Research and development
The organisational restructuring has led to the establishment of the
R&D and operations steering committee which has representatives
from the R&D, regulatory affairs teams and the Global operations
teams. The committee evaluates opportunities arising from internal
R&D activities as well as potential in-licensing and co-development
prospects.
R&D is focused on the development of new products
and supporting existing products – particularly through creating line
extensions. Innovative delivery systems and the use of advanced surface
technology are our areas of focus within the dermatology area.
Pipeline Development
We have
continued to advance our pipeline and expand its future potential
through the signing of two product development and commercialisation
deals with BMG Pharma, a privately-owned US-based company. BMG will be
developing and registering a number of gynaecology products from
Sinclair’s pipeline. Sinclair has in-licensed a range of skin
anti-infection products based on patented silver nanotechnology from
BMG. These innovative deals present Sinclair with significant pipeline
development opportunities and new product assets. We also acquired
proprietary organic zinc technology which may be combined with other
technologies or used alone, and a hydrogen peroxide delivery system
which can be used as an antibacterial in wound healing treatments.
There are 56 products and line extension projects in the current
R&D pipeline covering dermatology and gynaecology, many of which we
believe have the potential to deliver substantial revenues.
Regulatory Affairs
During FY 2009 we achieved five new product registrations in the EU. These registrations were the approval of the Decapinol Perio system for the management of gum pockets in periodontal disease, T-Go for symptomatic relief during teething, Sinlice to treat head lice, Herpclair to reduce the symptoms of herpes simplex, and DermaChronic foam for the treatment of sensitive skin or chronic skin conditions such as atopic dermatitis, xerosis, psoriasis and eczema.
Clinical Data
Supporting clinical and experimental data are of critical importance in demonstrating the efficacy and mechanisms of actions of our products and can also be a source of competitive advantage providing us with distinct product claims.
During the year, results of 18 proof of concept studies were accepted for publication, whilst four were published in peer reviewed journals, including:
- Atopiclair Cream: Treatment of pruritus in mild to moderate atopic dermatitis with a topical non steroidal agent. Veraldi S, Lunardon L, Schianchi R; The Journal of Drugs in Dermatology and two studies evaluating the emollient DermaChronic Cream and Cleanser and our acne product Papulex Cream Oil Free.
In addition ten clinical abstracts were presented at the 17th Congress of the European Academy of Dermatology and Venereology (EADV) during September 2008 in Paris.
Intellectual Property
Sinclair’s approach to product pipeline development combines the sourcing and developing of novel technologies externally with newly acquired and existing technologies to create new product concepts. In order to maximise the commercial benefits arising from the innovative advantages inherent in our products, Sinclair invests in the development of strong intellectual property for all of its new products. Currently 35 Sinclair products enjoy patent protection.
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