Amoxicillin Sodium

Republican governors’ concerns echo those raised by FDA Commissioner Robert Califf, M.D., last week. After FDA Commissioner Robert Califf, M.D., recently made comments about the untenable nature of generic drug production in the U.S., a clutch of governors has raised its own set of concerns about shortages. This week, 11 Republican governors sent a letter (PDF) to Congress demanding action on the spate of drug shortages plaguing the U.S. Citing shortfalls of critical meds like albuterol, amoxicillin and certain chemotherapies, the governors noted that shortages have sometimes lasted for years, often with “no good explanation for why.” One possible reason for the shortages, they added, is tied to the fact that more than 80% of active ingredients in prescription drugs sold in the U.S. come from overseas. “This limited supply chain creates a national security risk and leaves America competing with other nations for essential resources,” the joint letter states. The governors called on Congress to adopt a clutch of new policy solutions to ensure adequate supplies of medicines. Their letter calls for added transparency in the pharmaceutical manufacturing chain, ranging from the sourcing of raw materials to the finished product, including country of origin labeling. Additionally, Congress should help foster increased diversity in generic drug manufacturing with regards to both raw materials and final manufacturing, the governors said. The group is also pressing for more transparency from the FDA about ongoing shortages and events that can cause supply chain disruptions. They further want the agency to reconsider its expiration date guidance on certain medications. “The FDA and medical companies are currently restricted by federal law regarding their transparency policies,” the governors wrote. “Congress must grant additional authorities that allow more transparency throughout the drug manufacturing process.” The governors also appear to favor drug importation. The group requests that Congress enable waivers to allow the purchase of medications from Canada to quickly expand the U.S. supply chain. Lastly, the governors want the U.S. to foster a regulatory environment that is “more favorable” to domestic production. The governors’ concerns echo those raised by Califf last week. Discussing drug shortages during a presentation of the Alliance for a Stronger FDA, Califf said the “fundamental problem” is that “we essentially have two drug industries in the U.S.” There’s the “innovator industry,” where Califf said he thinks "the prices are too high,” and then there’s the generics industry, where “a lot of the prices are too low.”  “What I mean by that is that the price has been driven down below the cost of manufacturing and distributing the drug,” he said. “And we have an industry which is continuing to leave the U.S. because it’s not viable to run the business.” The FDA currently lists around 137 unresolved drug shortages on its online database. 

Prior Approval Supplement (PAS) for VOQUEZNA® TRIPLE PAK® and VOQUEZNA® DUAL PAK® assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2023 by the U.S. Food and Drug Administration (FDA) U.S. commercial launch for H. pylori and Erosive GERD planned for Q4 2023 Successfully completed Phase 3 PHALCON-NERD-301 trial for Non-Erosive GERD; regulatory submission on track to occur by year-end FLORHAM PARK, N.J., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, today reported financial results for the second quarter of 2023 and provided updates on recent regulatory and business progress. “We made great progress advancing key regulatory, financial, and commercial priorities during the second quarter, highlighted by our regulatory submissions for both Erosive GERD and H. pylori convenience packs, the successful execution of a capital raise resulting in $141.4 million in net proceeds, and commencement of our salesforce recruiting in anticipation of our product launches in the fourth quarter,” said Terrie Curran, President and Chief Executive Officer of Phathom. “Our manufacturing and regulatory teams have worked diligently to address the impurity cited by the FDA in the complete response letters we received in February, and we are pleased that our regulatory applications have been assigned PDUFA action dates later this year. We remain focused on onboarding a high-performing field force and completing the final preparations for our anticipated commercial launches.” Clinical, Regulatory, and Business Updates: In June 2023, Phathom submitted a PAS to the FDA for both VOQUEZNA TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA DUAL PAK (vonoprazan, amoxicillin). The submission of these supplements signifies a full response to the February 2023 complete response letter (CRL) and, subject to filing, the FDA has assigned a PDUFA goal date of October 30, 2023. The PAS contained three months of stability data supporting both VOQUEZNA-based convenience packs, which includes reformulated vonoprazan tablets, to support the commercial shelf life of vonoprazan. Phathom plans to provide six-month stability data during the regulatory review as previously agreed with the FDA. In June 2023, Phathom announced that the FDA acknowledged the New Drug Application (NDA) resubmission for vonoprazan for the treatment of Erosive GERD (gastroesophageal reflux disease) constitutes a complete response to the February 2023 CRL and assigned a PDUFA goal date of November 17, 2023. In May 2023, Phathom recorded $141.4 million in net proceeds from the completed public offering of its common stock. The total gross proceeds to Phathom from the offering were approximately $150.3 million, before deducting the underwriting discounts and commissions and other offering expenses. Phathom intends to use the net proceeds from the offering to fund the clinical development of vonoprazan, pre-commercial activities and commercialization expenses, and for working capital and general corporate purposes. In its Phase 3 PHALCON-NERD-301 trial for Non-Erosive GERD, Phathom successfully completed the 20-week blinded extension period where patients were administered vonoprazan 10 mg or 20 mg once-daily for further safety and efficacy evaluation. Topline results from the extension period are expected to be shared by the end of 2023. A regulatory submission remains on track for the second half of 2023 seeking approval of vonoprazan as a daily (QD) treatment for Non-Erosive GERD, the largest subcategory of GERD with an estimated U.S. population of over 45 million people. Phathom has currently secured coverage for 65% of commercial lives for first-in-class PCAB-based H. pylori infection treatments, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK. Phathom is in the process of recruiting and onboarding a national salesforce in advance of the planned fourth quarter 2023 commercial launches for H. pylori and Erosive GERD. Second Quarter 2023 Financial Results: Net loss for the second quarter ended June 30, 2023, was $41.0 million, compared to $50.9 million for second quarter 2022. Second quarter 2023 net loss included a non-cash charge related to stock-based compensation of $7.3 million compared to $5.9 million for second quarter 2022. Research and development expenses for the second quarter 2023 were $12.8 million, a decrease of $6.0 million compared to $18.8 million for second quarter 2022. The decrease was a result of decreased clinical trial costs, partially offset by increased chemistry, manufacturing and controls costs, and personnel costs. General and administrative expenses for the second quarter 2023 were $18.9 million, a decrease of $7.6 million compared to $26.5 million for second quarter 2022. The decrease was primarily due to a reduction in professional services, partially offset by increased personnel costs. As of June 30, 2023, cash and cash equivalents were $248.8 million. An additional $100.0 million is available under Phathom’s term loan with Hercules Capital, Inc. (Hercules) on October 1, 2023, and $175.0 million will be paid to Phathom upon FDA approval of VOQUEZNA for Erosive GERD under the terms of its revenue interest financing agreement. Based on its current operating plan, including expected product revenues, the funds available under its existing term loan with Hercules and cash to be paid under our royalty interest financing agreement following approval of VOQUEZNA for Erosive GERD, Phathom believes it will have sufficient capital to fund operations through the end of 2025. About Phathom Pharmaceuticals Phathom Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights in the United States, Europe, and Canada to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB). For more information about Phathom, visit the Company’s website at and follow the Company on LinkedIn and Twitter. Forward Looking Statements Phathom cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding Phathom’s expectations of generating and submitting to the FDA stability data necessary to support the proposed shelf life of vonoprazan; the potential approval of its Erosive GERD NDA and prior approval supplements for its H. pylori convenience pack NDAs, and anticipated product launches in H. pylori and Erosive GERD; a potential regulatory submission seeking approval of vonoprazan as a daily treatment for Non-Erosive GERD; and that Phathom will have sufficient capital to fund operations through the end of 2025. The inclusion of forward-looking statements should not be regarded as a representation by Phathom that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Phathom’s business, including, without limitation: Phathom may be unable to generate the required data to meet the acceptable intake of its nitrosamine impurity, or may be unable to reduce the impurity to an acceptable level throughout the shelf life of the product, to obtain approval for its Erosive GERD NDA or to bring vonoprazan to market for patients with Erosive GERD, if approved, or for patients with H. pylori; future nitrosamine data may be inconsistent with data generated to date; the FDA may not accept for review the H. pylori convenience pack supplements; risks associated with product manufacturing or formulation changes required to be made in connection with achieving the acceptable daily intake limit of the nitrosamine detected in vonoprazan drug product; the FDA may disagree that the existing safety and efficacy data, together with additional data, is sufficient to approve the Erosive GERD NDA or supplements to the H. pylori NDAs; the inherent risks of clinical development of vonoprazan; Phathom’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of vonoprazan that may limit its development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Phathom’s ability to access additional capital under its term loan facility and royalty interest finance agreements is subject to certain conditions; Phathom’s ability to obtain and maintain intellectual property protection for vonoprazan; Phathom’s ability to comply with its license agreement with Takeda; and other risks described in the Company’s prior press releases and the Company’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Phathom undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. MEDIA CONTACT Nick Benedetto 1-877-742-8466 media@phathompharma.com INVESTOR CONTACT Eric Sciorilli 1-877-742-8466 ir@phathompharma.com © 2023 Phathom Pharmaceuticals. All rights reserved. Selected Condensed Balance Sheets (Unaudited) (in thousands) June 30, 2023 December 31, 2022 Assets Cash and cash equivalents $ 248,847 $ 155,385 Total assets $ 265,039 $ 164,810 Total liabilities $ 247,439 $ 239,624 Total stockholders’ equity (deficit) $ 17,600 $ (74,814) Statements of Operations and Comprehensive Loss (Unaudited) (in thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Operating expenses: Research and development $ 12,764 $ 18,815 $ 24,242 $ 36,475 General and administrative 18,937 26,548 37,536 46,795 Total operating expenses 31,701 45,363 61,778 83,270 Loss from operations (31,701 ) (45,363 ) (61,778 ) (83,270 ) Other income (expense): Interest income 348 112 1,808 119 Interest expense (9,615 ) (5,667 ) (18,832 ) (8,426 ) Other income (expense) 3 (2 ) 23 (8 ) Total other expense (9,264 ) (5,557 ) (17,001 ) (8,315 ) Net loss and comprehensive loss $ (40,965 ) $ (50,920 ) $ (78,779 ) $ (91,585 ) Net loss per share, basic and diluted $ (0.84 ) $ (1.33 ) $ (1.73 ) $ (2.40 ) Weighted-average shares of common stock outstanding, basic and diluted 48,500,516 38,272,044 45,444,496 38,155,151