Gilead loses patent case to Bristol-Myers over its CAR-T therapy; Amneal beats Dr. Reddy’s on key generic approval

Gilead loses patent case to Bristol-Myers over its CAR-T therapy; Amneal beats Dr. Reddy’s on key generic approval

By PharmaCompass

2019-12-19Impressions: 1731

Gilead loses patent case to Bristol-Myers over its CAR-T therapy; Amneal beats Dr. Reddy’s on key generic approval

This week, Phispers brings you news on Bristol-Myers Squibb winning a patent case against Gilead’s Yescarta — a US$ 11.7 billion CAR-T therapy.

In the US, the Senate approved the appointment of Stephen Hahn as the FDA’s next commissioner and also passed a bill that would reform the way OTC drugs are regulated.

There is also news on various drug approvals and rejections in the US.

While Sarepta bagged a surprise FDA nod for its Duchenne Muscular Dystrophy therapy, drugmakers Gilead, BeiGene and Novartis announced failures of their drugs in various trials.

Similarly, while Amarin bagged an FDA approval to expand the heart benefits of its fish-oil derived therapy Vascepa, Correvio Pharmas heart drug Brinavess got voted out due to some serious safety risks.

And Amneal received FDA nod to launch the first generic version of Merck’s contraceptive — NuvaRing.


Gilead’s US$ 11.7 billion CAR-T therapy loses key patent case to Bristol-Myers Squibb

Bristol-Myers Squibb won a US$ 752 million jury verdict against Gilead Sciences Inc in a US patent dispute. The jury awarded the damages after finding that Yescarta (axicabtagene ciloleucel), a treatment sold by Gileads Kite Pharma unit, infringed on a patent exclusively licensed by the Juno Therapeutics division of Bristol-Myers.

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The patent relates to CAR T-cell immunotherapy for cancer. CAR-T is a type of cancer immunotherapy that harnesses the body’s immune system to fight cancer cells. In this case, the therapy removes a person’s cells, reengineers them and then puts them back in their body to attack cancer cells.

In August 2017, FDA had approved the first CAR-T therapy — Novartis’ Kymriah. And during the same month, Gilead Sciences had acquired Kite Pharma for US$ 11.9 billion for its most advanced CAR-T therapy candidate — axicabtagene ciloleucel.

The therapy — Yescarta — bagged FDA approval in October 2017, for treatment of adult patients with relapsed or refractory large B-cell lymphoma. Around that time, Juno had contended the company was infringing the patent it licensed by marketing the drug.

Bristol-Myers said in a statement that it was pleased with the verdict, while Gilead disagreed with the decision. Gilead plans to appeal against the verdict.


Amneal beats DRL in bagging generic nod to Merck’s contraceptive; buys stake in AvKare

Amneal Pharmaceuticals Inc has received approval to launch the first generic version of Merck’s NuvaRing in the US. NuvaRing is a hormonal drug used to prevent pregnancy and has an estimated market size of US$ 880 million.

Christened EluRyng, Amneal plans to launch the first generic version of NuvaRing this month. For some months, Amneal will have very limited competition for EluRyng.

Amneals win is a setback for Indian drugmaker Dr Reddys Laboratories (DRL), whose generic version of NuvaRing got delayed as the FDA asked for data pertaining to the drug. However, even its competitors (such as Teva and Mayne Pharma) received similar queries from the US drug regulator. The FDA approval for Amneal diminishes the market opportunity for DRL.

Amneal picks up stake in AvKare: Amneal is buying a 65.1 percent stake in Kentucky-based AvKare, which will become a standalone subsidiary of Amneal. The deal sets the enterprise value of AvKare at US$ 340 million.

AvKare sells its own private label generic drugs primarily to the Departments of Defense and Veterans Affairs. It buys most of the generic drugs from more than 50 vendors.

Amneal founders Chirag Patel and Chintu Patel said the deal is in line with the strategy they set out for the company when they re-joined Amneal as Co-CEOs in August this year. The brothers returned to Amneal after the board ousted Paul Bisaro, Amneals executive chairman, and Rob Stewart, the president and CEO.


Sarepta bags surprise FDA nod for DMD drug; setbacks for Novartis, BeiGene, Gilead

In August this year, there was news that the US Food and Drug Administration (FDA) had declined to approve Sarepta’s Duchenne Muscular Dystrophy (DMD) treatment — Vyondys 53 — citing risk of infection and kidney toxicity.

Post that, Sarepta had appealed the FDA rejection through a formal dispute resolution request. It also said it had addressed the kidney toxicity issue in the drugs label, which recommends monthly monitoring of patients.

Last week, FDA said it “considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease and the lack of available therapy.” Data from trials showed Vyondys 53 was reasonably likely” to predict clinical benefit in patients with DMD. However, the FDA said such benefit, including improved motor function, had not been established.

The FDA approval is contingent on results of a post-approval trial expected to conclude by 2024, the agency added.

Analysts have found the FDA’s volte-face to be confounding. In a Reuters report, HC Wainwright analyst Debjit Chattopadhyay said if the drug was not approvable four months ago, it cannot suddenly become approvable without significant new data, and potentially reflects some contrived decision making within the agency.”

Other analysts find FDA’s desire to make drugs available faster problematic. Healthcare economist Craig Garthwaite said: Were allowing things to come to market with far less evidence that they work and having people effectively pay the price for those drugs as if they did.”

DMD, a rare muscle-wasting disease, is caused by the absence of dystrophin, a protein that helps keep muscle cells intact. It disproportionately affects boys.

With two drugs now approved on the basis of ~1 percent expression of dystrophin, Sarepta is in a prime position to take its third DMD drug — casimersen — to the FDA.

Sarepta’s first DMD drug — Exondys 51 — was granted accelerated approval by the FDA. Last month, Sarepta had predicted that Exondys 51 will generate sales of US$ 370 to US$ 380 million in 2019. According to analysts, Vyondys 53 and casimersen could each bring in over US$ 500 million.

Gilead, BeiGene, Novartis announce drug failures: Gilead Sciences has said all combinations of its three drugs to treat NASH (short for non-alcoholic steatohepatitis) were unsuccessful in a mid-stage study.

NASH is a fatty liver disease related to obesity that affects about 5 percent of the global population. Gileads study tested three experimental drugs — selonsertib, cilofexor and firsocostat — that work on different mechanisms.

Similarly, BeiGene Ltd said this week that a late-stage trial failed to show that its cancer treatment Brukinsa was superior to Imbruvica, a rival drug from Johnson & Johnson and AbbVie Inc.

Brukinsa did not achieve the studys main goals of showing greater reduction in cancer signs compared with Imbruvica. However, it did show greater improvements in safety and tolerability, BeiGene said.

The results come merely a month after BeiGene scored a win with Brukinsas approval to treat patients with mantle cell lymphoma, who have received at least one prior therapy.

Meanwhile, Novartis reported that its asthma drug fevipiprant failed two more Phase III studies.

In October, fevipiprant had failed the first two Phase III studies. With a string of four straight failures, Novartis has scrapped the drug, which was earlier expected to be launched in 2020.


Stephen Hahn wins Senate vote to be new FDA commissioner

Last week, the Senate in the US voted 72-18 to confirm Stephen Hahn, chief medical executive of the MD Anderson Cancer Center in Houston, to be the next commissioner of the US Food and Drug Administration (FDA).

Hahn, a radiation oncologist, replaces Scott Gottlieb, who resigned in March. Hahn had been nominated around a month back.

Hahn is known for his steadfast refusal to answer questions on the vaping crisis in the US. After intense pressure from the vaping industry, the Trump administration had last month reversed a proposed ban on flavored e-cigarettes.

However, in response to questions from Senator Patty Murray on whether he supports a ban on flavored e-cigarettes, Hahn said: I look forward to hearing all of the data associated with this as a scientist and a researcher and a doctor. Seeing all the data and the complete set of data is important.”

Hahn also pointed to his background as an oncologist. I have seen the ravages of tobacco-related cancers,” he said. This is an important, urgent crisis in this country.”

In response to the opioid epidemic, Hahn called for a comprehensive holistic approach” to pain management that includes boosting approvals of non-opioid products that treat pain.


US Senate passes bill that introduces user-fee system for OTC drugs

The US Senate passed a bill that would reform the way over-the-counter (OTC) drugs are regulated in the country by introducing a user-fee system similar to the ones for prescription drugs and medical devices. The bill will now move to the House, and then to the President for approval.

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Once approved, the bill will become the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019. The bill aims to speed up the antiquated approval process for OTC drugs and would create an 18-month exclusivity period as an incentive for companies to bring innovative OTC products to market.

The new legislation would ensure OTC drugmakers and contract manufacturers are assessed annual facility fees beginning in FY2021. The bill would also create a two-tiered fee structure for OTC monograph order requests: US$ 500,000 for Tier 1 requests and US$ 100,000 for Tier 2 requests.

OTC drugs are reviewed and evaluated by the FDA as per the Over-the-Counter (OTC) Drug Monograph Process. It is a three-phase public rule-making process resulting in the establishment of standards (drug monographs) for an OTC therapeutic drug class. “OTC drug monographs are continually updated to add, change, or remove ingredients, labeling, or other pertinent information, as needed,” says the FDA website.


Heart drugs: Amarin bags expanded approval for Vascepa; Correvio’s drug voted out

Last week, the FDA gave its approval to expand the heart benefit claim Amarin Corp can make in promoting its fish-oil derived therapy — Vascepa. The benefits include reducing the risk of heart attacks and strokes in high-risk patients. This has opened a multibillion-dollar market opportunity for Amarin.

The decision comes a month after an independent panel of experts to the FDA voted unanimously in favor of allowing the broader claims based on positive clinical trial data.

Vascepa, a highly purified form of omega-3 fatty acid, won US approval in 2012 to lower high triglycerides — a type of blood fat that can increase the risk of heart disease.

The expanded label allows the company to tap into a market of up to 15 million Americans at risk of developing cardiovascular complications despite being on statins to lower cholesterol. Analysts forecast peak annual sales of Vascepa at around US$ 3.2 billion by 2030.

In clinical trials, Vascepa cut the combined rate of heart attacks, strokes, heart-related death, need for artery-clearing procedures and hospitalizations for unstable angina by 25 percent compared to placebo.

Correvio’s heart drug: Last week, independent experts to the FDA voted against Correvio Pharma Corps drug — Brinavess — for its ability to correct irregular rhythm in the upper chambers of the heart in adult patients. The experts cited serious safety risks, including low blood pressure and irregular rhythm in the lower heart chambers, and deaths during the trials.

A final decision is expected next week. While the FDA is not mandated to follow the panels recommendation, it generally does.

Brinavess aims to restore normal heart rhythm in patients experiencing erratic rhythm due to a condition known as atrial fibrillation (AFib) and is currently available in 41 countries including the European Union and Canada. AFib is a common cardiac rhythm disturbance that can lead to serious problems such as stroke and heart failure.

It clearly has benefit but it does have risk,” said panel member Barry Davis of the University of Texas School of Public Health, who voted against the drug. If this were the only drug or treatment around, yes, but there are other options.”

Correvio first filed a marketing application for Brinavess in 2006. Due to safety concerns, FDA declined approval to the drug. Later, US trials of Brinavess were put on hold following the death of a patient treated with the drug. The hold still remains in place.

Meanwhile, a day after Brinavess failed to bag the FDA approval, Correvio Pharma said it would explore options including a sale. The company declined to provide additional details.

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