Could FTC scrutiny of the Roche-Spark merger scuttle future pharma deals? Analysts are fretting

FiercePharma | August 02, 2019

Could FTC scrutiny of the Roche-Spark merger scuttle future pharma deals? Analysts are fretting
When Roche delayed its planned 4.8 billion dollars purchase of gene therapy developer Spark Therapeutics for the fifth time earlier this week, citing the Federal Trade Commissions FTCs review of the deal, one burning question emerged among pharma watchers- What the heck is the FTCs problem? Shortly thereafter, another troubling question bubbled up- If the FTC is going to be this nitpicky about one giant pharma company’s effort to buy a relatively small player, could that end up scuttling future deals? Bloomberg surveyed nine firms that specialize in mergers and acquisitions, and six of them said they're worried the FTC has changed its approach to reviewing deals. A similar majority said the change—which has yet to be fully understood—could give future dealmakers second thoughts. “You have to start wondering if this scrutiny will slow down or prohibit these kinds of deals, which would be a huge deal for the sector,” said Brad Loncar, CEO of Loncar Investments, in an interviewwith Bloomberg.

Spotlight

The market for the use of biosimilars in the treatment of rheumatoid arthritis is rapidly expanding as many high-profile therapies come off patent. Despite the increasing number of biosimilars, there remain clinical, regulatory and market access challenges for developers.

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Fiercepharma | June 16, 2020

Two years after launching, AstraZeneca spinoff Viela Bio has its first FDA approval in Uplinza following Friday's nod to treat certain patients with neuromyelitis optica spectrum disorder. Analysts expect that the medicine, which won approval to treat patients who are anti-AQP4 antibody positive, can generate $586 million by 2026, according to Evaluate. But the competitive landscape could pose a challenge for the biotech's first launch. Doctors could prescribe Roche’s Rituxan or its biosimilars off label before trying Uplinza, Evaluate Vantage reports, or payers could require them to try the cheaper options first. Uplinza is a B cell depleter like Rituxan, so if those older options don’t work, docs might go another route and try Alexion’s Soliris rather than move on to Uplinza, Vantage said.

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Orion Biotechnology Successfully accomplishes Phase 1 Clinical Trial of a First-in-Class Precision Engineered Ligand Analog for HIV Prevention

Orion Biotechnology Canada Ltd | October 16, 2020

Orion Biotechnology Canada Ltd., a clinical stage pharmaceutical company focused on precision engineering GPCR-targeted therapeutics, today announced the results of their Phase 1 study of OB-002H which is an investigational candidate microbicide for HIV prevention. The Phase 1 study was a first-in-man trial designed to evaluate the safety, acceptability, and pharmacokinetic profile of OB-002H gel. OB-002, a highly potent chemokine analog of CCL5 (a ligand for the CCR5 HIV co-receptor), has previously been shown to be completely protective in a non-human primate model of vaginal HIV transmission (Veazey R et al. JID 2009). The Phase 1 study design included open-label single-dose (vaginal and rectal) and multi-dose product (vaginal) administration of OB-002H gel to study participants followed by a randomised, double-blind, placebo-controlled multi-dose (vaginal) phase of product administration. During the multi-dose phase of the study, participants received study product once daily for five days. The study enrolled a total of 30 healthy volunteers in Warsaw, Poland at the BioVirtus Phase 1 Research Site. The product was well tolerated, and product-related genital adverse events were mild (Grade 1) or moderate (Grade 2) and transient.

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BUSINESS INSIGHTS

Ligand and GSK Expand Global Collaboration and License Agreement

Ligand Pharmaceuticals | December 22, 2021

Ligand Pharmaceuticals Incorporated announced today the expansion of an existing collaboration and license agreement between its subsidiary, Icagen, and GlaxoSmithKline. The expansion will leverage Icagen’s ion-channel-based discovery technology and unique expertise in small molecule therapeutics targeting transmembrane proteins. This new agreement builds upon the initial December 2020 agreement to identify and develop inhibitors of a specific genetically-validated molecular target relevant to neurological diseases. “We are very pleased to expand our collaboration with GSK to include a second neurological target. Over the past year this has been a productive relationship combining our technologies and expertise with GSK’s history of successfully working with others to access innovation and deliver next-generation transformational medicines.” Matt Foehr, President and COO of Ligand “We look forward to strengthening our collaboration to identify genetically-validated targets for neurological diseases utilizing Icagen’s technology,” said John Lepore, Senior Vice President, Head of Research, GSK. “Our expanded collaboration provides a framework to advance drug discovery by maximizing the strengths of our two scientific organizations to develop novel drug candidates efficiently and effectively.” In addition to all payments available under the original 2020 collaboration and license agreement, under the terms of the expanded collaboration and license agreement, Ligand will receive an upfront payment of $10 million and is eligible for development and regulatory milestones up to $67.5 million. Furthermore, should the potential new medicine receive regulatory approval in major markets, the deal provides for commercial milestone payments to Ligand of up to $60 million at first commercial sale, and up to $120 million in sales-related milestone payments. Ligand will receive tiered royalties on net sales of any drug that is commercialized by GSK. Ligand will be responsible for most preclinical activities up to lead optimization, with Ligand and GSK collaborating to identify candidates for entry into IND-enabling studies. GSK has the exclusive option to license any identified molecules and will be responsible for the further development and commercialization of any drug candidates identified through the collaboration. About Icagen Ion Channel Technology The Icagen technology is focused primarily on ion channel and transporter novel drug discovery. Ion channels and transporters are key components in a wide variety of biological processes that involve rapid changes in cells and have broad therapeutic applicability including oncology, metabolic disease, pain, neurological diseases, infectious diseases and others. The Icagen technology leverages proprietary expertise in the combination of biological assays, medicinal chemistry, and in silico and computational chemistry applications to enable the discovery of ion channel targeting therapeutics. Partners in the pharmaceutical industry leverage Icagen’s platform to develop first-in-class therapies for patients in need, typically under collaborative arrangements through the time of clinical candidate selection, with partners responsible for subsequent clinical development and commercialization. About Ligand Pharmaceuticals Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) ultimately to generate our revenue. Ligand’s OmniAb® technology platform is a patent-protected transgenic animal platform used in the discovery of fully human monoclonal and bispecific therapeutic antibodies. 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Spotlight

The market for the use of biosimilars in the treatment of rheumatoid arthritis is rapidly expanding as many high-profile therapies come off patent. Despite the increasing number of biosimilars, there remain clinical, regulatory and market access challenges for developers.