Indena is a global leader in the discovery, development, and manufacturing of plant-derived active ingredients for various industries including pharmaceuticals, health supplements, and personal care products. As an Italian corporation, Indena employs approximately 800 individuals, with a dedicated research team of 10%. The company operates in over 70 countries worldwide, with facilities for cultivation, production, and distribution.

Tags

Neoplasms

Nervous System Diseases

Immune System Diseases

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	3
Hemic and Lymphatic Diseases	1
Immune System Diseases	1
Nervous System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	3

Top 5 Target	Count

TOP1 x Tubulin	1
Tubulin	1

Drugs associated with Indena SpA

Ortataxel

Target

Tubulin

Mechanism

Tubulin inhibitors

Active Org.

Indena SpA [+1]

Originator Org.

Indena SpA

Active Indication

Glioblastoma

Inactive Indication

Advanced Renal Cell Carcinoma [+7]

Drug Highest PhasePhase 2

First Approval Ctry. / Loc.-

First Approval Date-

IDN-5404

Target

TOP1 x Tubulin

Mechanism

TOP1 inhibitors [+1]

Active Org.

Nerviano Medical Sciences S.r.l [+1]

Originator Org.

Indena SpA

Active Indication

Lymphoma

Inactive Indication

Advanced Malignant Solid Neoplasm

Drug Highest PhasePhase 1

First Approval Ctry. / Loc.-

First Approval Date-

Delphinidin chloride

Target

EGFR x Hyaluronidase x VEGFR2

Mechanism

EGFR antagonists [+3]

Active Org.

University of Wisconsin [+2]

Originator Org.

Sanofi

Active Indication

Neoplasms [+2]

Inactive Indication

Diabetic Angiopathies [+2]

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Indena SpA

NCT04705220 / RecruitingNot Applicable

Effect of Nutritional Supplementation With Turmeric on the Cognitive Performance of Subjects With Metabolic Syndrome

The EPICURO study aims to demonstrate the beneficial effects of a 6-month dietary supplementation with an improved bioavailable turmeric (MERIVA®) on inflammatory, oxidative and metabolic parameters together with cognitive performance, potentially resulting in the reduction of the risk of cognitive decline in subjects, male and female, with Metabolic Syndrome. The results obtained will provide novel insights on MERIVA® for improving the prevention of age-related cognitive decline and Alzheimer's disease.

Start Date08 Apr 2022

Sponsor / Collaborator

Indena SpA

[+2]

NCT05297032 / TerminatedNot Applicable

Evaluation of a Computational Model That Predicts the Effects of Quercetin on Metabolic Health Using Biological Age and Other Lipid-related Blood Metrics

Quercetin is a natural flavonoid compound widely found in vegetables, fruits, and nuts. It has a long history of use as a dietary supplement. This study aims to assess results from a computational model suggesting that quercetin may offer novel benefits to metabolic health. Participants will take quercetin (as Quercetin Phytosome, a proprietary formulation with enhanced absorption properties) for 90 days while keeping lifestyle habits consistent throughout to estimate net effects of quercetin as much as possible. Blood samples will be collected at the beginning and end of the study to assess the effects of quercetin supplementation on metabolic health metrics such as LDL cholesterol, blood sugar, liver, kidney and immune function and calculated metabolic age. In addition, questionnaires will be completed to ensure compliance with study requirements and assess potential quercetin benefits in the participants' quality of life. This work will provide a proof-of-concept from a computational model of nutraceutical compounds and proposes a new application of quercetin in support of healthy human metabolism.

Start Date24 Mar 2022

Sponsor / Collaborator

Indena SpA

ISRCTN32556347 / CompletedNot Applicable

Profiling Vaccinium macrocarpon components and metabolites in human urine and the urine ex-vivo effect on Candida albicans adhesion and biofilm-formation

Start Date15 Jan 2019

Sponsor / Collaborator

Indena SpA

100 Clinical Results associated with Indena SpA

0 Patents (Medical) associated with Indena SpA

Literatures (Medical) associated with Indena SpA

01 Sep 2017·Journal of Pharmaceutical and Biomedical AnalysisQ3 · MEDICINE

Pharmacokinetic profile of bilberry anthocyanins in rats and the role of glucose transporters: LC–MS/MS and computational studies

Q3 · MEDICINE

Article

Author: Baron, G ; Grandi, S ; Aldini, G ; Redaelli, V ; Riva, A ; Vistoli, G ; Regazzoni, L ; Altomare, A ; Morazzoni, P ; Carini, M ; Mazzolari, A

The aim of the present investigation was to better understand the pharmacokinetic profile of bilberry (Vaccinium Myrtillus) anthocyanins and the role of glucose transporters (sGLT1 and GLUT2) on their absorption. In particular, the absorption of 15 different anthocyanins contained in a standardized bilberry extract (Mirtoselect^®) was measured in rats by a validated LC-ESI-MS/MS approach. The plasma concentration peak (Cmax) of 11.1ng/mL was reached after 30min and fasting condition significantly increased the bioavailability of anthocyanins by more than 7 fold in respect to fed rats. Glucose co-administration did not interfere with the overall anthocyanin uptake. Bioavailability of each anthocyanin was then estimated by comparing the relative content in plasma vs extract. The 15 anthocyanins behaved differently in term of bioavailability and both the aglycone and the sugar moiety were found to affect the absorption. For instance, arabinoside moiety was detrimental while cyanidin enhanced bioavailability. Computational studies permitted to rationalize such results, highlighting the role of glucose transporters (sGLT1 and GLUT2) in anthocyanins absorption. In particular a significant correlation was found for the 15 anthocyanins between sGLT1 and GLUT2 recognition and absorption.

01 Jan 2010·Modern Dietary Fat Intakes in Disease Promotion

Dietary Plant Extracts to Modify Effects of High Fat Modern Diets in Health Promotion

Author: Stefano Togni

• In healthy populations, a correct diet can prevent typical deficiency diseases, which almost disappeared in advanced Western societies; however, some forms of “non-deficiency malnutrition” are now well known and easily understandable, especially in high-fat modern diets.

Nutrafoods

Correct identification of plants. DNA barcoding at the forefront of guaranteed authenticity

Author: Palumbo, Cosimo

A review.DNA based identification technologies are important for authenticating botanical, chemotaxonomic, and metabolomics anal. techniques.DNA- sequencing based technique is a powerful technol. but required knowledge of plant genetic diversity.Next Generation Sequencing is term used to describe various modern sequencing technologies.DNA- sequencing based tests play an important role in those sectors where adultration is serious concern, for example dietary supplement industry.The rising of quality levels, imply that the entire industry sector can be place where producers and consumers can trust and find safe and authetic product.

News (Medical) associated with Indena SpA

29 Feb 2024

·www.pharmaceutical-technology.com

HHS advocates for health equity through sickle cell initiative

At the Black Health Forum 2024, HHS secretary Xavier Becerra detailed plans for improved access to sickle cell disease therapies. Credit: Kevin Dietsch via Getty Images. Rounding off US Black History Month, Xavier Becerra, secretary of the US Department of Health and Human Services (HHS), has said more work still needs to be done to allow health equity. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. Submit Country Code * UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - Bissau (+245) Guyana (+592) Haiti (+509) Honduras (+504) Hong Kong (+852) Hungary (+36) Iceland (+354) India (+91) Indonesia (+62) Iran (+98) Iraq (+964) Ireland (+353) Israel (+972) Italy (+39) Jamaica (+1876) Japan (+81) Jordan (+962) Kazakhstan (+7) Kenya (+254) Kiribati (+686) Korea North (+850) Korea South (+82) Kuwait (+965) Kyrgyzstan (+996) Laos (+856) Latvia (+371) Lebanon (+961) Lesotho (+266) Liberia (+231) Libya (+218) Liechtenstein (+417) Lithuania (+370) Luxembourg (+352) Macao (+853) Macedonia (+389) Madagascar (+261) Malawi (+265) Malaysia (+60) Maldives (+960) Mali (+223) Malta (+356) Marshall Islands (+692) Martinique (+596) Mauritania (+222) Mayotte (+269) Mexico (+52) Micronesia (+691) Moldova (+373) Monaco (+377) Mongolia (+976) Montserrat (+1664) Morocco (+212) Mozambique (+258) Myanmar (+95) Namibia (+264) Nauru (+674) Nepal (+977) Netherlands (+31) New Caledonia (+687) New Zealand (+64) Nicaragua (+505) Niger (+227) Nigeria (+234) Niue (+683) Norfolk Islands (+672) Northern Marianas (+670) Norway (+47) Oman (+968) Palau (+680) Panama (+507) Papua New Guinea (+675) Paraguay (+595) Peru (+51) Philippines (+63) Poland (+48) Portugal (+351) Puerto Rico (+1787) Qatar (+974) Reunion (+262) Romania (+40) Russia (+7) Rwanda (+250) San Marino (+378) Sao Tome & Principe (+239) Saudi Arabia (+966) Senegal (+221) Serbia (+381) Seychelles (+248) Sierra Leone (+232) Singapore (+65) Slovak Republic (+421) Slovenia (+386) Solomon Islands (+677) Somalia (+252) South Africa (+27) Spain (+34) Sri Lanka (+94) St. Helena (+290) St. Kitts (+1869) St. Lucia (+1758) Sudan (+249) Suriname (+597) Swaziland (+268) Sweden (+46) Switzerland (+41) Syria (+963) Taiwan (+886) Tajikstan (+7) Thailand (+66) Togo (+228) Tonga (+676) Trinidad & Tobago (+1868) Tunisia (+216) Turkey (+90) Turkmenistan (+7) Turkmenistan (+993) Turks & Caicos Islands (+1649) Tuvalu (+688) Uganda (+256) Ukraine (+380) United Arab Emirates (+971) Uruguay (+598) Uzbekistan (+7) Vanuatu (+678) Vatican City (+379) Venezuela (+58) Vietnam (+84) Virgin Islands - British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. You will receive an email shortly. Please check for download the Report. Go deeper with GlobalData Reports LOA and PTSR Model - HBI-002 in Sickle Cell Disease Reports LOA and PTSR Model - Sanguinate in Acute Ischemic Stroke Premium Insights The gold standard of business intelligence. Find out more Related Company Profiles Vertex Pharmaceuticals Inc CRISPR Therapeutics AG View all “We are far from done in pushing the envelope when it comes to equity by design,” said Becerra. At the HHS Black Health Forum 2024, held on 28 February, the secretary announced a project for gene therapies, beginning with work towards access to sickle cell disease treatments. “We now have, within our grasp, not just a treatment, but a cure for sickle cell disease,” added Becerra. However, he highlighted monetary barriers to treatment access. On 8 December, the US Food and Drug Administration (FDA) approved two gene therapies for the treatment of sickle cell disease in patients 12 and older. Vertex Pharmaceuticals and CRISPR Therapeutics ’ CRISPR/Cas-9 therapy, Casgevy (exagamglogene autotemcel), and Bluebird Bio’s cell-based gene therapy, Lyfgenia (lovotibeglogene autotemcel), became the first US-approved gene therapies for sickle cell disease. See Also: The health risks of ultra-processed foods (UPFs) are worse than we think Indena’s CDMO services: Health is a joint project According to GlobalData’s pricing database, Casgevy has a US wholesale cost of $2.64 million whilst Lyfgenia wholesales at $3.72m in the US. GlobalData is the parent company of Pharmaceutical Technology. Becerra declared that the US Centers for Medicare and Medicaid Services (CMS) will soon begin an initiative to collaborate with as many states as possible to negotiate a deal with the pharmaceutical manufacturers of the two therapies. Headed by CMS administrator Chiquita Brooks La-Sure, the organisation plans to reach a deal on a reasonable price for gene therapies to increase access for patients. “If we do it together, we can bargain because we have the power of numbers behind us and we can negotiate the best deal,” says Becerra. Sickle cell disease is the name of a group of diseases caused by dysfunction in the red blood cells. Symptoms of the disease include anaemia, increased risk of infection and, in some cases, stroke and death. The US Centers for Disease Control and Prevention (CDC) reports that the disease affects approximately 100,000 Americans, disproportionately occurring in one in every 365 Black or African-American births. Becerra called the audience to action saying: “Make sure that your states are joining in this voluntary effort …to drive down the price and get the best bargain for those who have sickle cell disease and who are on Medicaid.” At the forum, the HHS secretary raised other examples of the department’s health equity actions, highlighting the extension of Medicaid postpartum coverage. HHS currently has a programme, in partnership with Congress, that allows it to partner with states to deliver 365 days of postpartum care to new mothers. Becerra says 44 states have joined the programme since it launched, but he encouraged the remaining states to join the initiative. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. By GlobalData Submit Country Code * UK (+44) USA (+1) Algeria (+213) Andorra (+376) Angola (+244) Anguilla (+1264) Antigua & Barbuda (+1268) Argentina (+54) Armenia (+374) Aruba (+297) Australia (+61) Austria (+43) Azerbaijan (+994) Bahamas (+1242) Bahrain (+973) Bangladesh (+880) Barbados (+1246) Belarus (+375) Belgium (+32) Belize (+501) Benin (+229) Bermuda (+1441) Bhutan (+975) Bolivia (+591) Bosnia Herzegovina (+387) Botswana (+267) Brazil (+55) Brunei (+673) Bulgaria (+359) Burkina Faso (+226) Burundi (+257) Cambodia (+855) Cameroon (+237) Canada (+1) Cape Verde Islands (+238) Cayman Islands (+1345) Central African Republic (+236) Chile (+56) China (+86) Colombia (+57) Comoros (+269) Congo (+242) Cook Islands (+682) Costa Rica (+506) Croatia (+385) Cuba (+53) Cyprus North (+90392) Cyprus South (+357) Czech Republic (+42) Denmark (+45) Djibouti (+253) Dominica (+1809) Dominican Republic (+1809) Ecuador (+593) Egypt (+20) El Salvador (+503) Equatorial Guinea (+240) Eritrea (+291) Estonia (+372) Ethiopia (+251) Falkland Islands (+500) Faroe Islands (+298) Fiji (+679) Finland (+358) France (+33) French Guiana (+594) French Polynesia (+689) Gabon (+241) Gambia (+220) Georgia (+7880) Germany (+49) Ghana (+233) Gibraltar (+350) Greece (+30) Greenland (+299) Grenada (+1473) Guadeloupe (+590) Guam (+671) Guatemala (+502) Guinea (+224) Guinea - Bissau (+245) Guyana (+592) Haiti (+509) Honduras (+504) Hong Kong (+852) Hungary (+36) Iceland (+354) India (+91) Indonesia (+62) Iran (+98) Iraq (+964) Ireland (+353) Israel (+972) Italy (+39) Jamaica (+1876) Japan (+81) Jordan (+962) Kazakhstan (+7) Kenya (+254) Kiribati (+686) Korea North (+850) Korea South (+82) Kuwait (+965) Kyrgyzstan (+996) Laos (+856) Latvia (+371) Lebanon (+961) Lesotho (+266) Liberia (+231) Libya (+218) Liechtenstein (+417) Lithuania (+370) Luxembourg (+352) Macao (+853) Macedonia (+389) Madagascar (+261) Malawi (+265) Malaysia (+60) Maldives (+960) Mali (+223) Malta (+356) Marshall Islands (+692) Martinique (+596) Mauritania (+222) Mayotte (+269) Mexico (+52) Micronesia (+691) Moldova (+373) Monaco (+377) Mongolia (+976) Montserrat (+1664) Morocco (+212) Mozambique (+258) Myanmar (+95) Namibia (+264) Nauru (+674) Nepal (+977) Netherlands (+31) New Caledonia (+687) New Zealand (+64) Nicaragua (+505) Niger (+227) Nigeria (+234) Niue (+683) Norfolk Islands (+672) Northern Marianas (+670) Norway (+47) Oman (+968) Palau (+680) Panama (+507) Papua New Guinea (+675) Paraguay (+595) Peru (+51) Philippines (+63) Poland (+48) Portugal (+351) Puerto Rico (+1787) Qatar (+974) Reunion (+262) Romania (+40) Russia (+7) Rwanda (+250) San Marino (+378) Sao Tome & Principe (+239) Saudi Arabia (+966) Senegal (+221) Serbia (+381) Seychelles (+248) Sierra Leone (+232) Singapore (+65) Slovak Republic (+421) Slovenia (+386) Solomon Islands (+677) Somalia (+252) South Africa (+27) Spain (+34) Sri Lanka (+94) St. Helena (+290) St. Kitts (+1869) St. Lucia (+1758) Sudan (+249) Suriname (+597) Swaziland (+268) Sweden (+46) Switzerland (+41) Syria (+963) Taiwan (+886) Tajikstan (+7) Thailand (+66) Togo (+228) Tonga (+676) Trinidad & Tobago (+1868) Tunisia (+216) Turkey (+90) Turkmenistan (+7) Turkmenistan (+993) Turks & Caicos Islands (+1649) Tuvalu (+688) Uganda (+256) Ukraine (+380) United Arab Emirates (+971) Uruguay (+598) Uzbekistan (+7) Vanuatu (+678) Vatican City (+379) Venezuela (+58) Vietnam (+84) Virgin Islands - British (+1284) Virgin Islands - US (+1340) Wallis & Futuna (+681) Yemen (North)(+969) Yemen (South)(+967) Zambia (+260) Zimbabwe (+263) Country * UK USA Afghanistan Åland Islands Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos Islands Colombia Comoros Congo Democratic Republic of the Congo Cook Islands Costa Rica Côte d"Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati North Korea South Korea Kuwait Kyrgyzstan Lao Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Réunion Romania Russian Federation Rwanda Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and The Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and The South Sandwich Islands Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates US Minor Outlying Islands Uruguay Uzbekistan Vanuatu Venezuela Vietnam British Virgin Islands US Virgin Islands Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Kosovo By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Submit Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. You will receive an email shortly. Please check for download the Report.

Gene TherapyDrug Approval

25 Jan 2023

·www.biospace.com

Jaguar Health Announces Completion of Key Milestone in Process of Establishing Indena S.p.A. as a Reliable Approved Crofelemer Manufacturer

Milestone supports the expansion of manufacturing volume required for potential additional indications for crofelemer, including cancer therapy-related diarrhea Crofelemer API (active pharmaceutical ingredient) manufactured by Indena can now be used by Jaguar for development work Patient enrollment expected to complete in Q2 2023 for company's pivotal Phase 3 OnTarget clinical trial of crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy SAN FRANCISCO, CA / ACCESSWIRE / January 25, 2023 / Jaguar Health, Inc. (NASDAQ:JAGX) today announced that the required procedure of registering the source of the active pharmaceutical ingredient (API) of crofelemer with the Agenzia Italiana Del Farmaco (AIFA), the Italian Medicines Agency, has been successfully completed. Resultingly, batches of crofelemer API manufactured by Milan, Italy-based Indena S.P.A. can now be used by Jaguar for further development work. "We are very pleased about the completion of this key milestone in the ongoing process of establishing Indena as an additional approved crofelemer manufacturer as we work to support the increased crofelemer manufacturing demand expected upon potential FDA approval of crofelemer for new indications, including approval for cancer therapy-related diarrhea (CTD)," said David Sesin, Ph.D., Jaguar's chief manufacturing officer. "Jaguar is honored to have had a long-standing relationship with Indena, a pioneer and world-class leader in plant-based pharmaceutical manufacturing." About Cancer Therapy-related Diarrhea A significant proportion of patients undergoing cancer therapy experience diarrhea, and diarrhea has the potential to cause dehydration, potential infections, and non-adherence to treatment in this population. Novel "targeted cancer therapy" agents, such as epidermal growth factor receptor (EGFR) antibodies and tyrosine kinase inhibitors (TKIs), with or without cycle chemotherapy agents, may cause increased electrolyte and fluid content in the gut lumen, which results in passage of loose/watery stools (i.e., diarrhea). Diarrhea has been reported as one of the most common side effects of TKIs and may result in cancer therapy drug holidays or reductions from therapeutic dose, potentially impacting patient outcome. Diarrhea is also a common side effect of some approved CDK 4/6 inhibitors. About Indena S.p.A. Indena is the leading company dedicated to the identification, development and production of high-quality active principles derived from plants, for use in the pharmaceutical and health food industries. Backed by a century of botanical experience, the company owns 100 patent families, has published more than 1,000 scientific studies, and co-operates with the world's most prestigious universities and private research institutions. Indena employs over 900 staff, investing a significant amount of its annual turnover in research, making this activity the key to its success. Headquartered in Milan, Italy, Indena has 4 production sites and 5 international branches throughout the world and manages sales in more than 80 countries. The company's experts communicate and interact constantly with the major international regulatory authorities and cooperate on the update of all the main pharmacopoeias. Learn more at indena.com About Jaguar Health, Napo Pharmaceuticals, Napo Therapeutics & Jaguar Animal Health Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Health's wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants harvested responsibly from rainforest areas. Our crofelemer drug product candidate is the subject of the OnTarget study, an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe. Jaguar Animal Health is a tradename of Jaguar Health. For more information about Jaguar Health, please visit . For more information about Napo Pharmaceuticals, visit . For more information about Napo Therapeutics, visit napotherapeutics.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements." These include statements regarding the potential for FDA approval of crofelemer for new indications, including CTD. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "aim," "anticipate," "could," "intend," "target," "project," "contemplate," "believe," "estimate," "predict," "potential" or "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact: Peter Hodge Jaguar Health, Inc. phodge@jaguar.health Jaguar-JAGX SOURCE: Jaguar Health, Inc. View source version on accesswire.com:

Phase 3

100 Deals associated with Indena SpA

100 Translational Medicine associated with Indena SpA

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Pipeline

Pipeline Snapshot as of 26 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

Phase 1 Clinical

Phase 2 Clinical

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Ortataxel ( Tubulin )	Glioblastoma More	Phase 2
IDN-5404 ( TOP1 x Tubulin )	Lymphoma More	Phase 1
IDN-5839	Neoplasms More	Preclinical
IDB-1031 ( Free radicals )	Respiratory Diseases More	Discontinued
Silipide	Ovarian Cancer More	Discontinued

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