Latest news with #OrangeBook
Business Insider
2 days ago
- Business
- Business Insider
Needham sees FDA's positive CP ruling as best-case outcome for Phathom
Needham notes that Phathom Pharmaceuticals (PHAT) is trading up 95%-plus this afternoon, following the company's announcement that the food and drug administration has approved the company's Citizen's Petition regarding Voquezna tablets. FDA has also communicated its intention to correct the Orange Book listing to reflect the full 10-year NCE exclusivity. This extends Voquezna's market exclusivity through 5/3/2032. Needham notes the CP/exclusivity issue had been a massive overhang on the stock since November 2024, but it views the news as clearly a best-case scenario and a significant clearing event for the stock. The firm believes Phathom Pharmaceuticals' shares now have a new support level, and thinks shares will move higher in the coming weeks as investors digest the news and take a fresh look at the story, which Needham believes is quite compelling given the strong Voquezna launch and TRx trends. The firm has a Buy rating on the shares with a price target of $28. Confident Investing Starts Here:
Yahoo
2 days ago
- Business
- Yahoo
Phathom Pharmaceuticals shares soar on FDA exclusivity grant
-- Shares of Phathom Pharmaceuticals Inc. (NASDAQ: PHAT) soared 128% after the FDA granted the company's petition for exclusivity in the Orange Book listing for its drug Voquezna (vonoprazan fumarate). The decision by the Food and Drug Administration to extend the exclusivity period to a full 10 years for Voquezna, under the umbrella of the Generating Antibiotic Incentives Now (GAIN) provisions, has been a significant catalyst for the stock's movement. The FDA's response to Phathom's citizen petition, which was received on December 11, 2024, allows the company to benefit from the extended exclusivity initially granted to Voquezna Triple Pak and Voquezna Dual Pak. These packages, which contain the new chemical entity (NCE) vonoprazan, were designated as qualified infectious disease products (QIDPs) and received an additional 5 years of exclusivity, totaling 10 years under the GAIN provisions. The FDA's decision is in line with its umbrella policy, which aims to encourage the development and improvement of drugs containing the NCE without compromising the innovator's exclusivity period. This FDA ruling is pivotal for Phathom as it ensures that Voquezna will benefit from the remainder of the NCE exclusivity recognized for the Voquezna Paks. The Orange Book will be updated to accurately reflect this extended period of exclusivity, which is a substantial win for the company. This exclusivity extension is particularly important as it protects Voquezna from generic competition and allows Phathom to capitalize on the market potential of its product without immediate threats. Related articles Phathom Pharmaceuticals shares soar on FDA exclusivity grant Neo Performance Materials stock surges on buyback plan BofA sees termination of Owens–Rotech deal as surprising but potentially positive Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
2 days ago
- Business
- Yahoo
Phathom Pharmaceuticals Announces Positive FDA Decision to Recognize 10 Years of Regulatory Exclusivity for VOQUEZNA® (vonoprazan) Tablets through May 3, 2032
FLORHAM PARK, N.J., June 06, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT) today announced that the U.S. Food and Drug Administration (FDA) has approved Phathom's Citizen Petition filed on December 11, 2024 and communicated the Agency's intention to correct the Orange Book to recognize the proper 10 years of New Chemical Entity exclusivity for VOQUEZNA® (vonoprazan) tablets, extending through May 3, 2032. About Phathom Pharmaceuticals, Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel treatments for gastrointestinal diseases. Phathom has in-licensed the exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB) that is currently marketed in the United States as VOQUEZNA® (vonoprazan) tablets for the relief of heartburn associated with Non-Erosive GERD in adults, the healing and maintenance of healing of Erosive GERD in adults and relief of associated heartburn, in addition to VOQUEZNA® TRIPLE PAK® (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA® DUAL PAK® (vonoprazan tablets, amoxicillin capsules) for the treatment of H. pylori infection in adults. For more information about Phathom, visit the company's website at and follow on LinkedIn and StatementsThis press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about Phathom's commercialization plans. 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: the timing of the correction to the Orange Book; the expected duration of patent term extension for VOQUEZNA; we may not be able to successfully commercialize VOQUEZNA, VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK, which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; 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 obtain and maintain intellectual property protection, including patent term extensions, and non-patent regulatory exclusivity for vonoprazan; Phathom may face competition earlier than expected if it loses or fails to obtain any of its patent protection or non-patent regulatory exclusivity for VOQUEZNA tablets; Phathom's ability to obtain and maintain intellectual property protection and non-patent regulatory exclusivity for vonoprazan; 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 most recent 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 CONTACTNick Benedetto1-877-742-8466media@ INVESTOR CONTACTEric Sciorilli1-877-742-8466ir@ © 2025 Phathom Pharmaceuticals. All rights VOQUEZNA DUAL PAK, VOQUEZNA TRIPLE PAK, Phathom Pharmaceuticals, and their respective logos are registered trademarks of Phathom Pharmaceuticals, Inc.
Yahoo
5 days ago
- Business
- Yahoo
Biofrontera Inc. Announces Patent for Propylene Glycol-Free Formula of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Now Listed in FDA Orange Book
Biofrontera received patent approval for the revised formulation of Ameluz® in April 2025, extending patent protection through to December 2043. The Orange Book is published by the U.S. Food and Drug Administration (FDA) and lists all approved prescription drug products, along with patent and exclusivity information. Inclusion signifies FDA recognition of the revised formulation's approved status and its intellectual property protection. WOBURN, Mass., June 03, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on the development and commercialization of photodynamic therapy (PDT), today announced the inclusion of the patent for its propylene glycol-free formulation of Ameluz® nanoemulsion gel in the US Food and Drug Administration's (FDA's) publication 'Approved Drug Products with Therapeutic Equivalence Evaluations' (commonly known as the Orange Book). The Orange Book is a key reference for healthcare providers, pharmacists, and payers and is the definitive source for identifying FDA-approved drug products. Inclusion of a drug in the Orange Book confirms that the FDA recognizes that the drug meets their rigorous standards for safety, efficacy, and quality. In addition, patents listed confer intellectual property protections which may include the drug's composition, formulation, or specific uses. Listing of the patent for the propylene glycol-free formulation of Ameluz® prevents generic competition as long as the patent is valid, which currently is December 2043. The revised formulation, which eliminates propylene glycol—a well-known allergen for some patients1—demonstrates Biofrontera's continued commitment to innovation and patient-centric development. It offers a significant improvement for individuals who are sensitive to this excipient without compromising the treatment's effectiveness. The patent for the revised formulation of Ameluz® was issued on April 22, 2025, and lasts until December 8, 2043. The formulation itself was accepted by the FDA and has been in use since 2024. 'We are proud to announce the inclusion of the patent for our propylene glycol-free formula in the Orange Book,' said Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. 'This recognition validates the differentiated profile of our propylene glycol-free formulation, offering physicians and patients a formulation that reduces the potential for allergic reactions while maintaining the efficacy of Ameluz® RhodoLED PDT.' References: Jacob SE, et al. 'Contact Allergy to Propylene Glycol: A Review.' Dermatitis. 2008;19(3):157–163. About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit and follow Biofrontera on LinkedIn and Twitter. Forward-Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of any extraordinary external events; any changes in the Company's relationship with its licensors; the ability of the Company's licensors to fulfill their obligations to the Company in a timely manner; the Company's ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company's ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company's licensed products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company's expectations; the Company's ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission (the 'SEC'), which can be obtained on the SEC's website at Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Contact:Investor RelationsAndrew Barwicki1-516-662-9461ir@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
19-05-2025
- Business
- Associated Press
SCIENTURE announces FDA Orange Book Patent Listing for ArbliTM, (losartanpotassium) Oral Suspension, 10mg/mL.
TAMPA, FL, May 19, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce that the U.S. Food and Drug Administration (FDA) has listed U.S. Patent Nos. 11890273 (the '273 patent) and 12156869 (the '869 patent), each with an expiration date of October 2041, in its Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) for Arbli™, (losartan potassium) Oral Suspension, 10mg/mL, approved under New Drug Application (NDA# N218772). The '869 patent and the '273 patent, both titled, 'Losartan Liquid Formulations and Methods of Use,' cover stable, liquid pharmaceutical compositions of Losartan and methods of treating patients in need of Losartan by administration of the novel formulations described. The listing reinforces Scienture's intellectual property position and may serve as a basis for statutory exclusivity and market protection under the Hatch-Waxman Act. Arbli™ is meant for the treatment of hypertension in patients greater than 6 years old, for the reduction of risk of stroke in patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy in certain patients with type 2 diabetes. Arbli™ is the first and only FDA approved ready-to-use oral liquid losartan in the U.S. market. Arbli™ is a novel proprietary formulation of losartan, a proven therapy for treating hypertension, which provides a tailored approach to patients that require or prefer an oral liquid option of losartan. Appropriate dosing is now easier, safe and effective, while providing the assurance of quality as an FDA-approved product. Arbli™ provides a safe and convenient option to patients requiring a liquid formulation and addresses the intrinsic risks associated with potential inconsistencies in the process of crushing tablets to extemporaneously compound losartan prescriptions. Losartan is classified as an angiotensin receptor blocker (ARB) for treating hypertension and is one of the highest prescribed molecules for this indication. Current products in the market containing losartan are available only as oral solids, which can be further compounded to a liquid formulation. Arbli™ is the first liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage. IQVIA data (March 2025) indicates a total annual sales of approximately $276 million and a prescription volume of 69 million (TRx) for losartan in the US market. 'This Orange Book listing marks a major regulatory milestone for our company and reaffirms our commitment to bringing safe, effective, and high-quality treatments to patients.' said Shankar Hariharan, Ph.D., President of Scienture, LLC. 'It's a testament to the rigor of our development program and the dedication of our team.' 'The listing of patents for Arbli™ in the Orange Book strengthens our IP position and enhances our commercial pathway in the U.S. market,' remarked Narasimhan Mani, Ph.D., MBA President of Scienture, LLC..' It validates our science, our team, and our belief in patient-first innovation. It is a key step forward in our mission to bring accessible, high-impact therapies to those who need them most.' About Arbli™ Arbli™ is the first and only oral liquid formulation of losartan approved by the U.S. FDA. Arbli™ comes in a 165 mL bottle as a peppermint flavored suspension that does not require refrigeration, and has been approved for a shelf life of 18 months from the date of manufacture when stored at room temperature, based on the data submitted in the NDA. Once the 24-months stability data is submitted to the FDA, the shelf-life of the product is expected to be extended to 24-months at room temperature. INDICATION Arbli™ is an angiotensin II receptor blocker (ARB) indicated for: IMPORTANT SAFETY INFORMATION You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. You may also contact Scienture at 1-833-754-4917. Please see the full Prescribing Information for complete product information. For more information, talk to your healthcare provider. About Hypertension Hypertension (high blood pressure) is a cardiovascular condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher). According to the CDC, hypertension, or high blood pressure, affects nearly half of adults in the United States, or 119.9 million people. Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher. Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the U.S. Factors that increase the risk of having high blood pressure include: older age, genetics, being overweight or obese, not being physically active, high-salt diet and drinking too much alcohol. Hypertension is clinically diagnosed if, when blood pressure is measured on two different days, the systolic blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood pressure readings on both days is ≥ 90 mmHg. About Scienture Holdings, Inc. SCIENTURE HOLDINGS, INC. (NASDAQ: 'SCNX'), is the parent company of its wholly owned subsidiary, Scienture, LLC a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture, LLC are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit and Cautionary Statements Regarding Forward-Looking Statements This press release contains certain statements that may be deemed to be 'forward-looking statements' within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch, the timing of such launches, and the success those products may have in the marketplace. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'ongoing,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC. Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law. Contact: SCIENTURE HOLDINGS, INC. 6308 Benjamin Rd, Suite 708 Tampa, Florida 33634 Phone: (866) 468-6535 Email: [email protected]
