Monday, August 19, 2024

‘Inhalation Is A New Vector Of Growth' For Amneal As Albuterol Goal Date Gets Closer

(8/16, Urte Fultinaviciute, Generics Bulletin) ...After fighting tooth and nail against originator Teva and its ProAir HFA (albuterol sulfate), Amneal is getting ready for the finale of the inhaler saga. During the recent Q2 FY2024 investor's call, one of the firm's co-founders and co-CEOs Chintu Patel said that Amneal's generic version of albuterol sulfate has a US Food and Drug Administration goal date in the fourth quarter of this year... Global Sub. Full

Considering Fundraising Options to Lower Debt: Biocon MD

(8/19, Financial Express) ...Biocon reported a healthy topline and bottomline during the April-June quarter, with its largest business segment biosimilars seeing a strong growth. However, the generics business faced significant pressure from pricing challenges and demand contraction. Siddharth Mittal, CEO & managing director, Biocon, discusses with FE how the company is focusing on launching new products and establishing strategic partnerships... Full

Xbrane Reveals Urgency To Find A Partner For One Of Two Biosimilars By October

(8/19, Dean Rudge, Generics Bulletin) ...Xbrane Biopharma has disclosed that it must secure an out-licensing deal by this October for one of its two biosimilar candidates that are up for grabs, in order to satisfy the company's working capital requirements from the beginning of November 2024 and onwards. However, the Swedish player believe this is "feasible," considering the "high level of interest" and uniqueness in its XB003 proposed biosimilar to UCB's Cimzia (certolizumab pegol); and the "revised streamlined clinical development focusing on outside of US markets based on positive European Medicines Agency feedback" for its Xdivane (nivolumab) proposed biosimilar to Opdivo... Global Sub. Full

Samsung Bioepis Hit By Amgen Denosumab Lawsuit

(8/19, Urte Fultinaviciute, Generics Bulletin) ...Amgen has asserted 34 patents for alleged infringement against Samsung Bioepis, which is the highest number out of the three lawsuits filed by the originator against a denosumab biosimilar maker...With multiple biosimilar companies nearing the filing stages in the US for their denosumab products, it begs the question of how many more lawsuits can Amgen afford to protect its biologics that brought in combined revenues of $1.73bn in Q2 2024, according to Amgen's latest earnings report... Global Sub. Full

Alvotech Moves Forward As Aflibercept Filing Lands On EMA's Desk

(8/16, Dean Rudge, Generics Bulletin) ...Alvotech is eyeing a European marketing authorization for its AVT06 proposed biosimilar to Eylea (aflibercept) 2mg in the third quarter of next year after the Icelandic firm's application was accepted for filing by the European Medicines Agency. Advanz Pharma will serve as Alvotech's chief commercialization partner in Europe upon potential approval, under the terms of a partnership forged earlier this year... Global Sub. Full

FDA Approves Celltrion's Phase 3 Trial of Zymfentra for Rheumatoid Arthritis

(8/19, Kim Chan-hyuk, Korea Biomedical Review) ...Celltrion said Monday that the U.S. Food and Drug Administration has approved a phase 3 clinical trial of its Remicade biosimilar, Zymfentra (CT-P13 SC, infliximab), for the indication of rheumatoid arthritis (RA). Celltrion will analyze the efficacy and safety of Zymfentra vs. placebo in 189 patients with RA... Full

Celltrion Eyes Top 5 Drug Maker by 2030

(8/19, Park Li-na, The Korea Herald) ...South Korean biopharmaceutical firm Celltrion Pharm unveiled Monday a new vision to become one of South Korea's top five pharmaceutical companies by 2023. Under Vision 2030, Celltrion Pharm said the company aims to make a quantum leap by enhancing its core business strengths and implementing differentiated growth strategies across its manufacturing, research and sales divisions... Full

Glenmark Launches OTC Eye Drops to Meet Growing Demand

(8/19, Anupama Ghosh, The Hindu BusinessLine) ...Glenmark Therapeutics Inc., USA announced today the launch of Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1 per cent (OTC), a generic version of Pataday® Twice Daily Relief... Full

Aurobindo Pharma to Commercialise China Plant in 3rd Quarter of FY25: CFO

(8/19, Press Trust Of India) ...Aurobindo Pharma expects its China facility to commence production in the next quarter with full-scale output anticipated only in the next fiscal year, according to Chief Financial Officer Santhanam Subramanian..."Our China plant is expected to be commercialised from Q3 FY25, and the ramp up is expected from Q4 FY25," Subramanian said in an analyst call... Full

Pfizer Is Staking Its Turnaround On Cancer Drugs

(8/19, Jared S. Hopkins, The Wall Street Journal) ...The drugmaker is betting much of its future on cancer drugs, wagering they can ring up billions of dollars in new sales and turn around a company struggling with falling Covid-19 revenue and the lower-priced competition that looms for some big-selling products...Pfizer expects Seagen drugs, known as antibody drug conjugates or ADCs, to generate $10 billion in annual sales by 2030... Sub. Req'd

Strides Pharma Arm Receives 'Voluntary Action Indicated' Classification from USFDA for Chennai Facility

(8/19, CNBC TV 18) ...The inspection resulted in a classification of "Voluntary Action Indicated" (VAI) for the Alathur facility, indicating that while some issues were noted, it does not warrant regulatory action and can be addressed by the company voluntarily... Full

Baltimore Settles for $152M with Opioid Distributor Cardinal Health, Bringing Total Winnings to $240M

(8/16, Madeleine O'Neill, The Baltimore Sun) ...Friday's settlement comes one day after a Baltimore judge declined to throw out the city's lawsuit against Johnson & Johnson, McKesson, Cardinal Health, AmerisourceBergen (now called Cencora), Teva Pharmaceuticals and Walgreens. The settlement means Cardinal Health will not participate in the trial, which begins Sept. 16... Sub. Req'd

Endo Trustee Sues McKinsey Over ‘Reckless' Opioid Sales Advice

(8/16, James Nani, Bloomberg Law) ...Consulting giant McKinsey & Co. should pay for the harm it caused pharmaceutical maker Endo International Plc through its "reckless" advice on marketing and selling opioids, a bankruptcy plan trustee said in a lawsuit. The suit, filed Thursday in the US Bankruptcy Court for the Southern District of New York, is brought on behalf of a trust created to pay unsecured creditors of Endo and its affiliates... Sub. Req'd

Biosimilar Uptake Lags in US Despite Potential Cost Savings

(8/16, Cameron Santoro, AJMC) ...Biosimilar uptake in the US has not met the expectations of many health care professionals who believe biosimilars can lead to reduced spending, according to a study published in Health Affairs... Full

When Payers Become Producers: Inside the PBM Private-Labeling Trend

(8/16, Adam J. Fein, Ph.D, Drug Channels) ...Regardless of what the future holds, biosimilar manufacturers will need to prioritize early market access planning to ensure utilization. As interchangeability becomes more of a given, differentiating a biosimilar from its competitors will require a smart marketing strategy to demonstrate its value to patients, providers, and payers-as well as their production arms... Full

Medicare Drug Price Cuts Add Fuel to Legal Fight Over Program

(8/16, Nyah Phengsitthy, Bloomberg Law) ....The list of negotiated prices is one piece of a puzzle that's been the foundation of several claims debating how far the government will go with price cuts. The unveiled prices may serve to either give a much needed boost in support for theories that the program causes financial harm to drugmakers, or further bolster US claims that an actual negotiation took place, health attorneys say. "Now that we have the prices for the first year, I wouldn't be surprised if we see that influence the litigation that's underway, whether through further filings or briefing on the impact of the actual price cuts," said Margaux Hall, a health-care partner at Ropes & Gray LLP... Full

Diabetes/Weight-Loss Drugs Expected To Be Negotiated Next, CMS Faces Hit If Coverage Expanded

(8/16, Gabrielle Wanneh, InsideHealthPolicy) ...Health policy experts predict popular diabetes and weight-loss treatments Ozempic and Wegovy could be next in line for CMS to negotiate Part D prices, as yet another study emerged this week predicting a huge financial hit to Medicare were Congress to lift the ban on CMS covering the drugs for weight-loss indications... Sub. Req'd

The Feds Are ‘Playing Nice' With Pharma, at Least for Now

(8/16, David Wainer, The Wall Street Journal) ...The bottom line is that the government is certainly extracting an additional discount, but it isn't a major one for many drugs. The overall net cut to spending, according to the Centers for Medicare & Medicaid Services estimate based on 2023 prices, is about 22%, though even that number is widely debated among analysts. The short-term overhang might be gone, but the long-term risk for pharma is still very much present... Sub. Req'd

A Better Deal: Medicare Discounts Surpass Estimated PBM-Negotiated Rebates

(8/16, Cathy Kelly, Pink Sheet) ...Medicare negotiators appear to have succeeded in obtaining discounts on the 10 drugs in the program that surpass current rebates...But analyses of the outcome of the first round of Medicare price negotiations are hampered by a lack of data from CMS...Factors including potential pricing and rebate changes between now and implementation of the negotiated prices in 2026 also make predicting the savings that will be created difficult... Sub. Req'd

Medicare Drug Price Deal: What's Next?

(8/17, Berkeley Lovelace Jr., NBC News) ...It's a major milestone in the Biden administration's push to reduce the skyrocketing costs of prescription drugs in the U.S. But there's a lot to still work out, including the burning question: Will older adults see the savings at all if drugmakers succeed in having the negotiations blocked by the courts... Full

Medicare Negotiations Have Concluded. What's Next for Court Cases Against the IRA?

(8/16, Nicole DeFeudis, Endpoints News) ...Multiple drugmakers say they are sticking with their legal strategies against the Inflation Reduction Act even though they agreed to negotiated prices for their therapies..."We continue to believe the IRA's so-called ‘negotiation' program violates the Constitution in several fundamental respects," a Merck spokesperson told Endpoints News on Friday...Novo Nordisk also confirmed to Endpoints on Friday that its legal approach "is not changing," and Novartis said in a statement on Thursday that it continues to believe "the price-setting provisions in the IRA are unconstitutional."... Full

Medicare Drug Price Cuts Could Have Limited Early Impact, But Grow with Time

(8/16, Jonathan Gardner, BioPharma Dive) ...The industry lobbying group PhRMA warned of the potentially dire consequences Medicare's new powers may levy on drug research and access. In a statement, the group claimed the threat of lower prices may cause private funding to dry up, research incentives to shift, and Medicare premiums to climb..."The likely already substantial [price] discounts given to Medicare could help somewhat reduce the impact of these and future negotiated prices," wrote RBC Capital Markets analyst Brian Abrahams in a note to clients. "With several of these initial 10 drugs already approaching their patent cliffs anyway, biopharma companies may have given more concessions to build goodwill in future negotiations."... Full

The Unintended Consequences of Government Price Setting in Medicare Part D

(8/16, Nicole Longo, PhRMA) ...Yesterday, the administration released the government-set prices for the first 10 medicines selected under the Inflation Reduction Act (IRA). The announcement left out important context about what is already happening in Medicare Part D because of the changes in the IRA and how Medicare patients are negatively impacted... Full

What the Newly Released Medicare Prices for 10 Drugs Do and Don't Tell Us

(8/16, Sarah Emond, STAT Plus) ...As our attention now turns to implementation, we must ensure that there are no unintended consequences for patients, especially related to the choices health plans and pharmacy benefit managers will make regarding the formulary placement of the negotiated drugs. Price transparency has a dark underbelly - it exposes the sometimes distortive impact of rebates on patient access... Sub. Req'd

HHS OIG: Medicare Faced Higher Costs For Stelara When Patients Self-Administered

(8/16, Maaisha Osman, InsideHealthPolicy) ...HHS' Office of Inspector General (OIG) found Medicare spent significantly more on the psoriatic arthritis drug Stelara when patients self-administered it under Part D compared to when it was administered by a physician under Part B, in a report released days before CMS announced its first round of negotiated Part D drug prices includes a 66% discount on Stelara. The negotiated price now brings the list price lower in Part D than it was in Part B... Sub. Req'd

The FTC Embraces Slant Over Reason With PBMs

(8/19, Patrick Hanks, RealClearMarkets) ...Pharmacy benefit managers are coming under increased public scrutiny for their role in the healthcare industry. Last month the FTC released an interim report on their two-year investigation into PBMs vertical integration and drug pricing. Which is seemingly in preparation to sue the three largest PBMs for their tactics to negotiate drug prices between manufacturers and clients... Full

What Democrats Could Do On Healthcare if Kamala Harris Wins

(8/19, Michael McAuliff, Modern Healthcare) ...The top-line item, healthcare analysts and policy experts predict, will still be reproductive healthcare and abortion, which Democrats up and down the ballot are emphasizing and which promises to be a recurring topic at the DNC in Chicago, which runs through Thursday... Sub. Req'd

Will the FTC Challenge a Deal that Would Give Novo Nordisk Control of Some Catalent Plants?

(8/19, Ed Silverman, STAT Plus) ...As the Federal Trade Commission scrutinizes the pharmaceutical industry, there is growing debate about whether the regulator may next target a deal that some experts say could make it easier for Novo Nordisk to boost production of a key drug — at the expense of competitors...The FTC is also formally investigating Teva Pharmaceuticals after the company refused to remove about two dozen patents for asthma and COPD inhalers from a key federal registry known as the Orange Book... Sub. Req'd

More Biosimilars, New Policy Levers Needed to Speed Biosimilar Adoption

(8/16, Victoria Johnson, HCP Live) ..."Research shows coverage restrictions on biosimilars when there were fewer competitors on the market, and from the small molecule literature, we know that uptake increases with each entrant. No research has reported the adoption of biosimilar infliximab across these two important market forces, and understanding their interaction can shed light on market dynamics," lead investigator Eric T. Roberts, PhD, research specialist, University of California - San Francisco, and colleagues wrote... Full

Patent Dance Insights: A Q&A On Reducing Legal Battles in the Biosimilar Landscape

(8/18, Cameron Santoro and Skylar Jeremias, The Center For Biosimilars) ...In an interview with The Center for Biosimilars®, Ha Kung Wong, JD, an intellectual property attorney and partner at Venable LLC, provided an overview of the patent legal system biosimilars must navigate under the Biologics Price Competition and Innovation Act (BPCIA) of 2009. He explained that the BPCIA establishes an optional framework for information exchange between biosimilar developers and reference product sponsors, commonly known as the "patent dance."... Full

Regulatory Convergence is Extremely Important

(8/19, Viveka Roychowdhury, Express Pharma) ...Dr Susana Almeida, secretary general, International Generic and Biosimilar Medicines Association (IGBA) explains to Viveka Roychowdhury the importance of recognising the value of generic and biosimilar medicines, the need to make affordable quality medicines as sustainable as possible and how building consensus around concepts like single global development will help achieve these goals... Full

Swiss Cost Containment Package 2 Makes Important Corrections

(8/19, The Pharma Letter) ...Interpharma, the association of research-based pharmaceutical companies in Switzerland, on Friday welcomed decisions by the National Council's Health Committee on Cost Containment Package 2. The committee has made certain corrections and is determined not to further weaken patients' increasingly poor access to innovative medicines. However, further improvements are needed in the plenary session... Sub. Req'd

Health Kiran Mazumdar-Shaw: Spearheading Pharma Innovation

(8/18, Kiran Mazumdar-Shaw, India Today) ...While the journey is challenging, the Indian pharmaceutical industry has the potential to become a global leader in high-value pharmaceutical exports with the right strategies and policies. By embracing value-addition over volume, the industry can achieve its ambitious target of $130 billion (Rs 10.9 lakh crore) by 2030, nearly tripling from the current $50 billion (Rs 4.2 lakh crore). This strategic shift will not only enhance India's global standing but also make a significant contribution to global healthcare... Full

Japan Tries to Win Back Big Pharma

(8/16, Jessica Davis Plüss and Tomoko Muth, Swissinfo.ch) ...A decade-long policy to bring down medicine prices amid concerns over the rising cost of healthcare has also deterred foreign pharma groups from launching their drugs in the country. The "attractiveness of the domestic pharmaceutical market is declining for domestic and foreign pharmaceutical companies", Hideki Sato, head of media relations at Chugai Pharmaceutical, told SWI swissinfo.ch by email. Chugai, a Japanese drug developer and manufacturer controlled by Switzerland-based Roche, was the country's third-biggest seller of prescription drugs last year... Full

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