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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.

*****

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

Speciality European Pharma secures distribution rights for Amphocil® for leading European markets

By Press Release, SEP
Press Release.

 

London, 13 July 2007: Speciality European Pharma Ltd (SEP), London, UK, today announced that it has obtained distribution rights to Amphocil® for Germany, France and Italy. Amphocil®, a product owned by Three Rivers Pharmaceutical LLC (Pennsylvania, USA), is presently marketed in a number of countries, including the USA, UK, Sweden, Austria and Portugal. Amphocil® is already approved in Italy and registrations for Germany and France will be initiated later this year.

Amphocil® (amphotericin B cholesteryl sulfate complex for injection) is a lipid form of amphotericin B used for the treatment of life threatening systemic fungal infections such as invasive aspergillosis. These severe fungal infections occur primarily in patients with suppressed or compromised immune systems due to disease or medication.

Commenting on this agreement, Geoff McMillan, Chief Executive of SEP said:

“This agreement provides us with a further regulatory stage product in one of our focus areas, critical care. It again demonstrates our ability to secure rights to late stage specialist products for the European market and follows the Company’s recent acquisitions of the approved products, Plenaxis and Haemopressin. We are delighted to be working with Three Rivers Pharmaceuticals and its European partner company Nespera Ltd towards the successful registration and marketing of this product in these key European countries.”

– Ends –

About Speciality European Pharma Limited:
The company was founded in April 2006 with the mission of identifying and acquiring specialist pharmaceutical products for the European market and is backed by Advent Venture Partners. In February 2007 the company completed the acquisition of two products, Haemopressin and Plenaxis®, both of which are approved in certain European markets, and Amphocil is now the third approved product for which SEP has secured certain distribution rights.

About Advent Venture Partners:
Advent Ventures is one of the most experienced technology venture capital firms in the UK. Established in 1981 it invests in both the Life Science and Information and Communications Technology sectors. Advent Ventures has over £500 million (US$ 900m) under management from institutional investors across Europe and the USA. 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).

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

Contact details:
Geoff McMillan, CEO
Speciality European Pharma Ltd
Suite 106, The Spirella Building, Bridge Road, Letchworth Garden City, Hertfordshire SG6 4ET, UK
Tel: +44 (0)1462 476516
Email: geoff.mcmillan@spepharma.com

Advent Venture Partners and Partech International announce Pertinence merger with Intercim

By Press Release
Press Release.

 

London, 5 July 2007: Advent Venture Partners (‘Advent Ventures’) and Partech International are pleased to announce that Pertinence SA, in which both were investors, has merged with U.S. manufacturing and execution systems (MES) company, Intercim.

The combined company will be called Intercim LLC and will bring together Pertinence’s manufacturing intelligence capabilities with Intercim’s manufacturing execution systems. The merged company will also boast a blue-chip client list that includes Airbus, Boeing, BMW, Sanofi Aventis and Siemens.

Pertinence has become a world leader in enterprise manufacturing intelligence software under the guidance of investors Advent Ventures, Partech International and Seeft Ventures, a third investor in the company. It has expanded in Europe and the US, and developed innovative systems for the aerospace, pharmaceutical, automobile and semiconductor industries.

Peter Baines, a General Partner at Advent Ventures said:

“We originally invested in Pertinence because we saw that it had a disruptive technology and the opportunity to dominate an emerging market. Over the past 5 years we have worked closely with Pertinence’s first class management team to grow the business and to develop its products and geographical reach. This merger with Intercim presents a great opportunity to reach a broader customer base in the US and strengthen its already solid market position.”

Philippe Collombel, General Partner at Partech International, said:

“We are delighted at the merger between Pertinence and Intercim. This transaction is part of Pertinence’s ongoing development and marks a major step toward creating a leading company in the industrial process optimization market. It is also a strong example of support for companies in our portfolio. We are convinced that this new entity will be a great success.”

Pertinence Chief Executive Amélie Faure said:

“The quality of our technology, our roots in top quality industries and our international development would not have been possible without the vision, confidence and commitment of our investors. The merger with Intercim was also possible thanks to Frédéric Halley, a Managing Partner of Tioga Ventures. We are now writing a new chapter of our history and we hope that they will be proud of it.”

– ENDS –

For more information please contact:

Peter Baines, Advent Ventures, 020 7932 2100
Kay Larsen / Francesca Reville, Penrose Financial, 020 7786 4888

Veronique Delorme, Partech International, +33(0)1 53 65 65 53

Notes to Editors:

About Advent Ventures:
Established in 1981 in the UK, Advent Ventures is one of the most experienced technology venture capital firms in Europe. It invests in the Technology and Life Sciences sectors. Advent Ventures has over £500 million ($1 billion) under management from institutional investors across Europe and the US. Advent portfolio company Cartesis was recently sold to Business Objects for $300 million.

Other technology investments include Snell & Wilcox (one of the key players in the digital media industry), Phyworks (integrated circuits for broadband telecommunications), BridgeCo (silicon and software solutions for home networking) and Qype (local search and user generated city guide). www.adventventures.com

About Partech International:
Founded in 1982, Partech International is a private equity company based in the US, Europe and Israel. Partech invests exclusively in the Information Technology sector and currently has $850 million in funds under management. Its international teams collaborate closely to identify the most innovative companies in the software, Internet, communications and components sectors as well as in the field of medical information technology.

In Europe, Partech investments include B3G, DailyMotion, DiBcom, JobPartners, Netsize and WAZAP. The company has also successfully invested in Ascend Communications, Business Objects, Cadence, Informatica, ISDNet, Travelprice and Vignette. In 2006, portfolio companies Visicu and Allot were listed on NASDAQ while Akimbi, DCT, Jungo and Meiosys were acquired. www.partechvc.com

About Pertinence:
Pertinence is a world leader in enterprise manufacturing intelligence. Pertinence systems allow analysis, extraction, application, control and sharing of Best Operating Practices (BOP) with software dedicated to optimizing complex industrial systems and processes. The innovative data analysis technology means that production engineers, operators and quality managers can derive the highest level of quality and performance from their existing processes. Pertinence Suite also reduces the time required to launch a product reliably and continually control the performance of the process.

Pertinence, a certified Microsoft partner, is based in Europe and the US. Its customers include major players actors in the pharma-biotech, aerospace, defence, industrial products and semiconductors industries such as Airbus, Boeing, BMW, Sanofi and Siemens.

Pertinence is also a partner of SAP in its “Powered by Net Weaver” initiative, which enables it to offer SAP clients its Business Package for Enterprise Manufacturing Intelligence by Pertinence system. www.pertinence.com

Biogen Idec and CardioKine partner to develop Lixivaptan, a novel Vasopressin Antagonist

By Cardiokine, Press Release
Press Release.

 

Lixivaptan to enter Phase III clinical trial in 2007 in heart failure patients.

 

Cambridge, MA and Philadelphia, PA (July 2, 2007) – Biogen Idec (NASDAQ: BIIB) and Cardiokine, Inc., a privately-held specialty pharmaceutical company focused on the development of drugs for the treatment of heart failure and related indications, today announced the signing of an agreement to jointly develop lixivaptan, an oral compound expected to enter a Phase III clinical trial this year for the potential treatment of hyponatremia in patients with congestive heart failure (CHF).

Lixivaptan is a selective V2 vasopressin receptor antagonist that, in clinical trials, has demonstrated promising activity in treating hyponatremia, an imbalance of sodium and water in the body. Lixivaptan works by causing water to be excreted from the kidney, without affecting sodium or other electrolytes. Particularly in heart failure patients, hyponatremia is associated with volume overload, a key symptom leading to hospitalization of these patients. In addition, hyponatremia is an important feature of other disorders including liver cirrhosis and syndrome of inappropriate antidiuretic hormone (SIADH), and can contribute to morbidity and negative outcomes.

“With this late-stage oral compound, we continue to leverage our global development and specialty market expertise to grow our business and broaden our therapeutic focus. An effective treatment for hyponatremia could be beneficial to patients with a variety of diseases, including heart failure,” said James C. Mullen, Biogen Idec’s President and Chief Executive Officer (CEO). “This program will expand our efforts in cardiovascular care and we look forward to working with Cardiokine to deliver this promising new product for patients.”

“We are extremely pleased to be partnering lixivaptan with Biogen Idec. We share an appreciation of the adverse health consequences associated with hyponatremia and have a common vision for lixivaptan. Biogen Idec’s proven development and commercialization capabilities in concert with Cardiokine’s development team will make this vision a reality,” said David Brand, President and CEO of Cardiokine.

Under terms of the agreement, Cardiokine will receive a $50 million upfront payment and up to $170 million in additional milestone payments for successful development and global commercialization of lixivaptan, as well as royalties on commercial sales. Biogen Idec will be responsible for the global commercialization of lixivaptan and Cardiokine will have an option for limited co-promotion in the United States (U.S.). The agreement is expected to become effective in the third quarter of 2007, and is subject to the satisfaction of certain closing conditions and customary approvals.

***

About lixivaptan
Lixivaptan is a highly potent, non-peptide, selective V2 vasopressin receptor antagonist. It antagonizes the action of vasopressin (also known as antidiuretic hormone, ADH) on the V2 receptors in the kidney-collecting duct, causing water to be excreted from the kidney, without affecting sodium or other electrolytes. Based on this mechanism of action, lixivaptan shows promise in the treatment of disease states associated with water retention and electrolyte imbalance.

About hyponatremia
Hyponatremia is the most common electrolyte disorder in clinical practice. It is estimated that the incidence of hyponatremia in hospitalized patients in the U.S. is greater than one million. Hyponatremia is recognized as an independent contributor to negative patient outcomes in many chronic diseases, most notably CHF, as well as cirrhosis and SIADH.

About Cardiokine
Cardiokine, headquartered in Philadelphia, is a privately held specialty pharmaceutical company focused on the development of pharmaceuticals for the treatment and prevention of heart failure and related cardiovascular and metabolic indications. Additional information about Cardiokine is available at www.cardiokine.com.

About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec’s significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For press releases and additional information about the company, please visit, www.biogenidec.com.

Biogen Idec Safe Harbor
This press release contains forward-looking statements regarding the agreement with Cardiokine and the development of lixivaptan. These statements are based on the companies’ current beliefs and expectations. Drug development involves a high degree of risk. Only a small number of research and development programs result in commercialization of a product. Factors which could cause actual results to differ materially from Biogen Idec’s current expectations include the risk that the company may not be able to demonstrate the safety and efficacy of lixivaptan at each stage of the clinical trial process; technical hurdles relating to the manufacture of lixivaptan may be encountered; the company may not be able to meet applicable regulatory standards or regulatory authorities may fail to approve lixivaptan; and the company may encounter other unexpected hurdles.

For more detailed information on the risks and uncertainties associated with Biogen Idec’s drug development activities, see the section entitled “Risk Factors” in Biogen Idec’s quarterly report on Form 10-Q for the fiscal quarter ended March 31, 2007 that was filed with the Securities and Exchange Commission, as well as other periodic and current reports of Biogen Idec filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Algeta’s Phase II Clinical Study Data for Alpharadin™ in Prostate Cancer Published in Lancet Oncology

By Algeta, Press Release
Press Release.

 

Oslo, Norway, 4 June 2007 – Algeta ASA (OSE: ALGETA), the Norwegian cancer therapeutics company, is pleased to announce that clinical Phase II study data for Alpharadin™ in prostate cancer, Algeta’s lead product candidate, has been published in the 3 June 2007 online issue of the leading peer-reviewed journal Lancet Oncology. This is first time comprehensive details and data from the Phase II trial have been published in this format.

The data was also presented by Professor Øyvind Bruland, of the Norwegian Radium Hospital, Oslo and founder of Algeta, in a Poster Discussion on 2 June at the American Society of Clinical Oncology’s annual meeting (1-5 June 2007, Chicago, USA).

In the paper, entitled “Bone-targeted radium-223 in symptomatic, hormone-refractory prostate cancer: a randomised, multicentre, placebo-controlled phase II study” by Nilsson et al., data is presented that demonstrate the clear potential of Alpharadin as a new treatment for patients with late-stage hormone-refractory prostate cancer (HRPC). These data are supplemented by the ASCO presentation. Algeta is currently preparing to start pivotal Phase III studies of Alpharadin in this indication in 2008.

Alpharadin treatment showed a statistically significant effect on survival – In the randomized double-blind, placebo-controlled clinical trial involving 64 HRPC patients, those patients treated with at least two injections of Alpharadin, a novel radiotherapy based on radium-223, survived on median nearly 25 weeks (53%) longer than those receiving placebo (71.0 weeks compared to 46.4 weeks). At the time of the 18-months follow-up assessment (February 2007), 15 (48%) patients in the Alpharadin group were still alive compared to 6 (22%) in the placebo group.

PSA levels reduced – Alpharadin treatment resulted in a reduction in levels of prostate-specific antigen (PSA), a widely recognized biomarker for progression of prostate cancer. The measurement of reduced PSA blood levels in response to Alpharadin treatment is indicative of a therapeutic effect. The beneficial effects on PSA levels lasted for up to three months after the end of treatment.

Positive effect on biomarkers – In addition, previously announced results on this trial to demonstrate its potential as a treatment for bone metastases in HRPC patients showed that Alpharadin has a significant positive effect on a range of biomarkers of bone turnover, including significantly reduced bone alkaline phosphatase (bone-ALP) levels compared with placebo.

Professor Sten Nilsson, Head of Department of Oncology Radiumhemmet at the Karolinska Hospital and Institute in Stockholm, Principal Investigator of the trial and lead author of the Lancet Oncology paper, commented:

“The positive results we have seen from this Phase II trial with Alpharadin are very encouraging and have been reinforced at each follow-up stage. Most importantly, patients treated with Alpharadin in this study demonstrated a statistically significant increased survival time and showed an overall benign side effect profile. Further positive effects on lowering blood PSA levels, the common biomarker of disease progression, and other biomarkers confirm our belief in the potential of Alpharadin in the treatment of late-stage hormone-refractory prostate cancer.”

Dr. Thomas Ramdahl, CEO of Algeta, said:

“The publication in Lancet Oncology and presentation at ASCO provide important endorsement of the quality of our Phase II trial of Alpharadin in prostate cancer. As we progress towards Phase III trials next year, we are very encouraged by the survival benefit shown in the present study, which is consistent with all other efficacy measures, as well as Alpharadin’s excellent side-effect profile.”

A reprint of the Lancet Oncology article is available from Algeta by request.

 

For further information, please contact:
Dr. Thomas Ramdahl, CEO: +47 23 00 79 90 / +47 913 91 458 (mob);
Dr. Roger Harrison, CBO: +47 23 00 79 90 / +47484 01302 (mob);
Geir Christian Melen, CFO: +47 23 00 79 90 / +47913 02965 (mob);
post@algeta.com Dr. Mark Swallow/Helena Galilee,
Citigate Dewe Rogerson: +44 (0)207 638 9571,
mark.swallow@citigatedr.co.uk

Further details of the BC1-02 Alpharadin™ Phase II clinical trial
The present trial was initiated in 2004 to study therapeutic efficacy of Alpharadin (based on radium-223) in 64 HRPC patients with painful skeletal metastases using biomarkers and clinical endpoints as outcome measures. Safety and changes in biomarkers are reported based on analyses at 12 months after the start of treatment. The double-blind placebo-controlled trial was conducted at 11 centres in Norway, Sweden and the UK.

All patients initially received palliative external beam radiotherapy before being randomized to receive four intravenous injections of Alpharadin (50 kBq per kg body weight) or saline (placebo), administered four weeks apart over a 12-week period. Levels of bone-ALP (primary endpoint), S-PINP (serum procollagen I N propeptide), S-CTX-I (serum C-terminal crosslinking telopeptide of type I collagen), S-ICTP (serum type I collagen cross-linked C-telopeptide) and PSA were analysed (Alpharadin versus saline) at regular time points throughout the study. 33 patients received Alpharadin and 31 patients received saline (placebo).

The results for all included patients (Intent-to-Treat) showed an increased median time of survival from 46.4 weeks in the placebo group to 65.3 weeks in the Alpharadin-treated group, a 41% increase in median survival time. The Cox proportional hazard ratio adjusted for covariates was 0.472 (p=0.020), indicating that patients receiving Alpharadin treatment had a 53% decreased risk of death at each time point compared with those receiving placebo. At the time of the 18 months follow-up assessment, 15 (45%) patients in the Alpharadin group were still alive compared to 8 (26%) in the placebo group.

For the Per-Protocol population (patients that have received at least two injections with study medication with preserved blinding), the results showed an increased median time of survival from 46.4 weeks in the placebo group to 71.0 weeks in the Alpharadin treated group, a 53% increase in median survival time. At the time of the 18 months follow-up assessment, 15 patients in the Alpharadin group were still alive compared to 6 in the placebo group.

Data presented also demonstrated a statistically significant effect on a range of biomarkers of bone turnover, including significantly reduced bone alkaline phosphatase (bone-ALP) levels from baseline to four weeks after the last injection compared with placebo (-65.6 % versus +9.3% in the placebo group, p<0.0001).

Furthermore, the median change of blood PSA level from baseline to four weeks after the last injection for Alpharadin (33 patients) was -23.8 % versus +44.9% in the placebo group (31 patients), P=0.003. The median time to PSA progression was 26 weeks with Alpharadin vs. 8 weeks with placebo (p=0.048).

In addition to this encouraging evidence of efficacy, Alpharadin was well tolerated with little or no myelotoxicity and demonstrated an overall benign side effect profile.

Algeta has two further pain palliation and therapeutic Phase II trials ongoing during 2007.

References:

1. Nilsson, S. et al A Randomized, Placebo-Controlled, Phase II Study of Radium-223 in the Treatment of Metastatic Hormone Refractory Prostate Cancer (HRPC). Presented at the ASCO Prostate Cancer Symposium, Orlando, FL, USA, February 22-24, 2007.

About Algeta
Algeta ASA (www.algeta.com) 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

Advent Venture Partners announces the appointment of Dr Richard Mason to the Life Sciences team as Executive-in-Residence

By Advent Life Sciences, Press Release
Press Release.

 

London, 1 May 2007 – Advent Venture Partners (“Advent Ventures”) today announces the appointment of Dr Richard Mason as Executive-in-Residence. Richard will provide expertise, experience and leadership skills to key companies in the Advent Ventures portfolio.

Richard joins Advent Ventures from Cambridge Antibody Technology plc (‘CAT’) where he was Senior Vice President, Business Development and Commercial Operations. During his time at CAT, Richard led multiple transactions, including the negotiation of CAT’s joint antibody discovery and development collaboration with AstraZeneca. Since 2005, he also chaired the R&D team responsible for CAT’s establishment of a therapeutic focus in oncology and the subsequent in-licensing of a number of antibody product candidates.

Prior to joining CAT, Richard co-founded the e-health company, Cambridge Health Informatics Limited, having previously gained an MBA from the University of Cambridge. Richard graduated in Medicine from the Medical School of St Bartholomew’s Hospital and also holds a degree in Immunology from University College London. He is a qualified physician and before entering the business world he worked for 5 years for the NHS in internal medicine.

Commenting on this appointment, Dr Raj Parekh, Advent Ventures General Partner, said

“We are delighted to have Richard join the team as part of our plan to add resources and skills to help our portfolio companies succeed. His outstanding track record in business development will be a major asset for many of our portfolio companies”

For more information please contact:

Dr Raj Parekh/Dr Richard Mason, Advent Venture Partners, 020 7932 2100

Shona Prendergast / Francesca Reville,

Penrose Financial, 020 7786 4884 / 4811

 

About Advent Venture Partners – Advent Ventures is one of the most experienced technology venture capital firms in the UK. Established in 1981 it invests in both the Life Science and the Technology sectors. Advent Ventures has over £500 million (US$ 900m) under management from institutional investors across Europe and the USA. It has backed around 60 life science companies of which, to date, 21 have obtained public listings and a further 9 companies have been sold including PowderMed (to Pfizer) and KuDOS Pharmaceuticals (to AstraZeneca). Recent investments by the Advent Life Sciences team include Norwegian radiopharmaceuticals company, Algeta; the US speciality pharma company, CardioKine Inc; the US medical device company NeoGuide, UK-based Thiakis which develops hormone-based treatments for obesity, the Swiss therapeutic antibody company, 4-Antibody and EUSA Pharma Inc, a new transatlanticspecialtypharmaceutical company.

PRINCETON, New Jersey, December 19, 2022 – F2G Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for olorofim for the treatment of invasive fungal infections in patients who have limited or no treatment options.

F2G has requested approval of the NDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) for a limited, well-defined population with invasive fungal infections and limited or no treatment options. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of June 17, 2023

The NDA is supported by strong efficacy data and a good tolerability profile seen during treatment of the first 100 patients in the Phase 2b open-label study, all of whom had limited or no treatment options for either proven invasive fungal infection (including aspergilllosis, lomentosporiosis, scedosporiosis, Scopulariopsis infections, and refractory extrapulmonary coccidioidomycosis) or probable pulmonary invasive aspergillosis (Study 32, NCT03583164).

“Invasive fungal infections cause substantial morbidity and mortality, particularly among immunosuppressed patients, and can prove to be lethal in also healthy individuals when they get into deeper tissues. Effective therapies do not currently exist for some of these fungi. And even when therapies exist, some patients with invasive infections may be refractory or unable to tolerate existing antifungal treatments, thus underscoring the urgent need for new and effective treatments,” said John H. Rex, MD, chief medical officer of F2G. “Olorofim is a novel mechanism antifungal therapy from the newly discovered orotomide class. It provides a new option for patients who have exhausted treatment alternatives.”

Francesco Maria Lavino, chief executive officer of F2G, added,

“We are committed to addressing rare fungal infections, and the acceptance of filing of olorofim NDA for use in this well-defined and high-need population marks a major milestone toward our goal of bringing new options to these patients. We are building an experienced commercial team in preparation for U.S. launch, pending FDA approval. If approved, olorofim will be the first of a new class of antifungal drugs.”

Olorofim is the only antifungal medication to be awarded Breakthrough Therapy Designation by the FDA. Olorofim works through a novel mechanism of action, different from existing classes of antifungals, exerting fungal cell death through inhibition of the enzyme dihydroorotate dehydrogenase (DHODH) in the pyrimidine synthesis pathway. It is active in vitro against Aspergillus spp. (including azole-resistant and cryptic species), rare molds (e.g., Lomentospora prolificans, Scedosporium spp., Scopulariopsis spp.), and dimorphic fungi (e.g., Coccidioides spp.).

About Olorofim

Olorofim (formerly, F901318) is F2G’s leading candidate from the orotomide class and is currently being investigated in a Phase 2b open-label study in patients who have limited treatment options for difficult-to-treat invasive, rare fungal mold infections such as azole-resistant aspergillosis, scedosporiosis, lomentosporiosis, and other rare mold infections. F2G has initiated a global Phase 3 trial (“OASIS”) to compare treatment with olorofim versus AmBisome® followed by standard of care (SOC) in patients with proven or probable invasive fungal infection due to Aspergillus species (NCT05101187). Olorofim has received orphan drug designation from the FDA for the treatment of coccidioidomycosis, scedosporiosis (including lomentosporiosis), invasive Scopulariopsis, and invasive aspergillosis. Olorofim has also received orphan drug designation from the European Medicines Agency (EMA) for the treatment of invasive aspergillosis, invasive scedosporiosis (including lomentosporiosis), and invasive Scopulariopsis. Olorofim has been granted Qualified Infectious Disease Product (QIDP) designation for invasive aspergillosis, invasive scedosporiosis, invasive lomentosporiosis, coccidioidomycosis, invasive disease due to Scopulariopsis species, and invasive fusariosis. Olorofim has received Breakthrough Therapy Designation for both “treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species” and “treatment of Central Nervous System (CNS) coccidioidomycosis refractory or otherwise unable to be treated with standard of care therapy.” Olorofim is not approved by the FDA or any other regulatory agency.

About F2G

F2G is a biotech company with operations in the UK, US, and Austria focused on the discovery and development of novel therapies to treat potentially life-threatening invasive fungal infections. F2G has discovered and developed a completely new class of antifungal agents called the orotomides which selectively target a key enzyme in the de novo pyrimidine biosynthesis pathway. This is a completely different mechanism from that of the currently marketed antifungal agents and gives the orotomides fungicidal activity against a broad range of rare and resistant fungal mold infections. For more information, please visit: www.f2g.com

Forward-Looking Statements

This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also, for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

Media Contact:

Gloria Gasaatura
LifeSci Communications
+1 646 970 4688
ggasaatura@lifescicomms.com

Advent Venture Partners’ portfolio company Algeta raises NOK 250 million in successful offering

By Algeta, Press Release
Press Release.

 

Oslo, Norway, 26 March 2007 – Algeta ASA, the Norwegian cancer therapeutics company, today announced the successful closing of its initial public offering. The offering was more than two times oversubscribed and was priced in the upper half of the price range at NOK 47 per share. Gross proceeds (before over-allotment) amount to NOK 250 million ($41 million). The offering took place in conjunction with Algeta’s listing on the Oslo Stock Exchange. Algeta shares are expected to begin trading on the Oslo Stock Exchange (ticker: ALGETA) on Tuesday, 27 March 2007.

The equity offering attracted a substantial number of international institutional investors, including many European and US investors with a focus on life science investments.

John Berriman, Chairman of the Board of Algeta, said:

“We are delighted to have successfully closed this offering, and very pleased to add so many international institutional specialist investors to our shareholder base. I would like to thank all those involved in the IPO process for their hard work, but special thanks are due to Thomas Ramdahl and his team for their unstinting efforts since the very early days of the company.”

Thomas Ramdahl, President and CEO of Algeta, said:

“With the recently announced Phase II data demonstrating a survival benefit for our lead product, Alpharadin, Algeta is at an exciting stage in its development. The funds raised from this offering will now allow us to accelerate the clinical development of Alpharadin and advance our pipeline of preclinical product candidates towards the clinic. I look forward with confidence to continued progress in the future.”

ABG Sundal Collier Norge and DnB NOR Markets acted as Joint Lead Managers and Terra Securities has acted as Co-Lead Manager. The issue comprises 5,319,148 new shares, and a further 797,852 shares have been allocated under the manager’s over-allotment option. The issued share capital of Algeta ASA after the equity offering (before over-allotment) will be NOK 8,231,654, equalling 16,463,308 shares of NOK 0.50 par value.

 

For further information, please contact:

Dr Thomas Ramdahl, CEO or Geir Christian Melen, CFO, +47 23 00 79 90 / +47 913 91 458 (mob), +47 23 00 79 84 / +47 913 02 965 (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 therapeutics company built on world-leading expertise in nuclear medicine and oncology and dedicated to the development of novel anticancer therapeutics based on alpha particle emitting radionuclides.

By harnessing the unique characteristics of alpha emitters, such as high potency and short range, Algeta is developing new therapeutic candidates and technologies targeting metastatic and disseminated tumors and promising unrivalled potency without unacceptable toxicities.

Algeta’s lead product candidate, Alpharadin, has completed one Phase II trial and is currently in two further Phase II clinical trials as a potential new treatment of hormone refractory prostate cancer. Based on results to date, it is expected to progress to clinical Phase III trials. Alpharadin is a novel bone-seeking radiopharmaceutical based on the alpha particle emitter radium-223 and may potentially target skeletal metastases from multiple cancer types.

Algeta is also developing other technologies for delivering alpha emitters including microparticles, liposomes and its receptor targeting technology, which is designed 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 as Anticancer Therapeutic Inventions.

Alpharadin and Algeta are trademarks of Algeta ASA.

Important Notice

This press release is not for distribution to United States, Canada or Japan news services or for dissemination in the same countries or elsewhere where such dissemination is not appropriate. This news release is not and under no circumstances is to be construed as a solicitation, offer, or recommendation, to buy or sell securities issued by Algeta. This press release may not be relied upon by any person to whom it was not intended to be provided. These materials are not an offer of securities for sale in the United States, Canada or Japan. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. Algeta ASA has not registered, and does not intend to register, any portion of the offering in the United States

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.

Advent Venture Partners invests in $175m financing round for EUSA Pharma Inc, new transatlantic specialty pharmaceutical company

By EUSA Pharma, Press Release
Press Release.

 

Thursday 1 March 2007 – EUSA Pharma Inc, a new transatlantic specialty pharmaceutical company focused on developing and marketing products for the hospital market both in Europe and the United States, announces the agreed acquisition of OPi SA (“OPi”), an integrated biopharmaceutical company. The acquisition will create a strong platform on which to build a significant transatlantic business. The acquisition is being funded with finance from a syndicate led by Essex Woodlands and 3i including, Goldman Sachs, Advent Venture Partners, NeoMed and NovaQuest.

OPi, which is headquartered in Lyon, France, develops and markets worldwide a range of specialty pharma drugs aimed at treating patients suffering from rare and severe diseases. Its primary focus is onco-haematology, with two drugs approved for the treatment of acute lymphoblastic leukaemia, Erwinase® (crisantaspase) and Kidrolase® (L-asparaginase). OPi is also active in other therapeutic areas, with commercialised hospital products targeting rare and severe diseases, and has a R&D portfolio including monoclonal antibodies at various stages of development.

Reasons for the Acquisition

EUSA Pharma’s strategy is to build a portfolio of products in oncology, pain and critical care, and to create a balanced company in the EU and USA, as reflected in the Company’s name. The acquisition of OPi gives EUSA Pharma an accelerated scale up providing the Company with an established infrastructure in Europe, plus product sales and rights in both the EU and the USA. OPi has four products in the market, a further two products in clinical development and a fully human anti-IL6 mAb in preclinical development. In 2006, OPi achieved sales of $23 million, a growth of 69% on 2005, and was profitable. EUSA Pharma has identified opportunities to add value through optimisation of current activities and an increased focus on commercial activities.

Background on EUSA Pharma

EUSA Pharma was founded in May 2006 by Bryan Morton with $53 million funding from Essex Woodlands. In July 2006, EUSA Pharma acquired a private company, Talisker Pharma. The acquisition included Rapydan™ and two development stage CNS products, one targeted at schizophrenia and one at Alzheimer’s disease. Rapydan™ is a rapid-onset anaesthetic patch which achieved regulatory approval in Sweden in January and is already marketed in the USA by Endo under the brand name Synera™. EUSA Pharma now expects Rapydan™ to be approved across Europe, including in the UK, France and Germany, beginning in the third quarter of 2007. The key differentiator of Rapydan™ is the inclusion in the patch of a heating element which aids the speed of onset and penetration of the anaesthesia. Rapydan™ represents EUSA Pharma’s first entry into the pain market.

The EUSA Pharma Executive Management and Board

EUSA Pharma’s management team has a solid track record of managing operations within global pharmaceutical companies. Bryan Morton, previously of Merck & Co Inc and founder of Zeneus Pharma, is President and Chief Executive. Jim Phillips, founder of Talisker, previously an international executive with Novartis, joined the EUSA Board as EU President in July 2006. Rolf Stahel, previously Chief Executive of Shire Pharmaceuticals, which he led from being a small private company to a FTSE 100 company worth $3.2 billion in nine years, is Chairman of the Group. Goran Ando, previously Chief Executive of Celltech Group, and Bill Crouse, a former J&J Executive and Managing Director of Healthcare Ventures, join the Board as Non-executive Directors. Petri Vainio joined the Board as Non-executive Director in May 2006 representing the founder Investor Essex Woodlands. Gilles Alberici, currently CEO of OPi, Andrew Fraser of 3i and Raj Parekh of Advent Venture Partners will also join the Board of EUSA as Non-executive Directors upon completion of the acquisition.

David Cook, Finance Director, was most recently with Zeneus Pharma as Group Financial Controller and then acting Chief Financial Officer. Dr Tim Corn is the Company’s Chief Medical Officer. Dr Corn was previously with Glaxo, MHRA, Elan and Zeneus Pharma. Zoe Evans, Legal Counsel and Company Secretary, has previous experience with companies in the sector including PowderJect Pharmaceuticals, Chiron Vaccines, Zeneus Pharma and Cephalon.

Bryan Morton, Chief Executive of EUSA Pharma, said:

“We have launched EUSA Pharma with a strong team and a clear strategy to become a significant transatlantic specialty pharma company. This acquisition gives EUSA an accelerated scale up: OPi has an outstanding R&D approach with some unique products in the market and the pipeline, but we will be able to bring a strong focus to commercial operations and plans.

We believe that the combination of EUSA Pharma and OPi is a strong platform for rapid growth. The Company plans to make more acquisitions to add further value in pursuit of our goal of becoming a $1 billion company.”

Gilles Alberici, Founder and Chief Executive of OPi, said:

“The team at OPi has successfully developed a number of attractive products and this is the right time to hand over the reins to a team ideally positioned to drive commercial operations to the next level, while maintaining a targeted R&D focus in specialised therapeutic areas. This is viewed as a significant leap towards the creation of a world class specialty pharma company. The acquisition also offers our investors a suitable exit and just reward for their support over the years. I have every confidence that the combined business has an exciting future.”

Rolf Stahel, Chairman of EUSA Pharma, said:

“The EUSA Pharma management team has worked extremely hard since the company was formed and that work has culminated in today’s acquisition. This marks the turning point in EUSA Pharma’s young and impressive history and gives us a strong base on which to build a fully integrated transatlantic specialty pharma company.”

For further information

EUSA Pharma Inc:

Bryan Morton, Chief Executive
Tel: +44 (0) 1865 338335
Fax: +44 (0) 1865 338105

Dr Jim Phillips, EU President & SVP Corporate Business Development,
Tel: +44 (0) 1483 549083
Fax: +44 (0) 1483 549100

OPi SA:

Gilles Alberici c/o Elizabeth Guichard, Tel: +33 (0) 4 37 49 8597, Fax: +33 (0) 4 37 49 8599, www.orphan-opi.com

Financial Dynamics:
Tel: +44 (0) 207 831 3113,
Fax: +44 (0) 207 242 8695,
Julia Philips, Ben Brewerton, Emma Thompson

Synera™ is a trademark of Zars, Inc

Rapydan™ is a trademark of EUSA Pharma (Europe) Ltd.


Notes to Editors

Business Strategy:

EUSA Pharma Inc is a transatlantic specialty pharmaceutical company focused on developing and marketing innovative products for the worldwide hospital market. The company was formally launched with the acquisition of OPi SA, in March 2007.

EUSA Pharma aims to create a $1 billion company by building a portfolio of products in the fields of oncology, pain and critical care, and to create a balanced company in the EU and USA. It will seek to in-licence, develop and market late-stage compounds.

The Company has an active partnering approach to take advantage of the opportunities presented by its outstanding infrastructure and capabilities. In addition, EUSA Pharma will seek to licence out portfolio products not in its core therapeutic areas such as its early stage CNS products, and to partner or out-licence its fully human anti-IL6 mAb in inflammatory diseases.

Following the acquisition of OPi, EUSA Pharma has four products in the market plus three products in clinical development and three products in preclinical development. EUSA Pharma’s management team has a proven track record of marketing within global pharmaceutical companies and an entrepreneurial edge in the creation of new pharmaceutical businesses.

Board and Management Team: Bryan Morton, President and Chief Executive, has a BSc in Pharmacology from Aberdeen University and an MBA from Durham University. He began his pharmaceutical career in sales and has held positions in medical information, marketing, sales management, business development and general management during a 29 year career in the healthcare industry largely with Merck and Co. Inc. and Bristol Myers Squibb. He has lived and worked in UK, USA, Australia and Belgium and in 2003 founded Zeneus Pharma through the acquisition of Elan’s European sales and marketing business. Backed by Apax, this venture resulted in the sale of Zeneus to Cephalon in late 2005 after two highly successful years of profitable operation. Bryan founded EUSA Pharma in May 2006 backed by Essex Woodlands.

Rolf Stahel, Chairman, worked for 27 years with Wellcome plc in Switzerland, Italy, Thailand, Singapore and the UK. As Regional Director, based in Singapore, he was responsible for 18 Pacific Rim countries. His last position with Wellcome was Director of Group Marketing, based in London and Beckenham, covering Group Strategy, R&D portfolio evaluation, marketing of existing and new products, and business development. Mr Stahel joined Shire Pharmaceuticals in March 1994 as its Chief Executive. At that time the company was privately held and had an estimated value of approximately $30m, revenues of $3m and 50 employees. In his nine years at the company he implemented six mergers and acquisitions transforming Shire into a FTSE 100 company with a market capitalisation of approximately $3.2bn, revenues of $ 1.1bn, and 1800 employees.

Mr Stahel is currently Chairman of Chesyl Pharma Ltd, Newron Pharmaceuticals SpA, and Deputy Chairman of Cosmo Pharmaceuticals SpA. He was also Chairman of PowderMed Ltd. from February 2005 until its sale to Pfizer Inc in November 2006.

Dr. Jim Phillips, President Europe & SVP Corporate Business Development, is a Medical Doctor and holds an MBA. Jim has previously held senior positions at both Johnson & Johnson and Novartis. He has worked in sales, medical & marketing, business development and general management with global board responsibilities. Jim led the buyout of Lifegard Technologies from J&J in 2000 and left Novartis to become interim CEO to Bone Medical Ltd, and led the successful IPO of that company in Australia in 2004.

In 2003 Jim founded and led Talisker Pharma Ltd, a specialty pharma company backed in 2005 by Endeavour Ventures. The Company was acquired by EUSA Pharma in mid-2006.

Dr. Petri Vainio, Non-executive Director, is a Managing Director of Essex Woodlands Health Ventures, one of the world’s largest and most established health care venture capital firms with nearly $2 billion of capital under management. Essex Woodlands invests world-wide in leading private companies in pharmaceuticals, biotechnology, medical technology and health care services. The Managing Directors of Essex Woodlands work closely with their portfolio companies as lead investors to build significant shareholder value over a period of several years.

Previously, Dr. Vainio served over 10 years as General Partner and leader of the health care investment practice at Sierra Ventures, a leading Silicon Valley venture capital firm with over $1 billion of capital under management. During his career, Dr. Vainio has served as a founding investor and board member of over twenty health care companies, most of which have become NASDAQ-listed or have been acquired by publicly-listed corporations. Dr. Vainio has helped these companies raise over $1 billion in venture capital financing and reach an aggregate market value of over $5 billion.

Dr. Gilles Alberici, Non-executive Director, brings 20 years of experience in the European pharmaceutical industry to the Board of EUSA Pharma. Gilles obtained his PharmD (1981) from Paris University and was then resident and researcher in immunology in one of France’s leading academic research hospitals, Institut Gustave-Roussy, where he received his PhD in 1985. He is the author of over 40 publications and 4 issued patents.

Gilles has also served as Development and Manufacturing Director of biological agents in the Mérieux Group. In 1994, he founded and led IMTIX, a Pasteur-Mérieux business unit, bringing Thymoglobulin (rabbit ATG) to more than 50 markets. He was also President of IMTIX-SangStat, the European affiliate of SangStat. In September 1999 Gilles founded OPi SA. From the time of the Company’s inception Gilles served as President and CEO of OPi SA and its subsidiaries.

Dr. Göran Ando, Non-executive Director, is Chairman of Novexel SA and Inion Oy, and Vice Chairman of Novo Nordisk A/S and S*Bio Pte Ltd. He is also a Non-executive Director of Enzon Pharmaceuticals, NicOx S.A., A-Bio Pharma Pte Ltd, Bio*One Capital Pte Ltd and Novo A/S. Dr Ando was previously Chief Executive of Celltech Group from April 2003. He joined Celltech from Pharmacia (Pfizer) where from 1995 he was Executive Vice President and President of R&D with additional responsibilities for manufacturing, IT, business development and M&A.

Prior to this, Dr Ando spent six years at Glaxo Group starting in 1989 as Medical Director, moving to Deputy R & D Director and then R & D Director. He was a member of the Group Executive Committee. Born in Sweden, Dr Ando is a Specialist in General Medicine and is a Founding Fellow of the American College of Rheumatology in the US.

William (Bill) Crouse, Non-executive Director, is Managing Director and a General Partner of HealthCare Ventures, one of the world’s largest venture capital firms specializing in biotechnology. HealthCare Ventures creates, finances, manages and builds high science biopharmaceutical companies. The company has led the strategic development and management of more than 90 companies with a combined market capitalization of greater than $50 billion in important and emerging fields such as genetic therapy, genomic sciences, and organ and cellular transplantation.

Mr. Crouse maintains extensive contacts with major pharmaceutical and biotechnology companies and has assisted HealthCare Venture’s portfolio companies in initiating and negotiating collaborative agreements which have resulted in more than $3 billion of funding to those companies. He has over forty years of experience in the pharmaceutical and diagnostics industry in general management, international operations, strategic planning, licensing, acquisitions, new product development, and sales and marketing. Prior to joining HealthCare Ventures, he was Worldwide President of Ortho Diagnostic Systems and a Vice President of Johnson & Johnson International from 1987 to 1993.

Andrew Fraser, Non-executive Director, is a Partner at 3i, a world leading private equity and venture capital company. 3i’s Venture Capital team invests in scaleable, ambitious technology and healthcare businesses, managing investments across Europe, US, Asia and Israel, valued at over $1.5bn.

Raj Parekh, Non-executive Director, is a General Partner at Advent Ventures which is one of the most experienced technology venture firms in Europe. He has over 20 years of experience in the Biopharmaceutical industry, and has acted as Chairman or Director of several European and US Biotechnology Companies. Established in 1981, Advent invests in both the Life Sciences and Information and Communication Technology. Advent Ventures has $1 billion under management from institutional investors across Europe and the US.

Dr. Tim Corn, Chief Medical Officer, qualified in medicine at King’s College Hospital, London after having gained a Master’s degree in biochemistry. Following training in neuropsychiatry, he became consultant and senior lecturer at the Maudsley Hospital, London and is the author of more than 50 scientific publications. He was elected Fellow of the Faculty of Pharmaceutical Medicine in 1996.

Tim has held senior clinical and regulatory positions at GlaxoWellcome, MSD Research Laboratories, Athena Neuroscience and Elan as well as in the UK regulatory agency. He has played a key role in seven regulatory approvals in Europe. Most recently he was Chief Medical Officer at Zeneus Pharma.

David Cook, Finance Director, graduated with a degree in Chemistry from The University of Oxford in 1990. He qualified as a chartered accountant (Institute of Chartered Accountants of England and Wales) in 1993. David worked for PricewaterhouseCoopers from 1991-2004 in both the UK and Australia in a variety of roles including audit, transaction services and management consultancy.

David joined Zeneus Pharma in 2004 as Group Financial Controller before joining EUSA Pharma in late October 2006 as Finance Director.

Zoe Evans, Legal Counsel & Company Secretary, graduated with a law degree and was called to the Bar by the Middle Temple in October 1999. She is also a fully qualified chartered secretary and an associate member of the Institute of Chartered Secretaries and Administrators.

Zoe began her legal career within the pharmaceutical industry when she joined PowderJect Pharmaceuticals Plc in 2001 as legal counsel and assistant company secretary and has since worked with Chiron, Zeneus Pharma and Cephalon as legal counsel and company secretary before joining EUSA Pharma.

Speciality European Pharma completes two major acquisitions and closes first major financing round of Euro 15million from Advent Venture Partners

By Press Release, SEP
Press Release.

 

Speciality European Pharma Limited (‘SEP’), London UK, today announced that it has acquired Proreo Pharma International AG of Liestal, Switzerland and, in a separate transaction, all worldwide rights to Plenaxis® from Praecis Pharmaceuticals Incorporated, a US company. At the same time SEP announced completion of a €15m ($19m) financing round provided entirely by Advent Venture Partners (‘Advent Ventures’), in conjunction with these acquisitions.

Commenting on the acquisitions, Geoff McMillan CEO of SEP said:

“The acquisition of Proreo Pharma International provides us with access to Haemopressin, a product already approved and marketed in Austria, Germany, Hungary, Korea, Pakistan, Switzerland and Taiwan with further significant potential for pan-European and international sales. Plenaxis® has already obtained marketing approval in Germany as a treatment for advanced or metastatic hormone-dependent prostate cancer. We aim to launch Plenaxis® in Germany and accelerate its approval in the major European territories.”

Geoff McMillan added:

“We are delighted to have had, from the outset, the support and financial backing of an investor like Advent Ventures. The rationale for founding SEP was to acquire products with potential for a broader pan-European appeal and these two acquisitions very much fall into that sweet-spot.”

– END –

Notes: Haemopressin (terlipressin) is indicated for the treatment of Bleeding Oesophageal Varices, a life-threatening medical condition associated with severe liver diseases such as cirrhosis and hepatitis.

Plenaxis® (abarelix) is the first gonadotropin releasing hormone antagonist to be approved for prostate cancer in any country in Europe. In Germany, Plenaxis® is indicated to initiate hormonal castration in patients with advanced or metatstic, hormone-dependent prostate cancer, if androgen suppression is appropriate.

About Speciality European Pharma Limited: The company was founded in April 2006 with the mission of identifying and acquiring specialist pharmaceutical products for the European market. It is backed by Advent Venture Partners a leading investor in the European healthcare sector, and has now completed the acquisition of two products, Haemopressin and Plenaxis®, both of which are approved in certain European markets, and for which registrations in further European and international markets will now be sought.

About Advent Venture Partners – Advent Ventures is one of the most experienced technology venture capital firms in the UK. Established in 1981 it invests in both the Life Science and Information and Communications Technology sectors. Advent Ventures has over £500 million (US$ 900m) under management from institutional investors across Europe and the USA. 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). Recent investments by the Advent Life Sciences team include Norwegian radiopharmaceuticals company, Algeta; the US speciality pharma company, CardioKine Inc; the US medical device company NeoGuide, UK-based Thiakis which develops hormone-based treatments for obesity and the Swiss therapeutic antibody company, 4-Antibody. For additional information please visit: www.adventventures.com.

For further information please call:

SEP: Geoff McMillan, CEO, + 44 (0) 20 7932 2105, Email: geoff.mcmillan@spepharma.com

Advent Ventures: Shona Prendergast/Francesca Reville, Penrose Financial, + 44 (0) 20 7786 4884/4864

Advent Ventures Portfolio Company Algeta Applies for Listing on the Oslo Stock Exchange

By Algeta, Press Release
Press Release.

 

Oslo, Norway, February 1st, 2007 – Algeta ASA, the Norwegian therapeutics company, today announced its application for listing on the Oslo Stock Exchange (Oslo Børs). Algeta is taking this step to accelerate the late-stage clinical development of its lead product – Alpharadin – and to provide a strong platform for further growth.

Algeta develops novel and proprietary therapeutics and technologies based on alpha particle emitting radionuclides targeting a broad range of metastatic and disseminated tumors. By harnessing the unique characteristics of alpha emitters, such as high potency and short range, Algeta’s products offer the potential of unrivalled potency without unacceptable toxicities.

Algeta’s lead product based on this technology is Alpharadin, a product being developed as a new treatment for skeletal metastases in patients with late-stage, hormone refractory prostate cancer. Algeta believes Alpharadin will also have potential in treating skeletal metastases originating from other types of cancer, such as breast and lung. This indication represents a large and unmet medical need, with more than 300,000 patients worldwide per year developing skeletal metastases from cancer.

Alpharadin is expected to progress to pivotal Phase III clinical studies based on positive Phase II data, which show that Alpharadin delays the progress of prostate cancer and reduces the extent and effect of metastasis. Detailed results from the first of several Phase II studies to be completed will be presented at the ASCO Prostate Cancer Symposium, which will be held on 22-24 February 2007 in Orlando, Florida, USA.

In addition to Alpharadin, Algeta is actively developing a portfolio of proprietary projects to deliver alpha particle emitting radiotherapies to various other tumor types, including breast, ovarian and gynecological cancers. The most advanced of these, TH-1, has experimentally linked alpha emitters to tumor-targeting peptides and clinically validated antibodies to deliver a lethal radiotherapeutic dose specifically to the tumor.

Commenting on today’s announcement, Algeta’s CEO Thomas Ramdahl, said:

“We believe our technology has tremendous potential for treating a wide range of cancers; alpha particle emitters, when targeted appropriately, are among the most potent sources for the lethal irradiation of tumor cells and metastases, causing minimal damage to normal tissues. With Alpharadin demonstrating good efficacy and safety in clinical trials, we are very excited about both the therapeutic and commercial potential of this product. This, in addition, to our advancing pipeline of novel alpha emitter delivery technologies, gives us great confidence that we can create a business with significant value and growth potential.”

Algeta’s Chairman, John Berriman, said:

“We have decided to take the Company public both to provide better visibility for Algeta’s unique products and technology and to provide sufficient flexibility and strategic funding options for their future development. In particular, a key focus and value driver for Algeta is Alpharadin, which we aim to progress through the next crucial stages of clinical development towards the market where we believe it has the potential to be very successful.”

ABG Sundal Collier and DnB NOR Markets have been appointedas lead financial advisors and Terra Securities isco-lead manage

For further information, please contact

Dr Thomas Ramdahl, CEO, +47 23 00 79 90, thomas.ramdahl@algeta.com

Geir Christian Melen, CFO, +47 23 00 79 84, geir.melen@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 therapeutics company built on world-leading expertise in nuclear medicine and oncology and dedicated to the development of novel anticancer therapeutics based on alpha particle emitting radionuclides.

By harnessing the unique characteristics of alpha emitters, such as high potency and short range, Algeta is developing new therapeutic candidates and technologies targeting metastatic and disseminated tumors and promising unrivalled potency without unacceptable toxicities.

Algeta’s lead product candidate, Alpharadin, has completed one Phase II trial and is currently in two further Phase II clinical trials as a potential new treatment for pathologies caused by skeletal metastases from prostate cancer. Based on results to date, it is expected to progress to clinical Phase III trials. Alpharadin is a novel bone-seeking radiopharmaceutical based on the alpha particle emitter radium-223.

Algeta is also developing other technologies for delivering alpha emitters including microparticles, liposomes and its receptor targeting technology, which is designed to enhance the potency of therapeutic antibodies and other tumor-targeting molecules by linking them to the alpha particle emitter thorium-227.

In September 2005, Algeta raised NOK 185 million (€23 million) in a venture fundraising involving new and existing investors. Currently, Algeta’s largest shareholders include venture capital firms HealthCap, Advent Venture Partners, Selvaag Venture Capital, SR One and NorgesInvestor.

The Company is headquartered in Oslo, Norway, and was founded in 1997 as Anticancer Therapeutic Inventions.

Forward-looking Statement: This news release is not and under no circumstances is to be construed as a solicitation, offer, or recommendation, to buy or sell securities issued by Algeta.

The information contained herein is not for publication or distribution, directly or indirectly, in or into the United States of America, Canada or Japan.

This news release contains forward-looking statements and forecasts based on uncertainly, 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- approvals of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.