g

 

 

 

Intra-vaginal rings (IVR)

+ A new delivery system with a 40 year track record

Drug release from polymeric vaginal rings has a strong history and reliable history (1960’s).  There are a number of successful IVR’s commercially available these services hormone replacement therapy (HRT) and contraception.  The IVR however can further be utilised for other active ingredients and independent market research (BCC Research) indicates that this advanced delivery system will show strong growth in the coming years.  QPharma has a strong and successful history in supplying vaginal rings to the commercial environment.  We believe that our IVR development and manufacturing teams are well experienced in all facets of development (feasibility to clinical supply) and commercial supply.  We are big enough to support all projects (mature pharmaceutical systems) but small enough to be flexible to meet your (understanding of regulatory guidelines) demands.  We recognise that we are a service company and thus our goal is to meet our customers expectations in terms of quality, timelines and costs.

+ IVR Benefits

+ Potential therapeutic areas [examples]:

+ Expertise

+ Market exclusivity

+ Services

+ Capabilities

+ Facility - Malmo, Sweden

 

+ IVR Benefits

  • Duration of use: Days to many months
  • Constant zero order release [as apposed to 1st order fluctuations]
  • Bypass 1st pass effect [low dose and reduced side affects]
  • Targeting of women’s reproductive areas [due to high blood flow from vagina]
  • Potential for improved compliance [once in place no patient input]
  • Not related to intercourse
  • Local or systemic effects [capable of high and low drug loads]
  • Simple to administer and use [woman can self administer]
  • Inert, biocompatible and comfortable for patient
  • Established [>40 years track record] “safe” delivery system
 



+ Potential therapeutic areas [examples]:

  • HIV
  • Contraception
  • Oncology - Reproductive cancers -  local effect
  • General cancers – systemic effect
  • In-Fertility
  • Infections
  • Urinary incontinence
  • Fibroids
  • HRT
  • Other reproductive health diseases (fibromas, endometriosis)
  • Pain

Combinations of the above may also be feasible.

+ Expertise

  • Manufacturing capability since 1975
  • Drug delivery development expertise since early 1990’s
  • Regulatory site approvals from US & EU since 1992
  • Commercial expertise in scale up, process improvement & manufacturing with 100% customer service levels since 1997
  • Experience with working with non-profit & commercial pharmaceutical organisations
  • Privately owned & financially stable CDMO
  • Flexible, but structured approach to development & manufacturing projects
  • Implementation of Quality by Design principals (MVA & DoE)
  • Transparent cost model bringing commercial expertise to development projects


+ Market exclusivity

  • Extend patent life of active substance (line extensions)
  • Differentiate a drug in competitive marketplace
  • A form of market entry barrier [compared to more recognised delivery systems such as tablets],
    few companies have expertise in producing IVR
  • Low cost of delivery system (cost of product / duration of use)
  • >1 active can be lorded into an IVR for treatment of >1 disease


+ Services

Our development strategy starts with an alignment our customer’s regulatory strategy and our standard development practices.
Each customer will have slightly different understanding of their respective regulatory guidelines and as a service company QPharma
will take a flexible approach in order to deliver technical data to support a regulatory filing.

+ Capabilities

People:  QPharma have aligned their development approach to that of the Quality by Design (QbD) principals.
Our scientists are fully trained in Design of Experiments and Multi Variant Analysis (MVA).  We are a member of ODIN (consortium between
academic and industry coordinated by the Department of Food Science, University of Copenhagen).  QPharma have many development
projects in different stages of development:

  • Feasibility (proof of concept)
  • Analytical Method transfer or development and validation
  • Development to support Phase I/II
  • Development to support Phase III
  • Technology transfers [external R&D/manufacturing to QPharma]

QPharma strongly believe in structure and our Project Managers have all received Project Management (PM) training such that we have a
common approach to run projects. All QPharma projects are supported by an internal steering group.


+ Facility - Malmo, Sweden

  • R&D:  GMP development suites
  • R&D: GMP pilot manufacturing suites
  • Commercial manufacture: Hormonal manufacturing suites
  • Commercial manufacture: Microbicide manufacturing suite
  • FDA and EU compliant

We have non-GMP and GMP facilities to support development of IVR’s based upon injection molding and extrusion. Our facilities can accommodate high potent products. We see IVR as a core business to the growth of QPharma and therefore our board has approved the construction of a new IVR’s facility (completion 2012) that will serve to develop and manufacture IVR’s for our growing list of customers.