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Dec 18
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Wyeth Pharmaceuticals acquires Thiakis in a transaction worth up to £100m

By Press Release, Thiakis
Press Release.

 

London, December 18, 2008. Advent Venture Partners (‘Advent Ventures’) today announces the sale of one of its portfolio companies, Thiakis, to Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE) for a total consideration of £100 million which includes upfront and clinical development milestone payments. Thiakis’s lead product candidate, TKS1225, is an analogue of the peptide hormone oxyntomodulin being studied for the treatment of obesity and the prevention and amelioration of associated conditions such as Type 2 diabetes and cardiovascular diseases.

Thiakis was founded in 2004 by Professor Stephen Bloom who is a world leading expert in the study of metabolic diseases at Imperial College, London, and by Dr John Burt who served as Chief Executive Officer, with support from Imperial Innovations (AIM: IVO).

Advent Venture Partners co-led the Series ‘A’ financing round for the company in 2006 along with Novo A\S and Imperial Innovations and co-investment from Royal Society, Esperante and others. Advent Ventures’ General Partner, Dr Raj Parekh, served on the Board.

Thiakis and its investors were advised by Credit Suisse, Morrison & Foerster and Rawlinson & Hunter.

About Advent Ventures:

Advent Ventures is one of the most experienced venture capital firms in the UK. Established in 1981 it invests in both the Life Sciences and the Technology sectors. It has over £500 million (US$ 765 million) under management from institutional investors across Europe and the USA. It has backed around 60 life science companies of which, to date, 22 have obtained public listings and a further 10 companies have been sold including PowderMed (to Pfizer) and KuDOS Pharmaceuticals (to AstraZeneca). Recent public listings include Amsterdam Molecular Therapeutics on Euronext Amsterdam. Recent investments by the Advent Ventures Life Sciences team include the Swiss therapeutic antibody company, 4-Antibody; UK medical device company, Starbridge Systems; and EUSA Pharma, a transatlantic specialty pharmaceutical company.

 

For further information please contact:

Francesca Reville
Penrose Financial
Tel 020 7786 4884

Dr Raj Parekh
Advent Venture Partners
Tel 020 7932 2100

Nov 21
Love0

Infinity Pharmaceuticals strikes major alliance to fully fund promising pipeline

By Infinity, Press Release
Press Release.

 

Infinity Announces Global Strategic Alliance With Purdue Pharma and Mundipharma Encompassing Infinity’s Early Clinical and Discovery Programs

Infinity Retains All U.S. Rights; Mundipharma Receives Ex-U.S.

Commercialization Rights to All Oncology Products Under Alliance.

Infinity to Receive Up to $75 Million Equity Investment, Access to $50 Million Line of Credit, and Significant R&D Funding Over Multiple Years.

Conference Call Being Held At 8:30 a.m. EST Today to Discuss Transaction.

 

CAMBRIDGE, Mass., Nov. 20, 2008 (GLOBE NEWSWIRE) –Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) today announced that it has entered into a global strategic alliance with Purdue Pharmaceutical Products L.P. and Mundipharma International Corporation Limited, focused on the research, development, and commercialization of Infinity’s early clinical and discovery programs, including IPI-926, Infinity’s novel inhibitor of the Hedgehog signaling pathway. Infinity expects that this alliance will enable it to aggressively pursue its goal of developing and commercializing its pipeline of innovative anti-cancer agents.

“Infinity’s mission is to discover, develop, and deliver to patients important medicines for the treatment of cancer,”

said Steven

H. Holtzman, chair and chief executive officer of Infinity.

“This alliance with Purdue Pharma and Mundipharma provides Infinity with the financial resources and independence to continue our productive discovery efforts, to expand our clinical development capabilities, and to build our own organization to commercialize our products in the United States. In a nutshell, we have the opportunity to realize all aspects of our mission in a manner that we believe will create meaningful treatments for patients and meaningful value for our shareholders.”

“Purdue U.S., Purdue Canada, and Mundipharma companies in Europe and Asia have been expanding their therapeutic scope significantly in recent years,”

said Jim Dolan, Senior Vice President of Licensing and Business Development for Purdue.

“Mundipharma’s presence in oncology outside of the U.S. is now well-established, and we expect that the broad alliance with Infinity will give us the opportunity to bring to market a number of innovative, best-in-class treatments for cancer patients. In addition, this alliance will also build upon our core franchise in pain on a global basis, with FAAH, a potentially innovative new product for neuropathic pain.”

The alliance will focus on the advancement of Infinity’s early-stage clinical and discovery pipeline of novel, small molecule drug candidates. This pipeline includes IPI-926, Infinity’s potent inhibitor of the Hedgehog pathway. IPI-926 is being evaluated in a Phase 1 clinical study in patients with advanced solid tumors and has demonstrated significant anti-tumor activity in a number of preclinical models. Infinity’s pipeline also includes several earlier stage discovery programs, including a program directed to fatty acid amide hydrolase (FAAH), an emerging target for the treatment of neuropathic pain.

Infinity’s Hsp90 inhibitor program, comprising IPI-504 (retaspimycin hydrochloride), which is in an international Phase 3 registration trial for patients with refractory gastrointestinal stromal tumors (the RING trial), and IPI-493, Infinity’s oral candidate currently in a Phase 1 study in patients with advanced solid tumors, remains partnered with AstraZeneca and is excluded from this alliance. Infinity’s program targeting the Bcl family of proteins, which was transitioned to Novartis in February of 2008, is also excluded from this alliance.

“This relationship provides an incredible opportunity for Infinity by affording us access to the capital necessary to do what our R&D team does best: to discover and develop important new medicines for patients,”

said Adelene Q. Perkins, president and chief business officer of Infinity.

“It enables us to continue to operate nimbly while building upon and enhancing our culture of citizen ownership that we hold so dear.”

 

Details of the Transaction

Infinity Pharmaceuticals, Inc. has entered into a strategic alliance agreement with Mundipharma International Corporation Limited to develop and jointly commercialize pharmaceutical products. Under the terms of the strategic alliance agreements, Infinity will retain U.S. commercialization rights for all oncology products developed under these programs. Infinity is obligated to pay Mundipharma a royalty on U.S. sales of these products. Mundipharma has the right to commercialize these products outside of the United States, and is obligated to pay a royalty to Infinity on sales outside of the U.S. Infinity will direct and lead all oncology discovery and development efforts on a worldwide basis.

Purdue has made an equity investment of $45 million in Infinity through the purchase of four million shares of Infinity common stock at $11.25 per share, a 112% premium over the closing price of $5.29 on November 19, 2008. Subject to Infinity shareholder approval and other customary closing conditions, these entities have agreed to invest an additional $30 million in Infinity to purchase two million shares of Infinity common stock and warrants to purchase up to six million additional shares of Infinity common stock. The warrants may be exercised between the second closing date (expected to occur in January 2009) and June 30, 2012 at prices ranging from $15 to $40 per share.

In addition, upon the second closing, Purdue will make available to Infinity a $50 million line of credit for use by Infinity for any business purpose, with principal and accrued interest to be repaid by the tenth anniversary of the second closing.

Under the alliance, Mundipharma will participate in Infinity’s Hedgehog program as well as new Infinity discovery and development programs (subject to certain opt-out rights outlined below) for three years, with an ability to extend this right for two additional one-year terms. Mundipharma will fund the costs of these programs until the later of the start of the first Phase 3 trial for the program or December 31, 2013. If a program commences Phase 3 studies after December 31, 2013, Infinity and Mundipharma will share the costs of development equally.

The alliance will also encompass Infinity’s discovery program directed to FAAH. Purdue and Mundipharma will have the right to assume development of the FAAH program at the conclusion of Phase 1 clinical studies by funding the research and development costs of the program through approval and paying a royalty to Infinity on global net sales.

Finally, under the alliance, Infinity grants to Mundipharma an option, on set terms, to participate in programs that Infinity may in-license during the term. Mundipharma will have the right to opt-out of development of any particular program on an annual basis, with the first opt-out right becoming available in July 2009 for the Hedgehog and FAAH programs. If Mundipharma elects to opt-out of a program, it will be obligated to continue funding that program for an additional year, and have the right to receive royalties on future sales based on the stage of development of the program when the election to opt-out took place.

 

Conference Call and Webcast Information

Infinity management will hold a conference call to discuss the transaction today, Thursday, November 20, 2008 at 8:30 a.m. EST. Callers may participate in the call by dialing 1-877-419-6598 (domestic) or 1-719-325-4916 (international) five minutes prior to the start time. An archived version of the webcast will be available in the Investors/Media section of Infinity’s website at http://www.infi.com beginning by 5:00 p.m. EST on Thursday, November 20, 2008 through 5:00 p.m. EST on Wednesday, December 3, 2008.

 

Important Additional Information Will Be Filed with the SEC

Infinity plans to file with the United States Securities and Exchange Commission (SEC) and mail to its stockholders a proxy statement in connection with the transaction. The proxy statement will contain important information about Infinity, the transaction, and related matters. Investors and security holders are urged to read the proxy statement carefully when it is available.

Investors and security holders will be able to obtain free copies of the proxy statement and other documents filed with the SEC by Infinity through the website maintained by the SEC at www.sec.gov. In addition, investors and security holders will be able to obtain free copies of the proxy statement from Infinity by contacting Monique Allaire at Monique.Allaire@infi.com or 617-453­1015.

Infinity and its directors and executive officers may be deemed to be participants in the solicitation of proxies in respect of the transaction described herein. Information regarding Infinity’s directors and executive officers is contained in Infinity’s Annual Report on Form 10-K for the year ended December 31, 2007 and its proxy statement dated April 10, 2008, which are filed with the SEC. As of October 31, 2008, Infinity’s directors and executive officers beneficially owned approximately 4,886,372 shares, or approximately 24 percent, of Infinity’s common stock. A more complete description will be available in the proxy statement.

 

About IPI-926

IPI-926 is a novel, proprietary inhibitor of the Hedgehog signaling pathway being evaluated in a Phase 1 clinical trial in patients with advanced solid tumors. IPI-926 is a derivative of the natural product cyclopamine that binds to and inhibits a key regulator of this pathway, the Smoothened receptor. The Hedgehog signaling pathway is normally active in regulating tissue and organ formation during embryonic development. However, abnormal activation of the Hedgehog pathway can lead to cancer and is believed to play a central role in allowing the proliferation and survival of several types of cancers, including pancreatic, prostate, lung, breast, and certain brain cancers. In preclinical models, IPI-926 has demonstrated significant anti-tumor activity and excellent pharmaceutical properties, including oral bioavailability, long plasma and tumor half-life, and dose-dependent inhibition of tumor growth, in a number of preclinical models.

 

About Fatty Acid Amide Hydrolase (FAAH)

Fatty acid amide hydrolase (FAAH) is an emerging target for the treatment of neuropathic pain. The enzyme FAAH degrades anandamide, which is an endogenous cannabinoid that produces an analgesic effect in response to pain. FAAH inhibition increases the duration of anandamide’s analgesic effect, prolonging pain relief at the site of release. Infinity’s FAAH inhibitor program is in lead optimization; the company expects to select a clinical candidate by early 2009.

 

About Infinity Pharmaceuticals, Inc.

Infinity is an innovative cancer drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for the treatment of cancer and related conditions. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging cancer pathways. Infinity’s two most advanced programs in Hsp90 inhibition and Hedgehog signaling pathway inhibition are evidence of its innovative approach to oncology drug discovery and development. For more information on Infinity, please refer to the company’s website at http://www.infi.com.

 

Safe Harbor For Forward-Looking Statements

Statements in this press release regarding the proposed transaction between Infinity and Purdue Pharmaceutical Products L.P. and Mundipharma International Corporation Limited, including, without limitation, the expected timetable for completing the transaction, the expected financial and operational benefits of the transaction, Infinity’s estimate of research and development payments to be made by Mundipharma over the next five years, the availability of the line of credit and any other statements about the parties’ future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “anticipates,” “expects,” “may,” “will,” “would,” “intends,” “estimates” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: For example, there can be no guarantee that the strategic alliance will continue for its full term or that Purdue and Mundipharma will continue to fund Infinity’s programs as agreed; that the parties will successfully discover, develop or commercialize products under the alliance; or that Infinity will satisfy the conditions to the closing of the second equity investment, including obtaining the necessary stockholder approval and clearance under the Hart-Scott-Rodino Act. In particular, Infinity’s management’s expectations could be affected by risks and uncertainties relating to a failure of stockholders to approve the second equity investment; a failure of Infinity and/or Mundipharma to fully perform under the alliance agreement and/or an early termination of the alliance agreement; results of clinical trials and preclinical studies that are the subject of the strategic alliance, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food & Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites, and publication review bodies; Infinity’s ability to enroll patients in its clinical trials; unplanned cash requirements and expenditures; Infinity’s ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing; and the other factors described in Infinity’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2008, as filed with the SEC on November 5, 2008, and other filings that Infinity makes with the SEC from time to time. Infinity 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:
Infinity Pharmaceuticals, Inc.

Investors

Monique Allaire
Monique.Allaire@infi.com
www.infi.com

Pure Communications, Inc.

Media

Sheryl Seapy
949-608-0841
Sheryl@purecommunicationsinc.com

 

(C) Copyright 2008 GlobeNewswire, Inc. All rights reserved.

Sep 23
Love0

Pathworks Diagnostics closes $20m Financing

By Pathwork Diagnostics, Press Release
Press Release.

 

Second Round of Funding Supports Commercialization of Recently FDA-cleared Pathwork® Tissue of Origin Test

 

SUNNYVALE, Calif. — Pathwork Diagnostics, a molecular diagnostics company focused on oncology, announced the closing today of a $20 million financing led by Abingworth. The announcement came on the heels of FDA’s clearance for the Pathwork® Tissue of Origin Test for diagnosis of tumors of uncertain origin, including poorly differentiated, undifferentiated and metastatic tumors.

”With this $20 million round of financing completed and the recent FDA clearance, the company is well positioned to fund important commercialization programs, including offering the Pathwork Tissue of Origin Test through an additional distribution channel, and building our pipeline,”

said Deborah J. Neff, President and Chief Executive Officer of Pathwork Diagnostics.

In addition to offering the Pathwork Tissue of Origin Test as a service through the CLIA-certified Pathwork Diagnostics Laboratory, FDA clearance of the in vitro diagnostic (IVD) kit version of the test will give Pathwork’s customers the opportunity to purchase an IVD kit and run the test in their own labs.

“Our channels to market are expanding and we are building our customer support team to provide outstanding service to our customers,” said Neff. “In addition, we are investigating new applications of our technology that will enable us to offer new, breakthrough diagnostic capabilities to the oncology community.”

Pathwork’s lead investor, Abingworth, based in London and with local offices in Menlo Park, Calif., specializes in the life sciences and healthcare industries.

“We are delighted to become an investor in this unique company,” said Ken Haas, Venture Partner with Abingworth. “Molecular diagnostics is already making a significant difference in the care of cancer patients and Pathwork, with its combination of a novel and proprietary approach, a validated test available through two commercial channels and a broadly applicable platform, is poised to be a leader in this field.”

Abingworth joins the existing investors participating in this round, including Prospect Venture Partners, Advent Venture Partners, Novus Ventures, Venrock and Versant Ventures.

“Completing this successful financing in the current economy, with well-respected investment firms is a strong vote of confidence in our technology and commercialization strategy”

said Neff.

About Pathwork Diagnostics
Pathwork Diagnostics, Inc., based in Sunnyvale, Calif., develops and commercializes high-value molecular diagnostics for oncology. The company delivers FDA-cleared, microarray-based tests to clinical laboratories and also provides diagnostic tests through its CLIA-certified laboratory. The company’s initial tests utilize Pathwork Diagnostics’ proprietary analytics and a companion Pathchip® microarray, which runs on the proven Affymetrix GeneChip® System. The company’s first test – the Pathwork Tissue of Origin Test – is now FDA-cleared as an in vitro diagnostic kit. A functionally equivalent version of the test is also available through Pathwork® Diagnostics Laboratory. The test aids in determining a tumor’s origin so that standard-of-care, cancer-specific treatment can begin. For more information, please call toll-free 1.877.808.0006 or visit www.pathworkdx.com.

© 2008 Pathwork Diagnostics, Inc. All rights reserved. Pathwork, Pathchip, Pathwork Diagnostics, and the Pathwork Diagnostics logo are trademarks or registered trademarks of Pathwork Diagnostics, Inc. Other names may be the trademarks of their respective owners.

Aug 28
Love0

Algeta Reports Positive Headline Phase II Data on Pain Palliation with Alpharadin

By Algeta, Press Release
Press Release.

 

Oslo, Norway, 28 August 2008 – Algeta ASA (OSE: ALGETA), the Norwegian cancer therapeutics company, today announced that the primary objective of its BC1-03 Phase II pain palliation study was met. The study showed that even single doses of Alpharadin in patients with painful bone metastases could produce increasing clinical benefit with increasing dose. Pain palliation is an important quality of life benefit in metastatic cancer patients. The trial also confirmed Alpharadin’s benign side-effect profile and, importantly for a drug in this clinical setting, no significant bone marrow toxicity was observed.

In men with HRPC life expectancy can be as short as 18 months, and it is estimated that 100,000 men in the EU and USA die from the disease each year. In 85% of these men the tumor will have spread into the bones. These metastases are a significant problem as they can cause intractable and debilitating pain as well as contributing to a further reduction in life expectancy.

The BC1-03 study was a double-blind randomised pain control study comparing the palliative effects of four different single dose levels of Alpharadin in patients with bony metastatic HRPC. The drug was given by i.v. injection mainly on an outpatient basis. The palliative efficacy of Alpharadin was measured using an assessment of bone pain as well as the patient’s consumption of analgesia. The primary study objective was to investigate whether there was a dose-response relationship with respect to pain palliation in this patient group. The study has shown the beneficial palliative effect of a single dose of Alpharadin and that there is a clear dose-response effect, with higher doses providing better pain relief.

The study also showed a dose-dependent reduction in bone alkaline phosphatase (ALP) ranging from no effect in the lowest dose group to a marked reduction in the higher dose groups. ALP is a severity marker of bony metastatic disease and of prognostic importance.

The study has also further confirmed the safety of Alpharadin and shown its benign side-effect profile. In fact, the higher the dose of Alpharadin that patients received, the fewer adverse events were experienced. This reproduces the safety profile of the earlier BC1-02 Phase II study where the Alpharadin group experienced fewer adverse effects than the placebo comparator group. Importantly for a drug in this clinical setting no significant bone marrow toxicity was observed in patients receiving Alpharadin.

The full results of the BC1-03 study will be submitted for publication in a peer-reviewed journal.

The principal investigator of the study Professor Sten Nilsson at the Karolinska Hospital in Stockholm said:

“These results showing the beneficial impact of Alpharadin in terms of pain palliation are important, as improved quality of life, alongside increased survival, are the two key goals of anti-cancer therapy of patients with skeletal metastases.”

Commenting on today’s further positive news with Alpharadin, Algeta’s President and CEO, Dr. Thomas Ramdahl, said:

“These results build on the positive Phase II clinical data package that we have already assembled with Alpharadin, the highlight of which was the significant survival benefits that we have already reported in patients with HRPC.

Based on our clinical trials to-date I am very confident that Alpharadin has the potential to become an important new therapy for patients with prostate cancer. This view has been reinforced by the enthusiastic and positive response we have received from key opinion leaders around the world to our unique approach to treating HRPC.”

Algeta has recently started enrolling patients for the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) study. This international study will evaluate Algeta’s targeted therapeutic Alpharadin in advanced, hormone-refractory prostate cancer (HRPC) that has metastasized to the skeleton. Approximately 750 patients are expected to be enrolled at more than 125 medical centers in Europe, Asia, South America and Canada. The Coordinating Investigator for the study is Dr. Christopher Parker, a leading clinical oncologist and specialist in prostate cancer, based at the Institute of Cancer Research and the Royal Marsden Hospital in the UK.

 

For further information, please contact

Dr. Thomas Ramdahl, CEO
Øystein Soug, CFO
+47 23 00 79 90 / +47 913 91 458 (mob)
+47 23 00 79 84 / +47 906 56 525 (mob)
post@algeta.com

For international enquiries:
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, has commenced an international phase III clinical trial in hormone-refractory prostate cancer (ALSYMPCA) 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.

Aug 14
Love0

SEP, the specialty urology company, closes a $15M series B financing

By Press Release, SEP
Press Release.

 

Speciality European Pharma Limited (SEP), the UK based, urology focused, specialty pharmaceutical company, is pleased to announce the successful completion of a €15M series B financing led by BSI, S.A., a wholly owned subsidiary of Generali Insurance. Other investors included Advent Venture Partners, the founding investor of SEP and Merifin.

 

The financing comes little more than two months after the completion of SEP’s divestment of its Swiss subsidiary. With the combined proceeds, the Company is well placed to roll out its European infrastructure expansion plans and to secure, additional urology focused products for distribution in Europe.

Commenting on the financing, Geoff McMillan, Chief Executive Officer of SEP, said:

“We are delighted to have secured this financing in difficult capital markets conditions and to have attracted such quality investors. 2008 has been an eventful year for SEP, with the German launch of Plenaxis, the Company’s prostate cancer product in February, the divestment of the Company’s Swiss subsidiary in April and now the raising of significant new expansion capital.

The money raised further strengthens SEP’s balance sheet and provides it with the necessary capital to complete the establishment of its European sales infrastructure and invest in and broaden its franchise of urology focused products.”

-ENDS-

 

For further information please contact:

SEP, Tel: +44 (0)1462 476 516
Geoff McMillan, Chief Executive Officer
Patrick Banks, Chief Financial Officer

About Speciality European Pharma
Founded in April 2006, SEP is a privately owned speciality pharmaceutical company. Its mission is to become the leading Urologist focused Specialty pharmaceutical business in Europe.

SEP owns worldwide rights to Plenaxis®, the world’s first approved GnRH blocker for the treatment of prostate cancer. Plenaxis® gives a rapid and sustained decline in testosterone levels, which gives quick and sustained control of prostate cancer and its symptoms. On stopping treatment with Plenaxis, testosterone levels rapidly recover while disease activity remains under control for some time. Plenaxis® was launched in Germany in February 2008.

SEP has distribution rights in certain European countries for two further products, Amphocil®, an anti fungal agent and Haemopressin®, a product for the treatment of Bleeding Oesophageal Varices. Both of these products are delivered to clinicians in a hospital setting.

SEP has established its own commercial operations in the UK, Germany, France and Italy and will market its products in other regions and territories through relationships with expert partners.

About Advent Venture Partners
Advent Venture Partners (“Advent Ventures”) is one of the most experienced venture capital firms in the UK. Established in 1981 it invests in both the Life Science and Technology sectors. Advent Ventures has raised over US$1 billion from institutional investors across Europe and the USA since 1998.

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

About BSI SA
BSI SA was founded in Lugano, Switzerland, in 1873, and is the oldest bank in the canton of Ticino, Switzerland. Since 1998 it has been 100%-controlled by the Generali Insurance Group. BSI specialises in asset management and related services for private and institutional clients. BSI SA is present in the major financial markets worldwide.

Mar 12
Love0

Novel therapy for treatment of obesity enters clinical trials

By Press Release, Thiakis
Press Release.

 

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

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

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

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

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

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

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

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

Mar 11
Love0

EUSA Pharma to Acquire US Specialty Oncology Company Cytogen

By EUSA Pharma, Press Release
Press Release.

 

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

  • $22.6 million acquisition expands EUSA’s product portfolio

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Feb 21
Love0

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

By Algeta, Press Release
Press Release.

 

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

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

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

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

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

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

 

For further information, please contact

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

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

 

About Algeta

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

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

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

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

Alpharadin and Algeta are trademarks of Algeta ASA.

Forward-looking Statement

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

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

Feb 18
Love0

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

By EUSA Pharma, Press Release
Press Release.

 

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

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

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

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

said Bryan Morton, Chief Executive of EUSA Pharma.

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

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

Feb 02
Love0

Speciality European Pharma launches Plenaxis in Germany

By Press Release, SEP
Press Release.

 

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

 

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

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

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

– Ends –

 

About SEP:

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

About Advent Venture Partners:

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

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