Rimegepant Sulfate

A recent settlement resolves allegations that Biohaven induced doctors to write Nurtec prescriptions by paying “improper remuneration," including through speaker payouts and meals at “high end restaurants." Over the years, the U.S. Department of Justice (DOJ) has taken a host of drugmakers to task over alleged kickback payments intended to boost prescriptions. Recently, Pfizer found itself in the agency's crosshairs thanks to one of its M&A plays.Now, Pfizer—which purchased neuroscience specialist Biohaven for $11.6 billion in 2022—is committing more than $59.7 million to resolve the kickback allegations against its subsidiary, the DOJ said Friday.The claims and ensuing settlement revolve around Biohaven’s CGRP receptor antagonist Nurtec ODT, which is cleared to both treat and prevent migraines in adults. The drug, which was the crown jewel in Pfizer’s Biohaven buyout, delivered $928 million in 2023 sales. Pfizer reports its fourth-quarter 2024 financial results next week, and the drug is expected to cross the $1 billion mark for the first time.The settlement resolves allegations—brought forward in a 2021 whistleblower lawsuit—that Biohaven induced doctors to write Nurtec prescriptions by paying “improper remuneration," including through speaker payouts and meals at “high end restaurants," according to a DOJ press release on Monday.Prescribers who attended multiple educational programs on the same topic “received no educational benefit from attending repeat programs,” the DOJ said in its release, while other Biohaven speaker programs were attended by people with no educational need to be there, such as speakers’ spouses, family members or friends.Pfizer’s buyout of Biohaven officially closed Oct. 3, 2022.“The settlement relates to alleged conduct at Biohaven before Pfizer’s acquisition of the company in October 2022 and does not include any admission of liability or wrongdoing,” a Pfizer spokesperson said in an emailed statement.Pfizer is “pleased to put this legacy matter behind us, so that we can continue to focus on the needs of patients," the company's spokesperson said. The allegations against Biohaven first came to light when an ex-staffer filed a whistleblower lawsuit against her former company in the summer of 2021. As part of the deal with the DOJ, the former staffer is in line to receive roughly $8.4 million as her share of the federal settlement, the government explained.While Nurtec was already on a rapid ascent by the time of Biohaven’s acquisition, Pfizer has helped raise the migraine med’s profile even more thanks in part to an ad campaign with award-winning musician and actor Lady Gaga.Biohaven isn't alone in facing allegations over kickbacks in recent years.Last fall, Teva Pharmaceuticals USA and Teva Neuroscience forked over a combined $450 million in a DOJ settlement to resolve claims that they leveraged assistance foundations to fund patients’ copays for the multiple sclerosis blockbuster Copaxone from 2006 through 2017. Prior to that, Biogen in 2022 finalized an agreement to pay $900 million to resolve a lawsuit alleging it paid kickbacks to doctors over a five-year span to boost sales of its own multiple sclerosis drugs. Novartis has also found itself in the DOJ’s sights, paying more than $642 million in 2020 to resolve claims that it offered kickbacks to doctors and illegal copayment support to Medicare to improve pharmaceutical sales. 

SAN DIEGO, Dec. 30, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that argenx's VYVDURA (efgartigimod alfa and hyaluronidase-qvfc), which is co-formulated with Halozyme's ENHANZE® drug delivery technology, was granted regulatory approval by Japan's Ministry of Health, Labour and Welfare (MHLW) for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). VYVDURA was approved for CIDP as a once weekly 30-to-90 second subcutaneous injection, which can be self-administered at home, and is the first and only neonatal Fc receptor (FcRn) blocker approved for the treatment of CIDP. "We are pleased that VYVDURA, with our innovative ENHANZE drug delivery technology, is now approved for two indications in Japan, enabling greater flexibility and optionality for generalized myasthenia gravis and CIDP patients," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We look forward to VYVDURA being a new treatment option for an even broader number of patients in Japan." The MHLW approval is based on the ADHERE Study, the largest clinical trial to date studying CIDP. In the ADHERE study, 69% (221/322) of patients treated with VYVDURA, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function and strength. ADHERE met its primary endpoint (p<0.0001) demonstrating a 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo. Ninety-nine percent of trial participants elected to participate in the ADHERE+ open-label extension. The safety results were generally consistent with the known safety profile of VYVDURA in previous clinical studies and real-world use. VYVDURA was also approved by the MHLW for manufacturing and marketing in January 2024 and launched in April 2024 for the treatment of generalized myasthenia gravis (gMG). In March 2024, VYVDURA was designated as an Orphan Drug for the treatment of CIDP by the MHLW. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched more than 800,000 patient lives in post-marketing use in nine commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and Idorsia Pharmaceuticals. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including offering flexibility to receive treatment in more convenient locations and broadening the treatment options for the indications referred to in this press release. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results or delays in launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-359-3016 [email protected] Samantha Gaspar Teneo 212-886-9356 [email protected] SOURCE Halozyme Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED