Lipella Pharmaceuticals Inc. (Nasdaq: LIPO), a clinical-stage biotechnology company focused on developing innovative therapies for serious diseases with unmet medical needs, today announced that U.S. Patent No. 12,138,345 for its proprietary liposomal drug delivery platform will be officially issued by the U.S. Patent and Trademark Office (USPTO) on November 12, 2024. This patent, titled "Delivery of Agents Using Metastable Liposomes," covers key technological innovations that enable the targeted delivery of therapeutic agents using liposome-based vehicles.
The patent’s claims cover Lipella’s method of using metastable liposomes to deliver therapeutic agents, providing broad intellectual property protection for the company’s drug delivery platform. This protection extends market exclusivity for Lipella’s two lead clinical assets, LP-10 and LP-310, which are currently in Phase 2 clinical trials. LP-10, a liposomal formulation of tacrolimus for treating hemorrhagic cystitis, and LP-310, an oral rinse for managing oral lichen planus, represent promising new approaches to addressing diseases with limited treatment options.
The FDA has started a review of Unicycive Therapeutics' drug for hyperphosphataemia in patients with chronic kidney disease (CKD) who need dialysis, which hopes to improve on 'onerous' phosphate binder therapy.
The US regulator is due to deliver a verdict on Unicycive's oxylanthanum carbonate (OLC) candidate by 28th June, potentially giving the Los Altos, California-based company its first approved product.
OLC is being developed as a more patient-friendly alternative to Takeda's phosphate binder Fosrenol (lanthanum carbonate), which is sold in a large chewable tablet formulation, while other drugs in the class can require patients to take as many as 12 pills per day.
In contrast, Unicycive's drug requires fewer and smaller pills to be taken and can be swallowed whole with water and, according to the company's chief executive Shalabh Gupta, that could offer "meaningful patient adherence benefits." The company hopes to get approval for a dose of one tablet – similar in size to a regular-strength aspirin – three times per day.
In a survey commissioned by Unicycive that was conducted in 2022, kidney disease specialists said that the greatest unmet need in the treatment of hyperphosphataemia with phosphate binders is a lower pill burden and better patient compliance.
A high phosphate level in the blood is a common complication of CKD, particularly affecting patients on dialysis. In severe cases, it can cause bone and muscle problems, as well as increase the risk of heart attacks and strokes.
The global market for hyperphosphataemia therapies is around $2.5 billion, of which $1.1 billion comes from the US, where there are more than half a million patients on dialysis and around 400,000 on phosphate binders.
Despite the availability of six FDA-approved phosphate binders, around 75% of patients fail to achieve serum phosphorus targets, according to Unicycive, which adds that an uncontrolled blood phosphate level is "strongly associated" with increased hospitalisation and death.
In its pivotal trial, 69% of evaluable patients achieved their target serum phosphate level at a dose of a 500mg pill taken three times daily.
The company has filed OLC for approval with the FDA using the 505(b)(2) regulatory pathway, a streamlined process that allows the manufacturer to draw on existing data with the originator drug.
That means Unicycive has only had to run three clinical trials – a phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of in CKD patients on dialysis – to support its marketing application.
"We are thrilled with the FDA acceptance of our first NDA, a significant milestone towards our efforts to bring this important treatment option to patients with kidney disease if approved," said Gupta.
AstraZeneca plans to invest a whopping $3.5 billion to expand its R&D and manufacturing operations in the US by 2026, as part of a drive to raise its revenues to $80 billion by the end of the decade.
The programme – part of the pharma group's Ambition 2030 effort – will include the construction of a new R&D centre at Kendall Square in the heart of the biopharma hub in Cambridge, Massachusetts, and a biologics manufacturing facility in Maryland.
There will also be expansion of cell therapy manufacturing capacity on "the West and East coasts," as well as specialty manufacturing in Texas, according to AZ, which said $2 billion of the investment is earmarked for the creation of more than 1,000 "new, high-skilled jobs contributing to the growth of the US economy."
The decision to invest in the US comes shortly after the election of Donald Trump as the US President-Elect, who has threatened to impose widespread tariffs on imports of goods, including pharmaceuticals, which has caused concern in Europe.
AZ chief executive Pascal Soriot said, however, that the big investment was driven by the "attractiveness of the business environment, together with the quality of talent and innovation capabilities […] in the US."
Crucially, the announcement does not seem to impact a planned £450 million ($578 million) investment in a vaccines manufacturing plant in Liverpool, UK, which in the summer was rumoured to be at risk of relocation to Philadelphia, which AZ has insisted was false.
It came as AZ reported its third-quarter results, headlined by a 20% increase in revenues to $12.95 billion, which will be discussed in full at a meeting today, along with other pressing matters, such as the recent revelations of a Chinese probe into current and former executives, including country president Leon Wang.
Soriot said that the company is taking the situation in China "very seriously," adding that "if requested, we will fully cooperate with the authorities." AZ's update reiterated that the company has not received any notification that it is itself under investigation.
The US is AZ's biggest market, currently accounting for 44% of its total revenues, and the investment programme ties in with AZ's plan to accelerate its development there, which is a key part of Ambition 2030.
"By expanding our R&D and manufacturing footprint, we aim to enhance the development of cutting-edge therapies and support the US leadership in healthcare innovation," said Soriot.
The company has also raised its sales and profit forecasts for full-year 2024 for the second time in successive quarters, saying it expects revenues to increase by a high teens percentage, up from its earlier prediction of a mid teens percentage rise.
Iran’s Foreign Ministry has strongly denied US claims that Iran was involved in an alleged plot to kill President-elect Donald Trump, dismissing the charge as a way to "complicate matters" between the US and Iran.
On Friday, the US Justice Department announced charges over the alleged plot, claiming that Iranian officials asked an Afghan national who currently resides in Tehran to surveil and ultimately assassinate Trump. "Who can in their right mind believe that a supposed assassin SITS IN IRAN and talks online to the FBI?!" Iranian Foreign Minister Abbas Araghchi wrote on X.
Araghci said that Iran respects the choice the American people made in the presidential election. "The American people have made their decision. And Iran respects their right to elect the President of their choice. The path forward is also a choice. It begins with respect," he said.
Araghchi also reiterated that Iran doesn’t seek nuclear weapons and signaled Iran is willing to talk with the US about its nuclear program.
"Iran is NOT after nuclear weapons, period. This is a policy based on Islamic teachings and our security calculations. Confidence-building is needed from both sides. It is not a one-way street," he said.
Also on Saturday, Javad Zarif, Iran’s vice president for strategic affairs, called on Trump not to continue the "maximum pressure" policy against Iran. "Trump must show that he is not following the wrong policies of the past," said Zarif, a veteran diplomat who served as Iran’s foreign minister during Trump’s previous time in office.
The previous Trump administration’s "maximum pressure" policy against Iran involved withdrawing from the 2015 nuclear deal, imposing crippling economic sanctions, and assassinating Iranian Quds Force Commander Gen. Qasem Soleimani.
Republicans have accused President Biden of being soft on Iran, but he has essentially followed the same policies. The problem for the US is that Iran found oil markets in Asia that aren’t afraid of US sanctions, a result of the US sanctioning so many different countries.
The Wall Street Journalreported that the next Trump administration is expected to "renew" the maximum pressure on Iran. Brian Hook, who oversaw Iran policy in the first Trump administration, is reportedly in charge of the transition for the State Department.
Florida’s Palm Beach County police on Nov. 8 arrested a Chinese national after he tried, again, to enter President-elect Donald Trump’s Mar-a-Lago residence, according to court records.
Li Zijie, a 39-year-old living in suburban Los Angeles on a student visa, allegedly arrived at the Trump property in an Uber on the afternoon of Nov. 7—the latest in a number of attempts he has made to get into the resort in the past few weeks.
He made the trip hours after getting out of a mental hospital, where he had spent the previous week after a similar effort made in late October, according to a police affidavit.
Li now faces two counts of trespassing, according to the county’s jail records. He’s being held in the Palm Beach County Main Detention Center, with bail set at $100,000.
The arrest has heightened security concerns around Trump, who narrowly survived an assassination attempt in July during a Pennsylvania rally. In September, the Secret Service identified a man pointing a rifle through a fence at Trump’s golf course in West Palm Beach while Trump was playing golf. The Justice Department said on Nov. 8 that it had stopped an Iranian plot to kill Trump and charged three men allegedly involved in a murder-for-hire network.
Li first tried to gain entry into Mar-a-Lago on July 19, six days after the Pennsylvania rally shooting, according to court documents viewed by The Epoch Times.
Li pulled up in a gray Toyota and told Secret Service agents he had information implicating China in the assassination attempt and wished to give them the documents. The Palm Beach police issued a trespass warning and told him not to return.
In the following days, Li drove into the town of Palm Beach at least four times but didn’t try to enter Mar-a-Lago, according to court records.
On July 30, officers observed Li driving toward the Mar-a-Lago checkpoint and placing paperwork about Trump on vehicles. He was arrested the next day for allegedly trespassing on the premises. A local court ordered him to stay 500 feet away from the resort and from Trump.
Li’s next attempt was on Oct. 30, when he tried to enlist help from a resident who lives nearby, according to court documents.
The woman had a Trump 2024 political sign in her yard. Li asked if she was a Mar-a-Lago club member and whether she could drive him inside. The woman refused, and after seeing him enter a white Toyota, she called the police, who placed Li in a mental hospital.
He returned to Mar-a-Lago on the day of his release.
In the affidavit regarding the latest intrusion effort, Palm Beach Police said that because of the “increased attempts by Li to gain entrance into Mar-a-Lago” to make contact with the president-elect, a future attempt could lead to an escalation of enforcement.
The Trump resort has faced repeated intrusion efforts, including two from Chinese nationals.
During Trump’s first term as president, a Chinese businesswoman carried four cellphones, a computer, and an external hard drive past the security checkpoint, telling a Secret Service agent that she was there to use the pool, then later presenting herself to reception as an attendee of an already-canceled event.
The woman, Zhang Yujing, was sentenced to eight months in prison for illegally entering the site. She was deported to China two years later, in November 2021.
After that incident, another Chinese national, Lu Jing, was arrested in December 2019 after she entered the property and began taking pictures. A judge later acquitted her of trespassing charges but issued a six-month sentence on a separate charge of resisting arrest.
During Trump’s 2018 Thanksgiving visit to the resort, a University of Wisconsin student sneaked into the Palm Beach club by standing with a group entering Mar-a-Lago. He pleaded guilty to a misdemeanor and apologized for the act.
The Epoch Times has contacted Li’s lawyer for comment.
Drugmaker AstraZeneca lifted its annual sales and profit forecast for the second time in less than four months on Tuesday, helped by resilient demand for its cancer and rare diseases medicines, after third-quarter results beat estimates.
The London-listed company now expects 2024 revenue and core earnings per share to grow by high teens percentage, from a previous forecast of an increase by a mid-teens percentage at constant currency rates for both revenue and EPS.
"We are highly encouraged by the broad-based underlying momentum we are seeing across our company in 2024, and growth looks set to continue through 2025, providing a solid foundation to deliver on our 2030 ambition," CEO Pascal Soriot said in a statement.
The drugmaker reported core EPS of $2.08 on total revenue of $13.57 billion for the quarter ended Sept. 30, above analyst expectations of $2.04 per share on revenue of $13.1 billion, according to a company-compiled poll.
Cardinal Health said on Monday it acquired majority stakes in GI Alliance and Advanced Diabetes Supply Group (ADSG) for about $2.8 billion and $1.1 billion each in an all cash deal.
GIA will operate as a platform within Cardinal Health's Pharmaceutical and Specialty Solutions segment, while ADSG will merge with it at-Home Solutions business, the company said.
