Court hands Novartis win in Gilenya patent fight; US states seek $26B+ in opioid crisis lawsuit
Novartis has picked up a win in a long-running patent fight against generic versions of its multiple sclerosis drug.
The company announced Monday afternoon that the validity of its Gilenya, or fingolimod, dosing regimen has been upheld by the US District Court of Delaware. As a result, a competing generic fingolimod being produced by HEC Pharm infringes on Novartis’ patent. The ruling can still be appealed.
Monday’s decision continues the injunction against fingolimod copycats, first granted to Novartis in June 2019. At the time, Mylan’s plans to produce a generic version of GSK’s Advair were also put on hold in order to allow the Novartis suit to proceed.
Novartis’ exclusivity window for Gilenya in pediatric treatments runs through December 25, 2027. The Swiss pharma first launched the MS drug back in 2010, netting huge profits over the years, including $738 million in the second quarter of 2020.
A throng of rival therapies have hit the market in recent years, however, such as Merck KGgA’s Mavenclad and Roche’s Ocrevus. And, back in December, the FDA approved three Gilenya generics approved by the FDA back in December — including HEC Pharm’s product. When those drugs launch remains to be seen, given the ongoing litigation.
States seek $26B+ in opioid litigation against distributors
US states have submitted a new request in ongoing litigation against drug distributors related to the opioid epidemic.
The states are seeking about $26.4 billion from distributors McKesson, AmerisourceBergen and Cardinal Health in an attempt to hold them accountable for widespread drug addiction, according to a Wall Street Journal report. J&J are also involved in the current talks.
Such companies have come under scrutiny for allegedly failing to stop orders from being diverted for improper use. The companies have denied the allegations, though some have reached settlements over inadequate order-monitoring programs.
More than 3,000 states, local governments and Native American tribes have sued pharmaceutical players over the opioid crisis. One case has gone to trial, penalizing J&J to the tune of $465 million, while another spurred bankruptcy filings from Purdue Pharma.
New NASH player enters ailing field
A major player in the South Korean market is putting up big cash hoping to find an effective treatment in the ailing NASH field.
LG Chem, a division of the LG multinational conglomerate, announced late Monday that it will commit $350 million to collaborate with Chinese biotech TransThera to develop and commercialize TT-01025, a preclinical NASH therapy that inhibits the protein SSAO/VAP-1. TransThera gets upfront cash and milestone payments while LG Chem obtains exclusive worldwide rights with the exception of China and Japan.
The candidate is currently expected to enter Phase I sometime early next year.
NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to fibrosis and impaired liver function. There are currently no approved drugs in the indication, but that doesn’t mean researchers haven’t tried over the years.
Back in June, the FDA rejected a compound from Intercept Pharmaceuticals after it yielded the field’s first positive Phase III data in February 2019. The move was criticized by the biotech’s CEO who called the review “incomplete” at the time. A Gilead three-drug cocktail also flopped a Phase II study in late 2019.
Currently, the new most advanced NASH candidate comes from Akero, whose lead drug beat placebo in Phase II trials measuring liver reduction. Analysts at the time called it the “best-in-class NASH data so far.”