Tuesday, July 16, 2024

Amgen, BMS and Merck Have the Most Exposure as Big Pharma Eyes $183B Patent Cliff: Analyst

(7/15, Kevin Dunleavy, Fierce Pharma) ...In the July 11 report, the analysts calculate that products losing exclusivity through 2030 are generating a combined $183.5 billion in annual sales, with Amgen, Bristol Myers Squibb and Merck facing the most exposure of their revenue. Meanwhile—citing company financial reports and data from Visible Alpha and FactSet—Morgan Stanley estimates that Big Pharma has $383.1 billion of firepower available for dealmaking. The companies sitting on the most dry powder are Johnson & Johnson, Merck and Novo Nordisk, the analysts said... Full

Biosimilars, A Deflationary Pull Against the Upward Push of Inflation

(7/15, Tony Hagen, Managed Healthcare Executive) ...In gross expenditures, before manufacturer discounts, overall prescription drug spending up 13.6%, or $89 billion, in 2023, to $722.5 billion. Overall, medical costs were expected rise 7% in 2024, according to the PwC Health Research Institute, the driven in part by unstoppable demand for glucagon-like peptide 1 agonists for weight loss and the rising number of highly costly cell and gene therapy products... Full

Lupin Gets US FDA Tentative Approval for Generic Sutab Tablets

(7/16, Pharmabiz.com) ...Global pharma major Lupin Limited announced that it has received tentative approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for sodium sulfate, magnesium sulfate, and potassium chloride tablets, 1.479 g/0.225 g/0.188 g, to market a generic equivalent of Sutab tablets, 1.479 g/0.225 g/0.188 g, of Braintree Laboratories Inc. Lupin is the exclusive first-to-file for this product and may be eligible for 180-day exclusivity. This product will be manufactured at Lupin's Nagpur facility in India... Full

Endo Introduces Generic Thiola EC Tablets

(7/16, Pharmabiz.com) ...Endo, Inc., a diversified specialty pharmaceutical company, announced the launch of tiopronin delayed-release tablets, a generic version of Travere Therapeutics' Thiola EC...The medication is used in combination with high fluid intake, alkali (low acid), and dietary changes to help prevent the formation of one type (cystine) of kidney stones in certain adult and paediatric patients. As a demonstration of its commitment to patients, Endo is offering copay assistance for those who meet eligibility requirements... Full

Facing a Tepid Alzheimer's Market, Lilly Looks to Build ‘A Sense of Urgency' to Jumpstart Sales of Donanemab

(7/15, Max Bayer and Ryan Cross, Endpoints News) ..."We're entering a space where there is a lot of denial, and there's a lot of complacency," Andrew Lechleiter, Lilly's vice president of Alzheimer's disease marketing, said in an interview with Endpoints News. "We need to create a sense of urgency." The drug will be sold under the brand name Kisunla. Lilly plans to first target dementia specialists and neurologists at larger and more advanced healthcare systems. Later, it plans to reach out to the broader neurology community and, ultimately, primary care... Full

Roche Details Early Obesity Data from GLP-1/GIP Agonist, Plans for Phase 2 Study This Year

(7/15, Max Bayer, Endpoints News) ...Roche shared additional Phase 1b data for the obesity drug it acquired in the Carmot Therapeutics deal that suggest a higher dose had yet to peak at six months...Jefferies analysts said CT-388 "looks competitive," citing the still-sloping pace of weight loss and no tolerability issues. Every patient given 22 mg of the drug reported at least a 5% reduction in weight at the 24-week mark and 45% reported at least a 20% reduction. Manu Chakravarthy, Roche's SVP and global head of cardiovascular, renal and metabolism product development, said Monday in an interview that the company plans to launch a Phase 2 study later this year... Full

CordenPharma Injects €900M to Boost GLP-1 Manufacturing in US and Europe

(7/16, Anna Brown, Endpoints News) ...In its biggest investment so far, CordenPharma is earmarking €900 million ($982 million) over the next three years to expand its peptide platform capacity in the US and Europe to meet rising GLP-1 manufacturing demand. The Swiss CDMO has "played a pretty significant role" in GLP-1 manufacturing so far and is now further expanding capacity, CEO Michael Quirmbach told Endpoints News in an interview... Full

Increased Use of GLP-1 Drugs Adds to Navitus' Drug Spend for 2023

(7/15, Denise Myshko, Managed Healthcare Executive) ..."The biggest thing that stands out is non-specialty growth," Ryan Schmidt, associate director, client financial support of Navitus, said in an interview. "We've been doing this for quite a few years, and this is the first time in a while that non-specialty drugs have exceeded specialty growth."...Non-specialty drug costs for Navitus clients have increased by 7.9% compared with 5.7% for specialty drugs. One of the largest impacts on drug spend is the growth of use in anti-glucagon-like peptide-1 (GLP-1) drugs to treat patients with diabetes... Full

Pharmas Are Underutilizing Social Media to Communicate with Doctors and Patients, HCPs Say

(7/15, Andrea Park, Fierce Pharma) ...In a survey of healthcare providers representing more than a dozen specialties by the physician influencer marketing agency MedFluencers, nearly 90% said they believe the pharma industry is underutilizing social media as a method of communication. For one, they suggested that patients may be getting a significant portion of their health information from online content, as 85% of the doctors surveyed said they'd had patients mention social media posts during their appointments... Full

What to Know About Trump VP Pick J.D. Vance's Health Care Views and Investments

(7/15, Rachel Cohrs Zhang and Sarah Owermohle, STAT) ...In 2022, [Sen. J.D. Vance] voiced support to AARP for Democrats' plans to negotiate drug prices in Medicare. However, he's toed the party line on other issues, like a bill proposing to exclude children brought to the U.S. by parents without legal immigration status from federal health insurance programs — an issue Trump brought up during the first presidential debate. At the same time, he has some ties to the drug industry... Full

J&J, Bristol Myers Fight US Drug Price Plan at Third Circuit

(7/15, Nyah Phengsitthy, Bloomberg Law) ...Pharmaceutical giants Johnson & Johnson, Bristol Myers Squibb Co., and AstraZeneca PLC are rejecting federal district court decisions that rule a government drug price-setting program is constitutional and voluntary. Opening briefs from Johnson & Johnson and Bristol Myers filed July 12 before the US Court of Appeals for the Third Circuit challenge an April decision from a federal judge in New Jersey that tossed the manufacturers' claims that the Medicare Drug Price Negotiation Program violates the First Amendment compelled speech doctrine and Fifth Amendment takings clause... Full

NEW COMPARISON: Prescription Rx Prices 50-90% Less Expensive from Canada Than Leading U.S. Pharmacy Prices

(7/15, Campaign for Personal Prescription Importation) ...Today, the Campaign for Personal Prescription Importation (CPPI) released a new price comparison of the most sought-after brand-name prescription drugs revealing that average Canadian drug prices are 50% to 90% less expensive than leading U.S. pharmacy prices...CPPI's drug price comparison findings are consistent with U.S. Health and Human Services data showing that identical medications from Canada cost up to 90% less than the price charged in the United States, with the top 60 drugs sold in America costing nearly four times as much as Canada... Full

Report: Pharma Hikes Prices of 195 Drugs, Many Higher Than Rate of Inflation

(7/15, Lecia Bushak, MM+M) ...P4AD pinpointed two drugs likely to be among the next 15 drugs to be included in Medicare negotiations in 2024: Novartis' autoimmune drug Cosentyx and AbbVie's AML treatment Venclexta. While Venclexta's 0.98% increase — from $25.44 to $25.69 — may seem minimal, P4AD executive director Merith Basey noted that the accumulative effect can be burdensome for patients... Full

CSRXP: Big Pharma is at it Again, Hikes Prices On Nearly 200 Prescription Drugs as Part of Mid-Year Increases

(7/15, The Campaign for Sustainable Rx Pricing) ..."Big Pharma continues to double-down on a business-as-usual approach to price-gouging American patients with nearly 200 price hikes in the last month, with an average increase outpacing the rate of inflation," said CSRxP executive director Lauren Aronson. "Big Pharma's latest major round of price hikes comes on the heels of a new seven-figure advertising campaign from PhRMA, designed to protect the patent abuse ‘status quo' that helps brand name drug companies block competition and repeatedly increase prices."... Full

BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed

(7/15, Sarfaraz K. Niazi, PhD, The Center For Biosimilars) ...Sarfaraz K. Niazi, PhD, discusses the challenges with pharmacy benefit managers that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption... Full

Pharma's 340B Legal Disputes Over Contract Pharmacies May Get A Boost With Chevron Ruling

(7/15, Cathy Kelly, Pink Sheet) ...Supreme Court ruling overturning the Chevron doctrine could help manufacturers prevail in 340B contract pharmacy litigation against the Health Resources and Services Administration. The expected uptick in litigation against federal agencies resulting from the ruling may not seem as rapid in 340B compared to other programs because there is already extensive litigation underway challenging HRSA policies... Sub. Req'd

Attorney General Bonta Leads Multistate Amicus Brief in Support of Drug Pricing Transparency

(7/15, California Attorney General Bob Bonta) ...The amicus brief, filed before the Ninth Circuit Court of Appeals, supports Oregon's defense of House Bill 4005, an Oregon law that requires pharmaceutical manufacturers to report certain information about specific new prescription drugs and historical information about pricing for existing drugs. Oregon's House Bill 4005 is similar to a 2017 California law, Senate Bill 17... Full

California Legislature Appears Poised to Pass Anti-Pharmacy Benefit Manager Legislation

(7/15, Katy Grimes, California Globe) ...Backing this bill is a broad coalition, which includes Big Pharma - "not an obvious alliance for California Democrats to make in the current political climate. PhRMA itself is backing the bill, but so too are Biocom California and California Life Sciences," the expert said... Full

Angry Patients Spur New State Watchdogs to Bring Down Drug Prices

(7/16, Anna Claire Vollers, Stateline) ...Spurred by fed-up consumers, states are trying to curb spiraling prescription drug costs by assembling special public boards to investigate and regulate pricing...But consumers have yet to see significant savings. Most boards have had a slow rollout as they hammer out administrative and funding issues that come with creating a new state entity... Full

Editorial: Pharmacy Benefit Manager Reform Will Save Pa. Pharmacies

(7/16, Pittsburgh Post-Gazette) ...New regulations reining in pharmacy benefit managers, the powerful middlemen between pharmacies and insurance companies, reached Gov. Shapiro's desk last week. The bill is a massive bipartisan win that will give pharmacies much-needed freedom — but the legislation stops short of enacting what pharmacies truly needed: reimbursement rate floors... Full

Hawaii Drug Pricing Lawsuit Targeting PBMs Gets Tossed by Judge

(7/15, Celine Castronuovo, Bloomberg Law) ...A federal judge dealt a blow to Hawaii's litigation against the country's three largest pharmacy benefit managers, dismissing the state's lawsuit that argued the companies inflated the costs of insulin and other drugs... Sub. Req'd

EMA Tightens Clock-Stop Rules To Address Impact On Drug Approval Timelines

(7/15, Vibha Sharma, Pink Sheet) ...A new template has been introduced to ensure that all requests for "extended clock-stops" by MAA applicants are "well justified." The focus is now on clamping down on unjustified requests, for example by refusing extended clock-stop requests for "immature dossiers" and not granting clock-stops for solving problems "that were evident prior to submission." The initiative is aimed at ensuring the faster approval of drugs intended for the EU market and making the EMA's drug assessment timelines more competitive with other regulators... Sub. Req'd

Parallel Imports and the Role of Pharmacies Still Unresolved in Pharma Package Negotiations

(7/16, Nicole Verbeeck, Euractiv) ...The ongoing pharma package negotiations were marked by Belgium's focus on combating medicine shortages and shaping the incentives system for new medicines development...Belgium's groundwork is expected to guide Council negotiations until 2026, with implementation projected for 2028. Katja Murray, Senior Director at FTI Consulting, noted that Belgium almost concluded negotiations on the shortages cluster, aiming for an intermediate compromise to set the direction for the Hungarian presidency, with a few outstanding issues that require resolution in subsequent negotiations... Full

Uptake Of Innovation Is UK's ‘Biggest Hurdle' In Life Sciences Competitiveness

(7/15, Eliza Slawther, Pink Sheet) ...The UK government's life sciences competitiveness indicators 2024 report has revealed that the nation is not reaching its potential in this sector, according to the Association of the British Pharmaceutical Industry. In response to the July 11, report, the ABPI said the UK "continues to underperform on its economic and research potential in life sciences, but could quickly unlock growth if the health system can unite behind innovation."... Sub. Req'd

Irish Goods Exports Rise to €91Bn As Pharma Rebound Continues, CSO Report Shows

(7/15, Ian Curran, The Irish Times) ...The value of Irish goods exports rose to €91 billion in the first five months of 2024, an increase of 10 per cent from January to May 2023, the Central Statistics Office (CSO) said on Monday. The improvement was mainly attributed to the increased output of pharmaceutical and medical products, which account for two-thirds of the State's export trade... Full

Dutch Pharma Production On The Up

(7/15, The Pharma Letter) ...An inventory by KPMG has shown rising production of medicines in the Netherlands...[Peter Bertens, VIG's manager for innovation and business climate] "First of all, drug production is an important economic activity, which is characterized by its often sustainable nature and the very high value that each employee adds to the product...In addition, by producing more drugs in your own country, you can reduce your dependency on other countries. Certainly, for drugs without complicated chemical production steps."... Full

Doug Ford Wants Canada to Approve Drugs Faster. Is That Possible?

(7/15, Kristin Rushowy, Toronto Star) ...Canada is a much smaller market than the U.S. or U.K. and that affects how fast drugs are submitted for approval, but there are ways for the federal and provincial governments to help move the process along so patients get faster access to them, say experts. Talk of the delay getting drugs to patients is top of mind for Premier Doug Ford, who arrived in Nova Scotia on Monday as the annual meeting of Canada's 13 provincial and territorial leaders began... Full

Pharma Sector Awaits Budget 2024 for Innovation Boost and Regulatory Reforms

(7/15, Express Pharma) ...Industry leaders highlight priorities ahead of Union Budget, calling for R&D incentives and reduced GST to propel growth and global competitiveness...[Aditya Sharma, Head of Process Solutions, Merck] "We believe that implementing a fresh PLI scheme for vaccines and biopharmaceutical raw materials is vital now to put the focus back on value-added domestic production with India-for-India and India-for-the-world production. This would stimulate new investments in both R&D and production initiatives"... Full

Supreme Court Dismisses Sun Pharma's Plea On Excess Price of Drug 'Roscilox'

(7/15, Ashish Tripathi, Deccan Herald) ...Judges Sanjay Kumar and Augustine George Masih rejected a claim made "baldly" by Sun Pharmaceutical Industries Ltd that it was not a ‘distributor' but only a ‘dealer' of Roscilox, a brand of a Cloxacillin-based drug formulation...The court dismissed the appeal by the company as devoid of merit, since it found no error in the Delhi High Court's judgement. The bench vacated the order of status quo passed in 2014... Full

Japan Makes Renewed Policy Efforts To Fill 'Drug Gap'

(7/16, Lisa Takagi, Pink Sheet) ...Japan has announced several new measures to tackle the lack of rare disease and other therapeutics in the domestic market, with the country's main industry association also issuing the first common national informed consent form in a bid to lighten the "huge workload" on trial site staff. As more and more therapies from small- to mid-size biopharma ventures enter Western markets, Japan is taking renewed steps to attract such products to its borders by enriching funding programs to support development programs in the country... Sub. Req'd

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