Press Release.
WALTHAM, MA – June 8, 2011 –Avila Therapeutics, Inc. a biotechnology company developing targeted covalent drugs that treat diseases through protein silencing, announced that it has entered into a Non‐Clinical Evaluation Agreement to access the National Institute of Allergy and Infectious Diseases’ (NIAID’s) preclinical services program to further evaluate AVL‐192, Avila’s targeted, irreversible covalent inhibitor of the HCV protease (NS3). Under the agreement, NIAID‐funded contractors are conducting preclinical studies of AVL‐192 to help enable its future clinical development, and Avila retains exclusive rights to this compound.
“We thank NIAID for their foresight in supporting this innovative program,”
said Dr. Juswinder Singh, Chief Scientific Officer of Avila.
“NS3 protease is now recognized as a key target of therapeutic intervention in HCV infection, and the ability of AVL‐192 to strike at known drug‐resistant mutations will be a critical feature of next generation protease inhibitors.”
AVL‐192 is a novel, orally‐available compound that rapidly and completely silences the HCV protease through highly selective, irreversible covalent bonding to the target protein. Preclinical data generated by Avila demonstrate that it is highly potent, selective, and effectively inhibits drug‐resistant mutations of HCV protease. AVL‐192 forms an irreversible bond with Cys159, a non‐catalytic amino acid that is present in all variants of HCV protease, thus creating the potential for inhibition across all known HCV genotypes. In addition, AVL‐192 has shown unusually high potency by demonstrating the ability to clear replicon cells as a monotherapy in vitro.
NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world.
About Avila Therapeutics™, Inc.
Avila Therapeutics is a clinical‐stage biotechnology company focused on the design and development of targeted covalent drugs to achieve best‐in class outcomes. This approach, called “protein silencing”, cannot be achieved through traditional chemistry techniques. The company’s product pipeline has been built using its proprietary Avilomics™ platform and is currently focused on cancer, viral infection and autoimmune disease. Avila’s most advanced product candidate, AVL‐292, a potential treatment for cancer and autoimmune diseases, is currently in Phase 1 clinical testing. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Venture, Novartis Option Fund, and Polaris Venture Partners. For additional information, please visit http://www.avilatx.com.
Press Release.
Positive Outcome of Interim Analysis of pivotal Alpharadin study: Primary endpoint met in Phase III ALSYMPCA study.
Alpharadin is in development for treating bone metastases in patients with castration-resistant prostate cancer.
Oslo, Norway, 6 June 2011 – Algeta ASA (OSE: ALGETA) today announced that an independent expert committee has recommended stopping its phase III,pivotal, ALSYMPCA study of Alpharadin (radium-223 chloride) for the treatment of bone metastases in patients with castration-resistant prostate cancer (CRPC) on the basis of statistically significant efficacy.
Based on a recommendation from the ALSYMPCA Independent Data Monitoring Committee (IDMC), following a pre-planned interim analysis, the study will be stopped and patients on the placebo arm will be offered treatment with Alpharadin. The overall survival result was statistically significant (two-sided p-value = 0.0022, HR = 0.699, the median overall survival was 14.0 months for Alpharadin and 11.2 months for placebo). The complete results from the study will be presented at an upcoming scientific meeting and submitted for publication in a peer-reviewed journal.
The safety and tolerability of Alpharadin were consistent with previous Phase I and Phase II trial outcomes and did not show any new or unexpected changes in the safety profile of Alpharadin.
Alpharadin is being developed by Algeta and Bayer Schering Pharma AG (“Bayer”). Under the terms of the collaboration Bayer will be responsible for the global filing. Bayer plans to discuss with the regulatory authorities in the near future regarding the filing strategy for Alpharadin, based on the IDMC’s positive recommendation to unblind this study and will offer patients in the placebo arm treatment with Alpharadin when the trial is unblinded.
The ALSYMPCA study (ALpharadin in SYMptomatic Prostate CAncer patients) is an international, double-blind, randomized, placebo-controlled phase III clinical trial evaluating the potential of Alpharadin plus best standard of care versus placebo plus best standard of care to treat symptomatic bone metastases in CRPC patients. The trial began in June 2008, enrollment in the trial was completed in January 2011 and 922 patients were randomized.
Dr Chris Parker, from the Royal Marsden Hospital, and Principal Investigator of ALSYMPCA, said:
”Around 90% of men with advanced prostate cancer have bone metastases, which are the main cause of disability and death in this disease. Advanced prostate cancer has a poor prognosis, and treatment options are limited. Based on the observed survival benefit and its safety profile, Alpharadin may become an important treatment for patients with bone metastases from advanced prostate cancer”
Andrew Kay, Algeta’s President and CEO, said:
“The positive outcome of the ALSYMPCA interim analysis is a tremendous result for Algeta, its shareholders and most importantly for the patients with CRPC who have bone metastases, which is an area of high medical need where there are few treatment options. Alpharadin, potentially the first alphapharmaceutical, demonstrated a survival benefit in this trial for patients with bone metastases and this is an exciting time for the company. We would like to thank all the investigators and patients who contributed to this clinical trial.”
Alpharadin is an investigational agent and is not approved for marketing by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), or any other health authorities.
For further information, please contact
Andrew Kay, CEO
Gillies O’Bryan-Tear, CMO
Øystein Soug, CFO
+47 2300 7990 / +47 4840 1360 (mob)
+47 2300 7990 / +47 4840 1411 (mob)
+47 2300 7990 / +47 9065 6525 (mob)
post@algeta.com
International media enquiries:
Mark Swallow/David Dible/Sita Shah
Citigate Dewe Rogerson
+44 207 638 9571
mark.swallow@citigatedr.co.uk
US investor enquiries:
Jessica Lloyd
The Trout Group
+1 646 378 2928
jlloyd@troutgroup.com
About Algeta
Algeta is a company focused on developing novel targeted therapies for patients with cancer based on its alpha-pharmaceutical platform.
Alpharadin is being developed under a development and commercialization agreement with Bayer Schering Pharma AG, and is in a global phase III clinical trial (ALSYMPCA) to treat bone metastases resulting from castration-resistant prostate cancer (CRPC). Alpharadin is also under investigation in phase IIa clinical trials as a potential new treatment for bone metastases in endocrine-refractory breast cancer patients, and in a phase I/IIa trial in combination with docetaxel chemotherapy for bone metastases in CRPC patients.
Algeta’s lead product Alpharadin (based on radium-223 chloride) is a first-in-class, highly targeted alpha-pharmaceutical under clinical evaluation to improve survival in patients with bone metastases from advanced cancer. Its localized action helps preserve the surrounding healthy tissue thereby limiting side-effects.
The development of bone metastases represents a serious development for cancer patients as they are associated with a dramatic decline in patient health and quality of life, ultimately leading to death. Bone metastases represent a major unmet medical need, occurring frequently in certain late-stage cancers, e.g. prostate (in approximately 75-90% patients), breast (up to 75 %) and lung (up to 40%). Algeta is also exploring the potential of Targeted Thorium Conjugates (TTCs), which are based on conjugating the alpha-emitter thorium-227 to targeting molecules, as a basis of a future pipeline of tumor-targeting alpha-pharmaceutical candidates.
The Company is headquartered in Oslo, Norway, and was founded in 1997. Algeta listed on the Oslo Stock Exchange in March 2007 (Ticker: ALGETA).
Alpharadin and Algeta are registered trademarks.
Forward-looking Statement
This news release contains forward-looking statements and forecasts based on
uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on results of operations and the financial condition of Algeta. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. These factors include, among other things, risks associated with technological development, the risk that research & development will not yield new products that achieve commercial success, the impact of competition, the ability to close viable and profitable business deals, the risk of non-approval of patents not yet granted and difficulties of obtaining relevant governmental approvals for new products.
Press Release.
SAN DIEGO, March 31, 2011 — Conatus Pharmaceuticals Inc. announced today 24-week interim results from a clinical trial with CTS-1027 in combination with Peginterferon Alpha-2a (Pegasys®) and ribavirin (Copegus®) in a treatment experienced, hepatitis C virus (HCV) null-responder patient population. Null-responder patients are the most difficult to treat patient population and are clinically defined as those patients failing to achieve an early virologic response (EVR) when undergoing treatment with the current standard of care (SOC; pegylated interferon and ribavirin). EVR is defined as at least a 2 log decline in HCV-RNA by week 12 of SOC treatment. The CTS-1027-04 clinical trial enrolled 67 HCV genotype 1 null-responder patients. The clinical trial is a single arm and open label design with sustained viral response (SVR; no detectable virus 24 weeks after the end of treatment) as its primary end point. At week 12, 51% (31/61) of patients receiving 15 mg twice a day of CTS-1027 in addition to standard doses of Pegasys® and Copegus® achieved an EVR on a per protocol (PP) basis. HCV-RNA was below quantifiable limit (BQL) in 5 patients (8.2%, PP) at week 12 and increased to 17 patients (34%, 17/50, PP) at week 24. This clinical trial is ongoing and final SVR results are expected in 2011.
Data from the CTS-1027-04 clinical trial were presented at the 46th annual meeting of the European Association for the Study of the Liver (EASL) held in Berlin, Germany, as Abstract 468.
Consistent with expectations, the majority of patients tested for genetic analysis of IL-28B (95%, 58/61) carried the CT or TT allelic variant. Patients possessing these genetic variants are predicted to be less responsive to the antiviral actions of interferon.
“Most other approaches to treat HCV infection are direct-acting anti-viral drugs whose activity is directed against virus proteins or enzymes with the objective of reducing the production of virus in infected cells. CTS-1027, by comparison, is distinctly different in that its activity is hypothesized to facilitate the immune clearance of virus-infected cells and decrease the frequency of new infections, both of which are of key importance in curing HCV infections.” said Alfred P. Spada, Ph.D., Senior Vice President of R & D of Conatus.”
“Clearance of infected cells is a slow but essential process to achieving a sustained viral response. It is intriguing to observe this significant improvement in viral load reduction at such a low dose of CTS-1027. A recently initiated Phase 2b clinical trial (CTS-1027-05) will test CTS-1027 at higher doses in combination with Pegasys® and Copegus® in the null-responder patient population.”
said Steven J. Mento, Ph.D, President and CEO of Conatus.
Conatus Pharmaceuticals Inc. is a privately-held biopharmaceutical company engaged in the development of innovative human therapeutics to treat liver disease and oncology. Conatus’ lead drug candidate, CTS-1027 is in multiple Phase 2 clinical trials for the treatment of hepatitis C virus (HCV). Conatus was founded by the executive management team of Idun Pharmaceuticals in July 2005 following the sale of Idun to Pfizer. For additional information, please visit
Press Release.
Mountain View, CA – February 16, 2011 – Versartis, Inc., an emerging biotechnology company developing novel therapeutics for patients with endocrine disorders, today announced completion of a $21 million Series B financing. The funding was lead by New Leaf Venture Partners and Advent Venture Partners’ Advent Life Sciences fund also joined the round along with existing investors Index Ventures and Amunix. Versartis plans to use the proceeds primarily to conduct clinical trials of its lead product, VRS-317, for growth hormone deficiency (GHD) in both adult and pediatric patients. VRS-317 is a once monthly form of recombinant human growth hormone (rhGH).
Effective with the close of the financing, Versartis announced the expansion of its Board of Directors to five members: Srini Akkaraju, M.D., Ph.D., Managing Director, New Leaf Venture Partners; Kevin Johnson, Ph.D., Partner, Index Ventures; Shahzad Malik, General Partner, Advent Venture Partners; Willem “Pim” Stemmer, Ph.D., Chief Executive Officer, Amunix; and Jeffrey L. Cleland, Ph.D., Chief Executive Officer, Versartis, Inc.
Commenting on New Leaf Venture Partners’ new investment, Srini Akkaraju, M.D., Ph.D., said,
“Based on the track record of Versartis management along with the encouraging preclinical data seen to date, we are optimistic that the potential of VRS-317 and its once-monthly dosing regimen address key unmet needs in the treatment of patients with growth hormone deficiency.”
“This is an exciting time to invest in Versartis,”
added Shahzad Malik, General Partner, Advent Venture Partners.
“Its focus on applying the proprietary XTEN technology to recombinant human growth hormone provides a significant opportunity to expand the current market for rhGH products.”
Preclinical data previously presented have demonstrated that VRS-317 provides comparable biological activity and safety to daily rhGH with a lower total monthly dose of rhGH. Versartis currently plans to begin enrollment in a multi-center Phase 1 study in adult GHD patients in the first quarter of 2011.
About Versartis
Versartis, Inc. is a biotechnology company developing therapeutics for the treatment of endocrine disorders. The company’s lead product candidate is VRS-317, a once monthly form of human growth hormone. Versartis is pursuing the development of new therapeutic proteins utilizing the Amunix novel half-life extension XTEN technology. XTEN is a novel hydrophilic sequence of natural amino acids and is expressed as a fusion protein with a therapeutically active peptide or protein. New compounds developed by Versartis using the XTEN technology are expected to provide improved therapeutic outcomes such as enhanced efficacy/compliance, fewer side effects, prolonged half-life (up to monthly dosing), as well as low-cost production and enhanced stability. Further information on Versartis can be found at www.versartis.com.
About NLV Partners
New Leaf Venture Partners is a leader in healthcare technology venture investing. Our investment professionals bring a unique blend of technological, clinical, and operational experience to our investments. We work closely with our entrepreneurs to help build successful portfolio companies. We focus primarily on later stage biopharmaceutical products, early stage medical devices, and laboratory infrastructure technologies.
New Leaf currently manages $1.1 billion in assets. This includes our newest fund, New Leaf Ventures II, L.P., which closed with commitments of $450 million in October 2007, New Leaf Ventures I, L.P. and the healthcare technology portfolio of the Sprout Group, one of the oldest U.S. venture capital fund groups. For more information please visit www.nlvpartners.com.
About Advent Venture Partners
Advent Venture Partners is one of Europe’s most established growth and venture capital firms, investing in technology and life sciences businesses run by great teams that want a pragmatic and well-connected partner by their side.
The Advent life sciences team is a leader in European life sciences venture capital. Its investments include: PowderMed, a therapeutic DNA vaccine company sold to Pfizer; Thiakis, an obesity treatment company acquired by Wyeth Pharmaceuticals; Respivert, a drug discovery company focused on respiratory diseases that was acquired by Johnson & Johnson; Cellnovo, a biomedical device company developing a revolutionary mobile insulin pump system; EUSA Pharma, a rapidly growing transatlantic speciality pharmaceutical company focused on late-stage oncology, pain control and critical care products; and, Algeta (ALGETA.OL), an oncology company developing treatments for bone metastases and disseminated tumour types.
In November 2010, Advent announced the final close of the first life sciences-focused fund raised by the firm, Advent Life Sciences.
Press Release.
LONDON, UK – February 4, 2011 – Cellnovo, developer of the first mobile diabetes management system, announced today that it raised £30 million ($48.4 million) in a Series B financing round led by Edmond de Rothschild Investment Partners (EdRIP), with Forbion Capital Partners; Auriga Partners; NBGI Ventures and Credit Agricole Private Equity joining Series A investors Advent Venture Partners, HealthCare Ventures and NESTA in the round.
Based in London, Cellnovo will use the funds to commercialize its system and expand to markets around the world. The Cellnovo system, developed in-house, is unique in several ways including: the accuracy and size of the pump’s technology, as well as the touch-screen, mobile-connected device that provides healthcare professionals and families immediate access to a myriad of information.
“Cellnovo is revolutionizing the way diabetes patients manage their disease,”
said Edmond de Rothschild Investment Partners, Partner, Raphael Wisniewski.
“We look forward to working with this exceptional management team in this first investment of EdRIP in a UK company.”
“We thoroughly examined the diabetes field and believe that Cellnovo’s approach to disease management is disruptive and will enable the company to soon leverage their tremendous market opportunit”
said Bart Bergstein, Managing Partner, Forbion Capital Partners.
The Cellnovo system’s advanced micropump technology enables people with diabetes to more efficiently manage their life-saving therapies while benefiting from greater personalization and portability. This mobile-connected, disease management approach to diabetes removes the burden of keeping journals and pushes information to healthcare professionals so they always have a real-time view of this information.
“We are honored that this extraordinary team of investors has demonstrated tremendous confidence in our system and our efforts,”
said Bill McKeon, Chief Executive Officer of Cellnovo. “This partnership will allow Cellnovo to advance diabetes management and improve the lives of diabetics around the world.”
Press enquires
Bill McKeon,
Chief Executive Officer,
Cellnovo Ltd.
Phone: +44(0) 203 058 1250
Email: press@cellnovo.com
About Cellnovo
A UK-based medical device company, Cellnovo develops and manufactures an innovative mobile diabetes management system. Comprised of a mobile connected micropump, mobile touchscreen controller, blood glucose meter and applications, the Cellnovo system provides intuitive operation, wireless Internet connectivity and real-time activity tracking – all industry firsts. Cellnovo’s management team offers extensive experience gained at the world’s premier medical device and wireless companies, including Medtronic, DuPont, Novo Nordisk, Abbott, AT&T Lucent, and other industry leaders. For further information, please visit www.cellnovo.com.
About Edmond de Rothschild Investment Partners
Paris-based Edmond de Rothschild Investment Partners is dedicated to minority investments into privately-owned companies. It has currently €800 million under management which is being invested primarily as life sciences venture capital and growth capital. Its Life Sciences Team of six professionals brings together over 30 years of experience in the Life Science industry and more than 50 years of private equity and venture capital experience. The team has approximately €300 million under management after having recently raised € 150 million through BioDiscovery 3. Edmond de Rothschild Investment Partners is an independently managed affiliate of La Compagnie Financière Edmond de Rothschild Banque.
About Forbion Capital Partners
Forbion Capital Partners is a dedicated Life Sciences venture capital firm with offices in Naarden, The Netherlands, and Munich, Germany. Forbion invests in life sciences companies in drug discovery & development as well as medical device companies addressing substantial unmet medical needs. Forbion’s investment team of nine investment professionals has built an impressive performance track record since the late nineties with successful investments in Rhein Biotech, Crucell, Neutec, Glycart, Borean, Impella, Alantos, Acorda, Fovea, PanGenetics, Argenta and Biovex. Current assets under management exceed $500M, split between three active funds and comprising some 27 promising portfolio companies. Forbion Capital Partners Fund II is supported by the European Investment Fund through its ERP and LfA facilities and comanages BioGeneration Ventures, an early stage fund focused on (academic) spin-outs and seed investments in the Netherlands.
About Auriga Partners
Auriga Partners is an independent venture capital firm. Based in Paris, it invests in information technologies and life sciences, in innovative high potential ventures, in seed or early development stages, in Europe, North America and Israel. Auriga Partners manages three funds for a total of around Euros 300 millions. Along with investing the necessary capital, Auriga Partners brings also its savoir-faire in developing and solidifying executive teams, organizing companies, broadening their networks and forming strategic and corporate partnerships.
About NBGI Ventures
NBGI Ventures, established in 2001, is the only European venture capital fund investing exclusively in medical device companies. With over €100 million in total commitments under management, NBGI Ventures is based in London and considers investments across Europe and the U.S. Companies it has supported to date include Advanced Cardiac Therapeutics (USA), BoneSupport (Sweden), EOS imaging (France), Estech (USA), Forth Photonics (UK), Quanta Fluid Solutions (UK), Reverse Medical (USA), SuperSonic Imagine (France), Symetis (Switzerland), Technolas/2010 Perfect Vision (Germany) and Upfront Chromatography (Denmark). NBGI Ventures is a division of NBGI Private Equity Limited, which is authorized and regulated by the Financial Services Authority.
About Advent Venture Partners
Advent Venture Partners is one of Europe’s most established growth and venture capital firms, investing in technology and life sciences businesses run by great teams that want a pragmatic and well-connected partner by their side. The Advent life sciences team is a leader in European life sciences venture capital. Its investments include: PowderMed, a therapeutic DNA vaccine company sold to Pfizer; Thiakis, an obesity treatment company acquired by Wyeth Pharmaceuticals; Respivert, a drug discovery company focused on respiratory diseases that was acquired by Johnson & Johnson; Cellnovo, a biomedical device company developing a revolutionary mobile insulin pump system; EUSA Pharma, a rapidly growing transatlantic speciality pharmaceutical company focused on late-stage oncology, pain control and critical care products; and, Algeta (ALGETA.OL), an oncology company developing treatments for bone metastases and disseminated tumour types.
About HealthCare Ventures
HealthCare Ventures is a leading life science venture capital firm investing in preclinical or early clinical stage, focused companies with the potential to transform patient care. Since its founding in 1985, HealthCare Ventures has raised $1.6 billion across nine funds and has invested in 99 companies, 63 as startup ventures.
About Crédit Agricole Private Equity
Crédit Agricole Private Equity is an AMF-accredited asset-management subsidiary of Crédit Agricole, specialising in direct private-equity investment in non-listed companies. A multi-specialist player, Crédit Agricole Private Equity’s team of 100 professionals manages €3.3 billion with specific expertise in LBO & Expansion, Venture Capital, Mezzanine, Co-Investment, Renewable Energy and PPP Infrastructure. The 12-strong venture capital team manages €470 million through FCPIs invested in young companies with high growth potential in 2 sectors: information technology and life sciences. Crédit Agricole Private Equity has signed up to the United Nations’ Principles for Responsible Investment (PRI).
About NESTA
NESTA is the UK’s foremost independent expert on how innovation can solve some of the country’s major economic and social challenges. NESTA is a world leader in its field and carries out its work through a blend of experimental programmes, analytical research and investment in early-stage companies. Its £50m evergreen venture fund invests in UK based technology businesses that have the potential to deliver high growth UK successes.
Press Release.
London, 24 November 2010: Advent Venture Partners today announced the final close of a $120M (£75M) venture capital fund, to be called Advent Life Sciences. The fund will be managed by General Partners Shahzad Malik and Raj Parekh, and is the first life sciences-focused fund raised by the firm.
The fund will invest predominantly in early- and mid-stage life sciences companies in the UK, Europe and the US. Advent Life Sciences will back companies that have a first- or best-in-class approach in a range of sectors within life sciences, including new drug discovery, enabling technologies, med tech and diagnostics.
Commenting on this close, Raj Parekh said,
“We are pleased to have closed our first life sciences fund at this level in an environment of unprecedented difficulty for raising European venture funds. We appreciate the support that our LPs have shown to the team and the sector, and we look forward to investing this fund at such an opportune time in the cycle.”
The fund was raised with the participation of the UK Future Technologies Fund, managed by the European Investment Fund, which invests in a range of technologies such as life sciences, digital technology, and advanced manufacturing.
Advent’s life sciences team has a first-class investment track record. Recent investments include Avila Therapeutics, Biocartis, Cellnovo, Respivert, Thiakis, Algeta and Amsterdam Molecular Therapeutics in all of which the Advent Life Sciences team led the formation of the Company and/or participated in the first venture round.
Press Release.
Scrip’s Biotech Company of the Year award seeks to acknowledge the vital importance to the industry of biotechnology’s cutting-edge science and entrepreneurial spirit. This year, from a strong field, the judges chose Algeta as the winner.
The Norwegian firm has enjoyed a transformational year during which it took a major step towards achieving its ambition of becoming a cancer-focused speciality pharma company. Its major achievement was the signing of an $800 million partnership deal with Bayer Schering Pharma for the development and commercialisation of its novel radiopharmaceutical product Alpharadin to treat bone metastases in prostate and other cancer patients.
The deal, one of the largest in 2009, crucially allows Algeta to retain an option for 50:50 co-promotion in the US. Its structure is such that milestone payments abased on the successful development of Alpharadin would be enough to enable Algeta to establish a functional US commercial operation in readiness for launch. Moreover, the company’s share price rose by 780% during 2009, making it the flagship company in the Norwegian biotech sector.
The judges said that the use of Algeta’s proprietary technology in developing a new class of radiopharmaceuticals could lead to a significant advance in the treatment of various cancers. “A very impressive year – great deal and creation of shareholder value,” they said.
Alpharadin is an alpha particle-emitting targeted agent that prolonged patient survival in a Phase II trials. Alpha particles have a potent but very short-range cytotoxic effect (2-10 cell diameters) and so deliver localised tumour death with minimal effect on surrounding normal cells.
For the full list of winner please click on the link below:
www.scripintelligence.com/multimedia/archive/00108/040_CF_Scrip_Awards_108838a.pdf
Press Release.
Covalent Inhibition Achieves Superior Potency Against Drug-Resistant HCV Mutants
BOSTON and WALTHAM, MA – Avila Therapeutics™, Inc., a biotechnology company developing novel targeted covalent drugs, presented results today of preclinical studies that demonstrate its orally-available targeted covalent drug candidate, AVL-192, achieves superior potency against drug-resistant mutations of the Hepatitis C Virus (HCV). These new data were presented today at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) international meeting in Boston, Massachusetts.
HCV protease (also known as NS3) is a promising target of intervention for the treatment of hepatitis C infection. However, medicines currently in late stages of clinical development are vulnerable to drugresistant mutations. AVL-192 is a novel, orally available compound that can rapidly and completely silence the HCV protease through highly selective, irreversible covalent bonding to the target protein. Preclinical data have demonstrated that AVL-192 achieves very high potency and selectivity for NS3 and also potently and effectively inhibits the drug-resistant mutations observed clinically.
Avila’s covalent approach to silencing the NS3 protein has resulted in a product candidate with a potential best-in-class profile due to the ability to retain potency against clinically-arising resistance
mutations, and potential breadth of activity across HCV genotypes with anticipated once-per-day dosing.
In a poster presentation at the meeting, entitled, “Second Generation of Covalent Irreversible Inhibitors Have Superior Potency Across Genotypes and Drug Resistant Mutants,” data were presented from preclinical studies that evaluated the efficacy of AVL-192 in biochemical and cell culture studies.
Highlights of the data demonstrate:
• AVL-192 has a time-dependent mode of action that delivers potent and rapid inhibition of WT NS3/4A and retains high potency against drug-resistant mutant NS3/4A proteases;
• AVL-192 is able to inhibit the protease long after the compound is removed, offering the benefit of less frequent dosing;
• AVL-192 as monotherapy can be curative in the replicon clearance assay;
• AVL-192 is highly selective and spares host proteases; and
• AVL-192 has high plasma exposure following oral administration in rats and dogs. “These new data reinforce our belief that our targeted covalent drug candidate AVL-192 has the potential to be a best-in-class, pan-genotype HCV therapeutic due to its unique mechanism of action,” said Juswinder Singh, Ph.D., Avila’s Founder and Chief Scientific Officer.
About Avila Therapeutics™, Inc.
Avila focuses on design and development of targeted covalent drugs to achieve best-in-class outcomes that cannot be achieved through traditional chemistries. This approach is called “protein silencing”. The company’s product pipeline has been built using its proprietary Avilomics™ platform and is currently focused on viral infection, cancer and autoimmune disease. Avila is funded by leading venture capital firms: Abingworth, Advent Venture Partners, Atlas Venture, Novartis Option Fund, and Polaris Venture Partners.
Press Release.
Decision Demonstrates Strength of Alliance and Underscores Complementary Capabilities of the Partners
CAMBRIDGE, Mass., — Infinity Pharmaceuticals, Inc. (Nasdaq:INFI) today announced that Purdue Pharmaceutical Products L.P. and its independent associated company, Mundipharma International Corporation Ltd., have exercised their right to assume worldwide development and commercialization activities for Infinity’s fatty acid amide hydrolase, or FAAH, program. The decision reflects progress made in the development of Infinity’s oral FAAH inhibitor, IPI-940. Data from the Phase 1 single-dose study showed IPI-940 demonstrated favorable pharmacokinetics and was generally well tolerated in healthy volunteers. Purdue is planning to initiate Phase 2 studies of IPI-940 in 2011.
The enzyme FAAH degrades anandamide, an endogenous cannabinoid that mediates the body’s own powerful analgesic and anti-inflammatory responses. IPI-940 blocks the action of FAAH, thereby increasing the therapeutic action of anandamide. As a novel inhibitor of FAAH, IPI-940 has potential application for the treatment of a broad range of painful conditions and inflammatory diseases.
“Purdue is a world leader in the development and commercialization of therapeutics for the treatment of pain, and we are pleased that they will be advancing IPI-940 through later-stage clinical development and into the marketplace,”
stated Adelene Q. Perkins, president and chief executive officer of Infinity.
“Purdue has been a wonderful partner. Working together, we will continue to leverage our complementary capabilities to bring important medicines to patients in pain and inflammatory diseases.”
“FAAH is a promising therapeutic target for a wide variety of pain and inflammatory conditions, and we look forward to advancing IPI-940 into Phase 2 clinical development,”
stated John H. Stewart, President and CEO of Purdue.
“This program fits well within our comprehensive analgesic plan and is a valuable addition to our expanding drug pipeline.”
Phase 1 Single Dose Study of IPI-940
The Phase 1 randomized study of IPI-940 enrolled 48 healthy adult volunteers and assessed the pharmacokinetics, pharmacodynamics, safety and tolerability of IPI-940 following single oral administration at escalating dose levels. In the study, administration of IPI-940 resulted in marked FAAH inhibition and increased anandamide levels. In addition, IPI-940 was well tolerated, with no observed dose-limiting toxicities or clinically significant changes in clinical laboratory values, vital signs or electrocardiogram parameters. Additional Phase 1 development of IPI-940 is ongoing.
Financial Guidance
Infinity is completing certain development activities to enable Purdue to begin Phase 2 studies. As a result of reimbursement for activities associated with the transition of the FAAH program to Purdue, Infinity now anticipates a year-end cash and investments balance of $90-$100 million, revised from an earlier expectation of $85-95 million.
About FAAH and IPI-940
FAAH plays a role in the endocannabinoid system (ECS), which is made up of a group of enzymes and receptors shown to play an important role in modulating painful and inflammatory conditions affecting the central nervous system and the body as a whole. In response to painful stimuli or inflammation, the ECS is activated and endocannabinoids are produced. Many endocannabinoids are fatty acid amides (FAAs), which produce the body’s own powerful analgesic and anti-inflammatory responses. FAAH breaks down FAAs, rendering the beneficial effects of FAAs short-lived. It is believed that inhibition of FAAH may enable the body to bolster its own analgesic and anti-inflammatory response. IPI-940 blocks the action of FAAH, thereby increasing the duration of the analgesic effect of FAAs. As a novel inhibitor of FAAH, IPI-940 has potential application for the treatment of a broad range of painful conditions and inflammatory diseases.
About the Strategic Alliance with Purdue and Mundipharma
Infinity entered into a strategic alliance with Purdue and Mundipharma in 2008 to develop and commercialize pharmaceutical products. The alliance includes product candidates arising from Infinity’s Hedgehog pathway, FAAH, phosphoinositol-3-kinase and discovery programs. Under the terms of the alliance related to the FAAH program, Purdue and Mundipharma will continue to be responsible for fully funding the FAAH program and Infinity will be entitled to worldwide royalties on any successfully-developed products. In addition, Purdue and Mundipharma are funding all research and development costs of other programs within the strategic alliance. Infinity retains U.S. commercialization rights for these products and will receive royalties on any product sales outside the U.S.
About Infinity Pharmaceuticals, Inc.
Infinity is an innovative drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity’s programs in the inhibition of the Hsp90 chaperone system, the Hedgehog pathway, fatty acid amide hydrolase and phosphoinositide-3-kinase are evidence of its innovative approach to drug discovery and development. For more information on Infinity, please refer to the company’s website at www.infi.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding the pursuit of later-stage clinical development and commercialization of IPI-940 by Purdue and Mundipharma, the potential applicability of FAAH inhibitors in pain and inflammatory diseases, the commencement of Phase 2 clinical studies of IPI-940 in 2011, the receipt of royalties by Infinity on sales of products arising from the strategic alliance, and year-end cash guidance. Further, there can be no guarantee that any positive developments in Infinity’s product portfolio will result in stock price appreciation. In particular, management’s expectations could be affected by risks and uncertainties relating to: efforts by Purdue and Mundipharma to continue developing IPI-940, which are outside of Infnity’s control; results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites; the ability to enroll patients in clinical trials of IPI-940; unplanned cash requirements and expenditures; and Infinity’s ability to obtain, maintain and enforce patent and other intellectual property protection for any product candidates it is developing. These and other risks which may impact management’s expectations are described in greater detail under the caption “Risk Factors” included in Infinity’s quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 4, 2010. Further, any forward-looking statements contained in this press release speak only as of the date hereof, and Infinity expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT:
Infinity Pharmaceuticals, Inc.
Jaren Irene Madden
617-453-1336
Jaren.Madden@infi.com
