Our team has previously demonstrated efficacy in performing a novel collagenase Clostridium histolyticum (CCH) injection protocol in men who previously failed to achieve a response to an initial 4 series of CCH.
The objective of the current study is to evaluate a protocol that incorporates limited in-office modeling for up to 4 series, followed by up to 2 additional salvage series to determine safety and efficacy compared to historical data.
Participants will receive up to 4 series of CCH injections using our previously published protocol, with mild in-office modeling. CCH injections are given on back-to back days, after which they are counseled to utilize Restorex and sildenafil daily, as instructed. Patients will undergo mild in-office modeling on day 2.
The sexual partners of study participants will also be invited to enroll in the study and will complete non-validated questionnaires detailing their level of support for the patient's treatment.

Start Date11 Oct 2024

Sponsor / Collaborator

Endo International Plc

NCT06065436

/ RecruitingNot ApplicableIIT

Impact of Concurrent Low Intensity Shockwave Therapy on Clinical Outcomes With Collagenase Clostridium Histolyticum in Peyronie's Disease: A Randomized Controlled Trial

The purpose of this research is to determine whether or not low-intensity shockwave therapy (LiSWT) with Xiaflex treatment will result in greater improvements to the curvature of the penis.

Start Date19 Jan 2024

Sponsor / Collaborator

Mayo Clinic

NCT06169319

/ CompletedPhase 2

A Phase 2, Double-blind, Randomized, Placebo-controlled, Dose-ranging Study to Assess the Efficacy, Safety, and Tolerability of EN3835 vs Placebo in the Treatment of Plantar Fasciitis (PFA)

This study will assess the efficacy, safety, and tolerability of 2 different doses of EN3835 compared to placebo.

Start Date12 Dec 2023

Sponsor / Collaborator

Endo International Plc

100 Clinical Results associated with Collagenase Clostridium histolyticum(Biospecifics Technologies Corp)

100 Translational Medicine associated with Collagenase Clostridium histolyticum(Biospecifics Technologies Corp)

100 Patents (Medical) associated with Collagenase Clostridium histolyticum(Biospecifics Technologies Corp)

2,120

Literatures (Medical) associated with Collagenase Clostridium histolyticum(Biospecifics Technologies Corp)

01 Dec 2025·LUNG

Effectiveness of Inhalational Tranexamic Acid in Patients with Nonmassive Hemoptysis–A Systematic Review and Meta-Analysis

Review

Author: Krishnamoorthy, Yuvaraj ; Salih, Anas ; Elanjeran, Rajkumar ; Rajendran, Gunaseelan ; Dinesh, Vasudha ; Ramkumar, Anitha ; Kannan, Rahini ; Mahalingam, Sasikumar ; Thirthar Palanivelu, Elamurugan ; Ponnaeasu, Sathya Prakasham

BACKGROUND:

Hemoptysis, the expectoration of blood from the lower respiratory tract, varies in severity and necessitates effective management to mitigate morbidity. Traditional treatments include bronchial artery embolization and pharmacological approaches. Tranexamic acid (TXA), an antifibrinolytic agent known for its efficacy in reducing bleeding during surgery and trauma, is being explored for its efficacy in treating Hemoptysis via both intravenous and inhalational routes. Inhalational administration has garnered interest because of its targeted action and minimal systemic effects. This study aimed to assess the effectiveness of inhalational TXA in nonmassive hemoptysis.

METHODS:

A systematic literature search encompassing PubMed Central, EMBASE, SCOPUS, and ProQuest was conducted. Randomized controlled trials (RCTs) and observational studies assessing the effectiveness of inhalational tranexamic acid for nonmassive hemoptysis were included. Comparative intervention effect estimates from meta-analyses are reported as pooled odds ratios and pooled mean differences with 95% confidence interval (CI).

FINDINGS:

Analysis of three RCTs and two observational studies, comprising 351 patients (192 cases and 159 controls), revealed varying risk levels of bias across the studies. Nebulized tranexamic acid was 3.85 times more likely to achieve hemoptysis cessation than alternative treatments across all RCTs. Moreover, patients receiving nebulized tranexamic acid required fewer (43%) pulmonary interventional procedures than those receiving other treatments. Despite showing a trend towards reducing posttherapy bleeding (20 ml less), conclusive results were hindered by wide CI, necessitating further investigation.

INTERPRETATION:

Nebulized tranexamic acid may be a potential therapeutic option for nonmassive hemoptysis. While our analysis suggests its potential benefits in halting bleeding and reducing the need for invasive procedures, the quality of the available evidence is limited due to the risk of bias and study limitations. This underscores the necessity for additional randomized controlled trials with larger sample sizes and rigorous study designs to strengthen evidence and optimize clinical utility.

PROSPERO REGISTRATION:

The registration for this systematic review and meta-analysis was completed through Prospero on January 30, 2024, with the registration number CRD42024501624.

01 Apr 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

Ranolazine attenuates mouse detrusor contractility: Evidence for the involvement of calcium-related mechanisms

Article

Author: Sari, Suat ; Kadioglu, Mine ; Dağlar, Gökçe ; Barut, Elif Nur ; Engin, Seçkin ; Erac, Yasemin

Ranolazine (RNZ) is a multifaceted ion channel modulator approved for the treatment of angina. Although various pleiotropic effects on the cardiovascular system have been demonstrated, its efficacy in the urinary system remains not fully understood. Here, we aimed to investigate the effect of RNZ on mouse detrusor smooth muscle (DSM) contractility and the mechanism(s) of its action by using isolated tissue bath technique. RNZ significantly decreased carbachol (CCh)-, KCl- and electrical field stimulation-induced contractility and induced relaxation in DSM concentration-dependently. Furthermore, RNZ-induced relaxation of KCl-precontracted DSM strips was not altered in the presence of 4-aminopyridine, BaCl₂, glibenclamide, TEA, propranolol, L-NAME or methylene blue, indicating that K⁺ channels, nitric oxide/cGMP pathway or β-adrenoreceptors are not involved in the relaxant effect of RNZ. Also, RNZ significantly inhibited the contractile response induced by CaCl₂, CCh, and Bay K8644 under Ca⁺⁺-free conditions. Regarding the molecular docking and cytosolic Ca⁺⁺ mobilization assays, RNZ showed affinity for the antagonist binding site of L-type Ca⁺⁺ channels and significantly decreased cytosolic Ca⁺⁺ level in A7r5 cells. These findings suggest the inhibition of Ca⁺⁺ influx and release may contribute to RNZ-induced DSM relaxation. Hence, our results provide strong evidence that RNZ has a notable relaxant effect on mouse DSM by inhibiting Ca⁺⁺ influx and release of Ca⁺⁺ from intracellular stores and it has the potential to be a therapeutic candidate for LUTS.

01 Mar 2025·ANESTHESIA AND ANALGESIA

Donation After Circulatory Death Liver Transplantation: Impact of Normothermic Machine Perfusion on Key Variables

Article

Author: Buckner-Petty, Skye A. ; Stoker, Alexander D. ; Gorlin, Andrew W. ; Mathur, Amit K. ; Frasco, Peter E. ; Lizaola-Mayo, Blanca C. ; Nguyen, Michelle C. ; Rosenfeld, David M.

BACKGROUND::

During orthotopic liver transplantation, allograft reperfusion is a dynamic point in the operation and often requires vasoactive medications and blood transfusions. Normothermic machine perfusion (NMP) of liver allografts has emerged to increase the number of transplantable organs and may have utility during donation after circulatory death (DCD) liver transplantation in reducing transfusion burden and vasoactive medication requirements.

METHODS::

This is a single-center retrospective study involving 226 DCD liver transplant recipients who received an allograft transported with NMP (DCD-NMP group) or with static cold storage (DCD-SCS group). Veno-venous bypass was not used in any patients. Infusion doses of norepinephrine, epinephrine, and vasopressin as well as bolus doses of vasoactive medications during reperfusion were recorded. Blood component therapy was recorded according to phase of liver transplantation and during the first 24 hours postprocedure.

RESULTS::

A total of 103 recipients in the DCD-NMP group and 123 patients in the DCD-SCS group were included. Post-reperfusion syndrome (PRS) incidence was reduced in the DCD-NMP group compared to the DCD-SCS group (10.7% [95% confidence interval, CI, 5.5%–18.3%] vs 42.3% [95% CI, 33.4%–51.5%]; P < .001). During the reperfusion period, patients in the DCD-SCS group required increased bolus doses of epinephrine and vasopressin compared to the DCD-NMP group (24.6 vs 7.5 µg; P < .001) and (5.4 vs 2.4 units; P < .001), respectively. The DCD-SCS group received a higher infusion dose of epinephrine during anhepatic phase, at reperfusion, and up to 90 minutes after reperfusion. In the postreperfusion period, there were significant increases in the transfusion of red blood cells (RBCs; 5.3 vs 3.7 units; P = .006), fresh frozen plasma (FFP; 3.4 vs 1.9 units; P < .001), cryoprecipitate (2.7 vs 1.8 pooled units; P = .015) and platelets (0.9 vs 0.4 units; P = .008) in the DCD-SCS group compared to the DCD-NMP group. During the first 24 hours postprocedure, transfusion of RBCs, FFP, and cryoprecipitate in the DCD-SCS group was increased compared to the DCD-NMP group ([2.6 vs 1.7 units; P = .028], [1.6 vs 0.8 units; P < .001], [1.5 vs 0.9 pooled units; P = .031]) respectively. Administration of tranexamic acid was more frequent in the DCD-SCS group during the post-reperfusion period compared to the DCD-NMP group (13% [95% CI, 5.7%–17.4%] vs 3.9% [95% CI, 1.1%–9.6% 95%]; P = .018).

CONCLUSIONS::

In DCD liver transplantation, use of NMP was associated with reduced incidence of PRS and decreased vasopressor and inotrope requirements at the time of allograft reperfusion compared to using SCS. Additionally, NMP was associated with reduced transfusion of all blood product components as well as antifibrinolytic agent administration in the post-reperfusion period. Reduced transfusion burden in the DCD-NMP group also occurred during the first 24 hours posttransplant.

News (Medical) associated with Collagenase Clostridium histolyticum(Biospecifics Technologies Corp)

13 Mar 2025

·www.prnewswire.com

Endo Reports Fourth-Quarter and Full-Year 2024 Financial Results

Endo achieved 2024 revenues and adjusted EBITDA expectations, while progressing the Company's strategic priorities XIAFLEX® hit record revenues of $516 million in 2024, up 9% versus 2023 The Company provides 2025 revenue guidance of $1,775 to $1,860 million and adjusted EBITDA guidance of $620 to $650 million MALVERN, Pa., March 13, 2025 /PRNewswire/ -- Endo, Inc. ("Endo" or the "Company") (OTCQX: NDOI) today reported financial results for the fourth quarter and full-year ended December 31, 2024. "We ended the year strong, with XIAFLEX® annual revenues exceeding $500 million for the first time and the successful launch of ADRENALIN® ready-to-use premixed bags," said Scott Hirsch, Interim Chief Executive Officer. "These milestones, along with the strategic realignment of our sterile product pipeline and the two recently announced transformative transactions, underscore our commitment to deliver growth and shareholder value." Separately, the Company announced that it has entered into a definitive agreement to combine with Mallinckrodt plc in a cash and stock transaction. ENDO FOURTH-QUARTER FINANCIAL PERFORMANCE (in thousands) CONSOLIDATED RESULTS Total revenues in fourth-quarter 2024 were $467 million, a decrease of 6% compared to $498 million in fourth-quarter 2023. This decrease was primarily attributable to competitive pressure across the Generic Pharmaceuticals and Sterile Injectables segments. Net Loss in fourth-quarter 2024 was $349 million, compared to a net loss of $2,441 million in fourth-quarter 2023. This change was driven by fourth-quarter 2023 adjustments to estimated allowed claims, including with respect to certain litigation matters and debt obligations that were reduced to actual payments upon emergence from the Chapter 11 process in second-quarter 2024. This was partially offset by fourth-quarter 2024 asset impairment charges and the application of fresh start accounting. Adjusted Net Income in fourth-quarter 2024 was $70 million, compared to $151 million in fourth-quarter 2023. This change was primarily due to increased interest and income tax expenses in fourth-quarter 2024. Adjusted EBITDA in fourth-quarter 2024 was $164 million, compared to $166 million in fourth-quarter 2023. This change was primarily driven by decreased revenues, partially offset by higher adjusted gross margin due to changes in segment and product mix. SEGMENT RESULTS Branded Pharmaceuticals segment revenues in fourth-quarter 2024 were $247 million, compared to $246 million in fourth-quarter 2023. XIAFLEX® revenues were $148 million in both fourth-quarter 2024 and fourth-quarter 2023. Fourth-quarter 2023 results included the benefit of a one-time reserve reversal of approximately $14 million following application of the final Inflation Reduction Act vial-wastage rebate determination to XIAFLEX®. Fourth-quarter 2024 XIAFLEX® revenues were primarily driven by an 8% increase in volume due to strong underlying demand. Sterile Injectables segment revenues in fourth-quarter 2024 were $92 million, compared to $96 million in fourth-quarter 2023. This change was primarily driven by competitive pressure on VASOSTRICT®, partially offset by the resolution of previously disclosed temporary supply disruptions. During fourth-quarter 2024, the Company launched three sterile injectable products, including ADRENALIN® ready-to-use (RTU) premixed bags, the first and only FDA-approved, manufacturer-prepared epinephrine premixed IV bags. Generic Pharmaceuticals segment revenues in fourth-quarter 2024 were $111 million, compared to $139 million in fourth-quarter 2023. This change was primarily attributable to competitive pressure across a number of products, mainly dexlansoprazole delayed-release capsules, partially offset by increased revenues from lidocaine patch 5%. International Pharmaceuticals segment revenues in fourth-quarter 2024 were $17 million, compared to $17 million in fourth-quarter 2023. BALANCE SHEET AND LIQUIDITY As of December 31, 2024, Endo had $387 million in unrestricted cash and cash equivalents. Net cash provided by operating activities in fourth-quarter 2024 was $30 million, compared to $115 million in fourth-quarter 2023. This change was primarily driven by increased interest and tax payments in fourth-quarter 2024 compared to fourth-quarter 2023. FINANCIAL GUIDANCE Endo is providing the following financial guidance for the full year ending December 31, 2025 based on Endo's current views, beliefs, estimates and assumptions. Guidance for the full year 2025 includes the International Pharmaceuticals business and will be updated following completion of the divestiture. All financial expectations provided by Endo are forward-looking, and actual results may differ materially from such expectations, as further discussed below under the heading "Cautionary Note Regarding Forward-Looking Statements." CONFERENCE CALL INFORMATION Endo and Mallinckrodt will host a joint conference call to discuss the proposed transaction and their respective fourth quarter and full year 2024 results today, March 13, 2025, at 8:00 a.m. ET. The webcast may be accessed through this webcast link or from the Investor Relations section of the Company's website at investor.endo.com/events. To access the call through a conference line, participants may dial 800-836-8184 (U.S. and Canada toll-free) or 646-357-8785 (outside the U.S.). Participants are advised to join 10 minutes prior to the scheduled start time. A replay of the webcast will be available following the event. FINANCIAL SCHEDULES The following table presents unaudited Total Revenues, Net (dollars in thousands): The following table presents the unaudited Condensed Consolidated Statement of Operations (dollars in thousands): The following table presents unaudited Total Revenues, Net (dollars in thousands): The following table presents the unaudited Condensed Consolidated Statement of Operations (dollars in thousands): The following table presents the unaudited Condensed Consolidated Balance Sheet (dollars in thousands): The following table presents the unaudited Condensed Consolidated Statement of Cash Flow data (dollars in thousands): SUPPLEMENTAL FINANCIAL INFORMATION Non-GAAP Financial Measures To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain financial information of Endo, Inc. in this release that are not prescribed by or prepared in accordance with GAAP. The Company utilizes these non-GAAP financial measures as supplements to financial measures determined in accordance with GAAP when evaluating operating performance and the Company believes that these measures will be used by certain investors to evaluate operating results. The Company believes that presenting these non-GAAP financial measures provides useful information about performance across reporting periods on a consistent basis by excluding certain items, which may be favorable or unfavorable, as more fully described in the reconciliation tables below. Despite the importance of these measures to management in goal setting and performance measurement, the Company stresses that these are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. Because of the non-standardized definitions, non-GAAP adjusted EBITDA and non-GAAP adjusted net income (unlike GAAP net income and its components) may differ from, and may not be comparable to, the calculation of similar measures of other companies. These non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses performance. These non-GAAP financial measures should not be viewed in isolation or as substitutes for, or superior to, financial measures calculated in accordance with GAAP. Investors are encouraged to review the reconciliations of the non-GAAP financial measures used in this press release to their most directly comparable GAAP financial measures. However, the Company does not provide reconciliations of projected non-GAAP financial measures to GAAP financial measures, nor does it provide comparable projected GAAP financial measures for such projected non-GAAP financial measures. The Company is unable to provide such reconciliations without unreasonable efforts due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations, including adjustments that could be made for asset impairments, contingent consideration adjustments, legal settlements, gain / loss on extinguishment of debt, adjustments to inventory and other charges reflected in the reconciliation of historic numbers, the amounts of which could be significant. The tables below provide reconciliations of certain of the non-GAAP financial measures included in this release to their most directly comparable GAAP metrics. Refer to the "Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures" section below for additional details regarding the adjustments to the non-GAAP financial measures detailed throughout this Supplemental Financial Information section. Reconciliation of Net Loss (GAAP) to EBITDA (non-GAAP) and Adjusted EBITDA (non-GAAP) The following table provides a reconciliation of Net Loss (GAAP) to Adjusted EBITDA (non-GAAP) (in thousands): Reconciliation of Net Loss (GAAP) to Adjusted Net Income (non-GAAP) The following table provides a reconciliation of Endo's Net Loss (GAAP) to Adjusted Net Income (non-GAAP) (in thousands): Reconciliation of Select Other Adjusted Income Statement Data (non-GAAP) The following tables provide detailed reconciliations of select other income statement data for Endo, Inc. between the GAAP and non-GAAP measure (in thousands): Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures About Endo Endo is a diversified pharmaceutical company boldly transforming insights into life-enhancing therapies. Our passionate team members collaborate to develop and deliver these essential medicines. Together, we are committed to helping everyone we serve live their best life. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to the statements by Mr. Hirsch and any statements relating to financial guidance, expectations, plans or projections, supply disruptions, pipeline development or realignment, product launches and submissions, strategic priorities, the combination with Mallinckrodt, improving performance, revenue growth, competition, demand and any other statements that refer to expected, estimated, predicted or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are examples of forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Endo may not currently be able to predict. Although Endo believes that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: with respect to the announced combination with Mallinckrodt, necessary governmental and regulatory approvals, satisfaction of closing conditions and shareholder approval; changes in competitive, market or regulatory conditions; changes in legislation or regulations; global political changes, including those related to the new U.S. presidential administration; our use of artificial intelligence and data science; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition such as those related to XIAFLEX®; the timing and uncertainty of the results of both the research and development and regulatory processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; litigation; the performance including the approval, introduction and consumer and physician acceptance of current and new products; the performance of third parties upon whom we rely for goods and services; issues associated with our supply chain; our ability to develop and expand our product pipeline and to launch new products and to continue to develop the market for XIAFLEX® and other branded, sterile injectable or generic products; the effectiveness of advertising and other promotional campaigns; and the timely and successful implementation of business development opportunities and/or any other strategic priorities. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-K and Form 10-Q and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. Copies of the Company's press releases and additional information about the Company are available at or you can contact the Company's Investor Relations Department at [email protected]. ##### SOURCE Endo, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial Statement

13 Mar 2025

·medcitynews.com

Pharma Firms Mallinckrodt and Endo Agree to Merge in $6.7B Cash and Stock Deal - MedCity News

Mallinckrodt and Endo, pharmaceutical companies that have each encountered business struggles, announced Thursday a $6.7 billion merger that they contend will result in a combined entity with the scale and flexibility to grow. When the deal closes, Endo will become a wholly owned subsidiary of Mallinckrodt. The combined company will take on a yet-to-be-determined name and is expected to trade on the New York Stock Exchange. Its headquarters will be in Dublin, where Mallinckrodt is currently based. Headquarters for the U.S., where the combined company will have most of its operations, will be determined at a later date. Globally, the combined business will have 17 manufacturing facilities, 30 distribution centers, and 5,700 employees. Mallinckrodt and Endo each sell branded and generic products. Mallinckrodt’s portfolio includes Acthar Gel, which has approvals for treating several autoimmune and inflammatory disorders. Endo markets Xiaflex, a drug approved for Dupuytren’s contracture and Peyronie’s disease. Each company also market opioid drugs, and both have been involved in opioid litigation that contributed to financial difficulties. Mallinckrodt reorganized under bankruptcy protection twice, first in 2020 and again in 2023. Mallinckrodt was delisted from the New York Stock Exchange following the second bankruptcy. Endo filed for bankruptcy protection in 2022; its shares trade over the counter. The Malinckrodt/Endo merger is expected to close in the second quarter of this year. On a pro forma basis, the combined business is expected to generate $3.6 billion in revenue in 2025. In the combined company’s first year, about $75 million in pre-tax synergies are expected from integrating the two business as well as R&D savings. The plan is for the combined entity to also shed some operations. The generic pharmaceuticals businesses of both legacy companies will be combined with Endo’s sterile injectables business. That combined business will be spun out at a later date, subject to customary approvals. With the merger, Mallinckrodt’s existing debt is expected to be refinanced while Endo’s debt is expected to remain outstanding. The two companies will finance the transaction with cash on hand as well as $900 million that Goldman Sachs has committed to Endo. Under terms of the merger agreement, Endo shareholders will receive $80 million in cash, subject to possible adjustment. Those shareholders will own 49.9% of the combined company; Mallinckrodt shareholders will own 50.1%. The boards of directors of both companies have approved the transaction, which still needs shareholder and regulatory approvals. When the deal closes, Paul Efron, an Endo board member, will be chair of the combined company’s board. Siggi Olafsson, Mallinckrodt’s current president and CEO, will take on that role for the combined company and will also be a member its board. “Our businesses are highly complementary, with durable, on-market products in our branded portfolios and extensive capabilities across the value chain in our generics businesses,” Olafsson said in a prepared statement. “This exciting combination will create a larger and more diversified entity with the scale and resources needed to unlock the full potential of both companies. Additionally, with a strong pro forma balance sheet and compelling synergy opportunities, we will have greater flexibility to invest in innovation and pursue growth opportunities.”

AcquisitionDrug ApprovalExecutive ChangeBiosimilar

13 Mar 2025

·www.pharmaceutical-technology.com

Mallinckrodt and Endo sign $6.7bn merger deal

The combined company is expected to be listed on the New York Stock Exchange. Credit: Anton Vierietin via Getty Images. Mallinckrodt Pharmaceuticals and Endo have agreed to merge in a $6.7bn deal, combining two pharmaceutical companies that recently emerged from bankruptcy proceedings tied to opioid litigation. According to the 13 March announcement, the merger will create a “larger, more diversified entity”, with Mallinckrodt shareholders holding a 50.1% stake and Endo shareholders receiving 49.9%, along with $80m in cash. Under the terms of the agreement, Mallinckrodt CEO Siggi Olafsson will serve as the president and chief executive of the combined company, while Endo director Paul Efron will take on the role of chairman of the board. Endo will continue to operate as a wholly owned subsidiary of Mallinckrodt, as per the 13 March announcement. This merger comes after both companies faced significant financial and legal challenges due to their involvement in the sale of opioid painkillers. The opioid crisis in the US has led to extensive litigation against pharmaceutical companies accused of fuelling widespread addiction and overdose deaths. Mallinckrodt and Endo were among those sued over allegations that they contributed to the crisis by misrepresenting the risks of opioid products. Mallinckrodt first filed for bankruptcy in 2020 after reaching a tentative $1.6bn settlement with 47 states, territories, and other claimants in the US over its opioid-related liabilities. The company filed for bankruptcy again in 2023 following declining sales of key products. Net sales of the company’s top-selling drug, Acthar – a gel used to treat certain autoimmune and skin diseases – dropped by $90.7m in 2023 from the previous year, as per the company financials. The Dublin-headquartered company emerged from bankruptcy in November 2023, having reduced its total funded debt by $1.9bn. In 2023, it also paid out $700m to victims of the opioid crisis to settle thousands of lawsuits for manufacturing a generic version of Oxycodone. Endo, headquartered in Pennsylvania, US, similarly filed for bankruptcy in 2022 due to opioid-related liabilities. The company agreed to pay $465m to the US government and $450m to state and municipal trusts to support opioid recovery programmes. The company also pleaded guilty to a misdemeanour related to its opioid marketing practices. Both companies have worked to reposition themselves as specialty pharmaceutical firms, divesting non-core businesses. Earlier this week, Endo sold its international pharma unit Paladin to Knight Therapeutics for up to $99m, while Mallinckrodt sold its Therakos division to private equity firm CVC Capital Partners for $925m in August 2024. Mallinckrodt now focuses on generics and specialty medicines, including Acthar Gel and Terlivaz (terlipressin) for hepatorenal syndrome. Endo’s portfolio includes Xiaflex (collagenase clostridium histolyticum) for Dupuytren’s contracture and Peyronie’s disease, as well as a range of generics and sterile injectables. As part of the merger – which is expected to close in H2 2025 – the generics and sterile injectables businesses of both companies will be spun off into a separate standalone entity upon deal completion. The new company will be listed on the New York Stock Exchange and is expected to generate approximately $3.6bn in revenue in 2025.

AcquisitionExecutive ChangeBiosimilarPatent Infringement

100 Deals associated with Collagenase Clostridium histolyticum(Biospecifics Technologies Corp)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	M09AB02	DB00048

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Cellulite	United States	Endo Global Aesthetics Ltd.	06 Jul 2020
Penile Induration	European Union	Swedish Orphan Biovitrum AB	28 Feb 2011
Penile Induration	Iceland	Swedish Orphan Biovitrum AB	28 Feb 2011
Penile Induration	Liechtenstein	Swedish Orphan Biovitrum AB	28 Feb 2011
Penile Induration	Norway	Swedish Orphan Biovitrum AB	28 Feb 2011
Dupuytren Contracture	United States	Auxilium Pharmaceuticals LLC	02 Feb 2010

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Plantar Fibromatosis	Phase 3	United States	Endo Pharmaceuticals, Inc.	14 Feb 2022
Skin Diseases	Phase 3	United States	Endo Pharmaceuticals, Inc.	26 Apr 2018
Fasciitis, Plantar	Phase 2	United States	Endo International Plc	12 Dec 2023
Contusions	Phase 2	United States	Endo Pharmaceuticals, Inc.	15 Jun 2022
Cutis Laxa	Phase 2	United States	Endo Pharmaceuticals, Inc.	01 Oct 2020
Cellulitis	Phase 2	United States	Endo Pharmaceuticals, Inc.	20 Dec 2019
Lipoma	Phase 2	United States	Advance Biofactures Corp.	01 Aug 2014
Bursitis	Phase 2	United States	Endo Pharmaceuticals, Inc.	01 Nov 2011
Protoporphyria, Erythropoietic	Phase 1	United States	Endo Pharmaceuticals, Inc.	18 Sep 2018
Uterine Fibroids	Phase 1	United States	Advance Biofactures Corp.	27 Oct 2016

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02948842 (CTgov)	Phase 2	Urethral Stricture	5	Clostridium Histolyticum Collagenase+saline	ipelxoaxnv = nqfwvkjkrb zgffdrxjws (mfxmsapqdm, ogjfqzhkaw - nrnynihzum) View more	-	03 Nov 2023
NCT04496167 (CTgov)	Phase 2	Bursitis	198	EN3835 (EN3835)	qwsvnwsemk(obslxziaoo) = ltxyphnpcy spwslfrmpj (rcbdvnmskr, 22.432) View more	-	13 Sep 2023
				Placebo (Placebo)	qwsvnwsemk(obslxziaoo) = uiomrpsywo spwslfrmpj (rcbdvnmskr, 21.942) View more
NCT04677712 (MOBI, CTgov)	Phase 4	Contusions \| Cellulite \| Skin Diseases	48	CCH-aaes (Cohort 1: CCH-aaes)	ukqsvijpzk = avwjyhnbcu vdwqzfqnwp (luswaownvn, kodvnlpnzu - sniwxtohtm) View more	-	21 Aug 2023
				Compression (Cohort 2: CCH-aaes + Compression Garment)	ukqsvijpzk = ogzvfzcwxh vdwqzfqnwp (luswaownvn, bqiotftbxx - lcjjtumqbo) View more
NCT04786106 (AUA2023)	Phase 4	Cardiovascular Diseases	40	Collagenase Clostridium Histolyticum + traction + sildenafil	clgnrhzdbu(yfegiadnvm) = ksbteqggfz mswowlhzlr (ziekjginul ) View more	-	01 Apr 2023
				Collagenase Clostridium Histolyticum (Penile surgery + traction + sildenafil)	clgnrhzdbu(yfegiadnvm) = qlflmzszei mswowlhzlr (ziekjginul ) View more
NCT04580303 (CTgov)	Phase 2	Cellulite \| Cutis Laxa	35	CCH (Uniform 0.1-mL 1-Aliquot Grid Injection Technique (Buttocks))	jetfulohbu = qvfdwjeiid hjvwhpprox (gsaijapgor, evkayvecjv - igptjrrawl) View more	-	28 Sep 2022
				CCH (Uniform 0.3-mL 2-Aliquot Grid Injection Technique (Buttocks))	jetfulohbu = gtzwtdmona hjvwhpprox (gsaijapgor, fzpgxmljwa - aeednivjxs) View more
NCT04496167 (Corporate Publications) Manual	Phase 2	Bursitis	198	Collagenase Clostridium Histolyticum	rxhechlbze(toegxkiotj) = While Phase 2 study participants receiving up to three doses of CCH showed some improvement in the change from baseline in the adapted American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Form composite score for the affected shoulder at the Day 95 visit, the difference compared to those study participants receiving placebo was not statistically significant. rfvqztboaf (akkmshdgrf ) View more	Negative	01 Jul 2022
				Placebo
AUA2022	Phase 3	Penile Induration	832	Collagenase clostridium histolyticum (CCH)	kkppogkrpd(wbbvyqamgs) = tjwrforgwn ceiagcajst (llnvswwcqg )	-	01 May 2022
				Placebo	kkppogkrpd(wbbvyqamgs) = vrluvbadwl ceiagcajst (llnvswwcqg )
AUA2022	Not Applicable	Penile Induration	-	XIAFLEX (Patients with prior CCH treatment)	ftqefjtobt(ofiefphkju) = kvsaxxvydc vbxkmxlbce (qnigmkopcy )	-	01 May 2022
				XIAFLEX (Patients without prior CCH treatment)	ftqefjtobt(ofiefphkju) = uyeetuukyv vbxkmxlbce (qnigmkopcy )
NCT04786106 (AUA2022)	Phase 4	Cardiovascular Diseases	40	Collagenase Clostridium Histolyticum + traction + sildenafil	njnzvzdkyw(ibiugwnqvs) = yiyytvhecs woxutasuff (pmyrstuipu ) View more	-	01 May 2022
				Collagenase Clostridium Histolyticum (Penile surgery + traction + sildenafil)	njnzvzdkyw(ibiugwnqvs) = dvdtlwjlkn woxutasuff (pmyrstuipu ) View more
NCT04236635 (CTgov)	Phase 2	Cellulitis	10	Collagenase Clostridium Histolyticum Single Injection Technique (Group 1: CCH Single Injection Technique)	mauzkcwnpr = lwzaqjlhkk zxctlvhecj (zgkguvnkvl, wqjoborird - bxhuwxtltv) View more	-	12 Apr 2022
				Collagenase Clostridium Histolyticum Single Injection Technique (Group 2: CCH Single Injection Technique)	mauzkcwnpr = xltkwsdrua zxctlvhecj (zgkguvnkvl, qsyzpaszoe - xweilnwers) View more

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