Thursday, June 13, 2024

Opioid Overdose Reversal Drug Manufacturers Commit To Increased Naloxone Capacities

(6/12, Adam Zamecnik, Generics Bulletin) ...Hikma, Teva, and other drug manufacturers have committed to increased supply of naloxone and nalmefene as part of a meeting with the White House Office of National Drug Control. Manufacturers of opioid overdose reversal drugs, including several leading generics firms, intend produce an additional 25 million doses of their products in the US following a meeting with the White House Office of National Drug Control... Global Sub. Full

Amid FTC Crackdown, Judge Says Teva Inhaler Patents are 'Improperly Listed' in FDA Orange Book

(6/12, Fraiser Kansteiner, Fierce Pharma) ...This week, a federal judge in New Jersey ruled that five of Teva's patents on the metered dose inhaler for its asthma med ProAir HFA are "improperly listed" in the FDA's Orange Book. In turn, Teva has been ordered to "correct or delete" the relevant patents, court documents show...A Teva spokesperson told Fierce Pharma that the company stands behind its intellectual property and intends to appeal the latest ruling in New Jersey. Teva stopped making brand-name ProAir HFA in October 2022, though the company continues to offer an authorized generic... Full

Teva Loses Inhaler Patent Case Against Amneal, Must Delete or Amend Orange Book Listing

(6/12, Tristan Manalac, BioSpace) ...District Judge Stanley Chesler agreed with the plaintiffs—Amneal Pharmaceuticals, with the backing of the FTC—that Teva's patents only apply to the inhaler device of ProAir HFA and not to its albuterol sulfate drug formulation. The judge ruled that Teva's inhaler patents do not claim a "finished dosage form" of albuterol, allowing Amneal to develop a generic version of the drug... Full

Amneal, Aided by FTC, Succeeds in Getting Teva Patents Removed from Orange Book

(6/12, Stephanie Head, IP WatchDog) ...The court found that Amneal provided sufficient evidence that Teva may have violated antitrust laws by prohibiting low-cost, generic alternatives from entering the market. By allowing Amneal's claims to proceed, the court recognized the potential for abuse in the Orange Book listing process and the importance of allowing other companies to enter the market with competing products. The court said: "There is no dispute that the Inhaler Patents contain no claim for the active ingredient at issue, albuterol sulfate. Amneal contends that the Inhaler Patents do not meet the requirement that they claim the relevant drug. The FTC agrees."... Full

Lotus Builds In Southeast Asia With Teva Thailand Acquisition

(6/12, Dean Rudge, Generics Bulletin) ...Lotus Pharmaceutical is set to further expand its oncology and women's health products while bolting on a fresh ophthalmic and respiratory portfolio and expanding its presence in Southeast Asia after agreeing to acquire Teva's operations in Thailand. The Taiwanese firm is targeting completion of the deal in the third quarter of 2024, at which time Teva Pharma Thailand would transition into a wholly owned subsidiary of Lotus and Lotus will undertake the sales and marketing of existing products of Teva Pharma Thailand... Global Sub. Full

Lotus Pharma Picks Up Teva's Thailand Operations for Undisclosed Sum

(6/12, Joseph Keenan, Fierce Pharma) ...The acquisition gives Lotus access to Teva's ophthalmic and respiratory portfolio, including leading ophthalmic products such as Natear, that will allow Lotus to enter pharmacy channels in Thailand...The sale is part of Teva's "Pivot to Growth" strategy that was announced a little over a year ago. The plan calls for the company to reduce its manufacturing footprint. It closed three sites last year and reduced its overall production sites to 49... Full

Piper Sandler Reiterates Overweight Rating On Teva Pharma (TEVA)

(6/13, StreetInsider.com) ...Piper Sandler analyst David Amsellem reiterated an Overweight rating and $20.00 price target on Teva Pharma..."As the footprint of the neuroscience segment grows (e.g., brisk Austedo growth; significant contribution from Teva's LAI antipsychotic franchise), coupled with stability (at a minimum) for the U.S. generics/biosimilars segment, further multiple expansion (from a current EV/2024E EBITDA of ~7.5x) is warranted in our view, in the context of high visibility into long term EBITDA stability and potentially meaningful growth. We reiterate our Overweight rating" [commented David Amsellem]... Sub. Req'd

‘We've Got The Broadest Pure-Play Oncology Portfolio In The industry' – Pfizer Talks Biosimilars

(6/13, David Wallace, Generics Bulletin) ...Speaking with Generics Bulletin in an exclusive two-part interview, Barry Chester – Pfizer's global commercial lead for supportive care oncology – spoke in detail about the company's approach to biosimilars and where it saw room for improvements to how the market functions. Overall, Chester said, the biosimilars market was "an important piece of the healthcare system delivering savings back."... Global Sub. Full

Alvotech And Stada Are Back With A Denosumab Biosimilar Deal

(6/13, Urte Fultinaviciute, Generics Bulletin) ...Alvotech and Stada are back on track with a fresh marketing license deal for the former's biosimilar rival to Amgen's denosumab brands Prolia and Xgeva, despite previously terminating their licensing and supply partnership for three of Alvotech's biosimilars, including denosumab... Global Sub. Full

Regeneron Blockade Leaves Biocon Facing 2027 Wait On US Eylea Biosimilar

(6/12, Dean Rudge, Generics Bulletin) ...Biocon has been handed a further setback in its attempts to launch a biosimilar to the market-leading Eylea in the US, after a US district court signed off on a permanent injunction against the Indian firm lasting until June 2027. Meanwhile, decisions on motions for preliminary injunctions against several other biosimilar sponsors are imminent... Global Sub. Full

Korean Regulator Oks Celltrion's Stelara Biosimilar

(6/13, Lee Han-soo, Korea Biomedical Review) ...Celltrion said it received approval for its Stelara biosimilar, Steqeyma (development code: CT-P43), from the Ministry of Food and Drug Safety on Thursday...This approval marks the second Stelara biosimilar in the Korean market, following the April approval of Samsung Bioepis' biosimilar Epystem, which was approved in both intravenous (IV) and SC forms. Celltrion plans to leverage this new approval to expand its portfolio of autoimmune disease treatments, which already includes tumor necrosis factor (TNF-a) inhibitors like Remsima, Remsima SC (sold as Zymfentra in the U.S.), and Yuflyma... Full

Dr Reddy's Inks Licencing Pact with US Pharma Firm

(6/13, Times Of India) ...Dr Reddy's Laboratories informed the bourses on Wednesday that it has inked a licencing agreement with US-based Ingenus Pharmaceuticals LLC for exclusive rights to commercialise cancer treatment drug Cyclophosphamide injection in the US market... Full

Biogen Executive Plays Down Looming Competition for its Alzheimer's Drug

(6/12, Sriparna Roy, Reuters) ...Biogen's Alzheimer's drug, Leqembi, will do well in the market whether a competitor comes or not, a company executive said at the Goldman Sachs Global Healthcare Conference on Wednesday. Leqembi, co-developed by Biogen and its Japanese partner Eisai, had won standard approval from the U.S. Food and Drug Administration last July. It sees a potential rival in Eli Lilly's experimental Alzheimer's treatment donanemab... Full

Analysts Tip Lilly's Alzheimer's Launch to Boost Rival Leqembi

(6/12, Nick Paul Taylor, Fierce Pharma) ...Eli Lilly looks set to make the long-deserted Alzheimer's disease market a two-horse town—but that may be a good thing for Biogen and Eisai. William Blair analysts are tipping the anticipated approval of a rival anti-amyloid therapy to boost Leqembi by helping raise awareness, although they also see possible risks to the early frontrunner after Lilly waltzed through its advisory committee... Full

Final Funding Blow For J&J's Spravato In England, Despite Reimbursement In 26 Other Countries

(6/12, Eliza Slawther, Pink Sheet) ...J&J says it has "exhausted all current viable avenues" to get its antidepressant nasal spray Spravato reimbursed on England's National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections..."The level of evidence available for mental health treatments is not on par with physical health evidence; with less data and reduced understanding of the treatment pathway. To account for the inherent uncertainties for mental health treatments, both recognition and flexibility are needed," Amanda Cunnington, senior director of patient access for Johnson & Johnson Innovative Medicine UK, told the Pink Sheet... Sub. Req'd

BMS Chief Boerner Says Company is Still Hungry for Deals After Spending More Than $20B On M&A Last Year

(6/12, Fraiser Kansteiner, Fierce Pharma) ...As some pharma giants pump the brakes on big M&A deals, Bristol Myers Squibb—hot off a series of rapid-fire acquisitions in 2023—says it still has dealmaking cash to deploy if the right target comes along. BMS can continue to indulge its business development appetite thanks to its strong balance sheet, CEO Christopher Boerner told investors this week at Goldman Sachs' 2024 Global Healthcare Conference... Full

Gilead's M&A Appetite is for Deals in the 'Mid-Single-Digit Billions,' CEO Says

(6/12, Max Bayer, Endpoints News) ...Gilead CEO Daniel O'Day says the company will likely look for more deals like its $4.3 billion purchase of CymaBay Therapeutics over the next few years, rather than big buys costing tens of billions of dollars. "I believe that we'll continue to look at smaller deals — think mid-single-digit billions on average — every few years," O'Day said. The CymbaBay move gave Gilead access to seladelpar, a late-stage primary biliary cholangitis treatment awaiting an FDA decision slated for the middle of August... Full

USFDA Issues Form 483 with Five Observations to Torrent Pharma Unit

(6/12, Press Trust Of India) ...Torrent Pharmaceuticals announced that the US Food and Drug Administration issued a Form 483 with five observations after inspecting its manufacturing plant in Indrad, Gujarat, from June 3 to June 12. The inspection included a pre-approval inspection and a Good Manufacturing Practice inspection. The company stated that there were no observations related to data integrity. Torrent Pharma plans to respond to the USFDA within the prescribed time frame and work closely with the agency to address the observations promptly... Full

PBMs Start to Embrace Biosimilars

(6/12, Tony Hagen, Managed Healthcare Executive) ...After standing in the way of patients and their access to Humira biosimilars (adalumumab), CVS is now going all in by pushing a biosimilar competitor, Hyrimoz, high up on its formulary and taking Humira down. Meanwhile, a huge specialty pharmacy, Accredo (Evernorth) is offering Humira biosimilars for the first time starting in June this year. Throughout 2023, the first year of Humira biosimilar competition, CVS clung to Humira as its preferred drug, which helped to almost stifle sales of the new competitor biosimilars that entered the market that year. By the end of 2023, biosimilars had just 2% of the Humira market... Full

Serve You Rx Launches Biosimilar Advantage Formulary to Provide Lower Upfront Cost Options for Specialty Drugs

(6/12, Serve You Rx) ...Serve You Rx, a full-service pharmacy benefit manager known for its unquestionable flexibility and unwavering commitment to doing what's best for its clients, today announced the launch of its new Biosimilar Advantage Formulary. This formulary strategy, designed to accelerate the adoption of biosimilars, positions selected biosimilars with lower upfront costs as preferred treatments while holding reference brands as excluded or non-preferred... Full

Massachusetts Sees First Decline in Opioid-Related Deaths in Years

(6/12, Yvonne Abraham, The Boston Globe) ...The number of people who died in Massachusetts from opioid-related overdoses fell by 10 percent in 2023, the largest decrease in the state in more than a decade, according to newly released state data. The news offered a hint of hope after two years of record-setting death rates... Full

Ransomware Attacks Surged After Change Healthcare Hack

(6/13, Tina Reed, Axios) ...The uptick, first reported by Wired, suggests that the $22 million Change's parent, UnitedHealth Group, paid out to hackers to unlock its systems may have emboldened bad actors to further target the vulnerable industry. "Ransomware attacks against health care providers get attention, they are widely reported compared to other types of ransomware attacks," Recorded Future analyst Allan Liska told Axios... Full

E&C Slots PBM Spread Pricing Ban In Medicaid To Pay For Streamlining Out-Of-State Kids Care

(6/12, Amy Lotven, InsideHealthPolicy) ...In a last-minute move, the House Energy & Commerce Committee laid plans late Tuesday to use a policy banning spread pricing by pharmacy benefit managers in Medicaid to pay for legislation that would facilitate children's access to out-of-state Medicaid services, according to a revised version of the Accelerating Kids Access to Care Act, obtained by Inside Health Policy... Sub. Req'd

Biden and Trump Are Fighting to Claim Credit for $35 Insulin. It Was Actually a Pharma Giant's Idea

(6/13, Rachel Cohrs Zhang, STAT) ...Eli Lilly, an $800 billion pharma giant and one of three insulin manufacturers in the United States, first proposed an experiment allowing Medicare insurance plans to offer $35 monthly insulin in 2019, CEO David Ricks and former Medicare agency chief Seema Verma said in interviews with STAT. "It is true. We approached CMS with that idea," Ricks said, referring to the government Medicare agency. Verma gave Ricks credit. "He is an unsung hero. He was actually the mastermind of all of this," she said... Full

BIOSECURE Act Amendment Left Out Of NDAA Consideration

(6/12, Jessica Karins, InsideHealthPolicy) ...Legislation that would ban American companies and federal agencies from contracting with some foreign-owned biotechnology firms failed to make the House Rules Committee's list of floor amendments to the fiscal 2025 National Defense Authorization Act (NDAA), cutting off a route for passage of a bill that has already had an impact of the biologics industry... Sub. Req'd

WuXi Shares Jump After BIOSECURE Act's Exclusion from Defense Spending Bill

(6/12, Zoey Becker, Fierce Pharma) ...WuXi AppTec and WuXi Biologics shares jumped after SmartKarma analyst Criss Wang flagged "obstacles" for the act's inclusion in the annual National Defense Authorization Act, sparking speculation about the bill's path to becoming formalized legislation in the U.S. The NDAA determines the Department of Defense's budget each year and had been expected to include the BIOSECURE Act this time around... Full

How the IRA Has Unraveled the "Biotech Social Contract"

(6/12, Mary Caffrey, AJMC) ...There's nothing wrong with trying to help consumers pay less out of pocket for drugs. But how you do this matters, and too many parts of the Inflation Reduction Act (IRA) do little for consumers while doing a lot to harm the biotech industry that has saved lives, according to experts who gathered in Newark, New Jersey, for an April 18, 2024, symposium on the impact of the 2022 law... Full

The J&J Lawsuit Should Be a Wakeup Call to the PBM Industry — And to Companies Everywhere

(6/12, Jake Frenz, STAT) ...The ongoing legal dispute involving Johnson & Johnson has again thrust the topic of pharmacy benefit managers into the spotlight. Ann Lewandowski, a J&J employee, sued the company for overpaying for its employees' prescription drugs through its PBM, Express Scripts, claiming that these overpayments resulted in higher health insurance premiums and out-of-pocket drug costs for employees. This lawsuit is a significant entrant in the recent groundswell of efforts to shine light on the traditional PBM industry and its opaque pricing structures and outdated evaluation models... Full

Hospitals Are Relying More On PBMs to Manage Manufacturers' 340B Contract Pharmacy Restrictions: DCI's 2024 Market Analysis

(6/12, Adam J. Fein, Ph.D., Drug Channels) ...Over the past four years, manufacturers' restrictions on 340B contract pharmacies have led hospitals to deepen their relationships with the largest PBMs—even as those PBMs have simultaneously limited hospitals' direct participation in specialty pharmacy networks. For an updated look at what's next for the 340B contract pharmacy market, join Adam J. Fein, Ph.D., on June 21 for his latest live video webinar: The 340B Drug Pricing Program: Trends, Controversies, and Outlook... Full

U.S. Healthcare Spending Rises to $4.8 Trillion in 2023, Outpacing GDP

(6/12, Ahmed Aboulenein, Reuters) ...Healthcare spending in the U.S. is projected to have risen 7.5% in 2023 to $4.8 trillion, federal data showed on Wednesday, outpacing the projected annual gross domestic product growth rate of 6.1%... Full

States Join Oklahoma Effort to Convince Supreme Court to Let Them Regulate PBMs

(6/12, Max Bayer, Endpoints News) ...The majority of states have signed onto an amicus brief asking the US Supreme Court to decide whether they have the right to regulate pharmacy benefit managers, part of an ongoing debate about who has what power to oversee the industry. The legal filing disclosed Monday included state attorneys general from 31 states and the District of Columbia, noting that "all states regulate pharmacy benefit managers (PBMs) to some degree." It follows a decision by the Tenth Circuit Court of Appeals last year that sided with the Pharmaceutical Care Management Association's challenge to a 2019 Oklahoma law, and the state's subsequent appeal... Full

Colorado Board Declares Second Prescription Drug to Be Unaffordable

(6/12, Ed Sealover, The Denver Gazette) ...Colorado's precedent-setting Prescription Drug Affordability Review Board has declared a second medication to be unaffordable, setting it up for a possible upper price limit after the board's decision to consider such a limit on another drug was met with a lawsuit...Board chairwoman Dr. Gail Mizner said that, while there are other medications that treat arthritis, as Stelara does, there are fewer options for treating inflammatory bowel diseases, such as Chron's Disease and ulcerative colitis. "If it wasn't working, there would be other drugs you could go with," said Dr. Amy Gutierrez, another PDAB member... Full

Looming Step Therapy Ban In Illinois Is ‘Game Changer,' Could Start Trend

(6/12, Tim Casey, Pink Sheet) ...Federal legislation on PBM reforms has stalled, but state efforts remain active. Illinois' Healthcare Protection Act includes several other limits on insurer power, including prohibiting prior authorization for inpatient mental health care...Kaye Pestaina, a vice president at KFF and director of the Program on Patient and Consumer Protection, told the Pink Sheet's affiliate publication AIS Health that "there's a lot more focus on step therapy" across the U.S. and adds "it wouldn't surprise me if there are other states that pass legislation in this area."... Sub. Req'd

Europe is Set to Shake Up the Way it Assesses New Medicines. Gene Therapy Makers Are Worried

(6/13, Andrew Joseph, STAT Plus) ...Starting next year, there will be a new, continent-level review of a drug's effectiveness compared to what else is on the market. It's a wonky policy shift in the arcane world of HTA — that is, "health technology assessment," which is when authorities review a new drug and determine what price is cost-effective — that has drugmakers big and small racing to adapt. Some have even been running dress rehearsals of the new procedures. "This is probably the biggest change to HTA in the last 20 to 30 years," James Ryan, a health economist at AstraZeneca, said at a recent industry conference... Sub. Req'd

Imports of Bulk Drugs from China Continue to Rise, May Scupper PLI Gains

(6/13, Manu Kaushik, Financial Express) ...As per government data, growth of pharma imports from China has risen in both value and volume terms over the past five years. In terms of value, India's pharma industry imported 72% of the bulk drugs and intermediates from China in FY24. This is significantly higher than 66% imports in FY21. Experts said that the dependence of imports is growing despite the concerted efforts by the government and the industry to reduce the reliance on China... Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: Registration is required to access FirstWord and Generics Bulletin. Click on the links below to register. If you have any questions or issues with access, contact InfoNOW or visit InfoNOW's Industry News page for more details regarding these subscriptions.

                                                         

FirstWord Pharma Plus: Enter your work email address on the Registration page along with your contact information in order to receive access.

  

Generics Bulletin by Informa:

•      Registration: Click on "Sign In" (link on the upper right side of the page). Enter your work email address in the "username" box and press the "Tab" button on your keyboard or click out of the box. You will then be automatically logged into the Informa news resource (no password required). You may be redirected to the Account Settings page to update your contact information.                                

•       Subsequent Access: If you're not automatically logged in, click on "Sign In" (link on the upper right side of the page). Enter your work email address. You will be automatically logged in (no password is required).

•      Note: You must be on the Teva Network (in a Teva location or connected via VPN) in order to access the Informa news resources. You can toggle between the Informa news resources by clicking the news resource on the top.