Thursday, December 5, 2024

Teva Reports Positive Outcomes from Episodic Migraine Trial in Young Patients

(12/5, Clinical Trials Arena) ...Teva Pharmaceutical Industries has reported positive outcomes from its multicentre Phase III SPACE trial of Ajovy (fremanezumab) as a preventive treatment for episodic migraine in young individuals aged six to 17 years... Full

Fremanezumab for Episodic Migraine Prevention Demonstrates Positive Phase 3 Data

(12/4, Joshua Fitch, Contemporary Pediatrics) ..."Over the last 30 years, the incidence of childhood migraine has increased but there has been little innovation in licensed treatments to manage this debilitating condition in children." Eric A. Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, Teva Pharmaceuticals, said in a statement..."We've already seen the benefits of [fremanezumab] in adults and the SPACE trial has confirmed that children with episodic migraine can also benefit from [fremanezumab]. This is a significant step forward for the care of migraine in children and adolescents who are having to live with this high burden," said Hughes... Full

Teva Presents Positive Data from Ajovy Pediatric Study

(12/4, Val Brickates Kennedy, Seeking Alpha) ...The Israeli drugmaker said the study showed Ajovy significantly reduced the monthly migraine days and monthly headache days versus placebo in children aged six to 17 over a 12-week period. Teva said the efficacy results were consistent with those from Phase 3 and real-world evidence studies in adults, with no new safety signals observed, according to a statement... Full

AstraZeneca's New EVP of International Amid China Investigation; Janux's $300M Offering

(12/4, Endpoints News) ...Teva's Ajovy bests placebo in pediatric migraine trial: Over 12 weeks, Ajovy "significantly" reduced monthly migraine days and monthly headache days compared to placebo in patients between six and 17 years old. The full data are set to be presented at the European Headache Congress in the Netherlands this week... Full

Piper Sandler Reiterates Overweight On Teva Pharma (TEVA) as Management Provides Updates

(12/5, StreetInsider.com) ...[David Amsellem] "...That said, the commentary from the team regarding other critical parts of the business (e.g., visibility into the expansion of the Austedo franchise; the operating leverage associated with layering in other neuropsychiatry-focused brand assets (particularly Teva's long-acting injectable antipsychotics); a growing biosimilars footprint, helping drive stability for the U.S. generics segment; organic brand pipeline advancement (e.g., the advancement of emrusolmin into Phase II in multiple system atrophy)) reinforces our view that further multiple expansion is warranted (from a current EV/2025E EBITDA of ~7x, and in the context an improving capital structure). We reiterate our Overweight rating and $23 PT."... Sub. Req’d

Teva: Becoming Increasingly Solid, But No Longer Undervalued

(12/4, Eugenio Catone, Seeking Alpha) ...Teva's stock has risen 105% in two years, outperforming the S&P 500, but it is no longer a bargain at $17.50 per share. The company's focus on debt reduction has been successful, with net debt falling to $15.70 billion, but high interest expenses remain a concern. Key drugs like AUSTEDO®, AJOVY®, and UZEDY® are driving revenue growth, with AUSTEDO® showing the most promise due to long patent life and rising demand. Despite strong performance and growth in generics and biosimilars, I recommend holding Teva stock, valuing it at $15 per share... Full

Goodbye Biosimilars: Coherus Sells Udenyca To Intas For Half A Billion

(12/4, Dave Wallace, Generics Bulletin) ..."By adding Udenyca to our growing portfolio of biosimilars, we will strengthen our business footprint in the US," commented Chrys Kokino, US president of Accord. "With an expanding presence in the market, we can fuel the internal innovation and external expansion needed to deliver more accessible treatment options to patients."... Global Sub. Full

Richter Eyeing 20%+ Margin On Denosumab As Part Of 2027 Profit Plans

(12/4, Dean Rudge, Generics Bulletin) ...Gedeon Richter is feeling good about its plan to launch a biosimilar denosumab product in the EU in 2025, as it continued to slow down losses for its biopharma unit ahead of plans to swing to profitability later in the decade. Gedeon Richter says that if its European denosumab filing continues along its current trajectory, "there's a high probability that we can launch on time and have a relatively short approval process, which gives hope that the denosumab launch taking place next year will be successful."... Global Sub. Full

US Market Opens Up For Henlius After First Shipment

(12/4, Dave Wallace, Generics Bulletin) ...Noting that "the US, as the world's largest biopharmaceutical market, imposes stringent requirements on drug supply systems and the comprehensive strengths of companies," Henlius president Wei Huang said "the successful entry of Hanquyou into the US market not only expands our international footprint but also lays a solid foundation for the globalization of our other products."... Global Sub. Full

GSK to Get Less from Zhifei Shingles Vaccine Deal; To Collaborate On RSV

(12/5, Yadarisa Shabong, Reuters) ...China's Zhifei will pay GSK about 2.3 billion pounds ($2.9 billion) for the exclusive rights to distribute GSK's shingles vaccine in China, the UK drugmaker said on Thursday, lower than previously agreed though the deal has been extended. The deal also now includes exclusive rights for China's largest vaccine company to explore a collaboration on GSK's respiratory syncytial virus (RSV) vaccine, Arexvy, in China, the world's No.2 pharmaceuticals market, for an initial term of 10 years... Full

Novartis Cannot Block Generic of Best-Selling Heart Drug, US Appeals Court Says

(12/4, Blake Brittain, Reuters) ...The U.S. Court of Appeals for the Federal Circuit upheld a Delaware federal judge's August decision that found Novartis failed to prove it was likely to win a patent lawsuit against MSN over the drug, removing a roadblock for MSN's launch of what would be the first U.S. Entresto generic. Novartis said in a statement that it disagrees with the ruling and is "considering all available options to vigorously defend our intellectual property rights, including further appellate options."... Full

Dr Reddy's Will Top Up Base Business with Innovation in India: M V Ramana

(12/4, G Naga Sridhar, The Hindu BusinessLine) ...After being one of the major players in the US and European markets, pharma major Dr Reddy's Laboratories is now keen on ramping up its position in the domestic market with a slew of measures. Out of a total revenue of 27,916 crore, its India business logged 4,640 crore in FY24. businessline spoke to M. V. Ramana, CEO, Branded Markets (India & Emerging Markets), Dr. Reddy's Laboratories on the company's plans... Full

Celltrion Starts Production at New Songdo Plant

(12/5, Hwang Joo-young, The Korea Herald) ...South Korean biopharmaceutical firm Celltrion announced Thursday that its third plant in Songdo, Incheon, has officially commenced commercial production, following the completion of a performance qualification test...Celltrion stated that the third plant focuses on small-batch production of multiple drug substances for its products, enabling the company to respond quickly to market demands and changes. The company also aims to maximize cost efficiency through high-titer technology, which increases output from the same volume of culture medium... Full

Aurobindo Pharma Wins USFDA Approval for Generic Cancer Drug

(12/5, Anupama Ghosh, The Hindu BusinessLine) ...Aurobindo Pharma Limited announced today that its subsidiary Eugia Pharma Specialities Limited has received US Food & Drug Administration final approval to manufacture and market Pazopanib Tablets, 200 mg...The generic drug is bioequivalent to Novartis Pharmaceuticals' Votrient Tablets and is indicated for treating advanced Renal Cell Carcinoma (RCC) and Soft Tissue Sarcoma (STS) in adult patients who have undergone prior chemotherapy... Full

UnitedHealthcare CEO's Killing Lays Bare Rising Security Risks Facing Health Care Leaders

(12/5, Annalisa Merelli and Jonathan Wosen, STAT) ...In recent years, the threat level seems to have risen for health care executives. Following the backlash against Covid-19 vaccines, Moderna and Pfizer began spending significantly on the personal safety of their leadership...Thompson's wife, Paulette Thompson, told NBC News her husband had received threats. The New York Police Department said in a press conference on his killing that, based on an initial assessment, he didn't appear to be traveling with a security detail. UnitedHealth did not comment on the company's security measures. NYPD officials said the killing appeared to be targeted, but they have not identified a motive or named a suspect... Full

UnitedHealth CEO's Killing Unleashes Social Media Rage Against Insurers

(12/5, Maya Goldman, Axios) ...Wednesday's shocking murder of UnitedHealthcare CEO Brian Thompson unleashed a wave of social media-fueled rage against health insurers, with posters lashing out over coverage denials and other business practices...Experts say the lack of sympathy may reflect an inherent truth about Americans and their health plans: People tend to like their own insurer but distrust the industry — and indeed, the health system at large... Full

Battling Big Pharma: A Conversation with Mark Cuban

(12/4, Wired) ...His time on Shark Tank may be over, but this serial investor is just getting started. The Cost Plus Drugs founder shares how he's demolishing–and rebuilding–the prescription drug industry with WIRED's Lauren Goode... Full

This CEO Sells Low-Cost Drugs, and He Says Big Pharma Might Not Be The True Adversary

(12/4, Robert Safian, Fast Company) ...Cost Plus Drugs CEO Alex Oshmyansky explains his hopes for helping to change healthcare for the masses on the latest episode of the "Rapid Response" podcast...With the help of co-founder Mark Cuban, CEO Alex Oshmyansky is radically re-engineering the pharma marketplace and dramatically cutting the price for many prescription drugs. Oshmyansky shares why Big Pharma might not be the true adversary, how Y Combinator got his company off the ground, and his hopes for helping to change healthcare for the masses... Full

U.S. Patent Office Pulls Controversial Rule to Curb Pharma Patent Abuse

(12/4, Ed Silverman, STAT Plus) ...Specifically, the proposed rule was crafted to stem the use of so-called patent thickets, which are wielded by drug companies to delay the arrival of lower-cost generic medicines in the marketplace. Essentially, thickets are collections of numerous patents that critics contend add only incremental changes to a drug and, therefore, produce little to no additional benefit to patients....As for industry, the Pharmaceutical and Research Manufacturers of America, a trade group that represents brand-name drug companies, wrote in its own comment that the rule would "negatively impact incentives for innovation for PhRMA's member companies. This in turn could have negative implications for future life-saving and life-enhancing therapies for patients in need."... Sub. Req’d

CSRxP: USPTO Withdrawal of Patent Thicket Rule Adds to Urgency for Congress to Pass Cornyn-Blumenthal

(12/4, The Campaign for Sustainable Rx Pricing) ..."We are disappointed in USPTO's decision to withdraw this proposed rule, which adds even greater urgency to the need for Congress to crack down on Big Pharma's egregious patent thickets by passing Cornyn-Blumenthal in the lame duck," said CSRxP executive director Lauren Aronson. "Big Pharma's patent thickets protect drug company profits not innovation, while keeping drug prices high for millions of American patients."... Full

Reminder: "Delinking" Is Pharma's Top Priority Because It Boosts Their Profits

(12/4, PCMA) ...A research paper, "Ending Pay for PBM Performance: Consequences for Prescription Drug Prices, Utilization, and Government Spending," from University of Chicago Professor of Economics Casey Mulligan, Ph.D, and published by the National Bureau of Economic Research, examined the consequences of "delinking" in Medicare Part D. According to the report, such a policy would undermine incentives for pharmacy benefit companies to maximize competition in the market and secure savings for patients and health plan sponsors, resulting in higher drug prices and handing drug companies a profit-boosting windfall... Full

Murphy Urges Congress to Take Action Against Pharmacy Benefit Managers

(12/4, U.S. Congressman Gregory F. Murphy, M.D.) ..."The Lower Costs, More Transparency Act, which has received bipartisan, bicameral support, directly addresses these concerns by making health care more affordable for patients and employers through increased transparency and competition. Unfortunately, Senate Majority Leader Chuck Schumer held it up for almost a year. This is unacceptable, and I will keep fighting until we get it signed into law."... Full

Policy Proposals Aim to Stimulate the Long-Term Sustainability of Infused Biosimilars

(12/4, Cameron Santoro, AJMC) ...Proposed policy solutions include increasing ASP-based reimbursement, shared savings models, and adjusting rebate calculations to enhance biosimilar uptake. The Inflation Reduction Act may impact Medicare's ASP payments, promoting biosimilar use over brand-name drugs... Full

Editorial: RFK Jr.'s Race Against the Cure

(12/5, The Wall Street Journal) ...Conservatives who support Donald Trump's choice of Robert F. Kennedy Jr. to lead the Health and Human Services Department say he will disrupt the healthcare bureaucracy. They may be right. But he could also disrupt access to life-saving medicines and the innovation ecosystem that creates them... Sub. Req’d

Trade Group Tells FDA that Semaglutide is Not Too 'Complex' for Compounding

(12/4, Nicole DeFeudis, Endpoints News) ...The Alliance for Pharmacy Compounding told the FDA last week that Novo Nordisk's weight loss medicine semaglutide is not too difficult to compound, pushing back against the Danish pharma's arguments that seek to limit pharmacies from making their own versions of the blockbuster drug...A Novo spokesperson told Endpoints News Wednesday that its intention is "keeping people safe from unapproved and potentially harmful versions of knock-off ‘semaglutide' drugs."... Full

AMA Urges Policymakers to Act Despite Report of Improved Opioid Epidemic

(12/4, Brian Nowosielski, Drug Topics) ...According to AMA's 2024 Overdose Epidemic Report, naloxone is being dispensed more often, prescription drug monitoring programs have increased, opioid prescriptions have decreased, and the number of buprenorphine prescriptions dispensed is currently plateauing. But despite seeing efforts to combat the opioid crisis finally come into fruition, the AMA is pressuring policymakers to strive for an end to this epidemic before it has the chance to worsen... Full

US FDA Generic Drug Approvals, Other Actions Declined As Approval Times Climbed In FY 2024

(12/4, Derrick Gingery, Pink Sheet) ...Full ANDA approvals dropped in FY 2024, compared to the previous year, while submissions increased slightly. Complete response letters also dropped, but quarterly mean and median approval times increased. The data may help shape the upcoming user fee reauthorization negotiations, which will begin in 2025... Global Sub. Full

New Task Force Looks to Bring Down Prescription Drug Prices

(12/5, Mike Savino, NBC Connecticut) ...The task force won't provide recommendations before the legislature returns to the Capitol on Jan. 8, but lawmakers hope to have proposals sometime this spring. They invited drug manufacturers and pharmaceutical benefit managers, professionals who negotiate drug prices, to join the task force. "PBMs can and should lower costs by 50% or more by sharing rebates provided by manufacturers with patients, yet they choose to charge you full price at the pharmacy counter," Pharmaceutical Research and Manufacturers of America spokesperson Stami Turk said in a statement... Full

Bills to Reduce Insulin and Other Prescription Drug Costs Return to the California Legislature

(12/4, Megan Myscofski, CapRadio) ...Assembly Speaker Robert Rivas framed California's new legislative session as a chance to increase affordability for people struggling financially. "I'm calling on us to consider every bill this session through their lens," said Rivas, a Democrat from Salinas, in a speech at the state Capitol this week. In response, Democratic Senator Scott Wiener of San Francisco reintroduced two bills meant to cut down drug costs... Full

2024 Regulatory Policy Forum Takes an In-Depth Look Into the "Once in a Generation" Changes to the EU Pharmaceutical Legislation

(12/4, Regulatory Focus) ...Discussions centered on the need for strategic planning, change management, sufficient piloting of new approaches, and the development of robust guidance, expertise, and resources to enable effective operation from Day 1 of the new framework... Full

Why Historical Data Will Be Important Under The New EU HTA Regulation

(12/4, Eliza Slawther, Pink Sheet) ...The incoming EU Health Technology Assessment Regulation will see historical data move "more center stage" for advanced therapies, because directly comparing highly individualized therapies is often unfeasible, an advanced therapies expert says... Global Sub. Full

UK Pharma Group Calls for Regulatory Reform

(12/4, The Pharma Letter) ...A new report from the Association of the British Pharmaceutical Industry (ABPI) lays out a roadmap for the agency to: "regain its world-class reputation," calling for more resources and the adoption of flexible licensing routes. Richard Torbett, chief executive of the ABPI, said: "This report sets out a clear roadmap for the MHRA's incoming leadership to ensure the UK can operate as a leading authority that supports the development of new medicines and can safely and swiftly bring new innovations and treatments to patients."... Sub. Req’d

Britain Drug-Cost Watchdog Says It Will Recommend Lilly Obesity Drug

(12/5, Maggie Fick, Reuters) ...Britain's drugs cost-effectiveness watchdog NICE said on Thursday it will recommend Eli Lilly's obesity drug Mounjaro be made available to around 220,000 people in the country via the state health system over the next three years... Full

Pharma Exports Prompt Denmark to Raise 2025 Growth Forecast

(12/5, Sanne Wass, Bloomberg) ...The Danish economy will expand faster next year than previously estimated, boosted by exports from drugmakers including Novo Nordisk A/S, the government forecast. Gross domestic product growth will probably come in at 2.9% next year, more than the 2.2% forecast published in August, the Economy Ministry said in a report on Thursday. The government also raised its estimate for this year's growth to 3.0%, from 1.9% seen before... Full

Canadian HTA Agency Consults On First Methods Guideline

(12/4, Francesca Bruce, Pink Sheet) ...A new methods guide from Canada's health technology assessment agency should help drug sponsors generate and report appropriate clinical evidence. Canada's Drug Agency (CDA), the national health technology assessment body, is seeking feedback on its first ever methods guide in a bid to improve transparency and understanding of its work, and to explain the types of evidence that can help show a product's comparative effectiveness... Global Sub. Full

India's Pharma Future Relies On Regulatory Strength

(12/5, Shreeyashi Ojha, BioProcess International) ...The Indian pharmaceutical industry, historically known for its dominance in the production of small molecules, is poised to establish itself as a major supplier in large molecule and biologics space. Coinciding with the country's centenary of independence, the Government of India aspires to reach a $500 billion valuation for the pharmaceutical industry by 2047. Although currently valued at $65 billion, the sector is projected to reach $120 billion to $130 billion by 2030... Full

Enhertu Among Drugs In Annual China NRDL Update

(12/5, Xu Hu, Pink Sheet) ...China's National Healthcare Security Administration (NHSA), the government agency that oversees health insurance schemes and organizes annual negotiations of drug prices, released on November 28, the updated 2024 National Reimbursement Drug List (NRDL), marking the seventh time this has been updated since the agency was established in 2018. The list will take effect on January 1, and the new inclusions bring the total number of reimbursed drugs under the list to 3,159... Global Sub. Full

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