Wednesday, January 24, 2024

Teva Price Target Raised to $15 from $13 at UBS

(1/24, The Fly) ...UBS raised the firm's price target on Teva to $15 from $13 and keeps a Buy rating on the shares. The firm expects Teva's revenue and EBITDA guidance for FY24 to bracket $16B and $5B, respectively, and UBS sees room for EBITDA margin expansion in FY24, driven by branded revenue growth, the analyst tells investors in a research note... Full

Teva Raised to Buy at Jefferies Citing a Positive Setup Ahead of 2024 Outlook

(1/23, Dulan Lokuwithana, Seeking Alpha) ...Jefferies upgraded Teva Pharmaceutical to Buy from Hold and raised its price target to $14 from $10 per share on Tuesday, citing an attractive valuation set up ahead of the generic drug maker's 2024 outlook... Full

Jefferies Raises Teva to "Buy"

(1/23, Shiri Habib-Valdhorn, Globes) ...Jefferies analysts say that Teva is implementing a growth strategy and expects several positive developments this year including strong guidance (with the publication of its end of year 2023 results) and positive updates about its drug products development pipeline in the second half of 2024. Jefferies says it is bullish on Teva's share due to a cautious consensus among analysts, despite the improvement in generics, continued strength in key products, the addition of new launches, and an upside from the launch of biosimilars... Full

Lupin Secures a Tentative USFDA Approval for Rivaroxaban Tablets

(1/23, Anjali Singh, Business Standard) ...The Mumbai-headquartered pharmaceutical giant Lupin Limited announced today that it has secured tentative approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Rivaroxaban Tablets. These tablets are a generic equivalent of Janssen Pharmaceuticals' Xarelto Tablets, a popular blood thinner used for various cardiovascular conditions... Full

Amneal Insists Generics Are Sustainable As It Eyes Further Growth Avenues

(1/24, Dean Rudge, Generics Bulletin) ...Amneal trumpeted its continued faith in the retail generics market at the recent J.P. Morgan Healthcare Conference, as the US-based player also discussed longer-term goals for its burgeoning injectables and biosimilars portfolios. Amneal says it is "probably the only company that can say our retail generics business grew over [the last] four years," even at a "modest" 2-3%, as the US-based player eyes high-single- digit growth for its overall top line in the coming years amid a greater push towards complex products and the growth of its other operations, including biosimilars and injectables... Global Sub. Full

France's Sanofi to Buy U.S. Drugs Project INBRX-101 for About $2.2 Billion

(1/24, Sudip Kar-Gupta in Paris, Ludwig Burger in Frankfurt, and Sneha SK, Reuters) ...French healthcare company Sanofi has agreed to buy U.S. biotech firm Inhibrx in a deal valued at up to $2.2 billion, bolstering its drug development portfolio with an experimental treatment for a rare genetic disease. The companies said the deal will give Sanofi access to Inhibrx's INBRX-101, currently in the second of three phases of clinical trials, while its other experimental drugs will be spun off into a separate company, with Sanofi retaining an 8% stake... Full

Lundbeck CEO Eyes Deals to Bolster Pipeline, Complement Growth Drivers Ahead of Patent Losses

(1/23, Zoey Becker, Fierce Pharma) ...Under a goal to bolster long-term growth prospects, Lundbeck's approach to M&A is really "programmatic" and "systemic," the CEO said in a recent interview. The strategy could include a series of "two or three" deals that build on the company's existing strengths and enable it to balance its pipeline, the chief said. For now, Lundbeck has two strong growth drivers on hand with its antipsychotic Rexulti, which recently scored an FDA approval for Alzheimer's disease agitation, and the migraine med Vyepti... Full

India's Glenmark Life Sciences Posts Q3 Profit Rise; Strong Orderbook Ahead, Says CEO

(1/23, Rishika Sadam, Reuters) ...Indian drugmaker Glenmark Life Sciences posted a 13% rise in third-quarter profit on Tuesday, helped by a robust performance by its core active pharmaceutical ingredient business...Revenue from its API business rose 6.4% to 5.11 billion rupees, making it the biggest contributor to the total revenue. APIs are crucial chemical compounds, used in drugs to help produce the desired health effects. The company has over 130 APIs in its portfolio across key therapy areas such as cardiovascular, oncology and anti-infectives and operates in the U.S., Europe, Latin America and India... Full

Samsung Biologics Posts Over 1 Trillion Annual Operating Profit in 2023, 1st in Korean Pharma

(1/24, Kim Jung-chul, Korea Biomedical Review) ...Samsung Biologics on Wednesday reported last year's consolidated sales of 3.69 trillion won ($2.76 billion) and operating profit of 1.11 trillion won. This represents a 23.1 percent year-on-year increase in sales and a 13.2 percent increase in operating profit compared to those in 2022... Full

J&J Profit Edges Past Street View After Deals Delay Stelara Competition

(1/23, Bhanvi Satija and Patrick Wingrove, Reuters) ...Johnson & Johnson on Tuesday reported quarterly results just above Wall Street expectations, helped by strong sales of its blockbuster psoriasis drug Stelara, which is expected to face fresh U.S. competition from biosimilar versions next year...Analysts have said the delay in biosimilar launches would make Stelara a larger contributor to J&J's 2024 and 2025 sales than previously anticipated. Sales of the drug are expected to be $10.54 billion in 2024, down 3% from $10.86 billion in 2023. Fourth-quarter Stelara sales came in at $2.75 billion, topping analysts' estimates of $2.63 billion... Full

Five-Year LOE Impact Approaches $200Bn

(1/23, David Wallace, Generics Bulletin) ...The total impact of brand losses of exclusivity in the next five years across the leading 10 worldwide markets has been valued at almost $200bn by the latest "Global Use of Medicines 2024" report from IQVIA. "Across the leading 10 developed markets, the impact of brand LOEs in the next five years is expected to increase by $111bn to $192bn," the report summarizes, with $133bn of this impact coming from small molecules and $59bn from biologics..."The next five years of expiry events will provide critical revenue opportunities for generic and biosimilar makers to sustain their businesses, especially considering the more modest period of expiry events in the past five years, which were historically low levels," the report observes... Global Sub. Full

Johnson & Johnson Statement on Washington State Opioid Settlement Agreement

(1/22, Johnson & Johnson) ...Johnson & Johnson and its U.S.-based Janssen Pharmaceutical Companies (collectively, the "Company") today announced a settlement agreement with the State of Washington and its participating subdivisions resolving their opioid-related claims against the Company. With this agreement, the Company has now resolved all pending opioid litigation by the State and its subdivisions, as well as all litigation brought by the U.S. state Attorneys General... Full

Southwest Airlines to Carry Naloxone After Push from St. Louis-Area Advocate

(1/24, Sarah Fentem, St. Louis Public Radio) ...Southwest Airlines will now carry the opioid overdose-reversal drug naloxone on flights. Ballwin resident John Gaal and other advocates have been lobbying the airline to carry naloxone, which is also called Narcan, to protect passengers from opioid overdoses since Gaal witnessed an apparent overdose on a Southwest flight in October 2022. "This stuff's happening on the ground and obviously 35,000 feet in the air," he said. "You know, you got to prepare for this stuff."... Full

Bipartisan Group of Lawmakers Seeks to Reign in Pharma Patent Thickets With New Bill

(1/23, Lia DeGroot, Endpoints News) ...Senators on both sides of the aisle are seeking to ease market entry for generics and biosimilars with a new bill that would create guardrails around patent thickets, or a conglomeration of patents that cover a single product and were most famously used to extend the monopoly of AbbVie's blockbuster Humira (adalimumab). The legislation would restrict the number of patents companies can assert in litigation... Full

PCMA Supports Bill to Address Big Pharma's Patent Thickets

(1/23, PCMA) ..."We applaud and support the bipartisan, bicameral legislation to crack down on drug companies' patent abuse. For far too long, drug companies have engaged in anti-competitive tactics that keep more affordable alternatives, such as generics and biosimilars, off the market so that they can extend their product monopolies to boost profits. Addressing the anti-competitive tactics egregiously and commonly used by drug companies is by far the most sure-fire way to actually reduce prescription drug costs for patients and employers.”... Full

PhRMA, BIO Push Back Against Rare String of Setbacks

(1/24, Neil Versel, BioSpace) ...The Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization entered 2024 a little battered, having lost multiple high-profile members and top executives over the past 18 months, not to mention enduring a political battle exemplified by the passage of the Inflation Reduction Act...Robert Zirkelbach, PhRMA's executive vice president of public affairs, downplayed the losses and denied that the organization is in any sort of trouble. "Members come and go for different reasons," he said. He mentioned Genmab, which joined PhRMA in December, as a new addition to PhRMA that he is proud of, as well as Genentech and Gilead Sciences, both of which joined in summer 2019... Full

Lower Drug Costs Are Just a Federal License Away. But They Require Biden Administration Leadership

(1/23, James Love, Scientific American) ...President Joe Biden, his allies and members of his staff have described the newly announced policy as a significant tool to lower drug prices. But the actual published document is less ambitious. Among other things, it avoids the core issue related to every past attempt to use march-in rights to address prices—the argument that U.S. taxpayers should not have to pay more than people in other high-income countries when the federal government funded the invention. Knowledgeable critics and supporters of march-in rights agree they are relevant to relatively few products... Full

Cancer Rx Assistance Program Proposed For Part D Fails In Court As OIG Win Streak Continues

(1/23, Cathy Kelly, Pink Sheet) ...Defeat for group covering about 50 drugs from various sponsors is in line with an earlier court battle fought, and lost, by Pfizer and means the OIG will continue to scrutinize cost sharing assistance programs with a narrow view of what comports with the federal Anti-Kickback Statute. Options for patient assistance programs in Part D remain limited after the Department of Health and Human Services Office of Inspector General notched another court win... Sub. Req'd

House, Senate Divide Complicates Opioid Talks

(1/23, Peter Sullivan, Axios) ...Key efforts to fight the opioid overdose crisis are among the many issues that Congress has punted to the looming March 1 government funding deadline...The House and Senate need to work out their differences on the SUPPORT Act reauthorization and related policies if the anti-addiction measures are going to hitch a ride on the larger government funding package. Lobbyists and aides say the chambers are not close to a deal and that there are at least three prominent sticking points... Sub. Req'd

Why Advanced Manufacturing Technologies Haven't Prevented Drug Shortages – And How They Could

(1/23, Bowman Cox, Pink Sheet) ...A decade later, another MIT retreat explores factors behind slow adoption of technologies touted in the first – and how the barriers could be overcome to deliver higher-quality, more shortage-proof generic drugs...In support of this vision, the US Food and Drug Administration has worked to facilitate the use of continuous and other advanced manufacturing technologies by promoting the benefits and clearing regulatory hurdles. But progress has been slow, and people are realizing it's because something's missing from the vision: money... Sub. Req'd

Health Experts: Climate Events Exacerbate Drug Shortage Problem

(1/23, Luke Zarzecki, InsideHealthPolicy) ...As global climate events continue to intensify, advocates say more transparency around drug manufacturers could help address challenges around weather events impacting drug shortages...Climate change's effects on the drug supply chain can ripple across the world since different parts of the supply chain rely on countries across the world. According to a report from the Center for American Progress, in 2021 nearly half of pharmaceutical ingredients used in the United States came from India. Not only is the drug sourcing stage impacted, but also manufacturing, distribution and others. A climate threat could stop access and create a shortage... Sub. Req'd

Pharma Industry Questions FDA On Platform Technology Designation Program

(1/23, Joanne S. Eglovitch, Regulatory Focus) ...The US Food and Drug Administration will soon be issuing guidance on its platform technology designation program, which should clear up many industry questions related to the program, asserted Phillip Kurs, regulatory counsel for FDA's Center for Biologics Evaluation and Research. During a session at the CASSS Well-Characterized Biotechnology Products conference in Washington, DC on Monday, Kurs said the new designation program also formalizes the existing pathway for getting products made on novel platforms approved... Full

Canada Raises Concerns About Safeguarding Drug Supplies As US Pursues Import Plan

(1/23, Jim Saunders, South Florida Sun Sentinel) ...The U.S. Department of Health and Human Services issued a summary Monday about a Jan. 12 discussion between U.S. Secretary of Health Xavier Becerra and Canadian Health Minister Mark Holland...But the Canadian agency Health Canada last week issued a more sharply worded summary of the discussion. It said Holland has "spoken to senior U.S. officials to express Canada's disappointment with the FDA decision and to advise that Canada will take all necessary measures to protect the Canadian drug supply."... Full

AAM Requests Federal Injunction to Block Illinois' Unconstitutional Drug Price Law

(1/23, AAM) ...Today, the Association for Accessible Medicines, the trade association representing America's manufacturers of generic and biosimilar medicines, filed a lawsuit against Illinois Attorney General Kwame Raoul, requesting that a Federal district court in Illinois enjoin the Attorney General from enforcing the price-control provisions of House Bill 3957. The Illinois law, an unconstitutional overreach signed into law in July 2023 and taking effect this month, grants Illinois sweeping powers to regulate the national pharmaceutical market, violating the United States Constitution and posing harm to vulnerable patient communities... Full

Keren Haruvi Named Chair of the Association for Accessible Medicines Board of Directors

(1/23, AAM) ...The Board of Directors of the Association for Accessible Medicines has named as its new Chairperson, Keren Haruvi, President of Sandoz North America, who was elected for a one-year term. "I am honored and excited about the opportunity to be the Association for Accessible Medicines Board of Directors Chair in 2024," said Keren Haruvi, Chairperson of the AAM Board of Directors. "During my tenure, my focus will be working with key stakeholders to promote predictable and sustainable access to high quality generic and biosimilar medicines for America's patients.”... Full

IGBA Statement for the World Health Organization's Executive Board Meeting 154

(1/23, IGBA) ...The International Generic and Biosimilar Medicines Association, giving voice to the manufacturers of quality-assured, safe, and cost-effective generic and biosimilar medicines, welcomes the World Health Organization Executive Board's focus on the Three Billion Targets in the EB154 agenda, linking the learnings from the General Programme of Work 13 (GPW13) to the newly developed GPW14 to accelerate progress in global health... Full

EMA's New Cost-Based Fee Structure Gets Final Go-Ahead From EU Ministers

(1/23, Ian Schofield, Pink Sheet) ...EFPIA has welcomed the adoption of the new regulation, which will take effect from January 2025. However, it cautioned that the EMA and the national agencies needed to have the necessary resources to do their job and that the new fee structure should be supported by revisions to the EU pharmaceutical legislation... Sub. Req'd

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