Friday, May 17, 2024

Teva Taps Matthew Shields to Oversee Manufacturing and Supply Division Amid Company Revamp

(5/16, Joseph Keenan, Fierce Pharma) ...Teva, which continues on track with its corporate revamp initiated a year ago, named pharma veteran Matthew Shields as executive vice president of its global operations division responsible for manufacturing and supplies...The appointment comes as the pharma giant pushes forward with its "Pivot to Growth" strategy that has seen Teva reduce its manufacturing footprint, closing three sites last year and reducing its overall production sites to 49, company execs said during an analyst call after Teva reported first-quarter earnings last week... Full

New EVP, Teva Global Operations Appointed

(5/16, Catherine Eckford, European Pharmaceutical Review) ...Matthew Shields has been appointed as Executive Vice President of Teva Pharmaceutical Industries Ltd.'s manufacturing and supply division. His position within Teva Global Operations will commence on June 3, 2024. He will be part of the company's Executive Leadership Team and be based at Teva's US headquarters. Mr Shields stated that he is "honoured" to take on his new role... Full

Teva Names Matthew Shields to Executive VP, Global Operations Role

(5/16, Sandra Levy, Drug Store News) ...Shields said, "Teva is clearly a company with incredible potential based on the early progress of its Pivot to Growth strategy, and its tremendous heritage in manufacturing important medicines serving the needs of patients around the world. I'm honored to take on this critical role, and eager to begin working with the talented team in Teva Global Operations, and my colleagues across the Company, to deliver on our inspiring purpose."... Full

Teva Lures Former Merck SVP to its Executive Team

(5/15, The Pharma Letter) ...Israeli generics giant Teva Pharmaceutical Industries has appointed Matthew Shields as executive vice president of Teva Global Operations, the company's manufacturing and supply division, effective June 3, 2024. Mr Shields succeeds Eric Drapé, who is leaving after 11 years with Teva, including more than four years as EVP global operations. Mr Shields will be a member of Teva's executive leadership Team and report directly to president and chief executive Richard Francis. He will be based in Teva's US headquarters in Parsippany, NJ... Sub. Req'd

Sudocrem Kicks Off Global Campaign to Highlight Versatility

(5/16, Daniel Selwood, The Grocer) ...Antiseptic cream Sudocrem has kicked off its first global campaign, ‘Not just for babies, for everybody'. Rolling out this week, the push sees the Teva Pharmaceuticals brand go beyond its longstanding focus on being exclusively a treatment for nappy rash. It includes messaging around its soothing properties and versatility in treating people of all ages for the likes of cuts, grazes, eczema and acne...Sudocrem had "firmly established itself as a versatile, essential, and cherished brand in households around the world", said Nicholas Lang, Teva Pharmaceuticals director of global OTC marketing... Full

Viatris Reveals Next Steps For Once-Monthly US Copaxone Rival After Rejection

(5/16, Dean Rudge, Generics Bulletin) ...Viatris intends to seek a meeting with the US Food and Drug Administration "in the next few months" – potentially in Q3 – after its Mapi Pharma-partnered proposed once-monthly glatiramer acetate ‘GA Depot' product, a follow-on to Teva's Copaxone treatment for relapsing forms of multiple sclerosis, was knocked back by a complete response letter...Now, the firm revealed that it would continue to work with Mapi to respond to the FDA comments, and then "determine the next steps" after its planned meeting with the agency... Global Sub. Full

Deals In Bag, Dr Reddy's Sharpens Top 5 Targeted Home Run

(5/17, Anju Ghangurde, Generics Bulletin) ...A string of strategic deals including with Sanofi, Bayer and Nestle marked the last couple of months at Dr. Reddy's Laboratories Ltd., as the Indian firm plugs portfolio gaps and builds momentum along its journey to break into the top five position on the Indian market...Dr Reddy's India business, adjusted for brand divestment income, on a "re-based comparator", grew 11% year-on-year (YoY) in Q4 and Israeli expects the growth in branded generics to continue with new product introductions and alliances, adding further impetus. That would mean that the expectation for the India business is to grow beyond the growth that is anticipated from branded generics... Global Sub. Full

Lundbeck Blames FDA-Imposed DTC Blackout for Slowdown in Rexulti Growth

(5/16, Nick Paul Taylor, Fierce Pharma) ...Lundbeck has learned an unwanted lesson in the value of DTC advertising. After pushback from the FDA forced Rexulti depression ads off the air, Lundbeck reported a flattening of prescriptions that appears to be rebounding now promotion has resumed...Lundbeck management discussed the impact of the four-month DTC blackout on a first quarter earnings call Wednesday. Thomas Gibbs, head of Lundbeck in the U.S., said growth outside of Alzheimer's disease moderated in the first quarter, a trend he attributed to the MDD campaign being off the air... Full

India's Biocon Posts Q4 Profit Fall as Higher Raw Material Costs Bite

(5/16, Rishika Sadam and Kashish Tandon, Reuters) ...Indian biopharmaceutical company Biocon reported a decline in its fourth-quarter profit on Thursday, as soaring raw material costs overshadowed growth in its biosimilar business in key United States and Europe markets...Its revenue from operations rose 16% to 29.47 billion rupees, boosted by a 12% increase in its biosimilars business...Revenue from the company's generic drugs business fell 3.5%... Full

In Big Pharma's Growth Rankings, Lilly Took Top Spot from Novo Nordisk in Q1

(5/16, Kevin Dunleavy, Fierce Pharma) ...With 18 of the industry's top 25 companies achieving year-over-year revenue gains, the first quarter of 2024 nearly matched the final quarter of last year, when 21 of the industry's top 25 companies posted sales increases. Additionally, nine companies realized double-digit growth in the first three months of this year, which was one more than in the previous period...Several giants of the biopharma industry are among the companies that posted single-digit revenue increases in the first quarter, including Merck (9%), GSK (6%), Bristol Myers Squibb (5%), Gilead (5%), Teva (4%), Sanofi (2%), Johnson & Johnson (2%) and AbbVie (1%)... Full

GlaxoSmithKline Pharma India Posts Higher Q4 Adjusted Profit On Strong Sales

(5/17, Kashish Tandon, Reuters) ...Drugmaker GlaxoSmithKline Pharma India reported a 49% rise in fourth-quarter adjusted profit on Friday, as strong demand for its generic medicines offset the impact of the government's ongoing price curbs on its key drugs...Revenue from operations rose 18% to 9.30 billion rupees, led by a 12% growth in its generic medicines portfolio which the company attributed to key focus brands Augmentin, Ceftum and Calpol... Full

GSK Raises $1.5 Bln from Sale of Remaining Haleon Stake

(5/17, Prerna Bedi, Reuters) ...British drugmaker GSK has raised 1.25 billion pounds ($1.52 billion) from a sale of its remaining stake in consumer healthcare company Haleon to institutional investors. The sale will allow GSK to sharpen its focus on vaccines, cancer and infectious diseases, which are part of CEO Emma Walmsley's plans to boost earnings at the drugmaker... Full

Zydus Lifesciences Inks Licensing, Supply Pact with MSN for Generic Cancer Drug in US Market

(5/17, Press Trust Of India) ...The company's wholly-owned subsidiary, Zydus Lifesciences Global FZE, has entered into an exclusive licensing and supply agreement with MSN Laboratories for Cabozantinib tablets for the US market, Zydus Lifesciences Ltd said in a regulatory filing. Cabozantinib tablet is the generic version of CABOMETYX of Exelixis... Full

Pharma Major Glenmark Gets USFDA Nod for Generic Ophthalmic Solution

(5/17, Press Trust Of India) ...Glenmark Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic brimonidine tartrate and timolol maleate ophthalmic solution indicated in the treatment increased pressure in the eye caused by glaucoma or other conditions... Full

Pharma is Rethinking How it Interacts with Patients After Eli Lilly Ripped Up the Playbook

(5/16, Shelby Livingston, Endpoints News) ...More pharma companies are considering taking a tip from Eli Lilly and offering their drugs directly to patients. "I would be surprised, and, I would say, be derelict if we were not thinking about that," said Eden Wells, Novartis' chief insights and decision science officer, in a panel Thursday at the Financial Times' US Pharma and Biotech Summit in partnership with Endpoints News... Full

Biogen CEO Viehbacher Undaunted by Lilly's Impending Alzheimer's Therapy, Saying it Will ‘Expand' Market

(5/16, Max Gelman, Endpoints News) ...Facing a challenging launch for the Alzheimer's drug Leqembi, Biogen CEO Chris Viehbacher said he would welcome competition from other companies, including Eli Lilly, which is aiming for an approval of its therapy later this year. "We actually think that Lilly coming into the market will just help expand this market," Viehbacher said Thursday, speaking at the Financial Times' US Pharma and Biotech Summit, held in partnership with Endpoints News... Full

Analysis of Pharmaceutical R&D Ranks Novo Nordisk and Johnson & Johnson Above Their Peers

(5/16, Matthew Herper, STAT Plus) ...When it comes to bringing an experimental drug to market and selling it, Novo Nordisk, the maker of the weight loss drug Wegovy, is tops, according to a new analysis...The analysis, the 13th edition of the Pharmaceutical Innovation and Invention Index, was produced by the consultancy Idea Pharma and released Thursday at the STAT Breakthrough Summit in San Francisco...The rankings themselves are interesting for those who follow pharma, and the data behind them provide some key insights into how the industry as a whole is doing when it comes to productivity... Sub. Req'd

Former Sandoz Exec Sentenced to Probation in Price-Fixing Case

(5/16, Zoey Becker, Fierce Pharma) ...Hecter Armando Kellum, a former senior executive at Sandoz, pleaded guilty back in 2020 to the charge of conspiracy to restrain trade. The federal charge stemmed from his participation in an anticompetitive price-fixing web for generic drugs from 2013 to 2015. The charge held a maximum sentence of 10 years in prison and a fine of up to $1 million, according to the 2020 plea agreement. In exchange for his guilty plea, Kellum agreed to cooperate with the federal investigation into the generics pricing conspiracy. Now, four years later, the former Sandoz employee has been sentenced to serve one year of probation and pay a $20,000 fine... Full

As Childhood Asthma Worsens, Insurers Restrict Access to An Essential Medication

(5/16, Chén Kenyon, Bianca Nfonoyim Bernhard, and Tyra Bryant-Stephens, STAT) ...But in the transition away from Flovent, some large insurers and their pharmacy benefit managers - both commercial and Medicaid - made a decision not to cover generic fluticasone. This decision was made on cost, as several FDA-approved alternatives in this class of medicines, called inhaled corticosteroids, are cheaper than generic fluticasone. This is a practice called non-medical formulary switching, which typically occurs when a PBM changes coverage to an alternative drug for which it can negotiate a better price, but is not necessarily better for patients... Full

HCP Perspectives: Access Challenges in Treating Diabetes & Obesity

(5/17, Adam J. Fein, Ph.D., Drug Channels) ...Today's guest post is from Dr. Preeti Parikh, a practicing pediatrician and VP, Executive Medical Director at GoodRx. At the recent Publicis Health Media HealthFront event, Preeti hosted a dialogue on the main stage with Dr. Minisha Sood. They discussed new GoodRx research and had a candid discussion about their daily challenges in caring for patients—especially those living with diabetes and obesity... Full

Sanders Seeks Denmark's Help To Lower Weight-Loss Drug Prices, Industry Says It Could Backfire

(5/16, Maaisha Osman, InsideHealthPolicy) ...Senate health committee Chair Bernie Sanders (I-VT) released data suggesting weight-loss drugs could soon cost the U.S. health system more than all other drugs combined and he is now asking Denmark to pressure Novo Nordisk to bring its U.S. prices down to those in that country, but industry experts said Thursday (May 16) using international reference pricing could backfire because it could lead to higher prices overseas... Sub. Req'd

CMS Proposal To Further Reduce Medicaid 'Best Prices' Thwarted, For Now

(5/16, Cathy Kelly, Pink Sheet) ...CMS will not move forward with a proposal to lower the best price in Medicaid by adding together all the drug discounts provided to different members in the supply chain. The agency will collect additional information from manufacturers on methods for ‘stacking' discounts. Regulatory experts see the move as an acknowledgement that the policy would not withstand legal scrutiny... Sub. Req'd

Second House Panel Advances Two-Year Telehealth Extension

(5/16, Rachel Cohrs Zhang, STAT) ...A House subcommittee on Thursday advanced legislation that would extend some pandemic-era telehealth policies in Medicare for two years, bringing the panel's approach in line with another committee...The progress is important as it helps define the scope of the health care legislation Congress will be considering in December, when several other health programs are expiring... Full

Regeneron Says Congress Wanted Tougher Kickback Claim Standard

(5/16, Daniel Seiden, Bloomberg Law) ...The government says that Regeneron funneled money into a charity to reimburse Medicare copays of patients taking macular degeneration drug Eylea. This conduct violated the Anti-Kickback Statute, and tainted claims submitted to Medicare, the government says. When the government brings this type of claim, it must show a but-for causal relationship between the kickback and a claim for services submitted to the government for reimbursement, Regeneron said in its Wednesday brief with the US Court of Appeals for the First Circuit... Sub. Req'd

Big Pharma Leaders Juggle Pricing and Access as IRA and Supply Constraints Loom Large

(5/16, Michael Gibney, Pharma Voice) ...Execs from J&J, Novartis, Novo Nordisk and AbbVie sound off on the Inflation Reduction Act, supply issues and launch preparations in a tricky environment. As Big Pharma looks back on the beginning of 2024, pricing and access stand out as major factors deciding the future of the industry...Here's what leaders at some of the largest pharma companies had to say about the industry environment in light of pricing and access pressures as they reported first-quarter earnings over the last few weeks... Full

Expert Discusses the Impact of Medicare Drug Pricing Reforms on the Pharmaceutical Industry

(5/16, Pharmacy Times) ...Corey Ford, vice president of reimbursement and policy insights at Cencora, discusses the impact of recent drug pricing legislation on the pharmaceutical industry and Medicare beneficiaries. He mentions that drugs could be limited due to formulary control, support programs for patients should be redesigned, and innovation could be potentially negatively impacted... Full

Pharma Facing Growing Risks From Geopolitics, Industry Leaders Warn

(5/16, Jessica Merrill, Pink Sheet) ...Industry leaders and experts at the Financial Times Pharma and Biotech Summit said the US relationship with China adds pressing risk to pharma. Pharmaceutical industry leaders worry about the frosty relations between the US and China and its growing risk for their businesses, especially with US elections approaching. "Amongst CEOs we are suddenly saying, hey we need to think about geopolitics," Biogen, Inc. CEO Christopher Viehbacher said May 16, during a keynote discussion opening the Financial Times Pharma and Biotech Summit in New York... Sub. Req'd

Patient Access to Medicines Must Be the Focus of US Drug Pricing Policy

(5/16, Justine Ra, Pharmaceutical Technology) ...While innovation has continued to advance with the arrival of CRISPR-based gene therapies and the boom of GLP-1 agonists, the sometimes unsustainable and unaffordable nature of drugs is tipping the balance within the drug development and marketing ecosystem, two experts at the Financial Times Live US Pharma and Biotech Summit said...The concern with the IRA is that the conversation about drug value and pricing is taking place in a system with "perverse incentives" and with a primarily fiscal and economic valuation mindset, said [CEO of National Pharmaceutical Council John O'Brien]... Full

FT US Pharma and Biotech Summit: Live Coverage

(5/16, Jonah Comstock, Pharma Phorum) ...We'll hear from Biogen president and CEO Christopher Viehbacher to kick things off. Then, after an investment panel featuring voices from GSK and Goldman Sachs, FDA associate director for policy analysis Tala Fakhouri will take the stage for a Q&A. The day will continue with breakout sessions on drug pricing and patient engagement, a cell and gene therapy panel packed with representatives of Bayer, Astellas, and Gilead's Kite Therapeutics, and another government Q&A, this one with FTC deputy director Rahul Rao... Full

Biotech CEO: Bayh-Dole 'Fix' Won't Lower Drug Prices

(5/17, John Glasspool, Boston Business Journal) ...The public-private investment partnership that Bayh-Dole created is critical for advances across not just the bio-medical field but also a swath of other industries including green technologies, super-computing, agriculture, quantum computing, national defense, public safety products and protections, infrastructure, and more. The unintended consequences of amending march-in rights will be disastrous. It will stifle research and innovations already in the pipeline, stymie new research and development across the economic board, and hurtle the U.S. back to where it was before 1980, when science sat on shelves instead of becoming products in medicine cabinets... Full

Majority Of US Patent Thickets Filed Post-FDA Approval, Study Finds

(5/16, Urte Fultinaviciute, Generics Bulletin) ...A new investigation has found that 72% of patent applications linked to the 10 top-selling prescription drugs in the US for 2021 were filed after receiving approval from the US Food and Drug Administration...The abstract of the study does not reveal what were the best-selling drugs in 2021, and other external sources have slightly varying lists. However, most lists have several common denominators such as Pfizer's Comirnaty, AbbVie's Humira, Moderna's Spikevax, Merck's Keytruda, and Bristol Myers Squibb's Revlimid... Global Sub. Full

Local Lawmaker Wants to Import, Stockpile Drugs from Canada to Address Drug Prices

(5/17, Samantha Wildow, Springfield News-Sun) ..."In an effort to lower drug prices for consumers across Ohio, we have introduced legislation that would allow the state of Ohio to contract with experienced, private companies to arrange the importation of drugs," [State Rep. Tom Young] said. The drugs would be required to be surplus or produced in excess of what the manufacturer normally makes to avoid negative supply chain internal issues, he said. The bill includes an appropriation of $2 million for the Ohio Board of Pharmacy to import drugs... Full

Reservations On EU Proposal On Compulsory Licensing Expressed by Pharma Trade Group

(5/17, The Pharma Letter) ...A coalition of several European organizations, including the European Federation of Pharmaceutical Industries and Associations, have been closely monitoring the developments regarding the EU Commission proposal for a regulation on European Union compulsory licensing for crisis management...While some improvements to the proposal were adopted by the European Parliament, including greater involvement of the rights-holder, a requirement for attempted voluntary licensing, and a reasoned approach to remuneration, there are other problematic provisions that remained, such as inadequate judicial review and forced technology transfer/trade secret sharing, the coalition members note... Sub. Req'd

UPS Healthcare Opens First Irish Pharma Logistics Facility

(5/16, Hazel King, Parcel and Postal Technology International) ...With Ireland's pharma market accounting for nearly 50% of the country's exports and there being a growing need for advanced temperature-controlled logistics to support this, UPS Healthcare has announced the opening of a first-of-its-kind facility to support this sector...Cathy O'Brien, vice president for international sales at UPS Healthcare, explained, "This investment marks our commitment to supporting Ireland's world-leading pharmaceutical and medical device industries."... Full

Drug Shortages: Pharma Decries 'Yet Another Tax' For Companies In Belgium

(5/16, Neena Brizmohun, Pink Sheet) ...A new annual tax that Belgium plans to start imposing on pharmaceutical companies to compensate for the costs arising from shortages of medicines that must then be replaced by more costly alternatives is unfair and could make the shortages problem even worse, says a Belgian industry group. The new so-called "unavailability contribution," which companies will have to pay based on their marketing authorizations and parallel import licenses for reimbursed drugs, "seems to punish precisely those companies that are currently helping to solve the problem of shortages," according to generics and biosimilars industry association Medaxes... Sub. Req'd

Colombia Signs Agreement With PAHO To Strengthen Regulatory Capacity

(5/16, Francesca Bruce, Pink Sheet) ...Colombia's health products regulator, INVIMA, and the Pan American Health Organization have signed a cooperation agreement centered on strengthening the country's regulatory capacity when it comes to medicines, medical devices, food and other products subject to health surveillance. The objective is to ultimately make both the country and the Americas region more self-sufficient in terms of providing health care, said INVIMA... Sub. Req'd

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