Thursday, April 11, 2024

Pfizer's Wyeth Reaches $39 Million Settlement in Effexor XR Antitrust Case

(4/10, Mike Scarcella, Reuters) ...Pfizer subsidiary Wyeth has agreed to pay $39 million to resolve claims from drug purchasers that it conspired with rival Teva to delay launching a less-expensive version of the antidepressant drug Effexor XR...Some retailer plaintiffs such as Kroger, Walgreens, CVS, Meijer and Rite Aid that filed individual actions against Wyeth have already settled. Those retailers, which are excluded from Tuesday's settlement, said they planned to continue to litigate claims against Teva... Full

Pfizer's Wyeth to Pay $39 Million to Settle Antitrust Claims On Effexor XR

(4/11, CPI) ...The settlement, revealed in a filing to a New Jersey federal court by plaintiffs' lawyers, comes after over 12 years of legal battles accusing Wyeth of colluding with rival Teva to delay the release of a cheaper generic version of the drug...The lawsuit, brought forth by drug purchasers including Rochester Drug Co-Operative and Stephen L. LaFrance Holdings, alleges that Wyeth and Teva engaged in anticompetitive practices, leading to inflated prices for Effexor XR. The plaintiffs claim that Wyeth made what is known as a "reverse payment" to Teva to delay the market entry of a generic version of the drug, resulting in consumers paying higher prices. While Wyeth has opted to settle, the case against Teva will proceed. Teva, for its part, has consistently denied the allegations... Full

Democrats Push More Drug Makers to Lower the Price of Inhalers

(4/10, Kirstin Garriss, WFTV Orlando) ...Earlier this year, several Democratic leaders criticized the four major inhaler manufacturers for having significantly higher prices in the U.S. compared to other countries. Since then, GSK, AstraZeneca and Boehringer Ingelheim have announced plans to drop the price of inhalers to $35/month. But lawmaker says there's still one major hold-out. "Teva you're up," said Rep. Auchincloss. "We're calling on Teva and all the other inhaler manufacturers to institute such a cap as well."... Full

Drug Shortages Reached a Record High as 2023 Drew to a Close

(4/11, Ed Silverman, STAT Plus) ...The reasons are varied, although many remain a mystery. In 60% of the cases, it was unclear why a shortage existed or drug manufacturers simply failed to provide explanations, according to the University of Utah Drug Information Service, which tracks shortages and provided data published in a new bulletin by the American Society of Health-System Pharmacists. Otherwise, the most common reason cited is a failure to meet demand, accounting for 14% of the shortages in 2023... Sub. Req'd

Drug Shortages Reach All-Time High

(4/11, Tina Reed, Axios) ...With 323 medicines in short supply, U.S. drug shortages have risen to their highest level since the American Society of Health-System Pharmacists began tracking in 2001...This high-water mark should energize efforts in Congress and federal agencies to address the broken market around what are often critical generic drugs, the organization says...Many of the issues behind shortages are tied to low prices for generics that leave manufacturers competing on price... Full

‘That's A Much Broader Statement': Hikma Grilled In Amarin Vascepa Skinny-Label Appeal

(4/10, Dean Rudge, Generics Bulletin) ...Hikma may have succeeded in dismissing Amarin's induced infringement claim against the firm over Hikma's skinny label generic Vascepa in the US, but a panel of judges for the US Court of Appeals for the Federal Circuit challenged that the generics manufacturer's public disclosures "sound like an actual statement, encouraging use for the broad sweep of things: that this generic can be used instead of the brand, without any narrowing...When [Charles Klein, Winston & Strawn] countered that Hikma's generic label, unlike Teva's generic label in GSK, did not actively induce infringement, Moore observed: "The difference between their press release and your press release is that when they said it was a generic equivalent, they also said for AB-rated purposes. Your press release doesn't do that. It doesn't have that limitation in it."... Global Sub. Full

Celltrion's Subcutaneous Infliximab Lands On Big PBM Formulary List

(4/10, Urte Fultinaviciute, Generics Bulletin) ...Not even one month has passed since the US launch of Celltrion's Zymfentra, but the Korean firm has already closed a deal with one of the top three pharmacy benefit managers in the US, placing its value-added infliximab biosimilar on their formulary...The company has also signed additional contracts with multiple mid-sized PBMs. With all deals combined, the firm said, "Zymfentra has captured approximately 40% of the private health insurance market, measured by the number of lives covered."... Global Sub. Full

Stada Tight-Lipped On Potential Sale Amid Reports Talks Are Underway

(4/11, Dean Rudge, Generics Bulletin) ...An article in Bloomberg suggested that the German firm, by way of its owners Bain Capital and Cinven, has begun talks with potential buyers, listing such other venerated private equity as Kohlberg Kravis Roberts & Co and CVC Capital Partners...Bloomberg concedes that no decisions have been made, and Bain and Cinven could decide to offload a minority stake or even keep Stada. "This is a question for our owners, on which we cannot comment," a spokesperson for Stada told Generics Bulletin. Enquiring then to Cinven, Generics Bulletin was told simply, "no comment."... Global Sub. Full

Novartis Begins Tender Offer for Cancer-Focused MorphoSys

(4/11, Miranda Murray, Reuters) ...Novartis said on Thursday it has launched a tender offer to acquire MorphoSys , a German developer of cancer treatments, for an aggregate 2.7 billion euros ($2.9 billion)...Novartis, which said the acceptance period begins on Thursday and will end at midnight on May 13, will take MorphoSys private after the deal, which is contingent on certain conditions, including a minimum acceptance threshold of 65%... Full

Strides Receives US FDA Approval for Fluoxetine Tabs 10 mg & 20 mg

(4/10, Pharmabiz.com) ...Strides Pharma Science said that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Singapore, has received approval for fluoxetine tabs 10 mg and 20 mg, from the United States Food & Drug Administration. The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug Prozac tablets of Eli Lilly... Full

FDA Lambasts Kilitch for Unsanitary Manufacturing Conditions and Issues Warning Letter to Natco, Too

(4/10, Fraiser Kansteiner, Fierce Pharma) ...The FDA came out swinging against Kilitch in a four-observation warning letter this week, blasting the company for keeping its manufacturing facility "in a state of disrepair, poorly cleaned and maintained." FDA officials pointed to residue on HEPA filters, instances of operators using "visibly dirty" restricted access barrier systems to make adjustments on the filling line and—perhaps most egregiously—"multiple barefoot employees" who were handling materials being transferred to a production area... Full

Endo Sues FDA Over its Handling of Generic Adrenalin Approvals

(4/10, Lia DeGroot, Endpoints News) ...In a 32-page lawsuit filed in the US District Court for the District of Columbia on Monday, Endo argues that the FDA unlawfully approved a generic version of epinephrine, which Endo markets as Adrenalin. Epinephrine is an injection used in the clinical setting to treat anaphylaxis and to increase blood pressure in patients with low blood pressure due to septic shock. The FDA granted final approval for a version of BPI Labs' epinephrine in February... Full

API Innovation Center Looks to Bolster US Cancer Drug Supplies with Apertus Deal, New Tech

(4/10, Joseph Keenan, Fierce Pharma) ...Amid shortages of cancer drugs in the U.S., the API Innovation Center will use continuous manufacturing technology and a partnership with Apertus Pharmaceuticals and the Glioblastoma Foundation to produce lomustine, which is used to treat brain tumors...There has been a push on the industry from both political, patient and other interests to "on-shore" more drug manufacturing in the U.S. after the COVID-19 pandemic spotlighted weak points in the pharma supply chain... Full

Mallinckrodt Reports 2023 Results After Second Restructuring

(4/10, Adam Zamecnik, Generics Bulletin) ...Mallinckrodt has reported sales down by 4% to sales $469m in the fourth quarter of 2023, despite generics sales leaping by 17.8% to $199m, dragged down by branded sales that declined by 15.6% to $271m. The firm said the generics increase was "primarily due to growth in finished-dosage products as the broader market experienced ongoing disruptions in product quality and supply."... Global Sub. Full

Biosimilars in Retina Space Expected to Grow in 2024, Coming Years

(4/10, Ashley Gallagher, Pharmacy Times) ...In a review, investigators focused on ranibizumab (Lucentis; Genentech), aflibercept (Eylea; Regeneron), and bevacizumab (Avastin; Genentech) as growth opportunities in the biosimilar space...In an interview with Pharmacy Times, Fran Gregory, PharmD, MBA, vice president of Emerging Therapies at Cardinal Health, said, "Our research was really focused on the area of retina specialists, with a lot of buzz and a lot of opportunity for cost savings in the retina space with Eylea, Avastin, and Lucentis biosimilars."... Full

ScionHealth to Purchase Drugs from Mark Cuban's Cost Plus Drug Company

(4/10, Joel Stinnett, Louisville Business First) ...The Louisville-based health care company will begin purchasing certain bulk drugs from Mark Cuban's Cost Plus Drug Company, according to a news release, making it one of the first health systems to do so. After purchase, the drugs will be delivered to a Columbus, Ohio-based Safecor Health unit-dose packaging center, where they will be packaged, stored and shipped the same day as requested by caregivers at various ScionHealth facilities, according to the release... Sub. Req'd

CMS Tailors Drug Buffer Stock Idea To Small, Rural Hospitals

(4/10, Gabrielle Wanneh, InsideHealthPolicy) ...The Biden administration is revisiting the idea of offering Medicare add-on payments to incentivize hospitals to create buffer stocks of essential medicines to avert shortages, but it is tailoring the plan to small, independent hospitals in its calendar year 2025 inpatient payment proposal out Wednesday (April 10)...The policy would affect small, independent hospitals with 100 patient beds or less and would allow the hospitals to create and sustain a six-month buffer stock of at least one of 86 essential medicines either directly or through a contract with a drug manufacturer distributor or intermediary... Sub. Req'd

Medicare Expects to Spend $3.5 Billion On New Alzheimer's Drug in 2025

(4/11, Bob Herman and Rachel Cohrs Zhang, STAT Plus) ...Medicare's actuaries expect the drug Leqembi, made by the Japanese drugmaker Eisai and sold in partnership with Biogen, to cost the traditional Medicare program around $550 million in 2024, and the entire Medicare program $3.5 billion in 2025, a spokesperson for the Centers for Medicare and Medicaid Services confirmed to STAT. That projection forecasts a large increase in uptake over the next year and a half..."Eisai has not spoken with representatives at CMS about this matter as it would not be appropriate," a company spokesperson said... Sub. Req'd

Regeneron Accused by Justice Department of Manipulating Medicare Pricing

(4/10, Ed Silverman, STAT Plus) ...The U.S. Department of Justice filed a lawsuit accusing Regeneron Pharmaceuticals of manipulating Medicare pricing by inflating the average sales price for its expensive and widely prescribed Eylea treatment for serious eye disease...A Regeneron spokesperson sent a note saying the company "believes that the allegations against us are without merit.”... Sub. Req'd

Inflation Reduction Act and The Impact On Biosimilars

(4/10, Dinakaran Balasubramanian, Contract Pharma) ...The Inflation Reduction Act which was signed into law in August 2022 announced several provisions on prescription drugs, with the aim of lowering the burden on people and reducing federal spending on drugs. Some of these provisions are targeted at high-cost biologic drugs, which are in turn expected to have a profound impact on the market dynamics for biosimilars. Direct price negotiation with manufacturers is one of the major policy changes that has been analyzed in detail. In this article the attempt is to focus on nuances around some of the other provisions and their impact to biosimilars... Full

Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion

(4/10, Skylar Jeremias, The Center For Biosimilars) ...A Biosimilars Council analysis of IQVIA data has revealed health plans and patients are missing out on billions in savings as a results of pharmacy benefit manager rebate policies that suppress biosimilar adoption...However, the researchers noted that biosimilars could see more favorable payer coverage in 2024, with the big 3 US payers expected to make a shift. Additionally, uptake for most of the highest volume adalimumab biosimilars has been driven by smaller payers who could gain more from low-cost, no-rebate policies... Full

Drugmakers Race to Find Alternative Suppliers as US Cracks Down On Chinese Biotech

(4/11, Oliver Barnes, Ian Johnston and Eleanor Olcott, Financial Times) ...Companies, including US-based Eli Lilly, Vertex Pharmaceuticals and BeiGene in Switzerland, have been talking with rival contract manufacturers to diversify production away from WuXi companies, according to several people familiar with discussions. "Everyone is reaching out to alternative [contract development manufacturing organisations] right now," said an executive at a US-based drug outsourcer, which competes with WuXi. "The companies' management teams have an obligation to ask if the Biosecure Act gets approved what is their plan B?"... Sub. Req'd

BIOSECURE: What's Coming Next?

(4/10, Brian Yang, Pink Sheet) ...The chief sponsor of the BIOSECURE Act in the US, Rep. Mike Gallagher, is leaving Congress early, but forecasts of the wide impact of the proposed legislation – which aims to restrict biotech's involvement with firms under control of a "foreign adversary" – show no signs of abating...Immediate passage of the bill is highly unlikely, and it is also still up in the air if there might be amendments that would possibly shield ongoing arrangements with Chinese contract services, where WuXi is a large player and also provides important services to some US biopharma companies... Sub. Req'd

PhRMA Asks Eighth Circuit for Full Review in Drug Discount Suit

(4/10, Nyah Phengsitthy, Bloomberg Law) ...The Pharmaceutical Research and Manufacturers of America is requesting a rehearing en banc from the US Court of Appeals for the Eighth Circuit after the court in March held that Arkansas' Act 1103 is not preempted by federal law. The state law prohibits drugmakers from restricting 340B drug discounts to providers through pharmacies used in the federal 340B Drug Pricing Program... Sub. Req'd

As Parliament Chapter Closes, Council Chapter Opens On EU Pharma Legislation to Deliver Equitable Access to Medicines

(4/10, Medicines for Europe) ...Today, the European Parliament formally endorsed the deal on the revision of the European Pharmaceutical legislation. This compromise is the result of intense and lengthy debate, which aimed to improve the access, availability, and affordability of medicines and to prevent further delays of this much needed reform. Medicines for Europe supports this step forward... Full

EU Parliament Adopts Updated Pharma Package Despite Some Political Disagreement

(4/11, Eliza Slawther, Pink Sheet) ...The MEPs adopted the new draft directive, with 495 votes in favor, 57 against and 45 abstentions, and the draft regulation, for which there were 488 votes in favor, 67 against and 34 abstentions. The move follows a vote on March 19, from the parliament's environment and public health committee, in which compromise amendments to the draft text were agreed. One of the major changes to the legislation adopted by parliament compared with the commission's proposal is a less severe reduction in the baseline period of regulatory data protection... Sub. Req'd

European Parliament Adopts Pharma Legislative Revamp by Wide Margin

(4/10, Zachary Brennan, Endpoints News) ..."Today's vote is a step towards delivering the tools to tackle present and future healthcare challenges, particularly for our market attractiveness and access to medicine across EU countries," Pernille Weiss, rapporteur for the directive, said in a statement. "We hope Council takes note of our ambition and commitment to create a robust legislative framework, setting the scene for effective negotiations."... Full

EU Pharma Reform Package Clears Key Parliament Vote

(4/11, Phil Taylor, Pharma Phorum) ...Also praised are the proposals to introduce a regulatory ‘sandbox' to test regulatory changes before they are rolled out more widely and incentives to meet the challenge of antimicrobial resistance (AMR) with the creation of a transferable exclusivity voucher (TEV) that would give developers of new antimicrobials an extra 12 months of RDP. The TEVs could be used for other antibiotics or sold to other companies... Full

English Funding For Aquipta Targets AbbVie's Migraine Drug To 170,000 People

(4/11, Neena Brizmohun, Pink Sheet) ...Aquipta is the first oral treatment that NICE has recommended for preventing chronic migraines in the fourth-line setting, and the second oral treatment for episodic migraines in the same setting...Regarding the current treatment options available via the NHS, people with at least four migraine days per month are offered a range of oral preventive medicines, including topiramate, propranolol and amitriptyline. If three of these have not worked or cannot be tolerated, people can be treated with the injectable CGRP receptor antagonists – Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab) or Vyepti (eptinezumab), from Novartis, Teva, Eli Lilly and Lundbeck respectively... Sub. Req'd

Migraine Pills to Be Offered On NHS for First Time in Boost for 170,000 Sufferers

(4/11, Canqi Li, Independent) ...Health minister Andrew Stephenson said: "Migraines affect millions of people in this country and this new treatment will help prevent recurring migraine attacks when other medicines have failed. "It will allow more people whose daily life is affected by this painful, debilitating condition to manage their migraines more effectively and to live their lives to the fullest."...If there are no appeals against its final draft guidance, Nice is expected to publish its final guidance on the drug next month... Full

Drugs Public Procurements On Verge of Serious Crisis in Russia Due to Failed Tenders

(4/10, The Pharma Letter) ...According to data from the Russian Ministry of Health, in the first quarter 2024 the share of failed tenders in the overall structure of tenders for public procurements of drugs in the Russian pharmaceutical market grew from 15% to 32.9% year-on-year basis. The government acknowledges the problem, explaining it by the lack of suppliers and suspension of production of certain drugs. Another reason is the ever-declining initial prices of auctions, which is caused by the ever growing number of generics in the local market and dumping policy that is used by certain suppliers and producers... Sub. Req'd

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