Today’s announcement of the results of CUV017 has brought with it a stream of updates from Clinuvel, on the website, YouTube and beyond.
In this post we summarise the days releases and developments.
Summary of today’s announcements
Wednesday, July 14th, 2010What makes a ‘gold standard’ in cGMP? (plus a new webcast)
Monday, July 12th, 2010
As previously discussed on the blog, Good Manufacturing Practice, or GMP is a vital consideration for pharmaceutical manufacture and quality control. This means that the processes, equipment, active ingredients, documentation and training are controlled and of a high standard prior to a drug being approved. To be in compliance with GMP, regulations should ensure that the drug substance is of adequate quality, when used in humans and becomes available commercially.
Ultimately, quality protects the public and ensures that the reality of a drug sold or prescribed is an accurate reflection of the claims and ingredients made not only on the label, but also of the exact nature of the formulation that was approved through rigorous clinical trials and analysis.
Jack Wood discusses Clinuvel’s manufacturing partner for SCENESSE®
Friday, July 9th, 2010Clinuvel Non-Executive Director Jack Wood discusses the selection of SurModics Inc as Clinuvel’s first commercial manufacturing partner for SCENESSE®. Click here to listen.
Necessary innovation: the vital role of manufacturing in pharmaceutical development
Thursday, July 8th, 2010
This morning Clinuvel announced a significant milestone in its development program for SCENESSE®: the signing of the first manufacturing agreement for the final drug product with SurModics, Inc., a leading provider of drug delivery technologies to the healthcare industry. It has taken over eight years for Clinuvel to reach this milestone. In this time, the company has refined SCENESSE’s active ingredient – afamelanotide – and arrived at a final injectable drug product which controls its release to achieve an optimal photoprotective response in patients.
From patent to patient
Thursday, July 1st, 2010
The dictionary defines a patent as …a grant made by a state or government that confers upon the creator of an invention the sole right to make, use and sell that invention for a set period of time.
The intention of a patent is to confirm in law the ownership of an intellectual property (IP), and ensure that benefits gained from use, sale, manufacture or distribution of that IP can be given to the creators, those who did the work to realise the product, idea or concept.
Put this simply, the concept of a patent remains true to its history. In 500BC the Greeks created the first patent as an encouragement to discover new refinements in luxuries, but today, the reality is much more complex. (more…)
The concept of senescence
Tuesday, May 18th, 2010
The human body functions and survives by maintaining a biological and physiological balance. Over tens of thousands of generations we have evolved numerous systems to care for and protect our health and well being at a cellular level.
As a response to damage, various cells are programmed to self-destruct. The process is known as apoptosis, and it works to ensure that defects to the nucleus of the cell arising from any damage are not replicated and passed on in subsequent generations of cells.
A second, and lesser known process, is the concept of senescence.
Orphan drug development legislation and regulation landscape
Monday, May 17th, 2010
Previously we have discussed the shifts which take place in the regulatory centers of the world specifically London and Maryland, which present an opportunity to the industry to respond to expressed need. Perhaps the greatest concern of every individual is access to health and quality of life.
This implies a strong directive for drug developers to respond to the identified needs of the patients and patient communities. But amongst those with therapeutic needs are some with more unaddressed medical requirements: patients with ‘orphan’ diseases.
Orphan diseases are rare and frequently untreated diseases. The previously referred shift towards patient driven drug development made a few voices heard and legislators in the European Community and United States started to act on behalf of the population. Here the legislators and regulators provided incentives to drug developers by reducing fees, providing exemptions and protection from competitors.
Patient driven drug development
Monday, May 17th, 2010
Pharmaceutical development is undergoing a defining shift following the ever-increasing regulatory rigor in the process of evaluating a new product. Our recent announcement reflects the conservative view we hold on 21st century drug development.
During development the innovator often seeks to create a market for the new product, a common concept applicable to various industries. The same holds true for afamelanotide: we identified and developed our lead product in an under-served market of porphyria. Adaptation to chemistry and technology, novel communication platforms, deep knowledge and relationships with academia facilitated today’s entry to market.
Broader implications of a landmark announcement
Monday, May 17th, 2010
I take a moment on this day to discuss a separate impact of the surprising development surrounding our photoprotective drug afamelanotide, despite this being a result where Clinuvel has not played any role other than making afamelanotide available to Italian patients.
Much as afamelanotide will assist and transform the lives of the population of Italian EPP patients, it also promises to evolve Clinuvel as a mature pharmaceutical company in Europe and the US.
Unexpected news for afamelanotide from Italy
Monday, May 17th, 2010
An unprecedented and unexpected announcement over the weekend has lead to the company’s announcement this morning that afamelanotide will be first made available to Italian erythropoietic protoporphyria (EPP) patients prior to its formal approval anywhere else in the world.
A governmental publication in Italy has confirmed that Clinuvel’s afamelanotide implant formulation can now be prescribed for patients diagnosed with EPP under Law 648/96, while marketing authorisation for the European Community is being prepared.
