Clinuvel Pharmaceuticals Ltd
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| Public | |
| Traded as |
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| ISIN | 🆔 |
| Industry | Biotechnology |
| Founded 📆 | 1999 (Epitan Ltd), 2006 (Clinuvel) |
| Founder 👔 | |
| Headquarters 🏙️ | Melbourne, Victoria, Australia (Global) |
Area served 🗺️ | |
Key people |
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| Products 📟 | SCENESSE (afamelanotide) |
| Revenue🤑 | AUD$65.722 million (2021)[1] |
 AUD$20.878 million (2021)[1] | |
| Members | |
Number of employees | 75 person (2022) |
| Divisions |
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| 🌐 Website | www |
| 📇 Address | |
| 📞 telephone | |
Clinuvel Pharmaceuticals Limited is a multinational biopharmaceutical company headquartered in Australia. The company has one commercial pharmaceutical product, SCENESSE (afamelanotide) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria, and develops other melanocortin derived products.
History[edit]
Epitan Ltd[edit]
Epitan Ltd was founded in 1999 and listed on the ASX in 2001.[2][3] The company licensed afamelanotide from the University of Arizona to develop the compound as a cosmetic tanning agent. In 2004 the US Food and Drug Administration rejected the company's strategy and in 2005 Epitan had run out of funding.[2][4] The company name was changed to Clinuvel in February 2006 as part of a change to its clinical strategy to focus on skin disorders.[5]
Retrophin take-over attempt[edit]
In 2014 American company Retrophin (now Travere Pharmaceuticals), led by Martin Shkreli, made an unsolicited take-over bid for Clinuvel, valuing the company at AUD$95m.[6][7] At the time Retrophin already owned 4.88% of Clinuvel's shares. Clinuvel rejected the proposal.[8]
Scenesse approvals[edit]
In 2010 Scenesse was listed on the Italian 648/96 listing by AIFA, enabling Italian physicians to prescribe the drug for erythropoietic protoporphyria patients prior to its formal approval, with Clinuvel subsidising its reimbursement.[2]
Scenesse was granted marketing authorisations for the treatment of adult erythropoietic protoporphyria patients in Europe in 2014, the USA in 2019 and Australia in 2020.[9][10]
Products[edit]
Afamelanotide[edit]
Clinuvel has developed and commercialised Scenesse as an injectable subcutaneous implant containing 16mg of afamelanotide.
Clinuvel has conducted or is conducting clinical trials of afamelanotide as a treatment for:
- Erythropoietic protoporphyria - phase III studies published in the New England Journal of Medicine reported that "Afamelanotide had an acceptable side-effect and adverse-event profile and was associated with an increased duration of sun exposure without pain and improved quality of life in patients with erythropoietic protoporphyria" [11]
- Polymorphous light eruption
- Solar urticaria[12]
- Acne[13]
- Actinic keratosis and squamous cell carcinoma in organ transplant recipients[14]
- Vitiligo[15]
- Stroke[16]
- Xeroderma pigmentosum[17]
In addition to the Scenesse formulation, Clinuvel has announced the development of afamelanotide in liquid injectable formulations as Prenumbra, with a clinical trial planned for stroke.[18]
References[edit]
- ↑ 1.0 1.1 [hhttps://annualreport.clinuvel.com/wp-content/uploads/2022/09/clinuvel-annual-report-2022-web.pdf "Annual Report 2022"] (PDF). Clinuvel Pharmaceuticals Limited. October 2022.
- ↑ 2.0 2.1 2.2 "Dr Boreham's Crucible: the story of Clinuvel, an Australian triumph". Stockhead. 20 October 2019.
- ↑ "Bright day dawns for EpiTan's debut". Australian Financial Review. 13 February 2001.
- ↑ "The Bronze Age". Forbes. 3 November 2021.
- ↑ "Epitan changes name to Clinuvel, announces new clinical program". Lab+Life Scientist. 27 February 2006.
- ↑ "Retrophin's bid to end Clinuvel's wilderness years". Evaluate. 28 July 2014.
- ↑ "Retrophin changes name to Travere Therapeutics". S&P Global. 17 November 2020.
- ↑ "Clinuvel scores long-awaited FDA win for rare skin disease implant Scenesse". FiercePharma. 9 October 2019.
- ↑ "FDA approves Clinuvel's rare genetic disorder treatment, shares at record high". Reuters. 8 October 2019.
- ↑ "Clinuvel Pharmaceuticals (ASX:CUV) receives TGA approval for Scenesse". The Market Herald. 27 October 2020.
- ↑ Langendonk JG, Balwani M, Anderson KE, Bonkovsky HL, Anstey AV, Bissell DM, Bloomer J, Edwards C, Neumann NJ, Parker C, Phillips JD, Lim HW, Hamzavi I, Deybach JC, Kauppinen R, Rhodes LE, Frank J, Murphy GM, Karstens FP, Sijbrands EJ, de Rooij FW, Lebwohl M, Naik H, Goding CR, Wilson JH, Desnick RJ (July 2015). "Afamelanotide for Erythropoietic Protoporphyria". N Engl J Med. 373 (1): 48–59. doi:10.1056/NEJMoa1411481. PMC 4780255. PMID 26132941.
- ↑ Haylett AK, Nie Z, Brownrigg M, Taylor R, Rhodes LE (February 2011). "Systemic photoprotection in solar urticaria with α-melanocyte-stimulating hormone analogue [Nle4-D-Phe7]-α-MSH". Br J Dermatol. 164 (2): 407–14. doi:10.1111/j.1365-2133.2010.10104.x. PMID 20969564. Unknown parameter
|s2cid=ignored (help) - ↑ McNeil MM, Nahhas AF, Braunberger TL, Hamzavi IH (November 2018). "Afamelanotide in the Treatment of Dermatologic Disease". Skin Therapy Lett. 23 (6): 6–10. PMID 30517779.
- ↑ "European Public Assessment Report: SCENESSE" (PDF). European Medicines Agency. 23 October 2014.
- ↑ Lim HW, Grimes PE, Agbai O, Hamzavi I, Henderson M, Haddican M, Linkner RV, Lebwohl M (January 2015). "Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial". JAMA Dermatol. 151 (1): 42–50. doi:10.1001/jamadermatol.2014.1875. PMID 25230094.
- ↑ "Clinuvel says afamelanotide well tolerated by first trial patients". Biotech Dispatch. 10 August 2021.
- ↑ "A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)". ClinicalTrials.gov. 16 December 2021.
- ↑ "PRÉNUMBRA® for stroke". Clinuvel. 28 July 2022.
External links[edit]
- Official website
- Business data for Clinuvel Pharmaceuticals Ltd: Google Finance
- Yahoo! Finance
- Bloomberg
- Reuters
- Clinuvel on ClinicalTrials.gov
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