Palm Beach, FL – August 9, 2023 – FinancialNewsMedia.com News Commentary – About 9.4% of the world population is aged 65 or above. Older people typically consume more medicines than the people in other age group thereby creating the demand for new, improved or less costly pharmaceuticals. This trend has been continuously growing for the past several years and is projected to continue for years to come. Further, new diseases including mutated forms of old diseases are also mounting. Urbanization and industrialization have led global movement of people and thereby introduction of new pathogens spreading at very high rate. Few such examples are SARS and Covid-19. Pharmaceuticals (biopharma, drug, medicine) are defined as any substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or any substance (other than food) intended to affect the structure or function of the body. Drugs are produced in forms such as pills, tablets, capsules, etc. Pharmaceuticals (biopharma, drug, medicine) are defined as any substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or any substance (other than food) intended to affect the structure or function of the body. Drugs are produced in forms such as pills, tablets, capsules, etc. Generic drugs are copies of innovative pharmaceuticals that contain the same active ingredients and are identical in strength, dosage form and route of administration and are comparatively cheaper than the innovative ones. Nearly, 40% of the all prescription drugs purchases were generic drug category. The generic-drug business model is based on high-volume treatments that target larger population. A report from Reogma.com projected that the global market for pharmaceuticals will grow by 4-5% CAGR, reaching USD $1.5 trillion by 2023. Active Biotech Companies active today in markets include: Palatin Technologies, Inc. (NYSE: PTN), Cardiff Oncology, Inc. (NASDAQ: CRDF), Biodexa Pharmaceuticals PLC (NASDAQ: BDRX), Bright Minds Biosciences Inc. (NASDAQ: DRUG), Eli Lilly and Company (NYSE: LLY).
The report said: “North America is expected to retain the leading position in the global pharmaceuticals market with market share of 45.33% in 2023. Asia Pacific pharmaceuticals market is expected to retain the second position with a market share of 24.07% in 2023. Europe on the contrary is expected to see a decline in the market share and will be worth 20.24% of global pharma industry in 2023. Latin America & Middle East and Africa (MEA) combined is expected to retain 7.53% and 2.96% market share respectively of global pharmaceuticals market in 2023. The spending on medicine in US is estimated to reach USD 647 billion by 2024, growing at a CAGR 4-7%; The consumer expenditure on medicine in Europe is projected to surpass USD 210 billion by 2024, growing at a CAGR 1-4%; The spending on medicine in China is likely to hit USD 401 billion by 2024, growing at a CAGR 5-8%; and The spending on medicine in Japan is estimated to reach USD 86 billion by 2024, growing at a negative CAGR 3-0%.”
Palatin Technologies, Inc. (NYSE American: PTN) BREAKING NEWS: Palatin’s Vyleesi® Licensee Fosun Pharma Reports First Commercial Sale in China and South Korean Licensee Kwangdong Pharmaceuticals Completes Enrollment in Phase 3 Clinical Study – Palatin Technologies, Inc., a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, announced that Fosun Pharma, the licensee of Vyleesi in China , reported its first sale in the Hainan Province of China . Palatin also announced that their South Korean licensee, Kwangdong Pharmaceuticals, completed enrollment in its Phase 3 clinical trial evaluating the efficacy and safety of Vyleesi in premenopausal women with HSDD. Data from this trial is anticipated by year end with a potential regulatory submission in the first half of 2024.
Vyleesi is the first and only as-needed treatment approved by the U.S. Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). Vyleesi is marketed by Palatin in the U.S. and the Company recently announced its sixth consecutive quarter of double-digit growth in Vyleesi prescriptions dispensed.
“We are excited by this significant achievement and advancement of Vyleesi in HSDD patients in China ,” stated Carl Spana , Ph.D., President, and Chief Executive Officer of Palatin. “This first commercial sale, coupled with the completed enrollment in the Phase 3 clinical trial in South Korea , strengthens our position in the Asian marketplace. After the Phase 3 data analysis is complete, we will be working closely with Kwangdong on the potential marketing application with the Korean regulatory authorities. We look forward to increasing patient use in China , to the potential approval in South Korea and expanding the availability and use of Vyleesi worldwide.”
Fosun’s first sale of Vyleesi was dispensed through a medical institution in the Hainan Province , a free trade port in China , under which certain imported pharmaceutical products can be sold in Hainan without first receiving registration approval from the Chinese National Medical Products Administration (NMPA). The establishment of the Hainan Free Trade Zone (FTZ) is expected to further boost the medical tourism zone project and leverage market opportunities created by the growing demand for medical products and services.
Palatin Technologies, Inc. also announced this week that it has entered a strategic partnership with UpScriptHealth, a leading direct-to-consumer telemedicine company providing telemedicine services to pharmaceutical and medical technology companies. Under terms of the agreement, UpScriptHealth will make Vyleesi available to the hundreds of thousands of patients in its proprietary Women’s Telehealth Platform. Vyleesi is the first and only as-needed treatment approved by the U.S. Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).
“We are excited to partner with UpScriptHealth, a pioneer in telehealth,” stated Carl Spana , Ph.D., President and Chief Executive Officer of Palatin. “This partnership fortifies our existing telehealth programs and provides a platform to create greater awareness of HSDD and access to Vyleesi through UpScriptHealth’s patient base of hundreds of thousands of women.” CONTINUED… Read these full Press Releases for Palatin Technologies at: https://palatin.com/investors/press-releases/
In other active biotech companies developments in the markets this week:
Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, recently announced plans to advance the company’s lead program to the first-line setting of metastatic colorectal cancer (mCRC) and conduct its new CRDF-004 trial with study execution support from Pfizer Ignite, a new end-to-end service for biotech companies.
“Our advance to the first-line mCRC setting is the result of a comprehensive data-driven review coupled with the agreement and support of the FDA. Ultimately, this decision moves Cardiff Oncology into a stronger position to realize the promise of onvansertib for the benefit of patients and all of our stakeholders,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “We are delighted to expand our relationship with Pfizer and conduct this new first-line trial beginning this fall through Pfizer Ignite, leveraging its clinical execution capabilities and expertise.”
Biodexa Pharmaceuticals PLC (NASDAQ: BDRX), a clinical stage biopharmaceutical company developing a pipeline of products aimed at primary and metastatic cancers of the brain recently announced that it has launched its new corporate website at www.biodexapharma.com as well as a patient focused website aimed at providing patients information about the therapeutic areas Biodexa is studying in it’s ongoing clinical programmes: www.resolvetrials.org.
Our new website reflects the company’s evolution from a drug delivery technology organisation to a drug development company focused on rare / orphan diseases and oncology with a mission to advance the development of medicines that offer patients a better future.
Bright Minds Biosciences Inc. (NASDAQ: DRUG), a biotechnology company focused on developing novel drugs for the targeted treatment of neuropsychiatric disorders and refractory epilepsy, recently announced positive results of the qEEG (Quantitative Electroencephalogram) data in Cohort 4 of its first-in-human Phase 1 study of its lead compound, BMB-101. On July 20, 2023, the Company announced completion of the study, along with positive topline data that demonstrated BMB-101’s excellent safety and tolerability profile in the single ascending dose, multiple ascending dose and food effects parts of the study. BMB-101 also demonstrated central target engagement and predictable plasma pharmacokinetics.
“The positive topline findings from our recently completed Phase 1 study of BMB-101, together with the observations from the qEEG portion of the study, validate our approach, as we continue to evaluate this important product candidate. BMB-101 is clearly [getting into the brain/achieving brain penetration] and activating the target receptors as we had predicted, setting us up for potential success in a number of indications that have been validated with the 5-HT mechanism. With this study complete, BMB-101 is now a Phase 2 ready asset, and we intend to move forward with an investigative new drug submission immediately,” stated Ian McDonald, CEO of Bright Minds.
Eli Lilly and Company (NYSE: LLY) recently announced topline results from the LIBRETTO-431 study evaluating Retevmo versus platinum-based chemotherapy plus pemetrexed – with or without pembrolizumab – as an initial treatment for patients with rearranged during transfection(RET) fusion-positive advanced or metastatic non-small cell lung cancer (NSCLC). The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS). This result was based on a pre-specified interim efficacy analysis conducted by an independent data monitoring committee (IDMC). Adverse events observed on Retevmo were generally consistent with those identified across the previously reported Retevmo development program (LIBRETTO-001, LIBRETTO-121, LIBRETTO-321).
The labeling for Retevmo contains warnings and precautions for hepatotoxicity (evidence of liver dysfunction), interstitial lung disease (ILD)/pneumonitis, hypertension, QT interval prolongation, hemorrhagic events, hypersensitivity, tumor lysis syndrome, risk of impaired wound healing, hypothyroidism, and embryo-fetal toxicity.
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