A Bioequivalence Study of Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule in Healthy Thai Male Volunteers Under Fasting Condition

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 28 days washout period between the doses.

Start Date24 Sep 2024

Sponsor / Collaborator

Bio-innova Co., Ltd

CTRI/2024/06/069461 / Not yet recruitingPhase 2/3IIT

Comparison of oral Minoxidil with oral Dutasteride in the treatment of Male Androgenetic alopecia- A Randomized Control Trial - NIL

Start Date05 Jul 2024

Sponsor / Collaborator-

CTRI/2024/06/068777 / Not yet recruitingPhase 3IIT

An Open label, Randomized, Non-inferiority Pilot study to evaluate the efficacy of daily and alternate day regimen of Oral Dutasteride in male patients with Androgenic Alopecia - NIL

Start Date01 Jul 2024

Sponsor / Collaborator-

100 Clinical Results associated with Dutasteride

100 Translational Medicine associated with Dutasteride

100 Patents (Medical) associated with Dutasteride

1,073

Literatures (Medical) associated with Dutasteride

01 Jan 2025·COMPARATIVE BIOCHEMISTRY AND PHYSIOLOGY C-TOXICOLOGY & PHARMACOLOGY

Effects of 5α-reductase inhibition by dutasteride on reproductive gene expression and hormonal responses in zebrafish embryos

Article

Author: Lee, Sang-Ah ; Adnan, Karim Md ; Yoon, Juyong ; Ryu, Chang Seon ; Jun, Indong ; Park, Chang Gyun ; Cho, Hyunki ; Kim, Young Jun

Steroid 5α-reductase (SRD5A) is a crucial enzyme involved in steroid metabolism, primarily converting testosterone to dihydrotestosterone (DHT). Dutasteride, an inhibitor of SRD5A types 1 and 2, is widely used for treating benign prostatic hyperplasia. An adverse outcome pathway (AOP) has been documented wherein SRD5A inhibition decreases DHT synthesis, leading to reduced levels of 17β-estradiol (E2) and vitellogenin (VTG), subsequently impairing fecundity in fish (AOP 289). However, the molecular and cellular mechanisms underlying these effects remain poorly understood. In this study, we assessed the impact of SRD5A inhibition on zebrafish embryos (Danio rerio). Exposure to dutasteride resulted in decreased DHT, E2, and VTG levels, showing a positive correlation. Dutasteride also downregulated the expression of reproduction-related genes (srd5a2, cyp19a1, esr1, esr2a, esr2b, and vtg), with interrelated reductions observed across these levels. Docking studies suggested that dutasteride's effects may operate independently of androgen receptor (AR) and estrogen receptor (ER) interactions. Furthermore, co-exposure of dutasteride (0.5 or 2 μM) with 0.5 μM DHT revealed gene expression levels comparable to the control group. These findings underscore DHT's pivotal role in modulating estrogenic function and the interplay between estrogenic and androgenic responses in vertebrates. Our proposed AOP model offers insights into mechanistic gaps, thereby enhancing current understanding and bridging knowledge disparities.

01 Dec 2024·BJU INTERNATIONAL

The ‘Prostate Embolisation AS first‐line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial’ (P‐EASY ADVANCE): a randomised controlled trial of prostate embolisation vs medication for BPH

Article

Author: Kua, Boon ; Brown, Nicholas ; Castree, Stephanie ; Wallace, Sean ; Schoeman, Joseph ; McBean, Rhiannon ; Esler, Rachel C. ; Walker, Duncan G. ; Yaxley, John ; Firouzmand, Sepinoud ; Gianduzzo, Troy ; Kiosoglous, Anthony ; Campbell, Peter

Objective:

To compare prostate artery embolisation (PAE) to the combination of tamsulosin and dutasteride therapy as a potential first‐line therapy for obstructive benign prostatic hyperplasia (BPH) in treatment‐naïve patients in the ‘Prostate Embolisation AS first‐line therapY compAred to meDication in treatment naïVe men with prostAte eNlargement, a randomised ControllEd trial’ (P‐EASY ADVANCE).

Patients and Methods:

A total of 39 men with enlarged prostates, moderate–severe lower urinary tract symptoms (LUTS) and obstructed/equivocal urodynamic studies (UDS), and who had no prior treatment for BPH, were randomised to receive either combined medical therapy with tamsulosin and dutasteride (medication) or PAE. Follow‐up UDS, International Prostate Symptom Score (IPSS), uroflowmetry and ultrasound were performed at short‐ to medium‐term intervals following interventions and compared to baseline.

Results:

The medication and PAE treatment groups had similar baseline characteristics, including prostate volumes (87.8 and 85.4 mL respectively), maximum urinary flow rate (Qmax; 6.5 and 6.6 mL/s, respectively), IPSS (19.5 and 21, respectively) and obstructed UDS (79% and 74%, respectively). Both interventions improved voiding and bladder outflow obstruction from baseline, with more patients unobstructed after PAE (63%) compared to medication (28%) (P = 0.03). PAE patients had significantly greater reductions in prostate size (P < 0.001), incomplete emptying (P = 0.002), total IPSS (P = 0.032), Qmax (P = 0.006) and quality of life (P = 0.001). Altered ejaculation, erectile dysfunction and nausea were more common in the medication group.

Conclusion:

Prostate artery embolisation was more effective than combined medical therapy at reducing urinary obstruction, decreasing prostate volume and improving LUTS in patients with BPH who had not previously been treated. This is the first randomised control study to compare PAE and combined medical therapy in exclusively treatment‐naïve patients and raises the potential of PAE as an alternative early treatment option for BPH. Further randomised comparative trials are planned to further validate the role of PAE in mitigating obstructive BPH.

01 Nov 2024·Reviews on Recent Clinical Trials

Is There an Association between 5a Reductase Inhibitors and Metabolic Syndrome? A Narrative Review of the Literature

Review

Author: Konstantinos, Tzelepis ; Ziogou, Afroditi ; Giannakodimos, Ilias ; Mitakidi, Evangelia ; Giannakodimos, Alexios

Finasteride and dutasteride are 5a Reductase Inhibitors (5a-RIs) and comprise the mainstay of treatment for the management of patients with benign prostatic hyperplasia. 5a-RIs are expressed in a variety of tissues, such as adipose tissues and liver, resulting in a reduction of glucocorticoid levels and affecting androgen regulation and metabolic function. As a result, the administration of these regimens may generate adverse metabolic events, such as liver disease, hyperglycemia, hyperlipidemia, and diabetes mellitus. Although several studies have tried to record these adverse metabolic events both in human subjects and animal models, the exact mechanisms of these actions have not been well described yet in the literature. Further well-designed clinical trials are needed to elucidate the exact role of 5a reductase inhibitors in the progression of the metabolic syndrome. The aim of this study was to systematically review the literature concerning the role of dutasteride or finasteride in the progression of metabolic adverse events and further investigate possible pathophysiologic mechanisms.

News (Medical) associated with Dutasteride

08 Nov 2024

·www.globenewswire.com

RECORDATI: CONTINUED DOUBLE-DIGIT GROWTH IN THE FIRST NINE MONTHS OF 2024 - REVENUE +12.0%, EBITDA(1) +11.8%, ADJUSTED NET INCOME(2) +9.5%

Consolidated net revenue of € 1,743.1 million in the first nine months, +12.0% or +9.3% on a like-for-like basis(3) and at constant exchange rates (CER)EBITDA(1) of € 665.7 million, +11.8%, revenue margin of 38.2% Adjusted net income(2) of € 445.4 million, +9.5% Net income of € 338.4 million, +11.1% Free cash flow(4) at € 434.3 million, +€ 42.5 million vs prior yearNet debt(5) at € 1,317.3 million, just below 1.6x EBITDAFinancial targets for FY 2024 confirmed, excluding any potential contribution from Enjaymo® Global Rare Diseases business to be further strengthened by announced agreement with Sanofi to acquire the global rights to Enjaymo®; deal expected to close by end of 2024, subject to regulatory approvals Isturisa®approved in China for the treatment of adult patients with Cushing syndromeResolution to distribute an interim 2024 dividend of € 0.60 per shareApproval of a new share buy-back program to service the stock option and performance shares plans Milan, November 8th, 2024 – The Board of Directors of Recordati S.p.A. approved the Group’s Interim Report on 30th September 2024, representing additional voluntary financial reporting (6). The Report was prepared using the assessment, measurement and recognition criteria prescribed by international accounting standards (IFRS). The Group’s Interim Report dated 30th September 2024 will be available on 11th November at the company’s offices and on the company’s website (www.recordati.com) and can also be viewed on the authorized storage system 1Info (www.1Info.it). Rob Koremans, Chief Executive Officer of Recordati, commented: “During the first nine months, we delivered double-digit revenue and profit growth, reflecting the strong performance across the business with more patients benefiting from our therapies. These results reflect the continued commitment of all our people, who are instrumental to our success. With a positive outlook for the remainder of the year, we are well positioned to achieve our upgraded financial objectives for FY 2024. Together, we will continue to build on our momentum and create lasting value for our stakeholders. “I am also pleased to highlight our recent agreement with Sanofi to acquire the global rights to Enjaymo®, the only approved treatment option for patients with cold agglutinin disease. This transaction will reinforce our strong commitment to serving patients with rare diseases and is a strong strategic fit to our portfolio, bringing a product with a robust profile, supported by a strong team, with attractive financial contributions expected on both the top and bottom lines.” Financial highlights Consolidated net revenue for the first nine months of 2024 was € 1,743.1 million, up 12.0% versus the first nine months of 2023 or 9.3% on a like-for-like(3) basis at CER. This was driven by strong business momentum across both Specialty & Primary Care and Rare Diseases. The adverse FX impact for the first nine months of 2024 was € 35.9 million (-2.3%), mainly driven by the devaluation of the Turkish lira, particularly in the first and third quarters, which was compensated by high price inflation in Türkiye. Specialty & Primary Care revenue totaled € 1,094.4 million in the first nine months of 2024, growing 11.1% or 6.5% on a like-for-like(3) basis at CER (+2.6% excluding Türkiye). This reflects a particularly strong performance from the Urology franchise with 51.4% growth versus the previous year, driven by the double-digit growth of Eligard® and the € 82.9 million contribution of Avodart® and Combodart®/Duodart®(7) (versus € 3.8 million in the third quarter of 2023). The Cardiovascular and Gastrointestinal franchises remained resilient and delivered slight growth, while the Cough and Cold business reflected solid in-market performance in the context of a softer flu season as compared to the previous year.Rare Diseases revenue totaled € 605.6 million in the first nine months of 2024, up 14.1% as compared to the first nine months of 2023, or 14.5% at CER, driven by the key growth franchises of Oncology and Endocrinology which continue to show substantial further growth potential. The Endocrinology franchise achieved net revenue of € 239.4 million, an increase of 36.0% and reflecting the continued strong performance of Isturisa® and double-digit growth of Signifor®. The Oncology franchise achieved net revenue of € 175.9 million, an increase of 17.1%, driven by double-digit growth from both Qarziba® and Sylvant®. The Metabolic franchise achieved net revenue of € 190.2 million, a decrease of 6.9%, mainly due to generic competition for Carbaglu® in the US and EMEA, with growth in other international markets. Adjusted operating income(8) was € 539.5 million for the first nine months of 2024, up 9.7% over the previous year, and 31.0% of net revenue versus 31.6% in the same period last year. Operating income was € 504.1 million in the first nine months of 2024, up 14.9% over the first nine months of 2023, absorbing gross margin-related non-cash charges of € 28.1 million (versus € 47.2 million in first nine months of 2023), arising from the unwind of the fair value step up of the acquired rare oncology inventory. Non-recurring costs were € 7.3 million in the first nine months of 2024, versus € 5.4 million in the first nine months of 2023, which includes € 2.5 million related to the agreement with Sanofi for the global rights to Enjaymo®.EBITDA(1) was € 665.7 million for the first nine months of 2024, up 11.8% compared to the first nine months of 2023, with margin of 38.2% of net revenue, in line with the previous year. Strong revenue and operating leverage were, in part, offset by a reduction in adjusted gross profit margin due to the consolidation of Avodart® and Combodart®/ Duodart® and product mix.Financial expenses were € 62.3 million, up by € 13.3 million compared to the previous year, including € 2.8 million in FX losses (mostly unrealized, compared to losses of € 0.3 million in the first nine months of 2023) and € 3.9 million of net monetary losses from hyperinflation accounting (compared to a gain of € 1.8 million in the first nine months of 2023). Adjusted net income(2) was € 445.4 million, 25.6% of revenue, up by 9.5% compared to the same period of 2023, with higher adjusted operating income partially offset by an increase in financial expenses and a higher tax rate, following a statutory tax rate increase in some countries. Net income was € 338.4 million, 19.4% of revenue, an increase of 11.1% versus first nine months of 2023, with the higher tax rate and financing expenses offsetting the higher operating income. Free cash flow(4) was € 434.3 million for the first nine months of 2024, an increase of € 42.5 million versus the the first nine months of 2023, driven by higher EBITDA which was slightly offset by higher interests and income taxes paid. Net debt(5) as of 30th September 2024 was € 1,317.3 million, or leverage of just below 1.6x EBITDA(6), compared to net debt of € 1,579.4 million on 31st December 2023. Shareholders’ equity was € 1,876.1 million. Pipeline and Corporate Development The Isturisa® new drug application (NDA) was approved by the China National Medical Products Administration (NMPA) in September for the treatment of adult patients with Cushing syndrome. On October 4th, the Group announced an agreement with Sanofi to acquire the global rights to Enjaymo®, a biologic which is the only approved targeted product for the treatment of cold agglutinin disease (CAD), a rare B-cell lymphoproliferative disorder. In 2022, Enjaymo® was granted approval by the U.S. Food and Drug Administration (FDA), the European Commission (EC) and the Japanese Ministry of Health, Labor and Welfare. Enjaymo® generated approximately € 100 million in revenue over the last 12 months as of August 2024 and is expected to generate revenue in excess of € 150 million in FY 2025, with peak sales potential of € 250-300 million. The transaction is expected to be immediately accretive at the EBITDA level, with margin above the current Rare Diseases average as of 2025. Under the terms of the agreement, Recordati will make an upfront payment of US$ 825 million and additional commercial milestone payments of up to US$ 250 million if net sales reach certain thresholds at or above the top end of peak year sales expectations. The transaction is expected to close by the end of 2024, subject to regulatory clearances (see also press release issued on October 4th 2024). The deal will be funded by existing cash and new committed bank debt facilities. Business outlook Thanks to continued strong momentum, the Group is on track to deliver the targets for FY 2024 as adjusted upward on July 30th (excluding any potential contribution from Enjaymo®): Net revenue between € 2,300 and € 2,340 millionEBITDA(1) between € 845 and € 865 million; margin of +/- 37%Adjusted net income(2) between € 560 and € 580 million; margin of +/- 24.5%Minimal contribution expected from Enjaymo®, subject to timing of regulatory approvals Additional resolutions Interim dividend 2024 The Board of Directors passed a resolution to distribute an interim 2024 dividend to shareholders of € 0.60 (gross of tax withholdings) per share outstanding at the ex-dividend date, thus excluding treasury stock held in the Company’s portfolio on that date. The 2024 interim dividend will be payable as of 20th November 2024 (record date 19th November 2024), with coupon no. 34, to shareholders registered on 18th November 2024. The Independent Auditor EY S.p.A. has issued the opinion required by Art. 2433 – bis, paragraph 5 of the Italian Civil Code, which is available at the company’s offices. The Directors’ Report and Recordati S.p.A. financial statements as of 30th June 2024, based on which the latter’s Board of Directors resolved the distribution of the interim dividend, are available at the company’s office and website (www.recordati.com), and can also be viewed on the authorized storage system 1Info (www.1Info.it). Limited assurance on sustainability reporting In compliance with the Italian Legislative Decree No. 125/2024 – transposing in Italy the EU Directive No. 2022/2464 on Corporate Sustainability Reporting (so called “CSRD”) – the Board of Directors, upon proposal of the Board of Statutory Auditors, has resolved to integrate – starting from this financial year 2024 - the mandate for activities regarding the limited assurance attestation on sustainability reporting, set forth by the aforementioned decree, to Ernst & Young S.p.A., by extending to such activities the current engagement granted by the Shareholders Meeting held on 29th April 2020 with respect to the attestation of the non-financial disclosure. Appointment of the new Financial Reporting Officer pursuant to art.154-bis of TUF The Board of Directors has appointed, until revocation and upon favourable opinion of the Board of Statutory Auditors Niccolo Giovannini - VP Group Finance, reporting to Luigi La Corte, Group Chief Financial Officer - as Financial Reporting Officer pursuant to art.154-bis of TUF and art.25 of the Articles of Association. The appointment is effective as of today, following the approval of Group’s Interim Report on 30th September 2024. Approval of a new share buy-back program to service the stock option and performance shares plans Today, the Board of Directors has also approved the launch of a new share buy-back program under art. 5 of (EU) Regulation no. 596/2014 for a maximum of 1,500,000 ordinary shares with a maximum cash outlay of € 90,000,000. This implements the resolution adopted by the Shareholders’ meeting held on 22nd April 2024 to purchase Recordati ordinary shares in order to service current and future stock option/performance shares plans in favour of the Recordati Group’s management or share-based incentive plans that might be approved by the Company in the future. All details required by the applicable regulations on the launch of the share buy-back program - whose start is envisaged on 12th November 2024 until 15th April 2025, following the end of the current buyback programme envisaged by 11th November 2024 as announced on 9th May 2024 - will be included in a specific press release that will be issued according to law and to which reference is made. (1) Net income before income taxes, financial income and expenses, depreciation, amortization and write-downs of property, plant and equipment, intangible assets and goodwill, non-recurring items and non-cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3. (2) Net income excluding the amortization and write-down of intangible assets (except software) and goodwill, non-recurring items, non-cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory pursuant to IFRS 3, and monetary net gains/losses from hyperinflation (IAS 29), net of tax effects. (3) Pro-forma growth calculated excluding revenue of Avodart® and Combodart®/ Duodart® for both 2024 and 2023.(4) Total cash flow excluding financing items, milestones, dividends, purchases of treasury shares net of proceeds from exercise of stock options.(5) Cash and cash equivalents, less bank debts and loans, which include the measurement at fair value of hedging derivatives. (6) Please note that Italian Legislative Decree 25/2016, which implements Directive 2013/50/EU, no longer stipulates the submission of an interim management report, which was previously required in terms of paragraph 5 of Art. 154- ter of Italian Legislative Decree 58/1998.(7) Trademarks are owned by or licensed to the GSK group of companies. Transition of commercialization effectively concluded.(8) Net income before income taxes, financial income and expenses and non-recurring items, non-cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3. Conference Call Recordati will host a conference call today, November 8th at 4:00 p.m. CET (3:00 p.m. GMT) to present the results for the first nine months of 2024. The dial-in numbers for the conference call service are: Italy + 39 02 802 09 11, toll free 800 231 525UK + 44 1 212818004, toll free (44) 0 800 0156371USA +1 718 7058796, toll free (1) 1 855 2656958France +33 1 70918704Germany +49 6917415712 Participants are invited to dial in 10 minutes before conference time. If conference operator assistance is required to connect, please dial *0. The slides that will be referenced during the call will be available at www.recordati.com under Investors/Company Presentations. The audio conference live webcast will also be available at the following link Recordati is an international pharmaceutical group listed on the Italian Stock Exchange (XMIL: REC), with roots dating back to a family-run pharmacy in Northern Italy in the 1920s. We are uniquely structured to provide treatments across specialty and primary care, and rare diseases. Our fully integrated operations span clinical development, chemical and finished product manufacturing, commercialization and licensing. We operate in approximately 150 countries across EMEA, the Americas and APAC with over 4,450 employees. We believe that health is a fundamental right, not a privilege. Today, our purpose of “unlocking the full potential of life” aims at empowering individuals to live life to the fullest, whether addressing common health challenges or the rarest. Investor Relations Eugenia Litz +44 7824 394 750 investorelations@recordati.itGianluca Saletta +39 348 979 4876 investorelations@recordati.itMedia Relations ICR Healthcare US:Alexis Feinberg +1 203 939 2225 recordatiuspr@westwicke.com UK, Europe & Rest of World:Jessica Hodgson +44 7561 424 788recordati@consilium-comms.com This document contains forward-looking statements relating to future events and future operating, economic and financial results of the Recordati group. By their nature, forward-looking statements involve risk and uncertainty because they depend on the occurrence of future events and circumstances. Actual results may therefore differ materially from those forecast for a variety of reasons, most of which are beyond the Recordati group’s control. The information on the pharmaceutical specialties and other products of the Recordati group contained in this document is intended solely as information on the activities of the Recordati Group, and, as such, it is not intended as a medical scientific indication or recommendation, or as advertising. RECORDATI GROUP Summary of the consolidated results,prepared in accordance with International Financial Reporting Standards (IFRS)(€ thousands) INCOME STATEMENTFirst nine months 2024First nine months 2023Change %NET REVENUE1,743,0811,556,17412.0Cost of sales(556,171)(490,495)13.4GROSS PROFIT1,186,9101,065,67911.4Selling expenses(360,709)(345,506)4.4Research and development expenses(204,849)(182,239)12.4General and administrative expenses(110,014)(93,630)17.5Other income/(expenses), net(7,240)(5,553)30.4OPERATING INCOME504,098438,75114.9Financial income/(expenses), net(62,319)(49,054)27.0PRE-TAX INCOME441,779389,69713.4Income taxes(103,379)(85,205)21.3NET INCOME 338,400304,49211.1Adjusted gross profit (1)1,214,9861,113,1679.1Adjusted operating income (2)539,518491,6089.7Adjusted net income (3)445,361406,5669.5EBITDA (4)665,666595,57311.8Net income attributable to: Equity holders of the Parent338,400304,49211.1Non-controlling interests00n.s.EARNINGS PER SHARE (euro) Basic(5)1.6401.48110.7Diluted(6)1.6181.45611.1(1) Gross profit adjusted from impact of non-cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3. (2) Net income before income taxes, financial income and expenses, non-recurring items and non-cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3.(3) Net income excluding amortization and write-downs of intangible assets (except software) and goodwill, non-recurring items, non-cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory (IFRS 3) and monetary net gains/losses from hyperinflation (IAS 29), net of tax effects.(4) Net income before income taxes, financial income and expenses, depreciation, amortization and write-downs of property, plant and equipment, intangible assets and goodwill, non-recurring items and non-cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory according to IFRS 3.(5) Earnings per share (EPS) are based on average shares outstanding during the respective period, 206.299.160 in 2024 and 205.421.410 in 2023. These amounts are calculated deducting treasury shares in the portfolio, the average of which was 2.825.996 shares in 2024 and 3.703.746 shares in 2023.(6) Diluted earnings per share is calculated by taking into account rights granted to employees.COMPOSITION OF NET REVENUEFirst nine months 2024First nine months 2023Change % Total revenue1,743,0811,556,17412.0 Italy258,631234,30410.4 International1,484,4501,321,87012.3 RECORDATI GROUP(€ thousands) Reconciliation of Net income to EBITDA(1) First nine months 2024First nine months 2023Net income338,400304,492Income taxes103,37985,205Financial income/(expenses), net62,31949,054Non-recurring expenses7,3445,369Non-cash charges from PPA inventory uplift28,07647,488Adjusted operating income(2)539,518491,608Depreciation, amortization and write-downs126,148103,965EBITDA(1)665,666595,573 Reconciliation of Net income to Adjusted Net income(3) First nine months 2024First nine months 2023Net income338,400304,492Amortization and write-downs of intangible assets(excluding software)100,15781,180Tax effect(22,619)(17,405)Non-recurring operating expenses7,3445,369Tax effect(1,943)(1,340)Non-cash charges from PPA inventory uplift28,07647,488Tax effect(7,019)(11,881)Monetary net (gain)/losses from hyperinflation (IAS29)3,900(1,759)Tax effect(935)422Adjusted net income(3)445,361406,566 (1) Net income before income taxes, financial income and expenses, depreciation, amortization and write-downs of property, plant and equipment, intangible assets and goodwill, non-recurring items and non-cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory (IFRS 3).(2) Net income before income taxes, financial income and expenses, non-recurring items and non-cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory (IFRS 3).(3) Net income excluding amortization and write-downs of intangible assets (except software) and goodwill, non-recurring items, non-cash charges arising from the allocation of the purchase price of EUSA Pharma to the gross margin of acquired inventory (IFRS 3) and monetary net gains/losses from hyperinflation (IAS 29), net of tax effects. RECORDATI GROUPSummary of the consolidated results, prepared in accordance with International Financial Reporting Standards (IFRS)(€ thousands) ASSETS30.09.202431.12.2023Property, plant and equipment187,848178,657Intangible assets1,847,7041,938,197Goodwill789,123778,350Other equity investments and securities16,86521,555Other non-current assets13,87112,458Deferred tax assets92,56776,674TOTAL NON-CURRRENT ASSETS2,947,9783,005,891 Inventories410,107404,831Trade receivables474,514445,193Other receivables102,46699,401Other current assets26,78219,924Derivative instruments measured at fair value6,71011,079Cash and cash equivalents235,020221,812TOTAL CURRENT ASSETS1,255,5991,202,240TOTAL ASSETS4,203,5774,208,131 RECORDATI GROUPSummary of the consolidated results, prepared in accordance with International Financial Reporting Standards (IFRS)(€ thousands) EQUITY AND LIABILITIES30.09.202431.12.2023 Share capital26,14126,141Share premium reserve83,71983,719Treasury shares(139,881)(127,970)Reserve for derivative instruments(2,180)(286)Translation reserve(301,627)(264,700)Other reserves61,53761,219Profits carried forward1,809,9971,636,451Net income338,400389,214Interim dividend0(117,396)Shareholders’ equity attributable to equity holders of the Parent1,876,1061,686,392Shareholders’ equity attributable to non-controlling interests00TOTAL SHAREHOLDERS’ EQUITY1,876,1061,686,392 Loans - due after one year1,264,8841,353,216Provisions for employee benefits21,40521,239Deferred tax liabilities134,488144,208TOTAL NON-CURRENT LIABILITIES1,420,7771,518,663 Trade payables276,907263,979Other payables198,213174,407Tax liabilities100,73867,110Other current liabilities4,6165,307Provisions for risks and charges19,24116,596Derivative instruments measured at fair value14,21219,993Loans - due within one year270,337355,752Short-term debts to banks and other lenders22,43099,932TOTAL CURRENT LIABILITIES906,6941,003,076TOTAL SHAREHOLDERS’ EQUITY AND LIABILITIES4,203,5774,208,131 RECORDATI GROUPSummary of consolidated results prepared in accordance with International Financial Reporting Standards (IFRS) (€ thousands) CASH FLOW STATEMENTFirst nine months 2024First nine months 2023OPERATING ACTIVITIES Net income338,400304,492Income taxes103,37985,206Net interest54,41848,158Depreciation of property, plant and equipment24,00321,577Amortization of intangible assets97,59182,304Write-downs4,55484Equity-settled share-based payment transactions10,1207,515Other non-monetary components41,06955,772Change in other assets and other liabilities(11,985)(20,538)Cash flow generated/(used) by operating activities before change in working capital661,549584,570Change in: - inventories(41,813)(31,681)- trade receivables(36,418)(73,753)- trade payables14,22330,082Change in working capital(64,008)(75,352)Interest received4,0073,923Interest paid(64,284)(50,314)Income taxes paid(82,634)(53,282)Cash flow generated/(used) by operating activities454,630409,545INVESTMENT ACTIVITIES Investments in property, plant and equipment(21,743)(17,998)Disposals of property, plant and equipment1,385329Investments in intangible assets(15,377)(345,597)Disposals of intangible assets2,351287Sale of non-current assets held for sale2,0003,000Cash flow generated/(used) by investment activities(31,384)(359,979)FINANCING ACTIVITIES Opening of loans144,872348,256Repayment of loans(320,185)(214,701)Payment of lease liabilities(8,311)(8,116)Change in short-term debts to banks and other lenders(71,722)(45,008)Dividends paid(130,220)(129,071)Purchase of treasury shares(78,087)(6,483)Sale of treasury shares52,74419,681Cash flow generated/(used) by financing activities(410,909)(35,442)Change in cash and cash equivalents12,33714,124Opening cash and cash equivalents221,812284,734Currency translation effect8713,422Closing cash and cash equivalents235,020302,280 DECLARATION BY THE FINANCIAL REPORTING OFFICERThe Financial Reporting Officer, Luigi La Corte, declares, pursuant to paragraph 2 of Article 154-bis of the Consolidated Law on Finance, that the accounting information contained in this press release corresponds to the Company’s documentation, books and accounting records.

Executive ChangeFinancial StatementDrug ApprovalAcquisition

07 Oct 2024

·www.pharmaceutical-technology.com

EMA starts review into hair loss drugs about potential link to suicidal thoughts

Androgenic alopecia is a hair loss condition that primarily affects the top and front of the scalp. Credit: PippiLongstocking via Shutterstock. The European Medicines Agency (EMA) has started a review of popular anti-baldness and enlarged prostate medicines finasteride and dutasteride over concerns about their possible impact on causing suicidal thoughts. Finasteride is marketed as Propecia for male pattern hair loss (androgenetic alopecia) and Proscar for treating benign prostatic hyperplasia (BPH), by MSD’s spin-off company Organon. BPH is a condition in which the prostate is enlarged causing problems with the flow of urine. Dutasteride, which is marketed by GSK as Avodart, has a similar mechanism of action and is used to treat BPH. Avodart is also sometimes used off label for hair loss, with generic versions of finasteride and dutasteride available in the market. The safety review was requested by the French regulatory agency, the National Agency for the Safety of Medicines and Health Products, which said that all available data on suicidal ideation and suicide related to finasteride and dutasteride-containing products as well as the impact of these possible risks on the benefit-risk balance of these products should be reviewed. Finasteride and dutasteride are linked to psychiatric side effects according to French regulators. Suicidal ideation was recently added to the patient information sheets and packaging for both Propecia and Proscar in the EU. However, French authorities argue that the new safety reports alter the risk profile of finasteride. This was highlighted in the 4 October Article-31 referral document: “Even though a causal association between finasteride and suicidal ideation has not been established, it was considered at least a reasonable possibility, given that known ADRs [adverse drug reactions] such as sexual dysfunction/impotence, depression, decreased libido, may lead to suicidal ideation.” See Also: WuXi debates sale of pharma operations as BIOSECURE Act advances Ascendis Pharma submits sBLA for growth hormone deficiency therapy This is not the first time that questions have been raised about the psychiatric symptoms of these drugs. In June 2022, the US Food and Drug Administration (FDA) ordered a warning about suicidal thoughts and behaviour on the drug’s label but rejected a request to remove Propecia from the market. This followed a 2017 petition from a patient advocacy group called the Post-Finasteride Syndrome Foundation, which ordered MSD to either stop selling the drug or require stronger warnings. In April 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) introduced a patient alert card to increase awareness among men taking finasteride about potential psychiatric and sexual side effects. Androgenetic alopecia or pattern balding is the main cause of hair loss in men but affects both men and women. According to GlobalData , there are 49 drugs in development for the condition. GlobalData is the parent company of Pharmaceutical Technology.

Drug Approval

04 Oct 2024

·endpts.com

EMA reviews hair loss products following concerns about suicidal thoughts

The European Medicines Agency is looking more closely at medicines used to treat hair loss and a condition caused by an enlarged prostate over concerns about suicidal thoughts. The review encompasses finasteride and dutasteride. Finasteride is the main ingredient in Organon’s hair loss product Propecia, and also its product for benign prostatic hyperplasia, Proscar. The safety review was requested by the French medicines agency, which concluded that while there is no established link between the drug and suicidal ideation, new safety assessments suggest it is “at least a reasonable possibility.” Dutasteride, also under review by the EMA , has a similar mechanism of action. Products containing the medicine include GSK’s Avodart, which is approved in the US for benign prostatic hyperplasia, but is sometimes used off-label to treat hair loss. Psychiatric side effects are a known risk of finasteride and dutasteride, according to European regulators. Suicidal ideation was recently added to the product information for both Propecia and Proscar in the EU. But despite warnings in the product information, French regulators argued that new safety reports may “seriously alter the risk profile of finasteride.” They noted that hair loss is “not a serious condition,” and the medicines are typically given to healthy men. Organon stood behind the safety of its finasteride products on Friday. The company said in a statement to Endpoints News that it will “work closely with the EMA to support this process.” “Regulatory agencies around the world thoroughly reviewed the safety and efficacy data for these medicines before their approval, and, together with the company, they have continued to review additional safety and efficacy data in the decades that these products have been on the market as part of routine post-marketing surveillance process,” Organon said. GSK didn’t respond to a request for comment as of press time. The EMA is expected to recommend whether the marketing authorizations for finasteride and dutasteride should stay the same, change, or be withdrawn. The FDA in 2o22 declined a petition to pull Propecia from the market, noting that the request “does not provide reasonable evidence to support a causal association between finasteride and depression.” However, the agency did require a label update adding suicidal ideation and behavior to the drug’s list of possible side effects. The agency didn’t respond Friday to questions about whether it will open a similar review of finasteride and dutasteride.

Drug Approval

100 Deals associated with Dutasteride

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KEGG	Wiki	ATC	Drug Bank
D03820	Dutasteride	G04CB02	DB01126

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Indication	Country/Location	Organization	Date
Androgenetic Alopecia	KR	Youngil Pharm	12 Dec 2024
Prostatic Hyperplasia	US	Waylis Therapeutics LLC	20 Nov 2001

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Localized Prostate Carcinoma	Phase 3	CA	GSK Plc	01 Mar 2007
Prostatic Cancer	Phase 3	US	GSK Plc	01 Mar 2003
Prostatic Cancer	Phase 3	JP	GSK Plc	01 Mar 2003
Prostatic Cancer	Phase 3	AR	GSK Plc	01 Mar 2003
Prostatic Cancer	Phase 3	AU	GSK Plc	01 Mar 2003
Prostatic Cancer	Phase 3	AT	GSK Plc	01 Mar 2003
Prostatic Cancer	Phase 3	BY	GSK Plc	01 Mar 2003
Prostatic Cancer	Phase 3	BE	GSK Plc	01 Mar 2003
Prostatic Cancer	Phase 3	BR	GSK Plc	01 Mar 2003
Prostatic Cancer	Phase 3	BG	GSK Plc	01 Mar 2003

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01758523 (Pubmed)	Phase 4	Alcoholism	142	Dutasteride 1 mg	oqkmamvtti(iutogkbicq) = Adverse events more common in the dutasteride group were reduced libido zuxyurqtpw (abefdcfdnu ) View more	Positive	01 May 2024
				Placebo
NCT00668642 (CTgov)	Phase 2	Advanced Prostate Carcinoma	20	Dutasteride (A: Dutasteride During First Off-Cycle)	zhojawusiy(vqqbaikruk) = vzjdpirdlv cjgidwhtzv (yfvcpgjxaz, nyejcuhslr - hrctxdtcra) View more	-	22 Aug 2023
				Placebo (B: Placebo During First Off-Cycle)	zhojawusiy(vqqbaikruk) = nsjuhdfmyv cjgidwhtzv (yfvcpgjxaz, isjiiktfnw - qwhyfkcziq) View more
NCT01342367 (Prospective Trial Of Oral-Only Hormonal Therapy With Radiation, CTgov)	Not Applicable	Non-metastatic prostate cancer	74	bicalutamide+goserelin+leuprolide (SOC Cohort)	vrfvcgrvep(dkzrpsizef) = bpxrdtwpmw ebqaxkarrz (irshmrpsiw, qkvchxrvdb - hmjdhrfimb) View more	-	28 Oct 2021
				finasteride+dutasteride+bicalutamide (Oral ADT Group)	vrfvcgrvep(dkzrpsizef) = yaypscfiyh ebqaxkarrz (irshmrpsiw, qpyitnfnmn - oawrqabgbb) View more
REDUCE (AUA2021)	Not Applicable	Prostatic Cancer \| Lower Urinary Tract Symptoms	-	DUTASTERIDE (Current smokers)	-	-	01 Sep 2021
				DUTASTERIDE (Former smokers)
MP28-13 (AUA2021)	Not Applicable	Lower Urinary Tract Symptoms Add-on	92	Dutasteride add-on treatment to alpha-adrenergic antagonist	gycystwpsw(qbjwpitmzx) = qptzjeykdm kvslbricei (nuftuuoupk ) View more	-	01 Sep 2021
NCT01758523 (CTgov)	Phase 4	Alcoholism	189	Dutasteride (Dutasteride)	tiuptxitwq(mntsgrdlgo) = zuuveirxib hzgvlpudqe (xnculbjcug, kodsnnqdxg - gzoedmnnxi) View more	-	26 Apr 2019
				sugar pill (Sugar Pill)	tiuptxitwq(mntsgrdlgo) = tfjvmupubb hzgvlpudqe (xnculbjcug, wcibmcgoxr - jidnsmllcg) View more
NCT02058368 (CTgov)	Phase 3	Prostatic Hyperplasia	607	Placebo (Placebo + Tam 0.2mg)	droortwgxo(otllsxfzjd) = jwmfydfwyh ppmiblbjdo (feykbzpfqa, rkkhfmmvis - jgxyxgsdga) View more	-	05 Apr 2019
				Dut (Dut 0.5 mg + Tam 0.2 mg)	droortwgxo(otllsxfzjd) = egsvirhhbs ppmiblbjdo (feykbzpfqa, zqtpfjegie - joooddxifm) View more
NCT02058368 (Pubmed \| Int J Urol) Manual	Phase 3	Prostatic Hyperplasia	607	tamsulosin+dutasteride	wrrphhlvoc(bsrhvdimcs): P-Value = < 0.05 View more	Positive	01 Nov 2018
				tamsulosin
NCT00056407 (REDUCE, Pubmed \| World J Urol) Manual	Phase 3	Urinary Tract Infections	6,045	Dutasteride	cjhwipdekr(hcrdeeabww) = rvpvavvqte cknpocqvcs (tnhmikptig ) View more	Positive	01 Oct 2017
				Placebo	cjhwipdekr(hcrdeeabww) = hhyvsvolas cknpocqvcs (tnhmikptig ) View more
NCT01393730 (CTgov)	Phase 2	Castration-Resistant Prostatic Cancer	40	Prednisone+Abiraterone+Dutasteride	yaiczhsqch(vxknkegrof) = sfkggatkmw qkuatozviz (xhgmfdgzrj, uhrngqacih - dczzraawha) View more	-	14 Jun 2017

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