sovaldi

MSD has taken a legal hit after a US appeals court upheld a ruling that the pharma giant had illicitly obtained patent rights for the treatment of hepatitis C, voiding its claim to an infringement verdict against Gilead to the tune of $200 million.

Image Credit: BruceBlaus

A partnership of the not-for-profit organisation Drugs for Neglected Diseases initiative (DNDi) and Egyptian drug firm Pharco Pharmaceuticals is working to bring a new, effective and affordable combination therapy to patients with hepatitis C (HCV).

The fate of pharma company’s profits and losses largely rests on product approvals and the sales team behind them but, when a record fine is looming over a company, it can also be dependent on the court rooms.

Gilead will be breathing a sigh of relief, after a judge overturned a record $2.54 billion decision against it. The case was brought by MSD, known as Merck in North America, regarding Gilead’s blockbuster hepatitis C drugs, Sovaldi and Harvoni.

MSD had alleged that Gilead infringed its patents and had initially won the case in December of 2016.

Gilead has officially launched its hepatitis C drug Sovaldi (sofosbuvir) in the Chinese market, but with one major caveat: it will cost 58,980 yuan ($8,937) in the region, just one-fifth of its price tag in the US – a price which has fallen rapidly from the $84,000 it originally launched at.

There are around 10 million cases of chronic hepatitis C in China, says Zhang Hong, Director of the Infectious Diseases Department at Shaanxi Provincial People’s Hospital, while the total number of such cases worldwide is 130 million, according to WHO estimates.

The FDA has given the go-ahead for two hepatitis C treatments for use in young and adolescent patients: Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) – both products of Gilead – making them the first FDA-approved direct-acting antiviral treatments for the illness in children and adolescents.

Both treatments were previously approved for the same indication in adults. They work by inhibiting the virus’ ability to replicate, and in the majority of cases can eradicate it from the body.

A US district judge has reversed a previous court decision which favoured MSD, called Merck in the US, over Gilead in a dispute related to patents on blockbuster hepatitis C drugs.

Gilead has been granted a patent for its hepatitis C drug, Sovaldi (sofosbuvir), in India which has sparked dismay among patient groups and NGOs in the region.

The drug effectively “cures” patients of the hepatitis C virus in over 90% of patients, but has been criticised in some quarters due to its high cost. Costing up to $1,000 per pill, a 12-week regimen of the drug lists for $84,000 in the US. According to the World Health Organisation, 150 million people globally have been infected with the liver-destroying hepatitis C virus.

Gilead’s dominance of the hepatitis C market is under severe threat after a federal jury ruled in favour of MSD and Ionis Pharmaceuticals, who claimed to hold crucial patents related to sofosbuvir, a compound key to Gilead’s global hepatitis C drug sales of $19 billion last year alone.

The judges say Sovaldi has been a 'game-changer' for hepatitis C

Gilead Science’s hepatitis C treatment Sovaldi has been awarded the British Pharmacological Society’s prestigious Drug Discovery of the Year 2016.

The Society says Sovaldi (sofosbuvir) dramatically improves the chances of a cure to the disease compared to historic treatments. 

The award is made to the team of Gilead researchers responsible for the development of Sovaldi, in recognition of the drug making a significant impact on an unmet medical need and offering a significant improvement over existing treatment options. 

The EMA has granted Gilead Sciences an accelerated assessment for its application for a new Sovaldi combination treatment.

The combination contains Sovaldi (sofosbuvir) and velpatasvir (SOF/VEL) for the treatment of hepatitis C.Velpatasvir is an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection.

Gilead is seeking aproval for the indication of SOF/VEL among patients with genotype 1-6 HCV infection, including patients with compensated and decompensated cirrhosis.