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Pharmaceutical Commercialization

Table of Contents

Overview of Clinuvel Pharmaceuticals Limited.

Clinuvel agrees with FDA on New Drug Application timelines.

Recommendation by NICE..

Addition of new analytical capacity.

Inclusion in S&P/ ASX 200 Index.

Progress in DNA repair program..

Positive correlation.

Conclusion and recommendations.

References.

Overview of Clinuvel Pharmaceuticals Limited

Clinuvel Group is one of the leading biopharmaceutical company that laid emphasis on establishing and delivering effective treatments for the patients suffering from serious skin and genetic disorders. It was established in 1987 when the researchers of the university launched an idea of synthesising human hormones to safeguard the skin. It obtained rights to technologies in Australia and in the year 2014, the European Commission and European Medicines Agency approved SCENESSE as first photo protective drug in the world (Clinuvel, 2020). In June 2018, it submitted new drug application to FDA to release SCENESSE in US. This application got approval on 8 October 2019. It focuses its research and development operations on the skin interaction with an objective to deliver innovative and effective medical solution for complicate problems (Clinuvel, 2020). It has expertise in pharmaceuticals, dermatology, pharmacology and various other specialties forming the foundation for recent offerings of products. With regard to skin product lines, it provides information related to skin types, discrete differences and complexions, items to avoid, organics, ingredients, naturals and many more (Clinuvel, 2020). Its scientists are interested in broadcasting information related to its field of expertise and motivate users to obtain knowledge while making use of its products.

Years

2015

2016

2017

2018

2019

2020

Share price ($)

3.008

4.325

6.566

11.464

34.52

24.891

Source : ASX.com (2020)

Clinuvel agrees with FDA on New Drug Application timelines

The share price of Clinuvel increased from $3.008 in 2015 to $4.325 in 2016 as it agrees with FDA on its new drug application timelines. In July 2016, SCENESSE is granted by FDA as a fast track designation for treating EPP. The positive benefit risk assessment of SCENESSE done by FDA helped in making the drug as the first organized photo protectant for adult EPP patients.

Recommendation by NICE

Moreover, the share price has increased further to $6.566 in 2017. Novel medical technologies are reviewed by NICE and it made recommendation for its use by the English National Health Service (Company announcement, 2016). European Commission has authorised SCENESSE after achieving a positive opinion from European Medicines Agency. The corporation has kept a transparent uniform price for SCENESSE for all the European countries. The corporation has expanded its laboratory facilities in Singapore to establish a wide range of various critical analytical operations (Company announcement, 2018).

Addition of New Analytical Capacity

New analytical capacity has been added as a part of the rise in research activities related to the next generation products and this will further be integrated into the newly built premises. It infers that the company has higher growth prospects and thereby the demand for its shares is continuously rising leading to the increase in share price to $11.464 in 2018. It is believed that Singapore being the leading economy and innovative nation will provide the company with the effective opportunities to establish its research and development activities.

Inclusion in S&P/ ASX 200 Index

The corporation got upgraded from S&P / ASX 300 Index to S&P / ASX 200 Index effectively from 24 June 2019. This has led to the significant rise in the share price of the company from $11.646 in 2018 to $34.52 in 2019. The primary stock market index of Australia is S&P / ASX 200 Index and is considered as the benchmark for the performance of equity in Australia (Company announcement, 2019). The corporation has successfully met the ranking requirements that are based on median liquidity and market capitalisation. This significant rise in the price of its share made it attractive investable security specifically for the institutions backed by its commercial progress and continuous advancements in the research and development activities.

Progress in DNA Repair Program

As per recent announcement made in September 2020, the company made progress in innovative DNA repair program (Company announcement, 2020). The major purpose of this program is to provide confirmation regarding SCENESSE that it helps in eradicating DNA damage and its regeneration. Although, the share price of the company declined to $24.891 but the company has high future growth prospects that will help it in restoring its previous position again and will fetch heavy returns to its shareholders.

Positive Correlation

Therefore, it can be claimed that there is a positive correlation among the share prices and the announcements made by the company as all the activities or the announcements made in the previous five years have led to the increase in its share price. The company is progressively and continuously working towards the research and development operations and is counted among the top 200 Australian companies. New analytical capacities are being added that will later on will be added to the premises. The performance of equity of the company is going good and therefore, it is now regarded as among the top 200 largest listed companies.

Conclusion and Recommendations on Clinuvel Pharmaceuticals Limited Analysis

It can be concluded that Clinuvel Pharmaceuticals Limited is a growing company that will provide successive returns to its shareholders. European Commission has authorised SCENESSE after achieving a positive opinion from European Medicines Agency. The people who have share ownership in this company must hold on onto its shares as the corporation got upgraded from S&P / ASX 300 Index to S&P / ASX 200 Index effectively from 24 June 2019. This has led to the significant rise in the share price of the company from $11.646 in 2018 to $34.52 in 2019.The company has made progress in DNA repair program. New analytical capacity has been added as a part of the rise in research activities related to the next generation products and this will further be integrated into the newly built premises. It infers that the company has higher growth prospects. The rise in its market capitalisation will helps in fetching superior returns to the investors.

References for Clinuvel Pharmaceuticals Limited Analysis

ASX. (2020). Charting. Retrieved from https://www.asx.com.au/prices/charting/?code=CUV&compareCode=&chartType=&priceMovingAverage1=&priceMovingAverage2=&volumeIndicator=&volumeMovingAverage=&timeframe=

Clinuvel. (2020). Product offerings. Retrieved from https://www.clinuvel.com/clinuvel/company-overview/product-offerings

Clinuvel. (2020). Mission, vision and values. Retrieved from https://www.clinuvel.com/clinuvel/company-overview/mission-vision-and-values

Clinuvel. (2020). History and future. Retrieved from https://www.clinuvel.com/clinuvel/company-overview/history-and-future

Company announcement. (2016). Clinuvel agrees with FDA on New Drug Application timelines. Retrieved from https://www.asx.com.au/asxpdf/20161109/pdf/43crmn5rqqv8rs.pdf

Company announcement. (2018). Clinuvel expands Singapore laboratory facilities. Retrieved fromhttps://www.asx.com.au/asxpdf/20181029/pdf/43zqcwlbh59n4c.pdf

Company announcement. (2019).Clinuvel included in S7P /ASX 200 Index. Retrieved from https://www.clinuvel.com/wp-content/uploads/2019/06/CLINUVEL-INCLUDED-IN-SP-ASX-200-INDEX.pdf

Company announcement. (2020). Clinuvel progresses DNA Repair program. Retrieved from https://www.asx.com.au/asxpdf/20200910/pdf/44mht7nhpcg0wz.pdf

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