Northeastern University

Gilead announced Wednesday that it will allow certain drug manufacturers to make and sell a generic version of its twice-yearly HIV shot lenacapavir in 120 low- and lower-middle income countries. But the pharma company’s plans won’t make lenacapavir accessible in many key countries where a twice-yearly prevention drug could be transformative for combating the spread of HIV, according to drug access experts. Two large studies have shown that lenacapavir given twice a year can reduce the risk of acquiring HIV. Lenacapavir made waves earlier this year when Gilead announced that the injection fully prevented HIV in a study with cisgender women, and the striking results led the trial to stop early. A second study showed the drug reduced risk in cisgender men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth. Lenacapavir is not yet approved anywhere in the world for HIV PrEP (pre-exposure prophylaxis), but Gilead said it plans to begin regulatory filings by the end of this year. The company is granting six drug manufacturers voluntary licenses to make and sell the drug for PrEP as well as treatment for certain adults with multi-drug resistant HIV, where it is already approved as Sunlenca. The manufacturers include Dr. Reddy’s, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero and Viatris subsidiary Mylan. In the US, Sunlenca has a list price of $42,250 for the first year and $39,000 every year after that. A study presented in late July showed the drug could be made for $40 . When asked about pricing of lenacapavir for PrEP, Gilead said in an email that the drug is experimental and “while we prepare for regulatory filings, it is too early to state the price.” Gilead said in its press release Wednesday that it’s also prioritizing lenacapavir registration in 18 countries “that represent about 70% of the HIV burden in the countries named in the license,” in order to provide lenacapavir until generics are available. However, advocates have been calling for Gilead to allow generic production of lenacapavir through the Medicines Patent Pool, a UN-backed program that would enable generic production for all low- and middle-income countries, not just the ones that Gilead has selected. “It is concerning that Gilead’s latest announcement seems to mention neither upper-middle income countries, where people cannot afford anything like lenacapavir’s current $42,250 price tag, nor a commitment to work with the UN-backed Medicines Patent Pool,” UNAIDS executive director Winnie Byanyima said in a statement in July in response to Gilead’s announcement of the Phase 3 results in cisgender women. UNAIDS’ press release noted that these upper-middle-income countries account for 41% of new HIV infections and 37% of all people living with HIV. Global estimates say that in 2023, 39.9 million people are living with HIV, including 1.3 million newly infected, while 630,000 died from AIDS-related illnesses last year. Brook Baker, senior policy analyst for Health GAP and professor emeritus at Northeastern University School of Law, pointed out that several excluded countries are those where Gilead conducted clinical trials, including Argentina, Brazil, Mexico and Peru, but the company has promised access only to trial participants. He added that the terms of Gilead’s agreement strongly deter manufacturers from making and selling the drug outside of the 120 countries that it has permitted. Baker said that Gilead’s moves “prevent supply to potentially profitable upper-middle-income markets.” Gilead said in an email Wednesday that it believes that “working directly with our licensees will ensure we are able to rapidly transfer our technology and address challenges as they arise,” and for middle-income countries, it is “exploring several innovative strategies to support access to LEN for PrEP (if approved), including tiered pricing, and are working with payors to establish fast, efficient pathways to help reach people who need or want PrEP.” Baker said that tiered pricing often comes with “no price transparency” and countries are “negotiating blind” with drug companies.

Experienced Life Sciences Executive Brings Strategic Expertise to Support Traws’ Further Transformation and Growth Director James J Marino Also to Step Down from Traws Board After a Decade of Service NEWTOWN, Pa., Sept. 20, 2024 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (Nasdaq: TRAW) (“Traws” or “the Company”), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases and cancer, today announced the appointment of Luba Greenwood as Director. In addition, Director James J. Marino is stepping down after nearly ten years of dedicated service, including four years as Chairman, due to other professional commitments. “We are honored to welcome Luba Greenwood to the Traws Board,” said Iain Dukes, PhD, Executive Chairman of the Traws Board. “Luba brings a rich depth of experience as a Board Member, Investor, Strategic Advisor and Company Executive through her industry roles, including as a board member for public life science companies across a range of therapeutic areas, as Managing Partner of Binney Street Capital (BSC), and as Vice President of Global Business Development and M&A at Roche. As we begin the next phase of Traws’ development, including the advancement of our novel respiratory antiviral therapies through Phase 1 studies and the progression of our oncology strategy, we look forward to benefitting from Luba’s considerable expertise in strategy, corporate development and corporate governance.” “I believe Traws is at a very important inflection point and I am excited to be part of the Company’s ongoing transformation,” said Luba Greenwood. “The Company has taken a very strategic approach to building and expanding its pipeline, starting with the April 2024 merger agreement with Trawsfynydd, one of the “Loch Companies” founded by the innovative i2020 Accelerator, supported by Torrey Pines Investments and Orbimed. Since April, the Company has delivered on its plan to advance the flu and COVID programs through Phase 1 dosing studies and initiate preparations to begin Phase 2 studies. In addition, it has progressed the development of its oncology strategy. I believe this is just the beginning for Traws and look forward to working with the Board and Management to create value for the Company’s investors and stakeholders.” Dr. Dukes commented further, “On behalf of the Traws Board of Directors, I want to express our sincere gratitude to Jim for his dedicated and enduring service. As an active member of the biotech community, Jim has contributed valuable advice and leadership insight to the Company through the years, including four years as Chairman. We wish him all the best in his future endeavors.” About Luba GreenwoodLuba Greenwood is an accomplished life science professional with substantial experience as an investor, board member, company executive, entrepreneur and industry leader. Ms. Greenwood founded and currently serves as the Managing Partner of the Dana Farber Cancer Institute Venture Fund, Binney Street Capital (BSC). In addition, Ms. Greenwood serves on the Board of Directors of several biopharmaceutical companies. Previously, Ms. Greenwood held roles as a senior executive or advisor for private and public biopharmaceutical companies, including Kojin Therapeutics, LUCA Biologics, Inc, and leading healthcare organizations including the Dana-Farber Cancer Institute. Prior to that, Ms. Greenwood held senior leadership and strategic business and corporate development roles for Verily Life Sciences LLC, F. Hoffmann-La Roche Ltd., and the Roche Diagnostics Innovation Center, East Coast. Ms. Greenwood received a B.A. in Biology from Brandeis University and a J.D. from Northeastern University Law School. About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company developing oral small molecule therapies for the treatment of respiratory viral diseases and cancer. The viral respiratory disease program includes two potentially best-in-class oral small molecules in Phase 1 studies: tivoxavir marboxil, a novel oral antiviral drug candidate for influenza and avian flu, targeting the influenza cap-dependent endonuclease, and ratutrelvir, targeting Mpro (3CL protease) for COVID19. In the cancer program, Traws is utilizing a partnering strategy, supported by investigator sponsored studies, to advance the oncology program which includes the novel proprietary multi-kinase CDK4-plus inhibitor, narazaciclib, and the multi-kinase inhibitor targeting cell cycle proteins including PLK-1, rigosertib. Traws is committed to delivering novel compounds for unmet medical needs using state-of-the-art drug development technology. With a focus on product safety and a commitment to patients in need or that are specifically vulnerable, we aim to build solutions for important medical challenges and alleviate the burden of viral infections and cancer. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, collaborations, merger integration, market conditions and those discussed under the heading “Risk Factors” in Traws’ filings with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Traws Pharma Contact: Mark GuerinTraws Pharma, Inc.267-759-3680www.trawspharma.com Investor Contact: Bruce MackleLifeSci Advisors, LLC646-889-1200bmackle@lifesciadvisors.com

Earlier this summer, when the Supreme Court eliminated a longstanding legal doctrine that deferred to federal agencies on interpreting federal law, many legal observers said the move could spell the end of some contentious FDA-led decisions, pushing the agency toward issuing guidance instead of rulemaking. In a Monday filing with the Supreme Court on a case related to FDA’s authority over flavored e-cigarettes, the FDA’s lawyers spelled out how they’re reading into the landmark decision, and other matters related to interpreting the law, regulations and issuing guidance. “The [Supreme] Court held long ago that courts must defer to an agency’s reasonable reading of an ambiguous regulation,” FDA’s lawyers write in their brief, which cites the Chevron decision, known as Loper Bright , from June three times. The agency also says that it should not be bound by private parties’ “good-faith” misinterpretations of its guidance, and that such a ruling could have a chilling effect on issuing guidance. While that doesn’t carry the force of law or regulation, it can help steer companies to understand the rules. “Any guidance document will contain ambiguities,” the FDA lawyers wrote, citing Loper Bright. “By automatically resolving all such ambiguities against the agency, the Fifth Circuit’s approach discourages agencies from providing guidance in the first place — an outcome that, in the long run, harms rather than helps regulated parties.” David Simon, associate professor of law at Northeastern University, told Endpoints via email, “FDA’s motive is plain: without deference, such broad delegations will always be subject to judicial review in some form, creating a system where courts second guess agency determinations on any number of issues. The net effect will be to reduce the efficiency of agency-decision making and potentially gum up the machinery the administrative state.” The agency also acknowledges the reality of the situation and tries to carve out space for its work on guidance. “But FDA faces a problem,” Simon adds. “It can only urge, but not demand, that courts defer to it.” The agency notes, “As this Court recently held, the APA requires reviewing courts to ‘determine the best reading’ of the law ‘by applying their own judgment. That holding forecloses any contention that courts should accord controlling effect to a private party’s purportedly reasonable but incorrect reading of a guidance document.” In the Monday filing, the agency also said it doesn’t have any legal obligation to issue guidance, but such guidance can help companies understand how it interprets the law and how it plans to exercise its discretion.