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Biotech / Medical : Vivus: into single digits

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To: MIKE DUBIS who wrote (273)4/21/1998 1:31:00 PM
From: sly-1   of 1016
 
I thought readers would appreciate having another
competing product in an already tight market ....

FYI - a press release from yet another(!) potential competitor

Monday April 20, 2:44 am Eastern Time

INTERVIEW-Big impotence role for PowderJect

By Jonathan Birt

LONDON, April 20 (Reuters) - Powderject Pharmaceuticals Plc on Monday
predicted huge market potential for its needle-free impotence injection, riding on the
coat-tails of a breakthrough tablet launched this month by Pfizer Inc (PFE - news).

Far from being a threat to its own product, Paul Drayson, chairman and chief
executive officer of the Anglo-U.S. group, said Pfizer's pill Viagra was expected to
massively increase the market for impotence treatments, which to date have been
inconvenient and sometimes painful.

''The male impotence market is going to grow significantly with the launch of this
oral treatment,'' Drayson told Reuters in an interview.

Earlier, PowderJect announced ''encouraging'' Phase I trial results from its
supersonic powder version of established impotence treatment Alprostadil, which it
said showed the fast-acting drug could be administered quickly and painlessly.

The PowderJect system -- which is already being explored by five of the ten biggest
drug companies in the world for use with their own drugs -- accelerates drug
particles to supersonic speed directly into the skin.

Although Alprostadil is highly successful at inducing erections, to date it has had to
be administered either through a needle directly into the side of the penis or through
a pellet inserted into the top of the penis.

Analysts said last week pent-up demand for an alternative treatment was shown by
dramatic early sales of Viagra, with some forecasting it will become one of the
biggest-selling drugs of all time.

''The Holy Grail in this has been to come up with a tablet that works. Pfizer's
Viagra has done that,'' Drayson said. ''But in around 20 percent of cases it won't
work, and the next line will be locally administered Alprostadil. Our aim is to
develop the best locally-administered method -- a gentle injection.''

Viagra, which has to be taken an hour before making love, acts by improving blood
flow to the penis and enhancing response to sexual stimulation through inhibition of
an enzyme, phosphodiesterase.

Alprostadil, which can work in less than 15 minutes, helps dilate blood vessels to
increase blood flow into the penis and cause an erection without sexual stimulation.

''The market to date has been held back because the drug that does work --
Alprostadil -- has to be delivered in a way that is relatively unpleasant,'' Drayson
said.

PowderJect's version, which is not expected to reach the market until 2001, would
compete directly with Pharmacia & Upjohn Inc's (PNU - news; PHU.ST)
CAVERJECT, where Aprostadil is injected into the penis with a needle, and Vivus
Inc's (VVUS - news)'s MUSE, where a pellet is inserted into the urethra.

Drayson estimated these forms of administration could cause some degree of pain in
around 30 percent of cases. ''They are invasive and they hurt. What Powderject
aims to do is take the same drug and administer it using a much more gentle,
non-invasive powder injection,'' he said.

''We have seen that PowderJect can deliver the drug painlessly to the penis and get
the required effect -- namely an increase in penis rigidity.''

Although two of the 98 injections administered in the Phase I trial resulted in some
local discomfort, Drayson said changes to the speed of delivery and drug particle
size should overcome this.

The company plans a second Phase I trial to resolve these issues, and Drayson said
the product was on target for launch in Europe in 2001 and in the U.S. in 2002.

''This is an enormous product opportunity for PowderJect. Our intention is to
partner with a major pharmaceutical company, and having got the data from this
Phase I we'll be in discussions with potential partners during 1998.''

Last month the company announced an agreement on gene-based vaccines with
Glaxo Wellcome Plc which it said could be worth up to $300 million over the next
few years.
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