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Nov. 28, 2002 - Connetics Corporation (NASDAQ: CNCT) , a specialty
pharmaceutical company focused on the development and commercialization
of dermatology products, announced recently it has received
the final milestone payment from Pharmacia Corporation (NYSE:
PHA) after the successful completion of a pre-determined milestone
with minoxidil foam.
In January 2002, Connetics announced a licensing agreement
granting Pharmacia Corporation exclusive global rights, excluding
Japan, to Connetics' proprietary foam drug-delivery technology
for use with Pharmacia's Rogaine(R) (minoxidil) hair loss
treatment.
"Pharmacia
has been a highly committed and terrific partner," said Thomas
G. Wiggans, Connetics President and Chief Executive Officer.
"Surveys among dermatologists and consumers have repeatedly
demonstrated a strong preference for Connetics' foam delivery
vehicle, and a high level of excitement for a minoxidil foam
product.
Patient
compliance is a significant challenge for hair loss treatments,
and we believe preference for the foam delivery vehicle could
create a significant therapeutic advantage over other forms
of minoxidil. The application of proprietary foam delivery
technology to the Rogaine product is a great example of the
opportunity to innovate and to strengthen existing brands."
Hairlosshelp
interviewed a representative from Connetics to learn more about
their proprietary foam technology.
HAIRLOSSHELP:
Tell
us about Connetics and the type of drugs you make.
CONNETICS:
Connetics Corporation (Nasdaq: CNCT)
is an independent pharmaceutical company focused on the development
and commercialisation of innovative therapeutics for the dermatology
market. The Company's marketed products are Luxiq® (betamethasone
valerate) Foam, 0.12% and OLUX™ (clobetasol propionate)
Foam, 0.05%; they are both indicated for scalp dermatoses.
A further two products will enter Phase III clinical trials
during the next few quarters. Connetics has a total of 170
employees including a 60-member field sales force detailing
major dermatology practitioners throughout the USA. In April
2001, Connetics acquired Soltec Research Pty Ltd. Soltec is
focused on discovering and developing innovative topical drug
delivery formulations. These formulations aim to improve the
management of dermatological diseases, provide significant
product differentiation, and extend product life cycles.
HAIRLOSSHELP:
How did your foam technology get
developed?
CONNETICS:
The foam technology was developed
by Connetics' Australian subsidiary, Soltec Research Pty Ltd.
Soltec had been researching better means of delivering drugs
to the skin, and particularly the scalp, and has found that
the foam technology is a particularly elegant and effective
means of achieving this goal. Several other Soltec-deveoped
foam products have been commercialised by companies other
than Connetics, including Bayer ("RID Mousse"),
Pfizer ("Banlice") and Ecolab ("Hexifoam").
HAIRLOSSHELP:
What current products do you have
using this technology?
CONNETICS:
See above. In addition we are developing
a clindamycin foam (acne), a ketoconazole foam (seborrheic
dermatitis) and an emollient version of our current Olux product.
HAIRLOSSHELP:
Tell us more about the minoxidil
foam product and how it works.
CONNETICS:
The mechanism of action of minoxidil
in promoting hair growth has been well studied and it is proposed
that this is unchanged by the foam delivery vehicle. However,
the DELIVERY of drugs is a critical part of their overall
effectiveness in the clinical setting, and this is where the
foam technology is superior. Many topical drugs are formulated
in "any old topical delivery vehicle". This is often
an expedient means of getting product to market, but it fails
to acknowledge that the consumer may find the product messy,
gunky or otherwise unpleasant to use. Obviously no drug will
work if it is not used, and if it used less than per the directions,
it will consequently work less than its true potential.
The foam vehicle, along with associated
minoxidil solubilisation technology, allows us to minimise
the amount of one of the ingredients of typical lotion products,
propylene glycol, that is both sticky and a source of irritation
in a significant proportion of patients, while at the same
time having a highly elegant and effective means of delivering
minoxidil to the scalp.
The foam technology is designed to retain
its "foamy" structure at room temperature, much
like a shaving foam, but to very rapidly disintegrate, or
"melt" at skin temperature. This ensures that a
dose of the product can be conveniently applied to the scalp
and rubbed in without it dripping or running down the forehead
or neck, and very importantly, without leaving a sticky residue
in the (remaining) hair.
HAIRLOSSHELP:
Does this product eliminate the need
for propylene glycol and alcohol?
CONNETICS:
We are working on several formulations
at the moment. One of these contains NO propylene glycol,
the other has a minimal amount. Both still contain alcohol.
HAIRLOSSHELP:
Are there any limitations to what
strength of minoxidil the foam can deliver since minoxidil
tends to crystallize at concentrations above 10%?
CONNETICS:
Our patented technology provides
a means of solubilising minoxidil at levels above 10%.
HAIRLOSSHELP:
Would this offer a benefit over a
liposomal type of vehicle in terms of delivering the drug
to the dermis and sub-dermis?
CONNETICS:
This is difficult to answer without
direct comparitive studies. Naturally we believe our technology
offers advantages at least in terms of simplicity of production,
cost, stability and probably cosmetic elegance.
HAIRLOSSHELP:
Have you done any human tests with
the minoxidil foam product?
CONNETICS:
No. Formal clinicals are planned
to commence within the next 12 months.
HAIRLOSSHELP:
Is the license with Pharmacia for
the new minoxidil based foam an exclusive one or will it be
available in generic form as well?
CONNETICS:
The license is exclusive. We do not
expect generic competition.
HAIRLOSSHELP:
Will Pharmacia need to test it for
the FDA to approve the new vehicle? Does it need FDA approval?
CONNETICS:
Yes, the product will require FDA
approval since it is a new formulation.
HAIRLOSSHELP:
How long will it take?
CONNETICS:
This depends on what studies the
FDA will require, but at least two years.
HAIRLOSSHELP:
How far is the development of the
product? Is it in the testing stages, or still in the early
development stages?
CONNETICS:
See above.
HAIRLOSSHELP:
Do you anticipate the product being
available within the next year?
CONNETICS:
No, except through clinical trials.
HAIRLOSSHELP:
Will there be any prescription needed
or will it be handled in the same way as the OTC version?
CONNETICS:
That depends on Pharmacia's marketing
strategy.
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