Taking over the entire oncology therapeutic market

can-gilead-sciences-inc-epclusa-be-the-game-changer-for-hepatitis-arenaSteve’s breakdown: Keep an eye on Gilead because this is big. The new drug is called Epculusa and we expect they are going to throw a boatload of cash behind the launch.

No word on who’s handling the advertising as of yet.

FOSTER CITY, CA: Gilead Science, Inc. has developed drug pipeline worth $21 billion and plans to take over the entire oncology therapeutic market. However, the investors are a bit hesitant due to the stagnant sale and growth of the company’s hepatitis C franchise.

Food and Drug Administration (FDA) has given a green light to Gilead’s single dose cocktail treatment Epculusa (sofosbuvir and velpatasvir) for the management and treatment of all six strains of the hepatitis C with an added benefit of cost effectiveness as compared to standard treatments.

Epclusa is thought to cause bradycardia (slow heart rate), whereas a combination of amiodarone and sofosbuvir can also be the cause of pacemaker intervention. Hence Epclusa and amiodarone combo is contraindicated.

Mount Sinai Beth Israel HoD Medicine in New York City Dr. Ira Jacobson said: “The approval of Epclusa represents an important step forward in the global effort to control and potentially eliminate HCV as it provides a safe, simple and effective cure for the majority of HCV-infected patients, regardless of genotype.”

He added: “Building on the established backbone of sofosbuvir, Epclusa demonstrated consistently high cure rates across all genotypes, including among patients with genotype 2 and 3, who traditionally have required ribavirin or other multi-pill regimens.”

Sovaldi and Harvoni are the pillars of Gilead. Both the drugs were launched in 2013 and 2014 aiming at capturing the HCV therapeutic market. The aforementioned drugs crossed the blockbuster mark in their first quarter. Approximately, 470,000 patients are managed by Sovaldi and Harvoni.

Despite the approval of Epclusa for the management and treatment of complete genotypes of HCV, Harvoni will maintain its status of SOC specifically targeting the genotype 1, due to its 8-week treatment schedule, whereas Epclusa is indicated for 12 weeks’ duration.

According to IMS Health stats, Harvoni is leveled as top prescription generator globally with over $18 billion revenue generation, while Sovaldi racked $6.6 billion in 2015. According to the University of Oxford statistics, HCV genotype 1 affected approximately 46% of Hepatitis patients globally in 2015.

Earlier this year, the regulatory agency approved the priority review for Epclusa. In addition to the above-mentioned review, the molecule has also been awarded breakthrough therapy (BTT) designation by virtue of which the drug is eligible to provide major achievements on the present standard of Care (SOC) options.

The European regulators have also given a go-ahead to Epclusa for the patients suffering from 1-6 genotypes of HCV.

Drugs Pricing Factor

Despite the fact that Gilead is putting its maximum efforts to provide drugs at a nominal price through the discounting process, drug pricing has always been a troublesome issue for the company, especially with Sovaldi and Harvoni.

On the other hand, Epclusa’s price would be half as compared to the SOC regimens specifically the patients with genotype 3. Epclusa’s 12-week treatment tagged a cost of $75,000, a decrease of $10,000 than Sovaldi and $20,000 than Harvoni. Merck’s Zepatier, priced at $54,000 for the whole course regimen, is expected to be the main market shareholder due to its pricing.

With the launching of novel molecules and combo drugs, the competition has increased between the drugmakers. Price and costing of the whole treatment regimen will play a vital role in the establishment and survival of the drug.

Gilead and Health Insurers

Express Scripts spokesman wrote at Statnews: “We are pleased that they have been responsive to the discussions we have been having over the past few years, and complement them on their restraint around the list price of this new drug. We will continue to negotiate with Gilead in regards to net pricing for our clients.”

To cover up the high prices of HCV drugs, Gilead worked on its relations with the health insurers and providing Sovaldi and Harvoni at a discounted prices. Due to this step, both the drug showed a boosting growth in the US market leaving behind all the competitors.

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