Monday, March 11, 2024

Teva Upgraded at J.P. Morgan On Upcoming Catalysts

(3/8, Dulan Lokuwithana, Seeking Alpha) ...Teva Pharmaceutical traded higher on Friday after J.P. Morgan reviewed its specialty pharma coverage and upgraded the Israel-based generic drugmaker, citing a favorable catalyst set up in the months ahead. Analyst Chris Schott highlighted Phase 3 data expected for the company's once-monthly atypical antipsychotic, olanzapine LAI, and Phase 2 data expected from a TL1A asset in H2 2024. "While we have been concerned that the investments required to develop these assets would preserve margins, the company has done an effective job of partnering these programs to address this dynamic," Schott wrote as he upgraded Teva to Neutral from Underweight with its price target raised to $14 from $11... Full

Germany's HIV Drug Shortage Creates Price Versus Safety Dilemma

(3/11, Laura Alviž, Bloomberg) ...A critical drug that prevents HIV infections is in short supply in Germany, leaving doctors and pharmacists with an increasingly difficult decision: pick medicines that are 10 times more expensive, or go without...Suppliers say they're aware of the problem. "We have significantly increased our planned quantities in line with the current situation," Teva Pharmaceutical Industries Ltd.'s Ratiopharm unit said in an emailed statement. "However, the situation remains tense as there is immediate demand for the medicines we have made available," it said... Sub. Req'd

$14k Bill After Dad's Devastating MND Diagnosis

(3/10, Jessica Wang, News.com.au) ...While edaravone has been approved by the Therapeutic Goods Administration, its manufacturer Teva Pharma has said it won't be available in Australia until it is listed on the Pharmaceutical Benefits Scheme. Things, however, could soon change, with Teva Pharma Australia looking to the Pharmaceutical Benefits Advisory Committee to have edaravone, or Radicava (its commercial name) listed on the PBS, with an announcement pending for April...A spokesperson for the Department of Health and Aged Care said that when "considering a medicine proposed for PBS listing, the PBAC is legally required to take into account the comparative effectiveness and cost-effectiveness of the medicine compared to other available therapies". They said the PBAC will consider a resubmission from Teva Pharmaceuticals to list edaravone on the PBS at its March 2024 meeting, and the outcome will be published on April 26... Full

Asthma Meds Have Become Shockingly Unaffordable - But Relief May Be On The Way

(3/8, Ana Santos Rutschman, The Conversation) ...The price of asthma medication has soared in the U.S. over the past decade and a half. The jump – in some cases from around a little over US$10 to almost $100 for an inhaler – has meant that patients in need of asthma-related products often struggle to buy them. Others simply can't afford them...The same asthma medication for which U.S. patients pay top dollar is available elsewhere at much cheaper prices. Consider the following case for inhalers. The pharmaceutical company Teva sells QVAR RediHaler, a corticosteroid inhaler, for $286 in the U.S. In Germany, Teva sells that same inhaler for $9... Full

Backward Drug Industry Incentives Are Hurting Asthma Patients

(3/11, Kenneth Mendez, Boston Globe) ...Flovent's price odyssey shows how making a medicine cheaper in America's convoluted drug marketplace can make medicines less accessible. Responsibility for this distorted system rests with employers, health plans, pharmacy benefit managers, drug manufacturers, and policy makers. The system needs to change. The list price of Flovent had grown so much in recent years that the company's manufacturer, GlaxoSmithKline, would likely be subject to new Medicaid penalties. Replacing Flovent with an authorized generic at a cheaper price allowed GlaxoSmithKline to avoid these Medicaid penalties — and continue to offer the medication to the asthma community... Full

Samsung Bioepis Announces Results of Humira Biosimilar Interchangeability Study in US

(3/11, Jasmine Choi, Business Korea) ...Samsung Bioepis announced on March 10 the clinical results of SB5, a biosimilar to the blockbuster drug Humira, at the American Academy of Dermatology Annual Meeting held in San Diego, California, in the U.S. on Feb. 8 (local time). This study aimed to verify whether SB5 can be interchangeably used with the original drug, Humira. The results showed that SB5 is biologically equivalent to Humira and also meets the interchangeability criteria... Full

Celltrion Files XOLAIR Biosimilar for Chronic Spontaneous Urticaria BLA

(3/11, Pharmaceutical Technology) ...Celltrion has filed a biologics licence application with the US Food and Drug Administration for a biosimilar candidate to XOLAIR (omalizumab), CT-P39, for chronic spontaneous urticaria. The submission is a significant step in bringing an interchangeable biosimilar for CSU treatment to the market... Full

Novartis Offers Glimpse at BTK Inhibitor Plans Beyond Lead Indications: #AAD24

(3/9, Max Gelman, Endpoints News) ...Novartis provided a peek Saturday of how it might expand development of its experimental drug remibrutinib, a BTK inhibitor being tested in a range of immunology and neurology conditions. In a platform trial examining five compounds in the chronic skin condition hidradenitis suppurativa, remibrutinib met its primary endpoint at both dose levels. The data are early, as only 66 patients received remibrutinib, split evenly between the 25 mg and 100 mg doses... Full

US FDA Declines to Approve Viatris's Injection for Multiple Sclerosis

(3/11, Sriparna Roy and Sneha S K, Reuters) ...The U.S. FDA has declined to approve Viatris and Mapi Pharma's once-a-month injection for treating relapsing forms of multiple sclerosis, the companies said on Monday. The companies were reviewing the content of the health regulator's complete response letter and would soon determine the appropriate next steps, they said... Full

Pfizer is Betting Big On Cancer Drugs to Turn Business Around After Covid Decline – Here's What to Know

(3/10, Annika Kim Constantino, CNBC) ...Pfizer is betting on cancer drugs to help it regain its footing after a rocky year marked by the rapid decline of its Covid business. The pharmaceutical giant has been trying to shore up investor sentiment after its shares fell more than 40% in 2023. Pfizer says its combined drug pipeline with cancer drugmaker Seagen could produce at least eight blockbuster medicines by 2030... Full

US FDA Delays Lilly Alzheimer's Drug Decision, Calls for Advisory Panel

(3/8, Julie Steenhuysen and Patrick Wingrove, Reuters) ...The U.S. Food and Drug Administration has delayed its decision on Eli Lilly's experimental treatment for early Alzheimer's disease and will hold a meeting of outside experts to discuss its safety and efficacy, the company said. The FDA's decision came as a surprise to company officials and many Alzheimer's experts, who had expected a full approval for Lilly's drug donanemab this month based on clinical trial data last year that showed the treatment was safe and effective... Full

A Lesson In Confidence Amid Development Hurdles: How Lilly Has Talked About Donanemab

(3/8, Derrick Gingery, Pink Sheet) ...The Alzheimer's disease candidate's positive milestones, and even its review delays, continue to produce confident statements in its future from the sponsor. Eli Lilly and Company's Alzheimer's treatment donanemab has inspired confidence throughout its development, even from US Food and Drug Administration Commissioner Robert Califf, despite development setbacks...As likely would be expected, Lilly Neuroscience president Anne White did not suggest any concerns. The company remained "confident in donanemab's potential to offer meaningful benefits to people with early symptomatic Alzheimer's disease," she said in an March 8, statement, even though the decision to convene an advisory committee was unexpected... Sub. Req'd

Lilly's Donanemab Delay: Labeling, Real-World Operationalization May Be Reason For Adcomm

(3/8, Sarah Karlin-Smith, Pink Sheet) ...Experts believe unexpected advisory panel may be used to craft labeling around need for tau imaging and when patients should stop drug. Most analysts still predict approval. Lilly told the Pink Sheet that the company and FDA were already engaged in drug labeling discussions prior to the news it would go to an advisory panel. Extended review could mean Lilly's TRAILBLAZER- ALZ6 Phase IIIb safety study that is looking at patient characteristics that might predict risk of amyloid-relate imaging abnormalities will read out preapproval... Sub. Req'd

Sun Pharma Recalls 55,000 Bottles of Generic Drug from US Market Due to Manufacturing Norms Violation

(3/10, The Press Trust Of India) ...Drug major Sun Pharma is recalling around 55,000 bottles of a generic medication to treat gout from the American market due to manufacturing practices norms deviations, according to the US health regulator. The New Jersey-based unit of the Mumbai-based drug major is recalling Febuxostat Tablets in 40 mg and 80 mg strengths, US Food and Drug Administration said in its latest Enforcement Report... Full

BeiGene Files Patent Suits Against Sandoz, MSN Group

(3/8, Nicole DeFeudis, Endpoints News) ...A day after winning an accelerated approval in follicular lymphoma, BeiGene filed complaints against Sandoz and subsidiaries of MSN Group over applications to market generic versions of Brukinsa. The company claims that Sandoz and MSN infringed patents on the blood cancer blockbuster and has asked the court to bar Sandoz and MSN from commercializing their generics until the patents expire. BeiGene noted in a securities filing that neither Sandoz nor MSN have challenged Brukinsa's key composition of matter patent which expires in 2034... Full

Report: 2024 Projected to Be A Big Year for Biosimilars in the Retina Space

(3/8, Ashley Gallagher, Pharmacy Times) ...The report includes legislative developments and new treatment as well as perspectives of retinal specialists as 2024 is expected to be a critical year for the retinal biosimilar space...Fran Gregory, PharmD, MBA, vice president of Emerging Therapies at Cardinal Health, said in an interview with Pharmacy Times. "In fact, we expect over $181 billion in savings through 2027, as the report notes, so it's really important for all of us to optimize that savings, opportunity, and play our part in in continuing to support biosimilar development and uptake."... Full

Biosimilars vs Bad Patents: Accessibility, Key Court Cases With Ha Kung Wong

(3/10, Cameron Santoro, The Center For Biosimilars) ...Ha Kung Wong, JD, an intellectual property attorney specializing in intellectual property law partnered with Venable LLP, discusses the patent system and biosimilar accessibility in an interview with The Center for Biosimilars®. He acknowledges concerns regarding "bad patents" that could limit access to biosimilars but expresses confidence that the FDA and USPTO [United States Patent and Trademark Office] will refine the system to only grant good patents... Full

CVS Pharmacy to Settle for $10 Million for Alaska Opioid Crisis

(3/8, State of Alaska Department of Law) ...The State of Alaska filed a complaint and consent judgment Thursday against chain pharmacy CVS to close out the settlement process that began two years ago involving the opioid crisis in Alaska. Once the settlement is final, the State will receive about $10 million over 10 years from CVS Pharmacy, Inc., or nearly $1 million a year for a decade. "I am glad CVS Pharmacy has stepped forward and chosen to settle with the State of Alaska," said Alaska Attorney General Treg Taylor. "I am hopeful that the series of opioid litigations that the State has engaged in will help prevent tragedies like this one in the future."... Full

Nirsevimab 90% Effective at Preventing RSV Hospitalizations in Infants, CDC Reports

(3/8, Mary Van Beusekom, MS, CIDRAP) ...The long-acting monoclonal antibody nirsevimab is 90% effective in preventing respiratory syncytial virus-related hospitalization in infants, according to the first real-world estimates from the US Centers for Disease Control and Prevention. The report from the New Vaccine Surveillance Network Product Effectiveness Collaborators, led by CDC scientists, was published yesterday in Morbidity and Mortality Weekly Report... Full

Health Care Providers Losing Up to $1B a Day from Cyberattack

(3/11, Tina Reed, Axios) ...Disruptions from the Change Healthcare cyberattack are costing health providers as much as $1 billion a day and creating enough of a drag to depress first-quarter earnings, analysts and industry officials say...Though the largest health systems can likely weather the storm, Moody's Investors Service warned "even large providers with thin margins and weak liquidity are not immune to challenges and will eventually face liquidity hurdles if the disruption lingers." Plenty of smaller providers, particularly physician groups and federally qualified health centers, are experiencing existential concerns... Full

Biden Signs Government Funding Bills to Avoid Partial Shutdown

(3/9, Brett Samuels, The Hill) ...President Biden on Saturday signed the government spending legislation to keep an array of federal departments open, as lawmakers turn their focus to the remaining appropriations bills. Biden signed the $460 billion package of six spending bills, which passed the Senate earlier Friday. The package funds military construction, water development and the departments of Veterans Affairs, Agriculture, Commerce, Justice, Energy, Interior, Transportation, and Housing and Urban Development... Full

How Big Pharma is Fighting Biden's Program to Lower Seniors' Drug Costs

(3/11, Tony Romm, The Washington Post) ...While manufacturers have since engaged in price discussions with the administration, they have also unleashed a blitz of legal challenges meant to upend the entire system. The intensity of their opposition was on display Thursday, as four pharmaceutical giants urged a federal judge in New Jersey to terminate the program before seniors would see any change to their drug costs... Full

Copay Comes Full Circle: An Industry Ready for Disruption

(3/8, Adam J. Fein, Ph.D., Drug Channels) ...The patient affordability industry, originally born from innovation, may be facing the perfect conditions for a major disruption. Copay savings cards sponsored by drug manufacturers appeared nearly two decades ago as a modern solution to make lifesaving treatments and medications more affordable for patients by reducing their out-of-pocket costs...After years with no major improvements, the industry is ready for a disruption, and the next evolution in copay will favor those providers who listen, innovate, and adapt... Full

Weekly Column: Pursuing Solutions For Idahoans Impacted By Drug Shortages

(3/11, U.S. Senator For Idaho Mike Crapo) ...As experts and officials have broadly affirmed, the structure of the generic drug market incentivizes a proverbial ‘race to the bottom' on pricing. Since 2016, generics have seen price erosion in excess of 50 percent. The razor-thin margins resulting from these dynamics trigger a host of dire consequences, from discouraging quality investments to spurring widespread outsourcing—including to China. Moreover, the generic drugmaker exit rate currently exceeds the rate of entry, and upwards of 40 percent of generic medication markets are supplied by a single manufacturer... Full

Charting a Sustainable Path for Generics

(3/8, Karen P. Langhauser, Pharma Manufacturing) ...The generic and biosimilar industry faces unprecedented threats to long-term sustainability," warned David Gaugh, AAM's interim president and CEO, in the opening plenary. During the annual meeting, panelists tackled the issues behind the increasing fragility of the industry that supplies more than nine out of every 10 prescriptions in the U.S. Price deflation, unfavorable policy, pharmacy benefit managers and biosimilar uptake were top of mind... Full

US FDA, USP Raise Questions About Valisure's Assertions Of Benzoyl Peroxide's Benzene Risks

(3/8, Bowman Cox, Pink Sheet) ...The US Food and Drug Administration and the US Pharmacopeia are evaluating a March 5, citizen petition alleging dangerous levels of benzene impurities in benzoyl peroxide, sold over the counter and by prescription for acne treatment. The sweeping petition from Valisure LLC, an analytical laboratory that screens US-marketed drug products for buyers, called for the FDA to suspend benzoyl peroxide sales, request recalls, and issue regulatory guidance and a regulation to protect consumers... Sub. Req'd

Illinois Urges Court to Toss Industry Suit Over Drug Price Law

(3/8, Celine Castronuovo, Bloomberg Law) ...The Association for Accessible Medicines, which represents generic and biosimilar manufacturers, "alleges no imminent injury in-fact to any of its members" as a result of the state law prohibiting certain price hikes on generic drugs, Illinois Attorney General Kwame Raoul (D) wrote in a brief filed Friday opposing AAM's motion for a preliminary injunction on the law... Sub. Req'd

Oregon Set to Tighten Rules for Pharmacy Benefit Managers. Here's What They Do

(3/10, Lillian Karabaic and Antonio Sierra, OPB) ...The Legislature passed a bill tightening regulations on companies that serve as pharmacy benefit managers. House Bill 4149 will require the pharmaceutical middlemen to apply for licensing from the state among other new rules. The bipartisan bill passed with overwhelming majorities in both the House and Senate... Full

EU Opens Long Awaited Consultation On Joint Clinical Assessments

(3/8, Eliza Slawther, Pink Sheet) ...Stakeholders have until April 2, to comment on the European Commission's draft implementing act for joint clinical assessments. Industry federation EFPIA says the proposal contains numerous challenges for pharmaceutical sponsors...Pharmaceutical industry federation EFPIA told the Pink Sheet that there were multiple problems with the commission's JCA proposals, warning that with less than a year until the start of application of the regulation, companies "urgently needed more clarity" on the process, timelines and methods in order to guide their preparations for JCAs when these kick in at the beginning of 2025... Sub. Req'd

Sandoz Swallows Up Remainder Of Rowex To ‘Expand Fully' Into Ireland

(3/8, Dean Rudge, Generics Bulletin) ...Sandoz has a goal of increasing generic penetration in Ireland, which lags behind its European neighbors. As part of that objective, the firm has opted to take full control of its Rowex joint venture, based in County Cork...Rowex offers dozens of branded and unbranded generic products, including the Airflusal Forspiro generic version of Advair (fluticasone/salmeterol); and generic Viagra (sildenafil citrate), which it sells under the name Sidena... Global Sub. Full

India Strikes Free Trade Deal With Countries Including Switzerland

(3/10, John Reed, Financial Times) ...India has announced a trade pact with four small European countries featuring what New Delhi described as a "binding" commitment by the partner states to invest $100bn and create 1mn jobs over 15 years...EFTA spokesperson Asdis Olafsdottir said the association's states "shall aim" to increase foreign direct investment into India by $50bn in the first decade of the agreement and another $50bn in the five years after that, with the hope that the investment created 1mn jobs in the country of 1.4bn people... Sub. Req'd

India Wins $100 Billion Investment Pledge in EFTA Trade Deal

(3/11, Shruti Srivastava, Bastian Benrath and Hugo Miller, Bloomberg) ...India offers "immense opportunity for trade and investment," Swiss Economy Minister Guy Parmelin said at the ceremony, adding that the South Asian nation would gain access to technology through the deal. The agreement will also benefit the pharmaceutical and medical devices industry of the bloc. Indian exporters will get liberalized access for their rice and other products to these European nations while high-end Swiss watches will become cheaper in India in a phased manner... Sub. Req'd

'Tough Negotiator': Swiss Official On India After Trade Deal with European Bloc

(3/11, Geeta Mohan, India Today) ...In the realm of pharmaceuticals and intellectual property rights (IPR), the India-EFTA agreement treads carefully, ensuring that the new stipulations do not escalate the cost of drugs in India. Helena Budliger clarified this aspect, emphasising the alignment with existing World Trade Organisation agreements. "So, there I have to be really clear. We have reached an IPR chapter which is really in accordance with what India has agreed upon in the framework of WTO. So we didn't do a TRIPS plus or plus, plus text." She further alleviated concerns about the potential increase in drug prices, stating, "India is a tough negotiator.”... Full

Cheap Alternatives, API Imports — Why Penicillin G Production, Set to Resume After 30 Yrs, Declined

(3/9, Sandhy Ramesh, The Print) ...The Union Minister for Health and Family Welfare, Mansukh Mandaviya, has announced that after a 30-year break, India will resume the production of the narrow spectrum antibiotic benzypenicillin or Penicillin G...Its production is set to resume under the central government's Production-Linked Incentive scheme that was launched to promote domestic manufacturing...The report added that there has been a decline in the imports of active pharmaceutical ingredients such as paracetamol in India after the introduction of the PLI scheme... Full

AstraZeneca Bets On Licencing Deals, Public-Private Partnerships for India Growth

(3/9, Viswanath Pilla, The Economic Times) ...British-Swedish drugmaker AstraZeneca is in the process of 15 new launches in India including novel products and new indications of existing assets in two years, said Sanjeev Panchal, managing director of AstraZeneca Pharma India. "We would be doing 15 new launches starting 2023 until 2025," he told ET. The products would be in the therapeutic segments of oncology; cardiovascular, renal, and metabolic diseases; respiratory and immunology; and rare diseases. Some of the new products would be biologics or monoclonal antibodies, Panchal said... Full

Fresenius Divests Norwegian Plant To Prange

(3/11, David Wallace, Generics Bulletin) ...Fresenius Kabi has completed a deal to divest its sterile pharmaceutical manufacturing plant in Halden, Norway, to Prange Group, with the buyer having taken over the facility "with equipment and full staff," alongside a commitment to continue manufacturing Fresenius Kabi's products. Financial details of the transaction have not been disclosed... Global Sub. Full

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