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Versartis Secures $55 Million in Series E Financing

By Press Release
Press Release.

 

REDWOOD CITY, CA – Feb 18, 2014 – Versartis, Inc., an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH) for the treatment of growth hormone deficiency (GHD), today announced that it has completed a $55 million Series E financing. Five undisclosed new investors, all of which are leading life science investment firms, joined existing investors Sofinnova Ventures, Aisling Capital, New Leaf Venture Partners and Advent Life Sciences in this round. Versartis was founded by Amunix, Inc. and Index Ventures to explore the clinical potential of novel drugs using Amunix’s XTEN technology. This financing brings the company’s total capital raised to $132 million.

The proceeds from this financing will primarily be used to prepare for an international Phase 3 pediatric GHD trial of VRS-317, the company’s proprietary long-acting rhGH for the treatment of GHD. VRS-317 is currently being studied in pediatric GHD patients in a Phase 2a clinical trial to evaluate the 6-month efficacy and safety.

“We are pleased to welcome our new investors to our investor syndicate,”

said Versartis Chief Executive Officer Jeffery L. Cleland, PhD.

“This financing will allow us to further advance the clinical development of our lead compound, VRS-317, which we believe has the potential to be a highly differentiated treatment for pediatric GHD.”

About Versartis

Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing VRS-317, a novel, long-acting form of recombinant human growth hormone, for the treatment of growth hormone deficiency (GHD). The company is currently completing a Phase 2a clinical trial of VRS-317 in children with GHD. Further information on Versartis can be found at www.versartis.com.

# # #

Cellnovo launches first Mobile Diabetes Management System at the ATTD Conference in Vienna, Austria

By Cellnovo, Press Release
Press Release.

 

Real-time tracking – an industry first for insulin pump technology

Swansea, 5 February 2014 – Cellnovo, the leading innovator in Mobile Diabetes Management technology, today announces the UK launch of the Company’s unique Diabetes Management System, the first of its kind with mobile connectivity able to provide immediate, wireless data updates, displaying real-time clinical information to patients, caregivers and healthcare professionals. Cellnovo is exhibiting and demonstrating the Cellnovo System at the international conference on Advanced Technologies and Treatment for Diabetes (ATTD) in Vienna, Austria from February 5-8.

The Cellnovo System will initially be rolled out to a group of participating centres throughout the UK as part of a phased launch that started in Wales at the end of 2013. It will subsequently be made available in a selection of leading centres in the Netherlands and France during H1 2014.

Eric A. Beard, Cellnovo Executive Chairman commented:

“The feedback we have received from patients and healthcare professionals during our extensive testing, trialing and local launch phases, has been excellent. Patients love the discreetness of the pump, its intuitive operation and the immediate availability of information. Healthcare professionals appreciate the benefits of a revolutionary system like ours, giving them access to true mobile health management tools. The UK launch is a significant milestone for the Company and we look forward to rolling out the product across Europe.”

The Cellnovo System is an innovative Mobile Diabetes Management System that comprises a wireless connected patch pump and a mobile touchscreen controller with an integrated blood glucose meter (“handset”). The proprietary software provides intuitive operation, internet connectivity and real-time tracking. It is the first device of its kind designed to allow patients the freedom to enjoy a full lifestyle with the comfort that they can closely monitor blood glucose levels, insulin use, activity and diet. The online data management system also displays real-time clinical information to healthcare professionals and caregivers.

Type 1 diabetes develops when the body is unable to produce insulin. The prevalence of diabetes has reached 371 million (8.3% of the world population)1 and Type 1 diabetes accounts for 10 per cent of all adults with diabetes. Multiple daily insulin injections do not provide the continuous precise insulin delivery of an insulin pump, which most closely mirrors the release of insulin in someone without diabetes. Today, in Western Europe and North America only 20% of insulin dependent patients are on pumps.

For further information please contact:

Cellnovo
Eric Beard, Executive Chairman    +44 (0)20 3058 1250

FTI Consulting

Julia Phillips / Simon Conway / Natalie Garland-Collins    +44 (0)20 7269 7121

Sources

1.    International Federation of Diabetes, 2012

About Cellnovo

Cellnovo, a UK-based medical device company, is a leading innovator in Mobile Diabetes Management technology. The Company’s proprietary Diabetes Management System comprises a wireless connected patch pump, mobile touchscreen handset/controller with an integrated blood glucose meter and applications. This system provides intuitive operation, wireless Internet connectivity and real-time tracking, all industry firsts which represent a revolution for insulin pump technology. For further information, please visit www.cellnovo.com.

UniQure Announces Pricing of Initial Public Offering

By Press Release, UniQure
Press Release.

 

Amsterdam, the Netherlands, February 5, 2014 – uniQure B.V. (“uniQure”), a leader in human gene therapy, today announced the pricing of its initial public offering of 5,400,000 ordinary shares at an initial public offering price of $17.00 per ordinary share. In addition, uniQure has granted the underwriters a 30-day option to purchase up to an additional 810,000 ordinary shares from uniQure at the public offering price, less underwriting discounts. After deducting the underwriting discounts and other estimated offering expenses payable by uniQure, the net proceeds of the initial public offering are expected to be approximately $81.9 million. The offering is expected to close on or about February 10, 2014, subject to customary closing conditions. uniQure’s ordinary shares have been approved for listing on the NASDAQ Global Select Market and are expected to begin trading under the symbol “QURE” on February 5, 2014.

Jefferies LLC and Leerink Partners LLC are acting as joint book-running managers for the offering. Piper Jaffray & Co. is acting as lead manager for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on February 4, 2014. The offering will be made only by means of a prospectus, copies of which may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 12th Floor, New York, NY 10022, or by email at Prospectus_Department@Jefferies.com, or by phone at 877-547-6340; or from Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by email at Syndicate@Leerink.com, or by phone at 800-808-7525.

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 uniQure
uniQure is delivering on the promise of gene therapy through single treatments with potentially curative results. We have developed a modular platform to rapidly bring new disease-modifying therapies to patients with severe disorders. We are engaged in multiple partnerships and have obtained regulatory approval of our lead product, Glybera, in the European Union for a subset of patients with LPLD.

uniQure:
Jörn Aldag
CEO uniQure
T: +31 20 566 8014
j.aldag@uniqure.com

Media inquiries:
Gretchen Schweitzer
MacDougall Biomedical Communications
T: +49 172 861 8540
gschweitzer@macbiocom.com

Agenus Prices Public Offering of Common Stock

By Agenus, Press Release, Publicly Listed
Press Release.

 

Lexington, MA (February 5, 2014): Agenus Inc. (Nasdaq: AGEN) today announced the pricing
of an underwritten public offering of 19,335,653 primary shares of its common stock at a price of
$2.70 per share. Agenus has granted the underwriters a 30-day option to purchase up to
2,900,347 additional shares of common stock to cover over-allotments, if any.

William Blair & Company, L.L.C. is acting as sole book-running manager for the
offering. Maxim Group LLC is acting as lead manager and H.C. Wainwright & Co., LLC and
MLV & Co. LLC are acting as co-managers for the offering. Geller Biopharm Inc. is acting as
financial advisor for the offering.

The shares will be issued by Agenus pursuant to a shelf registration statement that was
previously filed with, and declared effective by, the Securities and Exchange Commission
(SEC). A preliminary prospectus supplement related to the offering has been filed with the SEC
and is available on the SEC’s website located at www.sec.gov. A final prospectus supplement
related to the offering will be filed with the SEC.

This press release does 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. Any offer, if at all, will be made only by means of a
prospectus supplement and accompanying prospectus forming a part of the effective registration
statement, copies of which may be obtained, when available, from William Blair & Company,
L.L.C., Attention: Prospectus Department, 222 West Adams Street, Chicago, IL 60606, by
telephone at (800) 621-0687, or by e-mail at prospectus@williamblair.com.

About Agenus

Agenus Inc. is a biotechnology company working to develop treatments for cancers and
infectious diseases. The company is focused on immunotherapeutic products based on strong
platform technologies with multiple product candidates advancing through the clinic, including
several product candidates that have advanced into late-stage clinical trials through corporate
partners. Between Agenus and its partners, 23 programs are in clinical development.

Additional Information

Statements made in this press release include forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, regarding, but not limited to, the use of proceeds
from the offering. Forward-looking statements can be identified by the use of words such as
“may,” “will,” “plan,” “should,” “expect,” “anticipate,” “estimate,” “continue,” or comparable
terminology. Such forward-looking statements are inherently subject to certain risks, trends and
uncertainties, many of which Agenus cannot predict with accuracy and some of which Agenus
might not even anticipate, and involve factors that may cause actual results to differ materially
from those projected or suggested. These risks and uncertainties include, among others, the
factors described under the Risk Factors section of Agenus’ Current Report on Form 8-K, which
was filed with the SEC on February 4, 2014. Agenus cautions investors not to place considerable
reliance on the forward-looking statements contained in this release. These statements speak only
as of the date of this press release, and Agenus undertakes no obligation to update or revise the
statements.

Media and Investor Contact:
Jonae R. Barnes
Vice President
Investor Relations and
Corporate Communications
jonae.barnes@agenusbio.com
617-818-2985

First Clinical Trial for NeRRe Therapeutics

By F2G, Press Release, Private Companies
Press Release.

 

First Clinical Trial for NeRRe Therapeutics

Press Release:

Start of Phase II study of neurokinin-1 receptor antagonist orvepitant for intense pruritus induced by epidermal growth factor receptor inhibitors

First Clinical Trial for NeRRe Therapeutics

Stevenage, UK, 23 January 2014. NeRRe Therapeutics Ltd, which is focused on the development of neurokinin (NK) receptor antagonists for a range of indications, is pleased to announce the start of a Phase II study of the novel NK-1 receptor antagonist orvepitant. The proof-of-concept study, results of which are expected in 2015, is investigating orvepitant’s effectiveness as a treatment for the intense pruritus (itch) associated with epidermal growth factor receptor inhibitor (EGFRi) anticancer therapies. The itch intensity experienced by patients can be so severe that their EGFRi dose must be reduced or the treatment withdrawn; also pruritus along with rash has a significant effect on quality of life1.

The RELIEVE-1 trial is a randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of two daily dose levels of oral orvepitant on EGFRi-induced intense pruritus in oncology subjects. Its primary endpoint is the difference between orvepitant and placebo in reducing the intensity of pruritus over 4 weeks, as measured on a subject-recorded numerical rating scale. RELIEVE-1 is being undertaken in 15 clinical sites in Italy, with Dr Bruno Vincenzi from Università Campus Bio-Medico di Roma as lead investigator. Dr Vincenzi and his colleagues at the centre have pioneered the use NK-1 antagonists as anti-pruritics in this setting2. Chemistry, manufacturing and control support for RELIEVE-1 is being provided by Aptuit (Verona) Srl, with clinical operations assistance from the CRO Cromsource.

Dermatologic adverse events such as pruritus are a common feature of targeted anti-cancer therapies, with incidence of this symptom induced by EGFRia drugs in clinical trials ranging from 14.6% to 54.9% depending on the specific agent3. Open-label studies in patients suffering from refractory chronic pruritus have indicated that NK-1 receptor antagonism can provide rapid and highly effective relief as well as significantly improving quality of life.2,4,5,6

Dr Mike Trower, Co-founder & Chief Operating Officer of NeRRe Therapeutics said:  ‘We are very pleased to announce the start of RELIEVE-1, NeRRe’s first clinical trial, in this important area of unmet medical need. There is a strong rationale and a growing body of clinical evidence supporting the potential of orvepitant as an anti-pruritic for this devastating symptom commonly associated with EGFRis. Given its known effects on mood and sleep, orvepitant may also provide additional benefits for patient well-being.’

Dr Emiliangelo Ratti, NeRRe Therapeutics Co-founder added: ‘The intense pruritus induced by EGFRis can lead to significant suffering and poor quality of life, and we believe that a treatment for this troubling side effect would be welcomed by cancer patients and supportive care doctors alike. A successful study of orvepitant in this indication would provide further evidence of the broad therapeutic potential of the NK-1 receptor antagonist mechanism which NeRRe is exploiting in its pipeline.’

–ENDS–

a This includes monoclonal antibodies that target the extracellular domain of EFGR, small molecule tyrosine kinase (TK) inhibitors, and small molecule dual TK inhibitors.

For more information about NeRRe Therapeutics, please contact:
Dr Mike Trower, Chief Operating Officer
Tel: +44 (0) 1438 906960
Email:  info@nerretherapeutics.com

About NeRRe Therapeutics
NeRRe Therapeutics was formed in December 2012 and is focussed on the development of a portfolio of NK receptor antagonists acquired from GlaxoSmithKline (GSK), which have therapeutic potential in a broad range of indications. NeRRe Therapeutics was co-founded by Drs Emiliangelo Ratti and Mike Trower, both of whom are both former senior leaders of neurosciences drug discovery at GSK with intimate knowledge of the transferred assets and the neurokinin receptor system field. In 2012 NeRRe Therapeutics raised £11.5 million ($18.4 million) in Series A financing from two leading European financial institutions, Novo A/S (www.novo.dk/ventures) and Advent Life Sciences (www.adventventures.com), who are represented by Dr Martin Edwards (Chairman) and Dr Kaasim Mahmood respectively on the company’s Board.

NeRRe (www.nerretherapeutics.com) is based at the state-of-the-art Stevenage Bioscience Catalyst (www.stevenagecatalyst.com), the UK’s first open innovation bioscience campus.

About Orvepitant
Orvepitant is a ‘novel generation’ brain penetrant, selective and potent, small molecule NK-1 receptor antagonist7 that features high receptor occupancy and full and long lasting (≥24hrs) central NK-1 receptor occupancy8. It has previously completed extensive safety and toxicology studies to support its clinical development; and it has already demonstrated a positive antidepressant effect in a Phase II clinical study together with beneficial effects on sleep8.

References:
1.    Rosen AC et al. Am J Clin Dermatol. (2013), 14(4):327-33
2.    Santini D et al. Lancet Oncol. (2012), 13(10):1020-4
3.    Ensslin CJ et al. J Am Acad Dermatol. (2013), 69(5):708-20
4.    Duval A, Dubertret L. N Engl J Med. (2009), 1;361(14):1415-6
5.    Ständer S et al. PLoS One. (2010), 5(6):e10968
6.    Torres T et al. J Am Acad Dermatol. (2012), 66(1):e14-5
7.    Di Fabio R et al. Bioorg Med Chem. (2013), 21(21):6264-73
8.    Ratti E et al. J Psychopharmacol. (2013), 27(5):424-34

NeRRe Therapeutics Press Release here:

First Clinical Trial for NeRRe Therapeutics

By NeRRe Therapeutics, Press Release, Private Companies
Press Release.

 

Start of Phase II study of neurokinin-1 receptor antagonist orvepitant for intense pruritus induced by epidermal growth factor receptor inhibitors

First Clinical Trial for NeRRe Therapeutics

Stevenage, UK, 23 January 2014. NeRRe Therapeutics Ltd, which is focused on the development of neurokinin (NK) receptor antagonists for a range of indications, is pleased to announce the start of a Phase II study of the novel NK-1 receptor antagonist orvepitant. The proof-of-concept study, results of which are expected in 2015, is investigating orvepitant’s effectiveness as a treatment for the intense pruritus (itch) associated with epidermal growth factor receptor inhibitor (EGFRi) anticancer therapies. The itch intensity experienced by patients can be so severe that their EGFRi dose must be reduced or the treatment withdrawn; also pruritus along with rash has a significant effect on quality of life1.

The RELIEVE-1 trial is a randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of two daily dose levels of oral orvepitant on EGFRi-induced intense pruritus in oncology subjects. Its primary endpoint is the difference between orvepitant and placebo in reducing the intensity of pruritus over 4 weeks, as measured on a subject-recorded numerical rating scale. RELIEVE-1 is being undertaken in 15 clinical sites in Italy, with Dr Bruno Vincenzi from Università Campus Bio-Medico di Roma as lead investigator. Dr Vincenzi and his colleagues at the centre have pioneered the use NK-1 antagonists as anti-pruritics in this setting2. Chemistry, manufacturing and control support for RELIEVE-1 is being provided by Aptuit (Verona) Srl, with clinical operations assistance from the CRO Cromsource.

Dermatologic adverse events such as pruritus are a common feature of targeted anti-cancer therapies, with incidence of this symptom induced by EGFRia drugs in clinical trials ranging from 14.6% to 54.9% depending on the specific agent3. Open-label studies in patients suffering from refractory chronic pruritus have indicated that NK-1 receptor antagonism can provide rapid and highly effective relief as well as significantly improving quality of life.2,4,5,6

Dr Mike Trower, Co-founder & Chief Operating Officer of NeRRe Therapeutics said:  ‘We are very pleased to announce the start of RELIEVE-1, NeRRe’s first clinical trial, in this important area of unmet medical need. There is a strong rationale and a growing body of clinical evidence supporting the potential of orvepitant as an anti-pruritic for this devastating symptom commonly associated with EGFRis. Given its known effects on mood and sleep, orvepitant may also provide additional benefits for patient well-being.’

Dr Emiliangelo Ratti, NeRRe Therapeutics Co-founder added:

‘The intense pruritus induced by EGFRis can lead to significant suffering and poor quality of life, and we believe that a treatment for this troubling side effect would be welcomed by cancer patients and supportive care doctors alike. A successful study of orvepitant in this indication would provide further evidence of the broad therapeutic potential of the NK-1 receptor antagonist mechanism which NeRRe is exploiting in its pipeline.’

–ENDS–

a This includes monoclonal antibodies that target the extracellular domain of EFGR, small molecule tyrosine kinase (TK) inhibitors, and small molecule dual TK inhibitors.

For more information about NeRRe Therapeutics, please contact:
Dr Mike Trower, Chief Operating Officer
Tel: +44 (0) 1438 906960
Email:  info@nerretherapeutics.com

About NeRRe Therapeutics
NeRRe Therapeutics was formed in December 2012 and is focussed on the development of a portfolio of NK receptor antagonists acquired from GlaxoSmithKline (GSK), which have therapeutic potential in a broad range of indications. NeRRe Therapeutics was co-founded by Drs Emiliangelo Ratti and Mike Trower, both of whom are both former senior leaders of neurosciences drug discovery at GSK with intimate knowledge of the transferred assets and the neurokinin receptor system field. In 2012 NeRRe Therapeutics raised £11.5 million ($18.4 million) in Series A financing from two leading European financial institutions, Novo A/S (www.novo.dk/ventures) and Advent Life Sciences (www.adventventures.com), who are represented by Dr Martin Edwards (Chairman) and Dr Kaasim Mahmood respectively on the company’s Board.

NeRRe (www.nerretherapeutics.com) is based at the state-of-the-art Stevenage Bioscience Catalyst (www.stevenagecatalyst.com), the UK’s first open innovation bioscience campus.

About Orvepitant
Orvepitant is a ‘novel generation’ brain penetrant, selective and potent, small molecule NK-1 receptor antagonist7 that features high receptor occupancy and full and long lasting (≥24hrs) central NK-1 receptor occupancy8. It has previously completed extensive safety and toxicology studies to support its clinical development; and it has already demonstrated a positive antidepressant effect in a Phase II clinical study together with beneficial effects on sleep8.

References:
1.    Rosen AC et al. Am J Clin Dermatol. (2013), 14(4):327-33
2.    Santini D et al. Lancet Oncol. (2012), 13(10):1020-4
3.    Ensslin CJ et al. J Am Acad Dermatol. (2013), 69(5):708-20
4.    Duval A, Dubertret L. N Engl J Med. (2009), 1;361(14):1415-6
5.    Ständer S et al. PLoS One. (2010), 5(6):e10968
6.    Torres T et al. J Am Acad Dermatol. (2012), 66(1):e14-5
7.    Di Fabio R et al. Bioorg Med Chem. (2013), 21(21):6264-73
8.    Ratti E et al. J Psychopharmacol. (2013), 27(5):424-34

NeRRe Therapeutics Press Release here:

Bayer commences voluntary cash offer to acquire the entire issued share capital of Algeta

By Algeta, Press Release
Press Release.

 

Oslo, Norway, 20 January, 2014 – Algeta ASA (“Algeta”; OSE: ALGETA) today announced that Aviator Acquisition AS, a wholly-owned subsidiary of Bayer Nordic SE, has commenced the voluntary cash offer (the “Offer”) to acquire the entire issued share capital of Algeta for NOK 362 per share.

The Offer values the total share capital of Algeta at approximately NOK 17.6 billion (USD 2.9 billion) on a fully diluted basis. The Board of Directors of Algeta has unanimously decided to recommend that its shareholders accept the Offer.

The Offer period starts on 20 January, 2014 and expires at 9:00am CET on 24 February, 2014. Bayer has obtained pre-acceptances for approximately 14% of the shares in Algeta, including pre-acceptances from all members of Algeta’s Board of Directors, certain senior managers as well as from Algeta’s largest shareholder, HealthCap IV.

The consummation of the Offer remains subject to satisfaction or waiver of customary conditions, including a minimum acceptance of at least 90% or such lower percentage (not being less than 50%) of the outstanding Algeta shares as Aviator Acquisition AS determines and no material adverse change having occurred in Algeta. The German Federal Cartel Office’s clearance of Bayer’s acquisition of Algeta was announced on 6 January, 2014. No further antitrust approvals are required.

The Offer document, containing the full terms and conditions of the Offer, was published today by Aviator Acquisition AS. Subject to restrictions under applicable securities laws, the Offer document will be distributed to all shareholders listed in Algeta’s share register and will also be available at sebgroup.com/prospectuses and via www.algeta.com.

As set forth in the Offer document, the Offer period is scheduled to expire on 24 February, 2014 and may be extended, at any time and on one or several times, provided however, that the maximum Offer period may not exceed 10 weeks. Bayer expects to close the transaction during the first quarter of 2014.

Important Information about the Offer

The Offer described in this press release has commenced. This press release is neither an offer to purchase nor a solicitation of an offer to sell shares. The Offer to purchase all the shares of Algeta is contained in the Offer document filed by Aviator Acquisition AS with the Norwegian regulatory authority Oslo Stock Exchange (OSE) and approved by the OSE on 20 January, 2014. Algeta stockholders and other investors are urged to carefully read the Offer document before making any decision with respect to the Offer. The complete Offer document will, subject to restrictions under applicable securities laws, be distributed free of charge to all Algeta shareholders registered in Algeta’s share register in Verdipapirsentralen (the Norwegian Central Securities Depository), and at sebgroup.com/prospectuses.

###

For further information, please contact:
Oystein Soug     +47 90 65 65 25
Chief Financial Officer

Mike Booth     +1 646 410 1884
Communications & Corporate Affairs     ir@algeta.com

About Algeta

Algeta is a company focused on developing, manufacturing and marketing novel targeted therapies for patients with cancer. 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 expectations 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 Offer, conditions relating to the Offer and expected timing of the Offer, including the expected timing of closing. 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, satisfaction of conditions to the Offer and investor participation in the Offer.
This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

Agenus Enters into Definitive Agreement to Acquire Privately Held 4-Antibody AG

By Agenus, Press Release, Publicly Listed
Press Release.

 

  • 4-Antibody has a powerful platform for rapid discovery and optimization of fully-human antibodies against a wide array of  molecular targets
  • Lead programs target six immune checkpoint molecules
  • Checkpoint antibodies have produced unprecedented results against a variety of cancers affecting a large number of patients
  • Collaborations with the Ludwig Institute for Cancer Research and Memorial Sloan-Kettering Cancer Center

Lexington, MA – January 13, 2014


Agenus Inc. (Nasdaq: AGEN) a biotechnology company developing novel immune system activating treatments for cancers and infectious diseases, today announced that it has entered into a definitive agreement to acquire 4-Antibody AG, a private European-based biopharmaceutical company. 4-Antibody has a technology platform for the rapid discovery and optimization of fully-human antibodies against a wide array of molecular targets of interest. These targets include checkpoint molecules that regulate immune response to cancers and other diseases. The company has multiple preclinical immune checkpoint antibody programs targeting numerous checkpoint molecules, including GITR and OX40, as well as four additional undisclosed checkpoint programs. These checkpoint programs are being pursued through a strategic collaboration with the Ludwig Institute for Cancer Research and Memorial Sloan-Kettering Cancer Center (MSKCC) in New York.

Checkpoint-targeting antibodies have produced unprecedented clinical results in various cancers, such as melanoma, renal cell carcinoma and non-small cell lung cancer (NSCLC). There is also a growing interest in combining checkpoint-targeting antibodies with other immune stimulating agents.

Under the terms of the agreement, Agenus has agreed to acquire all of the outstanding stock of 4-Antibody for an initial payment of $10 million in shares of Agenus common stock, plus additional contingent payments, payable in cash or Agenus common stock, that may exceed $40 million based on the combined company achieving certain milestones. The transaction is expected to be completed by the end of February 2014, subject to customary closing conditions.

Agenus intends to maintain 4-Antibody’s current operations in Basel, Switzerland and Jena, Germany, and to retain the 4-Antibody management team as part of the combined company. In addition, Shahzad Malik, M.D., General Partner at Advent Venture Partners, 4-Antibody’s largest investor, will be appointed to Agenus’ Board of Directors upon the closing.

“This acquisition will initially provide Agenus with two leading edge checkpoint antibody programs targeting GITR and OX40 as well as programs targeting numerous additional checkpoint molecules,”

said Garo Armen, Ph.D., CEO and chairman of Agenus.

“With these assets, we will be uniquely positioned to pursue cancer immunotherapy with a broad portfolio of innovative approaches. Furthermore, we will gain a flexible platform for rapid discovery and optimization of fully-human antibodies against a wide array of molecular targets of interest.”

4-Antibody is in collaboration with leading institutions such as the Ludwig Institute for Cancer Research and MSKCC, and corporate collaborations include Brazil based Recepta Biopharma. The company is in discussions for additional potential corporate partnerships.

“The translational expertise of the Ludwig Institute and MSKCC, coupled with 4-Antibody’s powerful antibody discovery platform, has allowed us to generate a robust product pipeline of programs in the fast moving immune checkpoint field. Agenus’ extensive experience in pre-clinical and clinical development of immunotherapies provides a unique combination of resources for the speedy development of these programs,”

said Robert Burns, Ph.D, CEO of 4-Antibody.

About Checkpoint Antibodies
Considerable recent interest in the field of cancer immunotherapy has been generated by promising clinical data with monoclonal antibodies that bind to checkpoint molecules, such as cytotoxic T lymphocyte antigen-4 (CTLA-4) and programmed death receptor-1 (PD-1). Blocking these checkpoint molecules unlocks the braking mechanism that gets in the way of immune cells attacking cancer cells.
Other checkpoint molecules, such as GITR and OX40, act to stimulate immune function. 4-Antibody has cutting edge programs to discover and develop fully human or humanized monoclonal antibodies that act as agonists for GITR or OX40 signaling.

About Agenus
Agenus Inc. is a biotechnology company developing treatments for cancers and infectious diseases. The company has multiple immunotherapeutic products in its clinical development portfolio. Through partnerships involving its QS-21 Stimulon adjuvant, there are 21 candidates in clinical development. These include four late stage Phase 3 programs with GlaxoSmithKline. For more information, please visit www.agenusbio.com, or connect with the company on Facebook, LinkedIn, Twitter and Google+.

About 4-Antibody AG
4-Antibody has developed a powerful fully-human antibody drug-discovery and optimization technology platform which it is utilizing to generate a novel pipeline of antibody therapeutic candidates. The company’s proprietary discovery engine Retrocyte Display® generates high quality therapeutic antibody drug candidates quickly using a high-throughput approach incorporating full-length IgG format human antibody libraries expressed in mammalian B-lineage cells. 4-Antibody is a private company located in Basel, Switzerland and Jena, Germany. For more information please visit: www.4-antibody.com

Forward-Looking Statement
This press release contains forward-looking statements, including without limitation, statements regarding the proposed acquisition of 4-Antibody, the potential effects that the acquisition of 4-Antibody may have on the business of the Company, and the ability of 4-Antibody platform to generate product candidates and their potential application in the prevention and treatment of diseases. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the period ended September 30, 2013. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and Agenus undertakes no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Agenus’ business is subject to substantial risks and uncertainties, including those identified above. When evaluating Agenus’ business and securities, investors should give careful consideration to these risks and uncertainties.

Advent Life Sciences Announces Appointment of Alan Walts as Venture Partner

By Advent Life Sciences, Press Release
Press Release.

 

9th January 2014, London: – Advent Life Sciences announced today the appointment of Alan Walts as a Venture Partner.  Alan brings 27 years of biotech industry experience in corporate venture capital, business development, research and development, and general management at Genzyme Corporation.  He most recently managed Genzyme’s corporate venture fund, Genzyme Ventures (now Sanofi-Genzyme BioVentures), where he was responsible for identifying and managing a portfolio of investments.

Alan earlier led business and corporate development activities in Genzyme’s Therapeutics business, where he initiated and executed a number of transactions and new business initiatives that led to several innovative marketed products.  Alan’s roles at Genzyme also included President of Genzyme Pharmaceuticals and head of chemistry and biopolymer research.

Alan received a Ph.D. in chemistry from MIT in 1985, carried out post-doctoral research in biochemistry at MIT with Professor Christopher Walsh, and completed the executive Program for Management Development at Harvard Business School in 1993.

– Ends –

About Advent Life Sciences:
Advent Life Sciences is the dedicated Life Sciences team at Advent Venture Partners, one of Europe’s best established venture capital firms.  Advent Life Sciences predominantly founds and invests in early-stage life sciences companies in the UK, Europe and the US, that have a first- or best-in-class approach. Recent investments include:  UniQure (formerly AMT), a company that recently obtained the first EMA approval for a gene therapy product; EUSA Pharma, a speciality pharmaceutical company that obtained a BLA approval for its lead product Erwinase® and was subsequently acquired by Jazz Pharmaceuticals; Algeta (OSE: ALGETA), an oncology company that obtained FDA and EMA approval for Xofigo®, a treatment for bone metastases and disseminated tumours; Avila Therapeutics, a biotechnology company developing targeted covalent drugs acquired by Celgene; and CN Creative Ltd, a medical device company acquired by BAT.

For more information, please contact:

Melanie McIntosh
Advent Life Sciences
Phone: +44 (0) 20 7932 2100
Email: melanie.mcintosh@adventventures.com
www.adventventures.com

The Board of Directors of Algeta ASA unanimously recommends voluntary cash offer from Bayer to acquire the entire issued share capital of Algeta

By Algeta, Press Release
Press Release.

 

Not intended for US media

  • Offer at NOK 362 per Algeta share, in cash, valuing the total share capital of

Algeta at approximately NOK 17.6 billion (USD 2.9 billion) on a fully diluted basis

  • Offer unanimously recommended by the Board of Directors of Algeta
  • Pre-acceptance of the Offer on certain terms and conditions by HealthCap IV,

Algeta’s largest shareholder

Oslo, Norway, 19 December, 2013 – The Board of Directors of Algeta ASA
(“Algeta”; OSE: ALGETA) today announced an agreement with the Bayer
Group (“Bayer”) whereby Bayer, through Aviator Acquisition AS, a whollyowned
subsidiary of Bayer Nordic SE, will launch a voluntary cash offer (the
“Offer”) to acquire the entire issued share capital of Algeta for NOK 362 per
share in cash. The Offer values the total share capital of Algeta at
approximately NOK 17.6 billion (USD 2.9 billion) on a fully diluted basis. The
Board of Directors of Algeta has unanimously decided to recommend that its
shareholders accept the Offer. The recommendation will be made public
through the Oslo Stock Exchange and appended to the offer document.

 

The Offer price represents a 37% premium to Algeta’s closing share price on 25
November 2013 and a 48% premium to the three-month volume weighted average
stock price on 25 November 2013, the last trading day prior to the announcement of
Bayer’s preliminary acquisition proposal.

“The Board of Directors of Algeta has undertaken a careful review of the terms and
conditions of the Offer. We believe the Offer recognizes the strategic value of Algeta
and delivers a considerable cash premium to our shareholders.”

said Stein Holst Annexstad, Chairman of the Board of Directors of Algeta.

“Having worked with Bayer since 2009, the Board of Directors is convinced of Bayer’s commitment to establishing Xofigo® globally, and maximizing its blockbuster potential. We are also pleased that Bayer intends to further invest in the potential of Algeta’s Targeted Thorium Conjugate (TTC) research platform.”

Algeta’s largest and leading shareholder HealthCap IV1 has, on certain terms and
conditions, pre-accepted the Offer for all shares that it owns. In addition, Bayer has
received undertakings from each of the Directors and certain senior managers holding
shares in Algeta to tender their shares into the Offer, subject to certain conditions.
The total shares subject to these several commitments represent approximately 14%
of Algeta’s issued share capital.

Terms and conditions of the Offer

Under the terms of the Offer, Aviator Acquisition AS will make a voluntary offer to
acquire the entire issued share capital of Algeta for NOK 362 per share in cash. The
complete details of the Offer, including all terms and conditions, will be included in an
offer document expected to be distributed to Algeta shareholders in January 2014,
following approval by the Oslo Stock Exchange. The consummation of the Offer is
subject to satisfaction or waiver of customary conditions, including, without limitation,

1 The HealthCap managed funds HealthCap IV L.P. (3,324,407 shares), HealthCap IV Bis L.P. (2,402,147
shares), HealthCap IV KB (242,546 shares) and OFCO Club IV (90,900 shares)

a minimum acceptance of at least 90% or such lower percentage (not being less than
50%) of the outstanding Algeta shares as Aviator Acquisition AS determines,
regulatory approval by German competition authorities being obtained and no material
adverse change having occurred in Algeta. The Offer is not subject to any financing
condition. Bayer will finance the transaction with available cash and new debt. Bayer
expects to close the transaction during the first quarter of 2014.

The Board of Directors of Algeta has the right to withdraw its recommendation of the
Offer in the event a superior competing offer is announced that is not matched by
Bayer within three business days of being provided with notice thereof. Any such
amendment or withdrawal will permit Bayer to withdraw from the Offer. Algeta has
agreed to pay Bayer a break fee of 1.0% of the total Offer value in the event that the
Offer lapses following the announcement of a competing offer that results in the
acquisition of Algeta, payable upon completion of such competing offer. As part of the
agreement with Bayer and subject to customary exceptions, Algeta has entered into
undertakings not to solicit competing offers from third parties.

In the event the Offer is completed on the terms described above, there will be a
Change of Control Event under the Loan Agreement governing Algeta’s convertible
bonds due 2018. As described in the Loan Agreement, this would result in such bonds
being convertible at the Change of Control Conversion Price during the 60-day Change
of Control Conversion Period following the occurrence of such a Change of Control
Event (or notice thereof, if later). The conversion of bonds may, at the sole discretion
of Algeta, be settled, in whole or in part, by cash payment, as described in the Loan
Agreement.

Goldman Sachs International is acting as exclusive financial advisor to Algeta.
Skadden, Arps, Slate, Meagher & Flom LLP and Wikborg, Rein & Co. DA are acting as
legal advisors to Algeta.

DNB Markets has been engaged to provide the formal statement to be issued in
accordance with section 6-16 (1) c.f. 6-19 (1) of the Norwegian Securities Trading Act,
which includes a fairness opinion in support of the Board of Directors’ recommendation
of the Offer.

Centerview Partners provided an additional fairness opinion in support of the Board of
Directors’ recommendation of the Offer.

###

Xofigo® is a registered trademark of Bayer AG

For further information, please contact:

Oystein Soug +47 90 65 65 25
Chief Financial Officer

Mike Booth +1 646 410 1884
Communications & Corporate Affairs ir@algeta.com

About Algeta

Algeta is a company focused on developing, manufacturing and marketing novel
targeted therapies for patients with cancer. 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 expectations 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 Offer, our expectations as to the launch of the Offer, including the terms of the
Offer and expected timing, expected benefits of the Offer for the development of
Xofigo® and our Targeted Thorium Conjugate (TTC) platform . 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, satisfactions of conditions to the Offer, receipt of
regulatory clearance, and investor participation in the Offer.

About Xofigo® (radium Ra 223 dichloride)

Xofigo® is an alpha particle-emitting pharmaceutical. Xofigo’s active moiety mimics
calcium and selectively targets bone, specifically areas of bone metastases, by forming
complexes with the bone mineral hydroxyapatite. The high linear energy transfer of
alpha emitters (80 keV/micrometer) leads to a high frequency of double-strand DNA
breaks in adjacent tumour cells, resulting in a potent cytotoxic effect. Additional
effects on the tumour microenvironment including osteoblasts and osteoclasts also
contribute to the in vivo efficacy. The alpha particle range from Xofigo is less than 100
micrometers (less than 10 cell diameters), which minimizes damage to the
surrounding normal tissue.

Xofigo solution for injection is approved in Europe for the treatment of adults with
castration-resistant prostate cancer, symptomatic bone metastases and no known
visceral metastases.

Xofigo is approved in the US for the treatment of patients with castration-resistant
prostate cancer, symptomatic bone metastases and no known visceral metastatic
disease.

In September 2009, Algeta signed an agreement with Bayer for the development and
commercialization of Xofigo. Under the terms of this agreement, Bayer will develop,
apply for health authority approvals worldwide and commercialize Xofigo globally.
Algeta is eligible for royalties and milestones based on Bayer’s sales of Xofigo outside
the US, and Algeta US, LLC is co-promoting Xofigo with Bayer in the US.