Testosterone

FDA approval marks first and only subcutaneous anti-PD-(L)1 cancer immunotherapy SAN DIEGO, Sept. 12, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Roche received U.S. Food and Drug Administration (FDA) approval for Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs) with Halozyme's ENHANZE® drug delivery technology. Tecentriq Hybreza™ can be injected subcutaneously in approximately 7 minutes compared to 30-60 minutes for standard intravenous (IV) infusion of Tecentriq® (atezolizumab). The treatment will be available in the U.S. for all approved adult indications of intravenous Tecentriq®, including certain types of lung, liver, skin and soft tissue cancer. Tecentriq Hybreza™ is a subcutaneous product combination of atezolizumab, a monoclonal antibody that targets PD-(L)1 aiming to prevent cancer immune evasion, and Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20. "We are delighted that Tecentriq Hybreza has been approved in the U.S. for all approved adult indications of the IV treatment," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This approval represents another opportunity for our ENHANZE technology to provide patients and physicians with greater flexibility and a new option for how treatment is administered." The FDA approval is based on pivotal data from Roche's Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq® in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation. 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 eight 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 several pharmaceutical companies including 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 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 "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 uncertainties concerning whether new ENHANZE® collaborative products are ultimately developed, approved or commercialized, unexpected results or delays in launch or commercialization of our partner's product referred to in this press release, unexpected adverse events or patient 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. Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group. 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

A reversible male contraceptive could be a lot closer to reality than you think. Earlier this summer, doctors were tantalized by preliminary data showing that an experimental drug safely reduced sperm count. But several questions remained unanswered, including how effective the drug was at preventing pregnancies and how it would be commercialized. Now, a small biotech startup that wasn’t involved in the NIH-funded study is providing some answers. Charlottesville, VA-based Contraline won the exclusive rights to finish developing and commercializing the new hormone-based drug, the company exclusively told Endpoints News . The data from the Phase 2 study are still being analyzed and are set to be written up for publication later this year. But CEO Kevin Eisenfrats said in an interview that so far the drug looks more than 99% efficacious at preventing pregnancies. If that number holds, it would rank the drug among the most effective birth control options . IUDs and vasectomies are also more than 99% effective, while female birth control pills are about 93% effective and condoms are only 87% effective. “When I saw the interim data, I was so blown away. I thought, ‘We need to own this product,’” Eisenfrats said. “This is something I want to take. This is something my friends are going to take. This is something that’s going to change the world.” But the effectiveness of the drug will depend on people using it properly. The drug, called NES/T, is made of two hormones — nestorone and testosterone — formulated in a gel that’s rubbed on the shoulders daily. It takes an average of 8 weeks to start working, though it can take longer for some people. Diana Blithe, who helms contraceptive research at the National Institutes of Health, led the Phase 2 trial and presented the sperm count data at the Endocrine Society’s annual meeting in June. She told Endpoints in an email that the study was still ongoing and could not confirm the drug’s 99% efficacy. The study was scheduled to wrap up in July, and Eisenfrats said the efficacy phase of the trial is complete. He plans to start a Phase 3 study of about 400 couples next summer, and if all goes well, submit the drug for approval in 2028. It could become the first pharmaceutical birth control option for men, providing a long-overdue alternative to condoms and vasectomies. NES/T was developed by the Population Council, a nonprofit behind the early development of several birth control products, including the copper IUD and the abortion pill mifepristone . The NIH funded the recent clinical trial of NES/T and might help with the Phase 3 as well, according to Eisenfrats. But neither group takes drugs all the way to the market. Earlier this year, the Population Council began looking for a drug company to carry the torch. At first glance, Contraline might not seem an obvious choice. The 18-person startup has never taken a drug into advanced clinical studies and will need to raise significant funding in order to do so. Eisenfrats estimates that the Phase 3 trial will cost about $50 million, and he’s looking to raise at least $65 million in Series B funding for studies of NES/T and an injectable male contraceptive that Contraline is also developing. Despite that, the startup beat bigger and more experienced companies for the rights to a global exclusive license to NES/T, according to Eisenfrats. James Sailer, co-president of the Population Council and head of its biomedical research center, told Endpoints that the nonprofit is confident that Contraline will be able to raise the needed funds. He was more worried about the drug getting lost during a pipeline reprioritization at a bigger company or after an acquisition of a medium-sized company. “We’ve seen this many times,” Sailer said. There’s a lingering stereotype that men aren’t interested in new contraceptives, but Sailer said that data over the past 20 years have repeatedly, and increasingly, shown this isn’t true. “There are still people who don’t believe it,” he said. “But Contraline does believe it. They have looked carefully at the data and Kevin — he’s a true believer.” Eisenfrats has been obsessed with the idea of male contraception his entire adult life and pointed to the MTV show “16 and Pregnant” as a source of inspiration in his college admissions essay. “There were so many unintended pregnancies, and it just felt like the answer to that was better male methods,” Eisenfrats said. In 2015, just as he was wrapping up his bachelor’s degree in nanomedicine engineering and chemistry at UVA, he co-founded Contraline. In the nine years since Eisenfrats has been working on a hydrogel that’s injected into the vas deferens to block the ducts and prevent sperm from being transported out of the testes. Unlike vasectomies, which cut and tie these tubes, Contraline’s approach, dubbed ADAM, is designed to be easily reversible with a second injection that dissolves the hydrogel. The method, which Eisenfrats calls “the IUD for men,” is currently being tested in a 60-person safety study in Australia, with a Phase 2 trial planned for next year. Until Eisenfrats saw the NES/T data this summer, he never imagined that Contraline would also develop a hormonal contraceptive for men. The hormonal approach got a bad rap in 2016. In a study run by the World Health Organization, scientists injected progestins, synthetic versions of hormones that suppress sperm production, and testosterone in men every 8 weeks. Although the drug showed signs of working, the study was cut short due to frequent side effects, including acne and mood disorders. NES/T aims to overcome those problems by using a safer sperm-reducing progestin called nestorone — previously developed by the Population Council as a female contraceptive for the vaginal birth control ring Annovera — and striking a better balance of that molecule and testosterone, which is needed to maintain baseline levels of the hormone. “I always thought the side effects would make this a non-tolerable, non-useable product,” Eisenfrats said. But in the Phase 2 study, the most common side effects were mild acne and increased libido, he added. The drug might not have to completely stop sperm production to be effective. Having fewer than 15 million sperm per milliliter of semen is considered low. In the Phase 2 trial, having 1 million sperm per milliliter was the threshold for contraception. Half the men in the study, which enrolled 460 couples, hit this benchmark after 8 weeks, and 86% reached it after 15 weeks. Once sperm levels were low enough, the couples stopped using other forms of birth control for a year. The efficacy results have yet to be formally reported, but according to Eisenfrats, “it was better than 99% efficacy, which is virtually unheard of.” That efficacy figure also appears in the company’s investor presentation, which was shared with Endpoints, but it is unclear if the number includes the 14% of participants who hadn’t had their sperm suppressed by 15 weeks. The slide deck also mentions that “100% of patients recovered sperm counts and hormone levels” during a 24-week recovery period at the end of the study, but again it’s unclear if this number discludes some trial participants. Eisenfrats was reluctant to disclose details about the design of the Phase 3 trial because the NIH is still waiting on guidance from regulators. But he hopes that the study will be “similar and confirmatory” to the Phase 2 design since the two hormones in NES/T are already approved drugs on their own. Finding volunteers for the study shouldn’t be a problem. Contraline has a database of nearly 10,000 men, mostly aged 20 to 40, who are on a waitlist to be part of the company’s clinical trials. “We get emails every week from random guys,” Eisenfrats said. “We have done zero advertising of that.” Now the company must find funding to put NES/T through its final test. Contraline disclosed a $10.7 million Series A financing in 2021, but Eisenfrats said he’s raised about $30 million total since the company’s inception, including from investors at the Founders Fund, GV and MBX Capital. Eisenfrats is courting biotech-focused venture capital firms for the first time, pitching peak sales of NES/T between $1 billion and $2 billion in the US, assuming prescriptions cost $50 to $65 a month and are sold through telehealth companies like Hims or Ro. Sailer said that Contraline’s license to NES/T is contingent on the startup’s ability to raise money. If the startup fails, the Population Council will get the drug back. But if the Contraline and the drug are successful, the nonprofit will get royalties on future sales, and the NIH will get a cut, too. Eisenfrats and Sailer both declined to disclose further financial details. “They believe that the market is there, and they are very, very determined to be successful,” Sailer said. “And they understand that it’s going to take some trailblazing.” Editor’s note: This story was corrected. It previously misidentified the headquarters of Contraline.