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Novel therapy for treatment of obesity enters clinical trials

By Press Release, Thiakis
Press Release.

 

London, UK, 12 March 2008 – Thiakis Limited, the biopharmaceutical company focused on the development of peptide hormones for the treatment of obesity, announced today that it has successfully commenced dosing in a clinical trial of TKS1225, the Company’s novel oxyntomodulin analogue, for the treatment of obesity. The trial will initially focus on safety and tolerability before investigating the effects of TKS1225 on appetite and food intake.

TKS1225 is a potent, long acting analogue of oxyntomodulin, a naturally occurring peptide hormone involved in regulating food intake. Preclinical models have demonstrated TKS1225 to be highly efficacious, ameliorating glucose intolerance as well as causing a significant reduction in body weight.

Oxyntomodulin is a peptide hormone released by the gut following food ingestion, acting as a natural satiety signal to reduce food intake and increase energy expenditure. Clinical studies in human volunteers at Imperial College London demonstrated the effectiveness of oxyntomodulin in causing significant weight loss, reducing appetite and food intake.

“I am delighted to be announcing the initiation of clinical development for TKS1225,” Dr John Burt, Chief Executive Officer of Thiakis commented. “This programme has demonstrated the rapid progress from initial discovery to the start of human dosing that can be achieved by a focused biotech company. TKS1225 has the potential to provide a major new treatment option for obesity.”

Data from Thiakis’ development programme indicate that TKS1225 has the potential to improve glucose tolerance and increase insulin sensitivity, which are often impaired in obese people and underlie Type 2 diabetes, a common consequence of excess weight.

Thiakis Limited
Dr John Burt, Chief Executive Officer
telephone: +44 (0)20 7470 5621
email: info@thiakis.com

Thiakis is focused on the development of novel therapies for the treatment of obesity and other metabolic diseases. The Company’s core technology, derived from the research of Professor Steve Bloom at Imperial College London, is based on the peptide hormones oxyntomodulin and PYY(3-36), which are released by the intestines in response to food ingestion, and serve to regulate appetite as part of the body’s own natural energy balancing mechanisms. The Company’s lead development compound is a more potent and long lasting oxyntomodulin analogue, TKS1225, currently in clinical development. Thiakis’ intellectual property has been licensed from Imperial Innovations (AIM: IVO). In August 2006, Thiakis raised £10 million from a syndicate of venture capital investors, led by established biotech funds Novo A/S and Advent Venture Partners; Imperial Innovations made a significant investment in Thiakis in this financing round and The Royal Society also participated.

Obesity is a chronic, relapsing health risk defined by excess body fat, caused by the interaction of genetic, environmental, and behavioural factors. The incidence of obesity has shown a substantial increase over the past twenty years. The World Health Organisation (WHO) has identified obesity as an epidemic which is the largest global, chronic health problem in adults. Over 300 million adults are clinically obese, while 1 billion are overweight (WHO, 2003). Greater than 30% of the US adult population are classified as obese (WHO, 2007). 67% of men and 56% of women in the UK are either overweight or obese (Health Survey for England, 2006). Obesity increases the risk of death and major co-morbidities such as type 2 diabetes, hypertension, dyslipidemia, cardiovascular disease, osteoarthritis of the knee, sleep apnoea, and some cancers. Estimates of the economic costs of obesity range from 2 to 8% of total healthcare costs of the developed world. As a consequence, the market for therapies to promote weight loss and reduce the co-morbidities of obesity currently represents a substantial unmet medical need.

EUSA Pharma to Acquire US Specialty Oncology Company Cytogen

By EUSA Pharma, Press Release
Press Release.

 

  • Acquisition of US infrastructure completes build of EUSA’s transatlantic commercialization platform

  • $22.6 million acquisition expands EUSA’s product portfolio

  • EUSA raises over $50 million to fund acquisition and other investments

11 March 2008: Doylestown PA, USA and Oxford, UK – EUSA Pharma Inc (‘EUSA’), a transatlantic specialty pharmaceutical company focused on oncology, pain control and critical care, today announced that it has entered into a definitive agreement to acquire all the outstanding shares of Cytogen Corporation (NASDAQ: CYTO) for $22.6 million. Cytogen is a specialty pharmaceutical company with three oncology and pain control products on the American market, a specialist US sales force and an established commercial infrastructure. To meet the acquisition consideration, and fund further investments, EUSA Pharma has concurrently raised over $50 million in an investment round, led by TVM Capital, an international venture capital firm.

“The acquisition of Cytogen is of great strategic importance for EUSA as it completes the building of our transatlantic commercialization infrastructure, as well as fitting perfectly with our focus on oncology and pain control,” said Bryan Morton, Chief Executive of EUSA Pharma. “Over the last 18 months EUSA has built a strong European organization covering over 20 countries and marketing a portfolio of six specialty pharmaceuticals. Cytogen’s products and US infrastructure are the ideal complement to our business, offering us the opportunity to commercialize a rapidly growing portfolio of medicines on both sides of the Atlantic.”

Commenting on the acquisition, Rolf Stahel, Chairman of EUSA Pharma, said,

“The acquisition of Cytogen marks a step change in the growth of EUSA and completes the foundations of a world-class specialty pharmaceutical company. This transaction will transform our business, putting in place a truly transatlantic growth platform, and positioning the company as the partner of choice for future acquisitions and specialty product in-licensing.”

The acquisition of Cytogen brings to the enlarged EUSA group an established US commercial organization with a 40-strong specialist oncology sales force and three marketed products.

Caphosol® is a supersaturated calcium phosphate rinse indicated for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high-dose chemotherapy, and for the treatment of xerostomia.
ProstaScint® is a monoclonal antibody-based agent used to image the extent and spread of prostate cancer.
Quadramet® is a radiopharmaceutical for the treatment of pain in patients whose cancer has spread to the bones.

The enlarged group will have broad sales and marketing capabilities, via direct sales forces in the US and across Europe, and through distribution partners in a number of territories including Canada, South America and Asia. EUSA will have a portfolio of nine marketed medicines and five late-stage development products. The acquisition of Cytogen provides EUSA with the capabilities to commercialize a number of these medicines on both sides of the Atlantic.

In addition, the enlarged group’s transatlantic infrastructure provides the company with a strategic growth platform to exploit additional products through acquisition and in-licensing. With its highly focused business model, EUSA will have the opportunity to compete effectively with major players, making it an attractive partner for companies seeking specialist transatlantic commercial and late-stage development expertise.

Under the terms of the all-cash merger agreement Cytogen shareholders will receive $0.62 per share, representing a 35% premium on the company’s share price at the close of trading on 10 March 2008, and valuing the company at $22.6 million.

The Cytogen Board has approved the cash merger agreement and resolved to recommend that the company’s shareholders adopt the agreement. Completion of the acquisition is conditional on the approval of a majority of Cytogen’s shareholders and fulfillment of certain pre-closing conditions. Upon completion, EUSA intends to apply to delist all Cytogen’s issued shares from the NASDAQ stock exchange.

To meet the consideration for the acquisition, provide working capital to integrate and refocus the Cytogen organization and undertake further investments, EUSA Pharma has raised over $50 million in an investment fundraising. This investment round, which is conditional on the completion of the Cytogen acquisition, is led by TVM Capital and supported by EUSA’s existing investors, Essex Woodlands, 3i, Goldman Sachs, Advent Venture Partners, SV Life Sciences, NeoMed and NovaQuest.

During 2007, Cytogen’s revenues totaled $20.2 million, with the company making a net loss of $25.7 million for the year. At the end of December 2007 the company held cash and cash equivalents totaling $8.9 million. During 2007, Cytogen began a program to refocus its strategy, reduce costs and promote its products more effectively by building on its expertise in the oncology field. EUSA intends to accelerate this initiative and rapidly drive the business to profitability, while retaining the strengths of the Cytogen organization.

EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on in-licensing, developing and marketing late-stage oncology, pain control and critical care products. The company currently has six products on the market, including the antibiotic surgical implant Collatamp® G, Erwinase® and Kidrolase® for the treatment of acute lymphoblastic leukemia, and Rapydan®, a rapid-onset anesthetic patch which recently received Europe-wide approval. EUSA also has several products in late-stage development, notably Collatamp® G topical, a gentamicin impregnated collagen sponge for the prevention and treatment of infected skin ulcers, and CollaRx® bupivacaine implant* for local post-surgical pain control.

Founded in 2006, EUSA Pharma is supported by a consortium of leading life science capital investors, comprising TVM Capital, Essex Woodlands, 3i, Goldman Sachs, Advent Venture Partners, SV Life Sciences, NeoMed and NovaQuest. Since its foundation, the company has raised over $225 million in addition to the fund raising announced today, and completed several significant transactions, including the acquisitions of Talisker Pharma Ltd, the French biopharmaceutical company OPi SA and the European antibiotic and pain control business of Innocoll Pharmaceuticals Inc. As part of its rapid growth strategy the company has established commercial infrastructure in the US, a pan-European presence covering over 20 countries and a wider distribution network in a further 25 territories. EUSA Pharma plans to continue its aggressive program of acquisitions and in-licensing within its specialist areas of medical and geographic focus, in line with its ambitious target to create a rapidly growing $1 billion company by the beginning of the next decade.

*CollaRx® is a registered trademark of Innocoll Technologies Ltd.

Algeta receives IND Approval for Alpharadin(TM) to commence Clinical Development in the USA

By Algeta, Press Release
Press Release.

 

Oslo, Norway, 21 February 2008 – Algeta ASA (OSE: ALGETA), the cancer therapeutics company, today announced that it will shortly commence clinical development of Alpharadin(TM) in HRPC patients in the USA. Algeta filed its Investigational New Drug (IND) application for its lead product Alpharadin(TM) with the United States Food and Drug Administration (FDA) in December 2007. The statutory 30 day consultation period was extended by the FDA for a further 30 days by agreement with the company and the IND has now been cleared by the FDA without any objections being made to the application. Alpharadin(TM) has already been studied in phase II clinical trials in Europe and has demonstrated a potential for a significant survival benefit in hormone-refractory prostate cancer (HRPC) patients with skeletal metastases.

An initial Phase I pharmacokinetics, biodistribution and dosimetry study (BC1-08) with Alpharadin in HRPC patients with skeletal metastases will be conducted at the Memorial Sloan-Kettering Cancer Center in New York, one of the world’s leading oncology centers. This US trial will further expand the information obtained in a similar phase I study (BC1-05) conducted at the Royal Marsden Hospital in London, for which patient enrolment has recently been completed.

Following the start up of the BC1-08 trial, Algeta will continue discussions with the FDA to agree on the design of the further clinical development program for Alpharadin(TM)

“We are delighted to have been given the clearance by FDA to advance Alpharadin into clinical development in the United States, and to be working with one of the world’s leading cancer centers on our clinical program,”

said Dr. Thomas Ramdahl, President and CEO of Algeta.

“There is a great unmet medical need among men suffering from HRPC with skeletal metastases and the opening of this US clinical trial will be an important step in our overall clinical development of Alpharadin. As earlier announced, we plan to initiate an international pivotal phase III clinical trial with Alpharadin in HRPC patients during the first half of 2008.”

 

For further information, please contact

Dr. Thomas Ramdahl, CEO
+47 23 00 79 90 / +47 913 91 458 (mob)
Geir Christian Melen, CFO
+47 23 00 79 90 / +47 913 02 965 (mob)
post@algeta.com

Dr. Mark Swallow / David Dible
Citigate Dewe Rogerson
+44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

 

About Algeta

Algeta ASA is a Norwegian cancer therapeutics company built on world-leading, proprietary technology. Algeta is developing new, targeted cancer therapeutics that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.

Algeta’s lead product candidate, Alpharadin, is planned to enter Phase III clinical trials in hormone refractory prostate cancer before mid 2008 based on positive Phase II results. Alpharadin is a novel bone-seeking therapeutic based on the alpha particle emitter radium-223 and may target skeletal metastases from multiple cancer types, as well as primary bone cancers.

Algeta is also developing other technologies for delivering alpha emitters. These include microparticles, liposomes, and methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227.

The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

Forward-looking Statement

This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.

These factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.

EUSA Pharma out-licenses Preclinical-stage Human Antibody to GlaxoSmithKline for up to $44 million plus Royalities

By EUSA Pharma, Press Release
Press Release.

 

Doylestown PA, USA and Oxford, UK – 18 February 2008 – EUSA Pharma Inc (‘EUSA’), a transatlantic specialty pharmaceutical company focused on oncology, pain control and critical care, today announced that it has out-licensed the exclusive world-wide rights to its preclinical-stage human anti-interleukin-6 antibody to GlaxoSmithKline (GSK) for a consideration of up to $44 million, comprising an upfront fee and development milestones, plus royalties on future sales. As part of the agreement EUSA will pay approximately 50% of the overall consideration to its development partner for the antibody, Vaccinex Inc. GSK will fund and conduct all future development, production and commercialization of the product.

Interleukin-6 is a pro-inflammatory cytokine and B-cell growth factor and acts as a resistance factor to standard chemotherapy. EUSA’s product, OP-R003, is the first fully human anti-interleukin-6 antibody, with target indications in oncology and inflammatory diseases. OP-R003 is derived from a first generation murine antibody, elsilimomab, which has achieved promising clinical results as a lymphoma therapy. As a fully human antibody, OP-R003 has the potential to offer improved tolerability and a superior safety profile.

EUSA acquired OP-R003 as part of the company’s 2007 acquisition of OPi SA. OPi had previously entered a collaboration with Vaccinex, a specialist antibody discovery and development company, to optimize and develop OP-R003 as a therapy for rheumatoid arthritis and lymphoma.

“The out-licensing of this early-stage antibody is another strategic milestone for EUSA, as we continue to focus our business on marketed and late-stage products in the oncology, pain control and critical care areas,”

said Bryan Morton, Chief Executive of EUSA Pharma.

Commenting on the acquisition, Brian McVeigh, GSK’s Worldwide Business Development Director of M&A Strategy and Transactions, said,

“Interleukin-6 is increasingly recognized as an important biological target in a range of diseases, and consequently OP-R003 has great potential to meet a number of unmet medical needs.”

Speciality European Pharma launches Plenaxis in Germany

By Press Release, SEP
Press Release.

 

Plenaxis® is the first GnRH antagonist, a new class of hormone treatment which gives physicians added control of prostate cancer.

 

London, 25 February. Speciality European Pharma (SEP) today announced the launch of Plenaxis® in Germany. Plenaxis® is used to treat advanced and metastatic hormone responsive prostate cancer and it causes a rapid and sustained decline in testosterone levels, thereby giving quick control of prostate cancer symptoms. Once the disease is under control, the physician can choose to either keep the patient on Plenaxis® or to stop treatment and recommence once there is evidence of disease activity returning. This is attractive because, on stopping treatment with Plenaxis® the patient’s testosterone levels will return to the normal range whilst the disease remains under control. In addition to the quick control of testosterone, Plenaxis avoids any testosterone flare and removes the need for concomitant use of anti-androgen therapy.

Commenting on the launch of Plenaxis®, Geoff McMillan, the CEO of SEP, said “Plenaxis® is an important product, both for SEP and for sufferers of prostate cancer. Plenaxis is the first new type of hormone treatment for prostate cancer to be introduced for many years and it gives patients and physicians added control of this disease”.

Ken Watters, Chief Medical Officer of SEP added that “prostate cancer is an important cause of morbidity and mortality in males over 50 years old. The emerging treatment modalities are especially suited to Plenaxis® with it’s rapid and sustained disease control and quick testosterone recovery”.

– Ends –

 

About SEP:

Founded in April 2006, SEP acquired Proreo Pharma International in December 2006 and with it rights to Haemopressin®, a product sold in several European and international markets for the treatment of bleeding oesophageal varices. In January 2007 SEP acquired world-wide rights to Plenaxis®, the world’s first approved GNRH antagonist for the treatment of prostate cancer. In July 2007 SEP announced that it had secured rights for Amphocil®, a treatment for life threatening fungal infections, in Germany, Italy and France. SEP is backed by Advent Venture Partners.

About Advent Venture Partners:

Advent Venture Partners (“Advent Ventures”) is one of the most experienced venture capital firms in the UK. Established in 1981 it invests in both the Life Science and Technology sectors. Advent Ventures has raised over £1 billion from institutional investors across Europe and the USA since 1998. It has backed around 60 life science companies of which, to date, 19 have obtained public listings and a further 9 companies have been sold, including PowderMed (to Pfizer) and KuDOS Pharmaceuticals (to AstraZeneca).

Investments by the Advent Ventures Life Sciences team include Norwegian radiopharmaceuticals company Algeta; Dutch gene-medicine company Amsterdam Molecular Therapeutics; UK-based Thiakis, which develops hormone-based treatments for obesity; and the Swiss therapeutic antibody company 4-Antibody.

Algeta provides update on its late-stage clinical programme for Alpharadin in prostate cancer

By Algeta, Press Release
Press Release.

 

Oslo, Norway, 20 December 2007 – Algeta ASA (OSE: ALGETA), the cancer therapeutics company, is pleased to provide an update on its clinical development of Alpharadin in hormone refractory prostate cancer (HRPC).

 

Phase III trial programme:

Algeta has finalised the study design for its pivotal international Phase III trial programme. Regulatory filing for start up of the trial is planned to commence early in 2008, and the first patient is expected to enrol before mid-2008. Initially, the trial is planned to enrol a total of 450 patients and to include clinical centres in Europe, Asia/Pacific and South America.

The primary endpoint of the Phase III trial will be the overall survival benefit of Alpharadin in patients with skeletal metastases from HRPC. The double-blind, controlled trial will enrol symptomatic HRPC patients who will be randomised to receive Alpharadin plus best supportive care or placebo plus best supportive care. Patients will receive multiple injections of Alpharadin over a period of six months.

An independent safety and monitoring board will be established to review the safety data of the trial.

 

Ongoing Phase I and II trial programme:

Algeta’s Phase II clinical development programme of Alpharadin in HRPC involves three clinical studies. The major efficacy study (BC1-02) has already been reported, and demonstrated significant survival benefit and a benign side effect profile in HRPC patients. Algeta began preparing the Phase III trial based on these encouraging data.

In the second Phase II trial (BC1-03), a potential dose-response relationship of the pain palliating effect of a single injection of Alpharadin in patients with painful skeletal metastases from HRPC is being studied. Four different dose levels of Alpharadin, ranging from 5 to 100 kBq/kg will be evaluated in this randomised, comparative, double-blind design. Patient enrolment is now complete and preliminary data from this trial is expected to be available in Q2 2008.

In the final Phase II study (BC1-04), a potential relationship between dose and therapeutic effect in patients with symptomatic or non-symptomatic HRPC, as measured by levels of serum prostate specific antigen (PSA), a widely recognized biomarker for progression of prostate cancer, is being explored. The patients in the trial have been randomised to three different dose levels of Alpharadin for a blinded evaluation. Patients will receive three injections of Alpharadin given at six-week intervals and patient recruitment is now complete. The preliminary results from this trial are expected to be available in Q3 2008.

Finally, patient enrolment in an open Phase I dosimetry trial (BC1-05) is ongoing and patient enrolment is expected to be complete during Q1 2008. This trial will provide additional biodistribution, pharmacokinetic, dosimetry and safety data for Alpharadin.

Together, these trials will provide additional clinical efficacy and safety data to supplement that provided by the highly successful Phase II efficacy trial (BC1-02).

Dr. Thomas Ramdahl, President and CEO of Algeta, said:

“We have achieved two further important milestones in our Phase II trials by completing the enrolment of patients and we look forward to the first results in Q2 and Q3 in 2008. While these additional trials are important to support our overall clinical package for Alpharadin, our main focus is now on finalising preparations for the start of Phase III trials. We are well advanced in this process and have finalised the study design, which will measure the overall survival benefit of Alpharadin in HRPC patients, an unequivocal and internationally accepted endpoint for developmental prostate cancer treatments. We are on target for entering the first patient into the trial before mid-2008.”

 

For further information, please contact:

Dr. Thomas Ramdahl, CEO
+47 23 00 79 90 / +47 913 91 458 (mob)

Geir Christian Melen, CFO
+47 23 00 79 90 / +47 913 02 965 (mob)
post@algeta.com

Dr. Mark Swallow / David Dible
Citigate Dewe Rogerson
+44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

 

About Algeta

Algeta ASA is a Norwegian cancer therapeutics company built on world-leading, proprietary technology.

Algeta is developing new, targeted cancer therapeutics that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.

Algeta’s lead product candidate, Alpharadin, is expected to enter Phase III clinical trials in hormone refractory prostate cancer based on positive Phase II results. Alpharadin is a novel bone-seeking therapeutic based on the alpha particle emitter radium-223 and may target skeletal metastases from multiple cancer types, as well as primary bone cancers.

Algeta is also developing other technologies for delivering alpha emitters. These include microparticles, liposomes, and methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227.

The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

 

Forward-looking Statement:
This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.

Amsterdam Molecular Therapeutics Initiates Program for Late Stage Liver Cirrhosis and Reports Strong Progress in AMT-011 with trial fully recruited and European and US Submission On Track for first half of 2008

By Press Release
Press Release.

 

Amsterdam, The Netherlands – November 27, 2007 – Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, today announced it has signed an agreement with Digna Biotech/CIMA for the development of AAV-mediated insulin-like growth factor I (IGF-I) to treat late stage liver cirrhosis. At 10:30 a.m. CET today, the company’s management will hold a conference call to discuss today’s announcement and to provide a general business update. Access details can be found at the end of this release.

 

Liver cirrhosis:

Liver cirrhosis is the seventh-leading cause of death in the world and represents a late stage of progressive liver fibrosis. Today, no available treatment can stop or reverse the disease. The only option may be liver transplantation, which still carries a high-risk and, due to the lack of sufficient donors, is not available to many of these patients. More than 27,000 patients die of cirrhosis and chronic liver disease each year in the U.S. alone.

 

CIMA IGF-I program:

The agreement stems from the exclusive license to AMT from Digna Biotech to commercialize all gene therapy products resulting from the R&D activities performed at the Center for the Study of Applied Medicine (CIMA) at the University of Navarra, Spain. Employing more than 400 researchers, CIMA is one of the leading gene therapy research centers in Europe. The IGF-1 program is the first initiated under that agreement.

 

The group of Professor Prieto at CIMA has established in relevant animal models an extensive Proof of Concept demonstrating that expression of low levels of IGF-I in fibrotic and cirrhotic liver is associated with a favorable outcome of the disease and that gene-therapy-mediated IGF-I expression has promising effects on the progression of the disease as well as its systemic complications. Prieto and his collaborators have demonstrated that even low doses of AAV engineered to carry IGF-1 were sufficient to interfere with, or even reverse fibrosis and achieve a long term effect. AAV vectors constitute the gene therapy platform of choice of Amsterdam Molecular Therapeutics.

 

A pilot clinical trial conducted by investigators in Pamplona, Spain and Groningen, The Netherlands in a small number of cirrhotic patients supports the importance of IGF-1 in treating cirrhosis – both an increased serum albumin and improved energy metabolism were achieved as a result of (subcutaneous) IGF-I protein administration. Because of the short half-life of IGF-1, a treatment based on the subcutaneous administration of recombinant IGF-I would require almost constant infusion and is not considered practical. The gene-therapy-mediated induction of IGF-I expression bypasses this disadvantage and shows long-term effect, as the animal studies at CIMA have shown. Clinical studies will need to confirm the long-term safety and efficacy in men.

 

Ronald Lorijn, CEO of AMT, said, “We are very pleased with our agreement with CIMA, which gives us access to programs that are already well-advanced and that have tremendous potential. Our technology platform seems ideally suited to develop IGF-I for the treatment of liver cirrhosis, a very serious disorder, which not only causes great human suffering, but also comes at a very high cost for society. AMT is fully dedicated and equipped to add this new program to its product pipeline and plans to start the necessary pre-clinical studies including a full toxicology program next year. We are confident to continue to leverage our close relationship with Digna and CIMA to fill our pipeline with promising products that address unmet medical needs.”

 

Clinical Program AMT-011:

The clinical development of AMT’s lead product AMT-011 for the treatment of Lipoprotein Lipase Deficiency is proceeding according to plan. All patients have been recruited in the Canadian study. A total of 6 patients have been injected with AMT-011, completing the first 2 dose cohorts. The remaining 8 patients will be injected before the end of February, allowing the Company to file for registration with the EMEA, FDA and Health Canada before the end of the first half of 2008.

 

Conference call and webcast presentation:

AMT will conduct a conference call open to the public today at 10.30 CET, which will also be webcast. Netherlands dial in: +31 (0)800 949 4517 (toll free); US dial in: +1 866 291 4166 (toll free); UK dial in: +44 207 107 0611. The webcast can be accessed on the investors portion of AMT’s website at www.amtpharma.com. Please go to the website 15 minutes prior to the call to register, download and install the necessary audio software. Playback of the call will be availably for 24 hours after the call. Dial in: +41 91 612 4330; +44 20 7108 6233; or +1 866 416 2558. ID 428#. The archived webcast also will be available for replay shortly after the close of the call.

 

About Amsterdam Molecular Therapeutics:

AMT has a unique gene therapy platform that to date appears to circumvent many if not all of the obstacles that have prevented gene therapy from becoming a mainstay of clinical medicine. Using adeno-associated viral (AAV) vectors as the delivery vehicle of choice for therapeutic genes, the company has been able to design and validate what is probably the first stable and scalable AAV production platform. As such, AMT’s proprietary platform holds tremendous promise for thousands of rare (orphan) diseases that are caused by one faulty gene. AMT currently has a product pipeline with six products at different stages of development.

 

For information:

André Verwei, CFO
+31 20 566 5686
a.verwei@amtbv.com

 

Hans Herklots
+31 20 566 8125
h.herklots@amtbv.com

 

Certain statements in this press release are “forward-looking statements” including those that refer to management’s plans and expectations for future operations, prospects and financial condition. Words such as “strategy,” “expects,” “plans,” “anticipates,” “believes,” “will,” “continues,” “estimates,” “intends,” “projects,” “goals,” “targets” and other words of similar meaning are intended to identify such forward-looking statements. Such statements are based on the current expectations of the management of Amsterdam Molecular Therapeutics only. Undue reliance should not be placed on these statements because, by their nature, they are subject to known and unknown risks and can be affected by factors that are beyond the control of AMT. Actual results could differ materially from current expectations due to a number of factors and uncertainties affecting AMT’s business, including, but not limited to, the timely commencement and success of AMT’s clinical trials and research endeavors, delays in receiving U.S. Food and Drug Administration or other regulatory approvals (i.e. EMEA, Health Canada), market acceptance of AMT’s products, effectiveness of AMT’s marketing and sales efforts, development of competing therapies and/or technologies, the terms of any future strategic alliances, the need for additional capital, the inability to obtain, or meet, conditions imposed for required governmental and regulatory approvals and consents. AMT expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. For a more detailed description of the risk factors and uncertainties affecting AMT, refer to the prospectus of AMT’s initial public offering on June 20, 2007, and AMT’s reports filed from time to time with NYSE Euronext (Holding) N.V.

Emergent BioSolutions Signs $448 Million Three Year Contract with Department of Health and Human Services

By Emergent Biosolutions, Press Release
Press Release.

 

ROCKVILLE, Md.–(BUSINESS WIRE)–Sept. 26, 2007–Emergent BioSolutions Inc. (NYSE:EBS), announced today that it has signed a three year contract with the U.S. Department of Health and Human Services (HHS), with a total value of up to $448 million. Components of the contract include:

(i) $400 million firm fixed-price for delivery of 18.75 million doses of BioThrax(R) (Anthrax Vaccine Adsorbed) for inclusion in the strategic national stockpile (SNS);
(ii) $34 million for receipt of regulatory approval of 4-year expiry dating for BioThrax payable through a combination of a lump-sum payment reflecting a price per dose increase for certain doses delivered prior to approval and an increase in the per dose price to be paid for doses delivered following approval;
(iii) up to $11.5 million in milestone payments in connection with advancement towards a post-exposure prophylaxis (PEP) indication for BioThrax; and,
(iv) $2.2 million for logistics services and other related support.

The Company anticipates making deliveries for approximately 6 million doses under this contract by year-end 2007. As a result, the company reaffirms its expectation for full year total revenue growth of 10 to 15 percent, with a bias toward the upper end of the range, and full year positive net earnings.

Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions, stated, “”We are honored to continue our longstanding relationship with HHS to provide BioThrax as a critical component of our nation’s biodefense stockpile. I applaud the dedication and professionalism of the senior leadership within HHS and Biomedical Advanced Research and Development Authority in completing this important step towards enhancing our domestic biodefense infrastructure. Emergent BioSolutions remains dedicated to working with various government agencies in their commitment to procure medical countermeasures as a primary element of establishing the highest possible levels of biopreparedness.””

Under terms of the contract, HHS will purchase from the company an aggregate of 18.75 million doses of BioThrax through September 2010, for a firm, fixed-price of $400 million. In the event the company receives U.S. Food and Drug Administration (FDA) approval of the company’s pending supplement to its biologics license application (BLA) to extend the shelf life of BioThrax from three years to four years, the company will receive a lump sum payment reflecting a price per dose increase for certain doses delivered prior to approval and an increase in the price per dose to be paid for doses delivered following the date of approval, with a total value of approximately $34 million. If FDA approval of 4-year expiry dating is not received during the term of the contract, the company will not be entitled to receive any of the $34 million. The company submitted its supplement for 4-year expiry dating to the FDA in December 2006 and has been providing additional information to the agency in support of its application.

Under the contract, HHS will also provide up to $11.5 million in connection with advancing the company’s program to obtain a PEP indication for BioThrax. The PEP indication, which would expand the use of BioThrax beyond the current pre-exposure prophylaxis indication, is designed to permit the administration of BioThrax in combination with antibiotics following exposure to anthrax. These funds are payable upon the company’s achievement of specific program milestones. The company anticipates that it will receive $8.8 million of this amount in the fourth quarter of 2007.

In addition, under the contract the company has agreed to provide all shipping services related to delivery of doses into the SNS over the contract term, and will receive payment of an additional $2.2 million.

The contract has been funded with Federal funding through the Project BioShield Special Reserve Fund, which was created by an act of Congress in May 2004.

Previously, Emergent BioSolutions has provided 10 million doses of BioThrax to HHS for inclusion in the SNS under a May 2005 supply agreement for 5 million doses valued at $123 million and a May 2006 contract modification for an additional 5 million doses valued at $120 million.

Conference Call & Webcast: Company management will host a conference call at 9:00 am Eastern today, September 26, 2007 to discuss this announcement. Interested parties may participate in the live teleconference by dialing 866/383-8008 or 617/597-5341 or via a webcast accessible at www.emergentbiosolutions.com, under “”Investors””. A replay of the teleconference will be available on the company website or by dialing 888/286-8010 or 617/801-6888 and using the passcode 61817264, approximately one hour after the teleconference concludes. The replay will be available through October 10, 2007.

About BioThrax(R) (Anthrax Vaccine Adsorbed): BioThrax is the only FDA-approved vaccine for the prevention of anthrax infection. It is approved by the FDA as a pre-exposure prophylaxis for use in adults who are at high risk of exposure to anthrax spores. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Baccillus anthracis and contains no dead or live bacteria. BioThrax is administered by subcutaneous injection in three initial doses followed by three additional doses, with an annual booster dose recommended thereafter. Since 1998, approximately 20 million doses of BioThrax have been procured by the U.S. government. During that time period, over 6.5 million doses have been administered to over 1.6 million military personnel. BioThrax cannot cause anthrax infection.

About Emergent BioSolutions Inc.: Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission–to protect life. We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body’s immune system to prevent or treat disease. Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare. Our marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. More information on the company is available at www.emergentbiosolutions.com.

Safe Harbor Statement: This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including our performance under our contract with HHS and future payments from HHS to us under the contract, and any other statements containing the words “”believes””, “”expects””, “”anticipates””, “”plans””, “”estimates”” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials; our ability to identify and acquire or in license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 and subsequent reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

CONTACT: Emergent BioSolutions Inc.

Investors Contact:
Robert G. Burrows, Vice President, Investor Relations
301-795-1877, burrowsr@ebsi.com

or

Media Contact:
Tracey Schmitt, Director, Corporate Communications
301-795-1800, schmittt@ebsi.com

Alpharadin treatment more than doubles survival rate in prostate cancer patients

By Algeta, Press Release
Press Release.

 

Algeta presents new Phase II clinical trial data at ECCO

 

Oslo, Norway, 25 September 2007 – Algeta ASA (OSE: ALGETA), the Norwegian cancer therapeutics company, today presents new two-year survival data from its Phase II clinical trial with Alpharadin (radium-223) as a treatment for hormone refractory prostate cancer (HRPC).

The new clinical data from the Phase II trial involving 64 HRPC patients shows that more than twice as many patients receiving Alpharadin were alive (10 of 33) two years following start of treatment compared to those that receive placebo (4 of 31).

Previous data from the trial, presented earlier this year at ASCO and in the Lancet Oncology[1], has also shown that Alpharadin significantly reduces levels of prostate-specific antigen (PSA), a widely recognized biomarker for progression of prostate cancer, and other relevant biomarkers. The treatment regime of four injections of Alpharadin was well tolerated during the 12-week treatment period, and an extended treatment period may further delay disease progression.

Algeta’s CEO, Dr. Thomas Ramdahl said: “Alpharadin continues to demonstrate a very positive clinical effect in the treatment of prostate cancer and our preparations to begin pivotal Phase III trials with Alpharadin for the treatment of HRPC in 2008 remain on schedule.”

The clinical data will be presented today in a poster for the first time in Europe at the 14th European Cancer Conference (“ECCO 14”: 23–27 September 2007, Barcelona, Spain). A copy of the poster, entitled Placebo-Controlled, Randomized, Phase II study of Radium-223 in Metastatic Hormone Refractory Prostate Cancer (HRPC), is available at http://www.algeta.com/

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For further information, please contact
Dr. Thomas Ramdahl, CEO
+47 23 00 79 90 / +47 913 91 458 (mob)
post@algeta.com

Dr. Mark Swallow / Helena Galilee
Citigate Dewe Rogerson +44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

About Algeta:
Algeta ASA is a Norwegian cancer therapeutics company built on world-leading, proprietary technology.

Algeta is developing new, targeted cancer therapeutics that harness the unique characteristics of alpha particle emitters and are potent, well-tolerated and convenient to use.

Algeta’s lead product candidate, Alpharadin, is expected to enter Phase III clinical trials in hormone refractory prostate cancer based on positive Phase II results. Alpharadin is a novel bone-seeking therapeutic based on the alpha particle emitter radium-223 and may target skeletal metastases from multiple cancer types, as well as primary bone cancers.

Algeta is also developing other technologies for delivering alpha emitters. These include microparticles, liposomes, and methods to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227.

The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).

Alpharadin and Algeta are trademarks of Algeta ASA.

Forward-looking Statement: This news release contains forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Theses factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.

 

[1] Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study – Lancet Oncology 2007; 8: 587-594

CardiacAssist, Inc. Announces 1000th TandemHeart System Procedure

By CardiacAssist, Press Release
Press Release.

 

PITTSBURGH, July 18: CardiacAssist, Inc, a Pittsburgh-based medical device company has announced a new milestone with the completion of the 1000th worldwide procedure utilizing the TandemHeart System. The TandemHeart is used in all top 20 heart and heart surgery hospitals, as ranked by the U.S. News and World Report and is in use at 120 facilities worldwide.

An emergency case performed at Texas Heart Institute helped CardiacAssist push past the 1000th procedure mark. Centers performing cases within several days of the 1000th case include: Texas Heart Institute in Houston, TX; Lenox Hill Hospital, in New York, NY; New York Presbyterian Hospital in New York, NY; and Massachusetts General Hospital in Boston, MA.

The TandemHeart System is an extracorporeal circulatory support system that provides systematic extracorporeal circulatory support through a rapid cardiac catheterization procedure. The TandemHeart System is designed to provide 5.0 lpm of flow in the cath lab without the need for cardiac surgery. It is FDA approved for up to six hours for procedures not requiring full cardiopulmonary bypass.

“There is no doubt this device will continue to be an invaluable tool for cardiologists and cardiac surgeons as the standard of care continues to elevate”, said Michael Garippa, President and CEO of CardiacAssist. “We are indebted to the more than 200 different physicians who have performed TandemHeart System procedures. It is gratifying that so many hospitals have adopted the TandemHeart System for patients in dire circumstances.”

The TandemHeart System is comprehensively reimbursed by Medicare under existing DRG codes. The device can be placed rapidly in the cath lab or operating room, providing systemic, reliable extracorporeal circulatory support, formerly only available by cardiopulmonary bypass for critically ill patients.

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About CardiacAssist:
Founded in 1996, CardiacAssist, Inc. is a privately held, Pittsburgh-based medical device company that develops, manufactures and markets innovative products designed to provide cardiologists and cardiac surgeons with minimally invasive solutions for providing extracorporeal circulatory support. Its vision is to help advance the treatment of heart disease by bridging gaps in current treatment methodologies.

This press release may contain certain forward-looking statements that relate to CardiacAssist’s future business and financial performance. Such statements are subject to a number of risks and uncertainties that may cause the actual events or future results to differ from those discussed herein.

Media Contact:
Monica Bush, CardiacAssist, Inc.
412-963-7770
mbush@cardiacassist.com