Kadmon Corporation

Kadmon Corporation (originally Kadmon Pharmaceuticals) is a biopharmaceutical company based in New York City. It also has operations in Warrendale, PA and Brighton, MA. The company was founded in 2009 by Samuel D. Waksal,[2][3] founder and former CEO of ImClone Systems, now fully merged into Eli Lilly and Company. Waksal had served a federal prison sentence stemming from his fiduciary role as CEO in the 2001 ImClone stock trading case. When released in 2009 he was barred from serving as an officer for any publicly traded company but Kadmon was privately financed.[4][5]

Kadmon Corporation, LLC.
IndustryBiotechnology
Founded2009
FounderSamuel D. Waksal
Headquarters
450 East 29th Street,
New York, NY 10016
,
United States
Number of locations
4
Key people
Harlan W. Waksal, MD
(CEO)
Anastasios G. Konidaris
(Interim Chairman)
Productscapecitabine, dofetilide, entecavir, ribavirin, temozolomide, tetrabenazine, tobramycin
Number of employees
101[1]
ParentSanofi
Websitekadmon.com

In September 2014, amid plans to take the company to an IPO Harlan W. Waksal, brother of Samuel Waksal, became President and Chief Executive Officer while Samuel Waksal remained on with the title Chief of Innovation, Science and Strategy.[6] In early 2016 Sam Waksal left Kadmon and in June the company filed paperwork for its IPO.[7][8] On July 27, 2016 the company's stock began trading on the NYSE under the symbol KDMN[9] but switched to NASDAQ in October 2020.[10] On 8 September 2021, Sanofi announced it would acquire the company for $1.9 billion.[11] The deal completed in November and its stock was deregistered as it became a subsidiary of Sanofi.

As of 2019 Kadmon had ongoing clinical trials for KD025 in specific fibrotic and neurodegenerative diseases and tesevatinib to treat autosomal dominant polycystic kidney disease (PKD) and autosomal recessive PKD.[12]

Product acquisitions

During Waksal's leadership of ImClone the company was engaged in early stage research projects for 15 years before filing its first drug application.[13] Kadmon however immediately began acquiring drugs further advanced - either already marketed in the US or in the later stages of clinical development.[14] It acquired the Warrendale, PA-based company Three Rivers Pharmaceuticals and their Ribasphere and topotecan products.[15] It also signed an agreement with Ontario, Canada-based Valeant Pharmaceuticals for their Hepatitis C drugs ribavirin and taribavirin (now KD024).[16] Cancer drugs XL647[13] and XL844[14] were acquired from Exelixis. An inhibitor of several protein kinases, tesevatinib (XL647, KD019) entered Phase II clinical trial for certain indications of non-small cell lung cancer.[17][18] and in polycystic kidney disease.[19] XL844 is an inhibitor of protein kinases Chk1 and Chk2 and may increase the sensitivity of cancer cells to radiation therapy.[20]

In an acquisition atypical for a biotechnology company, an 1800-year-old Chinese herbal formula was added to Kadmon's portfolio. PhytoCeutica's PHY906 (KD018) is a formula of four botanical products that had long been used for the treatment of gastrointestinal distress. Preclinical studies have shown it to enhance the therapeutic activity of several anticancer agents.[21] In 2014 KD018 was in a Phase II trial in combination with irinotecan in metastatic colon cancer.[22]

In 2011 the company acquired rights from Brighton, MA-based Nano Terra Inc.[23] for their Pharmacomer Technology research platform and three drug candidates in clinical development.[24] These compounds include SLx-2119 (KD025), an inhibitor to Rho kinase 2 (ROCK2) with possible potential in fibrotic disease[25] and focal cerebral ischemia.[26] SLx-4090 (KD026) is a triglyceride transfer protein (MTP) inhibitor being explored for metabolic disorders.[27] SLx-2101 (KD027) is a phosphodiesterase 5 (PDE5) inhibitor, a class of drug used in the treatment of erectile dysfunction.[28]

In 2012 the rights to salirasib (KD032), a Ras antagonist in development for cancer therapy,[29] were acquired from Concordia Pharmaceuticals of Fort Lauderdale, FL.[30] It also acquired the rights from Burlington, MA-based Dyax Corp. for DX-2400,[31] a Matrix metalloproteinase-14 (MPP-14) targeted monoclonal antibody intended to inhibit tumor blood vessel formation and metastasis.[32]

Products

As of 2019 Kadmon produces several generic drugs approved by the Food and Drug Administration in the United States.

  • Capecitabine tablets, a nucleoside metabolic inhibitor for the treatment of colon and breast cancer[33]
  • Dofetilide capsules, a cardiac antiarrhythmic drug.[34]
  • Entecavir tablets, a virus nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection.[35]
  • Ribavirin for the treatment of chronic hepatitis C[36]
  • Temozolomide capsules, an alkylating drug for the treatment of glioblastoma multiforme and astrocytoma.[37]
  • Tetrabenazine tablets, a vesicular monoamine transporter 2 inhibitor indicated for the treatment of Huntington's disease.[38]
  • Tobramycin, as an inhalation nebulizer solution for the treatment of cyctic fibrosis.[39]

References
  1. "Company Overview of Kadmon Holdings, LLC". Bloomberg L.P. Retrieved 8 March 2019.
  2. "Biotechnology Company Overview of Kadmon Corporation, LLC". Bloomberg.com. Archived from the original on January 19, 2013. Retrieved 3 December 2012.
  3. Bartiromo, Maria. "Sam Waksal, Kadmon Pharmaceuticals CEO". CNBC.com. Retrieved 4 December 2012.
  4. "Former Imclone Chief Acquires Drug Company". The New York Times. 25 October 2010. Retrieved 7 December 2012.
  5. "2012 Private financing $50MIL". FORM D. US Securities and Exchange Commission. Retrieved 7 December 2012.
  6. "Kadmon Corporation Announces the Appointment of Dr. Harlan W. Waksal as President". Kadmon Corporation Announcements. Kadmon Corporation. Archived from the original on 13 November 2014. Retrieved 13 November 2014.
  7. Lash, Alex (June 13, 2016). "Kadmon Seeks IPO With Unusual Terms That Benefit Waksal, Debt Holders". Xconomy. Retrieved September 25, 2016.
  8. Carroll, John (June 10, 2016). "Sam Waksal Exited Kadmon With $25M Severance Deal Ahead of IPO". FierceBiotech. Retrieved September 25, 2016.
  9. "Sam Waksal's Kadmon Holdings shares open below offering price in debut". CNBC LLC. Retrieved 25 September 2016.
  10. Kadmon Corporation (October 13, 2020). "Kadmon to Transfer U.S. Stock Exchange Listing to Nasdaq" (Press release). Accesswire.
  11. "France's Sanofi to buy U.S. biopharma firm Kadmon in $1.9 bln deal". Reuters.com. 2021-09-08. Retrieved 2021-09-08.
  12. "35 Studies found for: Kadmon". Clinical Trials.gov. Retrieved March 8, 2019.
  13. Pollack, Andrew (31 October 2012). "ImClone Ex-Chief Embarks on New Biotech Venture". The New York Times. Retrieved 8 December 2012.
  14. Fitzpatrick Dimond, Ph.D., Patricia (3 November 2010). "Tales from the Biotech Crypt: Sam Waksal Is Back in Business". Insight&Intelligence. Genetic Engineering & Biotechnology News. Retrieved 8 December 2012.
  15. "Company Overview of Three Rivers Pharmaceuticals, LLC". Bloomberg Businessweek. Bloomberg.com. Archived from the original on January 18, 2013. Retrieved 8 December 2012.
  16. Ho, Solarina (1 November 2010). "Valeant, Kadmon sign deals on hepatitis C drugs". Thomson Reuters. Retrieved 8 December 2012.
  17. Chmielecki, Juliann; Pietanza, M. Catherine; Aftab, Dana; Shen, Ronglai; Zhao, Zhiguo; Chen, Xi; Hutchinson, Katherine; Viale, Agnes; et al. (2012). "EGFR-Mutant Lung Adenocarcinomas Treated First-Line with the Novel EGFR Inhibitor, XL647, Can Subsequently Retain Moderate Sensitivity to Erlotinib". Journal of Thoracic Oncology. 7 (2): 434–42. doi:10.1097/JTO.0b013e31823c5aee. PMC 3261336. PMID 22173702.
  18. Pietanza, M. Catherine; Gadgeel, Shirish M.; Dowlati, Afshin; Lynch, Thomas J.; Salgia, Ravi; Rowland, Kendrith M.; Wertheim, Michael S.; Price, Katharine A.; et al. (2012). "Phase II Study of the Multitargeted Tyrosine Kinase Inhibitor XL647 in Patients with Non–Small-Cell Lung Cancer". Journal of Thoracic Oncology. 7 (5): 856–65. doi:10.1097/JTO.0b013e31824c943f. PMID 22722787.
  19. Clinical trial number NCT01559363 for "A Safety, Pharmacokinetic and Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease" at ClinicalTrials.gov
  20. Riesterer, Oliver; Matsumoto, Fumihiko; Wang, Li; Pickett, Jessica; Molkentine, David; Giri, Uma; Milas, Luka; Raju, Uma (2009). "A novel Chk inhibitor, XL-844, increases human cancer cell radiosensitivity through promotion of mitotic catastrophe". Investigational New Drugs. 29 (3): 514–22. doi:10.1007/s10637-009-9361-2. PMID 20024691. S2CID 20865470.
  21. Liu, Shwu-Huey; Cheng, Yung-Chi (2012). "Old formula, new Rx: The journey of PHY906 as cancer adjuvant therapy". Journal of Ethnopharmacology. 140 (3): 614–23. doi:10.1016/j.jep.2012.01.047. PMID 22326673.
  22. "A Phase II Multicenter, Randomized, Placebo Controlled, Double Blinded Clinical Study of KD018 as a Modulator of Irinotecan Chemotherapy in Patients With Metastatic Colorectal Cancer". ClinicalTrials.gov. U.S. National Institutes of Health. Retrieved 9 August 2014.
  23. "Company Overview of Nano-Terra". Bloomberg Businessweek. Bloomberg.com. Archived from the original on June 23, 2013. Retrieved 8 December 2012.
  24. "Kadmon Pharmaceuticals and Nano Terra Announce Worldwide Exclusive Licensing Agreement for Three Novel Product Candidates". Nanowerk.com. Retrieved 8 December 2012.
  25. Boerma, Marjan; Fu, Qiang; Wang, Junru; Loose, David S; Bartolozzi, Alessandra; Ellis, James L; McGonigle, Sharon; Paradise, Elsa; et al. (2008). "Comparative gene expression profiling in three primary human cell lines after treatment with a novel inhibitor of Rho kinase or atorvastatin". Blood Coagulation & Fibrinolysis. 19 (7): 709–18. doi:10.1097/MBC.0b013e32830b2891. PMC 2713681. PMID 18832915.
  26. Lee, J; Zheng, Y; -von Bornstadt, D; Wei, Y; Balcioglu, A; Daneshmand, A; Yalcin, N; et al. (2014). "Selective ROCK2 Inhibition In Focal Cerebral Ischemia". Annals of Clinical and Translational Neurology. 1 (1): 2–14. doi:10.1002/acn3.19. PMC 3900310. PMID 24466563.
  27. Kim, Enoch; Stewart Campbell; Olivier Schueller; et al. (June 2011). "A Small-Molecule Inhibitor of Enterocytic Microsomal Triglyceride Transfer Protein, SLx-4090: Biochemical, Pharmacodynamic, Pharmacokinetic, and Safety Profile". Journal of Pharmacology and Experimental Therapeutics. 337 (3): 775–85. doi:10.1124/jpet.110.177527. PMID 21406547. S2CID 10523856. Retrieved 8 December 2012.
  28. Leonardi, R; Alemanni, M (2011). "The management of erectile dysfunction: Innovations and future perspectives". Archivio Italiano di Urologia, Andrologia. 83 (1): 60–2. PMID 21585174.
  29. Mashiach-Farkash, E; Rak, R; Elad-Sfadia, G; Haklai, R; Carmeli, S; Kloog, Y; Wolfson, HJ (2012). "Computer-based identification of a novel LIMK1/2 inhibitor that synergizes with salirasib to destabilize the actin cytoskeleton". Oncotarget. 3 (6): 629–39. doi:10.18632/oncotarget.525. PMC 3442289. PMID 22776759.
  30. "Kadmon Acquires First-in-Class Ras Antagonist From Concordia Pharmaceuticals". BioSpace, Inc. Archived from the original on 3 March 2016. Retrieved 8 December 2012.
  31. "Novel MMP-14 Inhibitor to be Developed in Multi-Indication Oncology Program". Dyax Corporation. Retrieved 8 December 2012.
  32. Devy, L.; Huang, L.; Naa, L.; Yanamandra, N.; Pieters, H.; Frans, N.; Chang, E.; Tao, Q.; et al. (2009). "Selective Inhibition of Matrix Metalloproteinase-14 Blocks Tumor Growth, Invasion, and Angiogenesis". Cancer Research. 69 (4): 1517–26. doi:10.1158/0008-5472.CAN-08-3255. PMID 19208838.
  33. "Capecitabine, prescribing information" (PDF). Retrieved March 8, 2019.
  34. "Dofetilide capsules, drug label information". Retrieved March 8, 2019.
  35. "Entecavir, prescribing information" (PDF). Retrieved March 8, 2019.
  36. "Ribashpere label information" (PDF). Retrieved March 8, 2019.
  37. "Temozolomide capsules, prescribing information" (PDF). Retrieved March 8, 2019.
  38. "Tetrabenazine tablet, prescribing information" (PDF). Retrieved March 8, 2019.
  39. "Tobramycin prescribing information" (PDF). Retrieved March 8, 2019.
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