I think it’s a mix of several things.
Perhaps a mini pre-NDA filing run up.
In Germany Florian Homm is actively promoting the stock.
And then the chair’s newsletter yesterday:
Whilst the Board of CLINUVEL looks back on a very successful 2017 it must now look forward to exciting times ahead. The Group will engage in many activities on several continents, and we are expecting to see the first fruits of internal research coming to the public eye.
Insurers and payors worldwide continue to restrict availability of reimbursements to patients needing “orphan drugs”. Nonetheless, as a counter-measure, we continue to broadcast the clinical successes achieved in the countries that do offer financial support for erythropoietic protoporphyria (EPP) patients1 in recognition of SCENESSE® (afamelanotide 16mg) as a treatment.
The long-awaited highlight for 2018 will be the final submission to the US Food and Drug Administration (FDA) of what has been a challenging SCENESSE® dossier as part of the new drug application (NDA). Activating pigmentation by way of a hormonal therapy in light-deprived patients – EPP – has proven a difficult task for even the most experienced scientific regulators and consultants. However, as the European and Swiss patients have shown, our concept is not only effective but also of long-term benefit, it is hoped that the FDA will not wish for North American patients to be excluded.
CLINUVEL’s clinical and regulatory team have adopted a strategy of full and open communication with regulatory bodies, and the FDA has signalled receptiveness by having first accepted the clinical data for submission, then waived carcinogenicity studies, granted Fast Track Designation, and organised three meetings with relevant patients and experts while the formal scientific review is yet to be concluded. This persistent approach taken by our management team has brought us to where we are today as a company. Those that operate in our industry will have insight as to when the theoretical diverges from what is practical and optimal and so will better understand and support the decision pathways of CLINUVEL. It has not gone amiss that the Company’s application to the FDA is to be submitted during these politically and economically sensitive times, and we continue to take technical and substantive measures to best position the Company’s application.
2018 will be my last full year as Chair of CLINUVEL and I would certainly prefer to exit my role as Chair with the knowledge that shareholders, active investors and the domestic business community view CLINUVEL as a successful Australian pharmaceutical entity, and one of the few to have withstood the test of time while taking a New Molecular Entity from concept to patients in two major global markets.
It is essential that CLINUVEL is positioned to ensure that continuity and stability of success are guaranteed long-term. Having worked with previous executive teams, and certainly at CSL one led by one of Australia’s greatest CEOs, I have come to appreciate up close the efforts and accomplishments of our current CLINUVEL management against significant odds and challenges. In golfing parlance they are certainly besting par on the biotechnology course.
As Chair of the Board I have led and participated in intense deliberation on the positioning and vision for the future of the Company to ensure they are consistent with the interests of our stakeholders. All knowledgeable consultants and key investors in our industry have made it clear that continuity under current management is preferred and mandatory for us to reach our long-term objectives. As a Board we are privy to key management decisions, and it has become obvious to us, and those with a standing in the sector, that Dr Wolgen’s intelligence, vision and forthright manner will succeed where others may well have walked away. This approach has taken CLINUVEL to the success it enjoys today.
At this critical point in time the Board considered it absolutely essential to persuade our Managing Director to sign one final employment agreement to prepare the Company for a handover by 2021. With Dr Wolgen’s commitment to guide CLINUVEL through the next three years, as Chair I believe it secures the interests of those stakeholders who have provided funding for our programmes over the past several years.
Together with the retention of the Managing Director’s services and the need to retain key personnel and have a succession plan in place for senior staff, the Company has put in place a Professional Development Program for senior managers. As part of that program Dr Emilie Rodenburger will be assisted and guided by our Acting CSO Dr Dennis Wright to become the Company’s next Chief Scientific Officer.
CLINUVEL will attract a wider audience in 2018, not the least by diversifying its product offerings to new markets. The knowledge gained as a specialty pharmaceutical company, and the confidence gained among the top academic experts worldwide, will need to be translated into a continuum benefiting a wider market. CLINUVEL will launch its premiere non-pharmaceutical product lines under private label. These dermatological products will be complementary to SCENESSE®. Fitting our 2018 strategy, CLINUVEL will exhibit its first conference display in Asia and Europe, our main targeted markets. This will be discussed by our Managing Director in more detail over coming months.
For the next twelve months Management and Board will give its best to achieve our objectives, and it gives me a sense of great pride and humility to have served as Chair over the past years. May we all look forward to an exciting 2018.
AI
