Monday, February 5, 2024

Teva Pharma (TEVA) Mentioned Positively at Oppenheimer

(2/5, StreetInsider.com) ...Oppenheimer analyst Leland Gershell reiterated a Perform rating on Teva Pharma. The analyst comments "4Q23 top- and bottom-line beats were helped by SNY's $500M upfront for TL1A that Street models may not have adequately reflected. Nonetheless, we are encouraged by the early innings of TEVA's Pivot to Growth strategy—with innovative product growth trends and evidence of generics stabilization giving us comfort on full-year '24 revenue guidance of $15.7–16.3B (+4% Y/Y ex-SNY; we project $16.0B), and newly-announced intention to divest API business could free up capital for greater R&D investment and should be neutral to margins... Sub. Req'd

Teva Pharma (TEVA) PT Raised to $17 at Barclays

(2/5, StreetInsider.com) ...Barclays analyst Balaji Prasad raised the price target on Teva Pharma to $17.00 (from $15.00) while maintaining a Overweight rating... Sub. Req'd

Teva Price Target Raised to $17 from $15 at Barclays

(2/5, The Fly) ...Barclays raised the firm's price target on Teva Pharmaceutical Industries to $17 from $15 and keeps an Overweight rating on the shares after meeting with management. The analyst says the company has confidence in meeting both its 2024 guidance 2027 goal. The firm increased estimates citing the "strong" 2024 guide and "growth engines aligning" across the generic and specialty units... Sub. Req'd

Teva Pharma (TEVA) PT Raised to $11 at Goldman Sachs

(2/5, StreetInsider.com) ...Goldman Sachs analyst Nathan Rich raised the price target on Teva Pharma to $11.00 (from $10.00) while maintaining a Neutral rating... Sub. Req'd

‘Stabilize' Is The Message For Teva In North America As It Plots Return To Growth

(2/5, Dean Rudge, Generics Bulletin) ...Introducing new products in the US in 2024, like its just-launched generic Korlym (mifepristone), continues to provide Teva with assurance that its North America generics business will stabilize "going forward." The sizable North America generics unit returned weaker-than-expected numbers per The Street's expectations in the final quarter of last year, markedly because of lower generic Revlimid (lenalidomide) sales. After receiving approvals for ten complex generics across 2022 and 2023, including generic Forteo (teriparatide), Teva says it plans to launch 13 products in the next two calendar years... Global Sub. Full

ICYMI: Baldwin Hosts Roundtable in Madison to Discuss Lowering Inhaler Costs and Holding Drug Companies Accountable

(2/2, United States Senator for Wisconsin Tammy Baldwin) ...Today, U.S. Senator Tammy Baldwin hosted a roundtable in Madison to hear from Wisconsin patients and providers and discuss her efforts to bring down the price of inhalers and hold big drug companies accountable...The Senators sent letters to the CEOs of the four biggest manufacturers of inhalers sold in the United States – AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, and Teva – which charge between $200 and $600 for each inhaler, typically purchased monthly... Full

Another Cancer Injectable Drug Goes Into Shortage

(2/2, Paige Twenter, Becker's Hospital Review) ...Multiple solutions of etoposide, an injectable used for testicular and small cell lung cancer, are on back order until spring. Three solutions from Accord Healthcare, two from Hikma Pharmaceuticals and one from Fresenius Kabi are in shortage, according to a drug supply database run by the American Society of Health-System Pharmacists. In 2022, Teva Pharmaceuticals stopped marketing the product... Full

India's Alembic Pharma Beats Q3 Profit View On Strong Domestic, US Sales

(2/5, Kashish Tandon, Reuters) ...India's Alembic Pharmaceuticals reported a bigger-than-expected third-quarter profit on Monday, driven by higher sales in the domestic and U.S. markets...New product launches and easing price erosion in the United States have benefitted generic drugmakers such as Alembic and also larger rivals, including Cipla, Dr. Reddy's and Sun Pharmaceutical Industries, all of which beat their third-quarter profit estimates on strong U.S. sales... Full

AbbVie Raises 2027 Sales Forecast for New Immunology Drugs to $27 Billion

(2/2, Leroy Leo and Patrick Wingrove, Reuters) ...The Chicago-based drugmaker has been counting on revenues from its newer immunology medicines to help make up for declining sales of blockbuster arthritis drug Humira. AbbVie said during an investor call its new prediction was based on growth seen for Skyrizi and Rinvoq, and that it expected the drugs to bring in $16 billion in sales this year. The drugmaker predicted 2024 Skyrizi revenue of $10.5 billion and Rinvoq sales of $5.5 billion... Full

Real Humira Competition May Not Arrive Until 2026, AbbVie Execs Tell Investors

(2/2, Zachary Brennan, Endpoints News) ...The best-selling drug of all time will soon face nine competing biosimilars, with some priced as much as 86% less than the brand-name version. But AbbVie executives are confident they're going to continue to protect their market share until 2025 or 2026. When asked about Humira's longer-term tail in revenue on today's earnings call, AbbVie president and COO Rob Michael said the "tail" will "start to emerge in the 2025 or 2026 timeframe."... Full

Bristol Myers CEO Outlines Transition Strategy Featuring 11 Key Brands, More Dealmaking

(2/2, Angus Liu, Fierce Pharma) ...For BMS, the anticoagulant pulled down $8.6 billion last year in the U.S., good for 10% growth over 2022. But given that the IRA pricing takes effect in 2026, BMS expects Eliquis' period of significant growth to end in 2025, chief commercial officer Adam Lenkowsky said on the call. As to whether the IRA will affect the commercial market, Lenkowsky said BMS is looking at various scenarios. Just because a payer wants to push for a new price in the commercial setting doesn't mean that BMS has to agree, he said... Full

Not A Headache: Revenues Grow For Migraine Drugs

(2/4, Les Luchter, Marketing Daily) ...Pfizer and Abbvie are just two of several players in a migraine drugs market that DataHorizzon Research estimates at $5.4 billion in 2022 and is expected to grow at 4.3% annually, to $8.2 billion by 2032...Other pharma companies in the migraine space include Lundbeck, which last month launched a "Say Yep" campaign for its Vyept intravenous migraine therapy. And last fall, Teva, which markets Ajovy, dropped years-old patent infringement lawsuits against Eli Lilly, which markets Emgality. Ajovy, Teva announced on Wednesday, had global revenues of $435 million in 2023, with CEO Richard Francis placing 2024 guidance for the drug at half a billion dollars... Full

Cigna Leans On Commercial Business, Pharmacy Benefits After Medicare Sale

(2/2, Khushi Mandowara and Sneha S K, Reuters) ...Cigna said on Friday it expects higher pricing for some commercial health insurance plans and strength in its pharmacy benefit management business from biosimilar and weight loss drugs, to help drive growth this year...Cigna executives said that growth in its PBM business in 2024 would be driven by powerful new GLP-1 weight loss drugs from Eli Lilly and Novo Nordisk, as well as biosimilar drugs, which are cheaper, close copies of complex biological treatments... Full

Samsung Bioepis, Celltrion Entangled in Patent Disputes With Original Pharmaceutical Companies

(2/2, Choi Mun-hee, Business Korea) ...According to industry sources on Jan. 31, Samsung Bioepis and Celltrion are embroiled in patent disputes with original pharmaceutical companies. Alexion Pharmaceuticals, a subsidiary of AstraZeneca, has filed a patent infringement lawsuit against Samsung Bioepis in the U.S. District Court for the District of Delaware. Alexion alleges that Samsung Bioepis has violated patents associated with Soliris, including material patents, through its developed biosimilar, "SB12."... Full

Neuro Biotech Alto Adds $128M in IPO Cash for Biomarker-Based Psych Drugs

(2/2, Frank Vinluan, MedCity News) ...Alto Neuroscience will apply the IPO proceeds toward clinical tests of its psychiatric drugs in patients who exhibit certain biomarkers. The company's two most advanced programs are depression drugs in mid-stage development...In addition to the two lead therapeutic candidates, Alto has two additional programs on the way to proof-of-concept mid-stage testing this year. ALTO-101, licensed from Sanofi, is in development for patients with cognitive impairment with schizophrenia. ALTO-203, acquired from Teva Pharmaceutical and its affiliate Cephalon, is in development for major depressive disorder patients who experience lack of motivation or pleasure. Preliminary data for both are expected in 2025... Full

Aduhelm's Goodbye: ENVISION Confirmatory Study To End In May, With BLA Withdrawal In November

(2/2, Sue Sutter, Pink Sheet) ...Biogen faces complex logistics in shutting down a multinational trial with more than 200 sites and approximately 1,000 patients enrolled; company also is facing calls to publish data collected from the unfinished study as well as other aducanumab trials..."The termination of ENVISION is yet another stark reminder that ensuring diversity in, and equitable access to, dementia clinical trials for minority participants remains a distant dream." [Madhav Thambisetty, Chief of the Clinical and Translational Neuroscience Section at the National Institute on Aging]. In response to questions from the Pink Sheet, Thambisetty said termination of ENVISION is disappointing... Sub. Req'd

Aurobindo Arm Formulation Unit Under U.S. FDA Scanner

(2/2, The Hindu) ..."The U.S. FDA inspected Unit-III, a formulation manufacturing facility of Eugia Pharma Specialities, a wholly owned subsidiary, in Pashamylaram, Sangareddy district of Telangana from January 22 to February 2. The inspection closed with 9 observations," Aurobindo Pharma said in a filing on Friday. The drugmaker said it will respond to the observations within the stipulated time... Full

Aurobindo Pharma Unit to Sell Business Assets to Empower for $52 Million Plus Lease Payments

(2/5, Ekta Batra and Hormaz Fatakia, CNBC TV 18) ...Eugia US Manufacturing LLC, USA, a wholly-owned step-down subsidiary of Aurobindo Pharma Ltd. has signed an asset purchase agreement with Empower Clinic Services New Jersey, LLC to dispose of its business assets as a going concern for $52 million, Aurobindo Pharma said in an exchange filing on Monday... Full

McKinsey's $230M Opioid Settlement With Cities, Schools Approved

(2/2, Joyce E. Cutler, Bloomberg Law) ...A US judge greenlighted McKinsey & Co.'s proposal to pay $230 million to settle claims that the consulting firm's marketing work turbocharged opioid sales and led municipal governments to divert public resources to stem painkiller addiction...Public governments and school districts filed the class-action lawsuit in 2021, alleging that McKinsey strategized and acted with Purdue Pharma LP and various other opioid manufacturers to create and employ marketing and sales practices to maximize opioid revenues. McKinsey agreed to the $230 million settlement in September... Full

A Startup Has Unlocked a Way to Make Cheap Insulin

(2/2, Emily Mullin, Wired) ...Recent measures by Congress cap monthly out-of-pocket costs at $35 for Medicare recipients, and insulin-makers have cut their list prices for certain products, but not all patients stand to benefit. One biotech startup, rBIO of Houston, is aiming to make insulin more affordable by producing a copycat version of the drug—known as a biosimilar. It's not the only company developing biosimilar insulin, but it says it has invented a new process to do so using custom-made bacteria... Full

Optum Perks Launches New Telehealth Platform for Prescriptions

(2/2, Paige Minemyer, Fierce Healthcare) ...Optum Perks is rolling out a new telehealth solution that aims to make it easier for patients to secure their prescriptions at a low cost...Users can access care on demand starting at $25 for hundreds of conditions and needs including acne, birth control, cold and flu, high blood pressure and more. It services are available for people with or without insurance. Ken Malley, president of Optum Perks, told Fierce Healthcare that while it's found success in offering discounts, the team wanted to address other barriers to care such as lack of access to providers... Full

Novartis' Entresto, Medicare Price Negotiation And The Impact Of ‘Bona Fide' Competition

(2/2, Cathy Kelly, Pink Sheet) ...Entresto may be subject to a negotiated price in Medicare Part D for one year before it will be excused because of generic competition under the government's current approach to implementing the program, Novartis predicted. The program could also envelop Kisqali in a few years, but the firm is not making adjustments on Leqvio and pelacarsen in response to the IRA...Asked what will happen to Entresto's negotiated price if, as expected, a generic launches in 2025, CEO Vas Narasimhan said: "Our position would be if there is a generic that's launched, that a medicine in our portfolio, per the current … guidance of the [Inflation Reduction Act], would not be eligible [for the negotiated price] at that point in time."... Sub. Req'd

Pharma Companies Raise Prices On Over 900 Drugs Amid 'Historic' Negotiations

(2/4, Ken Alltucker, USA Today) ...An analysis by the drug research firm 46brooklyn Research found that companies increased prices on 910 branded drugs in January, although the median increase was 4.7% – the lowest drug inflation rate in more than a decade, the analysis shows...Drug pricing experts say the new federal laws are likely forcing drug companies to think twice before implementing large price hikes. Indeed, 46brooklyn analysis suggests drug companies are making smaller increases. Some have opted to slash prices rather than pay lucrative Medicaid rebates... Full

CBO To Share Updated Analysis Of IRA's Drug Innovation Effects Feb. 7

(2/2, Gabrielle Wanneh, InsideHealthPolicy) ...The Congressional Budget Office plans to share its updated analysis of the Inflation Reduction Act's cost savings, effects on drug innovation and other information as part of a broader economic update that will be released Wednesday (Feb. 7), CBO Director Phillip Swagel told the House Budget Committee during a Jan. 31 oversight hearing on CBO. The update will revamp CBO's original evaluation of the IRA and the effects price controls like the new drug price negotiation policy in Medicare will have on the federal budget and future drug development... Sub. Req'd

Letter: We Need to Get the Facts Straight On Patents and Medicines

(2/4, Inforum) ...Regarding his recent letter about drug pricing, Rep. Matt Ruby misses important facts and the real reason why some patients can't access lower-cost treatments...The real crisis Ruby doesn't mention is tactics by insurance companies and pharmacy benefit managers that block access to low-cost treatments. Take insulin as an example. The three largest insurers and PBMs refused to cover biosimilar insulins that are a fraction of the price of brand insulin. Why? They are allowed to pocket larger rebates and fees by preferring higher-priced medicines, even though patients may pay more at the pharmacy... Full

Be Thankful for High Drug Prices

(2/4, David R. Henderson and Charles L. Hooper, The Wall Street Journal) ...No one in this country is happy that Americans pay for drug R&D while the rest of the world free-rides off our investment. But we don't run the world. If we try to free-ride too, there won't be a ride. When we look at our situation as it is, not how we wish it were, we can see what a good investment drug R&D is and how cheap-drug schemes such as importing drugs from Canada and "negotiating" Medicare drug prices generally won't work. If they do, we'll wish they hadn't... Sub. Req'd

If You're On Medicare, You Could Save Money On Drugs This Year

(2/3, Mark Miller, The New York Times) ...The lower costs are the result of the Inflation Reduction Act, or I.R.A., which was signed into law by President Biden in 2022 and is known mainly for its investment of more than $370 billion into climate and energy programs. Its changes to Medicare, which will help people who are enrolled in the prescription drug coverage plans known as Part D, are significant. Yet a recent survey by the nonprofit KFF found that most Americans weren't aware of them... Sub. Req'd

US Leans On Indian Pharma to Snub China. There's Just One Catch

(2/5, Anna Edney, Bloomberg) ...The Biden administration embraced a plan from India's government last year to edge China out of its position as a leader in making ingredients for generic pharmaceuticals sold in the US. But a new report shows that much of those ingredients are likely still coming from China anyway. America's reliance on China for drug ingredients has raised alarm bells in Congress. House committees will hold two hearings Tuesday on drug shortages and the US Food and Drug Administration's foreign inspection program, which has seen a large drop in visits to Chinese factories over the last few years, due in large part to the Covid pandemic... Sub. Req'd

Senate Working Group Proposes 340B Reforms

(2/2, Rachel Cohrs, STAT Plus) ...A bipartisan group of senators released a draft of legislation to resolve controversial disputes in the 340B drug discount program, according to documents obtained by STAT..."We look forward to working with Congress on issues crucial to fixing the 340B program, including patient affordability requirements, enforceable accountability measures and policies refocusing the program on true safety-net providers," said PhRMA Deputy Vice President of Public Affairs Nicole Longo... Sub. Req'd

Draft 340B Reforms Include User Fees, Clarity Around Contract Pharmacies

(2/2, Nicole DeFeudis, Endpoints News) ...Sens. John Thune (R-SD), Debbie Stabenow (D-MI), Jerry Moran (R-KS), Shelley Moore Capito (R-WV), Tammy Baldwin (D-WI), and Ben Cardin (D-MD) released draft legislation Friday in the hopes of sorting out some of those issues, including a proposal to institute user fees to help oversee the program. One area addressed in the draft is the use of contract pharmacies to expand where patients can access discounted drugs. Hospitals have added an increasing number of pharmacies requiring 340B prices in recent years, leading pharma companies to restrict the number of contract pharmacies they recognize under the program... Full

Seven Former FDA Chiefs Warn SCOTUS Could Create Drug Industry Chaos

(2/2, Jessica Karins, InsideHealthPolicy) ...A group of seven former commissioners and acting commissioners of FDA, including both Republican and Democratic appointees, warned the Supreme Court a decision against FDA in the ongoing case over the abortion drug mifepristone could shift the agency's stable approval process to a "chaotic patchwork" of court judgments... Sub. Req'd

E&C To Hold Oversight Hearing On FDA Foreign Inspections

(2/2, Jessica Karins, InsideHealthPolicy) ...The House Energy & Commerce oversight subcommittee will hold a hearing Tuesday (Feb. 6) on FDA's foreign inspections program, furthering lawmakers' probe into why inspections abroad have not returned to their pre-COVID levels despite concerns about the quality of drugs manufactured overseas and the impact on drug shortages. Lawmakers plan to discuss the importance of FDA's foreign drug inspection program and probe why it hasn't been widely restarted in countries like India and China, and how that affects domestic production... Sub. Req'd

More States Eye Drug Affordability Boards, PBM Regulations

(2/3, Peter Johnson, Pink Sheet) ...Some states are adding more ‘muscular attributes' to their Rx boards, such as setting upper limits based on the pending Medicare prices, but federal ERISA legislation still limits the boards' impact..."I do think the momentum is still strong, because states have the ability to do a lot more," Kate Sikora, associate principal at Avalere Health, tells AIS Health, a division of MMIT. "Federal bills typically get a little bit watered down by the time they actually pass. So some of these state laws are a little bit heartier – a little bit more robust – in terms of what they attempt to do."... Sub. Req'd

AAM Files Suit In Illinois To Block ‘Overreaching' Price Gouging Law

(2/2, Dean Rudge, Generics Bulletin) ...The AAM is taking legal action against the Illinois attorney general over a recently established state bill that aims to halt price spiking for generic drugs in the state, following successful challenge in other states...The AAM believes injunctive relief is warranted because the law would violate the commerce clause of the Constitution as it "claims" to have the power to regulate interstate commerce, including businesses and transactions outside the state of Illinois... Global Sub. Full

Canadian Drugs Can't Soothe America's Healthcare Pains

(2/3, Nigel Rawson and John Adams, The Hill) ...Drug manufacturers allot production to countries by assessing the number of patients who will take the medicine each year. They are highly unlikely to allocate more drugs to Canada from other countries or to increase production for Canada when they know that the medicines will be redistributed to the United States at prices that undercut their American business. We're staring at a slippery slope. Florida is not the only state that wants to import drugs from Canada; six other states have passed bills and a further six have pending legislation to import medicines from Canada... Full

First Came Florida. Now Colorado and Others Seek to Import Canadian Drugs

(2/2, Nathan Vander Klippe, The Globe and Mail) ...In February, Colorado intends to resubmit its application to grant pharmacists and wholesalers the ability to buy from Canada, incorporating what it has learned from Florida, which in early January was granted a two-year authorization by the U.S. Food and Drug Administration..."If this works in several individual states, I would say this could be the momentum for Congress to put more pressure on pharmaceutical manufacturers to make their drugs more affordable," Ms. Jaquez Lewis told The Globe and Mail in an interview... Sub. Req'd

WHO Outlines Priority Actions For Tackling AMR In 2024

(2/2, Eliza Slawther, Pink Sheet) ...A revised version of the World Health Organization's priority pathogens list is expected to be published early this year, Jean Pierre Nyemazi, a senior advisor for the World Health Organization, has said. "The priority pathogens list is finalized, at least at the technical expert level, so [we are] hoping by the end of March we will have it out there, or even probably before," Nyemazi said during a virtual Westminster Health Forum event on the next steps for AMR action in the UK... Sub. Req'd

UK Industry Urges Labour To Go Further With Life Sciences Plan

(2/5, David Wallace, Generics Bulletin) ...A life sciences plan unveiled by the UK's Labour party – which polls indicate is likely to take power after the country's imminent general election – could "go further in considering the role of off-patent medicines," the BGMA believes...Diane DiGangi Trench – the Sandoz UK country head who became BGMA chair late last year after previously serving as vice-chair (see sidebar) – said that Labour's plan "signals welcome prioritization, including the shifting of responsibility for life sciences to the secretary of state and the political empowerment of the Office for Life Sciences."... Global Sub. Full

Streamlined EU Supplementary Protection Certificate System Moves Ahead

(2/2, Ian Schofield, Generics Bulletin) ...A parliamentary committee says the proposals will remove the fragmentation in the EU SPC system and bring predictability for both the innovative and generics industry. A more harmonized, predictable and less costly EU-wide system for obtaining supplementary protection certificates for medicines has moved a step closer after the European Parliament's legal affairs committee unanimously backed two draft EU regulations that will now be voted on by the full parliament... Global Sub. Full

EMA: Should The Comparative Efficacy Requirement Be Waived For Biosimilars?

(2/2, Ian Schofield, Pink Sheet) ...A concept paper drawn up by the EU medicines regulator says that revisiting the need for comparative efficacy trials is considered "the next important step" in keeping the biosimilar pathway attractive for developers. The European Medicines Agency is considering a more "tailored" approach to the assessment of new biosimilar medicines, with a focus on whether to waive the requirement for comparative efficacy studies when the biosimilar shows a high degree of similarity to the reference drug... Sub. Req'd

EMA Proposes Waiving Comparative Efficacy Studies for Certain Biosimilars

(2/2, Joanne S. Eglovitch, Regulatory Focus) ...The European Medicines Agency is proposing to waive comparative efficacy studies for biosimilars with a straightforward mechanism of action, such as monoclonal antibodies and recombinant proteins, to reduce the need for human studies in comparing a biosimilar medicine under development with the reference product... Full

NPPA Warns of Penal Action Against Cos for Launching New Drugs Before Price Notification

(2/5, Pharmabiz.com) ...The National Pharmaceutical Pricing Authority has warned of penal action against the companies which launch new drugs, either a new combination or new strength and/or dosage, before they get prices fixed and notified by the drug price watchdog based on the current provisions...Such launch of new drugs before notification of retail price is blatant and deliberate violation of the extant provisions of law, said T Rajesh Kumar, deputy director of the Authority... Full

Quality Concerns Fail to Dent Indian Pharma Exports But Reputation Takes a Hit: Pharmexcil Chief

(2/5, Himani Chandna, News 18) ...Despite multiple complaints raised over the quality of Indian medicines, there is no impact on the export values of pharmaceutical products, said a top pharma official in the Narendra Modi government. "However, it has certainly made a dent in our image," Udaya Bhaskar, director-general, the Pharmaceuticals Export Promotion Council of India (Pharmexcil), told News18 while replying to the impact of issues like Gambia and Uzbekistan on pharmaceutical exports... Full

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