Tuesday, May 14, 2024

A Year After ‘Pivot To Growth', Teva Keeps Pushing Forward With Innovative Assets

(5/13, David Wallace, Generics Bulletin) ...Celebrating positive trial results for its long-acting injectable olanzapine, at the same time as reporting across-the-board growth for its generics business in Q1, Teva says it is pushing forward with its "pivot to growth" strategy almost a year after it was introduced by CEO Richard Francis...Then from 2028 onwards, Teva will look to "sustain growth" with innovative launches, a "sustainable innovative pipeline", focused business development and margin expansion... Global Sub. Full

Teva Plans To Launch Six Biosimilars By 2027

(5/14, David Wallace, Generics Bulletin) ...As well as focusing on near-term US biosimilar launches like its Alvotech-partnered US adalimumab and ustekinumab rivals to Humira and Stelara, Teva has outlined plans to launch a total of six biosimilars by 2027, with plenty more in the firm's pipeline..."I've been consistent in saying I don't have a crystal ball on this," Francis acknowledged. "And that's why I think having a broad portfolio that you bring to the market is a sensible approach. But I would say [we are] optimistic both for this year and optimistic for next year."... Global Sub. Full

Israel's Once-Dominant Drugmaker Is Revived by Innovation

(5/14, David Wainer, The Wall Street Journal) ...Teva shares have nearly doubled in the past year, giving it a market capitalization of about $18 billion. Last Wednesday, the company reaffirmed its 2024 guidance and reported first-quarter adjusted earnings per share that fell short of the FactSet consensus. The stock surged 13% anyway. The reason: strong results of its once-monthly injectable for schizophrenia...David Maris, a longtime industry veteran, is another bullish voice coming around to the stock..."The existential threat of its debt has significantly diminished," Maris notes in an interview... Sub. Req'd

Piper Sandler Reiterates Overweight Rating On Teva Pharma (TEVA)

(5/13, StreetInsider.com) ...Piper Sandler analyst David Amsellem reiterated an Overweight rating and raised the price target to $20.00 price target (from $19) on Teva Pharma. The analyst commented, "We recently hosted a dinner with Teva senior management and investors. Brand opportunities certainly were a key area of focus, and with that in mind, we gained more insights into TEV-‘749, the company's long-acting injectable (LAI) form of the atypical antipsychotic olanzapine, as well as more insights into TEV-‘248, an inhalable corticosteroid/short-acting beta agonist (ICS/SABA) combination incorporated into the company's multi-dose dry powder inhaler for rescue treatment of asthma exacerbations.”... Sub. Req'd

Celltrion Offers 85% Discount For Adalimumab Biosimilar In US

(5/13, Urte Fultinaviciute, Generics Bulletin) ...Nearing the first anniversary of the products' US approval, Celltrion has announced that its high-concentration and citrate-free biosimilar to AbbVie's Humira is now available at a low wholesale acquisition cost. Unbranded adalimumab-aaty will be priced with an 85% discount to the current WAC list price of Humira, while the branded version, Yuflyma, is available at a 5% discount to the list price of the originator... Global Sub. Full

Boehringer Partners with Cigna Unit to Push Humira Biosimilar After Slow Launch

(5/13, Nick Paul Taylor, Fierce Pharma) ...Boehringer Ingelheim has enlisted support for its attempt to prise AbbVie's fingers off the Humira money faucet, signing an agreement to provide Cigna's private label distributor with biosimilar copies of the aging blockbuster...News of the Boehringer agreement comes two weeks after Quallent struck a similar deal with Alvotech. Under the terms of that deal, Alvotech will make its high-concentration interchangeable biosimilar Humira for Quallent. Alvotech, which won a delayed approval in February, is also partnered with Teva. The back-to-back deals position Quallent to provide both high- and low-concentration Humira copies... Full

Roche Executives Discuss Innovation, Collaboration in Lymphoma Treatment

(5/14, Lee Han-soo, Korea Biomedical Review) ...Korea Biomedical Review recently met with Georgios Spitadakis, Hematology Integrated Disease Solution Lead at Roche, and Michelle Boyer, Head of Hematology Product Development at Roche, to discuss the company's sustained focus on lymphoma, its innovative approaches, and its commitment to collaboration with the Korean medical community... Full

CVS Suit Over Delayed Generics Dismissed by Second Circuit

(5/13, Nyah Phengsitthy, Bloomberg Law) ...Forest Laboratories, the brand manufacturer of the high-blood pressure drug Bystolic, won again in a case brought by CVS, Rite Aid, and other plaintiffs contending the drugmaker paid off generic manufacturers to delay generic products to the market, according to a Monday opinion from the US Court of Appeals for the Second Circuit... Sub. Req'd

Blood Pressure Drug Manufacturer Faces Sanctions Over Discovery

(5/13, Shweta Watwe, Bloomberg Law) ...Zhejiang Huahai Pharmaceutical Co. Ltd. will have to pay plaintiffs sanctions after the company's CEO didn't appear for a court-ordered deposition, and the company failed to fully comply with discovery requests in litigation over the adulteration of blood pressure drugs...The sprawling litigation over blood-pressure drug valsartan and biosimilars includes more than 1,200 consolidated cases. The tidal wave of litigation followed the US Food and Drug Administration's recalls of the drugs due to possible contamination with nitrosamines, which can increase the risk of cancer at high exposure levels... Sub. Req'd

Pharmaceutical Exec Testifies in Zantac Trial That Drug Was Safe and Effective

(5/13, Kaitlin Washburn, Chicago Sun-Times) ...A pharmaceutical executive was grilled for hours about the safety of Zantac on Monday in a Cook County courtroom in the first jury trial to determine whether the popular heartburn drug causes cancer. His testimony was part of the trial for a suburban Chicago woman's lawsuit claiming Zantac caused her colon cancer. The executive, a medical doctor who oversaw drug safety for decades at GSK, maintained that Zantac was a safe and effective drug... Sub. Req'd

A Biosimilars Roadmap: Understanding Payer Perceptions

(5/13, Tasmina Hydery, PharmD, PharmExec.com) ...As biosimilar manufacturers face new challenges, including pressures brought by the Inflation Reduction Act, it's increasingly important to prioritize early planning and develop robust evidence generation, communication, and market access strategies. For example, manufacturers should look to leverage real-world evidence on effectiveness and switching studies to help them overcome barriers to the adoption of pharmacy-benefit biosimilars... Full

Deloitte Pharma Study: R&D Returns Are Improving – Regulation Could Stifle Innovation

(5/13, Deloitte) ...Research and development returns in the global pharmaceutical industry are recovering, with last year's figures higher than those in the previous year. This was revealed by the annual analysis of 20 of the world's largest pharmaceutical companies by the audit and consulting company Deloitte...Artificial intelligence could speed up the development of drugs and therapies, but efforts to harness it are still in their infancy. The increase in regulatory requirements and guidelines is a concern for companies and could stifle innovation... Full

Group Argues Sanders' GLP-1 Price Estimate Omits Costs of Innovation

(5/13, Maaisha Osman, InsideHealthPolicy) ...As Senate health committee Chair Bernie Sanders (I-VT) demands Novo Nordisk share pricing and sales data for its lucrative type-2 diabetes drugs, Wegovy and Ozempic, a think tank has released a report countering the Yale University report Sanders relied on in calculating the drugs cost less than $5 to produce, saying it doesn't factor in the costs of creating an innovative medication...Novo's spokesperson told IHP the public debate doesn't consider the "complex reality" of developing these medications... Sub. Req'd

Diabetes Advocates To Push For PBM Transparency, Expanded Insulin Caps

(5/13, Luke Zarzecki, InsideHealthPolicy) ...The Diabetes Leadership Council and the Diabetes Patient Advocacy Coalition will be advocating for policy solutions for diabetes care on Wednesday (May 15) and Thursday (May 16), asking lawmakers to advance legislation to reform pharmacy benefit manager (PBM) practices, lower insulin prices for those privately insured, expand coverage of GLP-1 drugs and new technologies, and more... Sub. Req'd

Mark Cuban Calls for Employers to Publish Health-Care Contracts

(5/13, Sara Hansard, Bloomberg Law) ...Mark Cuban, the Dallas Mavericks basketball team minority owner who co-founded Cost Plus Drugs, said large employers that pay their own health-care claims should make their health insurance and pharmaceutical contracts publicly available. Publishing contracts with health-plan administrators and pharmacy benefit managers is "the Number One rule to fix the industry," Cuban said Monday during a taped interview that aired at a health-care price transparency conference... Sub. Req'd

RAND: Hospitals Charged Insurers 254% More Than Medicare Rates in 2022

(5/13, Noah Tong, Fierce Healthcare) ...The gap between insurance plans and Medicare's payments to hospitals for inpatient and outpatient services widened over the course of just a couple of years, a new study from RAND Corporation finds...Insurance prices for certain prescription drugs surpassed 278% of average sales price and 106% of average sales price paid by Medicare, according to the news release... Full

Size of 340B Market Triples Since 2018 and May Double Again, Report Says

(5/13, Zachary Brennan, Endpoints News) ...The 340B program, which essentially cuts the prices of certain outpatient drugs by 55% for hospitals and clinics, saw 16.5% growth in 2023, up from 12% in 2022, the report said. By comparison, pharma sales outside of the 340B program grew more slowly, IQVIA notes. "Several factors have the potential to accelerate the future growth of the 340B program, including state bills prohibiting the use of manufacturers' contract pharmacy restriction policies, and the potential for eligibility expansion stemming from recent court findings," the report says... Full

340B Grows and Grows, But Patients Do Not See the Savings

(5/13, Nicole Longo, PhRMA) ...As a federal safety-net program that is supposed to help vulnerable patients access affordable medicines, the exponential growth of 340B over the years should have resulted in tangible benefits for patients. But that isn't the case. Unfortunately, hospital systems and the chain pharmacies they contract with are exploiting the program to generate massive profits off the backs of hardworking Americans... Full

Biosimilars Are Gaining Ground. The IRA Could Push Them Even Further Next Year.

(5/13, Amy Baxter, Pharma Voice) ...A new study from Harvard University researchers examined the likely impact of the IRA on biosimilar coverage in Medicare, predicting that 2025 will take coverage away from brand-name biologics in favor of cheaper versions. The findings come as other reports suggest biosimilars in the commercial market are finally finding their footing...[Luca Maini] "Physicians, patients and PBMs, and all the stakeholders, need to be comfortable with the idea that biosimilars … are just as safe and effective as originator biologics."... Full

5 Trends Impacting Drug Spend in the U.S.

(5/13, Kelly Bilodeau, Pharma Voice) ...Drug spending increased $10.4 billion in 2023, partially driven by new brands and a shift toward higher-cost medications. And IQVIA predicts continued growth over the next five years, with anticipated manufacturer net revenues expected to grow 4%-7%, despite potential losses driven by patent expirations and the Inflation Reduction Act. "Oncology and obesity will drive growth through 2028," the report stated... Full

Generic Drug Quality Testing Gains Steam With Military Help

(5/14, Anna Edney, Bloomberg) ...A month ago, I attended a scientific conference in Bethesda, Maryland, to discuss the military's research priorities and left struck by something one of the researchers said about generic drugs. "I was under the impression the brand-name drug was the same as the generic, but that is not the case," said Miranda Janvrin, a researcher who is working on a drug quality study the US military is conducting through the Henry M. Jackson Foundation for the Advancement of Military Medicine. "This was not something taught at school."... Full

US FDA's Delay In Acting On Moderna RSV Vaccine Adds To Growing List of User Fee Goal Misses

(5/13, Bridget Silverman, Pink Sheet) ...The FDA expects to act on the Moderna RSV vaccine BLA by the end of May after missing its May 12, user fee goal date. "Administrative constraints" at the FDA forced the miss. After years of rigid discipline, the FDA has been growing more relaxed about meeting user fee goal dates...Missed goal dates used to be vanishingly rare, especially for novel agents, but the agency's priorities appear to be shifting. The COVID-19 pandemic was a recent major driver of disruption while travel restrictions prevented site inspections, but safety concerns can also lead to delays... Sub. Req'd

US FDA's Califf Says Adcomm Votes Not Vanishing Completely

(5/13, Derrick Gingery, Pink Sheet) ...At a Senate subcommittee hearing, the FDA commissioner says advisory committees remain important but need to be "meeting the purpose for which they exist."...Califf said no one is advocating for scrapping adcomm votes completely. If the FDA always agreed there would be no need for the agency, Califf said in response to criticism about discordance with adcomm recommendations. Califf said the public still does not understand that adcomms do not make the final decision on an application... Sub. Req'd

‘Do It Or We're Not Going To Approve Your Drug:' Industry Reps Ask FDA For Trial Diversity Sticks

(5/13, Sarah Karlin-Smith, Pink Sheet) ...FDA leadership has generally seemed apprehensive of going too hard on companies that don't meet clinical trial diversity goals, but some industry insiders say a stronger FDA is needed to spark real change. Delayed guidance could indicate if the agency will change course...As soon as the FDA starts rejecting applications or telling companies they will only get a label for a particular population due to diversity gaps, sponsor behavior will shift, [Bob Zambon, VP of technology strategy and strategic partnerships at contract research organization Syneos Health] said... Sub. Req'd

UK Prepares To Roll Out Expanded Subscription Model For Antimicrobials

(5/13, Ian Schofield, Pink Sheet) ...The UK government is expected shortly to launch an expanded version of its successful "subscription-model" pilot scheme in an effort to establish routine arrangements for the evaluation and purchase of antimicrobials by the National Health Service. The scheme will offer companies subscription contracts worth up to £20m ($25m) rather than the £10m agreed for the pilot scheme contracts awarded to Shionogi & Co's Fetcroja (cefiderocol) and Pfizer's Zavicefta (ceftazidime-avibactam) in 2022. It will also be expanded to all the nations of the UK, rather than just England... Sub. Req'd

Report Urges G7 Countries to Commit to Incentives for Antibiotic Development

(5/13, Chris Dall, MA, CIDRAP) ...The Global Coalition on Aging last week issued a report calling on G7 countries to commit to funding pull incentives and making other investments in antibiotic innovation...Noting that the current healthcare burden of antimicrobial resistance is estimated at $1 trillion globally, the experts agreed that if all G7 countries contributed their "fair share" to a $4.5 billion pull incentive to fund a single new antibiotic, the return on investment would be 5:1... Full

Sandoz Disavows U.K. Trade Group Over Dispute About Promoting a Biosimilar for Multiple Sclerosis

(5/13, Ed Silverman, STAT Plus) ...In an unusual move, Sandoz is no longer cooperating with a U.K. industry trade group following a dispute over allegations that the company inappropriately marketed a biosimilar medicine...We also asked Sandoz to explain its decision to walk away from PMCPA oversight and will pass along any reply. The trade group noted that if the company were to agree to adhere to PMCPA rules, it would have to agree to the administrative charges found in this case, provide a "full undertaking" of what occurred, and assure such infractions do not occur again... Sub. Req'd

Poles Disappointed Over Pharmaceutical Prices, State Subsidies Remain Low

(5/13, Paulina Mozolewska, Euractiv) ...Eighty-five per cent of Poles believe that drug prices in the country are too high, according to a survey conducted by Ariadna, the Nationwide Research Panel for Health Market. Despite this perception, the prices of reimbursed drugs in Polish pharmacies are among the lowest in the EU... Full

Chart of the Day : Focus On Fewer Products in the US is Yielding Good Results for Indian Pharma

(5/14, R. Sree Ram, Money Control) ...After Dr Reddy's Laboratories and Lupin, Cipla reported a healthy growth in the US business in FY24. Cipla's North America revenues increased by 26.9 percent in FY24. North America revenues of Dr Reddy's and Lupin grew by 28 percent and 33.8 percent, respectively. The healthy annual growth rates are a marked improvement from a couple of years ago when companies were struggling to overcome the price erosion in the base generic drug business. So, what is helping the companies? Their focus on high value products and difficult to make complex generic products... Sub. Req'd

India Can Be a Real Alternative to China in Pharmaceuticals

(5/14, Gopal Nadadur and Sam Ide, Nikkei Asia) ...The world would benefit from more diversified global supply chains for pharmaceuticals and India can be an important and resilient hub for this. New international investment into India's pharmaceutical sector would help to make this happen. India still has some ways to go in offering itself as a complete alternative to China but could get there with the government's initiatives and more support from like-minded partners... Full

Survey Finds Korean Oncologists Trust Biosimilars But Prescribe Originators More

(5/13, Cameron Santoro, The Center For Biosimilars) ...Korean oncologists found biosimilars to be as safe and effective as originators, but paradox exists: they still tend to prescribe originators over biosimilars...A majority of respondents said they found similarities between the originators and biosimilars, but only found them to be "similar but not interchangeable." Only 1.7% (n = 2/118) of respondents believed biosimilars were "interchangeable" with originators in terms of safety... Full

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