Discovered and developed by Eisai, perampanel is a first-in-class drug with a unique mechanism that selectively and non-competitively antagonizes AMPA-type glutamate receptors.

The global study conducted primarily in Europe and Asia, was a multi-center, randomized, double-blind, placebo-controlled, dose escalation, parallel-group study.

The study consisted of 706 patients from 25 countries who were randomized to placebo or one of three perampanel doses (2 mg, 4 mg or 8 mg). Patients randomized to receive perampanel started on 2 mg doses, then remained on 2 mg or increased dosage weekly in 2 mg increments to their randomized doses of 4 mg or 8mg.

Findings demonstrated that perampanel was effective in reducing median seizure frequency, and increasing responder rates (the percentage of patients who experienced a 50% or greater reduction in seizure frequency), the study’s two primary outcome measures, with high statistical significance in 4 mg and 8 mg doses compared to placebo. A linear trend for dose response was also highly statistically significant. The most frequently observed adverse events were dizziness, somnolence and headache, and the study confirmed that perampanel was well-tolerated.

This study is the first in a series of Phase III clinical trials being conducted as part of Eisai’s global development program for perampanel and two more Phase III studies are currently underway. Final results of all three studies are expected to be available within one year. Based on these results, Eisai plans to submit regulatory applications to the health authorities in the United States and the European Union before the end of Fiscal 2011.

Eisai defines neurology as a therapeutic area of focus and is committed the development of treatments such as perampanel, through which it seeks to make further contributions to addressing the diversified needs of and increasing the benefits provided to epilepsy patients and their families.

About E2007 (Perampanel)

Discovered and developed by Eisai, perampanel (generic name) is a novel investigational agent currently under development as a potential treatment for epilepsy, neuropathic pain, multiple sclerosis and migraine prevention. The compound selectively antagonizes the AMPA receptor, a type of receptor to which the neurotransmitter glutamate binds, and by preventing the excessive influx of calcium into brain cells, it suppresses the overactivity of excitatory nerves, thereby correcting excitatory-inhibitory nerve imbalance and inhibiting neuronal cell death.

About Eisai

Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care company that discovers, develops and markets products in more than 30 countries. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs more than 8,000 people worldwide. For more information, please visit www.eisai.co.jp .

Professor Andrew Loudon from the University of Manchester

Researchers funded by the Biotechnology and Biological Sciences Research Council (BBSRC) and the Medical Research Council (MRC) have successfully used a drug to reset and restart the natural 24 hour body clock of mice in the lab.

The ability to do this in a mammal opens up the possibility of dealing with a range of human difficulties including some psychiatric disorders, jet lag and the health impacts of shift work, like obesity.

Research was led by Professor Andrew Loudon from the University of Manchester and Dr Mick Hastings of the MRC Laboratory of Molecular Biology in Cambridge, working with a multi-disciplinary team of scientists from Pfizer led by Dr Travis Wager, and was published in PNAS.

Professor Loudon said “It can be really devastating to our brains and bodies when something happens to disrupt the natural rhythm of our body clocks. This can be as a result of disease or as a consequence of jet lag or frequent changing between day and night shifts at work.

Professor Janet Allen, BBSRC Director of Research

Most living creatures and plants have an internal body timing system – called the circadian clock. This is a complex system of molecules in every cell that drives the rhythmicity of everything from sleep in mammals to flowering in plants.

Light and the day and night cycle are very important for resetting the clock and the fine adjustments are made through the action of several enzymes, including one called casein kinase 1, which has been the centre of this research

Professor Loudon continued “The circadian clock is linked to the 24 hour day-night cycle and the major part of the clock mechanism ‘ticks’ once per day. If you imagine each ‘tick’ as represented by the rise and fall of a wave over a 24 hour period, as you go up there is an increase in the amount of proteins in the cell that are part of the clock mechanism, and as you go down, these substances are degraded and reduce again. What casein kinase 1 does is to facilitate the degradation part.

“So you can imagine that the faster casein kinase 1 works, the steeper the downward part of the wave and the faster the clock ticks – any change in casein kinase 1 activity, faster or slower, would adjust the ‘ticking’ from 24 hours to some other time period. Consider that if your body suddenly starts working on a 23 hour or 25 hour clock, many of your natural processes, such as sleeping and waking could soon become out of step with day and night.”

Dr Michel Goedert, Head of the Neurobiology Division at Medical Research Council Laboratory of Molecular Biology

The team found a drug that slows casein kinase 1 down and used it in mice where the circadian rhythm has ceased i.e. the clock has stopped ticking all together. In live mice and also in cells and tissue samples from mice, they were able to re-establish the ticking of the clock by using the drug to inhibit the activity of casein kinase 1.

Professor Loudon concluded “We’ve shown that it’s possible to use drugs to synchronise the body clock of a mouse and so it may also be possible to use similar drugs to treat a whole range of health problems associated with disruptions of circadian rhythms. This might include some psychiatric diseases and certain circadian sleep disorders. It could also help people cope with jet lag and the impact of shift work.”

Professor Janet Allen, BBSRC Director of Research said “The most effective way to develop drugs to treat a health problem is to understand the basic biology that underpins what is going on in our bodies. In this case, by understanding the basic biology of the enzyme controlling biological clocks the research team have been able to identify potential drug-based solutions to a range of issues that affect many people’s health and quality of life.”

Dr Michel Goedert, Head of the Neurobiology Division at Medical Research Council Laboratory of Molecular Biology said “We’re all familiar with jet-lag and that sense of being disoriented in time. What is probably less widely understood is how this effect can impact on those with certain mental illnesses. It is crucial to find out what can go wrong at the molecular and cellular level in the brain if we are to determine what treatments will work for patients. If further studies in humans confirm what this study has shown in mice, this could eventually lead to an entirely new approach to treating mental illnesses such as bipolar disorder.”

Dr. Wager, Associate Research Fellow, Pfizer said “It is amazing what can be accomplished when first-rate academic groups and pharmaceutical discovery units team up. Leveraging each other’s talents we now have a deeper understanding of the role casein kinase plays within biological systems. Having the ability to entrain or re-entrain an arrhythmic system opens the door to new treatment option for circadian rhythm disorders. Targeting the inhibition of casein kinase with small molecules may lead to the discovery of novel drugs for the treatment of bipolar depression and other circadian rhythm disorders. The burden of these disorders is enormous and new treatment options are needed.”

Kamada Ltd. today announced a definitive agreement with Baxter International Inc. ,  which will have exclusive commercial rights to Glassia (Alpha 1-Proteinase Inhibitor in the US, Australia, New Zealand and Canada.

Emphysema Image

Glassia, which was approved by the FDA on July 1, 2010, is provides chronic augmentation and maintenance therapy in individuals with emphysema due to congenital deficiency of alpha1-proteinase inhibitor, also known as alpha1-antitrypsin (AAT) deficiency. AAT deficiency is an under-diagnosed hereditary condition that may result in early onset emphysema. Baxter expects to introduce Glassia in the US during the fourth quarter of 2010, and will pursue distribution licenses for Glassia in the other countries for which it has obtained rights.

Baxter BioScience Global BioPharmaceuticals president Larry Guiheen said, “The agreement with Kamada underscores Baxter’s commitment to expanding the diagnosis of alpha1-antitrypsin deficiency by bringing new and innovative therapeutic options to Alpha-1 patients and their treating physicians.”

The distribution agreement includes an upfront cash payment by Baxter of $20 million. The agreement also includes a provision under which Kamada has agreed, for a limited period of time, not to initiate or enter any discussions or agreements relating to the commercialization of Glassia in certain other countries and for Kamada’s investigational next-generation inhaled therapy.

Under a separate license agreement, Baxter has been granted the right to process Glassia and will seek necessary regulatory approvals to enable it to do so. Under this agreement, Baxter may make additional payments of up to $25 million related to milestone achievements and the implementation of technology transfer related to the production of the therapy by Baxter, as well as royalties on product sales.

Aileron Therapeutics and Roche  announced today that they have entered into a collaboration to discover, develop and commercialise a new class of drugs called Stapled Peptide Therapeutics. As part of this agreement, Roche will work with Aileron to develop drug candidates against up to five undisclosed targets selected from Roche’s key therapeutic areas, which include oncology, virology, inflammation, metabolism and CNS.

Stapled Peptide Therapeutics are a result of Aileron’s breakthrough peptide stabilization technology, and are a potential solution to drug as-yet intractable disease targets, including those originating from long sought-after intracellular protein-protein interactions.

Under the terms of the agreement, Roche will provide Aileron guaranteed funding of at least $25 million in technology access fees and R&D support. Aileron is eligible to receive up to $1.1 billion in payments upon the achievement of discovery, development, regulatory and commercialisation milestones, if drug candidates are developed against all five targets. In addition, Aileron will receive royalties on future sales for any marketed products that result from the collaboration. Aileron will have substantial responsibility in collaboration with Roche to develop drug candidates against the selected targets up to clinical development.

“Roche is dedicated to advancing innovative therapies, and Stapled Peptides represent a potentially transformative new technology to create drugs for important disease targets that are intractable to currently available modalities,” said Jean-Jacques Garaud, Global Head of Roche Pharma Research and Early Development. “This collaboration with Aileron is a strategically important endeavour for advancing a novel approach to developing new medicines and will accelerate our progress toward our ultimate goal of bringing important new treatments to patients with unmet medical needs.”

“This alliance with Roche validates the broad potential for our Stapled Peptide platform across multiple therapeutic areas and classes of targets and also provides Aileron with capital to advance our platform and internal drug development pipeline,” said Joseph A. Yanchik, III, President and CEO of Aileron. “We took our time to carefully consider several opportunities for our first industry collaboration, and believe that Roche is an ideal partner for Aileron because of its history with peptide therapeutics and its commitment to tackling difficult disease targets.”

About Stapled Peptides

Aileron’s proprietary Stapled Peptide technology platform “locks” peptides into their biologically active shape, mimicking the structures found in nature. This process captures the best features of both small molecules and therapeutic proteins, ultimately endowing the peptide with unique and beneficial drug-like properties, including efficient cell penetration, improved pharmacokinetics, high-affinity binding to large target protein surfaces and excellent stability within the body. This unique combination of features could greatly expand the number of “druggable” therapeutic targets, by providing a unique opportunity to address the thousands of intracellular protein-protein interactions that remain a challenge for functional modulation by current therapeutics. In preclinical studies, Aileron’s Stapled Peptide Therapeutics have been shown to possess remarkable potency, in vivo stability and cell permeability.

About Aileron

Headquartered in Cambridge, Massachusetts, Aileron Therapeutics is a biopharmaceutical company leading the development of a new class of drugs called Stapled Peptide Therapeutics. Stapled Peptides are a breakthrough solution to address thousands of therapeutically important yet currently undruggable targets. Stapled Peptides have demonstrated their unique ability to penetrate cells throughout the body and modulate protein-protein interactions, critical control points for most human diseases. Founded in 2005 and supported by funding from a leading syndicate of investors, Aileron is building a robust pipeline of therapeutics for the treatment of cancer, infectious disease, metabolic disease and immune/inflammatory diseases. For more information: www.aileronrx.com.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80,000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information:

This work is supported by a Seeding Drug Discovery Award from the Wellcome Trust, to a team of researchers led by David Wynick, Professor of Molecular Medicine at the University of Bristol. The project aims to develop a new analgesic drug based on the protein galanin, a small protein that has been shown to reduce neuropathic pain in a number of models of diseases, including diabetes. In earlier studies, several compounds from the BioFocus screening collection were shown to amplify the therapeutic effect of galanin in vitro. In the two-year collaboration announced today, BioFocus will provide medicinal chemistry, biology and ADME/PK for this research project, with the goal to optimize these molecules for the treatment of diabetic neuropathic pain.

“This latest collaboration with the University of Bristol is a prime example of BioFocus’ ability to deliver results and thereby retain partners. Once again we see the BioFocus screening libraries deliver promising hits that are of interest to the academic and pharmaceutical communities,” said Onno van de Stolpe, CEO of Galapagos. “We are pleased that the University of Bristol has expanded and extended this successful relationship into other strong areas of BioFocus expertise.”

“Molecules from the BioFocus collection have shown promise in amplifying the therapeutic properties of galanin in models of neuropathic pain,” said Prof. David Wynick from the University of Bristol. “In this new collaboration with BioFocus, we aim to further optimize these molecules into potential clinical candidates for the treatment of chronic pain associated with diseases such as diabetes.”

Rick Davis, Business Development Manager at the Wellcome Trust, commented “Existing painkillers can prove largely ineffective against neuropathic pain so we are pleased to support this project, which addresses an area of huge unmet clinical need.”

About diabetic neuropathic pain

Diabetes is the most common cause of neuropathic pain, which is often experienced as a burning or electrical pain. Existing painkillers have proven largely ineffective in treating diabetic neuropathic pain, which is believed to be caused by damaged nerves as a result of exposure to toxins or inadequate blood supply. The World Diabetes Foundation predicts that the population of diabetes sufferers will increase from 285 million in 2010 to 438 million by 2030, given the increasing levels of obesity.

About the University of Bristol

The University of Bristol is one of the leading research universities in the UK, having an excellent national and international reputation in research, teaching and global discovery. The University is committed to combining its excellence in research and innovation with a vibrant enterprise culture and is working with government, industry and other partner organisations to encourage the growth of knowledge-based business in South West England. More info at: www.bris.ac.uk [1]

About Galapagos

Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology company specialized in the discovery and development of small molecule and antibody therapies with novel modes-of-action. The Company is progressing one of the largest pipelines in biotech, with four clinical and over 50 small molecule discovery/pre-clinical programs. Through risk/reward-sharing alliances with GlaxoSmithKline, Eli Lilly, Janssen Pharmaceutica, Merck & Co., Roche and Servier, Galapagos is eligible to receive €3.3 billion in downstream milestones, plus royalties. Together with its BioFocus and Argenta service operations, Galapagos has over 670 employees and operates facilities in six countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com

AVI BioPharma Discloses New Contract With U.S. Government for Potential Funding of up to $291 Million to Advance Development of Therapeutic Candidates for Ebola and Marburg Hemorrhagic Fever Viruses

AVI BioPharma, a developer of RNA-based therapeutics, yesterday filed a current report on Form 8-K with the U.S. Securities and Exchange Commission providing the following disclosure:

On July 14, 2010, AVI BioPharma, Inc. was awarded a new contract with the U.S. Department of Defense Chemical and Biological Defense Program through the U.S. Army Space and Missile Defense Command for the advanced development of the Company’s hemorrhagic fever virus therapeutic candidates, AVI-6002 and AVI-6003, for Ebola and Marburg viruses, respectively. The contract is funded as part of the Transformational Medical Technologies (TMT) program, which was pioneered to develop innovative platform-based solutions countering biological threats.

The contract is structured into four segments with potential funding of up to approximately $291 million. Activity under the first segment is to begin immediately and provides for funding to the Company of up to approximately $80 million. After completion of the first segment, and each successive segment, TMT has the option to proceed to the next segment for either or both AVI-6002 and AVI-6003. If TMT exercises its options for all four segments, contract activities would include all clinical and licensure activities necessary to obtain FDA regulatory approval of each therapeutic candidate and would provide for a total funding award to the Company of up to approximately $291 million.

The contract was granted in response to proposals the Company submitted to a Request for Proposal (RFP) issued in November 2009 and initially submitted by the Company in February 2010. Under an earlier contract the Company completed development activities that culminated in the opening of Investigational New Drug (IND) applications for both AVI-6002 and AVI-6003.

AVI-6002 and AVI-6003 are RNA-based therapeutic candidates from the Company’s anti-infective portfolio and use AVI’s proprietary PMOplus(TM) chemistry.

About the Transformational Medical Technologies (TMT) Program

The TMT program was created by the DoD to protect the Warfighter from emerging and genetically altered biological threats by discovering and developing a wide range of medical countermeasures through enhanced medical research, development, test and evaluation programs. The TMT Program Office is matrixed from the Joint Science and Technology Office — DTRA and Joint Program Executive Office — Chemical and Biological Defense, with oversight from the Office of the Secretary of Defense. For more information on TMT, visit http://www.tmti-cbdefense.org.

About AVI BioPharma

AVI BioPharma is focused on the discovery and development of novel RNA-based therapeutics for rare and infectious diseases, as well as other select disease targets. Applying pioneering technologies developed and optimized by AVI, we are able to target a broad range of diseases and disorders through distinct RNA-based mechanisms of action. Unlike other RNA-based approaches, our technologies can be used to directly target both messenger RNA (mRNA) and precursor messenger RNA (pre-mRNA) to either down-regulate (inhibit) or up-regulate (promote) the expression of targeted genes or proteins. By leveraging our highly differentiated RNA antisense-based technology platform, we have built a pipeline of potentially transformative therapeutic agents, including a clinical stage Duchenne muscular dystrophy candidate and anti-infective candidates for influenza and hemorrhagic fever viruses.

Recombinant Follicle Stimulating Hormone (rFSH) Would Expand Watson’s Global Presence in Women’s Health
Will Capitalize on Watson’s Eden Biodesign Biologics Capabilities

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced an exclusive, worldwide licensing agreement with Itero Biopharmaceuticals, Inc., a venture-backed specialty biopharmaceutical company, to develop and commercialize Itero’s Recombinant Follicle Stimulating Hormone (rFSH).  The product is currently in preclinical development as a biosimilar molecule for the treatment of female infertility.

Under the terms of the agreement, Watson will pay Itero an undisclosed licensing fee and make additional payments based on the achievement of certain development and regulatory performance milestones. Upon successful commercialization, Watson will also pay Itero a percentage of net sales or net profits in various regions of the world.  Watson will assume responsibility for all future development, manufacturing, and commercial expenses related to Itero’s rFSH product.

“Acquiring the rights to Itero’s rFSH product represents our first in-licensing of a biosimilar development project, and demonstrates the execution of our plan to build a pipeline of biosimilar products, through both internal development and external partnering with high quality biopharmaceutical companies such as Itero,” said Paul Bisaro, Watson’s President and CEO.  “This project will capitalize on the world-class biologics capabilities of our Eden Biodesign group and represents a substantial step in Watson’s goal to build a significant position in the global biopharmaceutical marketplace.”

“Our agreement with Itero also represents continued delivery on our commitment to expand our brand product pipeline with distinctive product opportunities in the growing women’s health market,” said Watson’s Fred Wilkinson, Watson’s Executive Vice President, Global Brands.  “The Eden and Brand research and development teams will manage the development activities, and if we are successful, the Brand commercial organization will add another major product to our portfolio.”

“We are excited to partner with an industry leader in women’s health to complete the development and commercialization of our first biologic asset.  Watson has a strategic focus on growing its women’s health business and this product targets the expanding $1.2 billion infertility segment of this market,” said V. Bryan Lawlis, Ph.D., President and CEO of Itero Biopharmaceuticals. “Itero has created significant value in our rFSH program in just two years, and this collaboration validates our business strategy and capabilities for the cost efficient development of protein therapeutics.  Moreover, it gives Itero the resources to further pursue the development of additional biopharmaceutical products and partnering activities.”

Development of the product will be managed by Watson’s Eden Biodesign biologics unit in collaboration with the Brand research and development team.  Founded in 2000, Eden Biodesign is an integrated biopharmaceutical development and manufacturing organization that provides strategic consultancy, world-class process development, cGMP manufacturing and analytical development services for every significant biopharmaceutical product technology. Eden’s state-of-the-art facility, located in Liverpool, UK, is custom designed for multi-product operation and supports the development of biopharmaceuticals from proof-of-concept through to cGMP manufacture for clinical trials, market launch and commercial supply.

About Itero Biopharmaceuticals, Inc.

Itero Biopharmaceuticals, Inc. is a San Mateo, California-based specialty biopharmaceutical developer focused on clinically and commercially differentiated protein therapeutics. Itero leverages strategic collaborations to provide capital efficient process and manufacturing development as well as global clinical development and commercialization. The company’s management team consists of accomplished executives with extensive development, manufacturing and commercialization experience relating to therapeutic proteins, including monoclonal antibodies.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women’s health. Watson has operations in many of the world’s established and growing international markets.

In the U.S., the Watson brand portfolio includes RAPAFLO®, GELNIQUE®, Oxytrol®, TRELSTAR® and INFeD®.  In addition, Watson markets the following brands under co-promotion agreements: AndroGel®, with Solvay Pharmaceuticals, Inc., and Femring®, with Warner Chilcott Limited.  The Watson brand pipeline portfolio includes a number of products, including URACYST®, under development for cystitis; and four novel new contraceptives.  All other trademarks are property of their respective owners.

Improvement benefited the most to people with more advanced Alzheimer’s. Comparison between the experimental  23-milligram tablet taken once daily with the immediate-release, 10-milligram pill now used,  was favorable to the new formulation,  according to the results released today at the International Conference on Alzheimer’s Disease in Honolulu. No new side effects were seen, the study said.

Tokyo-based Eisai is counting on long-acting and patch versions of Aricept, the world’s best-selling drug for Alzheimer’s, to buffer a potential sales decline when the medicine loses patent protection in the U.S. in November. The company, which generates 60 percent of Aricept’s global sales in the U.S., expects the drug’s revenue in that market to fall about 50 percent in the year ending March 2012, it said in March.

The new formulation is being reviewed by the U.S. Food and Drug Administration, which will make a decision by July 24. It plans to submit data this quarter for regulatory approval to sell the patch version. Eisai aims for the long-acting version of Aricept to reach more than $600 million in peak sales.

The study involved 1,467 people who had moderate to severe Alzheimer’s disease and underwent treatment with the immediate- release Aricept pill for more than three months. Patients then took placebo and either the immediate-release or extended- release pill for six months.

Aricept sales for Eisai rose 6.3 percent to 322.8 billion yen ($3.64 billion) in the year ended March 31, accounting for 40 percent of revenue. The Japanese company pays New York-based Pfizer a fee for co-promotion of Aricept in the U.S. and parts of Europe.

“Promoting apoptosis in cancer cells is a validated approach to the treatment of cancer, as many oncology drugs on the market today are known to kill tumor cells by activating apoptotic pathways, albeit through indirect means,” said Susan Molineaux, Ph.D., co-founder and Chief Executive Officer of Calithera.  “By targeting caspases directly, we hope to develop agents that have broad utility across many types of cancer, with greater specificity than current treatments and the potential to overcome chemoresistance.”

Calithera’s technology was developed by and licensed from the laboratory of co-founder James Wells, Ph.D., chair of the Department of Pharmaceutical Chemistry in the University of California, San Francisco School of Pharmacy.  Dr. Wells’s laboratory has successfully identified several novel compounds that selectively activate procaspases and trigger apoptosis in cancer cells.  Proceeds from the financing will be used to advance one or more caspase activators through preclinical development and into Phase 1 clinical trials in cancer patients.  In parallel, the company will expand its technology for targeting allosteric activating sites to other enzymes with therapeutic potential in cancer.

“Most drug discovery efforts are focused on identifying drugs that inhibit enzyme function,” said Dr. Wells.  “But, interestingly, many cellular enzymes remain dormant until activated.  In the case of caspases, they can be activated on demand by mimicking the natural process with small molecules.”

Expert Leadership Team in Place

The management team of Calithera brings to the company both deep scientific expertise and extensive experience in drug development.

Susan Molineaux, Ph.D., was most recently a founder and Chief Executive Officer of Proteolix, a company that developed proteasome inhibitors.  Proteolix was in late-stage clinical trials with carfilzomib in multiple myeloma when Onyx Pharmaceuticals acquired the company in 2009 for $851 million.  Prior to forming Proteolix, Dr. Molineaux held leadership positions at Rigel Pharmaceuticals and Praecis Pharmaceuticals.  Dr. Molineaux began her career as a scientist in the Immunology group at Merck.

Mark Bennett, Ph.D., Senior Vice President of Research at Calithera, was Vice President of Research at Proteolix.  Previously, he was Director of Cell Biology at Rigel Pharmaceuticals.  Prior to that, Dr. Bennett served as an Assistant Professor in the Department of Molecular and Cell Biology at University of California, Berkeley.

Eric Sjogren, Ph.D., Senior Vice President of Drug Discovery at Calithera, was most recently the Vice President and Head of Medicinal Chemistry at Roche, Palo Alto.  He held a series of positions during his 15-year tenure at Roche.  Prior to that, Dr. Sjogren was at Syntex for eight years.

About Caspases in Cancer

The direct activation and targeting of caspases represents a novel approach to inducing apoptosis in cancer cells and may have utility across a broad range of cancer types while avoiding chemoresistance.  Caspases are the proteases responsible for initiating apoptosis, or programmed cell death, in cancer cells.  Cancer cells grow in an uncontrolled manner in part through their ability to develop mechanisms to resist apoptosis.  Many classic cancer therapies (cytotoxic drugs and radiation therapy) work by inducing upstream pro-apoptotic pathways that then activate caspases to overcome this resistance.

About Calithera Biosciences

Calithera Biosciences was founded in 2010, with core technologies licensed from the University of California, San Francisco, to develop novel therapeutic approaches to the treatment of cancer.  The company is developing small molecules that directly activate caspases, the proteases responsible for initiating programmed cell death, or apoptosis, in cancer cells.  Calithera plans to develop activators of additional enzymes as therapeutic agents for the treatment of cancer and other proliferative diseases.  Located in South San Francisco, CA, Calithera Biosciences is privately held.

Infinity Pharmaceuticals, Inc. and Intellikine, Inc., a leader in the development of small molecule drugs targeting the PI3K/mTOR pathway, today announced an agreement under which Infinity obtained global development and commercialization rights to Intellikine’s portfolio of inhibitors of the delta and gamma isoforms of phosphoinositide-3-kinase (PI3K).

Under the terms of the agreement, Intellikine will receive $13.5 million in initial license payments, committed research funding over the first two years of the relationship to identify additional novel delta, gamma and dual delta/gamma-specific inhibitors of PI3K for future development, up to $25 million in success-based milestones for the development of two distinct product candidates, and up to $450 million in success-based milestones for the approval and commercialization of two distinct products. In addition, Intellikine will be entitled to receive royalties upon successful commercialization of products licensed to Infinity. For products directed primarily to oncology indications, Intellikine will have the option, at the end of Phase 2 clinical development and upon payment of an option fee, to convert its royalty interest in U.S. sales into the right to share in 50% of profits and losses on U.S. development and commercialization, and to participate in up to 30% of the detailing effort for these products in the United States.

The PI3Kdelta/gamma program licensed from Intellikine will be a part of Infinity’s existing strategic alliance with Mundipharma International Corporation Ltd. and will be governed by the same terms as Infinity’s internally-discovered programs. Such terms include Mundipharma’s funding of Infinity’s research and development expenses for the PI3K program through the later to occur of December 31, 2013 and the commencement of Phase 3 development, subject to aggregate funding caps across the partnered portfolio under a three-year rolling plan, and reimbursement of 50% of research and development expenses thereafter. In addition, Mundipharma will have commercialization rights outside of the United States to any successfully developed products, subject to the payment of royalties of up to 20% on net sales.

“This agreement is emblematic of Infinity’s strategy to use our scientific expertise and financial strength to expand our portfolio of high-quality development programs in areas where there is a significant unmet medical need and for which Infinity is well positioned to reveal — and then realize — the potential of such programs. We expect to seek additional opportunities to broaden our portfolio of innovative product candidates in the future,” said Adelene Q. Perkins, president and chief executive officer of Infinity. “We are excited to develop INK1197 in inflammation and to work closely with the Intellikine team to identify additional differentiated PI3Kdelta/gamma inhibitors for both inflammation and oncology,” said Julian Adams, Ph.D., president of research and development at Infinity. “Targets such as PI3Kdelta and PI3Kgamma have broad applicability across inflammatory and oncology indications, creating many opportunities to make a meaningful impact for patients.”

“Intellikine has rapidly assembled a leading pipeline of drug candidates against the PI3K/mTOR pathway,” said Troy Wilson, Ph.D., J.D., president and chief executive officer of Intellikine. “We are excited to work with our colleagues at Infinity, who share our strong scientific culture and sense of urgency to advance this program forward. Additionally, this collaboration provides us with significant resources to advance our own TORC1/2 and PI3Kalpha drug candidates. The opportunity to co-develop and co-detail PI3Kdelta/gamma drug candidates in oncology with Infinity is a key component of our strategy to build an oncology business.”

By virtue of the expansion of Infinity’s portfolio to include the PI3Kdelta/gamma program, Infinity expects to exceed the $65 million cap for 2010 set forth in the research plan under the Mundipharma/Purdue Pharma alliance. As a result, Infinity now projects a 2010 cash burn of between $35 and $45 million and a year-end cash balance of between $85 and $95 million, not including amounts that may be drawn by Infinity under the $50 million line of credit available from Purdue. Infinity continues to expect that its current cash and investments, together with research and development funding from Mundipharma and Purdue and proceeds from the line of credit, are sufficient to fund the company’s operations into 2013 and enable the company to reach key development milestones and evaluate additional external opportunities to strategically enhance its pipeline.

About PI3K and INK1197

The phosphoinositide-3-kinases (PI3Ks) are a family of enzymes involved in cellular functions, including cell proliferation and survival, cell differentiation, intracellular trafficking and immunity. The delta and gamma isoforms of PI3K are strongly implicated in immune-mediated inflammatory and allergic disorders. Restricted primarily to cells of the immune system, these two isoforms regulate diverse cellular functions of the immune system. INK1197 is an orally-available, small molecule, dual-selective inhibitor of PI3Kdelta and PI3Kgamma. INK1197 has demonstrated activity in preclinical models of rheumatoid arthritis, allergy and inflammation. Infinity intends to develop INK1197 in immune-mediated inflammatory diseases. Beyond INK1197, Intellikine will contribute its collection of novel PI3Kdelta-selective and PI3Kdelta/gamma dual-selective compounds, providing multiple opportunities for Infinity to develop differentiated therapies against inflammatory and autoimmune diseases as well as hematologic cancers.

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 and fatty acid amide hydrolase are evidence of its innovative approach to drug discovery and development.

About Intellikine, Inc.

Intellikine is a private, clinical-stage company focused on the discovery and development of innovative small molecule drugs targeting the PI3K/mTOR pathway. Intellikine’s most advanced program, INK128, a selective TORC1/2 inhibitor for the treatment of cancer, is currently in a Phase 1 clinical trial in patients with advanced solid tumors. In addition, Intellikine was recently awarded a $1 million grant from the Multiple Myeloma Research Foundation to advance INK128 as a potential treatment for patients with multiple myeloma. Intellikine is also advancing a first-in-class PI3Kalpha-selective inhibitor, INK1117, which is currently being prepared for human clinical trials in cancer. Beyond INK128 and INK1117, Intellikine has generated one of the leading pipelines of drug candidates against important therapeutic targets in this pathway.