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Dec 20
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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.

Nov 27
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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.

Sep 26
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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

Sep 25
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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/

###

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

Jul 18
Love0

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

Jul 07
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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

Jul 05
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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

Jul 02
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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.

Jun 04
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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

May 01
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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