licensing deal broke July 29, enthusiastically detailing the market position of Nucorion Pharmaceuticals, the $5 million venture-funded biotech firm his company helped co-found (where Ligand is a minority shareholder, owning less than 20 percent). Nucorion is majority-owned and funded by Silver River International Investment Ltd., boasts an impressive Scientific Advisory Board, and was essentially birthed by an assemblage of highly respected Chinese VCs who are affiliated with multi-billion dollar funds.
Higgins was also keen to point out the “substantial medical need in China for liver-related medicines,” as being fundamental to the licensing deal, and underscored how Ligand’s other revolutionary technologies were key to the company’s longer-term growth strategy. Technologies like the API delivery marvel that is the company’s patent-protected (uniquely modified) cyclodextrin, Captisol®. Or the therapeutic antibody generation platform OmniAb®, which allows for mono- and bispecific antibodies to be produced across three in-vivo platforms (OmniRat®, OmniMouse® and OmniFlic®), with similarly superior delivery characteristics.
For more information, visit www.Ligand.com or www.NucorionPharma.com
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