Friday, August 16, 2024

Weakening Patent Laws Puts Drug and Medical Innovation at Risk

(8/16, David Kappos, San Francisco Chronicle) ...In late June, generic drug maker Teva Pharmaceuticals launched a generic version of Victoza, a blockbuster diabetes drug, in the United States. Just days prior, the Food and Drug Administration tentatively approved another generic version of Victoza made by Hikma Pharmaceuticals...Without the potential payoff that patents provide, this cycle of continuous improvement would grind to a halt... Sub. Req'd

Coherus Enjoying Pegfilgrastim Revival As Amgen Royalty Dues Expire

(8/16, Dean Rudge, Generics Bulletin) ...Coherus BioSciences has seen a seismic jump in sales of, and market share for, its US biosimilar pegfilgrastim franchise. The firm is optimistic that the momentum will continue through the year...Sales of the biosimilar climbed by 60% year-over-year to $50.9m, as total Udenyca units increased by 25% quarter-over-quarter (up four percentage points) and the Udenyca franchise market share reached 29%, amid fierce competition... Global Sub. Full

Apotex Leans Into Brand Ambitions With Formosa Deal

(8/15, David Wallace, Generics Bulletin) ...Apotex has made another deal to expand its branded interests, announcing an agreement with Formosa Pharmaceuticals that will give it exclusive Canadian marketing and distribution rights to Formosa's novel APP13007 clobetasol propionate 0.05% ophthalmic suspension, a steroid for use in ophthalmology... Global Sub. Full

Celltrion Sees Little Threat From ‘Overheated' Biosimilar Competition

(8/15, David Wallace, Generics Bulletin) ...In a section of its Q2 results presentation covering "changes in the competitive landscape of the biosimilar market," Celltrion set out that it had identified 65 pharmaceutical companies that were developing biosimilar pipelines and conducting global clinical trials "akin to our company" between 2013 and 2023. However, of this 65 the firm said that only 15 had successfully commercialized their biosimilars in the US and Europe. And furthermore, Celltrion claimed, just four had reached annual biosimilar sales of over $1bn... Global Sub. Full

Celltrion Scraps Merger with Celltrion Pharm

(8/16, Dae-Kyu Ahn, The Korea Economic Daily) ...South Korea's largest biosimilar maker Celltrion Inc. said on Friday that it has scrapped a plan to merge with Celltrion Pharm Inc., an R&D and local distribution affiliate, in the face of opposition from minority shareholders. They argued Celltrion Pharm's enterprise value, based on its market capitalization, is significantly inflated, so their combination would undermine Celltrion shareholders' value... Full

'We Are Firing On All Cylinders': Bayer Pharma BD Chief Says Group Overhaul Not Slowing Dealmaking

(8/15, Angus Liu, Fierce Biotech) ...At Bayer, a groupwide restructuring is being rolled out as a top priority. But, to Juergen Eckhardt, M.D., who leads both the investment arm Leaps by Bayer and the pharma business development team, the ongoing overhaul won't disrupt the German company's dealmaking appetite... Full

KLOXXADO® 8mg Naloxone Nasal Spray Shelf-Life Extended from 24 Months to 36 Months

(8/15, Hikma) ..."The shelf-life extension is good news for frontline responders and the thousands of people who carry KLOXXADO® and who may need to use it at a moment's notice to reverse an overdose," said Dr. Hafrun Fridriksdottir, President, Hikma Generics. "We have a role to play in the fight against illicit fentanyl and as we approach National Overdose Awareness Day on August 31st , it's gratifying that we are supplying an important medicine that can save lives and help address the deadly overdose epidemic."... Full

European Medicines Agency Confirms Acceptance of Marketing Application for AVT06, A Proposed Biosimilar to Eylea® (Aflibercept)

(8/15, Alvotech) ...Alvotech, a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency has accepted a Marketing Authorization Application for AVT06, Alvotech's proposed biosimilar to Eylea® (aflibercept). The process to obtain marketing authorization could be completed in the third quarter of 2025... Full

Bio-Thera Solutions and Pharmapark Further Expand Partnership in Russia and Other CIS Countries with Addition of BAT2306, A Cosentyx® Biosimilar

(8/16, Bio-Thera Solutions) ...Bio-Thera Solutions, Ltd, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, today announced the company has reached licensing and supply agreements with Pharmapark LLC, for BAT2306, its secukinumab biosimilar, under which Pharmapark will have exclusive rights to distribute and market the drug with a status of a local product in Russia and other CIS countries. Bio-Thera and Pharmapark's partnership was initiated around a licensing and supply agreement for BAT2506, a golimumab biosimilar and previously expanded to include BAT2206, an ustekinumab biosimilar... Full

Aurobindo Pharma Arm Gets Warning Letter from USFDA for Telangana Unit

(8/16, Press Trust Of India) ...Aurobindo Pharma Ltd on Friday said its arm Eugia Pharma Specialities Ltd received a warning letter from the US health regulator for its formulations manufacturing unit in Telangana..."There is no impact on the existing supplies to the US markets," the company said. Aurobindo Pharma said it remains committed to work closely with the USFDA and continues to enhance its compliance on an ongoing basis... Full

GSK to Seek Dismissal of Florida Case Against Heartburn Drug Zantac

(8/15, Yadarisa Shabong, Reuters) ...British drugmaker GSK said on Friday it would seek a dismissal of an upcoming Zantac case in Florida, where plaintiffs alleged that its discontinued heart burn drug had caused prostate cancer. The move followed a Florida court ruling on Thursday in favour of GSK and other defendants. The ruling excluded testimony from experts that ranitidine, the active ingredient in Zantac and generic versions of the drug, was a significant risk factor for prostate cancer in the Wilson case... Full

Judge Rules Baltimore's $11 Billion Opioid Lawsuit Can Head to Trial

(8/15, Madeleine O'Neill, The Baltimore Sun) ...Baltimore's lawsuit against opioid manufacturers and distributors will proceed to a trial next month after a city judge on Thursday denied motions from the companies to throw out the case...Now the city's lawsuit against Johnson & Johnson, McKesson, Cardinal Health, AmerisourceBergen (now called Cencora), Teva Pharmaceuticals and Walgreens can proceed to a trial, though Thursday's rulings could also induce the companies to try to settle the case... Sub. Req'd

Mark Cuban Wants to Keep Shaking Up Healthcare. Here's Cost Plus Drug's Next Move

(8/15, Heather Landi, Fierce Healthcare) ...Entrepreneur and investor Mark Cuban wants to "f--k up" the U.S. healthcare system to make it more affordable, the billionaire told "The Daily Show" host Jon Stewart this week...Cuban's company is doubling down on its promise of transparency on drug pricing and will start publishing its customer contracts, Cuban told Stewart... Full

U.S. Unveils Price Limits for 10 Costly or Common Medications

(8/15, Noah Weiland and Rebecca Robbins, The New York Times) ...The negotiated prices, which take effect in 2026, are expected to save billions of dollars for Medicare, which is funded by taxpayers. But they will lead to direct out-of-pocket savings for only a subset of the millions of older Americans who take the drugs subject to negotiations... Sub. Req'd

Biden, Harris Hail Medicare Drug Price Cuts That Will Save Billions

(8/16, Jeff Mason, Patrick Wingrove, Trevor Hunnicutt, Reuters) ...Merck & Co's diabetes drug Januvia faces the steepest percentage price cut of the drugs on the list, decreasing 79%, while Novo Nordisk's insulin aspart products will face the second steepest of 76%, according to the government...Vanderbilt University professor Stacie Dusetzina said while the new discounts and savings were encouraging, they were not so aggressive that they would cause concern for the industry. "It suggests to me that companies are still going to be able to make profits have incentives to innovate," she said... Full

Pharma Investors Exhale Despite $7.5 Billion in Drug Price Cuts

(8/15, Fiona Rutherford and Robert Langreth, Bloomberg) ...Of nine publicly traded companies affected by the initial price cuts negotiated by Medicare, the US health program for senior citizens, only Merck & Co. Inc., AbbVie Inc., Eli Lilly & Co., which partners on Jardiance, and the American depositary receipts of Novartis AG shares fell on Thursday, and the declines were modest. The reason is that despite the Biden administration's victory lap over the drug price cuts that will take effect in 2026, they amounted to a 22% net price discount to what they cost last year... Sub. Req'd

5 Takeaways From First Medicare Drug Price Negotiations

(8/16, Nathaniel Weixel and Joseph Choi, The Hill) ...Drugmakers have said the process was not a legitimate negotiation, but all of them agreed to participate, and none pulled their drugs from the Medicare program. "The negotiations were comprehensive. They were intense. It took both sides to reach a good deal," Health and Human Services Secretary Xavier Becerra said of the talks... Full

Benefit Projected by CMS Price Setting Cannot Compare to Benefit of Generic and Biosimilar Medicines

(8/15, AAM) ..."Today's announcement by CMS only highlights the folly of this government price setting scheme. CMS projects average savings of 22 percent on these selected brand pharmaceuticals, a figure that pales in comparison to typical savings from generics and biosimilars," said David Gaugh, Interim President and CEO of AAM... Full

Novartis Statement on Maximum Fair Price for Entresto

(8/15, Novartis) ...Novartis believes the price-setting provisions in the IRA are unconstitutional and will have long-lasting and devastating consequences for patients by limiting access to medicines now and in the future. We acceded to a "maximum fair price" for Entresto for 2026 only to avoid other untenable options including catastrophic fines or the removal of all our products from both Medicare and Medicaid... Full

Biosimilars Forum Calls On CMS to Support Lower-Cost Biosimilars and Increase Access for Patients

(8/15, Biosimilars Forum) ......"When Congress passed the IRA, policymakers intended for the Biosimilar Special Rule to exempt products from negotiation with biosimilars. Several biosimilars for STELARA® are formally set to launch in 2025 and should able to meaningfully compete in a free market system. CMS should follow the intent of the IRA and immediately remove Stelara from the list..."... Full

PCMA Statement On Biden Administration's Medicare Negotiated Drug Prices

(8/15, PCMA) ..."While we share the Administration's goal to reduce prescription drug costs for America's seniors and to push back against the high prices set by drug manufacturers, the Administration has missed the mark by choosing several prescription drugs for which PBMs are already actively negotiating steep discounts that significantly lower costs for beneficiaries and taxpayers..."... Full

PhRMA Statement On Government Price Setting in Medicare Part D

(8/14, PhRMA) ..."While we share the Administration's goal to reduce prescription drug costs for America's seniors and to push back against the high prices set by drug manufacturers, the Administration has missed the mark by choosing several prescription drugs for which PBMs are already actively negotiating steep discounts that significantly lower costs for beneficiaries and taxpayers..."... Full

Lobby Groups: Still Unclear How CMS Will Protect Drug Pricing For Medicare Beneficiaries

(8/15, Sigi Ris, InsideHealthPolicy) ...CMS said Thursday it will use its comprehensive formulary review process for Medicare prescription drug plans to "assess any practices that may undermine access to negotiated prices for selected drugs for people with Medicare" but doesn't say how it would enforce this. The statement comes as drug makers and health care experts say the savings to beneficiaries from negotiated prices could be mitigated by plans' formulary practices and float potential solutions... Sub. Req'd

Biden Administration Touts Big Drug Savings From IRA, But Confidential Discounts Make it Impossible to Verify Their Size

(8/15, Zachary Brennan and Nicole DeFeudis, Endpoints News) ...While the full impact of negotiations remains to be seen, investment analysts at Leerink Partners looked at the results as a "sigh of relief" for pharma companies. CMS estimated that overall negotiated discounts would have resulted in 22% net savings for Medicare in 2023. Leerink analysts told investors on Thursday that the estimate is "not as bad as anticipated earlier this year." Raymond James research analyst and former HHS official Chris Meekins called the results a win for pharmaceutical companies, adding in a note to investors that CMS' comparison of negotiated prices to list prices "is significantly misleading."... Full

What Do Biden's Drug Price Comparisons Reveal? Not Much

(8/15, Rachel Cohrs Zhang, STAT Plus) ...The White House is touting just how much its new Medicare negotiation process cut drug prices. The problem is, the numbers it's using don't actually mean much...Medicare generally doesn't pay list prices for medications. Currently, prescription drug plans negotiate discounts off of the list prices at a smaller scale than the new program - but those prices are secret, even in a public program... Sub. Req'd

Medicare Unveils Negotiated Prices, But Near-Term Opportunity To Learn From Process Is Limited

(8/15, Cathy Kelly, Pink Sheet) ...Stakeholders hoping to learn from the initial round of Medicare price negotiations may have to wait until March for insight into the agency's approach because the price announcement was not very informative...Several manufacturers involved in the first round of negotiations also may be targeted in the second round and will be able to learn from their own experience, though they may be reluctant to share their insights publicly... Sub. Req'd

Round 1 Of US Drug Price Negotiations Suggests Medicare Can Beat Original Part D System

(8/15, Sarah Karlin-Smith, Pink Sheet) ...Medicare achieved smaller net spending discounts on aggregate on the first 10 drugs subject to government negotiations than was predicted by CBO as the IRA was being finalized. The difference may be in part due to implementation decisions made by CMS...Health policy experts say regardless of the specific percentage, Medicare showed there is a benefit to pooling the government's negotiation power... Sub. Req'd

Questions Remain About Whether Negotiated Drug Prices Will Save Money

(8/15, Denise Myshko, Managed Healthcare Executive) ...Industry leaders that Managed Healthcare Executive have spoken to say it's impossible to know whether Medicare's Maximum Fair Prices are better than the current rebates and discounts that plans have able to be negotiate themselves. Industry experts we've spoken to say Medicare will likely experience savings from net prices, but how much is still a question mark... Full

The Damage from Price Controls On Pharmaceuticals Begins

(8/15, Sally Pipes and Wayne Winegarden, Pacific Research Institute) ...There is one thing that the Biden Administration did get right today. This may be "a historic moment," but not the positive moment that they envision. Unless the "negotiation schemes" are abandoned, this may be the moment that signals to patients that fewer less innovative medicines will now be developed. If that is the case, today is nothing to boast about... Full

CVS Defeat Shows Quiet Ways Drug Middlemen Try to Influence Care

(8/15, John Tozzi, Bloomberg) ...A recent court defeat for CVS Health Corp. is shining a light on how health-care corporations wield their financial might over doctors and pharmacies in ways that can put profits over patient care...David Whitrap, a spokesman for CVS, said the case was "wrongly decided" and called the ruling against the pharmacy giant "an outlier." The company has had other victories against pharmacies upheld in court, he said in an email... Sub. Req'd

EMA Overhauls Guidance On Risk Minimization Activities

(8/15, Vibha Sharma, Pink Sheet) ...Drug companies may have to adjust their benefit-risk management strategies to ensure compliance with the European Medicines Agency's newly revised guidance on how to develop and evaluate risk minimization measures... Sub. Req'd

Indian Drugmakers Rush To Fill R&D Gap Left By US Peers

(8/16, Maitri Seth, NDTV Profit) ...Drugmakers in the US are curtailing their research and development investments due to slowdown in innovation after the Covid-19 pandemic, but Indian pharmaceutical companies are ramping up their R&D operations, countering the effects of the post-pandemic slowdown in the segment. In fact, domestic pharma companies believe that the R&D slowdown in the US will benefit the Indian drugmakers, creating more opportunities for demand-led growth in the pharma and healthcare sector here... Full

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