(Bloomberg Gadfly) — Pharma already leads the business world in unpredictability, with billions in sales potentially riding on a few points of statistical significance in a clinical trial.
But even within that context, a series of blockbuster medicines for Hepatitis C (HCV) have made for a roller-coaster ride for companies and investors. AbbVie Inc. last week threw another big curve at this market by pricing its newly FDA-approved drug Mavyret — which might be the most effective HCV medicine approved yet — at a massive discount.
Shares of Gilead Sciences Inc., currently the dominant force in HCV, fell 1.63 percent on Friday. But they still may not have absorbed the full potential impact of this price war.
A new cure for hepatitis C in children and adolescents is on the way, promising to help some of the silent victims of a nationwide heroin epidemic.
A Cincinnati Children’s Hospital Medical Center doctor who helped lead the research for the drug combination says the new medication regiment brings hope for all children with the disease.
“Years ago, I told my patients’ parents that, in your child’s lifetime, we’re going to have a cure for this,” said Dr. William Balistreri, lead author of the study and medical director emeritus for Cincinnati Children’s Pediatric Liver Care Center. Before this, he said, “there wasn’t anything that was really reliable.”
Two drug combinations from Gilead and AbbVie that could improve treatment of chronic hepatitis C have been granted accelerated review in the EU.
Gilead’s application is for a three drug combination of NS5B polymerase inhibitor sofosbuvir, NS5A inhibitor velpatasvir and pan-genotypic protease inhibitor voxilaprevir – given over 12 weeks – that could achieve a cure for chronic hepatitis C virus (HCV) patients who have failed other regimens.
The new directly-acting antivirals can now cure more than 90% of people with all hepatitis C virus (HCV) genotypes, but there is still room for better options for the most difficult-to-treat people.
(Reuters) – Merck & Co on Thursday was awarded $2.54 billion in royalties by a federal jury in a patent lawsuit against Gilead Sciences Inc over Gilead’s blockbuster hepatitis C drugs Sovaldi and Harvoni.
The jury in Delaware reached the verdict following a nearly two-week trial, finding that a patent acquired by Merck in 2014 on hepatitis C treatments was valid.
“The jury’s verdict upholds patent protections that are essential to the development of new medical treatments,” Merck said in a statement Thursday.
It’s official: Express Scripts has struck a hepatitis C deal with Gilead Sciences. After two years of stiff-arming the biotech’s next-gen meds, the pharmacy benefits manager welcomed the combo pill Harvoni onto its national formulary.
After AbbVie launched its competing Viekira Pak, Express Scripts cut an exclusive deal on that drug, leaving out Gilead’s Sovaldi and its combo cousin Harvoni. Those two brands found themselves on the PBM’s list of excluded meds for 2015 and 2016.
But when Express Scripts announced its 2017 formulary, lo and behold: Harvoni was no longer excluded. Nor was it guaranteed coverage, however. The PBM said it was weighing its options for Harvoni coverage, presumably in the thick of negotiations with Gilead.
– If Approved, SOF/VEL/VOX Would Be the First Once-Daily Single Tablet Regimen Available as a Salvage Therapy for Patients Infected with HCV Genotype 1-6Who Have Failed Prior Treatment with DAA Regimens Including NS5A Inhibitors –
FOSTER CITY, Calif.–(BUSINESS WIRE)–Dec. 8, 2016– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing sofosbuvir 400 mg, velpatasvir 100 mg, and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV)-infected patients. The data submitted in the NDA support the use of the regimen for 12 weeks in DAA-experienced patients with genotype 1 to 6 HCV infection without cirrhosis or with compensated cirrhosis.
“The remaining clinical need to treat HCV patients is a safe and effective cure for patients who have failed previous therapy with DAA regimens, including those with NS5A inhibitors,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “SOF/VEL/VOX has the potential to fill that need by offering single tablet dosing and high cure rates across all HCV genotypes for patients with and without cirrhosis, who have failed prior treatment with other highly effective regimens.”
The NDA for SOF/VEL/VOX is based on data from two Phase 3 studies (POLARIS-1 and POLARIS-4), which evaluated 12 weeks of the fixed-dose combination in DAA-experienced patients with hepatitis C genotypes 1-6, including those who failed prior treatment with an NS5A-containing regimen. Of the 445 patients treated with SOF/VEL/VOX, 430 (97 percent) achieved the primary efficacy endpoint of SVR12. The NDA is further supported by two additional Phase 3 studies (POLARIS-2 and POLARIS-3) in which 611 DAA-naïve HCV-infected patients received 8 weeks of SOF/VEL/VOX. The most common adverse events among patients who received SOF/VEL/VOX were headache, fatigue, diarrhea and nausea. These data were presented at the American Association for the Study of Liver Diseases (AASLD) annual meeting in November 2016.
The SOF/VEL/VOX fixed-dose combination is an investigational product and its safety and efficacy have not been established. It has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration for the treatment of chronic genotype 1 HCV patients who have previously failed an NS5A inhibitor-containing regimen.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that the FDA and other regulatory agencies may not approve the SOF/VEL/VOX fixed-dose combination, and any marketing approvals, if granted, may have significant limitations on its use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or1-650-574-3000.
In a decision announced to the parties Wednesday, October 5, the EPO has decided to maintain in amended form European patent EP 2,203,462 granted May 21, 2014 Gilead on Pharmasset treatment of hepatitis C. Médecins du Monde (MDM ) and several other complainants had committed an opposition to the patent with the EPO, whose decisions apply to 38 member states. In practice, the EPO annulled some of the patent including those covering the sofosbuvir. The written decision of the EPO will be sent to interested parties within six weeks.
The University of Minnesota is suing Gilead Sciences Inc., alleging the pharmaceuticals company’s lucrative Hepatitis C drugs infringe on a university patent.
In a lawsuit filed in Minnesota’s U.S. District Court Monday, the university claimed its intellectual property covers Gilead products that contain the drug sofosbuvir, including those sold under the brand names Sovaldi and Harvoni. Those Hepatitis C treatments have generated more than $20 billion in revenue for Foster City, Calif.-based Gilead.
The state university system said it brought its patent concerns to Gilead (Nasdaq: GILD) in August 2015, but the company continued its alleged infringement.