Friday, November 8, 2024

Teva Confirms Plans To Hive Off API Unit As 2024 Guidance Is Pushed Up Again

(11/7, Dean Rudge, Generics Bulletin) ...Teva has confirmed that a planned divestment of the firm's active pharmaceutical ingredient business, TAPI, is on track for completion in the first half of next year, as the Israeli company marked its seventh consecutive quarter of growth – albeit, swinging by hundreds of millions of dollars to an operating loss in the third quarter on the back of writing off a further $600m of goodwill related to TAPI... Global Sub. Full

Teva Reports Strong Generics Demand in Q3, Expects Higher 2024 Revenue

(11/7, Tristan Manalac, BioSpace) ...CEO Richard Francis in Wednesday's earnings call credited its Q3 performance to Teva's "Pivot to Growth" initiative which it launched in May 2023 "to get Teva back to growth." The company in Q3 renewed its focus on four main strategic pillars—"deliver on our growth engines, step up innovation, create a sustainable generics powerhouse and focus the business," according to Francis... Full

Investing in AI: Benefits, Regulatory Challenges

(11/7, Lori Ellis, BioSpace) ...In this episode, Konstantina Katcheves of Teva Pharmaceuticals and Sanskriti Thakur of TOWER Capital Group provide their insights on the impact of not only the benefits of the technology but the regulatory challenges and uncertainty surrounding AI... Full

Teva's Galafold Generic for Fabry Disease May Be Available in US

(11/7, Marisa Wexler, MS, Fabry Disease News) ...Amicus Therapeutics and Teva Pharmaceuticals have struck a deal that will allow the latter to sell a generic version of Galafold (migalastat), Amicus' chaperone therapy for Fabry disease, to patients in the U.S. Under the agreement, Teva will have its clearance on Jan. 30, 2037, assuming the U.S. Food and Drug Administration approves the company's generic therapy and that no other issues arise in the meantime... Full

Amneal Pharmaceuticals Swings to 3Q Loss While Sales Climb

(11/8, Dean Seal, Dow Jones) ...Revenue from its generics portfolio was up 9% from new product launches and biosimilars. Specialty drugs logged 19% revenue growth from promoted products in neurology and endocrinology, including its Parkinson's disease treatments Crexont and Ongentys... Sub. Req’d

Xanax Maker Viatris Beats Quarterly Estimates On Demand for New Generic Drugs

(11/7, Puyaan Singh, Reuters) ...Sales at Viatris' generic business have been boosted by new products such as Breyna, a cheaper version of AstraZeneca's asthma inhaler Symbicort, and lisdexamfetamine, a generic of Takeda's ADHD drug Vyvanse. The Canonsburg, Pennsylvania-based company reaffirmed its annual sales forecast of $500 million to $600 million for new products, which generated revenue of $133 million during the third quarter... Full

India's Lupin Beats Q2 Profit View On Strong Demand for Generic Drugs

(11/7, Kashish Tandon, Reuters) ...Indian generic drugmaker Lupin reported a bigger-than-expected rise in second-quarter profit on Thursday, driven by strong demand for its respiratory and diabetes management drugs. Consolidated net profit of the company, which makes biosimilars and active pharmaceutical ingredients, rose to 8.53 billion rupees (about $101 million) for the quarter ended Sept. 30, up about 74% from a year earlier and higher than analysts' estimates of 7.29 billion rupees, as per data compiled by LSEG... Full

Celltrion Q3 Net Profit Down Despite Record Quarterly Sales

(11/8, Kim Na-young, Yonhap) ...Celltrion Inc., a major South Korean drugmaker, said Friday its third-quarter net income dropped 62 percent from a year earlier despite posting the highest quarterly sales, mainly due to lingering effects from its 2023 merger with its sales and marketing affiliate... Full

Q2FY25: Alembic Pharma's Profit Rises 12 Percent to Rs 153 Crores; Reports Dip US Sales Growth

(11/7, Financial Express) ...The India Branded Business saw a growth of 6% to Rs.609 crore for the quarter. The company recorded strong growth in its speciality therapies, with 8% growth in gynaecology, 11% in cardiology, 18% in anti-diabetic, and 13% in ophthalmology...In the international business, the US Generics division grew by 5%, contributing Rs.467 crore, with eight new product launches in the US market. Ex-US International Formulations grew by 18%, reaching Rs.298 crore. During the quarter, Alembic received nine ANDA approvals, bringing the total to 214... Full

Jazz Pharma Revenues Rise 9% in Third Quarter

(11/7, The Pharma Letter) ...Jazz Pharmaceuticals has reported third-quarter revenue of $1 billion, a 9% increase over the prior year, fueled by strong performance in its key sleep and epilepsy portfolios...The company affirmed its full-year revenue guidance of $4 to $4.1 billion, with the neuroscience segment - led by products such as Xywav (calcium, magnesium, potassium, and sodium oxybates) and Epidiolex (cannabidiol) - expected to contribute $2.8-$2.9 billion... Sub. Req’d

Coherus Looks To Put Udenyca Supply Issues In The Rearview Mirror

(11/8, Dean Rudge, Generics Bulletin) ...Coherus BioSciences told investors during its November 6, third-quarter earnings call that the firm's labelling and packaging contract manufacturing organization is resuming final packaging of its Udenyca (pegfilgrastim) biosimilar this week, following a recent supply interruption... Global Sub. Full

Pfizer to Invest $1B in China Over Next Five Years — Reports

(11/7, Nicole DeFeudis, Endpoints News) ...Pfizer is doubling down on its commitment to China as the company continues to face activist pressure around its plans for a new phase of growth. Pfizer China President Jean-Christophe Pointeau said the company will invest $1 billion in the country over the next five years, according to local media reports... Full

Soft RSV Sales Reveal a Vaccine Market Failing to Catch Post-Covid Momentum

(11/7, Max Bayer, Endpoints News) ...Pfizer's third-quarter sales dropped 5%, while GSK had a massive 73% decline compared to the third quarter of 2023. Moderna, which had its adult vaccine approved over the summer, reported just $10 million in revenue, well below the other two pharmas. The figures validate pessimism heading into the vaccination campaign after the CDC slightly narrowed its RSV recommendations over the summer, and executives at all three vaccine manufacturers pointed to the revised recommendations as impacting the market in the second season... Full

Home Remedy: Indian Pharma Bets On Domestic Brands to Combat US Generics Slowdown

(11/8, Abhinaba Saha, Mint) ...Indian pharma companies have long been key providers of generic medicines to the US market, accounting for 47% of all generic prescriptions in 2022, according to a recent report by the IQVIA Institute. But with growth in this business plateauting because of weaker demand, stiffer competition and expiring patents, companies are increasingly tapping the domestic market for branded medicines and health products, which has plenty of room to grow... Sub. Req’d

Skyrizi Overtakes Humira: "Product Hopping" Leaves Biosimilar Market in Limbo

(11/7, Skylar Jeremias, The Center For Biosimilars) ...Skyrizi (risankizumab-rzaa) has taken the sales crown away from Humira (reference adalimumab) for the first time, just under 2 years after the first biosimilar to Humira entered the US market, according to AbbVie's financial report for the third quarter of 2024...Humira's global revenues fell to $2.227 billion, down 37.2% on a reported basis, with US sales declining 41.6% to $1.765 billion, while international sales decreased by 12.4% to $462 million. In contrast, Skyrizi saw a 50.8% global increase to $3.205 billion, and Rinvoq rose 45.3% to $1.614 billion... Full

Zentiva Responds To Rumors Of Potential Advent Sale

(11/7, Dave Wallace, Generics Bulletin) ..."At Zentiva, in general, we do not comment on speculations," a company spokesperson told Generics Bulletin in response to queries over the report. "Since 2018, Zentiva is owned by Advent International and has started an exciting growth journey," they underlined, with Advent acquiring the firm from former owner Sanofi for €1.9bn six years ago... Global Sub. Full

Daiichi Sankyo Partners Alteogen On Subcutaneous Enhertu

(11/8, Phil Taylor, Pharma Phorum) ...Alteogen will receive an upfront payment of $20 million, with another $280 million on offer from Daiichi Sankyo if the new formulation of Enhertu (trastuzumab deruxtecan) makes it to market and meets sales targets. If that does happen, HER2 inhibitor Enhertu could become the first drug in the antibody-drug conjugate (ADC) class to be delivered subcutaneously – which is a tall order for such a large molecule – rather than by intravenous infusion. That could make it possible for patients to receive the drug outside of clinic settings, and potentially even at home using a self-injector... Full

CerpassRx, Waltz Health Team Up to Bring Down Specialty Pharmacy Costs

(11/7, Paige Minemyer, Fierce Healthcare) ...CerpassRx, an independent pharmacy benefit manager, is teaming up with Waltz Health to launch a new AI-powered tool that aims to better manage specialty drug spending. Called Intelligent Specialty Engine, the tool leans on Waltz's capabilities to offer clients real-time data analytics and management options that are designed to drive down spending, create greater transparency and improve the experience for both the patient and the plan sponsor... Full

FDA Proposes Ending Use of Decongestant Found in Many Cold, Allergy Medicines

(11/7, Annika Kim Constantino, CNBC) ...The agency said an extensive review of available data determined that the ingredient, oral phenylephrine, doesn't actually relieve nasal congestion. It comes more than a year after advisors to the FDA unanimously reached the same conclusion... Full

Former FTC Official Expects Trump Admin To Back FTC's PBM Crackdown

(11/7, Gabrielle Wanneh, InsideHealthPolicy) ...Washington insiders expect Trump to scale back FTC's other anticompetitive activities, but the president-elect might embrace the commission's efforts to crack down on PBM practices considered to be opaque, anticompetitive and deceptive, according to David Balto, an antitrust lawyer who worked for FTC and the Justice Department's antitrust division during former President Bill Clinton's administration... Sub. Req’d

Robert Kennedy Jr's Influence Over Donald Trump Sparks Big Pharma Alarm

(11/8, Oliver Barnes, Financial Times) ...Kennedy, nephew of the late president John F Kennedy, wrote on X that his ambition was to "Make America Healthy Again by ending the chronic disease epidemic". He has also said he would install monitors in the White House with real-time data on obesity and depression rates in the US. But his influence over health policy "would be awful on a lot of levels", said one senior health executive... Full

Warp Speed For All And A Boost For Small Biotechs In Trump's Second Term, Ex-Official Says

(11/8, Sarah Karlin-Smith, Pink Sheet) ...The US Food and Drug Administration will likely experience "a lot of deregulatory pressure" in Trump's second term and focus on applying the principles of Operation Warp Speed, Trump's first term COVID-19 vaccine and therapeutic acceleration program, to more product reviews, predicted Tomas Philipson, a White House adviser during Trump's first term... Global Sub. Full

AAM & Biosimilars Council Statement On Presidential Election

(11/7, AAM) ...[CEO John Murphy III] "...AAM and the Biosimilars Council as always looks forward to working with Congress, regulators, and the White House on real solutions to help patients increase access to generic and biosimilar medicines and solidify a sustainable and robust generic marketplace that is currently under threat. There is bipartisan consensus on the need to support a robust and resilient generic and biosimilar market in the US, which supplies 90% of all prescribed drugs but only represents 13% of the spending and is the only element of the healthcare ecosystem where prices decrease..."... Full

Sponsors Responsible For Ensuring AI Is ‘Fit For Purpose,' Says EU Regulator

(11/7, Eliza Slawther, Pink Sheet) ...Pharma companies that use AI at any stage in the drug lifecycle must ensure that their algorithms, models and datasets are fit for purpose and explainable, according to Gabriel Westman, head of AI at the Swedish Medical Products Agency. Westman, who was speaking at a joint EU Heads of Medicines Agencies and European Medicines Agency multi-stakeholder workshop on enabling the safe and responsible use of AI on November 5, said he was "confident" that AI tools could support all aspects of the drug lifecycle if used "correctly."... Global Sub. Full

EU Council Adopts Wastewater Directive Threatening Generics Industry

(11/7, Urte Fultinaviciute, Generics Bulletin) ...The European Council has formally adopted the EU Urban Wastewater Treatment Directive, introducing an extended producer responsibility system, in which pharmaceutical and cosmetic sectors will have to finance wastewater treatment plants across Europe. "I am disheartened to see this law adopted by the Council today," said Adrian van den Hoven, director general of off-patent industry association Medicines for Europe... Global Sub. Full

FOPE Spots Potential Opportunities for Indian Cos in Australia & ECTA Seen to Propel Easy Market Access

(11/8, Pharmabiz.com) ...The Federation of Pharmaceutical Entrepreneurs (FOPE) has identified potential opportunities for Indian pharmaceutical companies to expand in Australia. Further, the India-Australia Economic Cooperation and Trade Agreement (ECTA) will facilitate strengthening of trade and investment in pharma among other sectors... Full

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