Novartis Multiple Sclerosis Drug Kesimpta Shows Substantial Benefit Of Up To 6 Years

 Novartis AG 

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 released data from the ALITHIOS open-label extension study showing sustained efficacy of first-line, continuous Kesimpta (ofatumumab) treatment for up to six years in recently diagnosed relapsing multiple sclerosis.

Recently diagnosed is defined as untreated patients starting treatment within three years of initial diagnosis.

These efficacy outcomes included 44% fewer relapses; 96.4% and 82.7% reductions in MRI lesions (Gd+ T1 and neT2), respectively; and 24.5% and 21.6% fewer 3- and 6-month confirmed disability worsening (CDW) events, respectively, versus those who switched from Sanofi SA’s 

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 Aubagio (teriflunomide) to Kesimpta.

In the first analysis, the low annualized relapse rate (ARR) experienced by recently diagnosed treatment-naïve RMS patients was further reduced in the ALITHIOS open-label extension study, from 0.104 to 0.050 (52.0% reduction), corresponding to an adjusted ARR of one relapse per 20 years.

• Rates of 3- and 6-month progression independent of relapse activity (PIRA) with first-line Kesimpta were also lower versus switch.
• The observed rapid increase in the proportion of participants with no evidence of disease activity (NEDA-3) with continuous first-line Kesimpta treatment was maintained up to six years.
• Patients initially randomized to teriflunomide, improvements across several efficacy outcomes were seen after switching to Kesimpta, including significant reductions in ARR (71.3%) and in MRI lesion activity (Gd+ T1: 98.5% reduction; neT2: 93% reduction), and rapid increase in rates of NEDA-3.1.
• Rates of 3- and 6-month CDW events remained higher compared to patients receiving continuous Kesimpta, indicating that the efficacy benefit of first-line Kesimpta on delaying disability worsening was not fully achieved in the switch group.

The second analysis looked at the overall ALITHIOS population:

• Data showed sustained efficacy of continuous Kesimpta up to six years, including low ARR (49.9% reduction between core Phase III trials and extension phase), suppression of MRI lesion activity (Gd+ T1: 56.7% reduction; neT2: 89.3% reduction), sustained reduction of 6-month CDW events (14.1%, relative to the switch group), lower rates of 6-month PIRA, and sustained high rates of NEDA-3.2.
• People switching from teriflunomide to Kesimpta experienced reductions in ARR (73.8%) and MRI lesion activity (Gd+ T1: 97.7% reduction; neT2: 91.8% reduction) and a rapid increase in NEDA-3 rates during the extension period.

Treatment with Kesimpta for up to six years was well-tolerated with no unexpected safety signals identified.

In fiscal year 2023, Kesimpta’s sales almost doubled to $2.2 billion.

https://www.benzinga.com/general/biotech/24/04/38296282/novartis-multiple-sclerosis-drug-kesimpta-shows-substantial-benefit-of-up-to-6-years

US Prepares To Reimpose Venezuela Oil Ban As Biden Seeks Scapegoat To Resume SPR Drain

For much of the past year, we had joked that behind the facade of western Democratic ideals, was a cold hard truth: the price of oil must not be allowed to go up in an election year. This was obvious in Biden's "kid gloves" treatment of Iran's regime, it was obvious when the US implemented "sanctions" on Russian oil that were breached within months with zero enforcement, it was also obvious when the US president became best friends with Venezuela's dictator Nicolas Maduro last October when, in exchange for a few thousands barrels of Venezuela's oil, the US lifted sanctions on the person that for years was one of western "democracies" biggest enemies.

Of course, there had to be some at least optical quid-pro-quo in exchange for the Biden detente so that the US president doesn't look not just senile but also totally stupid and incompetent, and sure enough Maduro agreed that he will hold "free elections" only to renege a few weeks later, while also rubbing Biden's face in Maduro's sudden leverage over the US president as we reported on various occasions:

And so, nearly half a year later after Biden's shocking detente with Venezuela's strongman, and having become the butt of all jokes, Bloomberg reports that Joe Biden’s administration intends to reimpose oil sanctions on Venezuela, ending a six-month reprieve, if Nicolas Maduro’s regime does not take steps in the next two days to honor an agreement to allow a fairer vote in elections scheduled for July.

The US plans to allow a Treasury Department license permitting oil and gas production to expire without renewal on Thursday, according to people familiar with the plan, who asked not to be identified without permission to speak publicly, if Venezuela fails to act.

The report goes on to note that the Biden administration has been trying to buy as much time as possible before finalizing the decision in hopes for an unlikely breakthrough that could change its plan, although that has clearly not happened.

Reimposing sanctions would end a brief respite that had foreign oil executives flocking to the South American nation. Renewed sanctions would set back Maduro’s efforts to restart Venezuela’s economy, which requires significant foreign investment to rebuild the country’s decaying oil infrastructure. Sanctioning the nation’s limited production will bear little immediate impact on the global oil market. But over the medium- to long-term, the lack of investment from Chevron Corp. and other outside investors could ultimately see Venezuela’s oil output decline.

Cracking down on the oil flowing from the country also threatens to drive rising US gasoline prices even higher. That poses a threat to Biden, who has struggled to calm voter anxiety over persistently high inflation in the US in an election in which the state of the economy is taking center stage.

But why now? Why would Biden's handlers lose so much foreign policy credibility over the past 6 months, just to U-turn now and go back to square one?  Well, as Bloomberg notes, if the license expires, "US actions would be taken to ease the impact on Americans and the US oil market."

Actions like what? Well, the same actions Pizza afficionado and White House senior adviser John Podesta said yesterday were on the docket unless oil prices drop, namely draining even more SPR oil.

"The president did it (release oil from SPR) before ... and I think he wants to keep the price of gasoline affordable and he will do what he can to make sure that happens," Podesta said at the BNEF Summit in New York. He stopped short of saying there would be a release from the SPR any time soon.

Of course he did, knowing the political outcry that would follow. But if the White House has a trigger, say an uncooperative Maduro to point the finger to, then an SPR drain is all but guaranteed.

Meanwhile, it was back when oil was $73 when various idiots made fun of us for pointing out that the SPR will never be refilled, aside for the occasional barrel here and there, injected purely for theatrical purposes.

We wonder what these upward-failing hacks will say when in its last days, the Biden admin's parting gift to the US will be to fully drain the SPR.

https://www.zerohedge.com/markets/us-prepares-reimpse-venezuela-oil-ban-biden-seeks-scapegoat-resume-draining-spr

Biden aims to triple tariffs on Chinese steel and aluminum imports

 President Biden is in Pennsylvania Wednesday to call for the tripling of tariffs on Chinese steel and aluminum imports, as well as protections for the U.S. steel and aluminum industry. 

At the U.S. Steelworkers headquarters in Pittsburgh Wednesday, the Pennsylvania-born president is urging the U.S. trade representative, Katherine Tai, to consider tripling the existing 7.5% tariff rate on Chinese steel and aluminum imports. American workers face "unfair competition" from Chinese imports, and high-quality U.S. products are undercut by "artificially low-priced" Chinese alternatives that use higher emissions, the White House says. 

The Biden administration is also pursuing anti-dumping investigations against countries that try to saturate markets with Chinese steel, and the U.S. is working with Mexico to make sure Chinese companies can't avoid tariffs by shipping steel there first. Tai is also launching an investigation into China's practices in the maritime, shipbuilding and logistics sectors, the White House says. 

The announcement comes amid the planned sale of U.S. Steel to the Japanese-owned Nippon Steel, which the president strongly opposes. 

As the president continues his three-day swing through Scranton, Pittsburgh and Philadelphia, his campaign is launching a six-figure, five-day ad blitz highlighting Mr. Biden's pro-labor stances. Pennsylvania is a battleground state this November, with former President Donald Trump and Mr. Biden neck-and-neck in polls. 

"Scranton values or Mar-a-Lago values," Mr. Biden said during a speech in Scranton Tuesday, referencing Trump's luxurious Florida resort. "These are the competing visions for our economy, and they raise questions of fundamental fairness at the heart of his campaign." 

https://www.cbsnews.com/news/biden-wants-to-triple-tariffs-chinese-steel/

NovaBay Prelim Eyecare and Wound Care Revenue Up13% for Q1, Lower Sales and Marketing

 Growth driven by efficient Avenova® direct-to-consumer e-marketing programs

NovaBay® Pharmaceuticals, Inc. (NYSE American: NBY) reports preliminary net revenue for its eyecare and wound care business for the first quarter of 2024 of $2.6 million, a 13% increase from the first quarter of 2023. This increase was achieved with lower sales and marketing expenses, and is attributed primarily to social media marketing programs aimed at consumer sales of the Company’s lead product, Avenova Antimicrobial Lid & Lash Solution.

"We started 2024 with strong revenue growth from our core eyecare business while reducing marketing spend by capitalizing on our e-marketing expertise," said Justin Hall, CEO of NovaBay. "Investing in direct-to-consumer marketing to leverage our clinical pedigree is a modern approach to the pharmaceutical industry’s traditional sales model. We are pleased that our social media programs are efficiently establishing consumer trust in the Avenova brand as eyecare professionals engage with new potential customers to share their personal experience, knowledge and recommendations."

NovaBay also announces the expansion of its Avenova Ambassador initiative, an efficient omni-channel, influencer-based social media program. This initiative involves content collaborations and affiliate partnerships with key medical influencers including optometrists and ophthalmologists, collectively known as Avenova "Docfluencers," as well as consumer-based influencers in strategic growth categories such as beauty and health and wellness. The Avenova Ambassador initiative is proven to be successful in reaching new customers while helping build brand awareness and loyalty via social media channels including TikTok, Instagram, YouTube, Facebook and Pinterest, as well as in email campaigns.

https://finance.yahoo.com/news/novabay-pharmaceuticals-reports-preliminary-eyecare-105900408.html

Sleep Apnea: Lilly, Resmed, Inspire

Eli Lilly said on Wednesday its weight-loss drug helped reduce episodes of irregular breathing in patients with obstructive sleep apnea across two late-stage trials. 

The trial results add to a growing body of clinical evidence that suggests GLP-1 drugs, which include popular treatments such as Lilly's Mounjaro and Novo Nordisk's Wegovy, have medical benefits beyond diabetes and weight loss. 

The data could also boost Lilly's chances of U.S. government insurance coverage, Wall Street analysts said ahead of results, and pave the way to expand use of its GLP-1 drugs, sold as Zepbound for obesity and Mounjaro for type 2 diabetes, in a new set of patients. 

Shares of the drugmaker rose 2.3% to $763.9 in premarket hours and have risen 28% this year. 

In the first Lilly study, patients received only tirzepatide, the active ingredient in Zepbound and Mounjaro, and showed a 55% improvement in symptoms of obstructive sleep apnea, compared with a 5% improvement in those who received a placebo. 

The second study tested the drug in combination with continuous positive airway pressure (PAP) therapy and patients showed an average 62.8% drop in events of irregular breathing. 

Obstructive sleep apnea, which is characterized by brief interruptions in breathing during sleep, affects roughly 1 billion people globally, according to a 2019 study published in The Lancet. 

Ahead of the Lilly data, analysts had expected to see a 30% to 50% improvement across both patient groups. 

Secondary goals of the studies - such as improvements in blood pressure levels in patients - were also being closely watched. Lilly did not provide detailed results for the secondary goals of the studies. It plans to present detailed data from the studies at a medical conference in June and submit data to the U.S. Food and Drug Administration and other regulatory agencies beginning mid-year. 

There are currently no drugs approved to treat the disease, although positive airway pressure therapy is a common treatment. The PAP therapy delivers constant air pressure and prevents airways from collapsing. 

continuous PAP therapy devices are among those approved by the FDA.

Inspire Medical Systems also makes an implantable device that helps keep a patient's airway open during sleep, without the use of a hose or mask. 

Shares of Resmed and Inspire Medical declined between 2% and 3% in premarket hours

https://finance.yahoo.com/news/1-eli-lillys-weight-loss-102712854.html

Arrowhead’s Plozasiran Poised for Dyslipidemia Market, $700M in Sales by 2032: GlobalData

 Following the release of positive Phase IIb results, Arrowhead Pharmaceuticals’ investigational antisense oligonucleotide plozasiran could rake in more than $700 million in sales by 2032 if it wins the FDA’s approval, according to a new report from data analytics firm GlobalData.

Plozasiran’s approval could also help satisfy a critical unmet medical need in dyslipidemia management and provide a treatment option that can “effectively lower triglyceride levels and prevent the complications associated with this disease,” Shireen Mohammad, cardiovascular and metabolic disorders analyst at GlobalData, said in a statement.

“Plozasiran offers hope for the dyslipidemia drug market,” Mohammad added. “According to GlobalData, plozasiran is forecasted to launch in 2026 and is a promising pipeline drug for the treatment of dyslipidemia.” If approved, the treatment could generate $707 million in sales for Arrowhead by 2032.

An investigational antisense RNA interference therapeutic, plozasiran works by targeting the liver protein ApoC3, which is a crucial player in lipid metabolism and also controls the levels of triglycerides in the blood. In dyslipidemia ApoC3 prevents the clearance of various lipids and lipoproteins from the body.

According to Arrowhead’s website, plozasiran’s mechanism of action allows it to disrupt the pathologic role of ApoC3, in turn normalizing lipid levels in patients and lowering their overall risk for cardiovascular diseases.

Earlier this month, at the American College of Cardiology’s 73rd Annual Scientific Session & Expo, Arrowhead presented data from the Phase IIb SHASTA-2 trial, showing that patients in the plozasiran arm saw a 74% decrease in triglyceride levels, while placebo comparators only showed a 17% reduction at 24 weeks.

At 48 weeks, plozasiran elicited a 58% drop in triglyceride levels, compared to only 7% in the placebo group.

ApoC3 levels also decreased by 48% after plozasiran treatment at 48 weeks. Placebo counterparts, on the other hand, saw a 4% increase in ApoC3.

In addition to SHASTA-2, Arrowhead is also running the Phase III PALISADE trial for plozasiran, evaluating its efficacy in FCS. The study completed enrollment in May 2023 and the company expects its primary portion to be completed by the second quarter of 2024. Readouts and regulatory filings will follow “shortly thereafter,” Arrowhead announced at the time.

In March 2023, the FDA granted plozasiran its Fast Track designation for the treatment of FCS, which will accelerate its review process and will allow the company more frequent interactions with the FDA. Plozasiran had previously earned the regulator’s Orphan Drug designation.

https://www.biospace.com/article/arrowhead-s-plozasiran-poised-to-target-dyslipidemia-market-hit-700m-in-sales-by-2032-globaldata/

Cullinan Targets Autoimmune Market, Nabs $280M in Private Placement

 Cullinan Oncology on Tuesday announced that it is expanding its business focus to include autoimmune diseases. As part of the company’s strategic adjustment, the biotech has also changed its name to Cullinan Therapeutics.

The Massachusetts-based company will now target systemic lupus erythematosus (SLE) as its first autoimmune indication, for which it will advance its investigational bispecific T cell-engager CLN-978. Cullinan is eyeing an Investigational New Drug application for the candidate in the third quarter of 2024 and is also planning to develop CLN-978 for other autoimmune conditions.

Originally designed as a treatment for B-cell non-Hodgkin lymphoma (B-NHL), CLN-978 is a bispecific T cell engager that targets both the CD19 and CD3 proteins. This mechanism of action could potentially achieve the destruction of CD19-expressing cells, according to Cullinan’s website. CLN-978 is also specifically engineered to have a human serum albumin-binding domain, which prolongs its serum half-life.

In a Phase I study in B-NHL, CLN-978 showed clinical activity in three patients, two of whom showed “rapid, deep, and sustained B cell depletion,” according to the company. The candidate also had a favorable safety profile, with two cases of grade 1 cytokine release syndrome and no documented episode of immune effector cell-associated neurotoxicity syndrome.

Cullinan has stopped patient enrollment in the study to reflect its strategic refocus. The company’s existing oncology assets—including its lead candidate Zipalertinib, which is being developed for non-small cell lung cancer—will not be affected.

Concurrent with its shift in business focus, Cullinan has also announced a $280 million private placement, which will help bump up its cash, cash equivalents, short term investments and interest receivables. The company now has a cash runway to support its operations into 2028.

Cullinan’s pivot to the autoimmune space comes after a series of small studies pointed to the potential of CAR-T therapy in autoimmune disorders. In February 2024, a paper published in The New England Journal of Medicine showed that eight SLE patients treated with CAR-T therapies reached disease remission after a median follow-up of 15 months.

Results were similarly positive for patients with systemic sclerosis and idiopathic inflammatory myositis. Eventually, all 15 study participants were able to stop immunosuppressive treatments.

The mounting data in hinting at the efficacy of CAR-T therapies in autoimmune disease has pushed many early industry movers to repurpose their pipelines. This group includes Kyverna and Cabaletta which made the move in early 2023 as well as Allogene and Arbor, which last month partnered to develop off-the-shelf CAR-T treatment for autoimmune conditions.

https://www.biospace.com/article/cullinan-targets-autoimmune-market-nabs-280m-in-private-placement/