ImpulsivWunder
17 years ago
http://www.starpharma.com/data/070718%20Signs%20Agreement%20for%20Condom%20Coating%20Applicatio...
Starpharma Signs Agreement for Condom Coating Application of VivaGel™
Melbourne, Australia; 18 July 2007: Starpharma Holdings Limited (ASX:SPL,
OTCQX:SPHRY) today announced that it has signed an agreement with a leading
condom company in relation to the use of VivaGel™ as a condom coating.
The agreement includes a program of evaluation and development and also
commercialisation rights covering condoms with VivaGel™ coatings within a
specified geographical region. The condom company, whose name may not be
disclosed for reasons of confidentiality, holds the leading market position within that
region. The market in question is in the developed world, and ranks within the top
five globally, measured by GDP.
The terms of the agreement were not disclosed.
"We are pleased to be able to report this solid progress in the commercialisation of
VivaGel™ as a condom coating," commented Starpharma CEO, Dr Jackie Fairley.
"This announcement reflects some of the growing momentum that we are achieving
as we work to bring VivaGel™ as a condom coating to market."
VivaGel™ is in development as a vaginal microbicide, to prevent infection with HIV
or genital herpes, under two FDA INDs*. It has also been shown to have a potent
contraceptive effect in animals. Its development as a condom coating represents a
line extension to the standalone, applicator delivered vaginal microbicide.
*IND: Investigational New Drug Application
About Starpharma:
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is a world leader in the development of dendrimer
nanotechnology for pharmaceutical, life-science and other applications. SPL is principally composed of two
operating companies, Starpharma Pty Ltd in Melbourne, Australia and Dendritic Nanotechnologies, Inc in
Michigan, USA. Products based on SPL’s dendrimer technology are already on the market in the form of
diagnostic elements and laboratory reagents.
The Company’s lead pharmaceutical development product is VivaGel™ (SPL7013 Gel), a vaginal microbicide
designed to prevent the transmission of STIs, including HIV and genital herpes.
In the pharmaceutical field Starpharma has additional specific programs in the areas of Drug Delivery and
ADME Engineering™ (using dendrimers to control where and when drugs go when introduced to the body),
Polyvalency (using the fact that dendrimers can activate multiple receptors simultaneously) and Targeted
Diagnostics (using dendrimers as a scaffold to which both location-signalling and targeting groups are added to
allow location of specific cell type, such as cancer cells).
More broadly the company is exploring dendrimer opportunities in materials science with applications as
diverse as adhesives, lubricants and water remediation.
SPL has a comprehensive IP portfolio that comprises more than 180 patents/applications issued and pending
across 32 patent families - a unique level of IP concentration among nanotechnology companies.
Dendrimers: A type of precisely-defined, branched nanoparticle. Dendrimers have applications in the medical,
electronics, chemicals and materials industries.
Page 2 of 2
Microbicides: A microbicide inactivates, kills or destroys microbes such as viruses and bacteria. Microbicides
may be formulated as gels, creams, sponges, suppositories or films with the purpose of reducing significantly
the incidence of STIs. They are intended for vaginal or rectal use to afford protection for varying periods, from
several hours up to days. Microbicides may also be designed to have a contraceptive function.
American Depositary Receipts (ADRs): Starpharma’s ADRs trade under the code SPHRY (CUSIP number
855563102). Each Starpharma ADR is equivalent to 10 ordinary shares of Starpharma as traded on the
Australian Stock Exchange. The Bank of New York is the depositary bank.
For further information:
Media
Starpharma
www.starpharma.com
Rebecca Wilson
Buchan Consulting
Tel: +61 2 9237 2800
Mob: +61 417 382 391
rwilson@bcg.com.au
Dr Jackie Fairley
Chief Executive Officer
+61 3 8532 2704
Ben Rogers
Company Secretary
+61 3 8532 2702
ben.rogers@starpharma.com
nlightn
18 years ago
New Nano Protection Against HIV And Herpes
Josh Wolfe, Forbes/Wolfe Nanotech Report
June.13.06, 10:50 AM ET
Long-time readers of my newsletter, Forbes/Wolfe Nanotech Report, may remember my bullish comments on a small Aussie company called Starpharma Ltd. I described the development of its lead product, VivaGel, as one of the top five nanotech breakthroughs of 2004, and added its stock to my Nanosphere portfolio in January 2005. Despite the recent drop in its share price, Starpharma's prospects are burning even brighter today.
Starpharma (nasdaq: SPHRF - news - people ) is a pharmaceutical company that works with nanoparticles called dendrimers--macromolecules with branching, treelike structures. Dendrimers are remarkable for their incredibly precise architecture and broad applicability, from industrial plastics and ship coatings to biological weapons combatants and medical imaging contrast agents. Starpharma is interested in their pharmaceutical applications, specifically in their ability to stop viruses in their tracks. Dendrimers can be custom designed to latch on to other molecules such as viruses, preventing them from latching onto the body's cells and wreaking havoc.
Starpharma's lead product is VivaGel, a dendrimer-based microbicide gel that can be applied internally to a woman's vagina to prevent sexually transmitted infections, including HIV and genital herpes. It can also be used as a condom coating. VivaGel had good results in Phase 1 human clinical trials: it appears to be non-toxic, non-irritating, and successful at preventing these STDs. Studies also show that viruses are not evolving resistance to the microbicide. The product is now in expanded phase 1-2 trials, being tested around the world in various populations. It's still got a ways to go, but all signs point in the right direction.
Microbocides, which are topical, do not carry the same risk of unforeseen setbacks or hidden side-effects as do internal drugs, which have to navigate through the body's entire system, so if VivaGel has made it this far, it's hard to imagine a real failure further down the line. Starpharma estimates the U.S. market for VivaGel products at approximately $4 billion.
Another great sign is that support for VivaGel development is largely coming from the U.S. government. The NIH's National Institute of Allergy and Infectious Diseases (NIAID) signed a $20.3 million contract to fund VivaGel development in October 2005, specifically for HIV prevention. Then, two months ago, the NIAID signed another agreement to fund clinical trials of VivaGel aimed to study its application for genital herpes prevention. The FDA has granted VivaGel fast track status, which has had little impact so far, but will really kick in at the phase 3 trial level, usually cutting the time it takes to get a product registered and on the market in half. The FDA's support of VivaGel has been something of a landmark: the product is the first dendrimer to go through the FDA system.
All of this government support means that Starpharma's spending is at a minimum. The NIAID is funding these trials directly, rather than giving the cash to Starpharma as a grant. Starpharma, of course, retains full commercial rights. "We have three years' cash in the bank," says CEO John Raff. "We're not burning very much money because everyone's supporting our work." At present, the company has $11.4 million on hand.
Despite all of this, Starpharma's stock has languished on the Australian Stock Exchange where its stock trades under the ticker "SPL.AX." It took a turn for the worse in late April--surprisingly at the same time the NIH decided to fund the genital herpes studies--dropping steadily from A$0.50 to its present A$0.38.
Starpharma began trading in America as an ADR level 1 sponsored by the Bank of New York (nyse: BK - news - people ) in January 2005. While these are illiquid pink sheet shares, Raff is optimistic. The company's aim is to move to a Nasdaq ADR 3 (virtually indistinguishable from Nasdaq companies) as quickly as possible, but that requires raising $25 million to gain the backing of bankers and gain liquidity in the U.S. market.
I think they will have no trouble getting the capital. Earlier this month, Starpharma announced that animal studies at Johns Hopkins University showed that besides preventing HIV and genital herpes, VivaGel may be a potent contraceptive as well. The studies were done with rabbits, which were given the same dose of the active ingredient SPL7013 that is found in VivaGel. The results showed a 75%-95% reduction in the number of embryos produced as compared to control groups. Rather than destroying sperm, as other contraceptive formulas do, VivaGel's dendrimers prevent the sperm from attaching to the egg much in the same way that they prevent, say, HIV viruses from attaching to the body's T-cells. By protecting against STDs and pregnancy, it can compete with the condom market. Even without the contraceptive bonus, VivaGel would be attractive to large potential markets such as the 38.6 million people worldwide infected with HIV or the one out of every five Americans that has genital herpes.
Don't expect cash flow until the end of 2008, when Starpharma expects to have VivaGel on the market. However, the company expects revenue from milestone payments and licensing within a year. The challenge for Starpharma will be to limit its ownership dilution as it partners with other major drug companies that it needs to get to the next level. "We need someone with a very big distribution network," Raff says. "It's not realistic for us to take it to market ourselves."
Starpharma is also in an enviable position, holding broad-based patents on various dendrimer applications. Starpharma holds 33% equity in the U.S.-based privately--held Dendritic Nanotechnologies Inc. (DNT), which Raff, who is a molecular biologist, co-founded with chemist Donald Tomalia. Tomalia himself discovered dendrimers back in 1979, when he was working at Dow Chemical (nyse: DOW - news - people ); Dow Chemical now holds 30% equity in DNT.
Starpharma's relationship with DNT links it into a much larger intellectual property space, as Tomalia retains many dendrimer-related patents. It potentially provides a direct connection to major pharmaceutical and biotech companies that DNT already deals with, including Pfizer (nyse: PFE - news - people ), Sigma-Aldrich (nasdaq: SIAL - news - people ) and Lumera (nasdaq: LMRA - news - people ).
When will the stock price move in the right direction? I think patience is still the key. As VivaGel hits its milestones, investors will warm to its shares. I continue to rate the stock a buy and believe its stock has suffered mostly because of liquidity issues as a Nasdaq 1 ADR. Starpharma's market capitalization is still a meager $41 million. When its ADR status and liquidity in the U.S. firm up, I believe many of us will be wishing we bought in at current depressed prices.
Excerpted from the June issue of Forbes/Wolfe Nanotech Report. Click here for more analysis by Josh Wolfe and to subscribe to Forbes/Wolfe Nanotech Report
nlightn
18 years ago
NIH Funds Clinical Development of VivaGel(TM) for Genital Herpes
Wednesday April 19, 11:39 pm ET
MELBOURNE, Australia, April 19 /PRNewswire-FirstCall/ --
* NIH is providing funding for the clinical development of VivaGel(TM) for
genital herpes
* Starpharma now has substantial development support from NIH for
VivaGel(TM) in key indications, HIV and genital herpes
* Funding is non-dilutive for shareholders and has no negative impact on
the commercial returns that Starpharma will receive from VivaGel(TM)
Starpharma Holdings Limited (USOTC: SPHRY; ASX: SPL) today signed an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to fund a clinical trial to test the use of VivaGel(TM) in the prevention of genital herpes. Genital herpes is the second indication for which VivaGel(TM) is being developed.
This latest support from the NIH is in addition to a previously announced US$20.3 (A$26m) million funding provided by the NIH to support the development of VivaGel(TM) for the prevention of HIV. In both cases funding is non- dilutive for shareholders and has no negative impact on the commercial returns that Starpharma will receive from VivaGel(TM).
"This additional support and validation for VivaGel(TM) from the NIH is great news for Starpharma. Genital herpes represents a significant market opportunity for VivaGel(TM) as there is currently no cure and no sufficiently wide-spread, effective means of protection", said Dr John Raff, CEO of Starpharma. "This new agreement with NIAID broadens the development opportunities for VivaGel(TM) and further de-risks the development path for VivaGel(TM). We judge that it would have cost millions of dollars to achieve this strategic product advance by other means."
The NIAID-funded trial will be conducted at established clinical sites in the US and Kenya. It is anticipated that the trial will commence in the first half of 2006. As part of this support, NIAID will also act as sponsor of an additional investigational new drug (IND) application for VivaGel(TM) for prevention of genital herpes with the US Food and Drug Administration (FDA). Starpharma will be co-sponsor of the clinical study, and the Principal Investigator will be Craig Cohen, MD, of the University of California, San Francisco.
Genital herpes is recognized as a key health concern in the US where it is one of the most prevalent sexually transmitted diseases. It is estimated that genital herpes currently infects between 15% and 25% of adults in industrialised countries with the incidence projected to rise drastically in the next decade. In the US alone, approximately 50 million Americans are already infected.
FURTHER INFORMATION
Starpharma Holdings Limited (USOTC: SPHRY; ASX: SPL) leads the world in the application of nanotechnology to pharmaceuticals. The Company's lead product in development is VivaGel(TM) (SPL7013 Gel), a vaginal microbicide designed to prevent the transmission of STIs, including HIV and genital herpes.
VivaGel(TM) is the first example of a product to come from Starpharma's dendrimer-based discovery pipeline, which also includes specific programs in the fields of ADME Engineering(TM) (using dendrimers to control where and when drugs go when introduced to the body), Polyvalency (using the fact that dendrimers can activate multiple receptors simultaneously) and Targeted Diagnostics (using dendrimers as a scaffold to which both location-signaling and targeting groups are added to allow location of specific cell type, such as cancer cells).
Dendrimers: A type of precisely-defined, branched nanoparticle. Dendrimers have applications in the medical, electronics, chemicals and materials industries.
Microbicides: A microbicide inactivates, kills or destroys microbes such as viruses and bacteria. Microbicides may be formulated as gels, creams, sponges, suppositories or films with the purpose of reducing significantly the incidence of STIs. They are intended for vaginal or rectal use to afford protection for varying periods, from several hours up to days. Microbicides may also be designed to have a contraceptive function.
Genital herpes: A recurrent, lifelong viral infection caused by the sexually transmitted herpes simplex virus type-2 (HSV-2). It is one of the most prevalent STIs, estimated to infect between 15% and 25% of male and female adults in developed countries. This figure is expected to rise to about 39% for males and 49% for females by 2025, unless effective preventive measures are found to reverse the trend. Herpes is estimated to affect one in six adults in America and new cases cost more than US$1.5 billion each year. The figures for Australia are similar with an estimated one in six adults suffering from genital herpes (3.4 million people).
HSV-2 infection has a marked effect on a sufferer's quality of life. The virus is highly contagious and women appear to be at greater risk of infection than men. HSV-2 infection can make people more susceptible to infection by HIV and increase the transmission rate of HIV. If transmitted from mother to baby, the disease has very serious consequences.
Media
Rebecca Wilson
Buchan
T: +61 2 9237 2800
M: +61 417 382 391
rwilson@bcg.com.au
Starpharma
John Raff
Chief Executive Officer
T: +61 3 8532 2701
john.raff@starpharma.com
Jackie Fairley
Chief Operating Officer
T: +61 3 8532 2715
jackie.fairley@starpharma.com
Ben Rogers
Company Secretary
T: +61 3 8532 2702
ben.rogers@starpharma.com
http://www.starpharma.com
Source: Starpharma Holdings Limited
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