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Wednesday, July 1, 2020

Amgen: Appeals Court Affirms Enbrel Patent Validity in Sandoz Dispute

Amgen Inc. on Wednesday said a federal appeals court has upheld the validity of two patents related to Enbrel, turning away a challenge from a unit of Novartis AG that had hoped to launch a biosimilar to the blockbuster rheumatoid-arthritis drug.
Amgen said the U.S. Court of Appeals for the Federal Circuit affirmed a lower court ruling that upheld the validity of the patents and resulted in an injunction prohibiting Novartis’s Sandoz unit from launching an Enbrel biosimilar.
That injunction stands, Amgen said Wednesday.
Biosimilars are near-copies of biologic drugs, such as Enbrel, that are made from living cells and are analogous to generic copies of traditional pill-form medicines.
The Thousand Oaks, Calif., biotechnology company had sued Sandoz, claiming its biosimilar infringed on certain Enbrel patents, while Sandoz had argued that the patents were invalid.

Fear, death in Cal.’s Imperial County

Customers trickle into the Calipatria Queen Market as cashier Terry Aguilera and her regulars talk about how the coronavirus pandemic is ravaging their sleepy town 40 miles north of the Mexican border.
Speaking through a face mask, Aguilera shares updates about who has gotten sick, who’s been moved to the intensive care unit and who they’ve buried in the last week.
She says it’s hard to understand why a small farming community like Calipatria and the rest of Imperial County have been hit so hard. The county, in the far southeast corner of California, has the state’s highest infection rate, by far.
Aguilera said three of her friends have died, and much of her extended family has been infected. She said people in the town of 7,114 now wear their masks religiously, and that many are suffering from anxiety and panic attacks.
“Somehow everybody is still getting sick,” Aguilera said from behind a Plexiglas barrier. “As soon as we get sick, we get the virus.”
Imperial County, an impoverished rural area along the Arizona and Mexico borders, has drawn statewide attention over the last week as Gov. Gavin Newsom called on officials here to fully reinstate a stay-at-home order. The county proposed a plan to do that Monday.

Imperial County at a glance

Population: 181,215
By race/ethnicity: 85% Hispanic, 10% non-Hispanic white, 3.3% Black
Per capita income: $17,590
People in poverty: 21.4%
Source: U.S. Census Bureau
But Imperial’s situation was alarming long before its leaders came under Newsom’s scrutiny.
Since the outset of the pandemic, the county’s infection rate has been about six times higher than California’s as a whole, with at least 2,835 cases per 100,000 people. Statewide, the average is 491 cases per 100,000 people.
The percentage of people tested in the county who are confirmed to have the virus has soared to nearly 23%, about four times the state total.
Longtime residents and community activists say Imperial County epitomizes the pandemic’s worst inequities. It’s a microcosm of the racial and economic disparities that exacerbate the disease’s uneven toll.
Almost a quarter of the county’s 181,215 residents live in poverty, and its population is 85% Latino, including many migrant farm workers and recent immigrants.
The county has high rates of asthma, diabetes and obesity. It ranks lowest out of California’s 58 counties on a wide range of public health indicators, according to a report from the Robert Wood Johnson Foundation.
Luis Flores, an activist with the Imperial Valley Equity and Justice Coalition who lives in Calexico, on the border with Mexico, started a petition in June to oppose county leaders who asked the state to let Imperial reopen more quickly.
The petition drew more than 2,000 signatures, but Flores said the debate was about more than reopening malls and churches. He said residents want to address disparities fueling the outbreak.
“We want to point attention to what feels like the crisis underneath this crisis,” Flores said. “The valley is sort of an extreme version of that, in part because a lot of the agricultural labor does reside in Mexico.”
Flores said migrant farm workers who cross the border every day to pick vegetables and work in meatpacking plants are often transported in crowded shuttle buses and aren’t given masks.
Local officials agree their shared borders with Mexico and Arizona — where infection rates have spiked amid loosened statewide restrictions on public life — could be fueling the county’s higher numbers. They note that no other California county faces that challenge.
“We aren’t the same,” said Jason Jackson, mayor pro tem of El Centro, the county’s largest city, with 44,000 residents. “We’ve got a state (Arizona) with different rules, and a country with different rules.”
Imperial County officials responded to Newsom’s demand on Monday by proposing to once again close retail stores and indoor church services, though a county spokeswoman said they won’t proceed until they hear back from the governor’s office.
The county was already moving slower than much of the state in reopening its economy.
On Monday, dozens of shoppers strolled through the Imperial Valley Mall in El Centro, where about half the stores were open.
Among the people there was Arthur Rodriguez, who works in a clothing store. He said he was alarmed by the county’s decision to allow retail businesses to reopen several weeks ago. He worries about carrying the virus home to his father and sister, who have health problems.
“It’s good for the economy, but it’s not good for us as humans,” Rodriguez said. “I don’t want to be exposed just because I have to work.”

Luis Olmedo, director of Comité Cívico del Valle, an environmental justice advocacy group, said the pandemic has laid bare the region’s inequities.
“We have been in endemic mode for a very long time,” he said. “If we ignore those (social) determinants, it’s like sending soldiers to war without the right equipment.”
The Imperial Valley is also medically underserved, with a ratio of about 4,250 people for every primary care doctor. Since the start of the pandemic, more than 500 patients have been transferred to other counties.
Environmental crises are rampant. Air quality is poor, in part because of dust and pesticides from agriculture. And toxic dust from the nearby Salton Sea is blowing through the region as the lake evaporates due to a warming climate.
Olmedo said the fight over shutdown orders speaks to a broader disconnect between the region’s largely low-income and disadvantaged population and much of its political leadership.
“The historical political influence here has been industry,” he said. “This push to reopen I call tell you is a corporate move.”

Sandoz May Appeal to US Supreme Court in Biosimilar Erelzi Case

Novartis AG’s Sandoz division is evaluating its options, including a potential appeal to the U.S. Supreme Court, after a U.S. court ruled against the company in a patent litigation related to the Sandoz biosimilar Erelzi.
The Swiss drugmaker said Wednesday that the U.S. Court of Appeals for the Federal District upheld a previous ruling declaring Amgen Inc.’s patents valid.
“Sandoz will continue its efforts to make Erelzi available to U.S. patients with autoimmune and inflammatory diseases,” said Carol Lynch, president of Sandoz U.S. and head of North America. “Our company respects valid intellectual property, however Sandoz continues to believe the patents asserted by Amgen are not valid, and that it should not be able to use them to extend the drug’s exclusivity.”
Sandoz’s biosimilar Erelzi was approved by the U.S. Food and Drug Administration in 2016 but the company hasn’t been able to launch it in the U.S. due to the patent litigation with Amgen.

South Korea to start talks on COVID-19 drug remdesivir purchases in August

South Korea has started distributing stocks of the COVID-19 treatment remdesivir that have been donated by Gilead Sciences Inc and plans to begin talks to purchase more supplies in August, its disease control agency said on Wednesday.
It is the first country to disclose a timeline for talks with Gilead. The drugmaker said this week it has priced remdesivir at $390 per vial in developed countries and agreed to allocate nearly all of its supply of the drug to the United States over the next three months.
One of the few treatments shown to alter the course of COVID-19, remdesivir is expected to be in high demand. The intravenously administered medicine has won emergency-use authorisation in several countries and full approval in Japan after a clinical trial showed it helped shorten hospital stays.
Only patients severely ill with COVID-19 are eligible for remdesivir and South Korea currently has 33 such patients, the Korea Centers for Disease Control and Prevention (KCDC) said.
KCDC director Jeong Eun-kyeong told a briefing that patients who developed symptoms in less than 10 days and were suffering from pneumonia and a shortage of oxygen would be considered eligible. A domestic panel of experts has found that anti-viral drugs like remdesivir are more effective if given in the early stages of the disease, she added.
The KCDC did not disclose how many doses have been donated by the US firm.
South Korea will consider whether remdesivir should be covered by national health insurance after the purchase negotiations in August, said Jeong.
Based on current treatment patterns, a course of remdesivir equates to $2,340 per patient.
South Korea has been battling small but steady outbreaks of the new coronavirus, with 51 new cases reported as of Tuesday, bringing the country’s total to 12,850 cases with 282 deaths.

Uber extends mask requirement for drivers, riders, launches new campaign

Uber Technologies Inc on Wednesday extended indefinitely a requirement for drivers and riders on its platform to wear a face covering or mask and launched a new campaign video to educate users about the policy.
The company began requiring masks on May 18 and on Wednesday extended the policy, which was originally slated to run out at the end of June.
“Extending our ‘No Mask, No Ride’ policy is the right thing to do. We want to send a clear message to everyone using Uber that we all have a role to play to keep each other safe,” Uber said in a statement.
A spokesman said not setting an expiration date for the policy was intentional as the company continued to monitor the situation and the spread of the novel coronavirus.
Uber’s stance comes as U.S. infections surge and the debate over public health measures and wearing a mask has taken on a partisan tone in the United States.
The company in a new campaign video showing Uber drivers and food delivery workers said wearing a mask was a way to thank them for their essential services during weeks of lockdown.
Since the requirement took effect in May, Uber drivers have needed to take a selfie to verify they are wearing a mask before starting work. A company executive in May said Uber was looking into developing a similar feature to verify riders’ compliance with the policy.
An Uber spokesman on Wednesday said there were no updates on the rider feature, but that Uber continued to look into the option.
The company said it has completed some 50 million mask detections with drivers and delivery people and completed more than 100 million ride-hail trips since May 18.

Corcept launches late-stage study of relacorilant in pancreatic cancer

Corcept Therapeutics (CORT +1.2%enrolls first patient in RELIANT, a Phase 3 trial of relacorilant in combination with nab-paclitaxel (Celgene’s Abraxane) in patients with metastatic pancreatic cancer.
The company plans to enroll 80 patients, with an interim analysis of data from the first 40 patients.
The primary endpoint is objective response rate, with secondary endpoints including progression-free survival and duration of response.
Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body’s other hormone receptors.

FTC, Justice Department have new guidelines for vertical mergers

Guidance on vertical mergers got its first major overhaul from the Federal Trade Commission and the U.S. Department of Justice in more than 35 years under new joint guidelines published June 30.
Vertical mergers are those that combine firms or assets at different stages of the same supply chain, such as healthcare company CVS Health’s acquisition of insurer Aetna. Previously proposed mergers like that of insurers Humana and Aetna would be considered horizontal.
FTC Chairman Joe Simon said in a news release that the new guidances “are an important step forward in maintaining vigorous antitrust enforcement, and reaffirm our commitment to challenge vertical mergers that are anticompetitive and would harm American consumers.”
Leaders said that the guidelines explain FTC and Justice Department investigative practices and will give the business community clarity about antitrust concerns, such as the type of evidence the FTC and Justice Department review and how they define markets.
To read the full guidelines, click here.