Posts Tagged ‘Biotechnology’

ASX Company News: Clinuvel Pharmaceuticals Signs Production Agreement

Friday, July 9th, 2010

Clinuvel Pharmaceuticals Limited (CUV) today announced it had entered a long term manufacturing agreement with SurModics, Inc., a leading provider of drug delivery technologies to the healthcare industry, for the manufacture of the novel SCENESSE® (afamelanotide) formulation. Under this exclusive arrangement, SurModics will commercially manufacture and supply Clinuvel with the unique product for an indefinite period. SCENESSE® will be manufactured by SurModics at its  recently opened, FDA certified facilities in Birmingham, Alabama.

During the past eight years, Clinuvel and SurModics have been fully committed to the development of this particular formulation. SCENESSE® is currently in late stage clinical trials in Europe, Australia and the USA. The innovative product is injected as a controlled-release subcutaneous formulation which delivers 16 mg of afamelanotide activating skin pigment and providing photoprotection for 60 days. The drug has been safely administered to over 500 patients in global clinical trials.

Clinuvel’s Chief Scientific Officer, Dr Hank Agersborg said: “We are pleased to have finalized arrangements for the manufacture of SCENESSE® implants as part of our commercialisation strategy. “Our technological evolution allows us to deliver Clinuvel’s proprietary molecule in pictogram quantities during a defined period of time and obtain optimum biological response.” SurModics Chief Scientific Officer, Dr Arthur J Tipton commented: “Today’s announcement represents a natural progression of our relationship with Clinuvel. Together, our teams have solved numerous scientific and technical issues over the years culminating in the signing of this licensing agreement. Clinuvel’s product provides a novel way to treat serious skin disorders. We are excited to support Clinuvel as they continue with their U.S. clinical trials, and are also encouraged by the positive clinical results Clinuvel has generated to date.”

SurModics’ vision is to extend and improve the lives of patients through technology innovation. The Company partners with the world’s foremost medical device, pharmaceutical and life science companies to develop and commercialize innovative products that result in improved diagnosis and treatment for patients. Core offerings include: drug delivery technologies (coatings, microparticles, nanoparticles, and implants). SurModics is headquartered in Eden Prairie, Minnesota and its SurModics Pharmaceuticals subsidiary is located in Birmingham, Alabama.  Clinuvel Pharmaceuticals Ltd is a leading and innovative Australian company focused on the development of SCENESSE® (afamelanotide), its proprietary first-in-class photoprotective drug. Clinuvel has identified five groups of patients with a clinical need for photoprotection.  Clinuvel will work closely with global regulators to facilitate marketing approval of SCENESSE®.

www.clinuvel.com

www.surmodics.com

http://www.traderdealer.com.au/Fundamentals/cuv

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Progen Pharmaceuticals To Manufacture Two Drugs For Zensun

Friday, May 28th, 2010

Progen Pharmaceuticals Ltd (PGL) announced today that the company’s biopharmaceuticals manufacturing subsidiary PharmaSynth Pty Ltd, had secured a new contract with Zensun (Shanghai) Sci & Tech Co Ltd. Zensun has successfully developed two drugs: the Recombinant Human Neuregulin-1 (rhNRG-1) injection, an anti-heart failure drug, and Recombinant Human ErbB3 fragment injection, a therapeutic vaccine against tumours. Both have undergone clinical trials. PharmaSynth has been contracted to manufacture rhNRG-1 for a forthcoming US based phase II clinical trial. PharmaSynth has expertise in recombinant proteins, bacterial and viral vaccines, whole cell therapeutics and small molecule synthesis and has previously manufactured this product for use by Zensun.

PharmaSynth’s CEO Les Tillack said the securing of this new contract demonstrated PharmaSynth’s position as an important Australian based contract manufacturer operating in the global market. “The opportunity to manufacture rhNRG-1 is an exciting one for PharmaSynth. We consider it a privilege to be involved with the development project for such a promising new drug. This project fits well with our core skills in recombinant protein manufacture and demonstrates our abilities as a world class biopharmaceutical contract manufacturing organization,” he said. Progen CEO, Sue MacLeman confirmed PharmaSynth Pty Ltd continued to expand into the global biopharmaceutical manufacturing market through a commitment to quality pharmaceutical manufacturing and flexibile service provision.

Progen Pharmaceuticals Limited is a biotechnology company committed to the discovery, development and commercialization of small molecule pharmaceuticals primarily for the treatment of cancer. Progen has built a focus and strength in anti-cancer drug discovery and development. Progen targets the multiple mechanisms of cancer across its three technology platforms of angiogenesis, epigenetics and cell proliferation. Progen has operations in Australia and the United States of America.  PharmaSynth is a Brisbane, Australia based, drug development and contract manufacturer serving the pharmaceutical, biotechnology and veterinary industries.

Zensun ( Shanghai ) Sci & Tech Co., Ltd. is a bio-tech pharmaceutical company well-versed in the demands of the international market with a high profit potential based on innovation. It is devoted to the research and development of new drugs through self-owned intellectual properties. With adherence to the tenet of “healing for life”, Zensun has long been focusing on the research of anti-tumor drugs and anti-heart failure drugs. Based on the innovative theory, Zensun has successfully developed two drugs: the Recombinant Human Neuregulin- 1 injection, an anti-heart failure drug, and Recombinant Human ErbB3 fragment injection, a therapeutic vaccine against tumors, both have undergone clinical trial. Zensun (Shanghai) Sci & Tech Co Ltd is based in the Peoples Republic of China.

www.progen-pharma.com

www.zensun.com

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Prima BioMed Contracts Fraunhofer Institute To Produce Vaccine

Friday, May 28th, 2010

Australian health care company Prima BioMed Ltd (PRR) is pleased to announce that it has entered into an agreement with the Fraunhofer Institute for Cell Therapy and Immunology in Leipzig, Germany (Fraunhofer IZI) to produce Prima’s CVacTM cancer immunotherapy product for the Company’s European clinical trials.

Preparation for production of CVacTM for the European trial has already commenced, and Prima and the Fraunhofer IZI are working together to prepare the facility to support CVacTM clinical trials in Europe in early 2011. This represents a significant milestone on the pathway to commercialisation of CVacTM in the European market.

The agreement also allows Prima to be eligible for millions of Euros in R&D grants from the Saxony Bank (Sächische Aufbaubank – SAB). The SAB grants are intended to assist small companies in product development to achieve success, and would subsidise a significant part of Prima’s production cost for CvacTM. In addition the agreement with Fraunhofer provides a number of other key benefits to Prima. Fraunhofer is among the foremost R&D institutes in Europe and it has strong collaborative networks throughout academia, government, and industry. Fraunhofer will help enhance the visibility of the CVacTM clinical program in Europe and globally.

Prima Chief Operating Officer and Managing Director for Europe, Matthew Lehman said: “The Fraunhofer Institute is among the foremost research and development organisations in the world and Prima is delighted to enter into this collaborative arrangement. Prima values the strong research partnerships we have, including the well-known Peter MacCallum Cancer Centre, the Burnet Research Institute, Stanford University and Fred Hutchinson Cancer Research Centre.”

Prima BioMed is focused on technologies in the fields of cancer immunotherapy and immunology. Prima’s lead product is the CVacTM ovarian cancer therapy treatment. It has completed two successful clinical trials and is progressing toward eventual commercialisation in the United States, Australia, Europe, and globally. The Company’s broader, long term goal is to develop commercial cancer treatment technologies and programs for global markets.

Fraunhofer IZI  is a member of the Fraunhofer Life Sciences Alliance. Its objective is to find solutions to specific problems at the interface between medicine, life sciences and engineering for partners in medicine-related industries and businesses. The Institute’s core competencies are in regenerative medicine, specifically cell-therapeutic methods of regenerating non-functioning tissue and organs through to the biological substitution with tissue cultivated in vitro (tissue engineering). The Institute works especially closely with hospital institutions, performing quality tests and clinical studies on their behalf. It also provides assistance in obtaining manufacturing licenses and certifications.

www.primabiomed.com.au

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Genera Biosystems JV Agreement With Major Equipment Manufacturer

Tuesday, May 25th, 2010

Genera Biosystems (GBI) today announced that it had signed a major collaboration agreement with one of the world’s leading diagnostic equipment and test manufacturers. The agreement will see Genera and their partner, who for reasons of commercial sensitivity, has asked to remain anonymous for the time being, collaborating on a programme of research and development designed to investigate the integration of the PapType HPV detection and genotyping test with the partner’s instrumentation platform.  In addition, the partner will have the opportunity to negotiate global rights to PapType for a period following completion of the work.

“Our principal commercialization strategy for PapType has always been to work through a global partner, and so this is a pivotal milestone” commented Genera Biosystems’ chairman, Mr. Fernando Careri. “Our development partner is a very substantial and highly regarded healthcare company, with global sales and marketing outreach. We see this agreement as a strong endorsement of Genera’s technology, and are very hopeful of a more substantive follow-on agreement being signed in due course.” The objective of the development programme, which follows on from 18 months of discussions between the two companies, is to optimise the PapType test to work on the partner’s instrument platform. The partner will meet all costs of the R&D programme, which is expected to take six to seven months. “A successful outcome will pave the way towards a compelling new approach to cervical cancer screening, which will add value to all the major stakeholders – pathology companies, healthcare payers, doctors, and of course the patients,” said Allen Bollands, Chief Executive Officer of Genera. “There is a very strong technological alignment between the companies, and we’re very hopeful that this agreement will be the start of what will grow to become an enduring and mutually beneficial partnership”.

The current version of PapType was recently approved by the TGA and is also registered in Europe. Genera is working with a range of partners, agencies and customers with a view, not only to the commercialisation of PapType, but also the development of other multiplexed diagnostic tests.

Genera Biosystems Limited (GBI) is a molecular diagnostics company that develops, manufactures and distributes advanced molecular diagnostic tests. Its first product, PapTypeTM, a test which simultaneously detects and genotypes human papillomavirus, is registered in Australia and the European Union.

www.generabiosystems.com

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CBio Secures $12.45 milllion Funding For Next 3 Years

Tuesday, May 18th, 2010

CBio Limited (CBZ) is pleased to announce that it has secured up to A$12.45 million in funding with the New York-based institutional investor SpringTree Special Opportunities Fund, LP (SpringTree). CBio has entered into a Convertible Loan Agreement with SpringTree which provides funding to the Company over a three-year period.

The minimum funding available under the facility is A$5.45 million, with the first tranche of A$200,000 available to CBio within the coming days. The remaining funds can be drawn down each month in tranches of between A$150,000 and A$350,000, subject to the requisite shareholder approvals. The loans under the facility will be repaid through the issue of shares and options according to a formula contained within the Convertible Loan Agreement.

CBio Managing Director Jason Yeates said the SpringTree funding facility is a significant aspect of the Company’s business plan into 2011 and beyond.  “This funding provides a level of financial stability for the Company for the next three years. It provides working capital needed to complete the current Phase II clinical trial as well as funding resources needed to explore a number of development activities planned for 2011,” said Mr Yeates.  “The Agreement also offers flexibility in that it can be cancelled should it not suit our circumstances in the future and allows the Board to now fully focus its energies on the strategic direction of the Company over what will be a critical next 12 months,” he said.

CBio is currently completing a 150-patient, phase IIa trial in Rheumatoid Arthritis at sites throughout Australia, New Zealand and Central and Eastern Europe. The Company expects results from the trial to be available in mid-2011.

SpringTree is a New York-based investment fund that makes debt and equity investments in small and mid-cap public companies around the world.  Eugene Tablis, a Managing Director of SpringTree Global Investors, LLC (SpringTree’s general partner (manager)) said the CBio opportunity is a great fit for the Fund. “While this is our first rheumatology therapeutics investment, this is our fourth Australian biotechnology investment and we have been very impressed with the quality of the Australian science that is often under-discovered by the global markets, as well as the quality of CBio’s management.”

www.cbio.com.au

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Mesoblast Acquires Angioblast Systems

Thursday, May 13th, 2010

Australia’s regenerative medicine company, Mesoblast Limited (MSB) announced that it will acquire its United States associate company, Angioblast Systems, Inc. (Angioblast).  Additionally, Mesoblast announced it has completed a capital raising of $37 million to fund the acquisition and advance operations of the expanded Mesoblast Group. These funds comprise $24 million invested immediately and $13 million committed subject to both shareholder approval and completion of the acquisition offer.

Mesoblast Chairman Brian Jamieson said: “We are delighted to bring the commercial rights to the patented adult stem cell technology platform under one umbrella. With Mesoblast moving to 100% ownership of Angioblast, Mesoblast shareholders will derive much greater potential benefit from product commercialisation, and from the broader strategic partnerships or collaborations Mesoblast will now be able to conclude.”

The capital was raised from United Kingdom institutional and sophisticated investors, as well as from new and existing Australian investors, at a share price of $1.70, representing a 12% discount to the Company’s closing price on May 3 2010. The placement was managed by Southern Cross Equities to international investors and in conjunction with Lodge Partners to domestic investors.

The acquisition has been structured on an agreed exchange ratio of Mesoblast shares for Angioblast stock. To acquire the remaining fully-diluted Angioblast stock which is not already owned by Mesoblast (approximately 67%), the Company proposes to issue an additional 94.6 million Mesoblast shares to Angioblast security holders. Together with Mesoblast’s current 140.6 million shares on issue, post-acquisition the Mesoblast Group will have a total of up to 235.2 million shares outstanding.

Angioblast stockholders will be given the election to take the acquisition consideration either as 100% Mesoblast fully paid ordinary shares or up to 15% in cash and the balance (a minimum of 85%) in Mesoblast fully paid ordinary shares. The cash component will enable Angioblast stockholders who are subject to United States federal tax to fund the payment of capital gains tax arising as a result of this transaction.

www.mesoblast.com

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Sunshine Heart Completes Heart Assist Implant

Thursday, May 6th, 2010

Sunshine Heart (SHC), a global medical device company focused on innovative technologies for advanced heart failure, announced that on Friday, 30 April Pennsylvania State University successfully completed an implant of the Company’s C- PulseTM heart assist system in a patient under a clinical trial approved by the US Food and Drug Administration (FDA). This patient, whose progress is as expected, is the first implanted at Pennsylvania State University and the sixth patient to be treated with the C-Pulse heart assist system.

Sunshine Heart is a global medical device company, committed to the commercialization of C-Pulse™ an implantable, non-blood contacting, heart assist therapy for the treatment of people with moderate heart failure. C-Pulse reduces the symptoms of heart failure through the use of counterpulsation technology which enables an increase in cardiac output, an increase in coronary blood flow and reduction in the heart’s pumping load. The Company has received approval from the US Food and Drug Administration (FDA) to conduct a 20 person US clinical trial with C-Pulse and patient enrolment has commenced. Sunshine Heart listed on the ASX in September 2004 has a presence in Australia, New Zealand and the United States of America.

www.sunshineheart.com

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Genetic Technologies Settles Licence Agreement

Thursday, May 6th, 2010

Genetic Technologies Limited (GTG) has executed a Settlement and License Agreement with respect to its non-coding patents with EraGen Biosciences Inc. (“EraGen”), based in Madison, Wisconsin, USA. This is the second such agreement that GTG has secured in the last week.  The license granted by GTG covers the activities of EraGen in relation to its genetic diagnostic and analysis products, limited to USA and Canada. The commercial terms of the license granted to EraGen are subject to confidentiality between the parties.

Although not a counterparty to GTG’s US patent infringement suit (ASX announcement 16 February 2010), discussions between GTG and EraGen regarding GTG’s non-coding patents have been proceeding for some time, and have now resulted in GTG granting to EraGen a non-exclusive license for all EraGen products, as well as the normalisation of past historical sales by EraGen.  Discussions with other parties both in the context of the patent infringement suit and external to that suit are ongoing and progressing. Further details will be released to the market when appropriate.

Genetic Technologies was an early pioneer in recognising important new applications for “non-coding” DNA (Deoxyribonucleic Acid). The Company has since been granted patents in 24 countries around the world, securing intellectual property rights for particular uses of non-coding DNA in genetic analysis and gene mapping across all genes in all species. Its three-pronged business strategy includes: 1) the global commercialisation of its patents through an active licensing program; 2) the expansion of its dominant commercial genetic testing business with a focus on oncology and cancer management; and, 3) the  commercialisation of its various research and development projects aimed at generating further intellectual property of potentially global commercial significance.

www.gtglabs.com

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Eastland Medical Systems Malaria Trial Successful

Thursday, April 29th, 2010

Eastland Medical Systems Ltd (EMS) in conjunction with its UK clinical consultants ProtoPharma Limited announces today the very positive results of the recently completed Phase IIa clinical trial of ArTiMist™, a patented sublingual delivery technology designed to administer the drug Artemether. ArTiMist™ was specifically designed to provide a rapid first line treatment of children with severe or complicated P. falciparum malaria, or uncomplicated P. falciparum malaria with gastrointestinal complications.

The majority of deaths from severe malaria in young children are caused by the delayed administration of effective malaria treatments. Moreover, oral treatment is not adequate for patients who are suffering from vomiting and diarrhea and oral absorption (tablets) is slower and often not possible. It is a fact that many deaths occur due to delays in transferring a patient to a hospital setting where trained staff are on hand.

The results show that ArTiMist™ was rapidly absorbed following first administration via the sublingual route. The new route of administration containing the new formula of Artemether was shown to be safe and well tolerated by patients. The three primary efficacy parameters were met and showed success in the reduction of parasite count within 24 hours after receiving the first dose.

The addressable market for ArTiMist™ is large. It is estimated that alone there are over 90 million children under the age of 5 (the most vulnerable patient population) in sub-Sahara Africa at “high risk” of contracting malaria. It is further reported that children are prone to between 1.6-5.4 episodes of malaria each year. Data relating to the more virulent P. falciparum malarial strain indicate 86 million reported cases in Africa annually and 287 million estimated cases in the overall population. Based on these figures and on the distinct advantages of ArTiMist™ over IV quinine, we have internally estimated a potential market size of between 80 -100 million units in Africa for the <5 years old demographic alone. Asia represents also a large potential market even though the socio-economic and healthcare infrastructure are generally in better shape than in sub- Sahara Africa.

www.eastlandmedical.com

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Progen Pharmaceuticals Secures Manufacturing Contract

Wednesday, April 21st, 2010

Progen Pharmaceuticals Ltd (PGL) are pleased to announce that the company’s wholly owned subsidiary PharmaSynth Pty Ltd, a contract biopharmaceuticals manufacturing organisation, has secured a new contract with Hunter Immunology Limited. While the details of this agreement are confidential this new contract further validates PharmaSynth Pty Ltd as an important Australian based contract manufacturer with expertise in recombinant proteins, bacterial and viral vaccines, whole cell therapeutics and small molecule synthesis.

Hunter Immunology Ltd is a late stage biopharmaceutical company focused on respiratory markets. Its lead product, HI-164OV is an orally-administered immunotherapeutic aimed at reducing the number and severity of acute bronchitis in moderate to severe COPD (Chronic Obstructive Pulmonary Disease).  “This new contract continues our good relationship with PharmaSynth which successfully produced material for our Phase IIa trial and will provide the active ingredient for our forthcoming Phase IIb trial” said Dr Kevin Healey, Managing Director of Hunter Immunology Ltd.

“”We are pleased that our team at PharmaSynth Pty Ltd has been able to secure this important contract. We look forward to further collaborations with other Australian biopharmaceutical companies and with the recent changes to the R&D Tax credit there are now even more incentives in place for PharmaSynth to work with other companies ” said Sue MacLeman, Chief Executive Officer, Progen Pharmaceuticals Ltd and Managing Director PharmaSynth Pty Ltd.

PharmaSynth has also been engaged to assist in the manufacture of Progen’s new clinical candidate PG545 for a Phase 1 trial expected to start later this year. As part of this, PharmaSynth is expanding its small molecule synthesis capabilities with the purchase of a pilot scale glass reactor train and the installation of a small fill and finish suite to manufacture sterile lyophilised vials.

Les Tillack, PharmaSynth’s CEO said that “This increase in our small molecule synthesis capabilities allows us to actively pursue the early phase synthetic molecule market which we see as an actively growing sector of the Biotech industry. This combined with over 15 years of experience in biopharmaceuticals allows us to potentially service most of the biotech projects in Australia and increasingly overseas.”

www.progen-pharma.com

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