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Conatus Pharmaceuticals Inc. Announces Pricing of Initial Public Offering

By Conatus Pharmaceuticals, Press Release
Press Release.

 

San Diego, CA – July 25, 2013 – Conatus Pharmaceuticals Inc., a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced the pricing of its initial public offering of 6,000,000 shares of its common stock at a public offering price of $11.00 per share, before underwriting discounts. The shares are scheduled to begin trading on the NASDAQ Global Market under the ticker symbol “CNAT” on July 25, 2013. In addition, Conatus has granted the underwriters a 30-day option to purchase up to an additional 900,000 shares of common stock at the same price to cover over-allotments, if any. The offering is expected to close on July 30, 2013, subject to customary closing conditions.

Stifel and Piper Jaffray & Co. are acting as joint book-running managers for the offering. JMP Securities LLC is acting as co-lead manager and SunTrust Robinson Humphrey, Inc. is acting as co-manager for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on July 24, 2013. The offering will be made only by means of a prospectus, copies of which may be obtained from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by calling (415) 364-2720 or by emailing SyndicateOps@stifel.com, and from Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by calling (800) 747-3924 or by emailing prospectus@pjc.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Conatus Pharmaceuticals Inc.

Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. Conatus is developing its lead compound, emricasan, for the treatment of patients in orphan populations with chronic liver disease and acute exacerbations of chronic liver disease. Emricasan is a first-in-class, orally active caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and cell death, or apoptosis. Conatus believes that by reducing the activity of these enzymes, emricasan has the potential to interrupt the progression of liver disease. Conatus was founded by the executive management team of Idun Pharmaceuticals in July 2005 following the sale of Idun to Pfizer. Conatus acquired the global rights to emricasan from Pfizer in 2010. For additional information, please visit www.conatuspharma.com.

Contact:
Charles J. Cashion
Senior Vice President and CFO
Conatus Pharmaceuticals Inc.
858-457-7221
ccashion@conatuspharma.com

uniQure signs EU commercialization agreement with Chiesi Farmaceutici

By Press Release, UniQure
Press Release.

 

uniQure signs EU commercialization agreement with Chiesi Farmaceutici for first approved gene therapy treatment, and raises EUR 45 million (USD 59 million)

  • Partnership with Chiesi Farmaceutici for commercialization of Glybera and co-development of hemophilia B gene therapies in  Europe and certain other territories
  • Investment by Coller Capital and other investors

Amsterdam, the Netherlands, July XX, 2013 — uniQure B.V., the leader in human gene therapy, today announced it has successfully raised a total of EUR 45 million, with EUR 31 million from Chiesi Farmaceutici SpA (Parma, Italy), and EUR 14.1 million in an investment led by Coller Capital (London, UK) with participation by existing investors.

uniQure’s agreement with Chiesi Farmaceutici (Chiesi), an international company headquartered in Parma, Italy, gives Chiesi exclusive rights to commercialize Glybera, the first gene therapy product approved in the European Union for the treatment of the orphan disease lipoprotein lipase deficiency (LPLD) for which there is currently no treatment, as well as for uniQure’s pipeline product for hemophilia B in Europe and selected other countries. Commercial rights for the US, Japan, and parts of Latin America and Asia, and Australasia remain with uniQure. In exchange, uniQure stands to receive high double-digit royalties on sales of both products. Furthermore, Chiesi will fund half of the remaining development costs for uniQure’s hemophilia B program, as well as take an equity stake in uniQure.

Separately, uniQure recently announced a raise of EUR 13.5 million in convertible debt led by Coller Capital, a leading global private equity investor; existing investors Forbion Capital Partners, Gilde Healthcare Partners, Lupus Alpha and Grupo Netco also participated. An additional EUR 0.6 million in equity funding was contributed by staff and other private investors.

“The agreement with Chiesi is a key component of our strategy to rapidly develop and commercialize multiple gene-therapy based treatments as well as being a tremendous validation of our technology platform,”

said Jörn Aldag, CEO of uniQure.

“With its focus on innovative therapeutics, Chiesi is the ideal partner for the commercialization of Glybera in Europe. The additional investment from Coller Capital, supplemented by our existing investors, allows us to continue apace with the development of the richest and most-advanced gene therapy pipeline in the industry. In the next 12-18 months, we anticipate clarifying the path toward an FDA filing for Glybera in the US, reporting results from a Phase I/II study in acute intermittent porphyria, and starting at least two Phase I/II studies for additional pipeline programs.”

About uniQure
uniQure is delivering on the promise of gene therapy, single treatments with potential curative results. We have developed a modular platform to rapidly bring new disease modifying therapies to patients with severe disorders. Our approach is validated by multiple partnerships and the regulatory approval of our lead product Glybera.www.uniqure.com.

About Chiesi Farmaceutici
Founded in 1935 in Parma, Italy, Chiesi Farmaceutici currently has 25 affiliates worldwide and markets its therapeutics in over 60 countries. Chiesi’s manufacturing plants in Parma, Blois (France) and Santana de Parnaiba (Brazil), and R&D centers in Parma, Paris, Rockville (USA) and Chippenham (UK) integrate their efforts to advance the Group’s pre-clinical, clinical and registration programs. At the end of 2012, the Chiesi Group’s total staff stood at over 3,800 people, more than 350 of whom are dedicated to R&D. The main areas of activity are in respiratory therapeutics and specialist medicine areas.

Contacts
Jörn Aldag                           Hans Herklots
CEO                                     Managing Director
uniQure                               Capricorn One
Tel : +31 20 566 8014        Tel: +41 79 598 7149
j.aldag@uniQure.com        capricorn1@bluewin.ch

Algeta announces that Xofigo® (radium-223 dichloride) has been approved by the US FDA

By Algeta, Press Release
Press Release.

 

  • New treatment for castration-resistant prostate cancer (CRPC) patients with bone metastases
  • Xofigo shown in a pivotal phase III trial to significantly improve overall survival
  • Algeta to host international conference call scheduled for tomorrow at 08:00 CET – details below

Oslo, Norway, 15 May 2013 – Algeta ASA (OSE: ALGETA) announces that the US Food and Drug Administration (FDA) has approved Xofigo® (radium-223 dichloride) injection for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is the first alpha particle-emitting radioactive therapeutic agent approved by the FDA, that has demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo, as shown in the pivotal phase III ALSYMPCA trial.

The commercial production of Xofigo is underway, and first doses are expected to be ready for patient treatment within a few weeks. Bayer has worldwide exclusive marketing rights for Xofigo. Algeta US, LLC and Bayer Healthcare will co-promote the product in the US.

Andrew Kay, Algeta’s President & CEO, said:

“We are delighted that the FDA has taken the decision to approve Xofigo so quickly. We are extremely pleased to be able to make this alpha particle-emitting pharmaceutical available to US patients with castration-resistant prostate cancer and symptomatic bone metastases. We will now finalize our launch preparations for Xofigo in the US, with the intention of launching it, with Bayer, as soon as possible. This approval is a major milestone for Algeta and puts us firmly on the path to deliver on our vision to be a world-class oncology company bringing novel targeted medicines to cancer patients through our leadership in alpha particle-emitting pharmaceuticals.”

“The development of bone metastases is a frequent consequence of advanced prostate cancer, and a major cause of disability and death in this disease,”

said Dr Chris Parker, Principal Investigator for the pivotal ALSYMPCA trial, from the Royal Marsden Hospital and Institute of Cancer Research (London, UK).

“Xofigo will be an important and welcome addition to the treatment regimes that are used for the treatment of this cancer.”

Bone is the most common site in the body to be affected by metastatic cancer and bone metastases are particularly prevalent in patients with prostate cancer. Approximately 90% of patients with metastatic prostate cancer show evidence of bone metastases. Bone metastases can lead to an increase in frequency of skeletal events. In addition, bone metastases have been shown to be the main cause of morbidity and death in patients with CRPC.

Efficacy and Safety Data Supporting Xofigo® Approval

The approval of Xofigo (radium-223 dichloride, radium-223) is based on data from the pivotal phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. At the interim analysis, radium-223 significantly improved overall survival (OS) [HR=0.695

(95% CI 0.552-0.875), p=0.00185]; median OS was 14.0 months with radium-223 plus best standard of care vs. 11.2 months with placebo plus best standard of care. Additionally, at the interim analysis there was a delay in the time to first symptomatic skeletal event (SSE) for patients treated with radium-223 vs. placebo.

An updated analysis, conducted after the study was unblinded, showed a further improvement in overall survival (OS) for patients treated with radium-223 vs. placebo, with a median OS of 14.9 months vs. 11.3 months; HR=0.695 (95% CI 0.581-0.832).
The most common adverse reactions (greater than or equal to 10%) in patients receiving radium-223 were nausea, diarrhea, vomiting and peripheral edema. The most common hematologic laboratory abnormalities (greater than or equal to 10%) of radium-223-treated patients were anemia, lymphocytopenia, leukopenia, thrombocytopenia and neutropenia.

About Xofigo® (radium-223 dichloride)

Xofigo® with the active ingredient radium-223 dichloride (radium-223) is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. Radium-223 mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of alpha emitters may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium-223 is less than 100 micrometers which may limit the damage to the surrounding normal tissue.

In September 2009, Algeta signed an agreement with Bayer for the development and commercialization of radium-223. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize radium- 223 globally. Algeta US, LLC will co-promote radium-223 with Bayer in the US.

Radium-223 is currently not approved by the European Medicines Agency (EMA) or other authorities outside the US. Bayer submitted a Marketing Authorization Application to the EMA for radium-223 in December 2012 for the treatment of CRPC patients with bone metastases.

For full prescribing information visit www.xofigo-us.com

About the ALSYMPCA Trial

The ALSYMPCA trial was a phase III, randomized, double-blind, placebo-controlled international study comparing radium-223 dichloride vs. placebo in symptomatic CRPC patients with bone metastases treated with best standard of care compared with placebo plus best standard of care. The trial enrolled 921 patients in more than 100 centers in 19 countries. The study treatment consisted of up to six intravenous injections of radium-223 or placebo each separated by an interval of four weeks.
The primary endpoint of the study was overall survival (OS). A key secondary endpoint was time to first symptomatic skeletal event (SSE), as defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic bone fracture, occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.

About CRPC and Bone Metastases

Prostate cancer is the most common non-cutaneous malignancy in men worldwide. In 2008, an estimated 899,000 men were diagnosed with prostate cancer and 258,000 died from the disease worldwide. Prostate cancer is the sixth leading cause of death from cancer in men.

A majority of men with CRPC have radiological evidence of bone metastases. Once the cancer cells settle in the bone, they interfere with bone strength, often leading to pain, fracture and other complications that can significantly impair a man’s health. Bone metastases secondary to prostate cancer typically target the lumbar spine, vertebrae and pelvis. In fact, bone metastases are the main cause of morbidity and death in patients with CRPC.

About the Patient Assistance Program

Bayer and Algeta offer patient assistance through Xofigo Access ServicesSM which will assist with obtaining coverage and patient support of Xofigo. Patients and providers may contact the program at 1-855-6XOFIGO (1-855-696-3446) for additional information.

Details of international conference call

A conference call for investors, analysts and the press, and hosted by Algeta’s senior management team, will take place tomorrow at 08:00 CET. To participate in the conference call, please dial the appropriate number below five minutes prior to the call:

US: +1 866 966 5335
UK: +44 20 3003 2666 (toll free 0808 109 0700)
Norway: +47 21 56 33 18 (toll free 800 19 457)

Password: Algeta

—-

To access the replay (available for seven days), please dial:

US: +1 866 583 1035
UK: +44 20 8196 1998
Norway: toll free 800 19 101

Participant pin code: 9227182

###

For further information, please contact: Mike Booth     +47 2202 4510
Communications & Corporate Affairs     ir@algeta.com

Media enquiries:

Mark Swallow     +44 207 638 9571
Citigate Dewe Rogerson     mark.swallow@citigatedr.co.uk

Knut Ekern     +47 22 04 82 00
Gambit Hill & Knowlton     knut.ekern@hkstrategies.com

US investor enquiries:

Tricia Swanson     +1 646 378 2953
The Trout Group     tswanson@troutgroup.com

About Algeta

Algeta is a company focused on developing novel targeted therapies for patients with
cancer based on its alpha-pharmaceutical platform. The Company is headquartered in
Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in Cambridge, MA
performing commercial marketing operations in the US. Algeta is listed on the Oslo
Stock Exchange (Ticker: ALGETA). For more information please visit www.algeta.com.

Forward-looking Statements

This news release contains certain forward-looking statements that are based on uncertainty, as they relate to events and depend on circumstances that will occur in the future and which, by their nature, may have an impact on results of operations and the financial condition of Algeta. Such forward-looking statements reflect our current views and are based on the information currently available to Algeta. Algeta cannot give any assurance as to whether such forward looking statements will prove to be correct. These forward looking statements include statements regarding our anticipated co-promotion of Xofigo in the US. 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 or uncertainties associated with the ability to identify and hire a sufficient number of qualified employees in the US, growth management, general economic and business conditions and the pricing environment, the impact of competition, the ability to successfully commercialize Xofigo, the risk that costs associated with the copromotion of Xofigo may be greater than anticipated, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining additional regulatory approvals for radium-223 and the other risks and uncertainties described in our annual report.

Xofigo® is a registered trademark of Bayer.

Xofigo Access ServicesSM is a service mark of Bayer.

F2G Ltd. Appoints Ian Nicholson as Chief Executive Officer Manchester

By F2G, Press Release, Private Companies
Press Release.

 

March 11th 2013

F2G Ltd. Appoints Ian Nicholson as Chief Executive Officer Manchester

F2G Ltd, the UK-based antifungal drug discovery and development company, today announced the appointment of Ian Nicholson to the position of CEO and to the Board of Directors . Ian has over 25 years of international experience in management and transactions within the life sciences sector. He is currently, and will remain, an Operating Partner of London-based Advent Life Sciences LLP. Previously he spent eight years as CEO of the privately held Oncology R&D company, Chroma Therapeutics Limited. Before that he was senior vice president for business development at UK biotechnology company Celltech Group, and has worked extensively in licensing, M&A, and market development in the UK, Europe and the US. Ian holds a BSc (Hons) from University College London and an MBA from Boston University.

Dr Richard White, Executive Chairman of F2G, commented

‘We are delighted to welcome such an experienced executive to lead the company, and I look forward to working closely with him.’

Dr. White will revert to his former role of Non-Executive Chairman. Ian Nicholson added

‘I am excited to join F2G at this critical stage and lead the company in the successful development of an important first-in-class drug to treat Aspergillosis, an area of high unmet medical need.’

About F2G Ltd: Based in Manchester, UK, F2G Ltd is dedicated to the discovery and development of new and clinically superior drug classes to treat life-threatening systemic fungal infections in at-risk patient populations. This is a growing health risk for which there are currently limited treatment options and for which demand is increasing globally Market growth is expected to increase with the emergence of new clinical indications in allergies and asthma. For more information visit www.f2g.com

British American Tobacco buys UK based e-cigarette technology company

By Press Release
Press Release.

 

19 December 2012

British American Tobacco announced today that it has acquired CN Creative Limited, a UK based start-up company who specialises in the development of e-cigarette technologies intended to offer smokers a less risky alternative to cigarettes.

The company, which has its own research and development facilities, currently has several e-cigarette products on the market as well as new, innovative e-cigarette technologies in the development pipeline.

Kingsley Wheaton, Director of Corporate and Regulatory Affairs at British American Tobacco, said:

“Our core business is, and will remain in, tobacco but we’ve always made it clear that our goal is to provide those adult smokers who are seeking safer alternatives to cigarettes with a range of reduced-risk products that will meet their varying needs.

“And we believe the innovative e-cigarette technologies that CN Creative has been developing over the past few years will help us move closer to achieving this goal.”

The acquisition of CN Creative is a natural extension of British American Tobacco’s approach to tobacco harm reduction that has been evolving over a number of years.

CN Creative acquired by British American Tobacco

By CN Creative, Press Release
Press Release.

 

CN Creative announced today that it has been acquired by British American Tobacco as part of the FTSE 100 Company’s long term commitment to tobacco harm reduction.

CN Creative, which has its own research and development facilities, currently has several e-cigarette products on the market as well as new, innovative e-cigarette technologies in the development pipeline.

Kingsley Wheaton, Director of Corporate and Regulatory Affairs at British American Tobacco, said:

“Our core business is, and will remain in, tobacco but we’ve always made it clear that our goal is to provide those adult smokers who are seeking safer alternatives to cigarettes with a range of reduced-risk products that will meet their varying needs. We believe the innovative e-cigarette technologies that CN Creative has been developing over the past few years will help us move closer to achieving this goal.”

The acquisition of CN Creative is a natural extension of British American Tobacco’s approach to tobacco harm reduction that has been evolving over a number of years.

CN Creative’s founders Chris Lord and David Newns explained: “This is an exciting opportunity that allows us to accelerate the development and successful launch of our innovative and new e-cigarette technologies”

ENQUIRIES
British American Tobacco Press Office
Will Hill/ Jem Maidment
+44 (0) 20 7845 2888 (24 hours)

British American Tobacco Investor Relations
Rachael Brierley +44 (0) 20 7845 1519

CN Creative Press Office
Nick Henderson/Richard McCann +44 (0) 845 500 1140
For website see www.cncbio.com

Advent Life Sciences Announces Appointment of Ian Nicholson as Operating Partner

By Advent Life Sciences, Press Release
Press Release.

 

17th December 2012, London: – Advent Life Sciences announced today the appointment of Ian Nicholson as an Operating Partner.  Ian brings over 20 years of international experience in management, licensing, mergers and acquisitions in the life sciences sector.  He was most recently CEO of Chroma Therapeutics Ltd, prior to which he held senior positions at Celltech Group plc, Oxford Asymmetry, Lonza AG and Amersham International plc. Ian has served on the Boards of several Public and Private Companies in the UK and Europe.  Ian holds a BSc (Hons) from University College London and an MBA from Boston University.

– Ends –

About Advent Life Sciences:
Advent Life Sciences is the dedicated Life Sciences team at Advent Venture Partners, one of Europe’s best established growth and venture capital firms.  Advent Life Sciences invests predominantly in early-stage and growth equity life sciences companies in the UK, Europe and the US.  It will back companies that have a first- or best-in-class approach in a range of sectors within the life sciences sector, including new drug discovery, enabling technologies, med-tech and diagnostics.

Advent Life Sciences is a leader in European life sciences venture capital.  Its investments include:  PowderMed, a therapeutic DNA vaccine company sold to Pfizer; Thiakis, an obesity treatment company acquired by Wyeth Pharmaceuticals; Respivert, a drug discovery company focused on respiratory diseases that was acquired by Johnson & Johnson; EUSA Pharma, a transatlantic speciality pharmaceutical company acquired by Jazz Pharmaceuticals; Avila Therapeutics, a biotechnology company developing targeted covalent drugs acquired by Celgene Corporation, Micromet, a biotechnology company acquired by Amgen and Algeta (OSE: ALGETA), an oncology company developing treatments for bone metastases and disseminated tumours.

For more information, please contact:

Raj Parekh
Advent Life Sciences
Ph: +44 (0) 20 7932 2100
Email: raj.parekh@adventventures.com

www.adventventures.com

Algeta’s partner Bayer submits New Drug Application to US FDA for Radium-223 Dichloride

By Algeta, Press Release
Press Release.

 

Oslo, Norway, 14 December 2012 – Algeta ASA (OSE: ALGETA) announces
that Bayer has submitted a New Drug Application (NDA) to the US Food and
Drug Administration (FDA) for radium-223 dichloride (radium-223) for the
treatment of castration-resistant prostate cancer (CRPC) patients with bone
metastases.

“Algeta has made significant progress during 2012 across all areas of its business and
the submissions by Bayer for marketing approval of radium-223 in both Europe and
now the US are great achievements on which to conclude the year,”

said Andrew Kay,Algeta’s President & CEO.

“Meanwhile, we continue to make significant investments in building our commercial operations in the US and we look forward, if approved, to copromoting this novel product for CRPC patients with bone metastases in this important market.”

Bayer submitted a Marketing Authorization Application (MAA) to the European
Medicines Agency (EMA) on 12 December 2012 for radium-223 for the treatment of
castration-resistant prostate cancer (CRPC) patients with bone metastases. Under the terms of the 2009 agreement with Bayer, the first complete submission for marketing approval triggers a €50 million milestone payment from Bayer to Algeta.

“This submission of radium-223 for the treatment of men with CRPC that has
metastasized to the bone brings us closer to a new treatment option for patients in the US dealing with this advanced form of cancer,”

said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development.

“We are looking forward to continuing discussions with the regulatory authorities to bring this innovative treatment option to patients as quickly as we can.”

The submission is based on data from the pivotal phase III ALSYMPCA (ALpharadin in
SYMptomatic Prostate CAncer) trial, which was conducted by Algeta. In the study,
radium-223 significantly increased overall survival by 44 percent (HR=0.695,
p=0.00007), resulting in a 30.5 percent reduction in the risk of death compared to
placebo. The median overall survival (OS) benefit in patients with radium-223 was 3.6
months, based on 14.9 months OS with radium-223 plus best standard of care (BSoC) vs. 11.3 months with placebo plus BSoC. These updated results were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012.

The most common hematologic adverse events for patients treated with radium-223
and best standard of care (BSoC) and compared to placebo and BSoC included anemia (31% vs. 31%), neutropenia (5% vs. 1%) and thrombocytopenia (12% vs. 6%). With respect to Grade 3 and 4 adverse events, the most common events included anemia (13% vs. 13%), neutropenia (2% vs. 1%) and thrombocytopenia (6% vs. 2%). The most common non-hematologic adverse events in patients treated with radium-223 and BSoC compared to placebo and BSoC included bone pain (50% vs. 62%), nausea (36% vs. 35%), diarrhea (25% vs. 15%) and vomiting (19% vs. 14%). With respect to Grade 3 to 4 adverse events, the most common events included bone pain (21% vs. 26%).

About the ALSYMPCA Trial
The ALSYMPCA trial was a phase III, randomized, double-blind, placebo-controlled
international study comparing radium-223 dichloride vs. placebo in symptomatic CRPC
patients with bone metastases treated with BSoC compared with placebo plus BSoC.
The trial enrolled 921 patients in more than 100 centers in 19 countries The study
treatment consisted of up to six intravenous administrations of radium-223 or placebo
each separated by an interval of four weeks.

The primary endpoint of the study was overall survival. Secondary endpoints included
time to occurrence of skeletal related events (SRE), changes and time to progression
in PSA and ALP, safety, and impact on quality of life measures.

About CRPC and Bone Metastases
Prostate cancer is the most common non-cutaneous malignancy in men worldwide. In
2008, an estimated 899,000 men were diagnosed with prostate cancer and 258,000
died from the disease worldwide. Prostate cancer is the sixth leading cause of death
from cancer in men.
A majority of men with CRPC have radiological evidence of bone metastases. Once the cancer cells settle in the bone, they interfere with bone strength, often leading to pain, fracture and other complications that can significantly impair a man’s health. Bone metastases secondary to prostate cancer typically target the lumbar spine, vertebrae and pelvis. In fact, bone metastases are the main cause of morbidity and death in patients with CRPC.

About Radium-223 Dichloride
Radium-223 dichloride (radium-223), formerly referred to as Alpharadin, is a
therapeutic alpha particle-emitting pharmaceutical with targeted anti-tumor effect on
bone metastases in development for CRPC patients with bone metastases.
In September 2009, Algeta signed an agreement with Bayer Pharma AG (Berlin,
Germany) for the development and commercialization of radium-223. Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 globally. Algeta will co-promote radium-223 with Bayer in the US, and is eligible for milestones as well as royalties on Bayer’s sales outside the US. The ALSYMPCA trial was initiated by Algeta in June 2008.
Radium-223 is an investigational agent and is not approved by the European
Medicines Agency (EMA), the US Food and Drug Administration (FDA), or other health authorities.

In terms of further development activities for radium-223, Bayer intends to conduct
studies in earlier settings of prostate cancer, including combination studies with other
agents, as well as exploratory studies in other tumors such as breast cancer and
osteosarcoma.

###

About Algeta
Algeta is a company focused on developing novel targeted therapies for patients with
cancer based on its alpha-pharmaceutical platform. The Company is headquartered in
Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in Cambridge, MA
performing commercial marketing operations in the US. Algeta is listed on the Oslo
Stock Exchange (Ticker: ALGETA). For more information please visit www.algeta.com.

Forward-looking Statements
This news release contains certain forward-looking statements that are based on
uncertainty, as they relate to events and depend on circumstances that will occur in
the future and which, by their nature, may have an impact on results of operations
and the financial condition of Algeta. Such forward-looking statements reflect our
current views and are based on the information currently available to Algeta. Algeta
cannot give any assurance as to whether such forward looking statements will prove
to be correct. These forward looking statements include statements regarding the
receipt of milestone payments, the build out of our US commercial organization and
future development activities. 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 or
uncertainties associated with the success of future clinical trials, the ability to identify
and hire a sufficient number of qualified employees for the US field force, growth
management, general economic and business conditions and the pricing environment,
the impact of competition, the ability to successfully commercialize radium-223 and
our other products, the risk that costs associated with the co-promotion of radium-223may be greater than anticipated, the risk that research & development will not yield new products that achieve commercial success, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining regulatory approvals for radium-223 and our other products and difficulties of obtaining relevant governmental approvals for new products, and the other risks and uncertainties described in our annual report.

Algeta’s partner Bayer submits Radium-223 Dichloride for EU Marketing Authorisation

By Algeta, Press Release
Press Release.

 

Oslo, Norway, 12 December 2012 – Algeta ASA (OSE: ALGETA) announces
that Bayer has submitted a Marketing Authorization Application (MAA) to the
European Medicines Agency (EMA) for radium-223 dichloride (radium-223)
for the treatment of castration-resistant prostate cancer (CRPC) patients
with bone metastases.

“The submission by Bayer of the MAA for radium-223 with the EMA is a significant
landmark for Algeta. It carries us further towards realizing our vision of becoming a
world class oncology company bringing novel targeted medicines to cancer patients,”

said Andrew Kay, Algeta’s President & CEO.

“I would like to thank the teams at both Algeta and Bayer, which have worked diligently together, for delivering this major accomplishment. Under the terms of our 2009 Agreement, the first complete submission for marketing approval triggers a €50 million milestone payment to Algeta from Bayer. This submission also brings us another step closer to the royalties we are due from the launch of the product in Europe. Meanwhile, we look forward to the initiation of new trials evaluating the broader clinical potential of radium-223 for treating cancer patients with bone metastases.”

“This submission reflects our commitment to developing innovative cancer treatments
for patients for whom only limited therapy options are available today,”

said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global
Development.

“With its novel mode of action and the proven survival benefit, radium-223 represents an innovation in the treatment of prostate cancer and is an important example of our growing oncology portfolio.”

The submission is based on data from the pivotal phase III ALSYMPCA (ALpharadin in
SYMptomatic Prostate CAncer) trial, which was conducted by Algeta. In the study,
radium-223 significantly increased overall survival by 44 percent (HR=0.695,
p=0.00007), resulting in a 30.5 percent reduction in the risk of death compared to
placebo. The median overall survival (OS) benefit in patients with radium-223 was 3.6
months, based on 14.9 months OS with radium-223 plus best standard of care (BSoC) vs. 11.3 months with placebo plus BSoC. These updated results were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012.

The most common hematologic adverse events for patients treated with radium-223
and best standard of care (BSoC) and compared to placebo and BSoC included anemia (31% vs. 31%), neutropenia (5% vs. 1%) and thrombocytopenia (12% vs. 6%). With respect to Grade 3 and 4 adverse events, the most common events included anemia (13% vs. 13%), neutropenia (2% vs. 1%) and thrombocytopenia (6% vs. 2%). The most common non-hematologic adverse events in patients treated with radium-223 and BSoC compared to placebo and BSoC included bone pain (50% vs. 62%), nausea (36% vs. 35%), diarrhea (25% vs. 15%) and vomiting (19% vs. 14%). With respect to Grade 3 to 4 adverse events, the most common events included bone pain (21% vs. 26%).

About the ALSYMPCA Trial
The ALSYMPCA trial was a phase III, randomized, double-blind, placebo-controlled
international study comparing radium-223 dichloride vs. placebo in symptomatic CRPC
patients with bone metastases treated with BSoC compared with placebo plus BSoC.
The trial enrolled 921 patients in more than 100 centers in 19 countries The study
treatment consisted of up to six intravenous administrations of radium-223 or placebo
each separated by an interval of four weeks.

The primary endpoint of the study was overall survival. Secondary endpoints included
time to occurrence of skeletal related events (SRE), changes and time to progression
in PSA and ALP, safety, and impact on quality of life measures.

About CRPC and Bone Metastases
Prostate cancer is the most common non-cutaneous malignancy in men worldwide. In
2008, an estimated 899,000 men were diagnosed with prostate cancer and 258,000
died from the disease worldwide. Prostate cancer is the sixth leading cause of death
from cancer in men.

A majority of men with CRPC have radiological evidence of bone metastases. Once the cancer cells settle in the bone, they interfere with bone strength, often leading to pain, fracture and other complications that can significantly impair a man’s health. Bone metastases secondary to prostate cancer typically target the lumbar spine, vertebrae and pelvis. In fact, bone metastases are the main cause of morbidity and death in patients with CRPC.

About Radium-223 Dichloride
Radium-223 dichloride (radium-223), formerly referred to as Alpharadin, is a
therapeutic alpha particle-emitting pharmaceutical with targeted anti-tumor effect on
bone metastases in development for CRPC patients with bone metastases.
In September 2009, Algeta signed an agreement with Bayer Pharma AG (Berlin,
Germany) for the development and commercialization of radium-223. Under the terms of the agreement, Bayer will develop, apply for global health authority approvals, and commercialize radium-223 globally. Algeta will co-promote radium-223 with Bayer in the US, and is eligible for milestones as well as royalties on Bayer’s sales outside the US. The ALSYMPCA trial was initiated by Algeta in June 2008.

Radium-223 is an investigational agent and is not approved by the European
Medicines Agency (EMA), the US Food and Drug Administration (FDA), or other health authorities.

In terms of further development activities for radium-223, Bayer intends to conduct
studies in earlier settings of prostate cancer, including combination studies with other
agents, as well as exploratory studies in other tumors such as breast cancer and
osteosarcoma.

###

About Algeta
Algeta is a company focused on developing novel targeted therapies for patients with
cancer based on its alpha-pharmaceutical platform. The Company is headquartered in
Oslo, Norway, and has a US subsidiary, Algeta US, LLC, based in Cambridge, MA
performing commercial marketing operations in the US. Algeta is listed on the Oslo
Stock Exchange (Ticker: ALGETA). For more information please visit www.algeta.com.

Forward-looking Statements
This news release contains certain forward-looking statements that are based on
uncertainty, as they relate to events and depend on circumstances that will occur in
the future and which, by their nature, may have an impact on results of operations
and the financial condition of Algeta. Such forward-looking statements reflect our
current views and are based on the information currently available to Algeta. Algeta
cannot give any assurance as to whether such forward looking statements will prove
to be correct. These forward looking statements include statements regarding the
receipt of milestone payments, the build out of our US commercial organization and
future development activities. 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 or
uncertainties associated with the success of future clinical trials, the ability to identify
and hire a sufficient number of qualified employees for the US field force, growth
management, general economic and business conditions and the pricing environment,
the impact of competition, the ability to successfully commercialize radium-223 and
our other products, the risk that costs associated with the co-promotion of radium-223may be greater than anticipated, the risk that research & development will not yield new products that achieve commercial success, manufacturing capacity, the risk of non-approval of patents not yet granted, risks in obtaining regulatory approvals for radium-223 and our other products and difficulties of obtaining relevant governmental approvals for new products, and the other risks and uncertainties described in our annual report.

Biocartis completes €34,5million ($44,5 million) Series D Fund Raising

By Biocartis, Press Release
Press Release.

 

Capital to be used to commercialize recently launched DMAT platform, validate APOLLO platform and build proprietary oncology content on both platforms.

Strong support from internal shareholders and a recognition of our achievements

Lausanne (Switzerland) – December 12, 2012 Biocartis, a molecular diagnostics company developing and commercializing innovative, high quality,  easy to use platforms and clinically relevant oncology assays, announced today the completion of a €34,5 million (approximately $45 million, CHF 42 million) Series D equity fund raising entirely backed by existing investors. The round was led by the Flemish investment company PMV (using its TINA-fund), and included RMM (Rudi Mariën), Valiance, Debiopharm Group™, Korys (investment holding of the Colruyt family), Philips, Johnson & Johnson Development Corporation (JJDC), the family office of Dr Paul Janssen, Luc Verelst, Benaruca (Rudi Pauwels, founder of Biocartis) and New Rhein Healthcare (Greg Parekh, CEO).

Greg Parekh, the CEO of Biocartis, commenting on today’s announcement said,

“Completing a major life sciences fundraising in today´s environment is recognition of the significant progress that Biocartis has made over the past year. We are now a commercial stage organization with a high quality team which has proven it can take platforms from development to commercialisation. We now look forward to building our menu of oncology tests; validating, registering and launching the Apollo platform; growing our commercial presence and ultimately helping shape the diagnosis and treatment of cancer.”

Rudi Pauwels, chairman and founder of the company, added:

“We have once more received a positive signal from our shareholders. They strongly believe in the potential of the company and our goal to becoming a fully integrated global molecular diagnostics company.”

Following the fundraising, Roald Borré, representing PMV, will join the Biocartis Board.

About Biocartis
Biocartis aims to improve healthcare outcomes by enabling the practice of personalized medicine anywhere, anytime. Biocartis’ ambition is to establish a new gold standard in diagnostic testing.

Biocartis provides innovative research and diagnostic systems with simultaneous multiplex detection and simplified workflows which require less hand-on time and improve sample consumption.  Additionally, Biocartis develops assays which have high clinical utility and compelling health economic value. Oncology is the primary focus of Biocartis as this is one of the greatest unmet needs for personalized medicine. Biocartis’ broad platform capabilities are well suited to address the growing need for individualized diagnosis and treatment of cancer patients.

Biocartis follows a unique alliance model which leverages the combined resources of its current alliance partners (bioMérieux and Janssen Diagnostics) and future alliance members to jointly and efficiently install and service a global base of instruments and develop a broad menu of diagnostic tests.

Biocartis is a rapidly growing company; to date Biocartis staff includes over 140 people. Biocartis SA is based at the EPFL’s Innovation Square in Lausanne, Switzerland; the Belgian entity which counts over 100 staff, is located in Mechelen.

The company raised in total close to EUR 150 million in equity.