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Home Country News Release - Starpharma`s Bacterial Vaginosis Study gets FDA Clearance
https://www.otciq.com/otciq/ajax/showFinancialReportById?id=33949
Starpharma Appoints Further VP Business Development to Meet Increasing Demand for its Technology
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today announced it has appointed Malcolm McColl to join the company's existing business development team as a Vice President to meet the growing market demand for pharmaceutical and life science applications of Starpharma's dendrimer technology, particularly in drug delivery.
Pharmaceutical Reports
Reports to support decision-making for pharma executives www.CuttingEdgeInfo.com
Malcolm is a seasoned business development professional with more than 20 years' experience with major biotechnology companies, including 13 years with CSL where he negotiated major agreements with Pfizer and Bayer, amongst many others. Malcolm joins Starpharma in August in the role of VP Business Development and will be supporting and enhancing Starpharma's already successful partnering activities and programs.
Malcolm returns to Australia from the UK where as Hospira's Business Development Director, Europe Middle East and Africa (EMEA), he was responsible for growing the global and EMEA business through an ambitious plan of targeted acquisitions and licensing activities. There he led negotiations and due diligence for a significant number of license agreements and transactions including Hospira's recent ~A$135M deal with Chemgenex for rights to Omacetaxine, a proprietary oncology product.
Dr Jackie Fairley, Chief Executive Officer of Starpharma, welcomed Malcolm to the executive team: “We are delighted to have Malcolm join Starpharma at this exciting stage of the company's development. His contribution will further enhance our already highly successful partnering activities in drug delivery, VivaGel®, in vitro diagnostics (IVD) and agrochemicals. Malcolm's international industry networks and experience will be a great asset in securing further commercial agreements and with this additional business development resource, Starpharma will significantly boost its commercial development capabilities.”
Starpharma has established a successful business model of partnering with market-leading companies to maximise the value of its dendrimer platform in a range of industries and applications. The company has a growing list of major companies that are actively exploring the use of Starpharma's proprietary dendrimer technology to enhance the performance their pharmaceutical products, including Lilly, GSK, and in animal health, Elanco.
The company also has established commercial relationships with leading companies, such as SSL International plc, Siemens Healthcare, and EMD Merck KgA for other applications of its proprietary dendrimer technology.
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 wider pharmaceutical field Starpharma has specific programs in the areas of Drug Delivery and Drug Optimisation technologies (using dendrimers to control where and when drugs go when introduced to the body) 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 224 patents/applications issued and pending across 56 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.
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 Securities Exchange (ASX). The Bank of New York Mellon is the depositary bank. Starpharma's ADRs are listed on International OTCQX (otcqx.com), a premium market tier in the U.S. for international exchange-listed companies, operated by Pink OTC Markets, Inc.
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) and the Monash Institute of Pharmaceutical Sciences (MIPS) have been awarded an Australian Research Council funding grant for the purpose of advancing a new drug delivery method that may benefit thousands of patients with particular types of cancer, HIV and lymphatic conditions world-wide.
HIV Treatment
Research HIV & AIDS: Causes, Signs, Diagnosis and Treatment Options. www.EverydayHealth.com
Innovation Minister Kim Carr awarded Starpharma and MIPS $420,000 as part of the ARC’s Linkage Projects scheme aimed at encouraging Australian institutions to undertake innovative and cutting-edge research projects in collaboration with industry and other partners.
“This funding will assist in advancing our collaboration with researchers from Monash University over the next three years, to further understand the full potential of Starpharma’s proprietary dendrimers in improving drug delivery,” said Dr Jackie Fairley, CEO of Starpharma. “This research has the potential to significantly improve the treatment of diseases, including metastatic cancer, lymphoma, HIV and metastitial tuberculosis.”
Professor Chris Porter, lead researcher and Associate Dean of Research at MIPS, said the technology has particular implications for the treatment of diseases which are spread via the lymphatics and lymph nodes.
“Our work so far suggests that careful design of the size and surface characteristics of certain dendrimers provides an opportunity to boost delivery to the lymphatic system, signalling the potential to significantly improve patient treatment,” Professor Porter explained. “This Linkage grant provides an excellent opportunity to explore these issues in detail and to advance the development of targeted therapeutics”.
The ability to target therapeutics in this way has the potential to enhance efficacy and reduce side effects and toxicity of treatments. The approach also prolongs the lifetime of the drug in question by slowing the process of drug breakdown. This maximises the opportunities for the drug to reach the relevant sites in the body before being cleared by the body’s natural mechanisms.
The delivery method relies on dendrimer technology. Dendrimers are precisely defined biofriendly molecules 3-10 nanometres in diameter. They are approximately spherical in shape with a surface which has many different sites to which drugs and other functional groups may be attached, allowing optimisation of how the drug interacts with the body.
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is a world leader in the development of dendrimer technology for pharmaceutical, life-science and other applications. SPL has two operating companies, Starpharma Pty Ltd in Melbourne, Australia and DNT, Inc in the USA. Products based on SPL’s dendrimer technology are already on the market in the form of diagnostic elements and laboratory reagents through licence arrangements with partners including Siemens and Merck KgA.
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 September 2008 Starpharma signed a full licence agreement with SSL International plc (LSE:SSL) to develop a VivaGel® coated condom. SSL manufactures and sells Durex® condoms, the market-leading condom brand worldwide.
Starpharma also has agreements in place with Lilly, Elanco, Stiefel Laboratories (a GSK Company), and Unilever as well as many research collaborations with some of the world’s leading organisations.
Here is a link to the Orbis Investment Management website.
http://www.orbisfunds.com/
The Orbis purchases are at .50 per share which I believe translates to $5.00 per ADR in the U.S. Encouraging, considering the size of their investment at a price currently above the U.S. market.
Starpharma Holdings (ASX: SPL) substantial shareholder Orbis Investment Management has acquired a further 6.55 million ordinary shares in SPL in a number of on-market trades at $0.50 per share on 18 June 2010.
Orbis now owns 27.4 million shares or 11.46% of SPL.
Friday, June 18, 2010
Orbis Investment Management Ups Stake In Starpharma To 8.7%
Substantial shareholder Orbis Investment Management has significantly increased its investment in Australian-listed biotechnology company, Starpharma Holdings (ASX:SPL, OTCQX:SPHRY).
Orbis acquired approximately 2.565 million shares on-market at an average price of A$0.64 per share between 21 May to 16 June. The share buy takes Orbis' interest to 20.8 million shares, or 8.7% of Starpharma.
Starpharma is a market leader in the development of dendrimer products for pharmaceutical, life-science and other applications. Its partnerships include Durex, Lilly, Elanco, Stiefel (now GlaxoSmithKline), Siemens and Merck.
Commencement of royalty revenue is estimated to commence in CY11 with VivaGel coated condoms.
Company Shareholder Update 4/28/2010
https://www.otciq.com/otciq/ajax/showFinancialReportById?id=31439
Starpharma Holdings Finishes Quarter With $24m Cash Position
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) has released its quarterly report for the period ended 31 March 2010.
The cash position at 31 March 2010 was $23.7m compared to the 31 December 2009 total of $24.3m.
Operating & investing cash outflow was $0.6m for the quarter. Receipts from customers included royalty and license income from partners including SSL International, Siemens Healthcare and Elanco, and grant payments from the U.S. National Institutes of Health (NIH) for VivaGel® development costs.
Operational highlights announced during the quarter included: the successful completion of a VivaGel® study in sexually active women; and signing of a new drug delivery collaboration with Eli Lilly and Company in human pharmaceuticals.
Successful Completion of VivaGel® Study in Sexually Active Women Melbourne, Australia; 12 March 2010
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today announced positive results of a clinical trial showing 3% SPL7013 Gel (VivaGel®) was comparable in terms of safety and tolerability with its matched placebo when administered vaginally, twice daily for 14 days in sexually active women. The study enrolled 61 healthy women who vaginally applied VivaGel®, a matched placebo gel without the SPL7013 active ingredient, or an alternative experimental placebo based on hydroxyethyl cellulose (HEC). All three groups were found to be comparable in terms of the percentage of women with one or more abnormal genital findings observed by the investigators during a pelvic examination which were related to the study gels. In addition, there was no statistically significant difference in the proportion of women who had one or more sign and/or symptom of genital irritation considered to be possibly, probably or definitelyrelated to administration of gels between the VivaGel®, matched placebo gel, and HEC gel treatment groups. The incidence of genital signs and symptoms reported with VivaGel in this study is in line with that reported in previous safety studies of VivaGel®, and of other topical vaginal products. Starpharma CEO, Dr Jackie Fairley, said, “We are pleased to report positive findings from this study, our first in sexually active women. These data provide further evidence of the safety and tolerability of the VivaGel® active ingredient, SPL7013, and will support its development as both a stand-alone gel (bacterial vaginosis, genital herpes and HIV), and as a condom coating.” Adverse events during the study were mainly mild, self-limiting, and resolved spontaneously. As with other studies of VivaGel®, there were no severe (grade 3) or serious (grade 4) adverse events reported. Adherence by participants to the required VivaGel® and matched placebo regimens was 95-100%, indicating the products were well tolerated by the participants. Blood tests (systemic laboratory parameters) showed no evidence of any treatment-related effects in study participants. Some further analysis of secondary assessments for the study is ongoing. As previously announced, Starpharma plans to commence further clinical studies of VivaGel®, including a phase 2 efficacy study in bacterial vaginosis, during 2010. The clinical study was funded by the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)*.
Encouraging News
PEGylated dendrimers: A novel mechanism of drug delivery
Monash Institute of Pharmaceutical Science (MIPS) researchers, in collaboration with the biotechnology company Starpharma Holdings Ltd (ASX:SPL) have developed a new method to deliver medications that may benefit thousands of patients with particular types of cancer, HIV and lymphatic conditions world-wide.
The Melbourne-based research team has shown how PEGylated Polylysine dendrimers, a new type of nano-sized drug delivery system, can be altered to target either the lymphatic system or the bloodstream. Lead researcher at MIPS and the Associate Dean of Research, Professor Chris Porter said the discovery has particular implications for the treatment of diseases which are spread via the lymphatics and lymph nodes. 'We are excited by the possibilities that this technology may provide in the improved treatment of particular types of diseases, including metastatic cancer, lymphoma, HIV and metastitial tuberculosis,' Professor Porter said.
Dendrimers are precisely defined, synthetic nanomaterials that are approximately 5-10 nanometres in diameter. They are made up of layers of polymer surrounding a central core. The dendrimer surface contains many different sites to which drugs may be attached and also attachment sites for materials such as polyethylene glycol (PEG) which can be used to modify the way the dendrimer interacts with the body. PEG can be attached to the dendrimer to 'disguise' it and prevent the body's defence mechanisms from detecting it, thereby slowing the process of breakdown. This allows the delivery system to circulate in the body for an extended time period, maximising the opportunities for the drug to reach the relevant sites. Professor Porter's group and Starpharma have been investigating dendrimer-based drug delivery systems for some time - but these most recent finding appear to hold particular promise. The data, published in the Journal of Controlled Release, demonstrates that by increasing dendrimer size by increasing the chain length of attached polyethylene glycol (PEG) chains, a dramatic increase in absorption efficiency after subcutaneous injection can be achieved and transported into the lymphatic system. Conversely, a shorter PEG chain was shown to lead to rapid absorption into the blood. 'Our work suggests that careful design of the size and surface characteristics of PEGylated Polylysine dendrimers provides an opportunity to choose whether these delivery systems are absorbed and distributed via the bloodstream or the lymphatic system,' Professor Porter said. 'The ability to target therapeutic treatments in this way offers the potential to maximise drug concentrations at sites of action within the lymphatic system - and importantly to minimise concentrations elsewhere, potentially reducing side effects and toxicity. It is still early days, but we're confident the potential for improved patient treatment is significant.'
Source: Monash University
This pogo stick is the funnest stock I have. Going away for a few days and set a sale @ 6.69 for the 3rd time.
Building that base of free shares. One day!
Well that officaly gave me my second chance at a double and had to bail half.
I would have just sat LT, but got a few that are in the dumps and screaming to buy.
Nice to have one winner in my stable.
News Thursday, February 11, 2010
Starpharma Holdings Cashed Up, Strong 2010 Pipeline
Jackie Fairley, chief executive officer of Starpharma Holdings (ASX: SPL, OTCQX:SPHRY) said today that 2010 is an exciting year for the company, with a focus on advancing lead product VivaGel® and working with SSL International to develop the VivaGel® coated condom.
US$39 billion market-capped Eli Lilly (NYSE: LLY) was also highlighted by Ms Fairley as a key partner and driver in the area of human pharmaceuticals. Starpharma’s dendrimer drug delivery technology will be applied to enhance compounds in Lilly’s human pharmaceutical portfolio.
Starpharma’s dendrimers have shown significant commercial applicability in the area of drug delivery and optimisation.
Significantly, the Company has a growing list of pharmaceutical companies that are actively exploring the use of Starpharma’s proprietary dendrimer technology to enhance and improve their pharmaceutical products.
SPL's cash position is strong with $22.7m of equity raised last calendar year.
Starpharma will pursue clinical testing of VivaGel® for Bacterial Vaginosis (BV), the most common vaginal infection worldwide.
Trials will commence of VivaGel® as a BV treatment in 2010, through to the completion of Phase 3 clinical trials with the aim of licensing the product to a major marketing partner. The product offers significant opportunity for licensing royalties to be achieved.
The BV clinical trial program complements the VivaGel® program under development for the prevention of sexually transmitted infections, which continues to progress as both a stand-alone product and a condom-coating.
Starpharma's signing of a research and collaboration agreement between its wholly owned US subsidiary DNT Inc and a prominent multi-billion dollar US based agricultural chemicals company is aimed at enhancing the performance of existing pesticides.
The pesticide market has a estimated market value of US$35.8 billion. DNT's Priostar® dendrimer technology is based on the same basic dendrimer technology that Starpharma already applies to various other uses. This provides further potential for SPL to gain additional revenues from leveraging the dendrimer technology in the agrochemicals market.
This might be a pretty big deal!
Starpharma and Lilly Sign New Drug Delivery Collaboration for Human Pharmaceuticals
MELBOURNE, Australia, Feb. 1 /PRNewswire-FirstCall/ --
Starpharma Holdings Limited (ASX:SPLASX:OTCQX:ASX:SPHRY) today announced the signing of a new agreement with Eli Lilly and Company (NYSE:LLY) under which Starpharma's dendrimer drug delivery technology will be applied to enhance compounds in Lilly's human pharmaceutical portfolio
Under the terms of the agreement Lilly will fund a collaborative research and development program with the aim of creating improved drugs incorporating SPL's proprietary delivery technology, to be commercialised by Lilly
The agreement announced today relates to the delivery of certain human pharmaceuticals, and is separate and additional to the contract signed in May 2009 in which it was agreed that Starpharma and Elanco (Lilly's animal health division) would work together to develop new animal health products with enhanced properties. The Elanco collaboration continues in its own right
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com/
About Starpharma
Starpharma Holdings Limited (ASX:SPLASX:OTCQX:ASX:SPHRY) is a world leader in the development of dendrimer technology for pharmaceutical, life-science and other applications. Products based on SPL's dendrimer technology are already on the market in the form of diagnostic elements and laboratory reagents through licence arrangements with various partners
In the pharmaceutical field Starpharma is developing VivaGel® as a vaginal microbicide and condom coating and has specific programs in the areas of Drug Delivery and Drug Optimisation technologies (using dendrimers to control where and when drugs go when introduced to the body) and Diagnostics. More broadly the company is exploring dendrimer opportunities in materials science applications including water remediation
For further information:
Media Buchan Consulting Kyahn Williamson Tel: +61 3 9866 4722 Mob: +61 401 018 828 Ellie Papathanasiou Tel: +61 2 9237 2800 Starpharma http://www.starpharma.com/ Dr Jackie Fairley Chief Executive Officer +61 3 8532 2704 Ben Rogers Company Secretary +61 3 8532 2702
Forward Looking Statements
This document contains certain forward-looking statements, relating to Starpharma's business, which can be identified by the use of forward-looking terminology such as "promising", "plans", "anticipated", "will", "project", "believe", "forecast", "expected", "estimated", "targeting", "aiming", "set to", "potential", "seeking to", "goal", "could provide", "intends", "is being developed", "could be", "on track", or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA's and other health authorities' requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any health authorities for sale in any market or that they will reach any particular level of sales. In particular, management's expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected clinical trial results, including additional analysis of existing clinical data, and new clinical data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Starpharma is providing this information as of the date of this document and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.
DATASOURCE: Starpharma
CONTACT: Kyahn Williamson, +61 3 9866 4722, mobile, +61 401 018 828, , or Ellie Papathanasiou, +61 2 9237 2800,, both of Buchan Consulting for Starpharma; or Dr Jackie Fairley, Chief Executive Officer, +61 3 8532 2704, or Ben Rogers, +61 38532 2702, , both of Starpharma
5 January 2010
ASX Company Announcements Office
Lapse of Unquoted Options
This is to advise that the following unquoted share options for Starpharma Holdings Limited (ASX: SPL; OTCQX: SPHRY) lapsed without exercise on 31 December 2009:
Issue Date Security Description
Option expiring on 31 December 2009.
Exercise price $0.9375 (86,000)
http://www.otcqx.com/otcqx/market/quote?symbol=SPHRY&tab=3
The increased volume and upward price movement of last week was encouraging, and perhaps SPHRY will begin to show up on more investor radar screens in 2010.
Happy Holidays to any SPHRY investors out there!
I hear your post.
I got in back @4 and then again big on the pullback close to $3.
Just give it time. Its not a quick flip stock due to the low volume. The daily spread will kill ya, so you just have to believe what they have. If you can hold LT then you will be fine.
I don't think they have exploited the US market yet and what I've been holding on for.
Now this news, they want to file with the FDA as a NDA. this will take 6 mos or so, but will have a nice return on the pps. They know its safe and works, so I think the clinical trials will be a breez with an FDA approval.
I just don't see how SPHRY will not be posting positive 10Q here on out.
I took a small position today, and, although I have some reservations about getting in at this level, I am even more nervous about missing the next move up. The products have huge potential if the company can develop the markets ahead of any competition.
Starpharma Announces $15.6 million Capital Raising
MELBOURNE, Australia, Nov. 18 /PRNewswire-FirstCall/ -- Starpharma Holdings Limited (ASX: SPL; OTCQX: SPHRY) is pleased to announce a successful capital raising of A$15.6 million through a private placement to institutional and sophisticated investors, taking the company's cash reserves to approximately A$24 million.
The lead investor in the placement was Orbis, an existing Starpharma shareholder and a highly regarded institutional fund manager. As a result of this additional investment Orbis will become a substantial shareholder in Starpharma. The company's largest shareholder Acorn Capital also participated in the raising, along with several other existing and new institutional investors.
The placement is for 30 million shares at $0.52 per share, a 9.7% discount to the volume weighted average price of the Company's shares over the prior 20 trading days. The placement was significantly oversubscribed and was managed by Shaw Corporate Finance.
The funds raised will primarily be used to finance a clinical trial program to develop VivaGel® for the treatment of bacterial vaginosis (BV) and to further strengthen the balance sheet for future development and partnering opportunities.
Dr Jackie Fairley, CEO of Starpharma said: "We are delighted with the success of this capital raising. The level of institutional demand was particularly high, and we appreciate the strong support received from both existing and new institutional shareholders."
"These additional funds take the company to a new level by allowing us to progress VivaGel® as a BV treatment through to the completion of Phase 3 clinical trials to support licensing to a major marketing partner," Dr Fairley added.
VivaGel® as a treatment for BV represents a significant development for Starpharma, with the global market for topical BV treatments alone estimated at approximately US$300-$350m.
"This is an exciting extension to the development program of VivaGel®. Bacterial vaginosis is the most common vaginal infection worldwide with more than 21 million women in the US alone suffering from the infection," said Dr Fairley.
Starpharma already has a significant licensing deal with SSL (owners of Durex® brand) for use of VivaGel® as a condom coating, NIH funded development programs for VivaGel® for the prevention of viral sexually transmitted infections, programs focused on drug delivery partnered with Elanco (Eli Lilly) and Stiefel (GSK), and a program for modifying pesticides with a multi-billion dollar US agrochemical company.
As the shares issued via the private placement fall within the 15% threshold permitted by the ASX Listing Rules, shareholder approval is not required.
About Starpharma
Starpharma Holdings Limited (ASX: SPL; OTCQX: SPHRY) is a world leader in the development of dendrimer technology for pharmaceutical, life-science and other applications. SPL has two operating companies, Starpharma Pty Ltd in Melbourne, Australia and DNT, Inc in the USA. Products based on SPL's dendrimer technology are already on the market in the form of diagnostic elements and laboratory reagents through licence arrangements with partners including Siemens and Merck KgA.
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 September 2008 Starpharma signed a full licence agreement with SSL International plc (LSE:SSL) to develop a VivaGel® coated condom.
For further information:
Media Buchan Consulting Kyahn Williamson Tel: +61 3 9866 4722 Mob: +61 401 018 828
Ellie Papathanasiou Tel: +61 3 9866 4722 Mob: +61 405 342 490
Starpharma http://www.starpharma.com/
Dr Jackie Fairley Chief Executive Officer +61 3 8532 2704
Ben Rogers Company Secretary +61 3 8532 2702
DATASOURCE: Starpharma Holdings Limited
CONTACT: Media, Kyahn Williamson, Tel: +61 3 9866 4722, Mob: +61 401
018 828, , or Ellie Papathanasiou, Tel: +61 3 9866
4722, Mob: +61 405 342 490, , both of Buchan
Consulting; Dr Jackie Fairley, Chief Executive Officer, +61 3 8532 2704, or
Ben Rogers, Company Secretary, +61 3 8532 2702, ,
both of Starpharma
$5.15 is my watch list trigger, but the spread of .15 is insulting. Got two buy orders in. These i will be flipping, Holding long on my cheapies I bought on Margin. I feel I earned those the hard way and no way would I ever sell.
I’m new to this stock. Is SPHRY FDA approved? Is it sold in the US or in other parts of the world? What opinion of price -4.65 to go up or down?
I got in back a few weeks ago just above $3.50. wanted to sell on a number of occasions, b ut stuck with it since it has stayed positive. Wish I bought more the other day when I was looking at BCRX and this one. BCRX is pissing me off and if SPHRY dips today off this hight I'll dump BCRX and take SPHRY into free shares and pray for a nice pull back. I'm trigger happy this AM.
US Patent Grant Extends VivaGel(R) Coverage to 2024
MELBOURNE, Australia, Sept. 22 /PRNewswire/ -- Starpharma Holdings Limited (ASX: SPL) today announced that it has received notification of the grant in the US of a key patent specifically relating to the use of SPL7013 to protect against sexually transmitted infections (STIs).
The granting of this patent means that any product presentation of SPL7013 (the active ingredient in VivaGel(R) ) is now protected in the US for an additional five years until 2024, with a possible further 12 month extension to 2025. Given the importance of genital herpes and other STIs in the US, this market is clearly a major commercial opportunity for VivaGel(R) products.
This composition of matter patent is the third patent for VivaGel(R) to be granted in the US, and adds to the already extensive patent coverage for the product in 26 countries covering all major markets.
VivaGel(R) is being developed as a condom coating in collaboration with SSL International plc (LSE: SSL) , the world's leading condom company. SSL markets the global brand Durex(R), and holds approximately 40% of the global branded condom market. Following a deal announced in 2008, SSL has exclusive marketing rights for the VivaGel(R) coated condom.
Starpharma is also developing VivaGel(R) as a vaginal microbicide to prevent the transmission of STIs, including HIV and genital herpes.
About Starpharma
Starpharma Holdings Limited (ASX: SPL) is a world leader in the development of dendrimer nanotechnology for pharmaceutical, life-science and other applications. SPL has two operating companies, Starpharma Pty Ltd in Melbourne, Australia and DNT, Inc in the USA.
The Company's lead pharmaceutical development product is VivaGel(R) (SPL7013 Gel), a vaginal microbicide designed to prevent the transmission of STIs, including HIV and genital herpes. In September 2008 Starpharma signed a full licence agreement with SSL International plc (LSE: SSL) to develop a VivaGel(R) coated condom. Starpharma's receipts under the agreement are estimated to exceed A$100m comprising royalties on SSL sales, further milestone payments, and development support.
For further information:
Media:
Buchan Consulting
Rebecca Wilson
Tel: +61 3 9866 4722
Mob: +61 417 382 391
rwilson@bcg.com.au
Ellie Papathanasiou
Tel: +61 2 9237 2800
epapathanasiou@bcg.com.au
Starpharma:
Dr Jackie Fairley
Chief Executive Officer
+61 3 8532 2704
Ben Rogers
Company Secretary
+61 3 8532 2702
ben.rogers@starpharma.com
www.starpharma.com
SOURCE Starpharma Holdings
Website: http://www.starpharma.com
To my chagrin, I failed to keep an eye on this OTCQX foreign issue, and it looks like I missed a good opportunity. The low of around $1.25 back in March would have resulted in a 125% gain, although the low volume would probably have limited dollar amount. Anyway, I think I will resume "watching", and I will try to revive some interest in this board.
New article on SPL posted to the website... just under the new scrolling headlines...
http://www.starpharma.com/data/Starpharma%...02008%20rev.pdf
Starpharma releases string of news announcements and presentations on new developments..
SPL 7013 inhibits Arthritis, Herpes (HPV), and Cancer!
And new Priofect Dendrimer Transfection Kits are released!
And, the results from the USCF Trials are due by the end of April! Wow.. What a month!
www.starpharma.com
http://www.starpharma.com/data/080422%20First%20commercial%20product%20launch%20DNT%20Priostar%20dendrimers.pdf
April 2008
First commercial product launch DNT Priostar dendrimers
22/04/2008
Excellence in Biotech Investment CEO Presentation
21/04/2008
SPL7013 Inhibits Clinically Relevant Strains of HPV-Herpes and Cervical Cancer
21/04/2008
Dendrimer SPL7013 Potential Application for Arthritis
14/04/2008
Presentation Dendrimers New Opportunities to Treat Diseases
10/04/2008
Interesting news here..
http://www.starpharma.com/data/080414%20Dendrimer%20SPL7013%20potential%20application%20for%20arthritis.pdf
My thoughts are that we may not see much news related to the condom deals until the contraceptive effects are supported thru efficacy trials.. and given that we are not yet in phase 2 trials.. this may still be quite some time. Others' thoughts?
Now, this potential new application to arthritis and osteoarthritis is especially exciting! With an aging boomer population and 90% of them having some degree of arthritis, the world demand will continue to rise remarkably -especially for a product that brings good relief. And, talk about possible quick path to market.. with the "topical" safety studies already completed.. SPL7013 being shown to be safe on men and women (mucus membranes).. and w/FDA approval in the wings; it would seem that the path to market for a slightly altered version in a hand cream would be quite easy.. and very quick, eh. Quicker than the the already "accelorated" condom coating application.
And what about this improvement to aesthetic appearance of the skin? How is this claim supported? What activity was observed to draw this conclusion I wonder? Sounds like we may be gearing up for an "over-the-counter" miracle cream, eh? SPL7013, "Kangaroo Tail Oil -better than Snake Oil; makes you look younger and eases pain in your joints"..
Just dont tell me to add it to my coffee in the morning to give me more energy.. lol.
Starpharma signs agreement with Unilever
Melbourne, Australia; 7 April 2008: Starpharma Holdings Ltd (ASX:SPL, OTCQX:
SPHRY) today announced the signing of an agreement with Unilever, to co-develop a
research tool using Starpharma’s Priostar® dendrimer technology. An undisclosed fee ispayable to Starpharma’s US subsidiary DNT Inc as part of the arrangement.
Under the agreement, DNT will make its Priostar® dendrimers available to Unilever as
imaging agents to analyse the microscopic structure of foods. Understanding the
microstructure is an important factor in creating appetizing food, determining properties
such as ‘mouth-feel’ and controlled release of taste and smell. Unilever’s research &
development scientists will use the dendrimers for analysis purposes as part of one of
their innovation projects.
“We are delighted to be working with a company of Unilever’s caliber and resources in
this highly innovative application of Priostar® dendrimers. This agreement underscores
the relevance of dendrimers across a wide variety of industries.” commented Dr Robert
Berry, President of Starpharma’s US subsidiary Dendritic Nanotechnologies Inc.
“Dendrimers are also relevant in the chemicals and materials industries, as well as the
pharmaceutical and medical sectors.”
This is the company’s second agreement with a commercial party for applications of
Priostar® and it extends Starpharma’s recent commercial arrangements for its
dendrimers. These include deals with EMD Chemicals, SSL Plc and dermatology
company Stiefel Laboratories Inc
Thanks Digger! Agreed, this stock will be explosive!
So, how much longer do you think it will be before she starts to get some traction?
Have you been to the board, Sharescene.com? Looks like there is a little banter about SPL there as well. It's an Austrailian security, and that's an Austrailian based board, so, there seems to be a little more active discussion there as well.
Looks like there has been some "insider buying" going on by the directors! Not like anyone has taken out a second mortgage on thier home or anything, but, it is nice to see the sentiment being expressed with their personal wallet!
I think we are getting much closer. The fact that Amphora was FDA approved as a microbicide and will be on the market later this year is a big step for all microbicides. And, the fact that Starpharma has two deals with condom companies already in place, contingent only on the FDA approval, put's them way ahead in the game with regard to market share and revenues.
And, I find the develpments by SPL especially exciting because they are the first demonstration that dendrimers will be effective! And, with SPL having the clear dominant IP of patents on dendrimers.. it will only get more exciting!
If you have been following the company, than you are aware several dendrimer/SPL related deals/collaborations were put in place last year! A few more of those this year, and some milestones being met (especially with Vivagel), we'll be on the way!
Impu-Wunder
I've been following this company for the past 2 or 3 years , I guess I'm tring to get my timing right, price is probably close to what it was then . Be like a rocket when she takes off though. Maybe you've already checked it out but theres a site - Nanalyze , that covers the co pretty well , a fella Micheal Trillion - pretty knowledgeable,would probabley like some more participation.
Monday, October 15, 2007
Dendrimers: The unpublished story
By Howard Lovy
The tiny dendrimer, nanotechnology’s tendriled, tattered and almost forgotten starlet, is at last emerging from nearly 30 years of patent-filing and science-paper purgatory and into the light of real-world products and partnerships. In 2007 alone, dendrimers have attracted about a million dollars in DARPA funds for research into a device that would automatically keep wounded soldiers free from pain on the battlefield; they have come to the apparent rescue of a company that had been having trouble getting its soft-tissue cancer treatment device to stop leaking radiation; and after success as MRI contrast agents, dendrimers are now being taken seriously as a candidate for a long-sought delivery agent for siRNA (gene silencing) therapy.
And by the time the U.S. Food and Drug Administration gives its anticipated 2009 or 2010 approval to the first dendrimer-based pharmaceutical, the former Dow Chemical Co. scientist who invented his pet molecule will have counted 30 years since he first synthesized this “beautiful” (his word) molecule in his Midland, Mich., lab. But Donald Tomalia says he doesn’t mind the nearly three decades in the cold. In fact, he says, the pattern for any “disruptive” technology is to first pay its dues for about 20 years before general acceptance. “We’re kind of on schedule there when you think about it,” Tomalia says.
Yet, even though an FDA nod for the dendrimer-based HIV microbicide VivaGel would place the stamp of government validation on concepts Tomalia has worked for a generation to prove, the journey itself has ripped the dendrimer’s reputation so ragged that skepticism still prevails in the financial and scientific communities.
Long, fruitless periods of development, intellectual property quaqmires, questions over toxicity, skepticism about cost and scaleability have reduced the once-darling dendrimer to the status of merely the first of many nanotech disappointments. The years since the dendrimer’s sensational arrival have seen the invention or discovery of many other “miracle” nanomaterials that would go through a cycle of hype, disappointment and, ultimately, cynicism and even boredom that would typify the new science/marketing phenomenon eventually known as “nanotechnology.”
Nanotech’s many-armed goddess
But Tomalia has always seen his dendrimers as different from all the exotic nanomaterials discovered later. Much-discussed buckyballs and nanotubes, for example, could carry their payloads in their bellies. But dendrimers have many arms. And it is what Tomalia has called those “beautiful” branches that first made him see what many of his contemporaries could not back in 1979 – the potential to custom-engineer one molecule to perform as many tasks as the laws of chemistry and physics would allow. Each appendage could have a separate task – one to sense disease and another destroy it, for example.
VivaGel, produced by the Australian pharmaceutical firm Starpharma, does a modest task if compared with some of those longer-term dendrimer dreams. Still, those talons of Tomalia’s appear to have come through.
“The specific chemical structure of a dendrimer and the fact that it binds at multiple active sites on the HIV/HSV-2 virus simultaneously … is a critical component of VivaGel's activity and the feature of dendrimers,” says Starpharma CEO Jackie Fairlie.
Dendrimers deployed against HIV
Anti-HIV microbicides are a target of opportunity for dendrimers because their development is being promoted by the world health community worried about the spread of HIV among women in the developing world. Microbicide gels are seen as a way to give women a better measure of protection against the disease, yet only a few have made it to clinical trials. The trials involving VivaGel are spearheaded by the Microbicide Trials Network, established in 2006 by the National Institute of Allergy and Infectious Diseases (NIAID) to help develop and evaluate anti HIV microbicides for the developing world. The group expect to conduct 17 clinical trials over the next seven years in Africa, India and the United States. VivaGel is now undergoing expanded safety trials at the University of South Florida in Tampa and the University of Puerto Rico in San Juan.
Public Enemy Number One for these new microbicides is a protein called GP120, which acts as a kind of docking clamp for HIV, seeking out and binding to healthy cells. All the microbicide candidates attack GP120 and try to gum up the works enough to prevent binding. But VivaGel stands out as more effective because the many-taloned polyvalent dendrimer is able to stick to HIV at multiple points simultaneously. Yes. It’s those dendrimer appendages.
But there are still many barriers to widespread commercialization, the main one being the high cost and length of time it takes to produce them. Ask any scientist, entrepreneur or venture capitalist who has looked at dendrimers and most will say the same thing. They are too expensive and time-consuming to produce. And they have gone practically nowhere after two decades of development.
Priostar and the dendrimers of tomorrow
Starpharma is using polylycene dendrimers, which according to Tomalia is now very old-school compared with what he’s got cooking with his new line of Priostar dendrimers. Not coincidentally, Tomalia says, that 20-year time period to general acceptance of disruptive technologies is also about the time it takes for an invention to go off patent. So, a couple of years ago, he decided that it was time to address cost and scaleability concerns while at the same time create a new class of dendrimers that give him a proprietary edge on the stiflingly overcrowded dendrimer patent landscape.
Tomalia’s company, Dendritic Nanotechnologies Inc., recently produced a new generation of dendrimers that many analysts say just might live up to the molecule’s original potential. DNT says its new Priostar dendrimers are not only less expensive, but less time-consuming to produce. Tomalia says the product will “beat the pants off” any rivals.
Since the Priostar family was announced more than a year ago, though, skepticism has remained high since he has released very few details about them. Tomalia is doing this on purpose. He said sharing his first series of dendrimer inventions far and wide lead to too many academicians filing his or her own "blocking patent" and pretty much stifling commercialization for two decades.
It’s an interesting statement, considering it is an academician who is among Tomalia’s chief critics.
Collaboration turns into rivalry
James Baker, a leading nanotech researcher and entrepreneur based at the University of Michigan is the brains behind Avidimer Therapeutics (formerly Nanocure Corp.), which is considered one of the few direct competitors to Tomalia’s company. Not only that, Baker is planning on using Tomalia’s soon-to-be-off-patent IP as the basis for dendrimer-based anti-cancer applications – the first of which is expected to go into clinical trials in fall 2007.
Together, Tomalia and Baker control most of the intellectual property behind dendrimers and represent two of the brightest minds and bitterest rivalries in the nanotech world.
Vahe Mamikunian, who has looked closely at nanotech IP as an analyst for Lux Research, says he knows of no other platform of material in the nanotech space that is as interesting as dendrimers. And he is not necessarily talking about the material, itself, but rather the “characters involved and what has happened to them in their efforts to commercialize them.”
Tomalia’s and Baker’s collaboration in the ’90s was a category-defying partnership between chemistry and biology – the kind of convergence that’s necessary as both of these disciplines reach the nanometer scale. But just as their partnership dissolved due to personality differences and priority disagreements, other classes of nanomaterials grabbed the spotlight from the dendrimer. Nanotubes, buckyballs, biosilicon and an increasing arsenal of other newly invented or discovered nanomaterials have grabbed the spotlight and imaginations of those who follow nanotech developments. And that is what seems to frustrate Baker the most – more than 20 years of lost opportunity. As for who is to blame, Baker is about as clear as U-M’s lawyers will allow him to be. “Unfortunately, the folks up in the center of the state have controlled dendrimer IP and that really stagnated the growth in the technology.”
Both Dow and DNT are located in the “center of the state.” It has been about seven years years since Tomalia and Baker went their separate ways, and Tomalia says he just does not want to be drawn into a public fight. So, he responds with a simple: “I think that sounds like Jim’s perspective.”
The Tomalia/Baker story was quite different a decade earlier. Their collaboration in the ’90s was a category-defying partnership between chemistry and biology – the kind of convergence that’s necessary as both of these disciplines reach the nanometer scale.
Baker was one of Tomalia’s few contemporaries to see the possibilities within dendrimers. But Baker, the biologist, saw primarily one thing: its wonderfully small size. Baker, when he met Tomalia in the ’80s, had been frustrated with viral-based vaccines that just could not get tiny enough to really go after disease.
Together, Tomalia and Baker broke new ground in dendrimer discoveries right up until the late ’90s. But from the beginning, Baker thought like a healer, not a chemist. And because dendrimers can get smaller than 5 nanometers and penetrate cell membranes, he always thought of dendrimers as potential anti-cancer delivery agents. Any other use seemed a waste of time. In fact, Baker hints, biology in the hands of a chemist could be quite antithetical to the concept of better living.
“My line to the materials science folks is, ‘Biology always trumps chemistry, because no matter how clever you think you are in doing something, in modifying something, you're putting it into a complex system, like biology, where the implications are just multiple,’ ” Baker said during an interview in June 2005. Baker gave the interview shortly after he demonstrated just what a skilled biologist could do with a dendrimer. He made international headlines when he used a classic “Trojan Horse” trick on cancer cells – essentially using their own receptors against them. Cancer cells crave folic acid more than healthy cells. So, using folate for bait, the dendrimer is sucked inside the cancer cell’s membrane. But the dendrimer also carries in its tendrils the anti-cancer drug methotrexate, which is released with disastrous consequences for the cancer cell. This method can be used also to simultaneously label the cells for fluorescent detection.
This technique, Baker says, delayed tumor growth in mice for 30 days, which is equivalent to about three human years. Baker licensed the technology to Avidimer Therapeutics.
There is a tinge of bitterness in Baker when he talks about his plans to, as he sees it, take more than two decades worth of dendrimer IP and finally put it to work for cancer therapeutics. Baker believes that Tomalia wasted time by playing chemist, rather than biotech entrepreneur, and true progress did not occur until Baker launched his nanotech institute at the University of Michigan about eight years ago, resulting in breakthroughs like the one he’s licensed to Avidimer. Tomalia, at Baker’s invitation, was scientific director of the Center for Biologic Nanotechnology from 1998 until 2000, when the collaboration went sour and the two went their separate ways.
Tomalia sees it differently. He says he left Baker back in 2000 because he knew he would need to launch a new platform. And to do that, he needed a fresh start at the newly created Michigan Molecular Institute at Central Michigan University. And it was there that he confidently says he “began our mission of reinventing what I would call a disruptive technology.”
The Model-D of nanotech?
And in the middle of Michigan, two figures loom large when it comes to disruptive technologies. One is H.H. Dow, who is often quoted as saying “If you can’t do it better. Why do it? And, of course, the other is Henry Ford. Tomalia was raised on a bedroom community to the General Motors’ plants of Flint and his neighbors, relatives and friends all worked on the assembly lines.
“And I think many of these ideas did get themselves into my thinking not only about entrpreneurship of Henry Ford but about the way he disrupted the automobile industry by coming up with these modular assembly lines,” Tomalia says. “That basically was the driver behind this Priostar platform for making dendrimers.”
Using the famous Ford assembly line as a model for how to take a luxury item and mass-produce it for the people, Tomalia and colleagues at DNT have produced Priostar. “This platform really is based on some very straightforward, simple chemistry that I’ve had experience in for many, many years.”
“We feel, with this assembly line, we’re going to make dendrimers available to the masses, if you like, the way Henry Ford … made automobiles accessible to everybody,” not just the very wealthy, not just the very top of the life science application area,” he says.
‘Click chemistry’ and Priostar
The first hint of what exactly is meant by Priostar came in a paper published recently in the New Journal of Chemistry, a peer-reviewed publication produced by the Royal Society of Chemistry. Tomalia reports “a versatile new strategy” for producing dendrimers involving modular “click chemistry.”
“We’ve kind of standardized certain components that we are able to click together, if you like, or hook together very simply and very quickly and so we basically can have a dendrimer factory with all of these parts sitting right next to an assembly line,” Tomalia says. “So, if we want to assemble a dendrimer that had this feature in the core and this feature in the interior and this feature on the surface we can start clicking these parts together.”
Tomalia says this paper is the first of many that will trickle out on Priostar, but he’s not going to give away the store this time around.
“It’s a red-hot area right now, so we’re taking a totally different tack, and that is we are only sharing samples and a lot of deep knowhow with customers that are committed to us, that we have some kind of collaboration going with.”
“There are plenty of dendrimers out there for people to play with and they don’t need our Priostar.”
Government funding and private partnerships
Jack Uldrich is a nanotechnology consultant, columnist and author of the book, “Investing in Nanotechnology,” released in 2006 by Platinum Press Inc. He evaluates nanotech companies primarily on the basis of their business models. Uldrich gives the advantage to DNT because the company’s focus on near-term applications.
“I think that’s how dendrimer technology is going to move into widespread use: First preventative applications, then diagnostics and then treatment,” Uldrich says. “Baker’s just going for treatment, which is fine, but I think that, at least from a business perspective, DNT is better positioned.”
It also doesn’t hurt, Uldrich says, that Dow has about a 30 percent equity stake in Tomalia’s company, giving DNT nice, big corporate shoulders to rest its head on if things ever get ugly. And then there’s Australia’s Starpharma, which owns about 33 percent.
DNT is working with the Nanotechnology Characterization Laboratory (NCL) – established just late last year by the National Cancer Institute – on developing dendrimers as MRI contrast agents. The partnership will help speed time toward approval for the agents as an Investigational New Drug (IND), a precursor to clinical trials.
Uldrich says these kinds of government partnerships, combined with a focus on generating revenue and keeping dendrimer costs down, makes DNT more of a potential winner than Avidimer.
Baker dismisses the cost issue as less important to the pharmaceutical industry than issues of biocompatibility and safety. Pharmaceutical companies, they say, understand that a biological manufacturing process is always going to be more expensive than any synthetic process.
“If you focus on cost, you miss the whole point of the fact that people are dying and we have a health system that really does promote the use of expensive therapies in order to save lives,” Baker says.
Lux analyst Mamikunian warns that it would be foolish to disregard cost – especially for other more cost-sensitive products such as electronics, photonics, catalysts and even printer ink toner – all possible dendrimer applications, but ones that are not likely to capture the attention of the biotech-focused Baker.
Mamikunian sees Tomalia’s Priostar as the last potential “saving grace” for dendrimers after two decades of development and thousands of research papers, yet few real-world applications to show for it and a graveyard full of companies lured in by the “promise and the hype.”
“This could be the architecture that really makes dendrimers a viable drug delivery mechanism,” he says. But, Mamikunian says, with little publicly available, independent validation of Tomalia’s claims for Priostar, he is not yet ready to declare the dendrimer completely resuscitated. At the very least, he says, it’s more economically viable than the old polyamidoamine (PAMAM) architecture – first invented by Tomalia and still used by Avidimer -- that he believes has been developed to its limits since 1979.
But, even assuming a marketable dendrimer-based drug-delivery vehicle is forthcoming, the parking lot in front of the FDA has become a great deal more crowded since the late ’70s.
“I think explicitly in the area that they are playing, it’s going to be a tough battle, not only with other dendrimers but with the other treatments that are being developed,” he says. Iron oxide or gold nanoparticles are examples of other engineered nanoparticles that show promise.
So far, so good on toxicity
And, still more tricky for regulators, nanomaterials are coming under scrutiny from an increasingly cautious or even fearful general public and a relatively new “nanotox” research community that is only beginning to understand these new materials’ properties, along with coming up with standard methods of testing them.
One of the first studies undertaken by the newly created NCL was on dendrimers synthesized by DNT’s staff. Tomalia says they were “practically dancing on the table” early this year, when dendrimers were found to be "incredibly benign … no immunoresponses, no acute toxicity responses of any kind."
NCL Director Scott McNeil confirmed those results, but cautioned that the dendrimer tests were performed in vitro and the results do not say anything about in vivo toxicity or biocompatibility. But, McNeil says, the trend looks good for dendrimers when it comes to toxicity. They appear to be fairly benign and biocompatible. Early work (about five years ago) on “naked,” or untreated, dendrimers were found to be somewhat cytotoxic, McNeil says. But the newer generations are more functionalized. Surface charge and surface chemistry, he says, are more important factors than size. The notion that dendrimers and other nanomaterials can just be attached or filled with therapeutics “is not holding up to in vitro scrutiny,” he says. “Immense difference” occur when surface charge is altered.
Nanotech analyst Mamikunian says that these differences between dendrimer types – not only in surface charge, but also the polymer strands that make up the “branches” make dendrimers “open to the highest degree of customization than any nanomaterial.”
And it appears that it is these branches – these “beautiful” branches – that are making the difference in the VivaGel trials.
In that way, the dendrimer might just be a first tentative showing of “real nanotech” that manages to crawl its way out amid the wreckage of sci-fi fantasies, investment hype and unfulfilled marketing promises.
Local biotech shines through overseas listing (from Austrailia)
Thursday, 13 Mar 2008 12:13PM
ASX-listed biotechnology firm Starpharma may not have flagged much interest from local investors, but the company has attracted the attention of US funds.
According to Jackie Fairley, chief executive of Starpharma, targeting US investors was a “natural avenue of support”, particularly when local investors continue to shy away from the biotech sphere.
“Biotechnology is still a relatively new sector to invest in and there is low investor understanding of the development timelines of biotechnology companies. This is partly because there is limited institutional support for biotech which puts you in the hands of the retail market, which is often volatile,” said Fairley.
Starpharma first opened its doors to American investors in 2005 when it launched a level one American Depositary Receipts program. The firm’s issued capital grew by over 10 per cent over a two-year period before Starpharma’s OTCQX – a US listing service – debut on 26 March last year.
Fairley said the firm saw an increase of over 55 per cent in trading volume “almost immediately” following its launch on the OTCQC. Approximately 25 per cent of the company’s shares are now held by US investors, with The Dow Chemical Company listed among the company’s largest shareholders.
“We recognise the limitations of just relying on domestic investor support in such a specialised sector,” said Fairley.
Biotech also sits at the speculative end of the market, which makes it a vulnerable target when the broader market is depressed, she said.
“By accessing US investment we are fundamentally diversifying our investor base and accessing investors with much better understanding of biotechnology, a greater number of specialist professional funds and a much larger pool of general capital generally,” said Fairley.
US investment firm Platinum Partners for instance invested $2.8 million in Starpharma last August.
“We invest in companies that we feel have the correct risk reward ratio based on our internal subjective measures,” said Michael Goldberg, principal of Platinum Partners.
Ruth Liew
in the news... March 12, 2008
http://www.nanowerk.com/news/newsid=4917.php
A new industrial-scale process for making big molecules with a big future
(Nanowerk News) Scientists are reporting discovery of a new method that will enable manufacturers to produce industrial-size batches of dendrimers for the first time. Dendrimers are giant molecules with tree-like branches with a range of potentially valuable commercial and industrial applications. The study is scheduled for the March 21 issue of ACS' monthly Journal of Organic Chemistry ("Kilogram-Scale Synthesis of a Second-Generation Dendrimer Based on 1,3,5-Triazine Using Green and Industrially Compatible Methods with a Single Chromatographic Step").
Enormous molecules called dendrimers could serve a variety of functions, including improving drug delivery to materials. Scientists report a method to manufacture them on an industrial scale for the first time (Image: American Chemical Society)
Dendrimers can be produced in custom-designed shapes, sizes, structures and weights suitable for specific uses. Those potential applications range from drug delivery and gene transfer to new materials, coatings, sensors, and herbicides. But because they require multiple steps to make, dendrimers are difficult to produce on an industrial scale.
In their new study, Abdellatif Chouai and Eric E. Simanek describe a practical large-scale synthesis of dendrimers that sidestep this barrier. Their method yields a so-called "uncommitted intermediate," a dendrimer scaffolding that can be built upon in countless ways. This intermediate "can be elaborated into a wealth of diagnostic and therapeutic dendrimers — some of which are currently being explored in our laboratory," the researchers add.
DNT's Priostar may mean growth in dendrimer applications
The challenges facing small tech companies when launching products are diverse and many, but almost all involve delivering at a price and quality standard that pleases customers while not slicing your margins too thinly. With their new Priostar dendrimer line, Dendritic Nanotechnologies looks to increase volume, retain quality and open new markets. Early reports are positive, making new applications for this promising technology possible.
DNT's Priostar may mean growth in dendrimer applications
Kimberlee Roth
Courtesy DNT-Representation of a fourth generation dendrimer sphere
Last week Mount Pleasant-based Dendritic Nanotechnologies Inc. announced a "significant breakthrough" in the production of dendrimers with its new "family" of polymeric molecule, Priostar
With their tree-branch structure and internal voids, dendrimers provide a platform for a range of applications, including targeted drug delivery, diagnostics, optoelectronics and consumer products. Their size, shape and reactivity, which determine what they can hold inside or on their surface, depend on their number of generations, or layers, and their chemical composition.
Established licensing arrangements with DNT earn some $1 million annually, and dendrimers have been incorporated into a few medical and defense-related products. But ask why they haven't been more widely adopted and their inventor, Donald Tomalia, now president and chief technical officer of DNT, says simply, "Complexity of synthesis and cost."
DNT's poly(amidoamine), orPAMAM, dendrimers can cost thousands of dollars per gram. A third generation PAMAM dendrimer takes eight reactions to produce and about a month's worth of time.
By contrast, the Priostar dendrimer, whose name incorporates the Greek word for “fast,” can be made with three steps over five days. That's due to cleaner, faster chemistry, less reagent waste, lower levels of dilution and expected ease of scalability.
Where PAMAM dendrimers doubled in the number of surface groups with each subsequent generation, meaning more available space to which to attach or encapsulate therapeutics or other substances, Priostar dendrimers triple with each generation. "We can now encapsulate the payload in two or three steps vs. four or five," explained Tomalia. And the new dendrimers are stable until about 350 degrees, vs. 130 for the PAMAMs.
According to early studies, he said, that means a decrease in cost of two to three orders of magnitude. "It will open up fields of use that weren't there before."
"Some of the earliest nanotechnology patents filed were for dendrimers, going back to 1985," said David Lackner, senior analyst with Lux Research Inc. "They've been looked at for a long time -- Xerox considered them for improved ink delivery -- but they were found to be too complicated and too expensive. Basically, companies have sought applications in a hunt-and-peck mode. DNT may be poised to reverse that trend if its work with its partners leads to a scalable process that exhibits desirable dendrimer properties quicker."
Tomalia said DNT has gotten positive feedback on Priostar dendrimers, which have been in development for the past two years, from government and commercial partners who are using them. He says they're particularly suited for OLEDs (organic light-emitting diodes) and other photonics applications that involve heat.
He added that the new processes allow for the control of design parameters that yield more than 50,000 combinations of size, composition, surface functionalities and internal "container" spaces.
Still to be done are further testing and characterization of Priostar properties to fully understand them, completing the patent process and finding business partners. DNT plans to establish limited partnerships with current and new customers to identify novel applications before making the new dendrimers available to researchers.
The firm’s lab is housed in the National Dendrimer and Nanotechnology Center, established in 2002 by DNT, Central Michigan University and the U.S. Army Research Laboratories. The center is part of CMU's Center for Applied Research and Technology (CART), a designated SmartZone.
On May 17 the university broke ground on a $5 million laboratory facility, a 17,000-square-foot expansion of the CART. The lab is funded by a $2.15 million grant from the U.S. Department of Commerce Economic Development Administration, matching support from CMU and a contribution from the Michigan Economic Development Corp.
Once completed, DNT will occupy about a third of the new space. CMU will lease the remaining space to other industry partners.
DNT's new production methods -- and the bigger digs -- bring the company closer to its mission of "establishing dendrimer technology as the preferred nanotechnology enabling platform." In the process of developing Priostar, Tomalia says he and other company scientists have "discovered some new nanoscale rules that we think will end up in undergraduate textbooks within the next decade. There are some good stories that we can't yet tell today." Kimberlee Roth is a freelance health, science and technical writer
http://72.3.174.178/news/detail.asp?contentid=3E6CB699-D7E5-4DA2-AD31-BD67C157ED85
Vivagel Awarded International Nanotech Award
http://www.asx.com.au/asx/research/CompanyInfoSearchResults.jsp?searchBy=asxCode&allinfo=on&asxCode=SPL
Sex Gel on Condoms to Block HIV and Herpes
A gel to block HIV and herpes infections, that is a new strategy to beat the emerging epidemic of sexually-transmitted infections (STIs).
Yes, an experimental lubricant developed by Australian researchers will now be coated on condoms under an agreement signed between Melbourne-based Starpharma and the owner of condom company Durex.
The vaginal microbicide, called VivaGel, has been found to prevent HIV and genital herpes in animal and human studies presented at the International AIDS Society conference in Sydney in July.
It is designed to work by preventing viruses from entering cells, avoiding infection.
The active ingredient in the microbicide is dendrimer, a molecule which binds itself to the viruses and prevents them from infecting healthy cells.
In early stage research, the gel also has been found to be a potent contraceptive.
VivaGel has undergone testing in Australia, the US and Kenya, and is still in clinical trials.
The gel-coated condoms are expected to hit the market worldwide in about a year, long before the gel itself is due to be approved for sale.
Starpharma chief executive Dr Jackie Fairley said microbicides were considered one of the most attractive new prevention options for STIs.
It is a much-needed option for third world nations like sub-Saharan Africa where HIV and genital herpes rates are the highest in the world, he said.
"We feel the health sector has focused on finding a cure or treatment to disease, whereas we believe very strongly that prevention is a preferable option in curbing the disturbing increase in STIs in both the developed and developing worlds," Dr Fairley said.
http://www.starpharma.com/data/080226%20Investor%20Presentation.pdf
Interesting points of consideration in latest presentation:
1) Commercialization for Condom Coating Gel license agreement is in Phase III!
2) Focus on additional testing for contraception will be a priority testing focus this year
3) “Value Drivers “ on slide 23.. Vivagel overall milestones seem vague and.. weak .. anyone else think so?
Specifically, phase III efficacy trial timelines seems fuzzy to me.. I have a tuff time seeing how they will complete phase III trials in less than 24 months… (which is their own projected time to market).. anyone else see this as a .. challenge?
-focus on Vivagel as a contraceptive.. ok, but who really cares.. stay focused on the HIV, HSV
-NDA requirements.. ok, but what are these.. how much time will this take.. and how relevant is this right now.. again, milestones that they have set.. over-all see.. weak.. like they set a really low bar.. seems way to vague to me.. others thoughts??
4) Prio-fect launch?? I thought they launched Priofect already…??
5) Now.. I do like the fact that they are working toward a full US listing with in 12 months.. but I am not sure what that means.. full listing on what board? Anyone?
new news on microbicide trials...
http://www.global-campaign.org/carraguard.htm.
This effectiveness trial enrolled 6,202 participants in three South African trial sites. The results showed that the product was safe and acceptable to women, but did not reduce their risk of acquiring HIV. No significant difference was detected in the rate of HIV sero-conversion among women using the test product and those using the comparator gel. These results are posted on
Population Council's website, www.popcouncil.org.
I'm on the sidelines; I'll hope to enter on time.
Best Stocks for 2008: Starpharma (SPHRY) ties biotech to nanotech
Filed under: International markets, Newsletters, Stocks to Buy, Best Stocks for 2008
For 25 years, Steven Halpern, editor of TheStockAdvisors.com, has surveyed the leading financial newsletter advisors asking for their favorite stocks for the coming year. This article is one of 100+ ideas in the Best Stocks for 2008 report.
"My favorite speculation for 2008 is Australia-based Starpharma (OTC: SPHRY), a 'home run' pick," says Gregg Early in The Real Nanotech Investor.
"The drug delivery sector has been revolutionized by the application of nanotechnologies. And one of the fastest up-and-coming countries in this sector is Australia.
"Starpharma has landed a few significant co-development and assessment deals with some major firms in recent months as it awaits FDA approval for its VivaGel, dendrimer-based topical cream that can prevent the spread of sexually transmitted diseases, specifically Herpes and HIV.
"VivaGel also has spermicidal qualities that are so compelling, one of Starpharma's recent co-development deals was with Durex, one of the world's top condom manufacturers. Durex is considering replacing the near-ubiquitous Non-oxynol 9 spermicidal coating with VivaGel, which is proving to be safe and more effective than N-9.
"The stronger Aussie dollar also means it's cheaper to operate in the country, so scientists are starting to move in and set to work. This timing puts Starpharma in a very good position to capitalize on the burgeoning talent pool.
"What's more, it purchased Michigan-based Dendritic Nanotechnologies (DNT) last year. DNT is a major manufacturer of dendrimers for laboratory and research use.
"Current customers are chemical giant Sigma Aldrich and a bioscience division of pharma giant Merck, which is using dendrimers in state-of-the-art anti-cancer siRNA research. This siRNA sector is getting very hot and Starpharma will also capitalize on that. The stock trades over the counter as a top tier Y share."
You'll be sorry if you sit on the sidelines for this one!!!
http://www.investaustralia.gov.au/media/Fi...ortMay12007.pdf
Starpharma
Melbourne nanotechnology drug-developer Starpharma received an international Frost & Sullivan Growth Strategy Leadership Award for its revolutionary vaginal microbicide VivaGel, designed to prevent HIV and other sexually transmitted infections. It has successfully completed Phase I clinical trials of VivaGel in Australia.
The active microbicide in VivaGel is SPL7013, one of a novel class of giant, multi-branched synthetic molecules called dendrimers. The multiple ‘arms’ of SPL7013 have reactive tips that clasp and inactivate a protein on the surface of HIV that enables it to attach to T-cells, the immune system’s lymphocyte cells in which HIV replicates.
SPL7013 has a second mode of action: it clasps multiple receptor proteins on the surface of the vagina that provide entry portals for other sexually transmitted viruses and bacteria, including the chlamydia bacterium. The molecule causes the cell surface to pucker around it, making the receptor proteins inaccessible to viruses and bacteria that cause chlamydia, genital herpes, hepatitis B and genital warts.
Currently there are no approved products for the prevention of HIV. In January 2006, the FDA granted Fast Track status to VivaGel as an Investigational New Drug in recognition of the potential of VivaGel to prevent HIV transmission. To extend the clinical application of VivaGel, Starpharma commenced an NIH-funded US clinical trial of VivaGel for genital herpes in October 2006. In October 2006, Starpharma completed acquisition of the investee company DNT.
DNT was awarded “Technology Innovation of the Year” by Frost and Sullivan in November 2005 for its work in developing a family of dendrimers which allowed precise control over the physical characteristics of the dendrimer while still being cost-effective enough to manufacture en masse. DNT was chosen for the award from several nanotechnology companies after a selection process that included primary participant interviews and extensive primary and secondary research.
Frost & Sullivan concluded that DNT’s dendrimer-based nanostructures “represent a potent delivery platform for a vast array of diagnostics and therapeutics and could be employed to manufacture a variety of biotechnology and pharmaceutical products.”
This guy tends to hype his pitch somewhat.. states the company in question here is in phase III trials -which as we all know is not accurate. Still, its a fun, mostly accurate read.. and its not difficult to discern that the very exctiing, potentially, highly profitable company in question he alludes to is none other than our little darling, Starpharma!
NANOTECH INVESTOR NEWS
January 16, 2008
Silver Bullet Cancer Treatment From Broccoli?
By GS Early
Last year at one of the world's pre-eminent biotechnology conferences, The Buzz among big pharmaceutical companies and their tech scouts centered around an innovative drug delivery system that is looking like the drug delivery sector's (and by implication, the world's pharmaceutical sector's) Silver Bullet.
And one "bionano" drug delivery company is so well-placed in the development and production of this technology that Bioshares, a leading independent global investment research firm that covers biotech, is calling it the "Holy Grail" for drug developers.
And big pharma and healthcare is lining up with billions in hand to get in on the action!
Bionano Drug Delivery is Set to Soar
Now you're probably wondering what could possibly be so special about a new drug delivery system.
After all we already get our drugs in liquids, creams, gels, wipes, capsules, caplets, inhalers, needles, tubes, patches...well, you get the idea. So what else could there possibly be?
In a word...it's dendrimers.
Not exactly a household name, dendrimers are tiny tree-like macromolecules with branching tendrils that reach out from a central core.
They would look much like a stalk of broccoli if you could see them. Of course, being 10,000 times smaller than the thickness of a human hair, dendrimers are not visible to the human eye. But they've been steadily capturing the imagination of scientists since the late 1970s when a legendary Dow Chemical scientist started building his theory.
Although they don't come up much in conversation on the tennis court or cocktail party, dendrimers already exist in many products that we currently use on a daily basis--electronics, industrial plastics, adhesives, lubricants, tires and cosmetics, are just a few sectors where dendrimers play a vital role.
What's most exciting about dendrimers is that, unlike many naturally occurring "nanostructures," dendrimers can be custom built. That means they can be designed and manufactured for a wide variety of applications.
Their precise architecture allows them to store a broad range of organic and inorganic molecules (medicine, cancer meds, targeted radiation, etc.) within the hollow cavities of their "broccoli florets," providing a way to deliver a vast array of custom applications.
But one application is shaping up to be a blockbuster breakthrough for dendrimer technology and much of the healthcare sector-along with dendrimer scientists-are lining up to snare their share of the profits.
If you're serious about making big profits, I urge you to continue reading this special investor alert. In it you'll see how you can get a free copy of my latest report detailing the companies best positioned to reap gains. But more on that in a minute...
A New Class of Drugs Within Striking Distance
So what exactly is this new application that has an entire industry standing at attention?
It's called siRNA or small interfering RNA, and it essentially works by turning on and off the individual genes that may have major impact in a number of diseases and disease processes.
However, a big piece of the puzzle has been missing up to now. RNA is very fragile; so while scientists have been able to work with RNA and siRNA in a controlled laboratory environment, there has been no reliable way to deliver siRNA to cells in the human body.
But all of that has changed, with the emergence of dendrimer technology.
These microscopic dendrimer molecules have actually evolved to a level where they are able to transport the siRNA strand straight to the disease source-such as cancer cells. They are then able to bind themselves to the cancer cells and destroy them. And precisely targeted drug delivery means less drugs have to be used, so toxicity, side effects and counterindications are significantly reduced—even eliminated.
This giant leap in modern medicine has taken big pharma by storm! Drug applications that we've never even dreamed of may now be possible!
Just think of the pharmaceutical companies that will line up to license, partner or buy the siRNA therapy, as well as the molecular missiles that transport them!
As a matter of fact, when Merck & Co. paid a stunning $1.3 billion in cash just last fall to acquire its own siRNA developer, it signaled that big pharma was ready to move aggressively to pick up siRNA technology.
And many other companies have also jumped on the bandwagon!
Aside from Merck, Pfizer, Purdue University, Astra Zeneca and Roche Holdings have made significant investments—that means billions of dollars--into siRNA research in just the past two years.
And this is just the beginning. Record-shattering profits will be made by the handful of leading companies-and investors-because when it comes to these cutting edge technologies, big pharma is always more interested in cutting development deals (or outright buyouts in time) with niche players in key strategic sectors.
And this is what's happening with this new generation of drug delivery technologies. The Big Boy will do the RNA and siRNA work, but they're looking for companies that have robust and unique drug delivery systems to complement their research.
And that's where one of my favorite companies comes in. It has already signed a deal with Merck's siRNA operation and builds dendrimers for some of the world's top research facilities, chemical companies and pharmas.
Nobel Prize-Winning Discovery Ready to Bear Fruit
And the fact is, this is far more science than fiction. Two years ago, siRNA was the discovery that landed the 2006 Nobel Prize in Physiology or Medicine.
And siRNA is now one of the hottest areas in drug research, with cancer therapies leading the pack.
My favorite in this sector, which I've recommended to my subscribers in Real Nanotech Investor, is continuing its strong run from development stage bionano to major drug delivery player.
With dendrimer technology that has proven to be some of the best in the world, the company has an exploding dendrimer business as well as a handful of products that could turn drug delivery on its head.
Chemical giant Sigma Aldrich is a big customer, as is Durex, the world's largest condom manufactuer, as well as the prestigious National Institutes for Health. And recently, Australia's leading cardiopulmonary research center and hospital has begun looking into the company's products in relation to heart therapies.
Early Success is Already in the Bag
But that's not all...this company also has a pretty amazing product barreling through its pipeline as we speak! It just entered Phase III trials under FDA Regulations with a topical lubricant utilizing dendrimer technology.
As a matter of fact, the lubricant-called a microbocide-is the first dendrimer-based pharmaceutical to ever enter human trials!
And it may very well be the cure for the most deadly and widespread virus known to mankind!
You see, this astonishing little microbocide has been found to prevent the spread of sexually transmitted diseases, including HIV and genital herpes.
In the US alone, AIDS is now the number one cause of death among African-American women between the ages of 25 and 34.
And that's just a drop in the bucket compared to sub-Sahara Africa where more than 24 million people were living with HIV at the end of 2006. In just the past year, the AIDS epidemic has claimed more than 2 million lives in this region and left millions of children orphaned. It is estimated that over $10 billion will be spent on AIDS relief in 2007.
And to further sweeten the pot, it was announced earlier this summer that the lubricant may be a potent contraceptive as well!
But even without the contraceptive bonus, this miracle drug will be the "Holy Grail" to the nearly 40 million people living with HIV and AIDS across the globe.
You don't have to be a math wiz to see the potential for a drug that inactivates the AIDS virus...and we haven't even talked about the possibilities for genital herpes, which infects one in five here in the US.
Profits on the "Fast Track"
The FDA has granted this promising new drug its "fast track status"-a process that facilitates and expedites the development of products that serve unmet medical needs of serious or life-threatening conditions.
Fast track also cuts the time it takes to get a product registered and on the market in half. Experts expect this miracle lubricant to come to market sometime next year.
I've already positioned my subscribers to get in on the ground floor of this technological revolution. Now you have an opportunity to subscribe to Real Nanotech Investor and settle in for a long and profitable ride too!
Commercial Opportunity is Second to None
As you've just seen, the commercial opportunity for the company that holds this patent will be staggering. Imagine...a drug that has the potential to stop the spread of AIDS!
But the real "Holy Grail" is this miracle delivery technology.
You see, with the first dendrimer-based drug candidate in the clinical stage, dendrimers as a drug delivery system have become a realistic tool for many other drug developers. And big pharma is lining up to license, partner or buy this technology from the one company that has a success under its belt.
As a matter of fact, the company that I'm recommending in my Real Nanotech Investor portfolio is already under contract to supply dendrimer kits to healthcare giant Sigma Aldrich. They've also entered an exclusive license and supply agreement to provide EMD Biosciences with their proprietary dendrimers, to name a few.
Another great sign of support is coming from the US government. Just weeks ago, they signed a contract with the US Department of Defense to develop a water purification and recovery system. And they've been contracted by the National Cancer Institute to develop a dendrimer-based diagnostic and therapeutic delivery system for ovarian cancer.
These partnering arrangements, licensing agreements and supply contracts will mean millions to the companies on the forefront of this technology. It could also mean millions to investors who get in on the ground floor!
You can learn about this fast-track stock-along with other breakthrough investment opportunities-in my latest report called Nanotech Pioneers: Small Stocks With Huge Profit Potential when you subscribe to my premium investment service, Real Nanotech Investor.
Nanotech Pioneers will tell you everything there is to know about the first astonishing dendrimer-based drug and its enterprising developer-guaranteed to reap outrageous profits in the coming months and years.
The info/Investor Update 2008 I pasted below is really easier to read at the following link..
http://www.starpharma.com/data/080117%20Shareholder%20Update%20Jan%202008.pdf
In October 2007, Starpharma signed a codevelopment
agreement with UK-based SSL
International plc (LSE: SSL) the owners of Durex®,
the world’s leading condom brand. SSL holds
approximately one third of the global market
share for branded condom sales. SSL has sales
in more than 100 countries and is the world’s
largest manufacturer and seller of branded
condoms. In 2005, global condom retail sales
were almost $3.2 billion.
This deal, when combined with Starpharma’s
previous condom coating deal announced earlier
in the year, offers Starpharma global coverage for
this application of VivaGel®.
Starpharma considers SSL a highly desirable
partner for condom coatings: SSL has a large
condom franchise and valuable experience
taking differentiated condoms to the market.
Starpharma also values SSL’s social marketing
program for condoms.
Undisclosed fees are payable to Starpharma
under the SSL agreement, which also provides
for the commencement of regulatory and market
development activities by the two parties.
The idea of introducing extra functionality into
condoms is not new. Since the late 80s, the
spermicidal compound Nonoxynol 9 (N-9) has
been widely used as a coating to enhance
condoms. Early suggestions that N-9 was also
effective in preventing the transmission of
sexually transmitted infections, including HIV,
have been refuted by subsequent clinical data.
N-9 may in fact increase the transmission of HIV.
Based on the new data, the US Food and Drug
Administration (FDA) formally ruled in December
2007 that N-9 does not protect against HIV
(see News in Brief), a ruling that supports the
continued development of other condom coatings
such as VivaGel® for the prevention of sexually
transmitted disease.
There is global demand by condom
manufacturers for premium products that offer
good margins and strong differentiation. The
VivaGel® condom coating is also an opportunity
for Starpharma to establish multiple commercial
applications of its microbicide technology.
New application of VivaGel® as a condom coating
The active ingredient of VivaGel®, SPL7013, has been shown in animal models to possess
microbicidal and potent contraceptive properties. The clinical development of VivaGel® as
a stand-alone microbicidal gel for the prevention of infection with the viruses that cause
genital herpes (HSV-2) and AIDS (HIV) is well established.
Now, Starpharma is also advancing a second commercialisation program for VivaGel® as a
condom coating, which may have a shorter time to market than the microbicidal gel due to
a potentially simpler regulatory path for condoms compared with pharmaceuticals.
Shareholder Update: January 2008
Welcome to this edition of Starpharma’s investor update, a periodic newsletter
designed to keep shareholders informed about recent developments.
This issue provides an update of our achievements for the quarter, which included the signing of
a significant co-development agreement with SSL International plc to coat Durex® condoms with VivaGel®.
The collaborative research project uses a number of antibodies
developed by researchers at the Baker, which are coupled to
Starpharma’s dendrimers and allow targeting of unstable plaques
in diseased arterial walls (and the blood clots which form on
these that can cause heart attacks and strokes). The highly
branched dendrimer structure also allows for the inclusion of a
contrast reagent, such as gadolinium used commonly in Magnetic
Resonance Imaging (MRI).
The principal current method for detecting vascular disease is
X-ray angiography, which is highly invasive and whilst identifying
narrowing of arteries, does not recognise unstable atherosclerotic
plaques that may rupture, resulting in a heart attack or stroke.
Heart attacks and strokes account for about 20 percent of deaths
in Australia.
The joint project application received funding of $327,000 in the
2007 round of National Health and Medical Research Council
(NHMRC) development grants.
Previously, Starpharma announced a similar project that
received $810,000 from the US National Cancer Institute for the
development of a diagnostic using a targeting protein specific for
ovarian cancer.
Success in this collaborative project will deliver three potential
benefits. It will provide a technique for which there is an urgent
need in cardiac medicine. It will also provide proof-of-principle
for other dendrimer-based imaging applications and a basis for
exploring the possibility of using dendrimers for the targeted
delivery of small molecule drugs.
Figure 1. A thrombus detected by
MRI in the laboratory (“in vitro”) using
the Baker Institute’s antibody as the
Targeting Protein for the dendrimer
complex (the bright line demarcates the
surface of the thrombus).
Figure 2. The result of a “control”
experiment in which the dendrimer and
targeting protein were not connected
via a linker, but added separately to
the tube. The gadolinium-loaded
dendrimer alone does not bind to the
thrombus, demonstrating that the
MRI-enhancing process shown in Figure 1 was a specific,
targeted effect, as intended.
Arterial Disease Detection Agent
With Melbourne’s Baker Heart Research Institute, Starpharma is exploring the use of
targeted dendrimers to diagnose vascular disease at an early stage.
2
When developed,
the imaging agent
may be used in
medical scanners,
such as the one
pictured here,
to improve the
scanner’s ability
to resolve features
in the body, giving
better diagnoses
FDA ruling on N-9 supports Starpharma’s
strategy for condom application for VivaGel®
In December, the US FDA introduced a ruling that requires the
makers of certain contraceptive gels, foams, films and inserts to
carry a warning that the products do not protect against sexually
transmitted diseases, including AIDS. It will be required for many
over-the-counter spermicidal products that contain N-9. It has been
shown that N-9 can cause irritation of the vagina or rectum and
thereby increase the possible sites of entry for a virus, such as HIV,
into the body.
Study SPL7013-004: Enrollment
and Follow-up Completed
Enrollment and follow-up has been successfully
completed and data analysis is currently underway in
study SPL7013-004, another NIAID (National Institute of
Allergy and Infectious Diseases) funded expanded safety
study of VivaGel®.
This trial was conducted in sexually abstinent women in San
Francisco, California, USA, and Kisumu, Kenya.
During the trial, routine interim safety reviews identified no
emergent pattern of product-related adverse events or participant
withdrawals from the study. Full results from this study are
expected in quarter 1, 2008.
Extension of patent life for VivaGel®
in Europe
In December 2007, the European Patent Office advised
Starpharma that its European patent application for the use
of SPL7013 for the prevention and treatment of sexually
transmitted diseases (based on PCT application published
as WO2/079299) has been accepted.
The acceptance extends the patent life in Europe to at least 2022
with the potential for a further extension up to five years under the
European pharmaceutical extension scheme.
Starpharma Holdings Limited Shareholder Update: January 2008
In December 2007, Starpharma announced the
signing of a collaborative research agreement
with Stiefel Laboratories, Inc. the world’s largest
independent pharmaceutical company that
specialises in dermatology.
Stiefel markets products in more than 100 countries
around the world. The agreement is Starpharma’s first
co-development agreement for the use of its dendrimers
for the delivery of dermal therapeutics to improve their effectiveness
and tolerability.
Under the terms of the agreement,
Starpharma will receive payments on
achieving certain technical milestones on
the path to creating a potential new
dendrimer-based dermatology product.
In addition to being an excellent development
partner, Stiefel has the market strength to
provide a straightforward route to market for
technology arising out of this collaboration.
Dendrimers for the delivery of dermatological agents
News in brief:
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 as diagnostic elements and laboratory reagents.
The company’s lead pharmaceutical product is VivaGel® (SPL7013
Gel), a vaginal microbicide designed to prevent the transmission of
sexually transmitted infections, including HIV and genital herpes.
Further information
www.starpharma.com
Starpharma Holdings Limited Shareholder Update: January 2008
Media Relations:
Rebecca Wilson
E: rwilson@bcg.com.au
T: +61 2 9237 2800
Company:
Dr Jackie Fairley, CEO
E: jackie.fairley@starpharma.com
T: +61 3 8532 2704
Ben Rogers, Company Secretary
E: ben.rogers@starpharma.com
T: +61 3 8532 2704
International Award for VivaGel®
In November 2007, Starpharma received a Nano 50TM Award for VivaGel® in the Product Category, recognising
significant current or near-term commercial applications for nanotechnology.
These awards recognise the top 50 international, products and innovators that have significantly impacted (or are expected to
impact) the state of the art in nanotechnology.
Dendrimers to improve drug
and cosmetic compound properties
Dendrimers can greatly improve the water solubility
of water-insoluble compounds for pharmaceutical and
cosmetic industries.
Many pharmaceutical companies discover new drugs with
therapeutic potential, but are unable to formulate them as effective
drugs, due to solubility problems which limit their application.
Likewise many cosmetic companies also have novel ingredients
that have solubility problems. Combining certain dendrimers with
these new drugs and ingredients overcome many of the formulation
problems.
As an example, dendrimers in combination with vitamin D (usually
highly insoluble in water) dramatically enhances its water solubility
by about 1000 fold. This greatly increases the number of formulation
strategies applicable to Vitamin D.
Starpharma has an active research program and several industrial
collaborations in place looking at using dendrimers to solve
the formulation problems associated with specific therapeutic
compounds and cosmetic ingredients.
Great stuff, I'l keep my eyes on it!
FDA Warning for N-9 - an Opportunity for VivaGel(R)
MELBOURNE, Australia, Dec. 21 /PRNewswire-FirstCall/ -- Starpharma Holdings Limited (ASX:SPL, OTC: SPHRY), developer of VivaGel(R) vaginal microbicide today welcomed a decision by the US FDA this week requiring makers of products containing nonoxynol 9 (N9) to carry a warning that the products do not protect against sexually transmitted diseases, including HIV/AIDS and that the use of N-9 products is associated with an increased risk of HIV.
Starpharma's VivaGel(R) is a vaginal gel, being developed to protect women from HIV and HSV-2 (genital herpes) during sex. VivaGel(R) does not use N9. VivaGel(R) is currently in mid-stage clinical trials in the US and Kenya to add to its portfolio of safety data before embarking on population-based efficacy testing.
In the December 18 FDA release they noted:
'FDA is issuing this final rule to correct misconceptions that the chemical N9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases, including HIV infection,' said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research (CDER).
'Clinical research has shown that N9 provides no protection against sexually transmitted diseases to the woman if her sexual partner is infected with an STD pathogen or HIV.'
In addition, FDA is requiring that the labels warn consumers that the chemical N9 in stand-alone vaginal contraceptives and spermicides can irritate the vagina and rectum, which may increase the risk of contracting HIV/AIDS from an infected partner.
'Starpharma welcomes this clear statement from the FDA,' commented Jackie Fairley, Starpharma's CEO. 'We feel that this emphasizes the urgent need for products such as VivaGel(R) to assist individuals protect themselves from infection with these serious diseases. Starpharma is intent on developing VivaGel(R), both as a stand-alone gel and, through our co-development agreement with SSL International plc, as a condom coating ('Starpharma and Durex sign co-development agreement for VivaGel(R)-coated condoms' Starpharma, 16 October 2007)' (see: http://www.starpharma.com/news-room.asp).
VivaGel(R) has fast track status for development for HIV from the FDA, and has received in excess of $26m funding support from the US National Institutes of Health (NIH) for its development for both HIV and HSV-2. VivaGel(R) is being developed as a potential coating on condoms and as a stand alone product to protect against the contraction of sexually transmitted infections. It has also been shown to have a contraceptive affect in animal trials.
The FDA's summary article can be found here:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01758.html
The full report by the FDA can be found here:
http://www.fda.gov/OHRMS/DOCKETS/98fr/07-6111.htm
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(R) (SPL7013 Gel), a vaginal microbicide designed to prevent the transmission of STIs, including HIV and genital herpes.
For further information:
Media
Rebecca Wilson
Buchan Consulting
Tel: +61 2 9237 2800
Mob: +61 417 382 391
rwilson@bcg.com.au
Ellie Papathanasiou
Buchan Consulting
Tel: +61 2 9237 2800
epapathanasiou@bcg.com.au
Starpharma
www.starpharma.com
Dr Jackie Fairley
Chief Executive Officer
+61 3 8532 2704
Ben Rogers
Company Secretary
+61 3 8532 2702
ben.rogers@starpharma.com
SOURCE Starpharma
Source: PR Newswire (December 21, 2007 - 7:01 AM EST)
News by QuoteMedia
www.quotemedia.com
Starpharma Signs Collaborative Research Agreement with Stiefel Laboratories, Inc.
MELBOURNE, Australia, Dec. 3 /PRNewswire-FirstCall/ -- Starpharma today announced the signing of a collaborative research agreement with Stiefel Laboratories, Inc., the world's largest independent pharmaceutical company specializing in dermatology, to apply Starpharma's dendrimer nanotechnology to certain drugs used dermally. Stiefel Laboratories has five Global Research and Development Centers and has products marketed in more than 100 countries around the world.
The collaboration will apply Starpharma's dendrimer technology to deliver drugs through the skin with the aim of improving the effectiveness and tolerability of certain dermal treatments. Under the terms of the agreement Starpharma will receive staged payments on successful completion of technical milestones within the collaborative project. The agreement also deals with commercialization rights arising from the collaboration. Confidentiality provisions restrict disclosure of further details of the collaborative program and agreement.
'This agreement is significant for Starpharma in that it expands the applications for dendrimer technology to a new and potentially lucrative drug-delivery area. We consider drug delivery applications of dendrimers to represent a highly attractive commercial opportunity and we are delighted to be working with such a strong international partner in dermatology,' commented Starpharma CEO, Dr. Jackie Fairley.
This is the fourth agreement signed by Starpharma this year to develop commercial applications for its dendrimer technology. Starpharma also has dendrimer drug delivery programs underway in cancer and protein therapeutics.
According to Gavin Corcoran, M.D., Senior Vice President, Global Research & Development for Stiefel Laboratories, this development agreement is aligned with Stiefel's commitment to advancing the field of dermatology.
'Our partnership with Starpharma and the resulting agreement will add to Stiefel's innovative technology offerings including the VersaFoam(TM), EPX(TM) and dimethylisosorbide (DMI) vehicles that have greatly enhanced topical drug delivery,' said Corcoran.
In February 2007 Starpharma entered into a worldwide exclusive license and supply agreement with EMD Biosciences, part of Merck KGaA's Performance and Life Science Chemicals division. Under the terms of that agreement, Starpharma supplies EMD with Priofect(R) transfection reagents based on Priostar(R) proprietary dendrimers for the DNA and siRNA transfection research markets. Additionally two co-development agreements have recently been signed in relation to condom coating applications of Starpharma's lead product VivaGel(R). One of the agreements is with SSL International Plc, the makers of Durex(R), and a second with an undisclosed condom manufacturer. VivaGel(R) is a vaginal microbicide being developed under IND to prevent the transmission of HIV and genital herpes during sexual intercourse.
About Starpharma
Starpharma Holdings Limited (ASX: SPL; Pink Sheets: 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.
About Stiefel Laboratories, Inc.
Founded in 1847, Stiefel Laboratories (a privately held company) is the world's largest independent pharmaceutical company specializing in dermatology. The company manufactures and markets a variety of prescription and non-prescription dermatological products. Some of the newest and best- known brands include Duac(R) (clindamycin, 1% - benzoyl peroxide, 5%) Topical Gel; Evoclin(R) (clindamycin phosphate, 1%) Foam; Luxiq(R) (betamethasone valerate, 0.12%) Foam; MimyX(R); Olux(TM) (clobetasol propionate, 0.05%) Foam; Olux-E(TM) (clobetasol propionate, 0.05%) Foam; Soriatane(R) (acitretin) CK CONVENIENCE KIT(TM); Verdeso(TM) (desonide, 0.05%) Foam; Brevoxyl(R) (benzoyl peroxide, 4% or 8%) Creamy Wash packaged in the convenient new BREVOXYL Acne Wash Kit; Extina(R) (ketoconazole, 2%) Foam; Oilatum(R); Physiogel(R); Stieprox(R) (ciclopirox olamine); REVALESKIN(TM); and Sarna(R). Its wholly-owned global network is comprised of more than 30 subsidiaries, manufacturing plants in six countries, research and development facilities on four continents, and products marketed in more than 100 countries around the world.
Stiefel Laboratories supplements its R&D efforts by seeking strategic partnerships and acquisitions around the world. To learn more about Stiefel Laboratories, Inc. visit www.stiefel.com.
For further information:
Media
Rebecca Wilson
Buchan Consulting
Tel: +61 2 9237 2800
Mob: +61 417 382 391
rwilson@bcg.com.au
Philippa Harris
Buchan Consulting
Tel: +61 2 9237 2811
Mob: +61 408 465 800
pharris@bcg.com.au
Starpharma
www.starpharma.com
Dr Jackie Fairley
Chief Executive Officer
+61 3 8532 2704
Ben Rogers
Company Secretary
+61 3 8532 2702
ben.rogers@starpharma.com
SOURCE Starpharma
Source: PR Newswire (December 3, 2007 - 5:00 AM EST)
I am a little late posting this news from Oct.
Starpharma and Durex Sign Co-Development Agreement for VivaGel(R)-Coated Condoms
SYDNEY, Australia, Oct. 16 /PRNewswire-FirstCall/ -- Starpharma Holdings Ltd (ASX: SPL, Pink Sheets: SPHRY) today announced the signing of an agreement with SSL International plc (LSE: SSL), owner of Durex(R), the world's leading condom brand.
The agreement, under which a commercial licence will be negotiated, sets out a co-development program for condoms with a VivaGel(R) coating. Undisclosed fees are payable to Starpharma under the co-development agreement, which also provides for the commencement of regulatory and market development activities by the two parties.
SSL is the world's largest manufacturer of condoms with approximately 30% share of the global market for branded condom sales, selling into over 100 countries around the world. Global condom retail sales in 2005 were approximately $3.2 billion(1)(1), with the top four companies representing as much as 70% of the market.
'We are delighted to be working with SSL, whom we believe will be an excellent co-development partner for VivaGel(R) as a condom coating,' said Starpharma's Chief Executive Officer, Dr. Jackie Fairley. 'In addition to SSL's unparalleled global commercial position and the strength of the Durex(R) brand, Starpharma also values the organisation's innovative approach, and its social-marketing program.
'Our development and commercialisation activities for VivaGel(R) are gathering momentum with this SSL agreement being the second of two unrelated condom coating agreements signed by Starpharma in the last three months,' concluded Dr. Fairley.
VivaGel(R) has been shown to have potent contraceptive and microbicidal properties in animal studies, and is also under development as a stand-alone gel to prevent the transmission of STIs, including HIV and genital herpes.
About Starpharma:
Starpharma Holdings Limited (ASX: SPL, Pink Sheets: 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(R) (SPL7013 Gel), a vaginal microbicide designed to prevent the transmission of STIs, including HIV and genital herpes.
For further information:
Media
Rebecca Wilson
Buchan Consulting
Tel: +61 2 9237 2800
Mob: +61 417 382 391
rwilson@bcg.com.au
Starpharma
www.starpharma.com
Dr. Jackie Fairley
Chief Executive Officer
+61 3 8532 2704
Ben Rogers
Company Secretary
+61 3 8532 2702
ben.rogers@starpharma.com
(1)(1) 'Condoms: A Global Strategic Business Report', March 2005, Global Industry Analysts Inc.
SOURCE Starpharma Holdings Limited
Source: PR Newswire (October 16, 2007 - 7:01 AM EDT)
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