Friday, March 8, 2024

JPMorgan Upgrades Teva Pharma (TEVA) to Neutral, 'We Remain Cautious'

(3/8, StreetInsider.com) ...JPMorgan analyst Chris Schott upgraded Teva Pharma from Underweight to Neutral with a price target of $14.00 (from $11.00). The analyst comments "We are moving to Neutral on TEVA ahead of upcoming catalysts. Teva continues to progress its innovative pipeline, particularly olanzapine LAI (phase 3 data expected in 2H24) and its TL1A (interim phase 2 data expected in 2H24). While we have been concerned that the investments required to develop these assets would pressure margins, the company has done an effective job of partnering these programs to address this dynamic.”... Full

Teva Upgraded to Neutral from Underweight at JPMorgan

(3/8, The Fly) ...JPMorgan analyst Chris Schott upgraded Teva Pharmaceutical to Neutral from Underweight with a $14 price target. Teva continues to progress its innovative pipeline, the analyst tells investors in a research note. The firm says that while it has been concerned the investments required to develop Teva's assets would pressure margins, the company has done an effective job of partnering programs to address this dynamic. It sees a more balanced risk/reward at current share levels... Full

Boehringer Ingelheim Caps Inhaler Out-Of-Pocket Costs at $35 After Political Pressure

(3/7, Katherine Lewin, Endpoints News) ...Senate HELP Committee Chair Bernie Sanders (I-VT), who took part in the January investigation, wrote on Thursday that Americans who have asthma and COPD are forced to pay up to 70 times more for the same inhalers as patients in Europe and other parts of the world. He also called on AstraZeneca, GSK and Teva to follow in Boehringer's footsteps. "If Boehringer Ingelheim can take action to cap the cost of inhalers at $35 in the United States and lower the list price of some of the inhalers it manufactures, these other companies can do the same," Sanders added... Full

Senator Markey Commends Reducing Inhaler Cost to $35 by Boehringer Ingelheim

(3/7, United States Senator for Massachusetts Ed Markey) ..."Boehringer Ingelheim's decision to cap the price of inhalers at $35 and reduce the list price of some of their products is recognition that unaffordable drug prices are unacceptable and immoral. While this is a positive step towards ensuring more Americans can afford their inhalers, BI's inhaler price caps should only be the start. No American should struggle to breathe while drug manufacturers inhale billions in profit. I call on AstraZeneca, GlaxoSmithKline and Teva to follow suit. We must work to ensure that corporate greed doesn't get in the way of every lifesaving and life-sustaining medication reaching the people who need it most."... Full

Teva's ESG Lead On Why Company Committed to Community-Led Mental Health Push

(2/28, Jack O'Brien, MM+M) ...Carol Richardson, senior director and ESG lead for North America at Teva, told MM+M that the company's Community Routes: Access to Mental Health Care program is a cornerstone of the pharma giant's sustainability push. The community-led program - which is conducted in collaboration with Direct Relief and the National Association of Free & Charitable Clinics - provides $75,000 in funding to 11 local health clinics across Florida, New Jersey and California…"From an ESG perspective, we're looking at providing access to medicines to underserved patient populations, including uninsured patients here in the U.S.," she said... Full

Fitch Revises Teva's Outlook to Positive; Affirms LT IDR at 'BB-'

(3/7, Fitch Ratings) ...Fitch Ratings has revised the Rating Outlook for Teva Pharmaceutical Industries Limited and Teva Pharmaceuticals USA, Inc.'s Long-term Issuer Default Ratings (LT IDRs) to Positive from Stable...With solid expertise in a variety of production technologies and an extensive patent portfolio, Teva is positioned well to capitalize on demand for both generic and biosimilar drugs over the medium to long term... Full

‘We Are Going To Be Deeply Engaged In The Biosimilar Arena' – Accord Sets Out US Strategy

(3/7, David Wallace, Generics Bulletin) ...Hot on the heels of Accord recently announcing a US filing for a Stelara biosimilar – as well as a settlement that will let it enter the market in May 2025 – Chrys Kokino, president of Accord US, talks about how the product fits into the firm's wider biosimilars strategy in the first part of a two-part interview with Generics Bulletin... Global Sub. Full

‘The US Is Catching Up' – Accord's Kokino On Biosimilar Market Dynamics

(3/8, David Wallace, Generics Bulletin) ...In the second part of his interview with Generics Bulletin, Chrys Kokino – president of Accord US – talks about how the US biosimilars market is catching up with Europe, as well as discussing aspects such as PBMs, the Inflation Reduction Act and biosimilar interchangeability... Global Sub. Full

Richter Takes Control Of German JVs To Wrap Up Teriparatide Biosimilar

(3/8, Dean Rudge, Generics Bulletin) ...Hungarian player Gedeon Richter has struck agreements worth more than €100m ($109m) to buy out a couple of joint ventures from its long-term German partner Helm, including a JV (Richter-Helm BioLogics) that owns the Terrosa (teriparatide) biosimilar to Forteo/Forsteo, in a move it believes will "create a very strong biotechnology platform allowing even better service offerings in a cost-efficient way."... Global Sub. Full

Fresenius Claims Edge With US Tocilizumab Biosimilar Approval

(3/7, David Wallace, Generics Bulletin) ...Fresenius Kabi has celebrated US approval for its Tyenne (tocilizumab-aazg) biosimilar rival to Actemra, noting that its version represented the "first tocilizumab biosimilar with an intravenous and subcutaneous formulation approved by the US Food and Drug Administration."...Other biosimilar developers chasing tocilizumab include Celltrion – which filed its version in the US earlier this year – and Dr Reddy's, which revealed positive Phase I results for its candidate in 2023... Global Sub. Full

Now It's Asthma Inhalers' Turn: Boehringer Will Cap Copays, Cut Some List Prices As Pressure Grows

(3/7, Cathy Kelly, Pink Sheet) ...Copays for all Boehringer Ingelheim GmbH inhaler products will be capped at $35 per fill for patients who are commercially insured, underinsured or uninsured beginning June 1 under a new program announced by the company on March 7...Boehringer Ingelheim USA President and CEO Jean-Michel Boers explained what prompted the copay cap initiative in an interview with the Pink Sheet. "Like everybody we're hearing the frustration … that we share as well, of patients being surprised and having sticker shock at the pharmacy counter," he said... Sub. Req'd

Novo Unlikely to Outsource API Production for GLP-1s But will Stay Engaged with Fill-Finish Partners

(3/7, Reynald Castañeda and Anna Brown, Endpoints News) ...Although the Danish giant's GLP-1 assets are still in short supply, EVP of Product Supply Henrik Wulff described Novo as the "clear leader" in diabetes and obesity GLP-1 volume. The company now has 25,000 workers in manufacturing alone, which is up from 16,000 staffers just over two years ago. During Novo's capital markets day on Thursday in Copenhagen, Wulff told investors that its yeast-based semaglutide API production is done in-house, which helps as it expands supply for its marketed drugs Rybelsus, Ozempic and Wegovy, as well as clinical-stage candidates CagriSema and amycretin. "API is our core technology," Wulff added... Full

Cigna Eyes $0 Out-Of-Pocket for Humira Biosimilar This Year

(3/7, Dulan Lokuwithana, Seeking Alpha) ...During its 2024 investor day, health insurer Cigna announced plans to offer a biosimilar for AbbVie's blockbuster arthritis therapy Humira later this year at $0 out-of-pocket expenses for eligible patients. Cigna said its specialty pharmacy unit, Accredo, will be tasked with launching the product, which it said would generate at least $60M in total savings and $3,500 per patient savings annually... Full

Mark Cuban's $141K Mistake: The Cost Plus Drugs Cofounder Says CEOs Don't Understand Health Care Coverage, and it's Costing Them Gig

(3/8, Lindsey Leake, Fortune) ...Cost Plus Drugs cofounder Mark Cuban urges business leaders to take a hard look at how their health dollars are spent. "Even though health insurance costs are the second-largest line item after payroll, CEOs don't really understand it or know anything about it," Cuban tells Fortune..."If you're using a big three PBM, you are getting ripped off," Cuban tells Fortune. "Period. End of story."... Full

Mark Cuban's Drug Company Inks First Health System Partnership, Inks Deal to Sell Directly to Community Health Systems

(3/7, Dave Muoio, Fierce Healthcare) ...Franklin, Tennessee-based for-profit Community Health Systems has signed onto a partnership with the billionaire-backed manufacturer to purchase pharmaceuticals like epinephrine and norepinephrine for its affiliate hospitals in Texas and Pennsylvania. The products are often used in emergency departments and intensive care units, with epinephrine currently listed on the Food and Drug Administration's list of ongoing drug shortages. Though the collaboration is beginning with just two states, the companies said they "expect to scale the partnership in numerous and meaningful ways."... Full

UCB Ups the Ante with CDMO Samsung Biologics, Signing $288M Deal

(3/7, Kevin Dunleavy, Fierce Pharma) ...UCB of Belgium and CDMO Samsung Biologics of South Korea have expanded their seven-year partnership with a new drug substance manufacturing deal worth 382 billion Korean won ($288 million). Among the drugs Samsung will manufacture for UCB is an anti-Tau candidate to treat progressive supranuclear palsy, which is in early-stage testing... Full

Astra-Sanofi RSV Shot Succeeds in Keeping Babies Out of Hospital

(3/7, Ashleigh Furlong, Bloomberg Law) ...A shot from AstraZeneca Plc and Sanofi that protects babies against a common respiratory virus proved more effective than expected at preventing hospitalizations during its US roll-out. The injected monoclonal antibody Beyfortus was 90% effective at keeping infants with respiratory syncytial virus out of hospital, according to early surveillance data from the US Centers for Disease Control and Prevention. The data, published Thursday, surpassed the 81% efficacy seen in a late-stage clinical trial, although that trial looked at more patients over a longer period... Sub. Req'd

State of the Union Address Lays Out Biden's Healthcare Priorities

(3/7, Michael McAuliff , Modern Healthcare) ...President Joe Biden mostly painted in broad strokes in his State of the Union Address Thursday when it came to healthcare, touting a raft of healthcare accomplishments and proposals aimed at lowering costs for patients but perhaps raising costs for companies. He also pointed to some new proposals, including expanding the number of drugs that can be negotiated by Medicare to 50 a year, extending a $2,000 cap on out-of-pocket drug costs to all Americans, and launching a $12 billion women's healthcare initiative... Sub. Req'd

Biden's Pharma Plans Keep Industry Fighting On All Fronts

(3/7, Sarah Karlin-Smith, Pink Sheet) ...While the agenda poses no near-term threat, it will keep pharma on its toes as industry juggles implementation of the new Medicare prices with fighting the IRA in court and trying to reform the original law...In statement released after the speech, Pharmaceutical Research and Manufacturers of America CEO Stephen Ubl said, "The IRA is stifling lifesaving research - like the very research needed to get the president's Cancer Moonshot off the ground - and creating access barriers for patients. There is bipartisan support for fixing some of the flaws of the IRA, yet the administration is rushing to make this bad law worse."... Sub. Req'd

In His State of the Union, Biden Takes Clear Aim at ‘Big Pharma'

(3/7, John Wilkerson, STAT Plus) ...President Biden blasted the pharmaceutical industry with its unflattering moniker, "Big Pharma," not once, but three times Thursday night, only the second time ever that sobriquet has been used in such a setting, after Biden's address last year...The pharmaceutical industry is working hard to dismantle the new law through a bevy of lawsuits. Administration lawyers faced off with pharmaceutical companies lawyers just hours before the address in a court in New Jersey... Sub. Req'd

In Fiery SOTU, Biden Proclaims "We Finally Beat Big Pharma"

(3/8, Jonah Comstock, Pharma Phorum) ...In a speech that ran more than an hour, President Biden's brief but fiery remarks about pharma came in at the 21-minute mark. "Americans pay more for prescription drugs than anywhere else in the world. It's wrong and I'm ending it," Biden said..."This year, Medicare is negotiating lower prices for some of the costliest drugs on the market that treat everything from heart disease to arthritis," he said. "Now, it's time to go further and give Medicare the power to negotiate lower prices for 500 drugs over the next decade. They're making a lot of money, guys. And they'll still be extremely profitable." He emphasised the effect of the negotiations on not only individual Americans, but on the federal deficit... Full

Pharma Giants, Government Spar in Court Over Medicare Drug Price Negotiation

(3/7, Rachel Cohrs, STAT Plus) ...Pharma industry giants including Bristol Myers Squibb, Johnson & Johnson, Novartis, and Novo Nordisk deployed a half-dozen lawyers to a courtroom here Thursday in a bid to dismantle Medicare's new drug price negotiation program, just hours before President Biden is set to glorify it in his State of the Union...A key area of contention throughout the hearing was whether participation in the Medicare program is voluntary, and whether drugmakers' option to exit Medicare and Medicaid programs is so onerous that it coerces the companies to go along with the drug price negotiation process... Sub. Req'd

IRA Litigation: NJ Judge Looks For Own Path In Evaluating Medicare Price Negotiation Program

(3/7, Brenda Sandburg, Pink Sheet) ...During oral argument in four cases challenging the IRA, Judge Zahid Quraishi suggested he may find that Medicare participation is voluntary but takings claim would still need to be considered. On question of whether the program is hurting innovation, Quraishi seemed skeptical... Sub. Req'd

Drugmakers in Court Fight Tax Penalties in Medicare Price Talks

(3/7, Nyah Phengsitthy, Bloomberg Law) ...Judge Zahid N. Quraishi of the US District Court for the District of New Jersey pressed the attorneys of four major drugmakers and the US Department of Justice on the impacts of the Medicare Drug Price Negotiation Program. "Is this a voluntary program?" Quraishi asked attorneys of the manufacturers...Attorneys for each drugmaker defended a variety of claims. They allege the program violates compelled speech under the First Amendment, the Fifth Amendment takings clause and due process, and excessive fines under the Eighth Amendment. Claims that the program violates the separation of powers doctrine and the Administrative Procedure Act were also argued by Novo Nordisk... Full

Passage Of Pharma-Sought Change To R&D Tax Credit May Be Delayed

(3/7, Jessica Karins, InsideHealthPolicy) ...CQ reported yesterday that many Senate Republicans are still undecided on the package and considering punting the issue until next year, when Republicans may have a stronger negotiating position. GOP senators told CQ they are aiming for improvements to the bill and if they can't secure them may put the matter off until 2025, when the Senate could flip to their party. Most of the provisions of a major 2017 tax bill are also set to expire in 2025; that bill introduced the restrictions on the R&D tax credit... Sub. Req'd

PhRMA Statement on President Biden's State of the Union Address

(3/7, PhRMA) ..."The IRA is stifling lifesaving research — like the very research needed to get the president's Cancer Moonshot off the ground — and creating access barriers for patients. There is bipartisan support for fixing some of the flaws of the IRA, yet the administration is rushing to make this bad law worse. Letting government bureaucrats arbitrarily set the price of medicines allows politics to dictate which cures are worth investing in and who should get access to them. It puts the government between patients and their doctors.” ... Full

Fighting to Make Prescription Drugs More Affordable

(3/7, Blue Cross Blue Shield) ..."In the United States, nearly 20% of health insurance premiums are driven by the cost of prescription drugs—which can often make life-saving medication out of reach for consumers. And 39% of Americans are having to skip or ration their medications because of rising prescription drug costs. "That's why BCBSA is advocating for common-sense, market-based solutions that help more Americans get the prescription drugs they need at prices they can afford. We will continue working with Congress and the administration to eliminate the practices that stifle competition and prevent families from accessing less costly and equally effective generic drugs and biosimilars.”... Full

Blue Shield of California CEO On PBM Shakeup: ‘It's Going to Become the Norm'

(3/7, Marissa Plescia, MedCity News) ...During a fireside chat hosted by MedCity News at ViVE, Blue Shield of California CEO Paul Markovich discussed the company's decision to largely move away from CVS Caremark as its PBM and partner with several other companies. Pharmacy benefit managers (PBMs) are getting a reprieve after PBM reforms were left out of congressional funding bills. But Blue Shield of California is still taking steps to lower prescription drug prices through its recent PBM shakeup, and predicts that others will follow, CEO Paul Markovich recently said... Full

Lawmakers Call for 'Line in the Sand' Between US and Chinese Biotech Companies

(3/7, Nicole DeFeudis, Endpoints News) ...Democrats and Republicans on the House Select Committee on the Chinese Communist Party railed against Chinese biotech companies in a Thursday hearing on national security, calling for a "line in the sand" between the US and "foreign adversary" companies...The House Energy and Commerce Committee is also marking up a bill Thursday that would prohibit the sharing of "sensitive information," including health and genetic data, with China and other countries... Full

Industry Advises FDA Not to Issue More Guidances Without Public Comment

(3/7, Mary Ellen Schneider, Regulatory Focus) ...The Pharmaceutical Research and Manufacturers of America and several industry groups objected to issuing more Level 1 guidances without prior public comment, emphasizing the importance of public participation in guidance development. "Although we agree with FDA that there is reason to reflect on the [good guidance practices] lessons from the pandemic, we encourage FDA to recognize that the circumstances were extraordinary and the exceptions that were invoked during that time should not be adopted as the Agency's general manner of practice, lest it erode FDA's exemplar practices for guidances," PhRMA commented... Full

European Commission Proposes Framework for Joint Clinical Assessments

(3/7, Ferdous Al-Faruque, Regulatory Focus) ...The European Commission has proposed a framework for joint clinical assessments as part of its effort to implement the EU health technology assessment regulation. The document outlines how to determine the scope of joint clinical assessments, how to share information between the relevant entities, how to select experts to help make joint clinical assessments, and more... Full

As Vote Nears, EFPIA Chief Sounds The Alarm Over Data Protection Cuts

(3/7, Ian Schofield, Pink Sheet) ...Nathalie Moll says that the European Commission's estimates of the costs to EU member states of regulatory data protection are "incorrect and over-estimated." With a key parliamentary committee preparing to vote on revisions to the EU's pharmaceutical legislation, European R&D-based industry group EFPIA has reiterated its concerns over a proposal to slice two years off the baseline period of regulatory data protection in an effort to foster earlier generic and biosimilar competition... Sub. Req'd

Generics Group Urges Action On Licensing Delays As MHRA Unveils Guidance For Established Products

(3/7, David Wallace, Pink Sheet) ...UK MHRA guidance outlining process changes aimed at shortening timeframes for assessing established medicines has been welcomed by the BGMA, which has emphasized the need to clear the regulator's current approvals backlog that the association says is exacerbating shortages...But while the British Generic Manufacturers Association has welcomed a faster assessment process, it has also underlined the need to clear the MHRA's current backlog of approvals, urging more definite action on a problem that the BGMA says is exacerbating the UK's current shortages situation... Sub. Req'd

Indian Pharma Seeks Relief from Price Controls

(3/8, The Pharma Letter) ...The WPI is subject to fluctuations, and while it surged in 2022 resulting in price hikes in 2023, there exists a possibility it has shrunk, potentially leading to price reductions this year according to the DPCO framework...Drug manufacturers are now concerned that a lower WPI could result in price reductions. As an expert said, "this link between WPI and drug prices has pharmaceutical companies navigating a delicate balance between escalating production expenses and government-regulated pricing, posing a threat to our profitability."... Sub. Req'd

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