Acrux ein Schnäpchen
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Das australische Biounternehmen entwickelt in erster Linie Präparate gegen Übelkeit, Angstsymptome und starken Schmerzen. Derzeit befinde sich das Unternehmen mit dem Präparat "Evamist", gegen Symptome der Wechseljahre, in Phase III. Evamist wurde bereits an Vivus lizensiert und soll noch 2006 die Zulassung erhalten. Die Produkt-Pipeline verspreche ebenfalls eine Aussichtsreiche Zukunft.
Seit dem Börsengang im September 2004 mit $ 1.00 sank der Kurs zeitweilig auf ein Tief von $ 0.46. Seit Juli diesen Jahres konnte sich der Wert deutlich erholen. Die Bodenbildung bei $ 0.48 wurde bereits hinter sich gelassen.
Der Wert scheint uns daher deutlich unterbewertet. Unser 12-monats-Kursziel liegt zwischen $ 1.15 und $ 1.35.
27 Sep 2005
Acrux Limited, the Australian pharmaceutical company that specialises in products delivering therapeutic drugs through the skin, today announced that it has been granted four more US patents relating to its transdermal drug delivery technology.
The four US patents provide additional protection for systemic delivery of drugs in specific therapeutic areas, namely analgesics (US patent number 6,916,486), hormones (6,923,983), anti-Parkinson's agents (6,929,801) and anti-emetics (6,916,487). These are "continuation in part" patents, related to Acrux's US patent number 6,818,226.
The new patents, which expire in February 2017, further extend the proprietary nature of Acrux's transdermal drug delivery technology for a number of products in the current pipeline. They provide protection for transdermal drug delivery systems, in the specific therapy areas, that consist of an effective amount of physiologically active agent (e.g. a therapeutic drug), a dermal penetration enhancer, which is a safe skin-tolerant ester sunscreen, and a volatile liquid. Acrux now has six patents granted in the USA.
Acrux CEO and Managing Director, Dr Igor Gonda said: "These new US patents provide additional protection for our products in our core areas of interest. Our patenting activity is at the heart of our business strategy to develop and commercialise patient-preferred patent-protected healthcare products for valuable global markets."
Igor Gonda
61-383-790-100
Research Australia
Quelle: www.dellarue.de (Forum)
Einfach im Dellarue-Forum nachlesen!
www.dellarue.de
EVAMIST™ SPRAY FOR MENOPAUSE SYMPTOMS
12. October 2005
Acrux’s licensee for its lead product in the USA, VIVUS Inc. (Nasdaq: VVUS), today
announced the completion of enrolment in its pivotal Phase 3 clinical study of Evamist™ (Estradiol MDTS®), an estradiol spray for the treatment of symptoms associated with menopause. VIVUS remains on track to submit a New Drug Application (NDA) for Evamist to the US Food and Drug Administration (FDA) in mid-2006. This Phase 3 trial is a multi-centre, randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of Evamist. The primary endpoint is the reduction in the frequency and severity of moderate-to-severe vasomotor symptoms associated with menopause at weeks 4 and 12 of the study. Over 400 patients were enrolled at 43 centres throughout the USA. The study was initiated in December 2004 under a Special Protocol Assessment (SPA) with the FDA. The SPA is a formal agreement that designates the agreed upon terms and conditions under which VIVUS will conduct and analyse the data from the Phase 3 trial. The SPA provides official confirmation from the FDA that the protocol design is sufficient for a Phase 3 trial which, if completed as agreed, can form the basis of the submission of a NDA that will include an efficacy label claim for Evamist for the relief of moderate to severe vasomotor symptoms associated with menopause. Acrux CEO Igor Gonda commented “We are very pleased with the rapid progress that VIVUS is making towards completion of development and commercialisation of our first product for a large US market, further validating our technology and business model. Acrux retains the rights for this product for the rest of the world”. VIVUS Senior Vice President of Product and Corporate Development, Peter Tam said "We believe Evamist has the potential to provide a practical and convenient option for the millions of women seeking a better treatment option for their menopausal.
Wednesday February 8, 8:30 am ET
NEW YORK & MELBOURNE, Australia--(BUSINESS WIRE)--Feb. 8, 2006--Acrux Limited (ASX: ACR - News), a Melbourne, Australia-based pharmaceutical company which has developed an innovative transdermal drug delivery system, announced today that two senior executives will be presenting on panels at the upcoming BIO CEO conference at the Waldorf Astoria in New York.
Acrux CEO Dr. Igor Gonda will join a panel of CEOs and pain experts to discuss the latest developments in pain relief. Dr. Nina Wilkins, who manages Acrux's intellectual property and business development, will discuss latest developments in reproductive health for men and women on a panel called "What's New in Sexual/Gender Health." Both panels are at 4 p.m. (U.S. EST) on February 14.
"Cure the Pain"
Dr. Gonda's panel, titled "Cure the Pain," will address key factors driving the growing demand for pain medication, including aging populations, greater use of strong pain drugs in emerging markets and concerns surrounding side effects and inadequate efficacy of existing treatments.
Gonda's presentation will focus on his company's work with fentanyl, a potent and widely used medication to treat chronic pain caused by cancer, arthritis and back injury.
"Transdermal fentanyl--in a 3-day patch--has become a key tool in the management of pain, with annual sales totalling more than $2 billion worldwide," said Gonda. "With Acrux's unique Patchless Patch® delivery system, we are developing a transdermal alternative to the traditional patch that provides the same advantages, and offers other benefits--such as dosing flexibility for more precise pain control, while avoiding some of the risks--such as skin irritation and residual drug."
With Acrux's delivery system, Fentanyl UDTS(TM), a patient would use a simple applicator to apply a single dose of quick-drying fentanyl formulation to the skin which rapidly creates an invisible, non-irritating reservoir of the medication within the skin. The fentanyl then slowly diffuses into the bloodstream throughout the day. With this application method, dosing frequency can be varied to control pain more effectively.
Fentanyl UDTS(TM) has had positive results in its Phase 1 trials and Acrux is funding additional small trials in Australia to gather further valuable data on the product, before securing a commercial partner for Phase 3 trials and marketing.
"What's New In Sexual/Gender Health?"
Dr. Wilkins' panel will look at the current climate and recent advancements in the multi-billion dollar reproductive health market. With FDA warnings about possible adverse effects from blockbuster male "gender health" drugs, such as Viagra, Cialis, and Levitra inspiring caution, safe new therapies and technologies for reproductive health will be highly prized. Approximately 13 million men in the U.S. today experience testosterone deficiency and researchers are now also investigating new treatments for women's arousal and desire.
Acrux is at the forefront of this exciting and growing area, with three women's health products and one men's health product in development using the company's transdermal delivery system.
"Our vision is that Acrux's once-a-day skin sprays will become a familiar and preferred means of treatment for women throughout their lives," said Wilkins. "Our contraceptive, our treatment for decreased libido and our treatment for menopausal symptoms are all in clinical development, with the first product nearing completion of Phase 3 in the USA. We are also developing a novel patient-friendly lotion for men faced with testosterone deficiency."
Acrux's transdermal drug delivery system consists of three proprietary components:
* MDTS® applicator--a small, hand-held, easy-to-use applicator that is designed to provide an easy and convenient means to deliver a preset dose of a therapeutic drug onto the skin
* ACROSS® penetration enhancers--commonly used safe, non-irritating materials, with properties that enable transport of the drug through the skin.
* Patchless Patch®--the drug delivery method itself, whereby a fast-drying formulation forms an invisible reservoir of the drug and enhancer in the outer layer of the skin, from which the drug is slowly released into the bloodstream.
"We are delighted to be invited to take part in the BIO CEO panels and look forward to some valuable insights into treatment options for patients in both these exciting areas. Acrux's participation reflects the breadth of our product pipeline and its advanced stage of development," said Gonda.
About Acrux (www.acrux.com.au):
* Acrux is a specialty pharmaceutical company, developing and commercializing a range of patented, patient-preferred healthcare products for global markets, using its innovative technology to administer drugs through the skin.
* Acrux's product pipeline includes treatments of hormonal deficiencies, pain and central nervous system disorders, as well as a contraceptive.
* The company has completed 20 human clinical trials with 8 different drug products. The lead product, Evamist(TM) (Estradiol MDTS®), is currently in a phase three clinical trial in the USA.
* Acrux has licensed USA rights for Evamist(TM) (Estradiol MDTS®) and Testosterone MDTS® to VIVUS and AUS/NZ distribution rights for Testosterone MDTS® and Fentanyl UDTS(TM) to CSL Limited. Acrux has also licensed its
technology to Eli Lilly for veterinary healthcare products.
Quelle: DEL LA RUE - Investment Team www.dellarue.de
rückschau bis 13.01.06 gleich 0
hmmm,oder habe ich was übersehen?
g-oj
Wobei schon allein 29 Mio. Aktien in festen Händen von Mitarbeitern sind, sowie 17,5 Mio. Optionen. Und dann hält Goldmann Sachs nochmal ca. 30 Mio. Dann bleibt nicht mehr ganz soviel Freefloat bei ca. 130 Mio. Aktien. Es sei auch gesagt das 79% der Aktien in Händen von 101 Anlegern sind die mehr als 100.000 Aktien halten. Also Großinvestoren.
Da bleibt nicht mehr viel für die "Kleinen" über! :)
Ordern von Acrux ist in Berlin fast aussichtslos, und wenn nur zu einen zuhohen Kurs.
Besser, ein Depot bei der comdirect, dort kann man problemlos in über 40 Ländern ordern, natürlich auch in Sydney!
06.05.2006
Acrux ist ein Pioneerunternehmen in der Entwicklung von Produkten für ein besseres Wohlbefinden.
Derzeit befinden sich 7 innovative Produkte in der Pipeline. Mit “Evamist (Estradiol MDTS)“ welches sich momentan in der FDA Phase III befindet, steht das Unternehmen kurz vor dem Zulassungsverfahren. Das Präparat kann die Behandlung der Wechseljahrbeschwerden revolutionieren. Die hervorragenden Aussichten wollte sich das ameri- kanische Unternehmen VIVUS nicht entgehen lassen und sicherte sich bereits im Vorfeld die Lizenzen für den amerikanischen Vertrieb. Gelingt es dem Unternehmen die Zulassung für “Evamist (Estradiol MDTS)“ in den nächsten Monaten zu bekommen, dürften sich Patienten sowie Investoren gleichermaßen freuen.
Noch lukrativer scheint derzeit die Zulassung von “Testosteron (MDTS)“ zu werden. Das Präparat könnte in Zukunft das einzig marktreife und geprüfte Präparat gegen die Störung der sexuellen Erregung der Frau werden und somit einen geschätzten Gesamtmarkt von 4 Milliarden USD abdecken. Das Potential des Testosteron-Präparates ist immens und lässt sich nur schwer schätzen. Bis andere Pharma-Riesen ein vergleichbares Präparat auf den Markt bringen, könnten sich Acrux und VIVUS einen entscheidenden Image und Know-how Vorsprung schaffen.
Der Börsengang im September 2004 brachte Acrux 27 Millionen ASD an frischem Kapital. Das Vorantreiben der bisherigen Forschungen verschlang aber auch einen Großteil der Reserven. Meilensteinzahlungen brachten Acrux regelmäßige Finanzspritzen, so dass das Unternehmen am 31. Januar noch 29 Mio. ASD ausweisen konnte. Der Aufwand könnte sich aber schon 2007 rentieren. Das innovative Evamist könnte schnell zum Blockbuster aufsteigen und sich einen großen Anteil vom 1,4 Milliarden USD Markt sichern. Das Potential ist für Acrux und VIVUS enorm. Als Nachteil von Acrux sehen wir vor allem das geringe Interesse von europäischen Anlegern. Der Umsatz am Börsenplatz Berlin-Bremen tendiert gegen null. VIVUS ist daher unser direktes Ausweichinvestment.
Acrux ist schon heute hervorragend aufgestellt. Die volle Pipeline bieten Anlegern lukrative Chancen. Anleger die den illiquide Markt fürchten, können durch VIVUS indirekt am Erfolgt von Acrux profitieren.