Novartis related Press Releases

PaxVax Expands Executive Management Team

Thu, 09 Feb 2012 08:21:35 -0500

Accomplished Vaccine Industry Executives Appointed to COO, CTO and CSO Positions

MENLO PARK, Calif.--(BUSINESS WIRE)-- PaxVax Corporation, developer of innovative and socially responsible oral vaccines against infectious diseases, announced the expansion of its executive management team with the appointments of Nima Farzan as Executive Vice President and Chief Operating Officer, Thomas P. Monath, M.D. as Chief Technology Officer, and Jonathan F. Smith, Ph.D. as Executive Vice President and Chief Scientific Officer.

Nima Farzan joins PaxVax from Novartis AG, where he spent more than seven years in positions of increasing responsibility in pharmaceutical marketing, sales and development in both US and global positions. Most recently, he was Vice President of Marketing for Novartis Vaccines USA, where he was responsible for marketing, market access, pricing and key account sales, and also helped launch multiple new vaccines. Prior to Novartis, Mr. Farzan worked in marketing and business development at DoubleTwist, Inc., a pioneering genomics company. Before that, he was a consultant at The Boston Consulting Group. Mr. Farzan received an M.B.A. from Harvard Business School and an undergraduate degree in Human Biology from Stanford University.

Dr. Monath has devoted his nearly 30-year career to the fight against infectious disease through his work in the military, corporate, academic and investment sectors. In addition to his new role at PaxVax, Dr. Monath is a Partner in the Pandemic and Biodefense Fund at Kleiner Perkins Caufield & Byers. He is also Adjunct Professor at Harvard School of Public Health. From 1992 to 2006, Dr. Monath was Chief Scientific Officer and Executive Director at Acambis, a publicly traded biopharmaceutical company, where he pioneered the development of ChimeriVax® vaccines against dengue, West Nile, Japanese encephalitis, as well as vaccines against yellow fever, Clostridium difficile, Helicobacter pylori and smallpox. In 1992, Dr. Monath retired as a U.S. Army colonel following 24 years in the uniformed services. From 1973 to 1988, he served as director of the Division of Vector-Borne Viral Diseases at the Centers for Disease Control; and from 1989 to 1992, he served as chief of the Virology Division, U.S. Army Medical Research Institute of Infectious Diseases. Dr. Monath earned his undergraduate degree from Harvard College and M.D. from Harvard Medical School and trained in internal medicine at the Peter Bent Brigham Hospital, Boston.

With more than 25 years of experience in virology, infectious diseases, immunology, and vaccine development, Jonathan F. Smith, Ph.D., is a pioneer in the development of novel vaccines and vaccine vector systems derived from RNA viruses. He joins PaxVax from Liquidia, where he was the company’s Chief Scientific Officer, responsible for overseeing research and development programs applying the company’s novel nanoparticle technology to vaccines and other applications. Prior to joining Liquidia in 2010, Dr. Smith was a co-founder and Chief Scientific Officer of AlphaVax, a biotechnology company focused on developing RNA replicon vaccines for infectious diseases, biodefense, and cancer. Prior to his 10 years at AlphaVax, Dr. Smith was a faculty member in the Department of Microbiology at the University of Maryland Medical School and Chief of Viral Biology at the United States Army Medical Research Institute of Infectious Diseases. Dr. Smith received his B.A. from Colby College and his Ph.D. in microbiology/virology from the University of Texas at Austin.

“Nima, Tom and Jonathan all have diverse and deep experience in the vaccine industry and round out our management team at a pivotal time for the company,” said Kenneth Kelley, Chief Executive Officer of PaxVax. “These talented executives will be responsible for driving the development and commercialization of our novel product pipeline as we advance our portfolio of vaccine candidates through the clinical trials process, led by our cholera vaccine.”

PaxVax has raised more than $50 million from investors including Ignition Partners and the Wellcome Trust, and is supported by grants from the U.S. National Institutes of Health (NIH) through the National Institute of Allergy and Infectious Diseases (NIAID) and its Division of Acquired Immunodeficiency Syndrome (DAIDS), as well as the Bill and Melinda Gates Foundation. More information is available at www.paxvax.com.

About PaxVax

PaxVax is a privately held company established in 2007 to develop and commercialize innovative and socially responsible vaccines against infectious diseases. PaxVax has a clinical-stage product portfolio, including a cholera vaccine entering Phase 3 and a pandemic H5N1 influenza vaccine entering Phase 2. The company also has vaccines in development for HIV and anthrax under R&D contracts with NIH/DAIDS and NIH/NIAID. The company’s proprietary adenoviral-based technology platform enables the rapid development of oral vaccines that can target any viral or bacterial protein antigen. The company's vaccine candidates are designed to be easier to manufacture, store, distribute, administer and deliver across the globe than conventional injectable vaccines while enhancing the desired immune response to the vaccine antigens. The company’s offices are headquartered in Menlo Park, Calif., and the R&D laboratories and licensed GMP production facility are based in San Diego, Calif.

CONTACT:

Bioscribe
Nicole Litchfield, 415-793-6468
Nicole@bioscribe.com

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Infectious Diseases Research Science

MEDIA:

Logo

AMAG Pharmaceuticals Announces the Appointment of Two Independent Directors to its Board

Tue, 07 Feb 2012 17:20:57 -0500

~Evaluation of Strategic Alternatives Ongoing~

LEXINGTON, Mass.--(BUSINESS WIRE)-- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced the appointment of Rajiv De Silva and Gino Santini to its board of directors, effective immediately. Mr. De Silva is currently president of Valeant Pharmaceuticals International, Inc. and chief operating officer of its Specialty Pharmaceuticals business. Mr. Santini retired in 2010 from a 27-year career at Eli Lilly and Company, where he held a variety of commercial and operational roles, serving most recently as senior vice president, corporate strategy and business development. The appointment of these two independent directors brings the AMAG Board to seven members.

“As we continue to evaluate strategic alternatives for AMAG, the perspective that Rajiv and Gino bring to the table will be invaluable to AMAG and our board,” said Michael Narachi, chairman of AMAG’s board of directors. “Rajiv’s operations experience at Valeant and Novartis, coupled with Gino’s long history as a successful commercial leader and experience defining and executing corporate strategy at Lilly will support the key decisions facing the board in the coming months. Their expertise will be valuable assets to the board as we explore a sale of the company and simultaneously establish a solid foundation from which to drive growth and profitability if AMAG remains an independent company. ”

Mr. De Silva, age 45, joined Valeant in January 2009. He was named Valeant’s president in October 2010 and is responsible for all specialty pharmaceutical operations, including sales and marketing, research and development, manufacturing and business development. From 2003 to 2009, Mr. De Silva held various leadership positions of increasing responsibility at Novartis AG, most recently as president, Novartis Vaccines USA and head, vaccines of the Americas. Prior to his time at Novartis, Mr. De Silva was a partner at McKinsey & Company, a management consulting firm, where he focused his consulting practice on the pharmaceutical industry. Mr. De Silva holds a Bachelor of Science in Engineering from Princeton University, a Master of Science from Stanford University, and a Master of Business Administration from the Wharton School at the University of Pennsylvania.

Mr. Santini, age 55, had a distinguished career with Eli Lilly that spanned nearly three decades. During his tenure at Lilly, Mr. Santini held various leadership positions of increasing responsibility, including manager of various international regions, president of the women’s health franchise and president of U.S. operations. Mr. Santini capped his career at Lilly as a member of the company’s executive committee and as the senior vice president of corporate strategy and business development. Mr. Santini, fluent in four languages, holds an undergraduate degree in mechanical engineering from the University of Bologna and a master’s in business administration from the University of Rochester.

Mr. Narachi continued, “While we continue the strategic review process, we are progressing our effort to identify and interview qualified candidates for the position of chief executive officer of AMAG.”

About AMAG Pharmaceuticals, Inc.

AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that manufactures and markets Feraheme® in the United States. For additional company information, please visit www.amagpharma.com.

About Feraheme

In the United States, Feraheme® (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter. For additional product information, please visit www.feraheme.com.

AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to our evaluation of strategic alternatives, including a potential sale of the company; our efforts to establish a solid foundation from which to drive growth and profitability if we remain independent; and Mr. De Silva's and Mr. Santini's potential contributions to our Board of Directors; are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.

Such risks and uncertainties include: (1) uncertainties regarding our ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme in new indications and in territories outside of the U.S., including the European Union, (3) the fact that significant safety or drug interaction problems could arise with respect to Feraheme, (4) uncertainties regarding our ability to manufacture Feraheme, (5) uncertainties relating to our patents and proprietary rights, (6) uncertainties regarding the outcome of our evaluation of strategic alternatives, including the risk that the process will not result in a transaction, and (7) other risks identified in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2010 and our Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2011. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.

We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

CONTACT:

AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical General Health

MEDIA:

GenVec Extends Research Collaboration with Global Pharmaceutical Company

Fri, 27 Jan 2012 08:20:53 -0500

GAITHERSBURG, Md., Jan. 27, 2012 /PRNewswire/ -- GenVec, Inc. (Nasdaq: GNVC), a biopharmaceutical company using differentiated, proprietary technologies to create superior therapeutics and vaccines, today announced that it has extended its Research Collaboration and License Agreement with Novartis (NYSE: NVS). Under the extension, Novartis will fund research at GenVec through January 2013 to support its hearing loss and balance disorders program.

"GenVec has worked closely with Novartis for the past two years to move this program forward and we remain committed to being a value added partner," noted Douglas E. Brough, Ph.D., GenVec's Vice President of Research. "This extension will allow GenVec to continue supporting this important effort."

About the Collaboration

In January 2010, GenVec entered into a worldwide licensing and collaboration agreement with Novartis to discover and develop novel treatments for hearing loss and balance disorders. Under the terms of the agreement, if certain clinical, regulatory, and sales milestones are met, GenVec is eligible to receive up to $213.6 million, including upfront and milestone payments in addition to royalties on future sales.

In August 2010, GenVec entered into an additional agreement with Novartis, to manufacture clinical trial material for up to two lead product candidates for this program.

About GenVec

GenVec is a biopharmaceutical company using differentiated, proprietary technologies to create superior therapeutics and vaccines. A key component of our strategy is to develop and commercialize our product candidates through collaborations. GenVec is working with leading companies and organizations such as Novartis, Merial, and the U.S. Government to support a portfolio of product programs that address the prevention and treatment of a number of significant human and animal health concerns. GenVec's development programs address therapeutic areas such as hearing loss and balance disorders; as well as vaccines against infectious diseases including respiratory syncytial virus (RSV), herpes simplex virus (HSV), dengue fever, influenza, malaria, and human immunodeficiency virus (HIV). In the area of animal health we are developing vaccines against foot-and-mouth disease (FMD). Additional information about GenVec is available at www.genvec.com and in the Company's various filings with the Securities and Exchange Commission.

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding funding, grants, collaborations, revenues, cash burn rates, the development of products and the success of the collaboration with Novartis, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by GenVec to secure and maintain relationships with collaborators; risks relating to the early stage of GenVec's product candidates under development; uncertainties relating to research and development activities; risks relating to the commercialization, if any, of GenVec's proposed product candidates; dependence on the efforts of collaborators and third parties; dependence on intellectual property; and risks that we may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations, are contained in GenVec's filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements.

Retail Investor and Media Contact:	Institutional Investor Contact:
GenVec, Inc.	S.A. Noonan Communications
Douglas J. Swirsky	Susan A. Noonan
(240) 632-5510	(212) 966-3650
dswirsky@genvec.com	susan@sanoonan.com

SOURCE GenVec, Inc.

Kedem Pharmaceuticals Initiates Development of Sublingual Anti-Cancer Drug, Gleevec®

Mark Hollmer — Mon, 16 Jan 2012 12:12:24 -0500

Kedem Pharmaceuticals Initiates Development of Sublingual Anti-Cancer Drug, Gleevec®

PHOENIX,, Jan. 12, 2012 /PRNewswire/ -- Kedem Pharmaceuticals Inc. (OTCBB: KDMP), a specialty pharmaceutical company with focus on sublingual drug delivery system is pleased to announce that has initiated the development of Gleevec®. Gleevec® is an important anti-cancer drug for the treatment of several blood related cancers in children and adults. In children the drug has demonstrated a powerful action against Chronic Myeloid Leukemia, possibly one of the most prescribed drugs for this condition. The drug is administered orally and in children there is a significant issue in getting the drug swallowed, due to size of the pill and bad taste. Our sublingual formulation with taste masking features makes the drug acceptable and pleasant in taste for the children with chronic dosage requirements.

About Gleevec®.

Gleevec® is the registered trade name for Imatinib, a specific inhibitor of tyrosine kinase BCR-ABL. BCR-ABL is a fusion protein created by the Philadelphia Chromosome abnormality that characterizes chronic myeloid leukemia (CML). Prior to discovery of Gleevec®, the disease (CML) treatment was very unsuccessful. However, with the discovery of Gleevec®, the treatment of CML has been tremendously successful. The oral prescription dose of Gleevec®, is marketed by Novartis Pharmaceuticals.

About Kedem Pharmaceuticals Inc. KDMP.OB

A specialty pharmaceutical company with expertise in drug delivery and formulation. The Company's lead therapeutic product is a male sexual enhancement drug that is delivered via sublingual route and is called X-Excite. The Company has several other drugs under development for fast and convenient delivery. These include drugs for osteoporosis, sleeping disorders, pain killers, migraine, anti-allergy medications, cardiovascular diseases, lung medications, and addiction replacement therapies. For more information visit www.kedempharmaceuticals.com

Forward-looking Statement
This press release includes forward-looking statements that involve a number of risks and uncertainties, including the success of the products in commercializing and developing. Additionally this press release include statement within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to high risks, uncertainties and other factors, including that the Regulatory Agencies may not agree to the claims made in the Company documents related to our products, and product development. There are risks that due to un foreseen reasons, matters could cause the actual results to differ materially from those referred in our fillings. Risks involved patent infringement, trademark and other commercially related actions that hinder the product development and marketing. Additional risks involve the ability of the Company to raise capital to fund its operations and the capital requirements for the development and marketing of its products. Investors are encouraged to review the risk factors listed or described from time to time in the Company's filings (10K) with the Securities and Exchange Commission, as well as to obtain independent third party opinions before investing in the Company's securities.

For further information, contact:

Kedem Investor Relations 1 866 465-6551

info@kedempharmaceuticals.com

Mrs. Kelly Black

Premier Media Services 1 480 649 8224

kblack@premiermediaservice.com

SOURCE Kedem Pharmaceuticals Inc.
Back to top

AnaptysBio Announces New Strategic Antibody Discovery

Fri, 06 Jan 2012 11:20:42 -0500

Alliances With Two Pharma Partners

SAN DIEGO, Jan. 6, 2012 /PRNewswire/ -- AnaptysBio, Inc., a privately-held therapeutic antibody company, today announced the initiation of new strategic alliances with two partners: Novartis and an undisclosed second pharmaceutical company. The strategic alliance announced today with Novartis is AnaptysBio's second collaboration with the Swiss-based pharmaceutical company and follows an initial partnership where AnaptysBio successfully delivered antibody candidates for Novartis' development pipeline.

(Logo: http://photos.prnewswire.com/prnh/20111205/SF16052LOGO)

Under the terms of each alliance, AnaptysBio will utilize its proprietary SHM-XEL platform for the discovery and maturation of novel therapeutic antibodies to multiple oncology-related therapeutic targets. Each pharmaceutical partner will receive worldwide rights to develop and commercialize a limited number of antibodies against each therapeutic target generated by AnaptysBio. In addition to an upfront payment and resource-based compensation, AnaptysBio is eligible to receive milestone payments and royalties associated with the development and sale of any products derived from these alliances.

AnaptysBio's proprietary SHM-XEL platform, which couples fully human antibody libraries with in vitro somatic hypermutation (SHM) in mammalian cells to generate high affinity lead candidates, replicates key features of the human immune system and overcomes limitations of prior antibody technologies. By harnessing the natural mechanism of antibody maturation under controlled conditions, SHM-XEL allows for the selection of optimal antibody properties such as high affinity, functionality, cross-reactivity and epitope diversity. The use of mammalian cell display permits AnaptysBio to optimize manufacturing-related parameters by selecting for high-level expression and stability in parallel. Simultaneous secretion of antibody variants by the mammalian cells utilized during SHM-XEL also permits incorporation of functional assays in the antibody discovery process. Key hallmarks of the SHM-XEL platform were recently published by AnaptysBio in Proceedings of the National Academy of Sciences (PNAS (2011), 108, 20455-20460).

"Our technology platform provides an integrated approach to antibody discovery using the natural biochemistry of somatic hypermutation in the context of mammalian cells," said Hamza Suria, president and chief executive officer for AnaptysBio. "We will continue to generate differentiated therapeutic candidates for our internal pipeline and under strategic alliances with select pharmaceutical partners."

About AnaptysBio

Founded in 2005, AnaptysBio, Inc. is a privately-held company focused on the generation of antibody therapeutics, and the leader in the use of somatic hypermutation (SHM) for antibody discovery and optimization. SHM is the body's natural process for generating potent antibodies. The Company's SHM-XEL platform couples SHM with mammalian cell display to generate antibodies for therapeutic applications through an iterative process of natural evolution and high-throughput selection under controlled conditions – a process that has been referred to as "naturalizing" antibodies. This versatile platform can be used for both discovery of new antibodies and optimization of existing antibodies to generate candidates with desired properties for therapeutic applications. AnaptysBio has established broad intellectual property around the use of SHM and is currently building a pipeline of novel therapeutic antibody product candidates. Major investors in AnaptysBio include founding investor Avalon Ventures, as well as Alloy Ventures, Frazier Healthcare Ventures, and Novo A/S. For more information, visit www.anaptysbio.com.

Contacts:

Julie Rathbun

julie@rathbuncomm.com

206-769-9219

SOURCE AnaptysBio, Inc.

Forma Expands Drug Discovery Team with Three Executive Appointments

Tue, 27 Dec 2011 09:20:42 -0500

WATERTOWN, Mass.--(BUSINESS WIRE)-- FORMA Therapeutics today announced three new additions to its R&D team, greatly expanding its oncology drug discovery capabilities. Jaime Escobedo, Ph.D., has been named Vice President, Biology; Mark J. Tebbe, Ph.D., has been named Vice President, Medicinal and Computational Chemistry; and Dennis France has been named Executive Director and Head, Biomolecular Screening. Each has significant experience in oncology drug discovery and development.

“Joining our science leadership team, these experienced drug hunters will drive FORMA’s astounding drug discovery engine,” said Kenneth Bair, Ph.D., Senior Vice President and Head of Research and Development of FORMA. “More importantly, each will foster the growth of FORMA’s scientists as we pursue our discovery programs focused on important cancer targets, including those involving cancer metabolism, protein-protein interactions and epigenetics.”

“Ken has created an incredible science management team at FORMA,” said Steven Tregay, Ph.D., Chief Executive Officer. “This team will play a central role in our expanding number of collaborations as we take on innovative targets that will lead to novel drugs useful in the treatment of cancer.”

Prior to joining FORMA, Dr. Escobedo was Head of Translational Biology and Pharmacology at Novartis Oncology (Emeryville, CA) and a member of the Oncology Decision Board that oversaw all oncology drug development programs. Prior to joining Novartis, Dr. Escobedo held the position of Vice President of Biological Discovery Research and Director of Molecular Technologies at Chiron Biopharmaceuticals and was a member of the Research Management Team, which supervised all drug discovery activities in Chiron Biopharma Research. Before joining Chiron, Dr. Escobedo was an Assistant Professor in the Department of Medicine at UCSF. Dr. Escobedo also served as an Associate Staff member for the Cardiovascular Research Institute and as the Principal Investigator at the Daiichi Research Center at UCSF. Throughout his career, Dr. Escobedo has authored over 70 publications in the field of cell growth regulation, tyrosine kinase receptors and cell signaling, and has been instrumental in filing numerous patent applications. Dr. Escobedo received his undergraduate degree from the Catholic University of Chile and received his Ph.D. in Genetics from Albert Einstein College of Medicine, Yeshiva University in New York.

Dr. Tebbe has held multiple leadership positions during his career prior to joining FORMA, including Head of Discovery Chemistry at Eli Lilly (Hamburg, Germany), Head of Chemistry at Eli Lilly (Research Triangle Park, North Carolina), and Manager of Global Operations for discovery chemistry at Eli Lilly. Dr. Tebbe is a demonstrated “drug hunter” with over 17 years of experience in drug discovery and development, including structure-guided drug design. He has expertise in the areas of infectious diseases, endocrine, and metabolism targets and has delivered clinical candidates in all of these areas. Dr. Tebbe is a co-inventor of Incivek™ (telaprevir), an HCV protease inhibitor discovered and developed during a collaboration between Vertex and Eli Lilly. He has platform-based experience with cell surface receptors/GPCRs (including ion channels), proteases and other enzyme targets, and has extensive experience in lead generation and target validation. Dr. Tebbe obtained his undergraduate degree from the University of Notre Dame and his Ph.D. in organic chemistry from Stanford University.

Mr. France previously served as Vice President of Oncology Lead Discovery at ArQule, Inc., where he focused on molecular targeted approaches to cancer from target selection through lead optimization, and substantially contributed to INDs filed for tivantinib (ARQ 197), a novel c-Met kinase inhibitor; ARQ 171, a novel checkpoint activating agent (9/06); ARQ 621, an Eg5 (KSP) inhibitor; and ARQ 092, a highly potent and selective inhibitor of Akt kinases. Dennis held roles of increasing responsibility at Novartis, his last position as an Executive Director in the oncology disease area where he was responsible for early target-based oncology lead discovery. While at Novartis, he also served as a key liaison for the collaboration between Novartis and the Dana-Farber Cancer Institute (DFCI). Prior to joining the pharmaceutical industry in 1987, Mr. France trained at leading medical research labs, including DFCI, the Mt. Sinai School of Medicine and the NYU Medical School. He previously served for nearly a decade as Chairman of both the MipTec Conference and the Laboratory Robotics Interest Group (LRIG) on enabling technologies for drug discovery. Mr. France has received a number of awards, including the ISLAR Pioneer Award in Laboratory Robotics, The Association for Laboratory Automation Achievement Award, the Novartis Pharmaceuticals Corporation Pioneer Award, and the Sino-American Pharmaceutical Association of New England Contribution Award. Dennis received a B.A. in Biology and Psychology from Vassar College.

About FORMA Therapeutics

FORMA Therapeutics targets essential cancer pathways to create transformative small molecule cancer therapies. FORMA’s novel approach to accessing high value drug targets, many of which pose significant challenges to conventional discovery approaches, leverages the integration of its innovative drug discovery technologies and oncology expertise, enabling efficient screening, discovery and rational development of small molecule drug candidates with qualified cellular mechanisms of action. FORMA is building a robust pipeline of cancer therapies in areas such as tumor metabolism, protein-protein interactions and epigenetics. FORMA is headquartered in Watertown, MA. www.formatherapeutics.com

CONTACT:

FORMA Therapeutics
Steven Tregay, 617-679-1970
CEO
or
Media Inquiries
MacDougall Biomedical Communications
Jennifer Conrad, 781-235-3060
jconrad@macbiocom.com

KEYWORDS: United States North America Massachusetts

INDUSTRY KEYWORDS: Health Biotechnology Oncology Pharmaceutical Medical Supplies

MEDIA:

Logo

BASF, GlaxoSmithKline, Merck and Novartis Among Companies to Schedule Partnering Sessions at CED Life Science Conference 2

Tue, 13 Dec 2011 07:20:58 -0500

Early registration encouraged to secure limited opportunities

DURHAM, N.C.--(BUSINESS WIRE)-- CED, the Southeast’s largest entrepreneurial support organization, today opened registration for partnering sessions at the CED Life Science Conference 2012, scheduled for February 15-16 at the Raleigh Convention Center. The partnering sessions will be open to all conference participants, and priority consideration will be given to those who register early.

Corporate partners confirmed for the conference include Abbott, BASF, Bayer Crop Science, GlaxoSmithKline, LabCorp, Merck, Novartis, and United Therapeutics. In addition to requesting opportunities to schedule 20-minute private networking meetings with these companies, participants also will have the opportunity to request meetings with investors, emerging life science companies and university technology transfer officers.

“We participated in two partnering sessions in 2011 that were quite constructive and vital for moving our company forward to potential licensing discussions,” said Steven E. Peterson, CEO of Trana Discovery, Inc. Peterson plans to participate in the partnering sessions in 2012, as well.

“Anytime we can bring people together to partner in forums such as this, we open doors to significant collaborations and opportunities to commercialize important new technologies,” said Norris Tolson, president and CEO of the North Carolina Biotechnology Center.

The CED Life Science Conference 2012 is presented in partnership with the North Carolina Biotechnology Center and North Carolina Biosciences Organization. Early registration and a full conference agenda can be found online at: http://www.cednc.org/lifescience.

About CED

CED’s mission is to identify, enable and promote emerging growth companies and to accelerate the entrepreneurial culture of the Research Triangle and North Carolina.

About NC Biotechnology Center

The Biotechnology Center is a private, non-profit corporation supported by the N.C. General Assembly. Its mission is to provide long-term economic and societal benefits to North Carolina by supporting biotechnology research, business, education and strategic policy statewide.

About NCBIO

NCBIO is dedicated to promoting the future growth and development of North Carolina’s bioscience industry. NCBIO advocates for state and federal public policies that encourage the growth of life science companies, support the development of a strong life science workforce, and promote research and technology transfer at universities and other institutions.

CONTACT:

CED
Jason H Parker, 919-266-0466
Associate Director, Marketing & Communications
jparker@cednc.org

KEYWORDS: United States North America North Carolina

INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical General Health

MEDIA:

Logo

First U.S. cell-based flu vaccine plant set for dedication

Mon, 12 Dec 2011 14:20:57 -0500

Facility’s ability to produce cell-based pandemic flu vaccine marks historic change

WASHINGTON--(BUSINESS WIRE)-- The first U.S. facility to use a faster and more flexible technology to make influenza vaccine was dedicated today, as part of an initiative that could provide vaccine supplies sooner in an influenza pandemic. The plant in Holly Springs, N.C., can create vaccine using cultured animal cells instead of the conventional process of using fertilized eggs. The facility is a public-private partnership of the U.S. Department of Health and Human Services, and Novartis Vaccines and Diagnostics, Inc. of Cambridge, Mass. This partnership will be maintained under contract for at least 25 years.

The dedication signals that in an influenza pandemic the facility can produce cell-based influenza vaccine that could be authorized by the U.S. Food and Drug Administration for use during the emergency.

“Today we’re marking the first change in influenza vaccine manufacturing in the United States in 50 years,” said Robin Robinson, Ph.D., director of the Biomedical Advanced Research and Development Authority in HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR). Robinson led the effort for HHS. “The pandemic readiness of this facility is a major milestone in national preparedness for pandemic influenza and other diseases.”

In an influenza pandemic, the new Novartis facility may be able to produce 25 percent of the vaccine needed in the United States. In addition, cell-based technology used in this facility for manufacturing seasonal and pandemic influenza vaccines may be adapted to produce vaccines for other known and unknown emerging infectious diseases in an emergency. The United States joins several European countries with the capability to manufacture cell-based influenza vaccines on a large scale.

Investing in new vaccine technology to improve the time necessary to produce pandemic vaccine and increase the nation’s surge capacity was recommended in two August 2010 reports, the Public Health Emergency Medical Countermeasures Enterprise Review released by Secretary Kathleen Sebelius and the President's Council of Advisors on Science and Technology Report to the President on Reengineering the Influenza Vaccine Production Enterprise to Meet the Challenges of Pandemic Influenza.

In addition to partnering to bring cell-based flu vaccine and adjuvant technologies to the United States, HHS and Novartis are partnering with Synthetic Genomics Vaccines of Rockville, Maryland on new technologies to shorten the vaccine manufacturing timeline by optimizing vaccine virus seed strains used for flu vaccine production.

BARDA and Novartis also are working with North Carolina State University to train scientists from other countries to use cell culture based manufacturing techniques similar to what is used in the new facility. The training program is part of a World Health Organization initiative to strengthen the ability of developing countries to produce flu vaccine, potentially reducing the global threat from influenza.

HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR is an HHS leader in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.

Within ASPR, BARDA provides a comprehensive integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing infrastructure for vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear threats, pandemic influenza, and emerging infectious diseases.

For more information on pandemic preparedness efforts, visit www.phe.gov or www.flu.gov and to learn more about partnering with HHS ASPR’s BARDA in public health preparedness visit www.medicalcountermeasures.gov. Contract opportunities are announced at www.fbo.gov.

Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.

CONTACT:

HHS Press Office
202-690-6343

KEYWORDS: United States North America District of Columbia North Carolina

INDUSTRY KEYWORDS: Health Biotechnology Infectious Diseases Public Policy/Government Healthcare Reform Pharmaceutical Other Policy Issues Manufacturing Public Policy White House/Federal Government Other Manufacturing Research FDA Science

MEDIA:

Logo

GenVec Achieves Second Milestone in Collaboration

Tue, 06 Dec 2011 08:20:59 -0500

GAITHERSBURG, Md., Dec. 6, 2011 /PRNewswire/ -- GenVec, Inc. (Nasdaq: GNVC) today announced that it has achieved the second milestone in its collaboration with Novartis (NYSE: NVS), related to the development of treatments for hearing loss and balance disorders. The milestone was triggered by the successful completion of certain preclinical development activities.

"Completing this milestone reflects sustained progress and we look forward to reaching additional milestones with Novartis in this very exciting program," said Dr. Paul Fischer, GenVec's President and Chief Executive Officer.

About the Collaboration

In August 2010, we entered into an additional agreement with Novartis, to manufacture clinical trial material for up to two lead product candidates for this program.

About GenVec

GenVec is a biopharmaceutical company using differentiated, proprietary technologies to create superior therapeutics and vaccines. A key component of our strategy is to develop and commercialize our product candidates through collaborations. GenVec is working with leading companies and organizations such as Novartis, Merial, and the U.S. Government to support a portfolio of product programs that address the prevention and treatment of a number of significant human and animal health concerns. GenVec's development programs address therapeutic areas such as hearing loss and balance disorders; as well as vaccines against infectious diseases including respiratory syncytial virus (RSV), herpes simplex virus type 2 (HSV-2), dengue fever, influenza, malaria, and human immunodeficiency virus (HIV). In the area of animal health we are developing vaccines against foot-and-mouth disease (FMD). Additional information about GenVec is available at www.genvec.com and in the Company's various filings with the Securities and Exchange Commission.

Retail Investor and Media Contact:	Institutional Investor Contact:
GenVec, Inc.	S.A. Noonan Communications
Douglas J. Swirsky	Susan A. Noonan
(240) 632-5510	(212) 966-3650
dswirsky@genvec.com	susan@sanoonan.com

SOURCE GenVec, Inc.

Novartis gains European Commission approval for Rasitrio®, a Rasilez-based triple combination pill to treat high blood pressure

Maureen Martino — Mon, 28 Nov 2011 07:52:06 -0500

Novartis gains European Commission approval for Rasitrio®, a Rasilez-based triple combination pill to treat high blood pressure

Pivotal phase III data showed significantly greater blood pressure reductions with Rasitrio compared to dual combinations of each of its individual components[1]
Up to 85 percent of patients may need multiple medications to help control their high blood pressure underscoring the need for effective combination treatments[2],[3]

Basel, November 28, 2011 - Novartis announced today that Rasitrio®, the first triple combination of aliskiren, amlodipine and hydrochlorothiazide (HCT) in a single pill,1 has received approval from the European Commission (EC) for the treatment of high blood pressure.

"For the first time, high blood pressure patients in Europe with complex needs will have access to a single pill combining the unique properties of Rasilez with two well-established and effective high blood pressure treatments," said David Epstein, Division Head of Novartis Pharmaceuticals. "Rasitrio is the first Rasilez-based triple combination pill available in Europe to help patients requiring multiple medications reach their treatment goal."

Rasitrio combines the first and only approved direct renin inhibitor (DRI) worldwide, Rasilez, with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide[4]. Rasilez is an important component of the treatment as it targets renin for optimal control of the RAAS (renin angiotensin aldosterone system)[5], which is a key regulator of high blood pressure. Rasitrio has been approved as substitution therapy for patients with high blood pressure that are adequately controlled by the combination of the three components at the same dose.

The approval of Rasitrio is based on pivotal phase III data involving more than 1,181 high blood pressure patients. The study showed that Rasitrio produced statistically significant blood pressure reductions compared to dual combinations of each of its individual components, including aliskiren/amlodipine 300 mg/10 mg, aliskiren/HCTZ 300 mg/25 mg and amlodipine/HCTZ 10 mg/25 mg[1]. The effect of Rasitrio was observed as early as one week after initiation of therapy and was maintained over the entire 24-hour dose interval[1].

Up to 85 percent of high blood pressure patients may need several medications to help them reach their goal[2],[3]. However, the management of multiple drugs can lead to compliance concerns, a major challenge for primary care physicians[6].

"Simplification of treatment for high blood pressure patients on three or more therapies is key to improving patient compliance and outcomes," said Professor Josep Redon, M.D., Hospital Clinico, University of Valencia, Spain. "This innovative triple combination therapy, which has demonstrated significant reductions in blood pressure during clinical trials, offers patients a new and convenient treatment option."

The single pill combination Rasitrio works to lower blood pressure in three ways. The Rasilez component directly binds to and inhibits renin, an enzyme produced by the kidneys that starts a process that can make blood vessels narrow and lead to high blood pressure[5]. The calcium channel blocker amlodipine lowers blood pressure by relaxing the blood vessel walls, and the diuretic hydrochlorothiazide increases the excretion of sodium chloride and water. All three complementary medicines enable blood to flow more easily, therefore lowering blood pressure.

It is estimated that about one billion people globally have high blood pressure[7],[8], with many remaining uncontrolled despite treatment[9]. High blood pressure alone can cause damage to the vital organs of the body, including the heart, brain and kidneys[8]. It is also linked with other conditions such as diabetes, where high blood pressure is estimated to cause up to 75% of diabetic cardiovascular complications[10]. However, if high blood pressure is properly controlled, the incidence of stroke and heart failure can be reduced by almost half and heart attacks by one quarter[8].

About Tekturna/Rasilez
Tekturna/Rasilez is approved in over 80 countries. Aliskiren was approved in the US and in the European Union in 2007 under the trade name of Tekturna and Rasilez respectively. Rasilez received approval in Canada in 2008, Japan in 2009 and China in March 2010. Tekturna HCT®, a single pill combination of aliskiren and hydrochlorothiazide (HCT), was approved in the US in 2008 for second-line treatment of high blood pressure, and in 2009 for first-line treatment of high blood pressure. This single pill combination was approved for add-on and replacement therapy in the European Union in 2009 under the tradename Rasilez HCT®. In 2009, Valturna®, a single pill combination of aliskiren and valsartan (Diovan®), was approved in the US. Tekamlo®, the single pill combination of aliskiren and amlodipine was approved in the US in August 2010 and in the European Union under the trade name Rasilamlo® in April 2011. Amturnide®, the triple combination of aliskiren, amlodipine and hydrochlorothiazide (HCT), was approved in the US in December 2010.

Novartis has a strong cardiovascular and metabolic portfolio, focusing on innovative treatments for high blood pressure and diabetes. These include Diovan® (valsartan), the number one selling branded blood pressure medication worldwide[11], Co-Diovan (valsartan and hydrochlorothiazide), a single-pill combination of valsartan with the most widely prescribed diuretic. Exforge® (valsartan/amlodipine), a single-pill combining two leading medicines for high blood pressure; Exforge HCT® (amlodipine/valsartan/HCT); and Rasilez® (aliskiren), the first and only approved direct renin inhibitor, and four single-pill combinations of Rasilez®, Tekamlo®/Rasilamlo® (aliskiren/amlodipine), Amturnide (aliskiren/amlodipine/HCT), Tekturna HCT®/Rasilez HCT® (aliskiren/HCT) and Valturna® (aliskiren/valsartan). For the treatment of type 2 diabetes, these include Galvus® (vildagliptin, a DPP-4 inhibitor) and Eucreas® (vildagliptin and metformin).

1. Sold in the US as Amturnide®.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "may," "will," "can," or similar expressions, or by express or implied discussions regarding potential future revenues from Rasitrio. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Rasitrio to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Rasitrio will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Rasitrio could be affected by, among other things, competition in general; government, industry and general public pricing pressures; unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected manufacturing issues; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2010, the Group's continuing operations achieved net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 121,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

References
[1] Data on file. Novartis 2011 (Study SAH2302).
[2] Dahlof B, et al. Cardiovascular Morbidity and Mortality in the Losartan Intervention for Endpoint Reduction in Hypertension Study (LIFE): a Randomised Trial Against Atenolol. Lancet 2002;359:995-1003.
[3] Pepine CJ, et al. A Calcium Antagonist vs. a Non-Calcium Antagonist Hypertension Treatment Strategy for Patients with Coronary Artery Disease. The International Verapamil-Trandolapril Study (INVEST): a Randomized Controlled Trial. JAMA 2003;290:2805-2816.
[4] Rasitrio Summary of Product Characteristics (SmPC) for European Union.
[5] Rasilez Summary of Product Characteristics (SmPC) for European Union.
[6] Burnier M, et al. Medication adherence and persistence as the cornerstone of effective antihypertensive therapy. Am J Hypertens 2006; 19:1190-6.
[7] Kearney P, et al. Global Burden of Hypertension: Analysis of Worldwide Data. Lancet 2005;365:217-23.
[8] Chobanian AV, et al. Seventh Report of the Joint National Committee on Prevention, Detection Evaluation and Treatment of High Blood Pressure. Hypertension 2003;42:1206-1251.
[9] Lloyd-Jones D, et al. for the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics-2010 update. A report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2010;121;e46-e215.
[10] El-Atat F, et al. Diabetes, Hypertension, and Cardiovascular Derangements: Pathophysiology and Management. Curr Hypertens Rep 2004;6:215-23.
[11] IMS Midas Worldwide Sales Data 2010.

# # #

Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
eric.althoff@novartis.com Catherine Peloquin
Novartis Pharma Communications
+41 61 696 8315 (direct)
+41 79 826 7452 (mobile)
catherine.peloquin@novartis.com