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☆ Focus: Drugmakers go under the skin, skirting early US Medicare price negotiations
▼ + stars: | 2023-07-28 | by ( Michael Erman | ) www.reuters.com time to read: +5 min

Each year, Medicare will add more drugs to the list, the names of which have not yet been disclosed. Faspro, launched in 2020, already accounts for more than 80% of Darzalex revenue, which is due to rise to $9.5 billion this year. Merck previously told Reuters it expects this version of Keytruda could replace the more time consuming infusion for most patients. Keytruda revenue is expected to top $24 billion this year and could exceed $30 billion as soon as 2026, according to analyst estimates. The company has said its expects revenue from subcutaneous drugs containing hyaluronidase to drive its growth going forward.

Persons: Srdjan, Johnson, drugmakers, Bristol Myers, Roche, Biden’s, Michael DiFiore, DiFiore, Joseph Wolk, Faspro, Halozyme, Helen Torley, hyaluronidase, Michael Erman, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: U.S, REUTERS, Wall Street, Merck & Co, Halozyme Therapeutics, Reuters, Bristol, Bristol Myers Squibb, Medicare, U.S . Centers, Medicaid Services, J, Reuters Graphics Merck, Merck, Thomson Locations: Ljubljana, Darzalex, Diego

☆ Launch of arthritis drug biosimilars ramps up US pressure on pricing 'middlemen'
▼ + stars: | 2023-07-25 | by ( Patrick Wingrove | ) www.reuters.com time to read: +5 min

Seven drugmakers this month launched their own versions, known as biosimilars, of AbbVie's (ABBV.N) flagship arthritis drug Humira, once the world's top-selling prescription medicine. Three have kept their list price within 5%-7% of AbbVie's, two priced at an 85% discount and two have offered both types of prices. For insured patients who are often on the hook for co-pays of 10% to 25% of the list price, the savings have been minimal. Reuters GraphicsThe Biden administration has made lowering drug prices a priority. Amgen offered 5% and 55% discounts to AbbVie's $6,922 per month Humira price tag, and both were included on drug coverage lists at two large PBMs.

Persons: Dado Ruvic, Humira, Ameet Sarpatwari, Biden, PBMs, Cigna, UnitedHealth, Amgen, Robin Feldman, Ron Wyden, Wyden, Chuck Grassley, Grassley, Patrick Wingrove, Moira Warburton, Josephine Walker, Caroline Humer, Bill Berkrot Organizations: REUTERS, Association for Accessible Medicines, Harvard Medical School, Reuters, Lawmakers, Federal Trade Commission, FTC, CVS, Biosimilars, Healthcare, Novartis, Sandoz, Reuters Graphics Reuters, University California College of the, Democratic, Republican, Thomson Locations: U.S, Humira, San Francisco, New York, Washington

☆ Lilly drug slows Alzheimer's by 60% for mildly impaired patients in trial
▼ + stars: | 2023-07-17 | by ( Deena Beasley | ) www.reuters.com time to read: +5 min

Lilly expects the U.S. Food and Drug Administration to decide by the end of this year whether to approve donanemab. The company had previously reported that 24% of the overall donanemab treatment group had brain swelling. The deaths of three trial patients were linked to the treatment, researchers reported. For high tau patients, donanemab was shown to slow disease progression by about 17%, while the benefit was 35% for those with low-to-intermediate tau levels. Both medications are also being studied in large trials to see if they have an impact on delaying onset of Alzheimer's disease symptoms.

Persons: Seth Gale, Brian Snyder, Eli Lilly, Anne White, Lilly, Susan Kohlhaas, Liana Apostolova, White, Liz Coulthard, donanemab, Deena Beasley, Ludwig Burger, Will Dunham, Bill Berkrot, Caroline Humer Organizations: Alzheimer Research, Brigham, Women’s, REUTERS, Alzheimer's Association International, U.S . Food, Drug Administration, Alzheimer’s Research, Indiana University School of Medicine, Doctors, University of Bristol, JAMA, FDA, Alzheimer's Association, Health Organization, New York Stock Exchange, Thomson Locations: Boston , Massachusetts, U.S, Amsterdam, Eisai

Wegovy is a weekly injection that can help patients shed 15% of their weight alongside diet and exercise changes. Walgreens (WBA.O), one of the biggest U.S. pharmacies, is experiencing supply shortages for the higher strengths, spokesperson Erin Loverher confirmed. Doctors in six U.S. states told Reuters patients are reporting problems filling their prescriptions for the higher doses. Three of the doctors said supply delays at pharmacies had resulted in patients missing their Wegovy injections at the prescribed weekly interval. "Patients are often having to delay their injections because it's harder for pharmacies to get Wegovy in stock," he said.

Persons: Erin Loverher, Novo, Alicia Shelly, Shelly, Robert Kushner, Wegovy, Kushner, Denise Wells, Wells, Holly Lofton, New York University Langone, Disha Narang, Narang, Maggie Fick, Patrick Wingrove, Elissa Welle, Caroline Humer, Bill Berkrot Organizations: Reuters, Walgreens, Wellstar, Northwestern University's Feinberg School of Medicine, Amazon Pharmacy, New York University, Northwestern Medicine, Barclays Research, Novo, Thomson Locations: U.S, Danish, Georgia, Chicago, Michigan, Chicago , New York, San Francisco, Detroit, Atlanta, Charlottesville , Virginia, London, New York

☆ Uninsured US patients pay up to $330 for Eli Lilly’s $25 insulin, Senator Warren says
▼ + stars: | 2023-07-13 | by ( Patrick Wingrove | ) www.reuters.com time to read: +3 min

Warren’s survey of chain and independent pharmacies across all 50 states, carried out between June 9 and 28, found a third of drug stores charged $164 or more to uninsured patients for Lilly’s Insulin Lispro. Lilly said at the time it would drop the price of its Lispro insulin injection, a generic version of its own branded Humalog, to $25 a vial. The senator’s office found chain stores charged uninsured customers an average of $123 per vial for the generic insulin, compared to $63 at independent pharmacies. “This is a deeply troubling finding, revealing that the pharmacies offering the most affordable Insulin Lispro were the least likely to have it in stock,” the report said. Around 8.4 million of the 37 million people in the United States with diabetes use insulin, according to the American Diabetes Association.

Persons: Eli Lilly, George Frey, Eli, Elizabeth Warren’s, Lilly, Joe Biden’s, drugmaker, Warren, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: Company, REUTERS, Novo Nordisk, Sanofi, U.S, National Community Pharmacists Association, Democrat, Walgreens Boots Alliance, Walmart, Rite, CVS Health, Aid, CVS, Walgreens, Rite Aid, American Diabetes Association, Thomson Locations: Provo , Utah, U.S, Indianapolis, United States, New York

☆ What is aspartame and what do the new WHO rulings mean?
▼ + stars: | 2023-07-13 | by ( ) www.reuters.com time to read: +4 min

Discovered in 1965 by American chemist James Schlatter, aspartame is about 200 times sweeter than regular table sugar. One group of experts, the International Agency for Research on Cancer (IARC), said aspartame is a "possible carcinogen". For aspartame, this limit is 40 milligrams of aspartame per kilogram of body weight per day. Aspartame's use in food products has been debated for decades and has also prompted some companies to remove the compound from their products. PepsiCo (PEP.O) removed aspartame from Diet Pepsi in 2015 but brought it back a year later.

Persons: James Schlatter, Gunter Kuhnle, Mills, Yoplait, JECFA, Elissa Welle, Savyata Mishra, Deborah Sophia, Caroline Humer, Catherine Evans Organizations: World Health, U.S . Food, Drug Administration, WHO, International Agency for Research, Cancer, FAO, United Kingdom's University of Reading, PepsiCo, Pepsi, FDA, IARC, National Library of Medicine, Thomson Locations: Diet, saccharin, United Kingdom, Spain, France, Italy, Denmark, Germany, Australia, New Zealand, New York, Bengaluru

Aspartame is one of the world's most popular sweeteners, used in products from Coca-Cola diet sodas to Mars' Extra chewing gum. In its first declaration on the additive, announced early on Friday, the Lyon-based International Agency for Research on Cancer (IARC) said aspartame was a "possible carcinogen". Several scientists not associated with the reviews said the evidence linking aspartame to cancer is weak. There was also some limited evidence that aspartame has some chemical properties that are linked to cancer, the IARC said. Scientists with no links to the WHO reviews said the evidence that aspartame caused cancer was weak.

Persons: Francesco Branca, " Branca, JECFA, Branca, Mary Schubauer, Paul Pharaoh, Pharaoh, Kate Loatman, Frances Hunt, Wood, Richa Naidu, Caroline Humer, Catherine Evans Organizations: World Health Organization, WHO, Agency for Research, Cancer, Food, Agriculture Organization, FAO, Reuters, Cedars Sinai Medical Center, International Council of Beverage Associations, International, Thomson Locations: Lyon, Geneva, United States, Europe, Cedars, Los Angeles

☆ Illumina CEO deSouza resigns after proxy battle with Icahn
▼ + stars: | 2023-06-12 | by ( ) www.reuters.com time to read: +3 min

The Grail deal "has kept a lot of investors out of the stock" TD Cowen analyst Dan Brennan said. The company's shares have lost about 60% of their value since completing the Grail deal in 2021. Illumina shares closed at $200.53 on the Nasdaq on Friday. Icahn has said he wants former Illumina CEO Jay Flatley to return. He had secured more than twice the number of shareholder votes than his challenger received in the proxy vote, which could have given him enough legitimacy to hang on.

Persons: Francis deSouza, Carl Icahn, Icahn, Illumina, Charles Dadswell, DeSouza, deSouza's, Cowen, Dan Brennan, Francis, John Thompson, Andrew Teno, Jay Flatley, Vicki Hollub, Alan Jope, Management's Nelson Peltz, Lavanya, Caroline Humer, Michael Erman, Anirban Sen, Mark Porter, Marguerita Choy, Edwina Gibbs Organizations: Nasdaq, LinkedIn, Unilever Plc, U.S . Federal Trade Commission, Thomson Locations: Illumina, Occidental, Bengaluru, New York, New Jersey

☆ Illumina CEO deSouza resigns after battle with Icahn
▼ + stars: | 2023-06-11 | by ( ) www.reuters.com time to read: +3 min

Analysts said they expect the company's shares to trade up on Monday morning after deSouza's resignation. The Grail deal "has kept a lot of investors out of the stock" TD Cowen analyst Dan Brennan said. The company's shares have lost about 60% of their value since completing the Grail deal in 2021. Illumina shares closed at $200.53 on the Nasdaq on Friday. Icahn has said he wants former Illumina CEO Jay Flatley to return.

Persons: Francis deSouza, Carl Icahn, Illumina, Charles Dadswell, DeSouza, Icahn, deSouza's, Cowen, Dan Brennan, Francis, John Thompson, Andrew Teno, Jay Flatley, Vicki Hollub, Alan Jope, Management's Nelson Peltz, Lavanya, Caroline Humer, Michael Erman, Anirban Sen, Jason Neely, Jan Harvey, Mark Porter, Marguerita Choy Organizations: Nasdaq, LinkedIn, Unilever Plc, U.S . Federal Trade Commission, Thomson Locations: Occidental, Bengaluru, New York, New Jersey

☆ Illumina CEO Francis DeSouza resigns after battle with Icahn
▼ + stars: | 2023-06-11 | by ( ) www.reuters.com time to read: +2 min

June 11 (Reuters) - Illumina (ILMN.O) Chief Executive Officer Francis DeSouza stepped down on Sunday, the gene-sequencing machine maker said in a statement, ending a battle with activist investor Carl Icahn in which the company's chairman left the company earlier this year. Illumina said it named Senior Vice President and General Counsel Charles Dadswell as interim CEO. Icahn in a tweet said he is happy with the recent changes at Illumina and considers them a "very positive occurrence." Icahn has said he wants former Illumina CEO Jay Flatley to return. Vicki Hollub, for instance, remains Occidental Petroleum's (OXY.N) CEO after the company cut a deal with Icahn over board seats in 2020 and after Icahn cashed out two years later.

Persons: Francis DeSouza, Carl Icahn, Illumina, Charles Dadswell, DeSouza, Icahn, John Thompson, Andrew Teno, Jay Flatley, Vicki Hollub, Alan Jope, Management's Nelson Peltz, Lavanya, Caroline Humer, Anirban Sen, Jason Neely, Jan Harvey, Mark Porter Organizations: LinkedIn, Unilever, U.S . Federal Trade Commission, Thomson Locations: Occidental, Bengaluru, New York

☆ Explainer: What health experts say wildfire smoke novices need to know
▼ + stars: | 2023-06-08 | by ( Nancy Lapid | Thomson Reuters | Nancy Has Been A Health News Editor At Reuters For More Than A Decade. Previously She Was A Writer | ) www.reuters.com time to read: +4 min

Many in those states are wondering what they need to know about a first-time wildfire smoke event. Are health risks lower during a first-time wildfire smoke event? People in the Northeast may like to think they are not at risk from the wildfire smoke drifting down from Canada because research on health effects comes largely from regions where people are exposed to wildfire smoke for weeks at a time, year after year. Particulates from wildfire smoke enter most buildings in high concentrations, experts say. Bein of UC Davis compared indoor wildfire smoke exposure to second-hand tobacco smoke exposure.

Persons: Doug Brugge, Keith Bein, Jasvinder Singh, Singh, Nancy Lapid, Caroline Humer, Jonathan Oatis Organizations: University of Connecticut School of Medicine, Air Quality Research, University of California, Medstar Franklin Square Medical, Environmental Protection Agency, UC Davis, Thomson Locations: Canada, U.S ., Davis, Medstar, Baltimore, U.S, United States, Northeastern

☆ Analysis: Stelara patent deal puts J&J back on path to $57 bln 2025 revenue forecast
▼ + stars: | 2023-06-05 | by ( Patrick Wingrove | ) www.reuters.com time to read: +4 min

Stelara, introduced in 2009, has been J&J’s top-selling drug since 2019, with sales reaching $9.7 billion in 2022. J&J is forecasting $57 billion in pharmaceutical sales by 2025 after reducing its previous view of $60 billion in April, citing currency dynamics that hurt its pharmaceutical business in 2022. That would add around $4.6 billion to average estimates for pharmaceutical sales, as long as no biosimilars enter the market before 2025. Amgen said last month the confidential settlement it signed with J&J will allow it to sell its Stelara biosimilar no later than Jan. 1, 2025. “If no Stelara biosimilars enter in 2024, I think growth should continue at around 4% in 2023 and 2024,” Huynh said.

Persons: Johnson, Amgen, ”, Vamil, Trung Huynh, ” Huynh, Teva, biosimilar, Divan, Alvotech, Patrick Wingrove, Caroline Humer, Bill Berkrot Organizations: Amgen Inc, Analysts, Stelara, Reuters Graphics Reuters, Reuters, New, J, Credit Suisse, Food and Drug Administration, Alvotech’s, Thomson Locations: New Brunswick , New Jersey, Alvotech’s Reykjavik

☆ Cancer vaccines poised to unlock 'new treatment paradigm' with Merck/Moderna data
▼ + stars: | 2023-06-05 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +5 min

The hope is for "a completely new treatment paradigm in cancer that will be better tolerated and unique to individual patients' tumors," said Dr. Jane Healy, an executive overseeing in early cancer treatment development at Merck. The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. Aiming at these unique proteins allows the immune system to kill cancer cells while leaving healthy tissue unscathed. With standard treatment, 90% of pancreatic cancer patients die within five years of diagnosis. The approach first primes the immune system with an older technology called a chimpanzee adenovirus vaccine that targets patients' tumors.

Persons: Andrew Kelly, Keytruda, Jane Healy, Germany's BioNTech, Vinod Balachandran, we've, we're, Andrew Allen, Healy, Julie Steenhuysen, Caroline Humer, Bill Berkrot Organizations: Merck & Co, REUTERS, CHICAGO, Moderna Inc, American Society of Clinical Oncology, Merck, Moderna, Memorial Sloan Kettering Cancer Center, Thomson Locations: Kenilworth , New Jersey, U.S, Chicago, New York, Nature

The Biden Administration’s signature drug pricing reform, part of the Inflation Reduction Act (IRA), aims to save $25 billion through price negotiations by 2031 for Americans who pay more for medicines than any other country. The first ever Medicare drug price reduction process begins in September, when the Centers for Medicare and Medicaid Services(CMS) identifies its 10 most costly drugs. Reuters has seen responses to CMS from five of the world's top drugmakers raising legal concerns with the law and the agency's proposed roadmap. Former CMS head Andy Slavitt, who now works at a venture capital company focused on healthcare, said the Medicare agency would have consulted lawyers. One said the Medicare roadmap, which did not go through a formal process with proposed and final rules, could be challenged in court for being unlawful as well.

☆ After weight loss, Alzheimer's may be next frontier for drugs like Ozempic
▼ + stars: | 2023-05-08 | by ( Natalie Grover | ) www.reuters.com time to read: +6 min

LONDON, May 8 (Reuters) - Diabetes drugs that also promote weight loss such as Novo Nordisk’s (NOVOb.CO) Ozempic, becoming a darling of celebrities and investors, are being studied to tackle some of the most difficult-to-treat brain disorders, including Alzheimer’s disease. Those successes followed decades of futility that had left many questioning the validity of the amyloid theory behind most experimental Alzheimer's drugs. She said she has since been approached by pharmaceutical companies at an increasing pace, and is currently running an Alzheimer’s trial evaluating intranasal insulin in combination with another diabetes drug. Four companies with GLP-1 drugs, including two larger drugmakers, say they are watching for results of trials testing Novo's drug in Alzheimer's. Dementia affects more than 55 million people globally and the market for Alzheimer’s drugs is expected to grow to $9.4 billion by 2028 and for Parkinson’s to $6.6 billion, according to pharmaceutical data provider Citeline.

May 4 (Reuters) - Moderna Inc (MRNA.O) on Thursday reported stronger-than-expected sales of $1.9 billion for its COVID-19 vaccine in the first quarter, driven by a surge of revenue deferred from 2022, but left its 2023 sales expectations unchanged. Moderna said it continued to expect COVID vaccine sales of $5 billion for the year based on advance purchase agreements. Moderna expects an additional $3 billion in deferred vaccine revenue in the second half of 2023. The results came two days after the company's rival Pfizer reported better-than-expected COVID vaccine sales for the first quarter and maintained its expectations for full-year sales. Moderna had generated around $36 billion in sales over the last two years from its COVID vaccine, its only commercial product and one of the most widely used shots for the virus.

☆ Factbox: What is APOE4 and how does it relate to Alzheimer's disease?
▼ + stars: | 2023-04-21 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +1 min

Three decades ago, scientists discovered that the gene also plays a role in Alzheimer's risk, though exactly how is still not clear. APOE3 is the most common, and does not raise Alzheimer's risk. APOE4 increases Alzheimer's risk and is linked with an earlier onset of the disease. Some 25% of people have one copy of APOE4 and 2-5% have two copies. Children of a parent with two copies of the APOE4 variant are presumed to have at least one copy, increasing their own risk.

☆ 'It totally backfired': The pitfalls of Alzheimer's genetic testing
▼ + stars: | 2023-04-21 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +8 min

CHICAGO, April 21 (Reuters) - Wendy Nelson watched her mother slowly die of Alzheimer's disease, unable to move or swallow at the end. When her father's memory began to fail a year later, one of her two sisters doubted it could be Alzheimer's, Nelson said. THE TESTING REVOLUTIONUntil recently, most doctors tended not to order genetic tests to determine Alzheimer's risk, because there were no effective treatments to slow or prevent the disease. US regulators recommend genetic testing before starting treatment with Leqembi. Some members of families with increased genetic risk of Alzheimer's say it might be better not to know at all.

Lilly has not previously discussed its Medicare coverage optimism publicly. The U.S. Centers for Medicare & Medicaid Services (CMS) did not immediately respond to a request for comment. Such "coverage with evidence development" requirements are rare and historically used by Medicare to evaluate medical devices. Amyvid, Lilly's Alzheimer's imaging agent that can detect amyloid plaques on PET scans, has been subject to CMS' evidence development program for a decade. "It shuts out many patients," said Dr. Maria Carrillo, chief science officer of the Alzheimer’s Association, "especially minorities and rural patients."

WASHINGTON, April 20 (Reuters) - Use of the drug misoprostol on its own to terminate pregnancies is on the rise in the United States as providers seek a preemptive alternative while a ban on abortion pill mifepristone is being considered in court. Misoprostol is already part of the only medication abortion protocol approved by the U.S. Food and Drug Administration, but only when taken in combination with mifepristone. The drug, which the FDA first approved in 1988 for gastric ulcers, is often prescribed off-label to treat miscarriages or induce abortions. "If providers are forced to stop providing mifepristone, misoprostol alone is also safe and effective," said Dr. Ushma Upadhyay, a public health professor at the University of California, San Francisco. Because misoprostol is approved for medication abortion in the United States as part of the two-drug combination, prescribing it alone to terminate pregnancies would also be considered off-label.

WASHINGTON, April 10 (Reuters) - A federal judge's decision last week to suspend the U.S. Food and Drug Administration's (FDA) approval of abortion pill mifepristone could severely weaken the agency if allowed to stand, health policy and legal experts said. The FDA approved mifepristone, part of a two-drug regimen that accounts for more than half of U.S. abortions, over 20 years ago. Banning its sale calls into question the FDA's power to regulate all drugs nationwide, the experts said. The challenge was brought by a coalition of anti-abortion groups and doctors seeking withdrawal of the FDA's mifepristone approval before Kacsmaryk, who is himself a conservative former Christian activist. Plaintiffs are arguing that the FDA in its 2000 approval did not adequately consider the drug's safety when used by girls under age 18 to terminate a pregnancy.

☆ RSV cases in US show signs of return to pre-pandemic seasonality - CDC
▼ + stars: | 2023-04-06 | by ( ) www.reuters.com time to read: +2 min

April 6 (Reuters) - Respiratory syncytial virus (RSV) circulation is showing signs of return to pre-pandemic seasonality in the U.S. after two years of irregular onsets and peaks, the Centers for Disease Control and Prevention (CDC) said on Thursday. Typically, cases of RSV virus that can cause severe illness or death in the very young and old rose in October before waning in April. The varying timing could be challenging for drugmakers racing to get their RSV vaccines to the market. In both pre-pandemic and pandemic periods, RSV cases began to surge earlier in Florida and the Southeast and later in regions further north and west, the researchers said. "Policy makers should consider RSV seasonality when making recommendations about the timing of studies and administration of new immunization and other RSV prevention products," the report said.

Any impact on the FDA will depend on details of the judge's ruling in the case known as Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The challenge was brought by a coalition of anti-abortion groups and doctors seeking withdrawal of the FDA's mifepristone approval before U.S. District Judge Matthew Kacsmaryk of the Northern District of Texas, a conservative former Christian activist. The court could order mifepristone pulled from the market while it considers a final ruling. It would call into question the entire drug approval process, said Laurie Sobel, associate director for Women's Health Policy at the Kaiser Family Foundation. 'SO MUCH UNCERTAINTY'The possibility of its approvals being overruled would likely see the FDA become more cautious, Lee said.

☆ Exclusive: US to build $300 mln database to fuel Alzheimer's research
▼ + stars: | 2023-04-03 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +4 min

The platform will draw on data from medical records, insurance claims, pharmacies, mobile devices, sensors and various government agencies, they said. The database could help identify healthy people at risk for Alzheimer's, which affects about 6 million Americans, for future drug trials. The U.S. Medicare health plan for older adults will likely require such tracking in a registry as a condition of reimbursement for Leqembi. Silverberg said the data platform could also help researchers working in other disease areas understand which patients are most at risk and the impact of medications. The system would be built in a secure computing environment with a number of restrictions to ensure the privacy of people's health data, Silverberg said.

If successful, Amgen would claim ownership of all antibodies that inhibit the PCSK9 protein, the mechanism of action for both Repatha and Praluent. Other companies could then do the same with their own antibody treatments in other disease areas. The case might also affect newer technologies used in medicine, such as CRISPR gene editing and messenger RNA, she said. A Washington, D.C.-based federal appeals court that covers U.S. patent cases invalidated Amgen's patent claiming ownership of all PCSK9 inhibitors as a whole in 2021. Amgen sued Sanofi and Regeneron in 2014.

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