Wednesday, March 27, 2024

FTC Sides With Amneal Over Inhaler Patent Dispute With Teva

(3/26, Urte Fultinaviciute, Generics Bulletin) ...After sending warning letters over more than 100 improper patent listings last year, the FTC has backed Amneal in its attempt to fight ProAir originator Teva over asthma inhalers. In its continued effort to tackle improper patent listings, the US Federal Trade Commission has filed an amicus brief urging a US Court to remove Teva's inhaler patents from the Food and Drug Administration's Orange Book, as such siding with defendant Amneal... Global Sub. Full

FTC Continues to Rage Against Device Patent Listings in the Orange Book

(3/27, Sara W. Koblitz, FDA Law Blog) ...In a seemingly run of the mill patent suit, Teva sued Amneal for infringement of 5 patents arising from the submission of Amneal's ANDA referencing Teva's combination product ProAir HFA NDA in fall 2023...In accordance with the Hatch-Waxman Amendments, Teva received a routine 30-month stay precluding FDA from approving Amneal's ANDA for 30 months so that the patent litigation can proceed. But this litigation coincided with FTC's recent intervention into antitrust issues in the Orange Book during which the FTC asked 10 sponsors in November 2023, including both Teva and Amneal, to delist device patents. Seizing on some opportune timing, Amneal, filed a counterclaim against Teva seeking a declaratory judgment of non-infringement and invalidity of all 5 patents, removal of those patents from the Orange Book, and relief from allegedly anticompetitive conduct in violation of state and federal antitrust laws... Full

Healthy Returns: Drugmakers Are Capping Inhaler Prices at $35 in a Win for Some Patients

(3/26, Annika Kim Constantino and Ashley Capoot, CNBC) ...British drugmaker GlaxoSmithKline announced its cost cap last week following similar moves by AstraZeneca and the privately held Boehringer Ingelheim. But there's one holdout: Teva Pharmaceuticals, another major inhaler manufacturer, has not made a similar commitment...Sanders applauded the three companies for announcing their cost caps. "This will significantly cut costs for millions of Americans with asthma and COPD so that they will be able to afford the inhalers they need," he said in a release last week. We'll be watching to see whether Teva announces its own cap... Full

Experts Say Medicaid Rebate Change is Behind Inhaler Price Cuts

(3/26, Lauren Clason, Roll Call) ...Teva was one of several companies that refused to pull any of the patents the FTC challenged. On Friday, the FTC took another step against the manufacturer, filing an amicus brief in a patent infringement suit Teva brought against Amneal Pharmaceuticals Inc. for attempting to bring a generic version of its ProAir HFA to market. The FTC argues the patents that Teva is claiming are improperly listed. The issues underscore the broader dynamics that lawmakers and regulators still face in unwinding the tangled drug pricing system. The copay caps are good for patients, Feldman said, but not nearly enough... Full

Teva Pharmaceutical Industries Limited

(3/26, FitchRatings) ...Fitch Ratings' revision of the Outlook on Teva Pharmaceutical Industries Limited's ‘BB-' Issuer Default Rating to Positive from Stable reflects Teva's progress in reducing its funded debt. The company plans to sell its active-pharmaceutical ingredient (API) business (or TAPI); the sale and related proceeds could meaningfully reduce debt if management allocates them for that purpose...With solid expertise in a variety of production technologies and an extensive patent portfolio, Teva is positioned well to capitalize on demand for both generic and biosimilar drugs over the medium to long term... Full

Teva UK and Closed Loop Medicine Partner to Bolster Personalized Medicines

(3/26, Isabel Cameron, BioPharma Reporter) ...Under the agreement, Teva UK will investigate opportunities to use Closed Loop Medicine's proprietary software as a medical device (SaMD) technology platform which aims to advance the development of personalized medicines with specific chronic disorders by combining dose-optimised drug therapy with digital care... Full

Teva UK Partners Closed Loop On Personalised Medicine

(3/27, Phil Taylor, Pharma Phorum) ...Applying the technology to Teva's established and new medicines could help to improve their effectiveness in the real world, according to the partners...Teva's general manager for the UK & Ireland, Kim Innes, commented that the company is aware "the patient experience can sometimes be less than optimal," just ahead of a new survey indicating that public satisfaction with the NHS is at its lowest level in decades. "As the largest supplier of medicines to the NHS, the potential to combine ‘drug' & ‘digital' could create significant improvements to lives of patients at great scale," she added... Full

One Foot In The Door? Trio Look To Reenter Annulled EU Generic Tecfidera Market

(3/26, Dean Rudge, Generics Bulletin) ...A topsy-turvy legal battle going back some years led to a raft of Tecfidera generics being pulled from the market in December last year. Now, three of the affected companies are a step closer to reentering the market, which is set to remain a Tecfidera monopoly until February 2025...Another two generic dimethyl fumarate sponsors that were forced to withdraw their products, Teva and Polpharma, were not listed among the CHMP's recommendations. Viatris's Mylan and Neuraxpharm had received their first Commission approvals granting pan-European marketing authorizations in May 2022... Global Sub. Full

Outlook Turns To Marketing Strategy After Scoring EU First For Ophthalmic Bevacizumab

(3/26, Neena Brizmohun, Generics Bulletin) ...Lytenava, from Outlook Therapeutics, is set to become the first ophthalmic formulation of bevacizumab to be approved in the EU, after the European Medicines Agency recommended in favor of using the VEGF inhibitor to treat wet age-related macular degeneration (wet AMD)...Outlook is assessing "both direct commercialization of the product and partnering in Europe on a country-by-country basis," according to a March 22, statement from the company, which is also seeking US approval for the product... Global Sub. Full

Merck's $11.5 Billion Bet On Its Next Big Drug Finally Arrives

(3/26, Peter Loftus, The Wall Street Journal) ...The drug, which will sell under the name Winrevair, treats a condition called pulmonary arterial hypertension that affects nearly 40,000 people in the U.S. In 2021, Merck paid $11.5 billion for the company developing the medicine. Some analysts estimate sales as high as $7.5 billion a year..."We see this as a multibillion-dollar potential opportunity for the company," Merck Chief Executive Rob Davis said in an interview. "Over time we think we can move into earlier lines of therapy and potentially into much broader patient populations."... Sub. Req'd

Celltrion Annual Shareholders' Meeting Addresses Expansion Plans, Stock Price Concerns, Director Remuneration

(3/26, Lee Han-soo, Korea Biomedical Review) ...Shin Min-chul, finance and administration division head at Celltrion, highlighted the incorporation of Celltrion Healthcare's objectives into Celltrion's articles of incorporation as part of the merger process, emphasizing the addition of distribution and sales operations...Celltrion has ambitious plans to expand its portfolio to 11 commercialized biosimilars by 2025 and aims to have 22 biosimilar products by 2030... Full

Pharmacies Take Appeal of $650 Mln Opioid Award to Ohio Top Court

(3/26, Nate Raymond, Reuters) ...Jeffrey Wall, a lawyer for Walgreens, told the Ohio Supreme Court that state law bars Lake and Trumbull counties' claims that the dispensing of addictive pain medications by the pharmacy chains created a public nuisance in their communities that the companies should be forced to help remedy. Wall said an amendment to the Ohio Products Liability Act that the state legislature adopted in 2007 explicitly barred all common-law public nuisance claims based on the sale of products that seek compensation from a manufacturer or supplier... Full

Insulin Users Face Shortage With Two of Eli Lilly's Insulins Through The Beginning of April

(3/26, Katherine Lewin, Endpoints News) ...The 10 mL vials of Humalog and Insulin Lispro Injection "are or will be temporarily" out of stock at wholesalers and some pharmacies, with Lilly adding that the company is manufacturing 10 mL vials of both products and will ship them out when they can. The company added that it is in ongoing contact with the FDA...A representative for Lilly told Endpoints News that "the dynamic nature of insulin supply and demand, coupled with a brief delay in manufacturing, led to this temporary supply constraint."... Full

Reuters Pharma USA 2024 - Day 1

(3/26, Jonah Cornstock, Pharma Phorum) ...Tuesday at Reuters Pharma USA kicks off with morning keynotes focused on innovation, transformation, and patient experience. We'll hear from executives at GSK, Biogen, Takeda, and Genentech, as well as tech giants like Oracle. Then, in the afternoon we'll check in on the Market Access track and hear from UCB and Bristol-Myers Squibb about the ongoing impacts of the US Inflation Reduction Act. After a break for some video interviews, we'll wrap the day up with some little tastes of AI and cell and gene therapy content... Full

How Amazon Pharmacy is Using AI to Deliver Medications Faster as it Expands Same-Day Delivery

(3/26, Heather Landi, Fierce Healthcare) ...Amazon Pharmacy expanded its same-day medication delivery service to New York City and Los Angeles, with plans to add a dozen more U.S. cities by the end of the year, the company announced Tuesday...Amazon Pharmacy is modernizing the home-delivery experience by reducing delivery speeds to hours in some cases. The company claims it outperforms the industry standard of up to two weeks... Full

HHS Releases Newest List of Inflation-Capped Part B Drugs

(3/26, Noah Tong, Fierce Healthcare) ...On Tuesday, the Department of Health and Human Services dropped its latest list of drugs capped by inflation rebates. From April 1 to June 30, 41 drugs that will have a lower coinsurance rate if a drug company raises prices quicker than the rate of inflation...The Centers for Medicare & Medicaid Services will invoice drug companies for rebates by fall 2025, where funds will then be deposited in the Federal Supplementary Medical Insurance Trust Fund... Full

CMS Estimates Savings for Patients from Medicare Inflation Rebates

(3/26, Denise Myshko, Managed Healthcare Executive) ...In the second quarter of 2024, the U.S. Department of Health and Human Services predicts that an estimated 763,700 people with Medicare Part B will benefit with lowered coinsurance as a result of the inflation rebates required on prescription drugs because of the Inflation Reduction Act...List of drugs subject to inflation rebate, second quarter 2024...Synribo (omacetaxine mepesuccinate): chronic myeloid leukemia; Teva...Fosaprepitant (Teva): nausea and vomiting... Full

Report on Part D Tiering Shows Low Coverage Rates for Biosimilars

(3/27, Skylar Jeremias, The Center For Biosimilars) ...Despite the US having more biosimilar options than ever before, Medicare Part D plans still prefer reference insulin glargine (Lantus) and adalimumab (Humira) over lower-priced biosimilar alternatives, according to a report from the Association for Accessible Medicines...Although some biosimilars, such as Cyltezo, were covered by a higher number of plans compared with other Humira biosimilars, overall coverage of Humira biosimilars remained low across all plans, likely because it was the first adalimumab biosimilar to be granted interchangeability status... Full

How Pharma Firms Using AI Should Navigate Regulatory Submissions

(3/26, Eliza Slawther, Pink Sheet) ...The artificial intelligence health care market is expected to grow by more than 500% from $29bn in 2024 to $187bn by 2030, and could bring much value to the pharma industry by streamlining drug discovery, clinical trials, and supply chain management, according to a report from global consulting firm Berkeley Research Group. Despite these impressive predictions, BRG noted in its ‘AI and the Future of Healthcare' report that uptake of AI has been slower in the pharmaceutical industry than other areas of health care such as diagnostics and imaging. One reason for the slower uptake of AI is the drug life cycle itself – as stated in the report, slower adoption of AI in pharma "has less to do with the promise of AI and more to do with long timelines for drug development and greater regulatory oversight."... Sub. Req'd

FDA Reduces Number of Samples to Retain for BA/BE Testing

(3/26, Joanne S. Eglovitch, Regulatory Focus) ...In a part-draft, part-final guidance issued on Tuesday, the US Food and Drug Administration finalized its policy on the quantity of reserve samples to be retained for bioequivalence and bioavailability testing to ensure that samples are comparable to reference listed drugs and to deter fraud in such testing... Full

Hospitals Urge More States To Pass 340B Laws In Wake Of AK Ruling

(3/26, Gabrielle Wanneh, InsideHealthPolicy) ...A circuit court decision upholding an Arkansas law that bars drug makers from imposing restrictions that interfere with how 340B hospitals utilize contract pharmacies has boosted hospitals' lobby for more than 20 other states to enact similar laws. By enacting similar laws, states potentially could get ahead of drug industry litigation aimed at limiting 340B hospitals' use of contract pharmacies, Hyman, Phelps & McNamara associate Faraz Siddiqui speculates... Sub. Req'd

AstraZeneca Sues Arkansas to Block Drug-Discount Program

(3/26, Mike Scarcella, Reuters) ...Pharmaceutical giant AstraZeneca has sued to block an Arkansas law that it said would unlawfully expand a federal drug-discount program to include for-profit pharmacy chains such as CVS and Walgreens. The Anglo-Swedish drugmaker's lawsuit, filed in Little Rock federal court on Monday against the Arkansas insurance department, said the state measure violates provisions of the U.S. Constitution and federal patent law...Arkansas said it will challenge the lawsuit... Full

This State Isn't Waiting for Biden To Negotiate Drug Prices

(3/26, Elisabeth Rosenthal, KFF Health News) ...As the federal government negotiates with drugmakers to lower the price of 10 expensive drugs for Medicare patients, impatient legislators in some states are trying to go even further. Leading the pack is Colorado, where a new Prescription Drug Affordability Review Board is set to recommend an "upper payment limit" for drugs it deems unaffordable...Colorado's plan is, in many ways, both broader and more prescriptive than the feds', covering all patients and potentially fixing an upper price limit rather than squabbling with the industry over an acceptable figure... Full

Amgen, Facing Potential Enbrel Price Cap in Colorado, Takes State's New Drug Affordability Board to Court

(3/26, Zoey Becker, Fierce Pharma) ...In a recently filed lawsuit in Colorado federal court, Amgen is challenging a vote from the state's newly created Prescription Drug Affordability Review Board...The board has deemed Enbrel's price to be "unfavorable." But in its complaint, Amgen called the board's determination an "unconstitutional" violation of due process and federal law... Full

Amgen Sues Colorado Over its Prescription Drug Affordability Board

(3/26, Ed Silverman, STAT Plus) ...Amgen has filed a lawsuit accusing a Colorado state board of violating the U.S. Constitution over a plan to pursue a first-in-the-nation move to cap the cost of a pricey prescription medicine...The state board has evaluated two other drugs so far, but Enbrel was the first deemed unaffordable for Colorado residents. The board has not yet begun discussions about what the payment limit could be. The decision triggered anxiety in the pharmaceutical industry, which, over the past several years, has been pushing back on various state efforts to control the costs of prescription medicines... Sub. Req'd

Fixing The UK Market: Government Must Move From ‘Transactional' To ‘Strategic' Approach

(3/26, David Wallace, Generics Bulletin) ...With the UK market experiencing approval delays, shortages, and regulatory complexity, the government's "policy vacuum" and complacent approach to off-patent medicines risk undermining the sector, says BGMA chair Diane DiGangi Trench. In an exclusive interview with Generics Bulletin, she urges a shift from a "transactional" to a "strategic" relationship with industry to fully unlock the benefits of generics and biosimilars... Global Sub. Full

India IPR Wheels Are Turning: Novartis, Bayer, Sun, Legal Heads Discuss Realities

(3/27, Anju Ghangurdge, Pink Sheet) ...Leaders from Novartis, Bayer, Sun Pharma, the Indian Pharmaceutical Alliance, Médecins Sans Frontières and Anand and Anand discuss India's evolving intellectual property rights landscape, including pre-grant oppositions, enforcement action and other realities. Concerns around evergreening, restrictions on patent-eligible subject matter and compulsory licensing were also key talking points at a recent conference in Hyderabad... Sub. Req'd

Pharma Companies Bet On Flagship Products to Grow in Strength

(3/27, Teena Thacker, The Economic Times) ...Indian drugmakers are leveraging flagship products or mother brands to launch newer combinations and develop therapy leadership, according to market research firm Pharmarack. For instance, anti-diabetes drug Glycomet has given USV a strong identity and established the company as a synonym for diabetic therapy. It has also made USV one of the most sought-after partners for multinational drugmakers for launching innovative therapies such as Vildagliptin from Novartis and Canagliflozin from Janssen in the Indian market... Full

Dr. Reddy's Enters into Exclusive Distribution Partnership With Sanofi Healthcare India Private Limited for Their Vaccine Brands in India

(3/27, Dr. Reddy's) ...Under the arrangement, Dr. Reddy's will have exclusive rights to promote and distribute Sanofi's wellestablished and trusted paediatric and adult vaccine brands Hexaxim®, Pentaxim®, Tetraxim®, Menactra®, FluQuadri®, Adacel® and Avaxim® 80U. These brands saw combined sales of approx. INR 426 crores (approx. USD 51 million) as per IQVIA MAT February 2024. Sanofi will continue to own, manufacture, and import these brands to the country... Full

Big Pharma CEOs Gather in Beijing to Show Continued Interest in China, Offer Policy Advice

(3/26, Angus Liu, Fierce Pharma) ...The CEOs of AstraZeneca, Bayer, Bristol Myers Squibb, GSK, Novartis, Pfizer and Takeda came together in Beijing to show the companies' continued interest in China and to offer their advice for the country's healthcare industry...Pfizer CEO Albert Bourla, while complimenting China's large market opportunity, urged the Chinese government to further improve its protection of intellectual property, according to a Pfizer social media post...Narasimhan, Takeda's CEO Christophe Weber and Organon's CEO Kevin Ali joined the helmsmen of Sinopharm and Amway on a CDF panel on health. Intellectual property and data protection were also on Narasimhan's mind... Full

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