Monday, January 13, 2025

Change Makers: Richard Francis On the Pillars of Innovation and Growth

(1/10, John Whyte, MD, MPH; Richard Francis, Medscape) ...Leading the charge towards a healthier future requires vision, bold ideas, and the courage to innovate. Richard Francis, the CEO of Teva Pharmaceuticals, is redefining what it means to lead in both generic drugs as well as new drug development. He talks about this need to pivot to growth, a strategy that is transforming his company. I recently traveled to sit down with Richard to learn about his new vision for Teva, his thoughts on what the real impact of AI on drug development will be, in addition to his belief that the adoption of biosimilars will accelerate. He also explained how sports has impacted his leadership style. It's all about the talent... Full

Teva Pharmaceuticals International Enters Collaboration to Commercialize Eye Disease Treatment

(1/13, MT Newswires) ...Teva Pharmaceutical Industries' Teva Pharmaceuticals International subsidiary said Monday it has entered into a collaboration with Klinge Biopharma and Formycon for the semi-exclusive commercialization of FYB203, Formycon's biosimilar candidate to Eylea, in Israel and Europe, excluding Italy... Full

Teva Enters Pact with Klinge Biopharma, Formycon to Commercialize FYB203

(1/13, The Fly) ...Under the terms of the agreement, Teva will lead the commercialization of FYB203 in the designated regions, to be marketed under the brand name Ahzantive, subject to regulatory approval. In return, Klinge will receive milestone payments and a portion from the product's revenue... Full

Teva Inks Commercialization Deal for Eylea Biosimilar

(1/13, The Pharma Letter) ...The collaboration, which combines Teva's extensive European distribution network with Formycon's biosimilar development expertise, builds on the firms' earlier success with Ranivisio (ranibizumab) commercialization in Europe. The move comes ahead of an expected regulatory nod from the European Medicines Agency this month. The US Food and Drug Administration approved the product in June 2024... Sub. Req’d

Samsung Bioepis, Teva Ink Rare Disease Treatment Partnership

(1/13, Kim Jee-hee and Lee Eun-joo, Pulse) ...Samsung Bioepis Co. announced on Sunday that it signed a partnership agreement with Teva Pharmaceutical Industries Ltd. for the commercialization of the rare disease treatment EPYSQLI (eculizumab) in the United States. The two companies plan to launch EPYSQLI in the U.S. market within the first half of 2025... Full

Samsung Bioepis to Partner with Teva to Market Soliris Biosimilar in US

(1/13, Lee Han-soo, Korea Biomedical Review) ...Teva U.S. Commercial Executive Vice President Chris Fox also said, "We are excited to enter this partnership with Samsung Bioepis, who share our commitment to accelerate the delivery of impactful and accessible medicines to patients." The collaboration enables Teva to leverage its extensive commercial capabilities and is aligned with our Pivot to Growth strategy, introducing a new biosimilar to our broad biosimilar portfolio, accelerating access to affordable treatment options, Fox added... Full

Samsung Bioepis Collaborates with Teva to Launch Epysylli in U.S. Market

(1/12, Heo Ji-yoon, Chosun Biz) ...Samsung Bioepis announced on the 12th that it has signed a commercialization partnership agreement with Teva Pharmaceutical Industries to enter the U.S. market with the rare disease treatment "Epysylli." Under this agreement, Samsung Bioepis will be responsible for product production and supply as the developer of Epysylli, while Teva will handle marketing and sales activities in the United States... Full

Samsung Bioepis and Teva Link Up On Soliris Biosimilar in USA

(1/11, The Pharma Letter) ...South Korean biosimilars developer Samsung Bioepis and Israel's Teva Pharmaceutical Industries have entered into a license, development and commercialization agreement for Epysqli (eculizumab-aagh), Samsung Bioepis' copy of Soliris (eculizumab-aagh), in the USA. Soliris is marketed by UK pharma major AstraZeneca and generated global sales of $1.44 billion in the first half of 2024... Sub. Req’d

ANI Continues To Spearhead FDA's CGT Path With Prucalopride Launch

(1/10, Generics Bulletin) ...ANI Pharmaceuticals will compete with a product bringing in annual sales of more than $150m after launching the first generic with 180-day exclusivity via the FDA's competitive generic therapy pathway. ANI Pharmaceuticals has championed its "superior R&D capabilities" after launching the first US generic version of Takeda's Motegrity (prucalopride) tablets..."We are delighted to build momentum early in 2025 with the approval of the first generic for Motegrity," Lalwani added, putting annual US sales of the reference brand at around $168m... Global Sub. Full

Wockhardt Sees New Drugs to Fight Superbugs as Next Growth Driver

(1/13, Satviki Sanjay, Bloomberg) ...The Mumbai-based company expects the drug Miqnaf, a short three-day treatment for infections caused by multi-drug resistant pathogens, to clock 5 billion rupees ($58.2 million) to 10 billion rupees in revenue annually from India alone, Chairman Habil Khorakiwala said in an interview. Miqnaf and other new drugs are expected to contribute a "fairly significant" proportion of the company's revenue from the financial year ending March 2027, he said. Shares have surged almost 192% in the past year versus 4.2% climb by the S&P BSE Sensex... Full

AEON's Value Tanks As It Closes $20M Offering Amid Botox Biosimilar Aspirations

(1/10, Dean Rudge, Generics Bulletin) ...AEON Biopharma says it is planning for a biosimilar biological product development type 2 meeting in 2025 for its proposed biosimilar to the world-famous Botox brand, after raising much-needed capital to keep it afloat in 2025... Global Sub. Full

Biogen CEO Confirms He's Shopping for Biotechs: ‘We Will Be Doing Deals'

(1/12, Adam Feuerstein, STAT+) ...Biogen would like to make additional biotech acquisitions in 2025 beyond Friday's offer to buy its financially troubled partner Sage Therapeutics, chief executive Chris Viehbacher told me Sunday. "We will be doing deals — the size of those deals, I cannot say," he said in an interview ahead of the J.P. Morgan Healthcare Conference... Sub. Req’d

Biogen Offers to Buy Out Struggling Neuro Partner Sage Therapeutics

(1/10, Andrew Dunn and Ryan Cross, Endpoints News) ...In a statement, Sage said it would "carefully review and evaluate the proposal made by Biogen to determine the course of action that it believes is in the best interest of the Company and all Sage shareholders." Biogen is interested in tapping its own commercial chops to boost sales of Zurzuvae, according to the offer letter. The two drugmakers partnered in November 2020 to jointly develop and sell Zurzuvae and another asset, SAGE-324. The latter drug failed a Phase 2 trial last year in essential tremor... Full

Gilead Roars into JPM25, Inking $1.7B Inflammation Deal with Leo Pharma

(1/11, Ben Adams, Fierce Biotech) ...Gilead Sciences continues its divergence out of its original infectious disease beginnings and into cancer and, now, more deeply than before, into inflammation, penning a major $1.7 billion deal with dermatology specialist Leo Pharma on the eve of the J.P. Morgan Healthcare Conference. The development and commercialization deal zeros in on Leo's preclinical STAT6 research programs, according to the Jan. 11 release... Full

GSK Kicks Off JPM Dealmaking with $1B+ Buyout of IDRx and its Rare Cancer Drug

(1/13, Max Gelman, Endpoints News) ...GSK announced Monday morning that it will acquire the privately-held biotech IDRx for $1 billion upfront, bringing a rare cancer treatment into the British drugmaker's fold. If all milestones are met, GSK will pay up to another $150 million...GSK CSO Tony Wood previously told Endpoints News that it's aiming to build "careful" momentum for its oncology pipeline. Both the IDRx buyout and a recent licensing agreement with Rgenta to develop splice modulators for different cancers appear to fall into that strategy... Full

CEOs Head to JPMorgan Pharma Event With M&A Hopes, High Security

(1/12, Gerry Smith, Michelle F. Davis and Robert Langreth, Bloomberg) ...The stakes for the biotech industry are high, with a swathe of blockbuster drugs facing the end of their exclusivity period. After patents expire, these drugs stop making much money for their owners, forcing big drug companies to find new sources of growth...Over 150 drugs with about $200 billion in annual sales face patent expirations from 2024 to 2030, according to health-care management consultant firm ZS. "These are very big numbers, very big holes" for pharma to fill, said Pratap Khedkar, chief executive officer of ZS. "Deals will grow for sure."... Full

Abbvie to Record $3.5 Bln Charge Related to Schizophrenia Drug

(1/10, Bhanvi Satija and Christy Santhosh, Reuters) ...Abbvie said on Friday it would record a charge of about $3.5 billion related to its experimental schizophrenia drug, emraclidine, which recently failed in two mid-stage studies...AbbVie said it is evaluating other Cerevel-related drug development programs and will monitor the remaining intangible assets of about $3.6 billion... Full

Pfizer, Sandoz Settle Patent Suit On Mektovi Cancer Drug Copies

(1/10, Christopher Yasiejko, Bloomberg Law) ...The Sandoz Group AG subsidiary's generic versions are blocked until the six asserted patents have expired, "except as provided for in the parties' Settlement and License Agreement," according to a stipulation and order of dismissal approved Thursday by Judge Gregory B. Williams in the US District Court for the District of Delaware. Three of the patents expire in October 2033, two in August 2030, and one in July 2031, a court filing from the case said... Sub. Req’d

Purdue's Sacklers Back New Bankruptcy Settlement for Opioid Lawsuits

(1/13, Alexander Gladstone, The Wall Street Journal) ...Certain members of the Sackler family who own Purdue have agreed to boost their total contribution to roughly $6.5 billion over time, the people said, up from $6 billion under a previous plan that was rejected last year by the Supreme Court... Sub. Req’d

Two Prolia Biosimilars, One for Xolair Are in the Offing, Says AscellaHealth Report

(1/11, Peter Wehrwein, Managed Healthcare Executive) ...FDA approval of two biosimilars to Prolia (denosumab) and a biosimilar to Xolair (omalizumab) are in the works, although none of them have PDUFA dates yet, according to AscellaHealth's most recent Specialty & Rare Pipeline Digest report... Full

FDA Warns Canadian Firm for Hostile Behavior During Inspection, Two Indian Facilities for GMP Issues

(1/10, Joanne S. Eglovitch, Regulatory Focus) ...FDA also warned Viatris, Inc. for multiple violations uncovered during an inspection of its Mylan Laboratories Limited facility in Indore, India last June. The violations concerned overarching issues related to data integrity in the site's testing of solid oral drugs...According to a company statement, following the inspection, 11 products have been placed on an Import Alert; however, four products will continue to be available in the market due to concerns about drug shortages... Full

Drug Industry Lawyers, Experts Helped Shape US Drug Price Cuts

(1/13, Nyah Phengsitthy, Bloomberg Law) ...Industry watchers are eyeing how the government and manufactures will approach the next negotiation round, which could start any day with the selection of an additional 15 Part D drugs. "The documentation here helps prove to the future administration that this process worked," said James Hodge, a health law professor at Arizona State University. "CMS helps strengthen that by following the book and getting drug companies to sit down and negotiate with them... Sub. Req’d

AARP: Prices Of Top Drugs Not Picked For Negotiation Skyrocket

(1/10, Gabrielle Wanneh, Inside Health Policy) ...List prices for the top 25 most expensive Medicare Part D drugs not selected for Medicare price negotiation have risen by an average of 98% since the drugs first entered the market, a new analysis of 2022 Part D spending data released Thursday (Jan. 9) by the AARP Public Policy Institute found. The seniors interest group says this and other findings from the analysis show how necessary the relatively new drug price controls in Medicare are to ensure beneficiaries can afford their medications... Sub. Req’d

Lawmakers Urge FTC to Release Newest Report On Pharmacy Benefit Managers

(1/10, Joseph Choi, The Hill) ...Sens. Elizabeth Warren (D-Mass.) and Josh Hawley (R-Mo.), along with Reps. Jake Auchincloss (D-Mass.) and Diana Harshbarger (R-Tenn.), wrote to the FTC in light of Tuesday's open commission meeting to consider issuing a second interim staff report on PBMs... Full

From PBMs to Biosecure, A Conversation with Rep. Auchincloss On The BioCentury Show

(1/12, Steve Usdin, BioCentury) ...Rep. Jake Auchincloss (D-Mass.), an influential voice in Congress on life sciences issues, gained stature last week when he was appointed to serve on the Energy & Commerce Committee, giving him a seat at the table for debates over legislation affecting FDA, CMS and NIH and a host of issues of critical importance to the biopharma industry... Full

New Coalition Seeks Legislation to Force Transparency for PBMs

(1/9, David Krechevsky, Hartford Business Journal) ...Calling itself Patients Not PBMs Connecticut, the Hartford-based group said it will push for bills in the state legislature to require PBMs to "be more transparent, stop keeping rebates intended for patients, stop interfering with patient access to needed care and reimburse pharmacies and physicians fairly."... Full

70+ Groups Urge Incoming Trump-CMS To Finalize Obesity Coverage Rule

(1/10, Luke Zarzecki, Inside Health Policy) ..."We urge the incoming administration to finalize this policy through the rulemaking process. By extending access to obesity medications for people living with obesity who lack access to comprehensive evidence-based care in Medicare and Medicaid, the proposed CMS rule would address an urgent health crisis and leading contributor to the ‘Unhealth' of Americans," a statement from the groups says... Sub. Req’d

In Debate Over Obesity Medications, FDA Shifts Toward Importance of Drugs in Subtle Ways

(1/10, Elaine Chen, STAT) ...This week, amid a slew of new recommendations that the FDA released ahead of President-elect Trump's inauguration, the agency posted draft guidance on obesity clinical trials, the first time it has done so since 2007. The new draft calls obesity "a chronic disease," whereas the previous guidance called it "a chronic, relapsing health risk."... Full

CDER Director Patrizia Cavazzoni Retires; Corrigan-Curay Named Acting Head

(1/10, Sue Sutter, Pink Sheet) ...CDER Director Patrizia Cavazzoni is retiring from the agency on January 18. Principal Deputy Center Director Jacqueline Corrigan-Curay will serve as acting CDER director. Cavazzoni's departure adds to the uncertainty for CDER staff and external stakeholders ahead of the administration change... Global Sub. Full

EU Looks at India as Best Option Over China, Reflecting Potential Shifts in Trade Dynamics

(1/11, Nandita Vijayasimha, Pharmabiz.com) ...The EU and other global markets are seeking to reduce dependency on China for active pharmaceutical ingredients (APIs) and other critical components due to geopolitical tensions and supply chain vulnerabilities... Full

Why 2025 Could See A Surge In EMA Approval Opinions For ATMPs

(1/10, Eliza Slawther, Pink Sheet) ...Marketing authorization applications for five new advanced therapy medicinal products were filed with the European Medicines Agency in 2024, the highest number in any year since 2020. The Pink Sheet looks at these and two other ATMPs that might get the thumbs up from the European Medicines Agency in 2025... Global Sub. Full

STADA's Stephan Eder Sets Access, Manufacturing and Sustainability at Heart of Medicines for Europe Presidency

(1/13, Medicines f or Europe) ...Stephan Eder, Head of Western Europe & Germany at Stada, has been elected by the Board of Medicines for Europe as its President for a two-year term (2025-2027)...Eder stated: "The off-patent medicines industry plays a critical role in public health and must be central to industrial, economic and environmental policy decisions. Seven out of every 10 medicines dispensed in Europe are generic medicines, including nine out of 10 on the EU Critical Medicines List, while the industry directly employs almost 200,000 highly qualified people. Ensuring the sustainability of this essential sector is vital for healthcare systems throughout Europe."... Full

Denmark Remains a Strong Exporting Nation, With Pharma a Central Player

(1/13, The Pharma Letter) ...New export figures for November from Statistics Denmark show that medicine constitutes a significant part of total Danish exports with a value of 153.6 billion kroner ($21 billion) in the first 11 months of 2024, of which 14.2 billion kroner is in November... Sub. Req’d

Korea's Biopharmaceutical Industry Surpasses U.S. in FDA Biosimilar Approvals

(1/13, Choi Mun-hee, Business Korea) ...Last year, South Korea outpaced the United States in biosimilar approvals by the U.S. Food and Drug Administration (FDA). According to data analyzed by the Korea Biotechnology Industry Organization on the FDA's 2024 biosimilar approval status, the FDA approved a total of 18 biosimilars last year, the highest number since the first biosimilar was approved in 2015... Full

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