Thursday, August 15, 2024

Teva's Transformation: From Generics Leader To Branded Drug Innovator

(8/14, Seeking Alpha) ...Step by step, Teva's management is making progress in transforming it from a generic drugmaker into one that will play a key role in the fight against immune-related disorders. Its revenue was about $4.16 billion in the second quarter of 2024, up 7.2% year-on-year. So, in addition to the growth in sales of its generic products, there is also increased demand for innovative medications, including Austedo and Uzedy. One of the key milestones in Teva's history will be the publication of results from a clinical trial evaluating the efficacy of duvakitug in the treatment of inflammatory bowel disease in late 2024... Full

‘It's Not Going To Be An Easy Market' – Hikma Talks Strategy For US Biosimilars

(8/14, David Wallace, Generics Bulletin) ...Hikma has used its 2024 first-half results call to lay out details of its strategy in multiple business areas, touching on its plans for US biosimilars, the latest on its small-molecule generics business, updates on its injectables unit, future opportunities in GLP-1s, and its US compounding business. The updates came as Hikma reported sales up by a tenth to $1.57bn in the first half, as operating profit jumped by 43% as reported and 48% at constant currencies to $351m... Global Sub. Full

Lupin Eyes Another Mirabegron Launch Amid Ongoing Litigation

(8/14, Urte Fultinaviciute, Generics Bulletin) ...Lupin has its eyes on the prize – strengthen its position and co-exclusivity of generic mirabegron. During a recent investors' call covering Lupin's financial first quarter, CEO Vinita Gupta said that the firm is evaluating when to launch its 50mg generic rival to Astellas' Myrbetriq, but it all depends on the ongoing litigation outcome relating to the US patent 10,842,780... Global Sub. Full

India's Glenmark Pharma Posts Higher Q1 Profit On Strong Demand

(8/14, Kashish Tandon, Reuters) ...Glenmark Pharmaceuticals reported a more than two-fold growth in first-quarter profit on Wednesday, helped by strong demand for its drugs and a marginal decrease in costs...Indian drugmakers are benefitting from strong domestic demand for chronic and specialty drugs. Last month, Mankind Pharma reported a 10% jump in profit, although it missed estimates due to higher costs... Full

Formycon Reports €26.9 Million Revenue for First Half 2024, Driven by Biosimilars

(8/14, Skylar Jeremias, The Center For Biosimilars) ...Formycon's revenues for the first half of 2024 amounted to €26.9 million ($29.4 million), showing a strong start to the year, according to the biosimilar developer's earnings report...According to the report, biosimilars have the potential to generate $212.7 billion in savings by 2032, with 45 blockbuster originator biologics losing market exclusivity between 2024 and 2032... Full

Cardinal Health Lifts 2025 Profit Outlook On Strong Demand for Costly Specialty Drugs

(8/14, Mariam Sunny, Reuters) ...Drug distributors have been benefiting from sales of specialty medicines used to treat complex conditions such as rheumatoid arthritis and cancer, along with cheaper versions of complex biotech drugs called biosimilars. This comes at a time when prices of generic medicines keep falling due to intense competition. Cardinal Health also beat Wall Street estimates for fourth-quarter profit and revenue, driven by strength in its pharmaceutical and specialty solutions unit... Full

Sandoz Debuts Denosumab Duo In Canada

(8/14, David Wallace, Generics Bulletin) ...Sandoz has debuted biosimilar competition to Amgen's denosumab brands Prolia and Xgeva in Canada, introducing its Jubbonti and Wyost versions as "the first denosumab biosimilars available in Canada, reflecting the Sandoz purpose of pioneering access for patients." So far, Sandoz is the only company to have won Health Canada approval for a denosumab biosimilar... Global Sub. Full

Eli Lilly's Billions: Can the World's Most Valuable Pharma Company Keep Inventing Drugs at This Pace?

(8/14, Matthew Herper, STAT Plus) ..."You've got to run the R&D engine better than anyone's ever run it before," David Ricks, Lilly's CEO, told STAT this week. "Probably, Lilly's looking at a period where we're going to be spending more on research and development than anyone in the whole industry, and will we do that productively? I think that's an open question."... Sub. Req'd

No Differences in Long-Term Drug Survival Between Biosimilar, Originator TNF Inhibitors

(8/14, Skylar Jeremias, The Center For Biosimilars) ...No significant differences in long-term survival due to inefficacy or adverse events were found between subcutaneous biosimilar and originator tumor necrosis factor inhibitors for rheumatic diseases, as shown by a retrospective analysis published in The Journal of Rheumatology. "In real-world practice, this can be reassuring when deciding to start a biosimilar. Concomitant [methotrexate] was associated with higher retention rate, and its use should be considered when appropriate," the authors suggested... Full

$1.6 Billion in Florida Opioid Deals Imperiled by State Court

(8/14, Alex Ebert, Bloomberg Law) ...The ruling imperils a series of settlements Florida Attorney General Ashley Moody's (R) office struck with seven of the world's largest health industry firms, which total more than $1.6 billion. The state reached deals with McKesson Corp., Cardinal Health Inc., and AmerisourceBergen Corp., Walmart Inc., Johnson & Johnson, Endo Health Solutions Inc., CVS Health Corp., Teva Pharmaceuticals Industries Ltd., Allergan Finance LLC, and Walgreen Boots Alliance Inc. Moody argued she needed to prevent Florida hospitals from bringing more suits against the opioid industry or risk blowing up the deals... Sub. Req'd

Medicare's Negotiated Drug Prices Will Save Taxpayers $6 Billion in First Year, White House Says

(8/15, Eleanor Laise, Dow Jones) ...Medicare has reached price agreements for all 10 drugs selected for the initial round of negotiations under the Inflation Reduction Act, and those price reductions are expected to save taxpayers about $6 billion in the first year they take effect, the Biden administration said Thursday... Full

Biden Administration Says IRA Negotiations Will Result in $6B in 2026 Medicare Savings

(8/15, Nicole DeFeudis and Zachary Brennan, Endpoints News) ...All drugmakers participating in negotiations have agreed to the government's final offer, officials told reporters, closing the book on the first round of a process that several pharmaceutical companies continue to fight in court. The negotiated prices will take effect in 2026 for Medicare's drug benefit, which covers about 50 million people, mostly senior citizens... Full

Stakeholders Gear Up For Administration To Tout Negotiated Drug Prices Thursday

(8/14, Maaisha Osman, InsideHealthPolicy) ...Drug industry stakeholders are on edge as the Biden administration gears up to tout its success in negotiating the first tranche of Medicare Part D drug prices Thursday (Aug. 15), with analysts watching to see how officials frame the decreases without divulging confidential data and whether they will also unveil new formulary policies... Sub. Req'd

Medicare Negotiated Drug Prices for the First Time. Here's What it Got

(8/15, Sydney Lupkin and Asma Khalid, NPR) ...The administration hasn't actually shared the specific agreed upon prices yet, but Health and Human Services Secretary Xavier Becerra has played up the savings. In a press call ahead of the announcement, Becerra said if the negotiated prices were in effect in 2023, Medicare would have saved $6 billion and beneficiaries would have saved $1.5 billion in out-of-pocket costs, such as copays at the pharmacy counter... Full

Experts Analyze IRA's Effect as the Industry Awaits Negotiated CMS Drug Prices

(8/14, Tyler Patchen, BioSpace) ...While the industry's immediate focus will be on the first 10 drugs, next year CMS will move forward with negotiations on another 15 drugs, with those prices taking effect in 2027. According to William Blair's webinar, these will be mature brands without any generics or biosimilars. Among this next batch could be AstraZeneca's non-small cell lung cancer treatment Tagrisso. However, Reid believes this drug will be exempt from negotiation as it carries an orphan designation. Other options include Teva's Huntington's drug Austedo, Pfizer and Astellas' prostate cancer treatment Xtandi and Novo Nordik's blockbuster diabetes drug Ozempic... Full

Medicare Drug Price Negotiation Program: Negotiated Prices for Initial Price Applicability Year 2026

(8/15, Centers for Medicare & Medicaid Services) ...On May 3, 2024, CMS published draft guidance for initial price applicability year 2027. This draft guidance details requirements and parameters for the second cycle of negotiations for the Negotiation Program, which will occur during 2025 and may result in negotiated prices that would be effective beginning in 2027. If a drug selected for the first cycle of negotiations has a negotiated price and is subsequently identified as a therapeutic alternative to a drug selected for the second cycle of negotiations, the agreed-upon negotiated price from this first cycle of negotiations could serve as an input into the initial offer development process for the drug selected for the second cycle of negotiations... Full

Klobuchar Revives IRA Expansion Calls As HHS Preps To Announce Negotiated Drug Prices

(8/14, Gabrielle Wanneh, InsideHealthPolicy) ...Building off her party's excitement of the Biden administration's planned Thursday announcement of new prices for the first 10 Medicare Part D drugs selected to undergo price negotiations, Sen. Amy Klobuchar (D-MN) has reignited calls for lawmakers to pass legislation that would expand the scope and accelerate the implementation of Medicare's new negotiation authority... Sub. Req'd

Azar: Trump Could Try To ‘Out-IRA' Biden On Drug Negotiation If Elected

(8/14, Jessica Karins, InsideHealthPolicy) ...Former president Donald Trump may not seek to dismantle CMS' drug pricing negotiation program if elected to another term, according to former HHS Secretary Alex Azar, who said Trump could instead seek to please economic populists in the Republican Party by building on the program and out-negotiate the Biden administration by seeking to get even lower drug prices... Sub. Req'd

Ex-Trump Officials Argue Biden's Drug Pricing Efforts are ‘Backfiring'

(8/14, Brett Samuels, The Hill) ...The Health Market and Policy Network issued a memo first obtained by The Hill one day before the Biden White House will reportedly detail the savings from the first Medicare negotiations on the price of 10 prescription drugs. "We understand the temptation to see this as a win. But the evidence continues to mount that there is no such thing as a free lunch," the memo states..."The cost of price controls is steep, and the program's effects are backfiring on all of us," the Health Market and Policy Network memo states. The group called for bipartisan fixes to the Inflation Reduction Act "before more harm befalls seniors."... Full

Editorial: Drug Price Controls Mean Fewer Cures

(8/14, The Wall Street Journal) ...A portent came last week from Charles River Laboratories, a top research contractor that helps drug makers with clinical trials. The company warned in its quarterly earnings report that pharmaceutical companies are slashing research and development owing to the IRA's drug price controls...At the same time, many drug makers face a looming "patent cliff" on older medicines that could bring more generic competition. As the Charles River CEO explained, companies usually boost R&D when this happens so they can replenish their pipeline of novel medicines. Instead, they are cutting back because of the IRA and perhaps worries that Ms. Harris would double down... Sub. Req'd

While Medicare Drug Price Negotiations Don't Apply to Private Insurance, 3.4 Million People with Employer Coverage Take at Least One of the Selected Drugs

(8/14, KFF) ...Among the 167 million people with employer-sponsored insurance in 2022, 3.4 million used at least one of the first 10 drugs identified for Medicare price negotiations, according to a new KFF analysis. Medicare is expected to release the negotiated drug prices, which will go into effect in 2026, by no later than September 1, 2024... Full

CMS Issues Proposed Rule on the Medicare Part B and Part D Inflation Rebate Program; HPM Issues Detailed Summary

(8/15, Alan M. Kirschenbaum, Michelle L. Butler, Faraz Siddiqui, Sophia R. Gaulkin, FDA Law Blog) ...Since 1991, the Centers for Medicare and Medicaid Services (CMS) has administered inflation rebates in the Medicaid Drug Rebate Program (MDRP), but the IRA brings inflation rebates to Medicare. The two inflation rebate programs share many features in common, with key differences... Full

Study: GLP-1s, Insulin Cost Effective Compared To No Treatment

(8/14, Luke Zarzecki, InsideHealthPolicy) ...A study by actuaries at the SOA Research Institute found GLP-1s and insulin are cost effective when compared with no treatment at all, with GLP-1s offering a higher cost savings, particularly if rebates are factored in. The findings come as lawmakers and policymakers point to high GLP-1 and insulin costs in their calls to lower prescription drug costs... Sub. Req'd

Arthritis Patients Resort to An Inconvenient Medicare Workaround to Avoid Pricey Drugs

(8/15, Joseph Howlett and Andrea Tamayo, STAT) ...The next year could bring changes for rheumatoid arthritis patients on Medicare. After Humira's patent protection finally expired in 2023, biosimilars are becoming more widely available. The added price competition could make Humira more affordable, though rebate schemes can work against this by disadvantaging biosimilars. Even more promising, the coverage gap's cost will be greatly diminished in 2025, as part of President Biden's Inflation Reduction Act. The law will put a yearly cap of $2,000 on what seniors pay out of pocket for their prescription drugs in Part D, which they can choose to split into monthly payments... Full

FTC Interim Report Shows Need for Action On Pharmacy Middlemen: Q&A

(8/14, Kerry Dooley Young, Medscape) ...Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with Medscape Medical News. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana... Full

Working to Lower Prescription Drug Prices in Pennsylvania

(8/14, Pennsylvania State Representative Ryan Mackenzie) ...The new law aims to bring more transparency and fairness to the pharmaceutical industry system by requiring PBMs to disclose financial information on rebates and payments received from drug manufacturers and how these funds are distributed. Additionally, the legislation seeks to limit or ban practices like patient steering and clawbacks, which can be detrimental to consumers and pharmacies. Under the Act, the Pennsylvania Insurance Department will develop a process for resolving certain pharmacy complaints against PBMs... Full

UK's NHS Demands New Standard to Fight Antimicrobial Resistance

(8/14, The Pharma Letter) ...The "BSI Kitemark for Minimized Risk of Antimicrobial Resistance (AMR)" aims to ensure responsible antibiotic manufacturing and reduce the environmental impact that contributes to the growing AMR crisis...The NHS antibiotic subscription model is the first in the world to pay companies a fixed annual fee based on the drugs' value to the NHS and their availability, rather than the volume of sales. Courtney Soulsby, BSI global director of healthcare sustainability, described the NHS requirement as a "critical step forward" in safeguarding antibiotic efficacy... Sub. Req'd

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