Friday, February 2, 2024

For Sale, Buyer Sought: Teva Confirms API Unit Is On The Block

(2/1, Dean Rudge, Generics Bulletin) ...Amid a concerted push towards a "new era" focused especially on biosimilars and novel products, Teva has put its increasingly independent active pharmaceutical ingredient business, TAPI, on the chopping block, matching up with reports from last year that suggested the Israeli firm was seeking around $2bn for the "world-leading provider" of small molecule APIs...Fielding questions from investors on Teva's January 31, annual financial results call, company president and CEO Richard Francis was asked about TAPI's profitability and its overall importance to Teva's margins, especially how that was leading the firm to a valuation. "On the whole, I think it's pretty neutral with regard to what it does to margins," Francis said... Global Sub. Full

Teva to Spin Out API Business in Pursuit of Future Growth

(2/1, The Pharma Letter) ...Teva said the move would allow it to maximize current and potential revenue streams and reallocate capital in pursuit of its growth strategy. In a statement, the firm said the divestment would also allow it to "better address distinct, growing markets," with its portfolio of products. The newly-independent company will also be free to pursue new growth strategies and maximize opportunities in a global API market worth some $85 billion in revenues... Sub. Req'd

Vermont Wins Key Motion in Suit Against Pharmaceutical Giant

(2/1, BlueCross BlueShield of Vermont) ...Blue Cross and Blue Shield of Vermont recently won a key victory in its lawsuit against a multinational pharmaceutical manufacturer. On January 22, 2024, Chief Judge Geoffrey W. Crawford of the U.S. District Court for Vermont issued a ruling largely denying Teva Pharmaceutical's motion to dismiss a putative class action brought by Blue Cross and Blue Shield of Vermont and The Vermont Health Plan (together, Blue Cross VT). The ruling brings Blue Cross VT and the putative class one step closer to economic relief for harms flowing from the anticompetitive tactics of Teva Pharmaceuticals alleged in the lawsuit... Full

US Senator Calls Out Big Pharma Over Improper Inhaler Patents

(2/1, Urte Fultinaviciute, Generics Bulletin) ...In the individual letters, Baldwin urged the companies to remove patents for specific inhalers, highlighting the unaffordability of these products. The Senator called out AstraZeneca for its Symbicort (budesonide/formoterol), while Boehringer Ingelheim, Teva, and GSK had more products to account for...The Israeli pharma company Teva was asked to remove patents for QVAR 40 and QVAR RediHaler (beclomethasone dipropionate HFA), ProAir DigiHaler (albuterol sulfate), and ProAir HFA, which was discontinued by the company in October 2022... Global Sub. Full

Celltrion Files Tocilizumab In US

(2/2, David Wallace, Generics Bulletin) ...Korea's Celltrion has become the latest biosimilars developer to file a rival to Actemra (tocilizumab) with the US Food and Drug Administration, submitting its CT-P47 candidate...A spokesperson for the firm told Generics Bulletin that the filing "marks the beginning of Celltrion's efforts to expand its portfolio of biosimilars in the US market and grow the availability of cost-effective options for patients with autoimmune diseases."... Global Sub. Full

Lupin Receives US FDA Approval for Generic Multaq Tablets

(2/2, Pharmabiz.com) ...Global pharma major Lupin Limited announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for dronedarone tablets USP, 400 mg, to market a generic equivalent of Multaq tablets, 400 mg of Sanofi-Aventis US LLC. The product will be manufactured at Lupin's Goa facility in India... Full

Pharma Insights Q&A: Specialty Gx Drugs and Biosims Fuel Dr. Reddy's Growth Engine

(2/1, Tim Wright, Express Pharma) ...In this Q&A, Dinakaran (Dina) Balasubramanian, head of commercial strategy and insights for biologics at Dr. Reddy's Laboratories, says specialty generic drugs and biosimilars are driving the company's future growth prospects... Full

Takeda's Q3 Profits Take a Hit Due to New Generic ADHD Drugs

(2/1, Hannah Green, Boston Business Journal) ...The Japanese pharma company, whose U.S. headquarters are in Cambridge, said it saw a "significant revenue impact" due to competition from new generic drugs. At the same time, it highlighted two new U.S. FDA approvals and outlined its efforts to broaden the reach of its existing drug products in the third quarter...Takeda said it remains on track to hit its guidance for the fiscal year that ends in March. That guidance was revised in October, when the drugmaker cut that full-year profit forecast by 36%. Part of that decision was driven by Takeda losing exclusivity on its ADHD drug Vyvanse, which it acquired when it bought Shire Pharmaceuticals in 2019... Sub. Req'd

India's Torrent Pharma Posts Higher Q3 Profit On Strong Domestic Demand

(2/2, Kashish Tandon and Ashna Teresa Britto, Reuters) ...Indian drugmaker Torrent Pharmaceuticals reported a 30% rise in its pre-tax profit for the third-quarter on Friday, buoyed by robust domestic demand...Torrent, which makes drugs for diabetes, pain management, cancer and infections, logged a one-time gain of 880 million rupees during the period from the sale of a U.S. facility, it said... Full

Deal Hungry Merck Plans More Phase 3 Launches Than in 2023

(2/1, Max Bayer, Fierce Biotech) ...After more than 20 phase 3 trials got underway in 2023, Merck is planning for even more this year, according to Dean Li, Ph.D., head of Merck Research Labs, on Thursday. Meanwhile, CEO Rob Davis says the company is hunting for more mid-sized deals... Full

Roche, Pipeline Bulging from Deal Spree, Axes 8 Oncology and Neurology Programs to Speed Up R&D

(2/1, Nick Paul Taylor, Fierce Biotech) ...In the fourth quarter, Roche removed eight drug candidates and replaced them with eight different prospects, shifting the balance of its pipeline away from neurology and, to a lesser extent, oncology and toward immunology, cardiovascular and metabolism in the process. The number of neurology prospects fell from 18 to 12, although one of those was moved to another part of the pipeline. CEO Thomas Schinecker said the the resources will be shifted "to projects we want to accelerate." He also foreshadowed similar pipeline cuts to come in the first quarter during a fourth quarter earnings call Thursday... Full

Sanofi Expects RSV Antibody to Breach Blockbuster Status in 2024, Even As Supply Hitch Drags On

(2/1, Fraiser Kansteiner, Fierce Pharma) ...As Sanofi strives to become a global immunology leader, it's also busy making the most of a crucial immunization rollout with partner AstraZeneca. On both fronts, Sanofi expects to see dividends in 2024. Last year represented a "pivotal" stretch for the drugmaker, one in which the French pharma largely proved its thesis that it can become a global immunology powerhouse, CEO Paul Hudson said on a call with investors Thursday... Full

An Elegy For Aduhelm

(2/1, Michael McCaugha, Pink Sheet) ...Biogen's decision to discontinue is Alzheimer's treatment Aduhelm cements its status as one of the most spectacular commercial failures in biopharma history. But its impact on biopharma policy is still extraordinary...The decision cements Aduhelm's status as one of the great commercial failures in biopharma history – though, as anyone who remembers Exubera can testify, the competition is stiff. Still, Aduhelm stands out as the rare commercial flop that will be remembered as so much more. Its commercial life may have been short and unsuccessful, but its legacy on the US biopharma market is likely to be substantial... Sub. Req'd

Rite Aid Completes $575 Million PBM Sale To MedImpact

(2/1, Bruce Japsen, Forbes) ...Rite Aid completed the sale of its Elixir pharmacy benefit management (PBM) company to another PBM, MedImpact Healthcare Systems, for $575 million, the drugstore chain said Thursday..."We are pleased to finalize the sale of Elixir, marking another important milestone in our transformation to strengthen our long-term financial position," Rite Aid chief executive officer and chief restructuring officer Jeffrey S. Stein said... Full

Ad Firm Publicis, Drugmaker Hikma Settle US Opioid Cases for $500 Million

(2/1, Nate Raymond, Reuters) ...A division of French advertising company Publicis Groupe SA and drug company Hikma Pharmaceuticals have reached separate settlements worth a collective $500 million to resolve claims that they helped fuel the deadly U.S. opioid epidemic. The settlements announced by U.S. state attorneys general on Thursday add to the more than $50 billion that drug manufacturers, distributors, pharmacy operators and consultants have agreed to pay to resolve lawsuits and investigations over their roles in the drug addiction crisis... Full

Lankford Calls for Answers in CVS' Attempt to Block Access to Low-Cost Prescriptions

(2/1, Senator James Lankford) ...Senator James Lankford (R-OK) sent a letter to the President and CEO of CVS Health Karen Lynch and Executive Vice President of CVS Health and President of CVS Caremark David Joyner to question CVS' move to prefer their own biosimilar instead of allowing customers to also access other low-cost biosimilars on the market... Full

CMS Makes Initial Drug Price Offers, Highlights New IRA Research

(2/1, Gabrielle Wanneh, Maaisha Osman, InsideHealthPolicy) ...CMS has submitted its initial lower price offers to drug makers for the 10 Part-D drugs selected for the program's inaugural round of price negotiations in Medicare, along with a justification of the agency's price and decision-making, HHS said Thursday (Feb. 1), prompting outcry from the brand drug lobby that the price offers were made behind closed doors, are politically motivated and don't account for the true value of drugs... Sub. Req'd

U.S. Makes Initial Offers in Medicare Drug Price Negotiations

(2/1, Noah Weiland, The New York Times) ...Health policy experts said the announcement of the initial round of offers amounted to a kind of starting gun, giving the Biden administration the chance to take an aggressive posture and test the willingness of drugmakers to acquiesce. The proposals help in "setting the tone for the rest of this back and forth," said Andrew W. Mulcahy, a health economist at the RAND Corporation who has advised the Biden administration on the implementation of the drug price negotiations... Sub. Req'd

Just How Low Did The Government Go With First IRA Offers? Pharma's Not Telling

(2/1, Nicole DeFeudis, Endpoints News) ..."We will not comment on confidential discussions between Merck and CMS," a Merck spokesperson said Thursday. "We can reiterate our belief that the price of Januvia reflects its value to patients and society and we have asked CMS to recognize that value as a part of this process. We continue to be more concerned with the long-term impact of government price-setting on biopharmaceutical innovation more broadly." Boehringer Ingelheim said in a similar statement that it remains "committed to engaging in conversations with CMS." An AstraZeneca spokesperson said Thursday that the company "continues to comply with the law requiring manufacturers to engage in price setting discussions with the Medicare program."... Full

In Medicare Negotiation Process, HHS Sends First Price Offers As Industry Blasts Lack Of Transparency

(2/1, Eric Sagonowsky, Fierce Pharma) ...Despite litigation and denouncements from the biopharma industry, Medicare price negotiations under the Inflation Reduction Act are rolling on. And today, the government is sending out its first round of offers on affected drugs...In a Thursday statement, HHS secretary Xavier Becerra called the initial offers "another milestone on the march to ensure people with Medicare get fair prices for prescription drugs."... Full

Health Secretary Weighs in On Sky-High Drug Prices, Efforts to Combat Them

(2/1, ABC News) ...The Biden administration has pushed a solution through the Inflation Reduction Act and gave Medicare the power to negotiate prescription drug prices directly with drug companies. ABC News' "Start Here" spoke with United States Secretary of Health and Human Services Xavier Becerra about the negotiations, which started Thursday... Full

Corrected: Bipartisan IRA Fix Seeks to Align Small Molecule and Biologic Negotiation Periods

(2/1, Zachary Brennan, Endpoints News) ...A spokesperson for Rep. Greg Murphy (R-NC), a co-author on the bill, told Endpoints News that two House committees — Ways and Means and Energy & Commerce — want to mark up the bill. The other two co-authors are Rep. Don Davis (D-NC) and Energy & Commerce Health Subcommittee Chair Brett Guthrie (R-KY). The current disparity in the IRA, PhRMA and others have claimed, is discouraging small molecule research and investment... Full

PhRMA Statement on CMS' Initial Price-Setting "Offer" to Biopharmaceutical Companies

(2/1, PhRMA) ...[PhRMA Senior Vice President of Public Affairs Alex Schriver] "This continues to be an exercise to win political points on the campaign trail rather than do what's in the best interest of patients. Government bureaucrats are operating behind closed doors to set medicine prices without disclosing for months how they arrived at the price or how much patient and provider input was used. This lack of transparency and unchecked authority will have lasting consequences for patients long after this administration is gone."... Full

Why US Medicare Drug Price Assessments And Negotiations Should Not Use Canada As A Model

(2/1, Nigel S. B. Rawson and John Adams, Health Affairs) ...In a recent article in Health Affairs Forefront, John Lin and colleagues discussed approaches to health technology assessment and price negotiation in three other high-income countries (Canada, France, and Germany) to see what lessons can be learned from them. Here, we argue that Canada's HTA process is not a model for CMS going forward because of its lack of flexibility, limited patient and provider input, lack of transparency, inadequate accountability, and poor track record of timely decision making... Full

Medicare Has Different Standards Than The FDA. That's How It Should Be

(2/2, Diana Zuckerman, STAT) ...As a scientist who is on Medicare, I see both sides of the argument. Of course, I'd like Medicare to pay for everything that could help keep us healthy or cure a serious disease, but the disconnect between FDA decisions and Medicare decisions is enshrined in statues that are interpreted by policymakers. Since FDA approval is based on studies paid for by drug or device companies, rather than taxpayers, the FDA says it can't require the research to include people of color or older patients. However, the agency could approve treatments only for the types of patients that were studied... Full

Healthcare Providers Favour Pricing Control As US Drug Costs Soar

(2/1, Akosua Mireku, Pharmaceutical Technology) ...Over the last few years, several companies have seen rises in inflation as they recovered from the impact of Covid-19. GlobalData highlighted geopolitical issues, inflation, and supply and demand imbalance as key factors delaying economic recovery. GlobalData's report on the impact of inflation on the healthcare sector during H2 2023 asked physicians, from China, the UK, the US, Japan, Italy, France, and Germany, for their opinions on the rise in drug prices. The survey found that more than 50% of respondents predicted that prices would increase as inflation rates increased... Full

U.S. Drug Prices Are 278% Higher Than Other Developed Countries, Says RAND Study

(2/1, Peter Wehrwein, Managed Healthcare Executive) ...A RAND analysis published today shows that difference is growing and remains substantial even when the comparison is with U.S. net prices — prices calculated once rebates by manufacturers are factored into the price. Unbranded generics are an exception to the higher U.S. drugs prices, according to the RAND researchers. Their analysis found that U.S. prices for unbranded generics were 67% of price in the 33 comparison countries when their prices computed into a single price for the purposes of this RAND analysis... Full

Drug Affordability Board Receives List of Rx's to Begin Cost Review Selection Process

(2/1, Danielle J. Brown, Maryland Matters) ...Following a board meeting Monday, the state's Prescription Drug Affordability Board is now working with a large list of "eligible" prescription drugs that meet certain statutory or regulatory that could indicate a drug is difficult for Marylanders to afford. But the "eligibility list" is not currently available to the public. The board members are working with a list of what are called National Drug Codes, or NDCs, which serve as the identifier for medicines registered with the U.S. Food and Drug Administration... Full

Ohio Antitrust Suit Against Drug Middlemen Hovers Between Courts

(2/1, Marty Schladen, Ohio Capital Journal) ...A lawsuit accusing huge health care companies of colluding to jack up prices is stalled as the sides fight over which court should hear it. Ohio Attorney General Dave Yost last March sued Express Scripts, Humana and other companies, accusing them of violating state antitrust law and the Ohio Deceptive Practices Act. But even though the state attorney general is suing the companies under Ohio law, they're continuing their efforts to have the case heard in federal court, where they want it dismissed... Full

AMR: UK's Subscription Scheme ‘One Way Forward,' But New Economic Models Needed

(2/1, Eliza Slawther, Pink Sheet) ...Stimulating the development of novel antibiotic drugs and diagnostics will require new funding models as part of the broader "push and pull" incentives strategy, says the director of health & life sciences at Innovate UK. Tackling the global health threat posed by antimicrobial resistance will require numerous points of intervention and cross-sector partnerships, including the development of new economic strategies, according to Richard Hebdon, director for health & life sciences at Innovate UK, the country's national innovation funding agency... Sub. Req'd

Budget 2024: Reduction in GST On Essential Drugs Would Be Beneficial, Say Expert

(2/1, Sushmita Panda, Financial Express) ...Finance Minister Nirmala Sitharaman will present the interim budget 2024 on Thursday. Healthy industry experts have expressed various demands that should be included in the budget 2024...According to Dr Gayatri Kamineni, COO, Kamineni Hospitals, potential initiatives to curb this critical issue are likely to include reductions in Goods and Services Tax (GST) on essential drugs or tax concessions for pharmaceutical companies manufacturing generic versions of crucial medications... Full

Adalimumab Takes Flight in India: Biosimilars Soar

(2/1, The Pharma Letter) ...The growth of adalimumab in India has been significant, driven by its indications for treating various conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, psoriasis, and ulcerative colitis. An official highlighted adalimumab's versatility across therapeutic areas as a key factor in its expansion. He said the drug's efficacy in addressing diverse inflammatory conditions contributed to its widespread adoption... Sub. Req'd

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.