Monthly Archives: January 2009

Neglected Diseases – FDA Review Vouchers – a new source of revenue

Posted on January 26, 2009 by admin| 3 Comments

In September 2008 the FDA launched a new federal programme designed to increase the amount of work being undertaken in certain neglected tropical infectious diseases. (implemented by the FDA amendments act of 2007). This programme will award a sponsor of a drug for a tropical disease a voucher entitling the company an expedited review for any other drug application. The expedited review can reduce the time for a review from 18 to 6 months saving upwards of a year, which can add extra time on market giving some additional $300million plus in additional sales.

Whilst most small companies developing drugs in Tropical Diseases would be unlikely be in a position to take full advantage of these vouchers and access there full potential value, the regulations allows the original sponsor company to sell this voucher to another company. This is the real trick to these regulations. This voucher represents a significant asset, to be exploited and can be a critical element of your licensing negotiations with larger companies once you have developed your product, and these neglected tropical diseases are likely to be considered orphan in the USA so reduced development programmes and speedier registration are likley ot be obtainable.

On its own its impact is interesting but when combined with other regulatory pathways it can be a powerful way of building value quickly into your product, fast tracking you to approval, generating an valuable asset and getting your technology ready for a mainstream registration via a licensing deal with a larger pharmaceutical company.

We have looked at these regulatory strategies as part of our work as drug development consultants. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch

→ 3 Comments

Posted in regulatory

Tagged , ,

Data Exclusivity Extends Market Protection to 11 years without a patent being required

Posted on January 19, 2009 by admin| 1 Comment

Data exclusivity is an important tool in the area of pharmaceuticals and biological therapies, when you successfully apply for a product license in many European countries. This period of data exclusivity was originally implemented to cover areas where patent protection was limited. When a generic application is made for an existing drug, the pre-clinical and clinical work is not repeated instead the generic applicant references the existing products regulatory filing which the authorities hold. Data exclusivity means that for the period the regulatory authorities will not allow your data to be used for generic applications. This does not guarantee market exclusivity but it does increase the work load and expense required from a generic manufacture who is seeking to launch a product. Data exclusivity last for 8 years in the majority of European countries, then there is an additional 2 years of market exclusivity after this point, during which generic applications can be filed and considered but no licenses will be awarded until the period ends this allows a 10 year market exclusivity. Another important note is that if a new indication is filed in the first 8 years an additional year of data exclusivity can be added on brining total protection up to 11 years. This extra year can also be applied if the product successfully switches from Prescription only to Over the Counter.

This can be a great tool if your seeking a new indication for an existing generic drug, or if your development has taken a long time which has resulted in only a short time left on your patent when you complete your licensing applications.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it.

If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com

→ 1 Comment

Posted in regulatory

Tagged , , ,

New FDA review rules, new EMEA & FDA paediatric rules and new EMEA safety rules are going to torpedo your development project and knock a large amount of the value out for your IP if your not ready!

Posted on January 13, 2009 by admin| Leave a comment

We have the course that will ensure your well prepared, and at only £500 its great value.

Click Here for Course Details

FDA: At the end of 2007, the USA government announced a wide ranging and disruptive review of the FDA mandate. It affects most element of what the FDA do and consequently what is required of the drug development industry. These new rules are now in force and companies need to be ready to deal with it. If your not doing the right things at Proof of Concept stage you might find your not ready to go into man when you think you are, its going to impact the value of your IP and your credibility to investors.

Paediatric: the FDA and EMEA have put in place some tough new rules governing the area of Paediatric clinical trials (Its not just for paediatric drugs these rules will impact every programme). You have to have a plan for paediatric plan, and in the near future you will need to have started the implementation of that plan before they will consider your technology for approval. If your not ready and have not considered these things your going to wast time and reduce the value of your IP. As you go into man, this is when you need to start considering these things.

EUCTD: We all think we know how the Clinical Trials Directive was going to impact, but now that we have been living with these rules for some time now we can now see the reality of these rules and the exceptions that have been thrown up. You need to make sure your all over these rules as it will impact your future development.

We are running a course in February that will assist you tackle these issues are come out smelling of roses.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com

→ Leave a comment

Posted in regulatory

Tagged , , , ,

Conditional Approval – An important short cut to the market

Posted on January 6, 2009 by admin| Leave a comment

The EMEA (European Medicines Agency) can recommend a product is given Conditional Approval, the CHMP (Committee for Medicinal Products for Human Use) bases a positive opinion on the data available. Usually this data is not sufficient to award a full approval, but is of such a positive nature and the drug of such obvious benefit to a group with high unmet medical need that they will allow it to go to market whilst the clinical data is strengthened.

The FDA has a similar approval process.

The CHMP make this recommendation on the understanding that the company will undertake an agreed programme of works aimed at strengthening the data package. The company are under an obligation to fulfill this programme of work. In order to ensure that they do the conditional approval is reviewed annually until full approval is granted.

This can be an important regulatory avenue for companies that have relatively well known drugs that are being targeted at a new indication, as long as there is considerable unmet medical need, and very strong indication of safety, and a good indication of ethicacy. Because you can in effect go to market after phase 2, and the revenues raised can help fund your phase 3 programme, it can accelerate your development and maintain your equity standing.

If conditional approaval in pursued in an orphan indication you could be in the market place with a very limited number of patients and perhaps a single clinical trial.

During our work as development consultants we have pursued this path for clients and it is an effective tool for maximising the outcomes of R&D spending but also improtant in ensuring patients with a despirate need for drugs can get access as quickly as possible.

If you would like to know more about this please feel free to get in touch.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com

→ Leave a comment

Posted in regulatory

Tagged , ,