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Jan 28
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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 The itch intensity experienced by patients can be so severe that their EGFRi dose must be reduced or the treatment withdrawn; also pruritus along with rash has a significant effect on quality of life1.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:

Jan 23
Love0

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:

Jan 20
Love0

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.

Jan 13
Love0

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.

Jan 09
Love0

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

Dec 19
Love0

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.

Jul 25
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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

Jul 09
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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

May 15
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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.

Mar 11
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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