Attention Deficit Disorder

Advocates are bargaining with Congress and the Biden administration to plug the hole they expect will drown progress they’ve made to expand telehealth options for patients. The Drug Enforcement Administration is reaching the final steps of its proposed rulemaking process for the prescription of controlled substances via telehealth, but its plans have been leaked.The agency’s rule, which is under review at the White House, is a far cry from the unfettered access telehealth advocates were hoping for, a former DEA official told them, according to an anonymous source who spoke to Fierce Healthcare.The telehealth prescribing flexibility has been used since 2020 to prescribe medications for conditions like substance use disorder and attention deficit disorder. The DEA proposed two rules for telehealth controlled substance prescribing early last year but pulled them back after receiving 38,000 public comments.The new proposed rule was expected to be out in September, according to the administration's schedule of regulatory actions. The rule would set a post-pandemic norm for patients receiving medications through telehealth. Though the proposed rule has not been approved by the White House’s Office of Management and Budget, advocates are already scrambling to change course. The Department of Health and Human Services is also concerned with the rule as drafted. Lobbyists said HHS lodged hundreds of complaints against the DEA's draft rule.According to the former DEA official, per Fierce Healthcare's source, the draft telemedicine prescribing rule that the DEA has been working on since it scrapped its last attempt proposes that when a patient and provider have not had an initial in-person visit, the types of medications they can prescribe should also be limited.The unpublished rule reportedly restricts schedule II substances, like Adderall, from being prescribed at all unless an in-person visit has occurred. Schedule III-V substances can be prescribed based solely on a telehealth visit.But, the draft rule reportedly only allows providers to do 50% of prescribing online, in an effort to prevent misuse and diversion. The other 50% of prescribing must be done in person.The draft rule would also require prescribers to check all 50 states’ prescription drug monitoring programs before prescribing a controlled substance to a patient who they have not seen before in person.However, there is not a national prescription drug registry where prescribers could easily check if the patient had obtained the medication in another state. In social media posts since the DEA's leaked draft rule, many providers have attested to the fact that there is not a single state that can check against all other states' prescription drug monitoring registries. Providers also said that DEA would need to make a type of national PDMP registry available to them in order to carry out the stipulations of the draft rule.In response to the leaked information, major telehealth advocacy groups are gathering signatures for letters they will send to Congressional leaders and the White House asking for a two-year extension of current flexibilities. Lobbyists have also taken to the Hill to work on solutions.The letters, reviewed by Fierce Healthcare, ask Congress and the White House to step in to help the DEA promulgate the special telehealth registration system to track which telehealth providers can prescribe controlled substances. Hundreds of organizations have signed on so far.The letters stress that the DEA is out of time to promulgate a rule for the telehealth prescribing of controlled substances before the waiver expires at the end of the year.  Because the DEA has effectively run out of time to hold a public comment period, review the comments and put forward a final rule, the letter to Congress encourages leadership to add the extension to the expected end-of-the-year legislative package. The letter to the White House Domestic Policy Council asks it to work with DEA on a two-year extension. A telehealth lobbyist told Fierce Healthcare that the Biden administration has the authority to extend the pandemic flexibilities without action from Congress. The administration used this authority in May 2023 to extend the flexibilities until the end of 2024. An extension from the administration would likely be easier than passing an extension through Congress, the lobbyist said. However, given that other telehealth extenders are likely to make a year-end legislative package, the lobbyist said there should be room to include an extension of the DEA rules as well. Republicans and Democrats in both chambers have supported opening up telehealth prescriptions of controlled substances.Senator Mark Warner, D-Virginia, released a statement after media reports of the restrictions in the forthcoming rule. Warner advocates that the DEA lift some of the reported restrictions on telemedicine prescribing without the patient and provider being required to meet in person.“As currently reported, the DEA’s proposal provides an even worse solution than the one put forth under the first proposed rule," Warner said in a statement. "This arcane approach would represent a significant step back for patients who rely on telemedicine for critical medications, and yet another failure by the DEA to establish a meaningful special registration, which Congress has repeatedly directed it to do for over a decade."

• Executed Global Licensing Agreements that could provide up to $292 million in income • Received Cash Milestone Incomes of $116,000 • Achieved Significant Improvements in Earnings • Obtained Multiple Patents and FDA Approvals FREMONT, CA, Aug. 15, 2024 (GLOBE NEWSWIRE) -- ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, is pleased to announce its financial results and key operational highlights for the second quarter ended June 30, 2024. Key Financial and Operational Highlights: 1. Significant Global Licensing Agreements: - Vitargus® Licensing: Along with our subsidiary, BioFirst Corporation, we secured licensing agreements with ForSeeCon Eye Corporation that have the potential to provide up to a total of $187 million in income. The agreements include total upfront payments of $60 million that can be paid in cash or shares of ForSeeCon stock, milestone cash payments of $7.0 million and potential royalties up to $120 million after the product launches, of which there can be no guarantee; initial $116,000 milestone payment received in June 2024. This agreement underscores our commitment to advancing innovative therapies and enhancing shareholder value. - Oncology Products Licensing: Along with our subsidiary and affiliate, BioLite, Inc. and Rgene Corporation, we entered into a total of 8 licensing agreements with OncoX BioPharma, Inc., that have the potential to provide up to an aggregate of $105 million in income. The agreements include total upfront payments of $55,000,000 that can be paid in cash or shares of OncoX stock and royalties up to a total of $50 million after the product launches, of which there can be no guarantee. These potential payments and relationships will further solidify our financial foundation and strategic partnerships. 2. Financial Performance: - Earnings Per Share (EPS): Demonstrated a remarkable year-over-year improvement of approximately 86.8%, with EPS improving to -$0.09 in Q2 2024 from -$0.68 in the same period last year. This significant progress reflects our successful efforts in managing operational expenses and capitalizing on milestone payment revenue from licensing agreements. - Revenue Growth: Revenue increased to $117,142 in Q2 2024, a substantial rise from $6,109 in Q2 2023. This growth directly results from our strategic execution of licensing agreements, which have begun generating meaningful cash inflows. - Shareholders' Equity: As of June 30, 2024, shareholders' equity stood at $7.8 million, maintaining a solid financial foundation despite challenging macroeconomic conditions. 3. Strategic Partnerships and Market Positioning: - ABVC has strategically aligned itself with promising partners that we believe will ultimately enhance the value of ABVC's equity holdings. These partnerships are pivotal in driving shareholder value as we believe they will help market valuations grow. - We believe the Company is poised for significant market capitalization growth, leveraging its pipeline accomplishments and international partnerships to bring breakthrough therapies to market. 4. Operational and Regulatory Milestones: - Patent and FDA Approvals: Received multiple patents and regulatory approvals across the US, Taiwan, and Australia for treatments targeting major depressive disorder, ADHD, and ophthalmology. These achievements highlight our continued progress in expanding our intellectual property portfolio and advancing clinical trials. - Neurology and Oncology Advancements: Completed Phase II trials for MDD, initiated Phase IIb trials for ADHD, and received FDA approval for multiple IND applications, positioning us for continued growth and innovation in these critical therapeutic areas. Management Commentary: Dr. Uttam Patil, ABVC Chief Executive Officer, commented, "We are thrilled with the substantial progress we have made in Q2 2024. Our financial performance and strategic licensing agreements have enhanced our cash reserves and strengthened our position in the biopharmaceutical industry. We remain focused on advancing our pipeline, expanding our partnerships, and driving sustainable growth for the benefit of our shareholders." Board of Directors Statement: "We sincerely thank our shareholders for their continued support and confidence in ABVC. Our focus remains on advancing our licensing agreements and maximizing the value they bring. The execution of these agreements provides us with a solid foundation for future growth and stability. We are excited about these partnerships' prospects and are committed to driving our strategic goals forward." Outlook: We believe ABVC BioPharma is on a promising trajectory, focusing on sustainable growth, innovation, and value creation through strategic partnerships. Our improving financial strength and unwavering commitment to advancing healthcare solutions prepare us for future success. We sincerely thank our shareholders, partners, and dedicated team for their continued support and look forward to a prosperous future. Recent Operational Highlights Patents and FDA Approvals The Company received a US patent (US 16/936,032), valid until September 04, 2040, a Taiwanese (TW I821593) Patent, valid until July 22, 2040, and an Australian (AU2021314052B2) Patent, valid until April 09, 2041, for Polygala extract for the treatment of major depressive disorder. The Company received a US (US17/120,965), valid until December 20, 2040, and Taiwanese (TW 110106546), valid until February 24, 2041, Patent for Polygala Extract for treating Attention Deficit Hyperactive Disorder. A Taiwanese Patent (TW I792427) for Storage Media for the Preservation of Corneal Tissue was obtained on February 11, 2023, and is valid till July 19, 2041. As we work towards expanding our patent map into global coverage, we eagerly await the results of patent applications in the European Union, China, Japan, and others. On December 30, 2022, the Company received US FDA approval for the IND ABV-1519 to proceed with the Combination therapy for treating Advanced Inoperable or Metastatic EGFR Wild-type Non-Small Cell Lung Cancer was approved and the study can proceed. The IND was then submitted to the Taiwan FDA, and the approval was received on January 04, 2024. The United States Food & Drug Administration (US FDA) has approved four INDs, ABV-1501 for Triple Negative Breast Cancer (TNBC), ABV-1519 for Non-Small Cell Lung Cancer (NSCLC), ABV-1702 for Myelodysplastic Syndrome (MDS), and ABV-1703 for Pancreatic Cancer Therapy. Neurology The MDD Phase II trials for ABV-1504 were completed successfully with good tolerance to the drug, and no serious adverse effects were reported. The product is ready for an End-of-Phase 2 meeting with the FDA to finalize the protocol for Phase III trials. At the same time, we commenced the ADHD Phase IIb trials at the University of California, San Francisco (UCSF) and five other sites in Taiwan. The trials are heading for the interim report, which we expect to complete by the end of Q3 2024. ABV-1601 for MDD in cancer patients has completed Phase I study preparation, including the Site Initiation Visit (SIV). The study is set to initiate by the end of 2024. On July 31, 2023, ABVC signed a legally binding term sheet with a Chinese pharmaceutical company, Xinnovation Therapeutics Co., Ltd, for the exclusive licensing of ABV-1504 for Major Depressive Disorder (MDD) and ABV-1505 for Attention-Deficit Hyperactivity Disorder in mainland China. Under this agreement, Xinnovation will hold exclusive rights to develop, manufacture, market, and distribute our innovative drugs for MDD and ADHD in the Chinese market and shall bear the costs for clinical trials and product registration in China. We are negotiating definitive agreements with Xinnovation and are excited that the licensing deal carries a possible aggregate income of $20 million for ABVC if all expected sales are made, of which there can be no guarantee. This transaction remains subject to the negotiation of definitive documents and therefore there is no guarantee that this transaction will occur. In November 2023, each of ABVC and one of its subsidiaries, BioLite, Inc. ("BioLite"), entered a multi-year, global licensing agreement with AIBL for the Company and BioLite's CNS drugs with the indications of MDD (Major Depressive Disorder) and ADHD (Attention Deficit Hyperactivity Disorder) (the "Licensed Products"). The potential license will cover the Licensed Products' clinical trial, registration, manufacturing, supply, and distribution rights. The Licensed Products for MDD and ADHD, owned by ABVC and BioLite, were valued at $667M by a third-party evaluation. The parties are determined to collaborate on the global development of Licensed Products. The parties are also working to strengthen new drug development and business collaboration, including technology, interoperability, and standards development. As per each of the respective agreements, each of ABVC and BioLite shall receive 23 million shares of AIBL stock that the parties value at $10 per share (not independently validated) and if certain milestones are met, $3,500,000 and royalties equaling 5% of net sales, up to $100 million, which is not guaranteed. Ophthalmology Vitargus®, a vitreous substitute, is a groundbreaking, advanced-staged R&D product that we believe will be the first biodegradable hydrogel used in retinal detachment surgery. Vitargus® has completed the feasibility study in Australia and was approved by the Australian Therapeutic Goods Administration (TGA) to initiate the next trial phase in two participating sites. This is vital to obtaining final regulatory approval for Vitargus® in Australia. The Science Park Administration in Taiwan approved ABVC's plan to set up a pilot Good Manufacturing Practice (GMP) facility to produce Vitargus® and to pursue the process development work for manufacturing optimization. We are undertaking this project, proposed by ABVC's Taiwan affiliate and co-development partner, BioFirst Corporation, to upgrade the Vitargus® manufacturing processes so it can ultimately handle the global market supply. ABVC and BioFirst Corporation expect to complete the facility's construction in Hsinchu Biomedical Science Park, Taiwan, in 2024. Oncology/Hematology The United States Food & Drug Administration (US FDA) approved the Investigational New Drug (IND) application for the proposed clinical investigation of BLEX 404, the primary active ingredient in ABV-1519, for advanced inoperable or metastatic EGFR wild-type non-small cell lung cancer. This treatment is being co-developed by BioKey, Inc. ("BioKey") and by the Rgene Corporation, Taiwan. The study received approval from the Taiwan FDA. This is the fourth IND approved by the US FDA for BLEX 404. The previous three INDs are for the combination therapies of triple-negative breast cancer, myelodysplastic syndromes (MDS), and pancreatic cancer. CDMO BioKey, a wholly-owned subsidiary of the Company based in Fremont, California, produces dietary supplements derived from the maitake mushroom in tablet and liquid forms. BioKey has entered the second year of the distribution agreement with Define Biotech Co. Ltd. BioKey is currently set to produce an additional $1 million worth of products for the global market. We continue to work on distribution for the US and Canadian markets with Shogun Maitake. On the regulatory services front for our clients, we received two ANDA approvals from the US FDA. We have a three-year contract, worth up to $3 million, for clinical development services between BioKey and Rgene Corporation. With this base, we are actively developing BioKey as a contract research, development, and manufacturing organization (CRDMO) to become a one-stop solution for pharmaceutical services. About ABVC BioPharma, Inc. ABVC BioPharma, Inc. is a clinical-stage biopharmaceutical company focused on utilizing its licensed technology to conduct proof-of-concept trials through Phase II of the clinical development process at world-famous research institutions (such as Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center) and then out-licensing the products to international pharmaceutical companies for pivotal Phase III studies and, eventually, generating global sales. The Company has an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development. Forward-looking Statements This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction. Contact:Uttam Patil Email: uttam@ambrivis.com

WEDNESDAY, Aug. 14, 2024 -- Not all babies born prematurely will suffer long-term developmental problems, a new study finds. Preemies tend to fall into three risk categories, with about one in five (20%) scoring above average on standard cognitive tests, researchers reported Aug. 13 in the journal Child Development . A second profile representing 41% of preemies scored above normal on tests of memory, vocabulary and reading, but below average on tests of pattern recognition and working memory, researchers said. And a third profile representing nearly 40% of preemies scored below normal on all tests, suffering both cognitive and attention deficits. “Our study dispels the notion that every preterm child is born with cognitive and behavioral deficits,” said lead researcher Iris Menu , a post-doctoral scholar of child and adolescent psychiatry with the NYU Grossman School of Medicine in New York City. About 13 million babies are born prematurely each year, and preterm birth has been linked to a higher risk of ADHD, problems with social development and lower grades, researchers said in background notes. But the tendency to lump preemies into a single group hinders efforts to tailor care for any one child, they added. For the study, researchers analyzed cognitive and behavioral data for nearly 1,900 boys and girls born prematurely who had reached 9 to 11 years of age. The team found that children who fell within the first profile did an average 21% better on standard cognitive tests than kids in the third profile. Children in the first profile also fared better when it came to attention deficits, with only 2.5% suffering from them compared with about 10% of those in the third profile. First-profile children also did better in school, with more than 66% achieving a grade average of A- or better compared with about 61% of the second profile and 32% of the third, results show. “Precision psychiatry is not based on a general diagnosis, because two patients with the same diagnosis, like preterm birth, may have totally different experiences,” said senior researcher Moriah Thomason , vice chair for research of child and adolescent psychiatry at the NYU Grossman School of Medicine. “Our work highlights the complexity of preterm birth, and promises to improve treatment for each individual child.” Brain scans of the children revealed that the kids in the third profile had brains an average 3% smaller by ages 9 to 11 than kids in the first profile. Researchers also found weaker connections between two key brain circuits in third-profile kids -- the dorsal attention network that plays a role in sustaining attention, and the default mode network that handles brain processing when a person isn’t focused on a specific task. The connection between these two networks was 11% weaker in third-profile kids compared to first-profile children. This profiling approach could help researchers better direct education , therapy and drug treatment to the preemies most likely to need it, researchers said. “Based on these results, we call for the launch of social and structural interventions that ensure all preterm-born children receive equitable care,” Menu said in a university news release. “Children that get speech, physical and behavioral therapy almost every day, which is more likely to happen in affluent households, tend do better on the study tests, but there are other factors involved,” Menu added. “For instance, children in communities where more are covered by health insurance were less likely to belong to Profile 3.” The team also noted that Black preterm children were nearly four times as likely to fall into the lower-performing third profile. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.