Friday, July 5, 2024

Teva Agrees $750M Deal To Draw A Line Under Israeli Tax Tussle

(7/5, Dean Rudge, Generics Bulletin) ...The terms of Teva's agreement with the Israel Tax Authority resolve all pending litigation with respect to taxes payable for the company's taxable years 2008-2020...The agreement has no impact on Teva's 2024 financial outlook, which the company has reaffirmed. According to the Israeli firm, the agreement allows Teva to "end this historical income tax issue, and to continue to focus on its commitment to the health of patients and on the continued implementation of its ‘Pivot to Growth' strategy."... Global Sub. Full

After Denosumab Deals, Alvotech Lines Up Filings

(7/4, David Wallace, Generics Bulletin) ...Following positive clinical trial results for its AVT03 proposed denosumab biosimilar to Prolia/Xgeva, Alvotech is planning filings in "major global markets." Launches are expected to follow through recently-agreed partnerships...Alvotech's denosumab is due to be marketed in Europe by Stada, under a recently-agreed collaboration that gave the German firm semi-exclusive commercial rights in Europe, including Switzerland and the UK. Dr Reddy's also holds semi-exclusive rights to the AVT03 candidate in Europe and the UK, as well as exclusive rights to Alvotech's denosumab in the US. Alvotech's frequent US biosimilars collaborator Teva has its own in-house candidate that is currently in Phase III trials... Global Sub. Full

Amneal Adds Xolair Rival To Biosimilars Pipeline

(7/5, David Wallace, Generics Bulletin) ...Amneal Pharmaceuticals is adding a biosimilar rival to Xolair (omalizumab) to its biosimilars pipeline, with the Kashiv Biosciences-developed product becoming the eighth biosimilar in the firm's portfolio. With three biosimilars already on the market in the US – Alymsys (bevacizumab-maly), Fylnetra (pegfilgrastim-pbbk), and Releuko (filgrastim-ayow) – Amneal also has denosumab rivals to Prolia and Xgeva in its pipeline, courtesy of a recent partnership with mAbxience... Global Sub. Full

Dr Reddy's Lab Pushes the Pedal to Touch 1.5 Billion Patients by FY30

(7/4, Sanket Koul, Business Standard) ...Hyderabad-based pharma major Dr Reddy's Laboratories is targeting to reach 1.5 billion patients by the financial year 2029-30 (FY30) from the current 704 million patients...In a joint message to DRL shareholders, K Satish Reddy, chairman of DRL, and GV Prasad, co-chairman and managing director, DRL, highlighted the importance of anticipating healthcare trends of the future as demographics, disease patterns, and business models evolve... Full

Reddy's, Zydus Shake Hands On Next-Generation Pertuzumab In India

(7/4, Dean Rudge, Generics Bulletin) ...Dr. Reddy's Laboratories can look ahead to providing "the complete standard of care for HER2-positive breast cancer patients in India," after striking a deal for Zydus Lifesciences's biosimilar to Genentech's Perjeta (pertuzumab)... Global Sub. Full

Dr Reddy's to Work ‘Closely' with USFDA On Biosimilar Rituximab to Launch it in US

(7/4, Naga Sridhar, The Hindu BusinessLine) ..."Our dossier for the proposed rituximab biosimilar candidate received a Complete Response Letter from the USFDA. We will continue to work closely with the USFDA to address and resolve all concerns within stipulated timelines in order to make this biosimilar rituximab available to patients in the U.S. as soon as possible,'‘ Dr Reddy's Chairman K Satish Reddy and Co-chairman and Managing Director G V Prasad said in their message to the shareholders in the Annual Report for the year 2023-24... Full

Fresenius Debuts Subcutaneous Tocilizumab Biosimilar In US

(7/3, David Wallace, Generics Bulletin) ...Fresenius Kabi has become the first firm to market a subcutaneous tocilizumab biosimilar in the US, introducing an SC version of its Tyenne rival to Actemra just a couple of months after the intravenous launch... Global Sub. Full

Alteogen Eyes Partnerships And 2025 Approval For EU Eylea Biosimilar

(7/5,Dean Rudge, Generics Bulletin) ...Alteogen's Altos Biologics says it intends to negotiate license agreements with "potential distributors worldwide," in the wake of filing its ALT-L9 proposed biosimilar to Eylea (aflibercept) with the European Medicines Agency. The Korean firm is allied on development of its aflibercept biosimilar with Japan's Kissei Pharmaceutical. It expects to receive approval in Europe by 2025, "aligned with the [Eylea] substance patent expiration."... Global Sub. Full

Alembic Pharmaceuticals Receives USFDA Tentative Approval for Ivosidenib Tablets

(7/4, Business Standard) ...Alembic Pharmaceuticals today announced that it has received tentative approval from the US Food & Drug Administration for its Abbreviated New Drug Application for Ivosidenib Tablets, 250 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product, Tibsovo Tablets, 250 mg, of Servier Pharmaceuticals LLC... Full

ANI Pharmaceuticals Secures FDA Approval, Launches Delayed-Release Naproxen

(7/3, Burl Gilyard, Star Tribune) ...ANI Pharmaceuticals this week announced Food and Drug Administration approval to produce a delayed-release form of naproxen, the main ingredient in Aleve pain reliever. Naproxen treats moderate pain and inflammation and can be a treatment for arthritis. "ANI remains committed to driving growth through superior new product launch execution, in keeping with our purpose of 'Serving Patients, Improving Lives,'" said Nikhil Lalwani, CEO of ANI, in a statement... Full

AbbVie Cuts 2024 Profit Forecast On R&D Expenses

(7/3, Mariam Sunny, Reuters) ...AbbVie lowered its 2024 adjusted profit forecast on Wednesday, citing $937 million in milestones, and research and development expenses related to acquisitions. The drugmaker has been focusing on expanding its pipeline since its blockbuster arthritis drug, Humira, lost patent protection last year... Full

Indivior CEO Expects Ongoing U.S. Opioid Crisis to Drive Sales Growth

(7/3, Sabela Ojea, The Wall Street Journal) ...Addiction-treatment company Indivior expects continued revenue growth in the U.S., citing the ongoing opioid crisis...The company expects the number of Americans in need of addiction treatments to be steady in the next two years. That trend should continue to drive demand at Indivior, which makes drugs that treat opioid dependence, given that only 25% of the adults who in 2022 needed an opioid use disorder treatment received recommended medications, according to the Centers for Disease Control and Prevention... Sub. Req'd

Olon Expands With GTP Acquisition

(7/5, David Wallace, Generics Bulletin) ...Italian active pharmaceutical ingredients specialist Olon Group has struck a deal to acquire French biotech contract development and manufacturing organization GTP Bioways, in a move that Olon says will allow it to "expand and diversify its technological offerings."...Paolo Tubertini, CEO of Olon group, said the deal "implies a strong and significant strengthening of Olon's service pipeline with the aim of creating new business opportunities, acquiring new customers and high-potential market areas, and ultimately continuing the company's growth."... Global Sub. Full

Experts Want to Make it Easier to Get RSV Vaccines. Did They Make it Harder Instead?

(7/3, Max Bayer, Endpoints News) ...Last week, experts on the CDC's panel that sets vaccine recommendations created new guidance for who should get RSV shots heading into the second-ever season of vaccination for the respiratory disease. The goals of the Advisory Committee on Immunization Practices were to create clearer advice for older Americans and to make access easier. But in doing so, there are concerns that it may have, paradoxically, left fewer people eligible... Full

Ozempic-Maker Blasts Biden in Price Row

(7/3, Seb Starcevic, Politico) ...Novo Nordisk hit back at such claims on Wednesday, telling POLITICO it was "disappointed that a very difficult and complex problem is being oversimplified and mischaracterized for political purposes."...Ozempic's price "has decreased approximately 40 percent since launch and over 80 percent of Americans with insurance only pay $25 or less per month" for the medicine, the pharma added. "Unfortunately, even when we lower our prices, patients in the United States often don't receive the savings — this is a problem."... Full

Federal Judge Tosses Boehringer Ingelheim's IRA Lawsuit, Deciding Medicare Negotiations Are Voluntary

(7/4, Nicole DeFeudis, Endpoints News) ...Judge Michael Shea ruled against Boehringer's constitutional arguments, finding that the company's participation in the price negotiation program is voluntary and does not constitute a taking of property or a violation of speech...Together with Eli Lilly, Boehringer markets Jardiance, a treatment for type 2 diabetes and one of the 10 medicines whose prices are being negotiated... Full

Judge Tosses Boehringer Bid to Block Biden Drug Price Plan

(7/3, Nyah Phengsitthy, Bloomberg Law) ...The manufacturer argued the program violates the First Amendment prohibition on compelled speech, Fifth Amendment due process and takings clauses, Eighth Amendment excessive fines clause, the Administrative Procedure Act, and the unconstitutional conditions doctrine..."I find that BI's participation in Medicare and Medicaid is voluntary, even if BI has a considerable economic incentive to participate," Shea wrote... Full

IRS Finalizes Excise Tax Rules for Medicare Drug Price Talks

(7/3, Erin Slowey and Nyah Phengsitthy, Bloomberg Law) ...The IRS released final rules Wednesday on procedures for the excise tax imposed on sales by manufacturers, producers, or importers of designated drugs if they refuse to comply with the Biden administration's drug price negotiation program...Manufacturers allege the excise tax violates the Eighth Amendment's prohibition on excessive fines. They claim the tax provides no other purpose than to force drugmakers to comply with the program. The IRS wrote in the final rule it received several comments in response to the proposed regulations, some of which concerned whether the program's tax is unconstitutional... Sub. Req'd

PhRMA, White House Spar Over Medicare Price Negotiation Messaging

(7/4, Cathy Kelly, Pink Sheet) ...A Milliman study found that 3.5 million Medicare Part D beneficiaries could see an average 12% higher cost sharing for drugs that undergo the price negotiation process in 2026 compared to the previous year...However, the study's narrow focus does not present a complete picture by focusing on the impact of negotiation without considering other Part D changes that will reduce beneficiary costs, drug pricing policy expert Stacie Dusetzina said... Sub. Req'd

PhRMA Reiterates Concerns with IRA Price Setting Program, Urges CMS to Mitigate Harm

(7/3, Nicole Longo, PhRMA) ...As long as the price setting provisions of the Inflation Reduction Act (IRA) remain in place, patients and innovation are stuck in the crosshairs. The administration has a responsibility on behalf of patients across the country to mitigate these harms and address the unintended consequences of the law. In response to CMS's draft guidance for the second year of price setting under the IRA, PhRMA outlined five key concerns... Full

Mark Cuban Confronts Donald Trump Ally Mike Pompeo

(7/4, Jesus Mesa, Newsweek) ...Mark Cuban has once again taken to social media—this time targeting former Secretary of State Mike Pompeo—accusing him of supporting pharmacy benefit managers, which Cuban blames for high drug prices and the closure of independent pharmacies. Cuban was responding to an op-ed written by Pompeo on Fox News, in which the former secretary of state argued that the Biden administration's policies targeting PBMs will raise prescription drug costs for Americans... Full

J&J, Novartis Drugs to Face Colorado Board's Payment Limits

(7/3, Celine Castronuovo, Bloomberg Law) ...Top-selling arthritis and psoriasis drugs from Johnson & Johnson and Novartis AG are likely to see caps on what health plans in Colorado pay for the medications after votes Wednesday by the state's drug pricing review board...A J&J spokesperson said in an email that the board's work is a form of government price setting, and that the vote doesn't address insurance benefit design and supply chain dynamics that the spokesperson argued are responsible for high patient costs... Sub. Req'd

Colorado PDAB Considering UPL For Cosentyx, Stelara

(7/3, Luke Zarzecki, InsideHealthPolicy) ...A Novartis spokesperson did not respond to whether the company will be following in Amgen's footsteps but said the company disagrees with the decision. "Novartis disagrees with the Colorado Prescription Drug Affordability Board's decision to set an upper payment limit on Cosentyx (secukinumab). Novartis is confident in both the value and affordability of Cosentyx and remains concerned that the imposition of an upper payment limit could negatively impact Coloradans' access to therapies," the spokesperson said in a statement to Inside Health Policy... Sub. Req'd

Mississippi Judge Rejects Efforts by Novartis, PhRMA to Block 340B State Law

(7/3, Nicole DeFeudis, Endpoints News) ...Novartis said it plans to appeal. "The unfortunate reality today is that the overwhelming majority of 340B discounts are not passed on to patients, nor are they used to strengthen the safety net as intended," a Novartis spokesperson told Endpoints News. "We believe the widely acknowledged program integrity concerns under the 340B program will only be exacerbated by statutes such as the one we have challenged in Mississippi." PhRMA deputy VP of public affairs Nicole Longo told Endpoints that the law "violates the US Constitution while doing nothing to lower costs for patients."... Full

What Does Labour's UK Election Win Mean For Generics And Biosimilars?

(7/5, David Wallace, Generics Bulletin) ...For BGMA chair DiGangi Trench, it was "critical that the life sciences strategy [of a new government] covers the off-patent segment of the market," with the previous government approach to generics and biosimilars having been marked by a "complacency" towards the benefits the sector brought to the NHS...Key priorities cited by DiGangi Trench for the UK market included improving the sluggish performance of the MHRA, tackling shortages, and addressing the complexity of post-Brexit regulation... Global Sub. Full

Labour Sweeps To Power In UK: What Will It Mean For Pharma?

(7/5, Ian Schofield, Pink Sheet) ...Labour Party leader Sir Keir Starmer, who will become the UK prime minister, said that "change begins now," echoing Labour's pre-election manifesto pledge to "stop the chaos, turn the page and rebuild our country."...As well as a broad pledge to fix the "broken" National Health Service and make it "fit for the future" – for example by doubling scanning capacity to detect and treat cancer and other conditions earlier – Labour has already outlined a number of policy ideas specifically targeted at life sciences... Sub. Req'd

EU Joint Clinical Assessments: ATMPs Need ‘More Ambitious' Approach

(7/3, Eliza Slawther, Pink Sheet) ...EU-wide joint clinical assessments, a key part of the Health Technology Assessment Regulation, will not solve all access problems faced by EU citizens who are eligible for treatment with an advanced therapy medicinal product. This is according to Jo De Cock, former general administrator for the Belgian HTA body RIZIV-INAMI, who spoke during a June 24, webinar hosted by European pharma trade association EUCOPE on cross-border access to ATMPs in the EU. He contended that while JCAs "can be fruitful," he believed "we should be more ambitious."... Sub. Req'd

Netherlands Follows Belgium & Luxembourg In Piloting Electronic Medicine Pack Leaflets

(7/4, Francesca Bruce, Pink Sheet) ...VIG, the Dutch innovative medicines association, plans to run a pilot on replacing paper pack information leaflets for hospital medicines with electronic versions. However, permission for a derogation from an EU Directive must first be granted..."The goal of the pilot project is to demonstrate whether the electronic package leaflet, in lieu of a paper version, has no (negative) effects on the proper use of medicinal products in a hospital setting and the provision of information to patients," said Dijkstra's letter to the commission... Sub. Req'd

French To Review The ‘Gamble' Of Early Access Decisions

(7/3, Ian Schofield, Pink Sheet) ...The HAS, whose responsibilities include evaluating drugs for reimbursement purposes, is to set up a working group to look at what improvements could be made to the current evaluation process for drugs submitted for early access. Among other things, the group will look at the criteria for early access, how to address the uncertainties due to the lack of comprehensive clinical evidence at the time of the early access decision, and what constitutes a "reasonable" timetable for obtaining confirmatory data. It is expected to produce its conclusions by the end of the year... Sub. Req'd

Germany's New Medical Research Act Will Allow Pharma Companies Confidentiality On Price

(7/5, Jeremias Lin, Euractiv) ...Germany adopted its Medical Research Act, Thursday (July 4), the new law will allow pharma companies to negotiate the price of patent-protected medicines in private...The act is an important part of a wider strategy proposed in 2023, to improve the investment and production of pharmaceuticals and medical devices. The strategy already appears to be bearing fruit, with Germany becoming an increasingly attractive location for the pharmaceutical industry, as seen by the billion-euro investment by French pharmaceutical giant Sanofi. Eli Lilly of the US and Daiichi-Sankyo of Japan, also announced similar plans... Full

Debate On Guidelines For Canada's Controversial Pricing Mechanism Moves To Next Phase

(7/3, Neena Brizmohun, Pink Sheet) ...The Patented Medicine Prices Review Board in Canada has launched the second phase of consultations on the development of new guidelines relating to its controversial drug pricing mechanism. Stakeholders have until September 11, to comment on a newly released "Discussion Guide," which provides a proposed framework that "indicates a direction on certain issues and provides a range of options on others," said the PMPRB, whose mandate is to ensure that medicine prices are not excessive... Sub. Req'd

Battling the Rising Tide of Fake Medicine

(7/4, Jessica Davis Plüss and Pauline Turuban, Swissinfo.ch) ......"We're getting better at detecting falsified medicines through measures like improved traceability, but the problem isn't diminishing," said Cyntia Genolet, a specialist in counterfeit drugs at the International Federation of Pharmaceutical Manufacturers and Associations, a Geneva-based industry lobby group...The rise of online pharmacies has made it much "easier for counterfeit medications to reach consumers", said Mario Ottiglio, a spokesperson for Fight the Fakes, an alliance of organisations raising awareness of falsified medicine... Full

Drug Makers Pin Hopes On Budget for Import Duty Cut in Raw Materials; Research Incentives

(7/5, Priyanka Sharma, Mint) ...The Pharmaceuticals Export Promotion Council of India (Pharmexcil), a trade promotion agency set up by the commerce ministry, has sought a reduction in basic customs duty (BCD) on imported raw materials for making antibiotics from 7.5% to 5% and enhanced tax incentive for companies to invest in research. The agency has pitched for allowing double the amount of research spending made by companies as a deduction while computing their taxable income. Now, 100% deduction of research spending is allowed... Full

Japan to Subsidize Antibiotics Supply Chain to Reduce China Exposure

(7/5, Taizo Wada, Nikkei Asia) ...Japan will soon move to support the domestic antibiotics industry as part of public and private efforts to reduce the supply chain's heavy exposure to China. The measures will include subsidies to makers of active ingredients. A government purchasing scheme is also planned. The new program will be created as early as the current fiscal year... Full

Chinese Public Healthcare Insurance Official Defends Steep Drug Price Cuts

(7/4, Dexter Yan, Pink Sheet) ...In the run-up to China's annual drug price talks, scheduled for November in an update to the National Reimbursement Drug List, a senior official at the National Healthcare Security Administration made a rare public appearance to defend the agency's tough price-cutting stance, which could dampen pharma companies' hopes of negotiating a premium for their innovative drugs... Sub. Req'd

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