Biometrics: Therapy

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AbbVie Submits for EU Marketing Authorization its Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Chronic Hepatitis C

NORTH CHICAGO, Ill., May 8, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) submitted marketing authorization applications (MAAs) to the European Medicines Agency (EMA) seeking approval for the company's investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection. The MAAs are supported by data from the largest all-oral, interferon-free clinical program in GT1 patients conducted to date1, which consists of six Phase III studies that include more than 2,300 patients in over 25 countries.

"These regulatory submissions bring us closer to offering adult genotype 1 chronic hepatitis C patients an all-oral, interferon-free regimen which has the potential to provide a promising advancement for the hepatitis C community in the European Union," said Scott Brun, M.D., vice president, Pharmaceutical Development, AbbVie. "This regulatory milestone, on the heels of our submission of a New Drug Application in the U.S., represents an important step for our pipeline."

Accelerated Assessment Granted
The EMA has granted AbbVie's request for accelerated assessment for ABT-450/ritonavir, ombitasvir (ABT-267), and dasabuvir (ABT-333), a designation that is granted to new medicines of major public health interest. Review of AbbVie's MAAs will be conducted under the centralized licensing procedure which, when finalized, provides one marketing authorization in all 28 member states of the European Union (EU). Although accelerated assessment could shorten the EMA's review time by approximately two months, it does not guarantee a positive opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) or final approval by the European Commission. If approved, ABT-450/ritonavir, ombitasvir (ABT-267), and dasabuvir (ABT-333) could be available for marketing in the EU in the first quarter of 2015.

Globally, approximately 160 million people are chronically infected with hepatitis C2 and an estimated 3 million to 4 million people are newly infected each year.3 In Europe, approximately 17.5 million people have chronic hepatitis C,4 with GT1 as the predominant genotype.4

About AbbVie's Investigational HCV Regimen
The AbbVie investigational regimen consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ombitasvir (ABT-267) 25mg, dosed once daily, and dasabuvir (ABT-333) 250mg with or without ribavirin (weight-based), dosed twice daily. The combination of three different mechanisms of action interrupts the hepatitis C virus replication process with the goal of optimizing sustained virologic response rates across different patient populations.

Additional information about AbbVie's Phase III studies can be found on www.clinicaltrials.gov.

AbbVie's HCV Development Program
The AbbVie HCV clinical development program is intended to advance scientific knowledge and clinical care by investigating an interferon-free, all-oral regimen with and without ribavirin with the goal of producing high sustained virologic response rates in as many patients as possible, including those that typically do not respond well to treatment, such as previous non-responders to interferon-based therapy or patients with advanced liver fibrosis or cirrhosis.

ABT-450 was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for hepatitis C virus protease inhibitors and regimens that include protease inhibitors. ABT-450 is being developed by AbbVie for use in combination with AbbVie's other investigational medicines for the treatment of hepatitis C.

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 25,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2013 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission.

AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 Comparison based on review of data from www.clinicaltrials.gov for phase 3a programs of Gilead, BMS and BI as of November 15, 2013.
2 Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect. 2011; 17(2):107-15.
3 World Gastroenterology Organisation. World Gastroenterology Organisation Global Guidelines: Diagnosis, Management and Prevention of Hepatitis C. April 2013. http://www.worldgastroenterology.org/assets/export/userfiles/WGO_Hepatitis%20C_Final%20Version.pdf. Accessed April 25, 2014.
4 EASL Clinical Practice Guidelines: management of hepatitis C virus infection. European Association for the Study of the Liver. J Hepatol. 2014;60:392-420.

SOURCE AbbVie

XBiotech Issued Patent for Antibody Therapy to Treat Chronic Sterile Inflammatory Diseases

AUSTIN, Texas, March 11, 2014 /PRNewswire/ -- XBiotech announced today that the United States Patent and Trademark Office (USPTO) granted another key patent to support the Company's growing portfolio around its lead product candidate. The new patent grants XBiotech exclusive rights to target a unique molecule associated with chronic sterile inflammation. The patent relates to antibodies and methods of using these antibodies to treat, prevent, and detect disease progression associated with a key mediator of chronic inflammation. USPTO issuance of the patent further establishes XBiotech as a pioneer in a new generation of antibody therapy to treat the crucial inflammatory process involved in progression or exacerbation of multiple chronic diseases. The Company reports that in the past year, 7 patents have been issued relating to its lead therapy and that over 100 patent applications are currently pending.

XBiotech's Vice President of Corporate Development, Dr. Stanley Kim stated, "The '489 patent further strengthens XBiotech's intellectual property portfolio which we believe dominates the chronic inflammatory space. And by continuing to innovate and re-think every step involved in bringing new therapeutics to market, we have developed and are pursuing broad patent protection for several new ground-breaking discoveries."

BACKGROUND
Chronic sterile inflammation is a crucial process involved in the pathology of chronic diseases. Sterile inflammation stimulated by cancerous tumors results in the formation of new blood supply to tumors; in the walls of the artery, sterile inflammation results in the creation of atherosclerotic plaques and occlusive arterial disease and in the white adipose tissue, sterile inflammation reduces insulin responsiveness, an underlying cause of poor glucose control in type 2 diabetics. XBiotech's True Human™ antibody technology targets a key triggering molecule that drives chronic sterile inflammatory processes. XBiotech is re-defining chronic inflammatory disease, and revolutionizing the treatment of some of the most important diseases in the modern world.

XBiotech is using a disruptive True Human antibody technology to achieve unprecedented tolerability and safety for antibody therapy. True Human antibodies, as the name applies, are literally cloned directly from a mature human immune response and are not subject to further modification to alter natural binding activity. A True Human antibody is therefore not to be confused with so-called fully human antibodies which are, without exception, synthetic.

Billions of unique antibodies are produced by the immune system to potentially bind and neutralize a limitless number of potential infectious agents. Thus if the human genome contained individual antibody genes that encoded only a billion different antibodies (only a fraction of the potential antibodies), there would be 20,000-times as many genes needed just for encoding antibodies as there would be for encoding the rest of the entire human genome! The size of a single cell would have to take on monstrous proportions to contain all these antibody genes. Clearly, it would be highly impractical to encode a significant antibody repertoire in the human germline.

The hallmark of vertebrate immune systems is the ability to shuffle, recombine and selectively mutate a relatively small number of genes to create a phenomenal, essentially unlimited number of antibody genes. Elucidating the mechanisms behind the ability to shuffle germline genetic sequence to produce unique antibody genes was indeed one of the major achievements of biological research in the 20th century.

It was a remarkable discovery that cells in the body contained genetic sequences that were not in the germline and were thus not heritable. But uncovering the marvelous genetic mechanism behind antibody genes opened up a new set of problems. If antibody genes were in fact not encoded in the human genome, and the products of these genes were indeed unique, why were these unique antibody molecules not in turn recognized by the immune system as foreign substances—like any other foreign substance such as a virus or bacteria? This question led to another cornerstone advance in medicine: understanding how the body established tolerance to antibodies.

Now well understood for the past quarter century is the process tolerance achieved through selection and deletion of antibody producing cells. When a unique antibody is made from a single antibody producing cell, or B lymphocyte, the molecule is first displayed on the surface. What happens next is crucial to deciding the fate of that cell harboring the unique antibody gene. If the antibody is harmful, or autoreactive, the cell which created it undergoes further genetic rearrangement in an attempt to produce an acceptable antibody. If the antibody it produces remains harmful, the cell is stimulated to launch a suicide program and the cell is thereby deleted. On the other hand, if the antibody is not harmful, the cell is selected and is able to grow, producing identical daughter cell clones and copious amounts of antibodies as necessary. There is no more defining feature of the vertebrate immunity than this process of selection and deletion—the fundamental step that enables antibody diversity while assuring that unique antibodies are also well tolerated by the body.

To date each and every therapeutic antibody on the market—without exception—has been derived through synthetic gene sequence modification and/or from animals. The use of the term "fully human" to describe a number of marketed therapeutic antibodies has thus created some confusion. There are indeed no human antibodies currently marketed.

The antibody targeting chronic sterile inflammation in development by XBiotech was derived from a natural antibody produced within the human body. The sequence of the antibody was thus subjected to selection processes in a human to make sure it specifically binds the intended target on the one hand, but at the same time is not autoreactive. XBiotech's True Human antibody products are expected to be the best tolerated antibodies ever developed for human therapeutic purposes.

ABOUT XBIOTECH
XBiotech is leading the commercialization of biological therapies, including the discovery and development of True Human™ antibodies. The Company's lead product candidate—now in two unique Phase III registration studies—represents a novel, breakthrough treatment for advanced colorectal cancer. XBiotech has also developed manufacturing technology to reduce infrastructure needs, lessen capital requirements and shorten lead times for development of biological drugs. New manufacturing technologies are at the heart of XBiotech's approach to next generation biological therapies, including the production of highly competitive biosimilar or biobetter products.

Contact:
Ashley Otero
XBiotech
info@xbiotech.com
512.386.2930

SOURCE XBiotech

XBiotech Issued Patent for Antibody Therapy to Treat Chronic Sterile Inflammatory Diseases

Contact:
Ashley Otero
XBiotech
info@xbiotech.com
512.386.2930

SOURCE XBiotech

Research by Structural Genomics Consortium and DiscoveRx Points to New Multi-Targeting Approaches to Cancer Therapy

DiscoveRx Corporation, Fremont, CA, Contact: Sailaja Kuchibhatla, skuchibhatla@discoverx.com. (PRNewsFoto/DiscoveRx Corporation)jwplayer.key="2kY/GKwZ2uQZmDlQ9VYArfZt2b4+KhHX3+DM4zisgtE=";OXFORD, United Kingdom and FREMONT, Calif., March 5, 2014 /PRNewswire/ -- The Structural Genomics Consortium (SGC) and DiscoveRx Corporation today announced the publication of findings that suggest compelling new multi-targeting approaches for cancer therapy. In a study entitled "Dual kinase-bromodomain inhibitors for rationally designed polypharmacology," which appeared on-line in Nature Chemical Biology (http://www.nature.com/nchembio/index.html), the researchers demonstrate that several clinical kinase inhibitors also potently inhibit diverse bromodomain epigenetic reader proteins.

Kinase inhibitor-based targeted therapies have had clinical successes. However, a substantial proportion of patients fail to respond initially, and acquired resistance to these drugs remains problematic. Inhibition of multiple oncogenic proteins in the same tumor is an established strategy to address these challenges, but the discovery of inhibitors targeting multiple rationally chosen kinases is difficult, and combination therapy approaches require complex clinical investigations.

The finding that several oncology-focused clinical kinase inhibitors also potently inhibit bromodomains, including the established cancer target BRD4, demonstrates the feasibility of a "single agent, inter-family" multi-targeting approach. The structural biology data presented indeed suggest actionable dual inhibitor design strategies. Co-senior author Stefan Knapp, Principal Investigator at the SGC (based at the University of Oxford) commented, "The diversity of the kinase catalytic site and the acetyllysine binding pockets in bromodomains will allow optimization of inhibitor potency for both target classes, which will facilitate the development of therapeutic dual inhibitors."

Among the kinase inhibitors shown to have potent BRD4 activity are the JAK2-FLT3 inhibitor TG-101348 and the PLK1 inhibitors BI-2536 and volasertib. "Since FLT3 and BRD4 can be independent drivers in acute myelogenous leukemia, the TG-101348 data raise hope for the development of an optimized dual FLT3-BRD4 inhibitor, which would be anticipated to improve patient outcomes," said co-senior author Daniel Treiber, Sr. Director of Research at DiscoveRx.

Co-author Neil Shah, Leader of the Hematopoietic Malignancies Program at the UCSF Helen Diller Family Comprehensive Cancer Center, agrees that multi-targeting single agent therapies could offer significant advantages. "Attempts to clinically test therapeutic combination strategies that exploit synergistic interactions are often hampered by significant obstacles such as the potentially unacceptable cost and toxicity of combining two drugs, as well as practical difficulties inherent in working simultaneously with two pharmaceutical companies," he said. "This work excitingly demonstrates that in some cases, rational medicinal chemistry efforts can circumvent many of these issues and potentially rapidly advance medical science."

Importantly, the dual BRD4-kinase inhibitors were also shown to exhibit complex, unique polypharmacologies across a panel of human primary cell disease models (BioMAP® systems). "Our strategy of using both target-based and phenotypic screening approaches represents a paradigm shift in developing single agents that can act as ready-made combination therapies that may be more efficacious and overcome clinical obstacles," said co-first author Alison O'Mahony, Sr., Director of Research at BioSeek, a division of DiscoveRx.

About the Structural Genomics Consortium
The Structural Genomics Consortium (SGC) (http://www.thesgc.org/) is a not-for-profit, public-private partnership that conducts pre-competitive research to facilitate the discovery of new medicines. Based at the University of Oxford and University of Toronto the SGC's work contributes to new hypotheses in understanding and treating human disease, and the subsequent identification of new targets for drug discovery. The SGC's primary objectives are to produce and characterize the 3-dimensional structures of soluble proteins and of integral membrane proteins, to generate selective chemical probes for epigenetic proteins and kinases, and to release these into the public domain. As part of its mission the SGC generates medically relevant reagents and knowledge related to human proteins and proteins from human parasites, which it shares through over 250 collaborations with researchers worldwide. Since 2004 the SGC has solved over 1400 protein structures and has generated 19 chemical probes for epigenetic proteins (http://www.thesgc.org/chemical-probes/epigenetics).

About DiscoveRx Corporation
Founded in 2000, DiscoveRx is a leading provider of next generation drug discovery screening and profiling platforms. Utilizing its three proprietary technology platforms beta-galactosidase-based enzyme fragment complementation (EFC), KINOMEscan® and BioMAP® (http://www.biomapsystems.com), DiscoveRx offers an industry leading portfolio of over 1000 target-based and human primary cell-based systems for oncology, metabolic disease, inflammation, autoimmunity, CNS and cardiovascular research at global pharmaceutical, biotechnology and academic institutes. For more information, visit http://www.discoverx.com.

University of California Disclaimer
The information stated above was prepared by the Structural Genomics Consortium (SGC) and DiscoveRx Corp. and reflects solely that opinion. Nothing in this statement shall be construed to imply any support or endorsement of the SGC or DiscoveRx, or any of its products, by The Regents of the University of California, its officers, agents and employees.

Logo - http://photos.prnewswire.com/prnh/20130912/SF78575LOGO

SOURCE DiscoveRx Corporation

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AbbVie Submits for EU Marketing Authorization its Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Chronic Hepatitis C

XBiotech Issued Patent for Antibody Therapy to Treat Chronic Sterile Inflammatory Diseases

XBiotech Issued Patent for Antibody Therapy to Treat Chronic Sterile Inflammatory Diseases

Research by Structural Genomics Consortium and DiscoveRx Points to New Multi-Targeting Approaches to Cancer Therapy