Novartis has obtained the marketing rights for Luxterna oustide the United States thereby building upon its gene therapy treatments which includes Kymriah. We note Luxturna was approved in the United States on Dec 19, as one-time gene therapy to restore functional vision in children and adult patients with biallelic mutations of the RPE65 retinal pigment epithelial 65 kDa protein gene. The market authorization application was filed with the European Medicines Agency on July 31, Novartis will make an upfront payment as well as pay milestones and royalties to Spark Therapeutics.
NVS and Conatus Pharmaceuticals CNAT signed an exclusive worldwide option, collaboration and license agreement covering development and commercialization of emricasan discussed below. Steven Mento and Alfred Spada.
Emricasan is one of the only two dual anti-apoptotic and anti-inflammatory drug candidates in clinical development for NASH. Apoptosis is a highly coordinated programmed cell death that maintains normal liver health by the swift removal of unwanted cells comparable to the amount of cells generated.
Conatus will receive significant payments if certain development, regulatory and commercial milestones are met.
Furthermore, Conatus is eligible to receive tiered double-digit royalties on emricasan single agent sales and tiered single to double-digit royalties on sales of combination products containing emricasan.
Conatus has the option to co-commercialize emricasan in the US, including combination therapies, on a cost-sharing and revenue-sharing basis in lieu of U.
Conatus retains limited rights to develop other pan-caspase inhibitors. The option to co-commercialize in the United States preserves future flexibility for Conatus, and the ability to continue pursuing independent development of other compounds affords us the opportunity to build a portfolio of potential products to drive further long-term value for our shareholders.
Mento, CEO Conatus, concluded by saying that the near-term infusion of capital and Phase 2b cost-sharing allows it to fund ongoing operations through It is reasonable for me to hypothesize that the trend of innovative products-driven organic growth is bound to continue in the foreseeable future as Novartis streamlines its global output and implements in-house drug development and partnership programs.
At the moment, Novartis is not considered a leader or a trailblazer in the clinical development of anti-NASH therapeutics. However, its clinical alliance with Conatus on emricasan, a Phase 2b anti-NASH drug candidate, is a game-changer that moves Novartis closer to an otherwise impossible mission of it being considered a major contender in this expanding and competitive field of anti-NASH drug candidates.
Significant interest from investors in NASH-related diseases has contributed to the momentum. The license agreement gives Conatus long-term financial security to execute ongoing and future clinical drug development.
Conatus trading chart Likewise, several analysts were enthused at the license agreement as reflected in their comments. Conatus has an institutional ownership of Financial Risks All clinical trials are associated with significant risks that could result in partial or total loss of capital. Obviously, Conatus would be strongly impacted by any potential clinical setback of emricasan since it is its lead drug candidate.
Setbacks in clinical trials including delays, serious adverse events, negative clinical outcomes, constitute the most significant downside risk, as this could lead to downward pressure, possible selloff and also uncertainty with regards to the scientific integrity of emricasan.
Current trading price represents a good buying opportunity for both companies. Furthermore, emricasan could also have broad therapeutic application in severe PH mediated by other etiologies such as HCV infection since anti-HCV therapies are not always associated with reduction in severe PH even if the virus is cleared.
Equally important, presumed clinical efficacy in PH could make for a positive forecast of emricasan potential hepatoprotective benefits in NASH cirrhosis and possibly fibrosis. Morris Birnbaumchief scientific officer for internal medicine for Pfizer, told Reuters last year "we are actively looking on the outside for opportunities Additional important information on the license agreement is that it sets the stage for simultaneous development of oral combination therapies for the treatment of NASH fibrosis including emricasan and one of the Novartis internal FXR agonists, Tropifexor, currently in clinical development.
My previous articles have provided detailed information on Tropifexor and how and why it differs from Ocaliva.
Briefly, tropifexor is a synthetic, highly efficacious orally available and selective non-bile acid new generation FXR agonist that is liver-targeted and undergoes extensive enterohepatic cycling Tully et.
Tropifexor has demonstrated a safe and tolerability profile that is devoid of pruritus intense itching and high LDL associated with Ocaliva by Intercept Tully et.
Epilogue My articles are predominantly on liver diseases and a common question from readers is will there be a buyout. I have always responded no, without really elaborating. Mento gives a very succinct answer that I should have given:Novartis, Pfizer team up on liver-disease drugs.
Novartis AG (skybox2008.com) and Pfizer Inc. (PFE) are teaming up to target a complex type of liver disease, underscoring the growing willingness of drug. Find the Novartis events calendar for upcoming Investor Relations events, including healthcare, strategy, pharmaceutical conferences, and more.
Published: Mon, 5 Dec The purpose of this paper is to critically evaluate the strategic decisions that have occurred over the corporate history of Nestle mentioned in the case and to what extent has Mergers and Acquisitions and Strategic Alliances played a role in NESTLE’s strategy in that period.
Get the latest news and analysis in the stock market today, including national and world stock market news, business news, financial news and more. Corporate structure. Novartis AG is a publicly traded Swiss holding company that operates through the Novartis Group.
Novartis AG owns, directly or indirectly, all companies worldwide that operate as subsidiaries of the Novartis Group. Download the full company profile: L'Oréal Company Profile - SWOT Analysis Download the full company profile: Coca-Cola Company Profile - SWOT Analysis Download the full company profile: Procter & Gamble Company Profile - SWOT Analysis Euromonitor International's report on Pfizer Inc delivers a detailed strategic analysis of the company's business, examining its performance in the .