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Link Healthcare Obtains Extensive Regional Rights To Secrelux From Sanochemia
Sydney/Pretoria/Singapore/Tokyo/Auckland: 14 May 2013. Specialist pharmaceutical and medical technologies business, LINK Healthcare (‘LINK’) is pleased to announce that it has signed an agreement with Sanochemia Pharmazeutika AG for regional rights to Secrelux®, a pancreatic function diagnostic.
LINK has been assigned the exclusive rights to Secrelux® for Australia, New Zealand, Japan, South Africa and Asia excluding Korea and Philippines. LINK will give high priority to both the supply and registration of the product in these selected markets.
Secrelux® makes possible early and clear diagnosis of pancreatic carcinomas as the precursor to targeted therapeutic intervention. Its advantage lies in the fact that it induces a marked increase in pancreatic juice secretion and bicarbonate production for a period of one to two hours which facilitates the identification of pancreatic dysfunction. Secrelux® is already marketed in Germany and elsewhere in Europe and internationally on a named-patient basis through Sanochemia and its subsidiaries.
Executive Chairman of LINK Healthcare, John Bacon, commented:
“We are delighted to be partnering with Sanochemia to broaden the supply of this important diagnostic drug. Pancreatic cancer is reportedly the fourth most common cause of cancer-related deaths. It affects older individuals and its initial symptoms are quite non-specific. A reliable indicator of pancreatic function is an important diagnostic tool and we believe its availability will be welcomed across the region.”
About Sanochemia (Germany, UK, Switzerland & USA)
SANOCHEMIA, the Specialty Pharma Company, is an internationally active player with a long-standing tradition in the development and manufacture of active pharmaceutical ingredients and drugs. The Company specialises in segments of the oncology, pain management, neurodegeneration and, in particular, imaging diagnostic markets. Significant progress has already been made in the global marketing of the Company’s radiological products. The marketing and sale of clinical diagnostics is undertaken by the relevant group subsidiaries in Germany, the UK, Switzerland and the USA. Activities in other markets are delegated to a network of strong cooperation partners.
In the area of R&D, the focus is on the development of products to extend its in-house portfolio of human and veterinarian drugs. Through the acquisition of Alvetra und Werfft GmbH, SANOCHEMIA has succeeded in consolidating its standing in the area of veterinary medicine and also acquired additional subsidiaries in promising markets.
About LINK Healthcare (Australia, New Zealand, Southern Africa, Singapore & Japan)
LINK Healthcare is a privately owned specialist pharmaceutical and medical technologies business. LINK’s mission is to strive for excellence in the marketing of vitally important and unique range of specialists products that enhance the well-being of people throughout the regions of Australia, New Zealand, Asia and Southern Africa.
LINK provides exceptional regulatory, sales, marketing, customer service and supply chain infrastructure and is partnered with major blue chip pharmaceutical companies from around the world, allowing the company to offer a unique and substantial portfolio of ‘medicine that matters.’
The range includes specialist proprietary and in-licensed products sold under the LINK Pharma, LINK Medical Technologies, EQUITY Pharmaceuticals, EQUITY Medical Technologies, HOMEMED & NOVAGEN Pharma brands.
LINK Healthcare has an extensive range of prescription pharmaceuticals in essential therapeutic areas including Allergy, Anaphylaxis, Analgesia/Anaesthesia, Anti-infective, Anti-retroviral, Cardiology, Endocrinology, ENT, Gastroenterology, Intensive care, Metabolic disease, Neurology, Oncology, Orphan Drugs, Palliative care, Psychiatry, Radiography, Transplantation and Toxicology.
In Australia and Southern Africa the group also commercialize a unique range of medical technology products focused in the specialist areas of advanced wound care, diabetes and point of care testing.
For more information about LINK Healthcare visit www.linkhealthcare.com.au
FOR FURTHER INFORMATION
See website for Secrelux® approved Product Information.
Contact LINK Healthcare on 61 (2) 8401 9777
Corporate and Media Enquiries:
Mr John Bacon
Gentium To Initiate Clinical Development in Japan and Expand Named-Patient Program Access to Asia and Japan
VILLA GUARDIA (COMO), Italy, December 5, 2012 (GlobeNewswire) - Gentium S.p.A. (NASDAQ: GENT) (the “Company”) today announced the Company’s entry into an agreement with the National University Corporation Hamamatsu University School of Medicine (“HUSM”), Fukushima Medical University (“FMU”) and LINK Healthcare (“LINK”) to support a clinical trial to evaluate the safety and pharmacokinetics of Defibrotide in healthy adults. An investigational new drug application for Defibrotide was recently submitted to Japan’s Pharmaceuticals and Medical Devices Agency (“PMDA”).
Under the terms of the agreement, Gentium will provide free drug and technical support and LINK will provide administrative and logistical support for the clinical trial conducted by HUSM. If desired outcomes are achieved following the completion of the Phase I clinical trial, a Phase II Clinical Trial will need to be completed before submitting a marketing authorization application for Defibrotide to the PMDA.
The clinical trial is supported by a Health and Labour Sciences Research Grant (2012) and is categorized by the grant program as a study to support practical drug/medical device use during the reconstruction of disaster-hit areas in Eastern Japan.
“We expect this clinical trial to provide important safety and pharmacokinetic data necessary to support a future marketing authorization application for Defibrotide in Japan and Gentium is pleased to have the opportunity to collaborate with FMU in this important endeavour”, commented Dr. Carin Heringa, Senior Vice President and Scientific Director of Gentium.
Professor Kazuo Umemura, the Principal Investigator for the clinical trial, commented, “The clinical study will evaluate the safety and pharmacokinetics of Defibrotide in Japanese healthy adults at a translational research center at Hamamatsu University Hospital. We look forward to treating Japananse patients with veno-occlusive disease (VOD) with Defibrotide as soon as possible.”
Adrian Haigh, Senior Vice President of Commercial Operations at Gentium said, “We are pleased to be able to strengthen our relationship with LINK and we are confident in LINK’s ability to provide Defibrotide in additional geographies on a named-patient basis.”
Executive Chairman of LINK Healthcare, John Bacon, said “We are proud to participate in this vital study and hope that it will provide broader access to this important drug for the treatment of VOD, a potentially life-threatening condition associated with stem cell transplantation. Furthermore, we are pleased to be strengthening our relationship with Gentium across our entire footprint.”
In June 2011, the Company announced the appointment of Link as exclusive distributor of Defibrotide in Australia and new Zealand. Gentium and LINK plan to expand the distribution territories covered in their existing agreement to include Asia and Japan as LINK has recently established an operations and distribution facility in Singapore to serve the central Asian markets and purchased a business specializing in named-patient distribution in Japan.
Gentium S.p.A., located in Como, Italy, is a biopharmaceutical company focused on the development and manufacture of drugs to treat and prevent a variety of diseases and conditions, including vascular diseases related to cancer and cancer treatments. Defibrotide, the Company's lead product candidate, is an investigational drug that has been granted Orphan Drug status by the U.S. FDA and Orphan Medicinal Product Designation by the European Commission both to treat and to prevent VOD and Fast Track Designation by the U.S. FDA to treat VOD.
About LINK Healthcare
LINK Healthcare is a privately owned specialist pharmaceutical and medical technologies business which offers a unique and substantial portfolio of products throughout the regions of Australia, New Zealand, Asia and Southern Africa. LINK provides exceptional regulatory, sales, marketing, customer service and supply chain infrastructure and is partnered with pharmaceutical companies from around the world. Its specialist proprietary and in-licensed products are sold under the LINK Pharma, LINK Medical Technologies, EQUITY Pharmaceuticals, EQUITY Medical Technologies, HOMEMED & NOVAGEN Pharma brands.
About Fukushima Medical University
Fukushima Medical University promotes, through the highly advanced level of medical and nursing research of the faculty members, the welfare of the population of the prefecture and educates doctors and nurses to work for medical and welfare organizations in the prefecture after graduation. The University, its affiliated institute and hospital endeavour not only to carry out pioneering research that has gained worldwide recognition, but also to practice patient-oriented medicine with the highest ethical standards. Its ultimate goal is to fulfill its function of research and education for the local as well as international community.
About the Health and Labour Sciences Research Grants Program
The Health and Labour Sciences Research Grants program aims to promote scientific research directly addressing national healthcare, welfare, and medical needs, and offers a competitive study environment for pioneers of research.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that involve a number of risks and uncertainties the outcome of which could materially and/or adversely affect actual future results and the market price of Gentium's securities. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms and other comparable terminology. These statements are not historical facts but instead represent the Company's belief regarding future results, many of which, by their nature, are inherently uncertain and outside the Company's control. It is possible that actual results, including with respect to the possibility of any future regulatory approval, may differ materially from those anticipated in these forward-looking statements. Specifically, the risks and uncertainties that could affect the development of Defibrotide include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with Defibrotide in particular, including, without limitation, the potential failure of Defibrotide to prove safe and effective for treatment and prevention of hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation, and the risk factors listed or described from time to time in Gentium's filings with the Securities and Exchange Commission including, without limitation, Gentium's most recent filings on Forms 20-F.
SOURCE: Gentium S.p.A.
Salvatore Calabrese, +39 031-5373-260
SVP & CFO
The Trout Group
Tricia Swanson, +1 646 378 2953
Colistin-LINK plays significant role in treating superbugs.
Specialist pharmaceutical and medical technologies business, LINK Healthcare (‘LINK’), reports that one of its products, Colistin-Link, is gaining stature in the treatment of multi drug resistant bacteria.
Today, infectious disease kills more people than cancer and so called “superbugs”, bacteria that don't respond to antibiotics, are emerging as a major health threat. In a recent episode of the ABC’s Four Corners program†, Colistin-Link was portrayed as the drug of last hope for fighting serious infections. Specifically, it was identified as the only remaining antibiotic effective against the deadly new superbug, New Delhi metallo-beta-lactamase or NDM-1.
Colistin is an older and well established drug that has steadily maintained a niche position for the treatment of resistant infections. In 2005 LINK recognised the opportunity to add this clinically important product to its portfolio and completed an acquisition of the Australian and New Zealand rights from Pfizer. Colistin has now emerged as a critical agent in the defence against NDM-1.
Executive Chairman of LINK Healthcare, John Bacon, commented:
“Australia is in a region that is vulnerable to the evolution of superbugs as the emergence of NDM-1 demonstrates. While we are always concerned about the development of further resistance we are pleased to see Colistin taking on an important role in the management of this particular superbug.”
“Colistin typifies the much needed specialist products that make up LINK’s portfolio. We strive to identify opportunities to acquire products that, while not necessarily fashionable, serve useful and sometimes critical niches in the market.”
“In this way, LINK ensures the continuity of a broad range of clinically important products, many of which have seen recent resurgence in clinical practice.”
†The Four Corners program "Rise of the Superbugs", reported by Geoff Thompson and presented by Kerry O'Brien, was aired on Australian television on October 29 2012 on ABC 1.
LINK Healthcare announces expansion in Africa and Asia.
Australian-based specialist pharmaceutical and medical technologies business, LINK Healthcare today announced a significant expansion of its operations in the 'Triple A' regions of Australasia, Asia and Africa.
LINK has completed a series of acquisitions and agreements which have seen it emerge as a multinational operation with annual sales approaching $100m and more than 125 employees.
Key among the newly completed deals is a merger and acquisition agreement with South Africa's Equity Pharma Group. Equity Pharma Group is a strong brand in Southern Africa which is focused on speciality medicines, specific generic medicines (such as HIV medicines) and specialist medical technology products.
Executive Chairman of LINK Healthcare, John Bacon, said, "This acquisition is particularly pleasing because South Africa's pharmaceutical sector is increasingly being supported by government with strong growth anticipated for the foreseeable future."
LINK has also recently established an Asian base in Singapore to commercialise its first product for Asian markets. In October 2011 LINK was granted a licence from Salix Pharmaceuticals, Inc. of North Carolina, USA to market Relistor® (methylnaltrexone) in Australia, New Zealand, South Africa and Asia. The new Singapore office is handling all commercial operations in the Asian region.
In addition, has established its Japanese Branch Office and made a successful bid for the pharmaceutical distribution assets of RHC USA Corporation in Tokyo. Japan is the second largest market for pharmaceuticals in the world after the USA, accounting for 11.2% of the global pharmaceutical industry.
Mr Bacon said, "We are delighted to have Equity incorporated into our group and expect to sign several agreements in the coming months to expand the distribution of existing products across the company's whole footprint."
The LINK group now controls advanced regional distribution facilities in Australia, South Africa and Singapore with satellite offices in Japan, New Zealand and Hong Kong.
Link Healthcare & Martindale Pharma Partner to Provide Acetylcysteine Link Injection in Australia.
Specialist pharmaceutical and medical technologies business, LINK Healthcare (‘LINK’) is pleased to announce that it has recently launched in Australia Acetylcysteine-LINK Injection, for the emergency treatment of paracetamol overdose.
LINK is collaborating with Martindale Pharma, leaders in the manufacture and supply of specialty pharmaceuticals in the UK, to supply and distribute injectable acetylcysteine under the LINK Pharma brand in Australia. Acetylcysteine-LINK Injection was approved for marketing in February this year by the Australian Therapeutic Goods Administration (TGA).
Acetylcysteine injection is recognised for the treatment of paracetamol overdose by the World Health Organisation (WHO) which includes acetylcysteine in its Model List of Essential Medicines for Adults and Children. Paracetamol is the most widely used over-the-counter analgesic agent in the world but is also subject to both accidental and deliberate overdose. It is reportedly the leading pharmaceutical agent responsible for calls to poisons information centres in Australia and New Zealand.
Waterford's EirGen Pharma partners with South African firm 7/11/2011
EirGen Pharma, currently on an Enterprise Ireland trade mission to South Africa, has secured a significant partnership agreement with South African pharmaceuticals company Equity Pharmaceuticals to develop and commercially supply five oncology products from its Waterford facility.
This week's Enterprise Ireland trade mission to South Africa, where 28 Irish firms are holding meetings with their South African counterparts, is being led by Ireland's Minister of State for Trade and Development, Jan O'Sullivan, TD.
The deal size between EirGen Pharma and Equity Pharmaceuticals is €3m per annum, based on an anticipated 20pc market share of the €15m market for this portfolio of oncology products, said Enterprise Ireland today.
Tom Brennan and Patsy Carney co-founded EirGen Pharma in 2005. It employs 45 people at its plant in Waterford, which focuses on the development and supply of niche highly potent drugs typically used in cancer treatment.
Innovative Irish firms make their marks internationally O'Sullivan said the partnership is another "major win" for an Irish company that has carved out a successful business in international markets.
"EirGen Pharma's success confirms that ambitious, innovative Irish companies are highly regarded for their quality of product and service, innovative capabilities and customer focus. Irish companies are winning more and more business in South Africa, and the potential for continued growth is strong. Enterprise Ireland is working with them in the region to strengthen their business links, develop strategic partnerships and win new business contracts," added O'Sullivan. Speaking after the announcement, Carney said the company was "delighted" to have secured this agreement with one of South Africa's fastest-growing pharmaceuticals companies.
"EirGen and Equity plan to take a significant share of the current market of €15m for these products. We also see further potential in our partnership in the future as we are currently jointly evaluating four other additional oncology products for potential entry to the South Africa and other markets in the region," he added. Johann Willemse, CEO of Equity Pharmaceuticals, said the partnership was a reflection of the company's commitment to bring therapeutically important, high-value products to the South African market.
Enterprise Ireland's head of International Sales and Partnering, Kevin Sherry, who is accompanying O'Sullivan on the visit, said the partnership with Equity Pharmaceuticals is a very significant one for EirGen.
"South Africa is recognised as the regional economic powerhouse in sub-Saharan Africa. It is a growing market where an increasing number of Irish companies are establishing a foothold and securing sales. This trade mission is about building on that success, assisting more Irish companies to win more business and thereby increase exports, which will directly sustain and create jobs in Ireland."Download Document
LINK Healthcare announces licence deal for Relistor®
LINK Healthcare today announced it had been granted a licence to market Relistor® (methylnaltrexone) in Australia, New Zealand, South Africa and Asia from Salix Pharmaceuticals, Inc. of North Carolina, USA. Relistor subcutaneous injection is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.
For full article details, please download the PDF.
ANAPEN 500μg receives marketing approval
LINK Pharma has received marketing approval in both Australia and New Zealand for
"ANAPEN 500," a 500 microgram adrenaline auto-injector. "ANAPEN 500" is approved for
adults with a mean body weight of 60kg or more, or adults at high risk of severe
anaphylaxis for whom a 300 microgram dose may not be sufficient. Australian and
International resuscitation guidelines recommend an initial treatment of 500 micrograms
adrenaline as a front line treatment for all patients suffering from anaphylaxis with a body
weight of greater than 60kg. Up until now, no auto-injector product has met this need.
ANAPEN 500 compliments LINK's currently marketed ANAPEN adrenaline auto-injector
range, which deliver either 150μg or 300μg, and are PBS listed. LINK Pharma plans a
regional launch for "ANAPEN 500" in the coming months.
LINK Pharma adds ampoules to adrenaline portfolio
LINK Pharma has acquired the range of adrenaline products previously sold by Astra
Zeneca Australia. The registrations for both 1:1000 and 1:10,000 strength ampoules have
been recently transferred. This range is a perfect fit with LINK'S ANAPEN adrenaline
auto-injector, which was launched in 2010.
Gentium Appoints LINK Pharmaceuticals as Exclusive Distributor of Defibrotide in Australia and New Zealand
VILLA GUARDIA (COMO), Italy, June 15, 2011, (GLOBE NEWSWIRE) -- Gentium S.p.A.
(NASDAQ: GENT) announced the appointment of LINK Pharmaceuticals as exclusive distributor of Defibrotide in Australia and New Zealand. Under the terms of the agreement, LINK will be responsible for managing named patient requests.
For full article details, please download the PDF.Download Document
Stallergenes obtains a marketing authorisation for oralair® in Australia
Antony (France), 18 May 2011 - Stallergenes S.A. has announced that the Australian health authority, the Therapeutic Goods Administration (TGA), has approved the grass pollen sublingual immunotherapy tablet, Oralair® in adult and pediatric indications.
A proven ability to build and sustain an agile sales and marketing solution is ideally suited to specialist pharmaceuticals and medical devices, which are marketed to a targeted group of medical specialists.
For full article details, please download the PDF.Download Document
Stallergenes - LINK Pharmaceuticals partnership in Australia
Stallergenes and LINK are pleased to announce the reinforcement of their partnership for the Australian market. Stallergenes has recently created a dedicated Australian affiliate company to work alongside LINK, providing management, medical and marketing support to answer the specific needs of allergy clinicians and patients with allergies.
For full article details, please download the PDF.
Anapen® Registered for Marketing in Australia
SYDNEY, NSW, OCTOBER 28, 2008. LINK Pharma, a specialist Australian-owned pharmaceutical company, is pleased to announce that the Anapen® adrenaline auto-injector has been approved for marketing in Australia. LINK has been working towards providing an alternative adrenaline auto-injector device for the many Australians who may be at risk of anaphylaxis. The registration of Anapen® in Australia brings LINK Pharma a step closer to this goal. The launch of Anapen® represents the first stage in the roll out of a new LINK Immunology Business Unit with further product launches planned. The recently announced distribution partnership with the French Immunotherapy company Stallergenes will be included in this Business Unit and will commence operation on 1st December 2008.
Anapen® has been successfully launched in 14 countries in Europe and North America. LINK is proud to be the first company to launch Anapen® in the Southern Hemisphere. LINK will be launching both Anapen® 300µg and Anapen® Junior 150µg early in 2009 and the company is looking to work closely with ASCIA, the immunology profession, Anaphylaxis Australia and other relevant stakeholders to ensure the product is marketed within a strong framework of patient education.
LINK's new Immunology Business Unit is headed by Sales & Marketing Manager, Mr. Kenneth Allan with Ms. Sabrina de Miranda stepping into the Product Management role. Healthcare providers can obtain further information on Anapen,® it's mechanism of action and the Anapen® training device at www.analert.com.au
LINK Pharmaceuticals: second major acquisition in 2008 (25/09/08)
LINK Pharmaceuticals today announced a second major acquisition for 2008 with the transfer of the former Novartis products Apresoline, Deseril and Hygroton.
This transfer is an extension of LINK’s on-going partnership with the UK company Amdipharm.
Amdipharm recently completed the acquisition of these products from Novartis for several international markets and LINK will market them in Australia on Amdipharm’s behalf.
LINK Pharmaceuticals Acquisition (20/05/08)
LINK Pharmaceuticals today announced the transfer of the Akineton, Erythocin IV and the EES (erythromycin) product range from Abbott Australia.
This transfer is the result of LINK’s on-going partnership with the UK company Amdipharm.
Amdipharm recently completed the acquisition of these products from Abbott for several international markets and LINK will market them in Australia on Amdipharm’s behalf.
Zostrix on the Shelves. 1 July 2007
On 1st July 2007 the big three pharmaceutical wholesalers took stock of both Zostrix and Zostrix HP. As a result retail pharmacies should have stock soon after that date. This is good news for those suffering the pain associate with osteoarthritis, diabetic neuropathy and post-herpetic neuralgia.
ZOSTRIX is registered by the Australian authorities in two strengths for the treatment of pain. The 0.025% cream is approved for pain associated with osteoarthritis and the 0.075% formulation is approved for the relief of neuropathic pain.
LINK Pharmaceuticals’ Managing Director Mr. John Bacon commented that “ZOSTRIX is a highly effective treatment with good clinical evidence of efficacy. The side effect profile is excellent and we expect the product to be an important part of our growing portfolio.” For more information, visit www.zostrix.com.au
Naprosyn Suspension Re-listed by PBS. 18th January 2006
On April 1st 2006 patients will have access to the liquid formulation of Naprosyn (naproxen) through the Pharmaceutical Benefits Scheme.
This completes a two year joint project between LINK Pharmaceuticals and Roche Products to secure the long-term supply of this product in Australia for the treatment of chronic arthropathies and bone pain for patients unable to take solid forms of NSAIDS.
Moving ahead, Roche will continue to market solid Naprosyn formulations and LINK will distribute and co-promote the more specialist liquid formulation.
For further information please contact the Customer Service Department of LINK Pharmaceuticals.
LINK Completes Second Acquisition From Pfizer. 12th July 2005
LINK Pharmaceuticals announces the acquisition of two antibiotic products from Pfizer for the territories of Australia and New Zealand. The two injectable products, colistin and chloramphenicol are both essential treatments for serious infections. While the use of chloramphenicol is now highly restrictive due to the high incidence of serious side effects, it still has an important role in the treatment of highly resistant organisms.
Colistin is an essential treatment of serious gram-negative infections, particularly Pseudomonas aeruginosa.
In announcing the acquisition, Managing Director John Bacon commented “we are pleased to complete this acquisition with Pfizer’s regional office. Both products are a very good fit to our current range. Chloramphenicol is quite a low volume product but it’s maintenance on the market is critically important. Colistin is also an important antibiotic but in this case we believe it has some potential for growth.”