Thursday, January 16, 2025

JP Morgan Week 2025 - Day 2

(1/14, Jonah Comstock, Pharma Phorum) ...What happens after a company gets acquired? Kansteiner asks. How do you integrate an acquisition into your culture. [Christine Fox, Executive Vice President, U.S. Commercial, Teva Pharmaceuticals] says that too many companies don't think about that question and end up losing valuable talent that is part of what they paid for in the acquisition..."The smaller the company the more strategic the choices are," Fox says. "If you're a large company you can afford to keep assets that may not line up with your expertise."... Full

Ustekinumab Approvals Arrive In UK And Canada For Formycon And Fresenius

(1/15, Dave Wallace, Generics Bulletin) ..."The earliest date for commercialization of Otulfi in the UK is defined in a confidential settlement agreement between Formycon, Fresenius Kabi and Johnson & Johnson signed in March 2024," Formycon highlighted, revealing no further details. The settlement also covers Canada. In the US, the biosimilar is set to hit the market next month under a separate settlement agreed in 2023... Global Sub. Full

Bio-Thera and World Medicine Signs an Exclusive License and Commercialisation Agreement for BAT2206, a Proposed Stelara® Biosimilar

(1/16, Bio-Thera Solutions) ...Through this strategic collaboration with Bio-Thera Solutions, World Medicine aims to offer more advanced and effective treatment options for Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, while improving the quality of life for patients. This agreement introduces a new treatment alternative for adult patients with moderate to severe Crohn's disease and other autoimmune conditions who have not responded adequately to conventional treatments, cannot tolerate them, or have contraindications to such therapies... Full

Amgen Reveals Ocrelizumab Biosimilar Ambitions

(1/16, Dave Wallace, Generics Bulletin) ...As Bob Bradway addressed the J.P. Morgan Healthcare Conference in San Francisco, the Amgen chief executive discussed the firm's biosimilars business – including an ocrelizumab rival to Ocrevus that has just been added to its pipeline. Meanwhile, the CEO also outlined his expectations for imminent biosimilar competition to Amgen's Prolia and Xgeva denosumab brands... Global Sub. Full

Viatris Launch Plans Continue To Drag On, But Confidence High On Quartet

(1/16, Dean Rudge, Generics Bulletin) ...Viatris expressed confidence at the J.P. Morgan Healthcare Conference that it will hit its targets for complex injectables in 2025, while providing an update on its GLP-1 ambitions and its delinquent manufacturing facility in Indore, India...For the company's proposed generic to octreotide, Teva last year leapfrogged Viatris, launching the first-and-only US generic version of the synthetic polypeptide indicated to treat acromegaly and severe diarrhoea for carcinoid syndrome. "We're very confident," insisted Viatris' chief R&D officer, Philippe Martin. "We believe we're at the end of the conversation with the [US Food and Drug Administration]. And so, we feel that we'll be able to launch all of them this year."... Global Sub. Full

Novartis Wins Temporary Pause to Entresto Generic Launch in US

(1/15, Blake Brittain, Reuters) ...The U.S. Court of Appeals for the District of Columbia Circuit halted the launch, which could have begun as early as Thursday, while it considers Novartis' emergency request for a longer pause. A separate ruling on Wednesday from U.S. District Judge Dabney Friedrich in Washington had cleared a hurdle for MSN to introduce the first U.S. generic of Switzerland-based Novartis' best-selling drug, which brought the company more than $6 billion in revenue in 2023... Full

Alembic Pharmaceuticals Gets USFDA Nod for Generic Antidepressant Tablets

(1/15, Press Trust Of India) ...Alembic Pharmaceuticals Ltd on Wednesday said it has received final approval from the US health regulator for its generic version of Brexpiprazole tablets used in treatment of major depressive disorder. The approval by the US Food & Drug Administration is for the abbreviated new drug application (ANDA) for Brexpiprazole tablets of strengths 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, the company said in a statement... Full

Eli Lilly's Omvoh Earns FDA Approval for Crohn's Disease

(1/15, Max Gelman, Endpoints News) ...The FDA approved Eli Lilly's Omvoh in Crohn's disease, the company announced Wednesday, handing the drug its second indication after giving it a green light for ulcerative colitis in late 2023. While Lilly is largely known for its diabetes and obesity medications, the company has slowly expanded a small suite of drugs like Omvoh targeting immunological diseases. In addition to Omvoh, Lilly also has Ebglyss, which was approved last September for eczema, and two older drugs in Taltz and Olumiant... Full

Samsung Biologics, Celltrion Announce Major Expansion into ADC Production

(1/16, Kim Hyo-in and Kim Seo-young, The Chosun Daily) ...South Korea's two leading biopharmaceutical companies, Samsung Biologics and Celltrion, unveiled ambitious plans to enter the antibody-drug conjugate (ADC) market at the J.P. Morgan Healthcare Conference in San Francisco on Jan. 15...Samsung Biologics, the fourth-largest global contract development and manufacturing organization (CDMO), aims to leverage ADCs as a major growth driver in the coming years... Full

Celltrion Seeks Large-Scale M&A in Q4, Eyes 2027 Nasdaq Debut

(1/15, Young Chan Song, The Korea Economic Daily) ...Celltrion founder and Chairman Seo Jung-jin said the target company Celltrion is looking to acquire is in the health functional food industry. "By the fourth quarter, the domestic stock market will have recovered from its low, creating favorable conditions for an M&A," he said on Tuesday at the 2025 JP Morgan Healthcare Conference, the world's largest pharmaceutical and biotech investment event in San Francisco... Full

JPM25: Takeda Spotlights 6 Pipeline Assets that Could Pull Down Up to $20B in Collective Peak Sales

(1/15, Fraiser Kansteiner, Fierce Pharma) ...As it stands, Takeda is banking on the success of six main mid- and late-stage candidates: oveporexton, zasocitinib, rusfertide, fazirsiran, mezagitamab and elritercept. Assuming they all win approval, the clutch of potential new drugs could collectively generate peak sales between $10 billion and $20 billion—representative of roughly one-third to two-thirds of Takeda's current annual revenue—CEO Christophe Weber said during the company's conference presentation Tuesday... Full

AbbVie CEO Says Psychiatric Drug Space Challenging, More Cautious On Investments

(1/15, Sneha K, Christy Santhosh, Reuters) ...AbbVie plans to "commit less capital" towards experimental medicines for psychiatric disease, CEO Robert Michael said at an industry conference on Wednesday, months after its experimental schizophrenia drug failed in two mid-stage studies..."Psychiatry is a challenging area," Michael said at the JPMorgan Healthcare Conference. "We would be certainly thoughtful, we can commit less capital, particularly in psych, but it doesn't change our willingness to take calculated risks," he added... Full

JPM25, Day 3: AbbVie's 'Clear Runway to Growth' Allows it to Focus On Early-Stage Acquisitions

(1/15, Angus Liu, Zoey Becker, Kevin Dunleavy, Fraiser Kansteiner, Eric Sagonowsky , Fierce Pharma) ...After its sudden rise and precipitous fall during the COVID-19 pandemic, Emergent BioSolutions is trying to reestablish its unique role as a drug developer combating urgent public health threats. During the J.P. Morgan Healthcare Conference, the Maryland company laid out its plan...One of its small steps came on Tuesday when the company revealed that it has gained exclusive commercial rights in the U.S. and Canada to Kloxxado, an emergency nasal spray for opioid overdose, from Hikma Pharmaceuticals... Full

WuXi Companies See Growth After ‘Limited' Biosecure Impact

(1/15, Amber Tong, Bloomberg) ..."Sure, Biosecure had an impact on our business," Chris Chen, WuXi Biologics chief executive officer, said Wednesday in a presentation at the JPMorgan Healthcare Conference in San Francisco. Although the company managed to garner some 150 projects around the world in 2024, it was a relief that the bill didn't pass, he added... Sub. Req’d

On JPM Day 3, One Topic Was On Everyone's Mind

(1/15, Allison DeAngelis, Jason Mast, Angus Chen, and Elaine Chen, STAT) ...Ricks spoke about Lilly's earnings miss, the Inflation Reduction Act, and his engagement with the incoming Trump administration. He also made some news on Zepbound, saying Lilly is considering offering more doses in vials at lower cost. Ricks said that while he thinks some people who are relying on compounding pharmacies for the drug don't actually have obesity, he acknowledged that there are some patients who do have obesity or diabetes and are turning to compounding due to "real cost pressures" from the branded treatments... Full

During JPM Week, Virtual Care Companies Strut Their Plans to Make GLP-1 Drugs Work Harder, Cost Less

(1/16, Katie Palmer, STAT+) ...At the J.P. Morgan Health Care conference this week in San Francisco, drugmakers had their sights set on the next generation of GLP-1 medications, alternatives, and a growing list of indications beyond diabetes and obesity. Meanwhile, the digital health industry was squarely focused on managing the impact of existing drugs, which have placed enormous pressure on health care spending... Sub. Req’d

Sun Pharma Unit Taro to Acquire 100% Stake in Antibe Therapeutics for An Undisclosed Sum

(1/16, Meghna Sen, CNBC TV-18) ...Taro Pharma, the US-based unit of India's largest drug manufacturer Sun Pharmaceuticals Ltd., has entered into an agreement with Canada-based biotech company Antibe Therapeutics. Following the development, Sun Pharmaceuticals has agreed to acquire 100% stake in Antibe Therapeutics. The acquisition will likely be completed by March 7, 2025, the company said... Full

FDA Explains Why it Rejected Vanda's Stomach Drug in Late 2024

(1/15, Zachary Brennan, Endpoints News) ...Rarely does the FDA publicly release its reasoning for rejecting a potential new drug. But for DC-based Vanda Pharmaceuticals' gastroparesis drug, the FDA on Wednesday spelled out why it issued a CRL last September. One of the pivotal trials for tradipitant, in-licensed from Eli Lilly more than a decade ago, failed to show a statistically significant difference between it and placebo on a nausea severity scale, the FDA said in a Federal Register notice..."FDA is wrong," a spokesperson for Vanda told Endpoints News via email. "FDA must evaluate all scientific evidence put before it. And FDA's approach is dangerous. It will result in the American public being denied access to effective therapeutics."... Full

Pharma Digs in On Changes it Wants from Trump Administration

(1/16, Deena Beasley, Reuters) ...CEOs of some of the largest drugmakers said this week they were encouraged after Trump said at a meeting with pharma executives late last year that these middlemen need to be eliminated. "PBM reform is top of mind with legislators," Victor Bulto, president of Novartis' U.S. operations said in an interview this week during the JP Morgan Healthcare Conference in San Francisco... Full

Drugmakers Tout Limits of IRA Impact Ahead of Next Negotiation Round

(1/15, Alexis Kramer, Endpoints News) ...Johnson & Johnson, AstraZeneca and Pfizer leaders reiterated during the JP Morgan Healthcare Conference that the federal government's price negotiations still won't have a material effect on their bottom lines...AstraZeneca's chief financial officer and executive director Aradhana Sarin noted in a presentation on Tuesday that the company faces "headwinds," including "pricing pressures" and the IRA. But she said she still expects "the base business to have strong momentum in terms of revenue going into 2025," according to an AlphaSense transcript... Full

Medicare Negotiated Drugs Can Face Immediate Generic, Biosimilar Substitution, CMS Proposal Confirms

(1/15, Cathy Kelly, Pink Sheet) ...Stelara, Xarelto, Januvia and Farxiga, which are expected to have biosimilar or generic competition before the end of 2026, could be the first negotiated drugs subject to the policy...The situation may push generics to launch at prices lower than historical norms to encourage Medicare plans to switch to them sooner. The move also could benefit the commercial market unless the generics offer lower net prices to Part D plans through confidential rebates... Global Sub. Full

What to Expect in the Sequel to Medicare's Drug Price Negotiation Program

(1/15, Amy Baxter, Pharma Voice) ...The next wave of drugs selected for Medicare's price negotiation plan is expected any day now, with up to 15 treatments poised to make CMS' list for the 2027 plan year. While the selected drugs are scheduled to be published by Feb. 1, they could come before President-elect Donald Trump's inauguration on Jan. 20, according to Sean Sullivan, professor of pharmacy at the University of Washington School of Pharmacy... Full

Medicare's New $2,000 Cap On Out-Of-Pocket Drug Costs Could Save Enrollees Thousands, AARP Says

(1/16, Annika Kim Constantino, CNBC) ...Most Medicare patients who hit the new $2,000 cap on out-of-pocket spending for prescription drugs could see significant savings, according to a report from AARP. The findings suggest the spending maximum could be hugely beneficial for older adults in Medicare who struggle to afford high-cost drugs for cancer, rheumatoid arthritis and other serious conditions... Full

Medicare Director, at JPM Conference, Gives Tips On How to Lead the Nation's Largest Payer

(1/15, Angus Chen, STAT+) ...Over the last three years that Meena Seshamani has led the Center for Medicare, the service has seen sweeping change — much of it driven by the passage of the Inflation Reduction Act of 2022, she said. This week, Seshamani highlighted just a few of these changes, including caps on certain drug prices, as some of her proudest accomplishments — and gave some parting advice on how she did it for the next leaders of Medicare... Sub. Req’d

DEA Unveils Telehealth Rules for Adderall, Buprenorphine, Other Controlled Medications

(1/15, Ley Facher, STAT) ...The Drug Enforcement Administration on Wednesday issued an announcement 16 years in the making: it will create a special registration process for prescribers wishing to provide controlled substances, like opioids or stimulants used to treat ADHD, via telemedicine..It also carries a number of restrictions that prompted instant pushback. Among other rules, providers seeking to prescribe Schedule II medications, which include Ritalin and Adderall, would need to be physically located in the same state as their patients... Full

Big Pharma's January Price Increases and Price Hikes on Popular Medications for Seniors Provide Reminder Drug Companies Set the Price

(1/15, PCMA) ...In case you missed it, Big Pharma kicked off the new year with price increases on hundreds of brand name drugs. These price hikes are nothing out of the ordinary, as drug companies consistently increase the price of the drugs they create – at rates higher than the rate of inflation. These increases, despite what Big Pharma would have policymakers believe, are not driven by anything other than big drug companies' aiming to maximize their profits. That is because drug companies set the price — and the price is the problem when it comes to Americans facing difficulty affording their prescription drugs... Full

Insulin Prices Dropped. But Some Poor Patients Are Paying More.

(1/16, Katie Thomas, The New York Times) ...Under the 340B program, clinics buy the discounted drugs on behalf of their patients. When those patients have insurance, the clinics can then bill insurers for the regular, higher price, pocketing the difference. But now that spread — the difference between how much they pay for the drug and what insurance will cover — has dwindled. That has left clinics with less money to spend on services that are not otherwise covered by government grants or insurance, such as helping patients find housing... Full

Tariffs On Generic Drugs Will Increase Drug Shortages

(1/15, John Murphy, DC Journal) ...While most manufacturers can pass on the cost of new tariffs to their customers, unlike brand manufacturers, the same cannot be said of generics. Generic manufacturers sell their medicines to a highly consolidated, competitive market where three middlemen control purchases for more than 80 percent of the market. As a result, they face lopsided contract terms that can significantly limit their ability to be reimbursed beyond the already very low margin rates these purchasers offer... Full

Exit Interview: US FDA's Patrizia Cavazzoni Says CDER Staff In ‘Best Place Possible'

(1/15, Sue Sutter, Pink Sheet) ...Departing CDER Director Patrizia Cavazzoni believes the center is in the "the best place possible" in terms of hiring and retention at the start of 2025. Cavazzoni highlighted key successes in 2024, including a monumental effort to bring Baxter's hurricane-devastated manufacturing facility in North Carolina back online. She would like to see the FDA publish reviews of drugs that receive complete response letters because "there is a lot to be learned from failure."... Global Sub. Full

Newsom Committed California to Making its Own Insulin. It's at Least a Year Behind His Schedule

(1/15, Kristen Hwang, Cal Matters) ...Gov. Gavin Newsom's ambitious plan to produce a cheap, generic insulin for the 3.2 million Californians with diabetes is behind the schedule he announced and unlikely to make it to market for several years, industry experts say. Civica, Inc., the nonprofit drug manufacturer contracted to produce insulin for California, has not started clinical trials or applied for approval from the federal Food and Drug Administration, both of which are likely to take more than a year to complete... Full

Columbus Sues Drug Companies Over Insulin Price Gouging

(1/15, FOX 28) ...Columbus City Attorney Zach Klein announced that the city has filed a lawsuit against several drug companies and pharmacy benefit managers (PBMs) for allegedly inflating insulin prices for decades, costing taxpayers millions...The companies named in the lawsuit include Eli Lilly, Novo Nordisk, Sanofi-Aventis, CVS Health, CVS Pharmacy, Caremark Health, United Health Group, Express Scripts Pharmacy, Optum Rx, among others... Full

Improving Biosimilar Access Through Global Regulatory Convergence

(1/15, Skylar Jeremias, The Center For Biosimilars) ...Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is crucial to improving market access, reducing costs, and enhancing patient outcomes, according to a recent commentary emphasizing the need to address regulatory disparities... Full

EU Pharma Reform & Reducing Reliance On Asian Imports: What To Expect in 2025

(1/15, Neena Brizmohun, Pink Sheet) ...The European Commission is planning to propose a Critical Medicines Act soon to tackle the EU's reliance on imports of active pharmaceutical ingredients and finished medicines from Asia. The Council of the EU is expected to begin formal discussions for the Critical Medicines Act on June 13. The council is also expected to discuss the EU's pharmaceutical package of reforms at the June 13, meeting... Global Sub. Full

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