Friday, February 9, 2024

Why is There An ADHD Medication Shortage in 2024? What's Making Generics of Vyvanse, Adderall and More So Scarce

(2/8, Alexander Tin, CBS News) ...Supply from drugmakers for the stimulant medications most commonly prescribed for ADHD are still falling short of demand, the Food and Drug Administration says, and many Americans who rely on these treatments are wondering why the nationwide shortage is continuing into its second year...According to the FDA database, Teva Pharmaceuticals is "manufacturing and distributing" its Adderall medication "consistent with historic levels," and it continues "to see unprecedented demand." Despite that demand, the drugmaker said its branded Adderall products are all currently available without limits. That is unlike some other versions of amphetamine mixed salts made by Teva, as well as competing generic drugmakers, which are listed as struggling to meet demand... Full

High-Dose Opioid Reversal Spray No Better Than Lower Dose in Field, US Study Finds

(2/8, Mariam Sunny, Reuters) ...A high-dose version of the opioid reversal spray naloxone, made by Hikma Pharmaceuticals, did not result in an increased survival rate compared with lower-dose versions of the drug when administered in emergency situations by New York law enforcement, according to a U.S. study...Emergent Biosolutions' Narcan, the first nasal spray emergency treatment for opioid overdose, was approved by the FDA in 2015 as a prescription drug at a 4 mg dose. Apart from Emergent, Israel-based Teva Pharmaceutical Industries, Padagis Israel Pharmaceuticals and Amphastar Pharmaceuticals also manufacture 4 mg versions of naloxone nasal spray... Full

Higher Naloxone Doses Have No Impact On Overdose Survival, Study Shows

(2/8, Lev Facher, STAT) ...The new paper, published Thursday in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report, showed no significant difference in survival rates between people who were revived using 4- and 8-milligram sprays of naloxone, commonly known by the brand name Narcan. People receiving the smaller dose also did not require a higher total number of sprays, despite having received just half the initial amount. The researchers found only one major contrast between those receiving different dose sizes: Those who received a double dose were over 2.5 times more likely to experience severe withdrawal symptoms, like vomiting... Full

Rani Shares Positive Oral Ustekinumab Data After Last Year's Challenges

(2/8, Adam Zamecnik, Generics Bulletin) ...Rani Therapeutics has shared positive topline data from a Phase I trial of its orally administered biosimilar to Johnson & Johnson's Stelara (ustekinumab) known as RT-111 after undertaking strategic measures at the tail end of last year...Amgen is currently in pole position in the US and can launch its biosimilar from January 1, 2025 onwards. Other players have also negotiated their own settlements, allowing for launches which will continue through next year. As such, Alvotech and Teva are allowed to launch AVT04 on February 21, 2025... Global Sub. Full

Amneal Announces Complete Response Resubmission for Parkinson Therapy IPX203

(2/8, Marco Meglio, Neurology Live) ...After receiving a complete response letter from the FDA in July 2023, Amneal Pharmaceuticals has announced it has presented its complete response resubmission to the FDA for its investigational agent IPX203, an oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules... Full

India's Zydus Lifesciences Beats Q3 Profit Estimates; Approves Shares Buyback

(2/9, Kashish Tandon, Reuters) ...Indian generic drugmaker Zydus Lifesciences reported a bigger-than-expected rise in third-quarter profit on Friday, driven by strong sales in its domestic and overseas markets...However, its U.S. formulations business fell 4.3% from last year. India's generic drugmakers, which draw a significant share of revenue from the crucial U.S. market, are recovering from the effects of eroding prices in the largest drug market in the world... Full

India's Biocon Posts Profit On Biosimilar Boost, Divestment Gains; CFO Resigns

(2/8, Rishika Sadam, Reuters) ...Indian biopharmaceutical company Biocon Ltd swung to a third-quarter profit on Thursday, boosted by its biosimilars business and the sale of some of its non-core units, and said Chief Financial Officer Indranil Sen had resigned. Sen, who has been with the company for nearly a decade, resigned from the role to pursue career opportunities outside of Biocon, it said. He will be with the company until March 15... Full

Biocon Arm Gets Complete Response Letter from USFDA for Bevacizumab Biosimilar Licence Application

(2/9, CNBC TV 18) ...Global biopharmaceuticals company Biocon on Friday, February 9, said the United States Food and Drug Administration has issued a complete response letter for its licence application for the cancer drug Bevacizumab. The US drug regulator has called for completion of a pre-approval inspection of its manufacturing facility, the company said in a stock exchange filing... Full

Biocon Expands Sandoz Partnership to Sell Biosimilars in Australia

(2/8, Sreejith Rajan, The New Indian Express) ...Bangalore-based Biocon Biologics Ltd announced a new partnership with Sandoz AG to promote, sell and distribute two of its cancer biosimilars - Trastuzumab and Bevacizumab - in Australia. The 5-year exclusive agreement provides Sandoz the rights to market these medications under BBL's brands OGIVRI and ABEVMY. Trastuzumab biosimilar OGIVRI is a cheaper version of Roche's breast cancer drug Herceptin, while Bevacizumab biosimilar ABEVMY mirrors Roche's Avastin that treats several tumor types. Both biosimilars were previously distributed in Australia by another pharmaceutical firm before this deal... Full

AstraZeneca Hit CEO Pascal Soriot's $45B Revenue Goal After All. But is Enhertu Approaching a Plateau?

(2/8, Angus Liu, Fierce Pharma) ...AZ actually "overachieved," Soriot argued Thursday, because he had previously adjusted that goal to $40 billion based on shifting foreign exchange rates. The British pharma's 2023 revenue marked a 3% increase compared with 2022's level, or a 6% increase based on constant exchange rates. As AZ embarks on the next 10-year cycle, the company will refresh its long-term strategy during an investor event in May. As to whether there will be a new 10-year revenue target, the company hasn't decided yet, Soriot said... Full

US Senate Democrats Grill Pharma CEOs On Drug Prices

(2/9, Ahmed Aboulenein, Reuters) ...U.S. Senate Democrats grilled three top pharmaceutical executives over the high cost of prescription drugs on Thursday but failed to extract any commitments from them to lower prices. Bristol Myers Squibb CEO Chris Boerner, Merck CEO Robert Davis, and Johnson & Johnson CEO Joaquin Duato appeared before the Senate Committee on Health, Education, Labor, and Pensions, with Davis and Duato only agreeing to do so last week in response to a subpoena threat... Full

Sen. Cassidy Gives Strong Defense – And Asks Tough Questions – Of Pharma CEOs At Hearing

(2/8, Sue Sutter, Pink Sheet) ...Senate Health, Education, Labor and Pensions Committee Ranking Member Bill Cassidy (R-LA) used the appearance of three biopharma company CEOs to hammer home on concerns about blocking biosimilar competition and the affordability of gene therapies. Cassidy's comments and questions during a 3.5-hour long hearing on drug pricing suggested he was more interested in the weeds of policymaking and legislation on market-based pricing, competition and reimbursement than on scoring rhetorical points... Sub. Req'd

Senate Grills Pharma CEOs, Who Emerge from Hearing On Drug Prices Largely Unscathed

(2/8, Nicole DeFeudis, Endpoints News) ...CEOs largely parried lawmakers' questions, sticking to their message of blaming PBMs and citing the high cost of innovation..."Patients sometimes pay more for their medicines than their insurers. Clearly, this part of the system is not working as intended," J&J CEO Joaquin Duato told the Senate Committee on Health, Education, Labor and Pensions, which is led by Sen. Bernie Sanders (I-VT). Duato said J&J's average net prices have been on the decline for the past several years, coming in at a roughly 60% discount from list prices in 2022... Full

Pharma CEOs Hold Firm Amid Sanders' Grilling

(2/8, Peter Sullivan, Axios) ...The CEOs fell back on innovation and blamed PBMs. The CEOs repeated longstanding industry arguments that PBMs bear much of the blame for high prices, because they don't always pass the discounts they negotiate to patients. And they said higher prices are needed to fund innovation. The PBM trade group countered that the drug companies' strategy "is designed to avoid accountability and further boost profits and pricing power."... Sub. Req'd

Pharma CEOs Signal Doubt On Lowering Prices in Sanders Showdown

(2/8, Nyah Phengsitthy, Bloomberg Law) ..."Will you commit today at Bristol Myers Squibb to reduce the list price of Eliquis in the United States to the price that you charge in Canada, where you make a profit?" Sen. Bernie Sanders (I-Vt) asked CEO of Bristol Myers Squibb, Chris Boerner, in a Thursday hearing before the Senate, Health, Education, Labor and Pensions Committee. "We can't make that commitment primarily because the prices in these two countries have very different systems," Boerner said...Johnson & Johnson‘s CEO Joaquin Duato said he will commit to lower the price of medication Stelara in 2025 when competing drugs enter the market... Full

PBMs Take Bulk of Blame as Senators Question BMS, J&J and Merck CEOs On High Drug Prices in US

(2/8, Kevin Dunleavy, Fierce Pharma) ...Bernie Sanders, I-Vermont, put the leaders on the defensive by citing their compensation and then referring to hundreds of needy cancer patients who had set up GoFundMe pages in hopes of collecting contributions to pay for their drugs...A constant target throughout the hearing from both the lawmakers and the CEOs were pharmacy benefit managers, the middlemen who manage prescription drug benefits on behalf of health insurers. When asked by Sen. Mitt Romney, R-Utah, what lawmakers could do to reduce the cost of drugs, Boerner took direct aim at PBMs... Full

In a Showy Hearing, Bernie Sanders Gets Few Answers About Lower Drug Prices

(2/8, Rachel Cohrs, STAT) ...The subject of the hearing was why the United States pays more than foreign countries for prescription drugs. Sanders trotted out data about prices in the United States compared with other high-income countries like Japan and France. Sen. Chris Murphy (D-Conn.) pressed the CEOs as to whether they see the United States as shouldering the cost burden for drug innovation in the rest of the world. The CEOs, and some Republican senators, hammered on differential levels of access to medications in foreign countries. Cassidy told the story of a woman who traveled to the United States to pay out of pocket for a cancer treatment after coverage for the treatment was rejected in Canada... Full

Senate CEO Hearing On Drug Prices Could (Almost) Have Taken Place Five Years Ago

(2/8, Cathy Kelly, Pink Sheet) ...For the most part, the hearing did not address the significant reforms now being implemented in Medicare under the Inflation Reduction Act or proposals to build on those reforms. So it seems unlikely to lead to new policies...The IRA only came up a handful of times. Sen. Ben Ray Lujan, D-NM, called into question Bristol Myers Squibb's arguments that the Medicare negotiation program will significantly impede innovation by suggesting that recent public statements by the company regarding that issue are at odds with each other... Sub. Req'd

AstraZeneca CEO Calls Opening IRA Drug Price Offer ‘Relatively Encouraging' in First Characterization of Talks

(2/8, Drew Armstrong, Endpoints News) ...The government's first offer to AstraZeneca under the IRA's drug price negotiations that began this month is "relatively encouraging," CEO Pascal Soriot said Thursday, at least compared with the industry's low expectations...The word "relatively" may be a crucial caveat from Soriot, given that the drug industry had been bracing for a very low first offer. But the remarks are the first characterization by any drugmakers whose products are on the list for price negotiations with the US government. Drugmakers have almost entirely refrained from commenting, not wanting to be drawn into a public back-and-forth with a Biden administration that has made drug costs a major part of its agenda... Full

Johnson & Johnson Case Signals Employee Drug Price Suits to Come

(2/9, Sara Hansard, Bloomberg Law) ...A novel lawsuit from an employee suing Johnson & Johnson Inc. for allegedly mismanaging drug benefits appears a harbinger of litigation to come against companies, especially those that rely on pharmaceutical industry middlemen to negotiate pricing and rebates...Johnson & Johnson case appears to be the first case brought by an employee against a major company alleging breach of ERISA fiduciary duty over mismanagement of health plan funds. "The allegations and legal theories asserted in the complaint are meritless and, therefore, we will be moving to dismiss the complaint in its entirety," Johnson & Johnson media relations Senior Director Tesia Williams said in an email... Full

Part D Drug Spending Cap Could Save Money for 1.5 Million Medicare Beneficiaries Next Year

(2/8, Christina Mattina, AJMC) ...Starting in 2025, Medicare beneficiaries will have their out-of-pocket spending on Part D prescription drugs capped at $2000, as specified in the Inflation Reduction Act of 2022 (IRA). According to a new KFF analysis,1 more than 1 million beneficiaries could benefit from this change... Full

Millions of People with Medicare Will Benefit from the New Out-of-Pocket Drug Spending Cap Over Time

(2/8, Juliette Cubanski, Tricia Neuman, and Anthony Damico, KFF Health News) ...While a cap on out-of-pocket costs will help millions of Part D enrollees over time, higher plan costs to provide the Part D benefit could also mean higher plan premiums, a dynamic that the Inflation Reduction Act's premium stabilization provision was designed to mitigate. Although KFF polling shows that a relatively small share of older adults is aware of the Inflation Reduction Act's $2,000 cap on out-of-pocket drug costs for Part D enrollees that takes effect in 2025, millions of them will benefit from this cap in the years to come... Full

EMA Shift To Drop Biosimilar Studies Shows Industry Has ‘Moved The Needle'

(2/8, David Wallace, Generics Bulletin) ...Responding to a recent EMA concept paper on re-evaluating the need for comparative efficacy studies to support biosimilar applications, Medicines for Europe says the development shows that cumulative experiences with biosimilars have "moved the needle" in terms of regulatory science... Global Sub. Full

Editorial: The Guardian View On India-UK Trade Talks: Don't Make it Harder for the Health Service

(2/7, The Guardian) ...India is known as the "pharmacy of the world", supplying vital generic medicines at low prices to health services including the NHS. You'd think it would be in the interest of the UK government to keep it that way. Yet, as campaigners writing to the Guardian last month pointed out, a trade deal nearing completion with India could take a wrecking ball to that arrangement – cheered on by big pharma, which stands to profit... Full

Swiss Pharma's Big Bet On Slovenia

(2/9, Jessica Davis Plüss and Céline Stegmüller, Swissinfo.ch) ...The tougher environment led many big, established pharma companies to sell their generics units or outsource production to third parties and pivot to higher margin drugs...Sandoz, the largest generics maker in Europe and one of the five largest globally, has focused new investments on launching new generics and biosimilars that are more complex to produce and command higher prices...The de-prioritisation of cheaper generics could have spelled disaster for Slovenia's pharmaceuticals sector, but the government moved quickly to provide support, including offering incentives to attract foreign investment that would move the industry up the value chain... Full

China's Public Payer Proposes Relaxing Novel Chemical Drug Pricing

(2/9, Dexter Yan, Pink Sheet) ...Only drugs awarded high points under a government-designated scoring method will benefit most from a new pricing scheme in China. The criteria include the products' innovativeness in terms of pharmaceutical sciences, the clinical value for patients and clinical evidence from clinical studies. China's healthcare security authorities are moving to loosen their grip on the pricing of newly approved, novel chemical drugs, a key part of proposed policies to streamline the government procurement of such medicines nationwide... Sub. Req'd

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