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OpGen Announces $23.6 Million Seires A Financing; CHL Medical Partners, Highland Capital Partners and Versant Ventures Lead Round
Madison, WI – September 12, 2007
OpGen, Inc. today announced that the company has raised $23.6 million in equity financing. The round was led by CHL Medical Partners, Highland Capital Partners and Versant Ventures, with previous investor Mason Wells also participating. In conjunction, CHL's Ron Lennox will become chairman of the Board of Directors and will also be joined on the board by Corey Mulloy and Bijan Salehizadeh from Highland, and Versant's Brian Atwood.
“We are delighted to partner with three top-tier venture firms to advance OpGen's efforts in the field of clinical microbiology," said Colin Dykes, Chief Scientific Officer of OpGen. “Each has a stellar track record and expertise in commercializing technologies for diagnostic and research applications, which will be critical as we continue to grow and expand our operations.”
OpGen delivers breakthrough capabilities to identify microorganisms using a unique method to analyze DNA extracted directly from the microbial cells. “Optical Mapping” has been used by organizations worldwide for comparative genomic analysis of a range of organisms of importance to human health, including tracing the origins of food-poisoning cases such as the recent outbreak linked to contaminated spinach. With this new financing the company will develop commercial instrumentation systems for the clinical microbiology marketplace.
"Currently, clinical microbiology laboratories depend on isolating and growing microorganisms from clinical samples,” stated Ron Lennox. “This is a lengthy process and provides only a simple taxonomic identification. The results are rarely timely enough to influence choice of therapy and can lead to excessive use of expensive broad-spectrum antibiotics. OpGen's new system will provide data capable of identifying bacteria down to the strain level, within a single shift."
“There is a huge unmet need for systems to rapidly and accurately diagnose clinical infections and to control nosocomial infections,” added Corey Mulloy of Highland . “We believe that OpGen's technology is uniquely placed to meet this need and to transform clinical microbiology.”
OpGen is actively expanding both its product development and senior management team. A retained search for a new Chief Executive Officer is currently under way.
About OpGen
OpGen is commercializing a novel single molecule DNA analysis technology, "Optical Mapping", for rapid identification and analysis of microorganisms. The system can be used to obtain detailed genetic information with no requirement for prior sequence data, PCR, cloning, or probes. Applications of the new commercial systems include clinical microbial analysis, forensic microbiology and the development of novel molecular diagnostic products. For more information, please visit www.opgen.com or call 603-441-8100.
Millennium Pharmacy Systems Completes $40 Million Financing
Wexford, PA – June 12, 2007
Millennium Pharmacy Systems, Inc. (“MPSRx”), a privately-held healthcare services company providing contract pharmacy services to the long term-care industry, announced the recent completion of a $40 million equity financing. Essex Woodlands Health Ventures (EWHV) led the investment group, which included new investors Ascension Health Ventures and Steve Wiggins, an Operating Partner at EWHV, and existing investors CHL Medical Partners, Boulder Ventures, and individuals.
“We are pleased to secure the financing needed to facilitate the continued rapid scaling of our innovative business,” said Gary Duty, President and Chief Executive Officer and a co-founder of MPSRx. “We believe that the MPSRx system is now gaining benchmark status as the standard of medication management in the long-term care industry.” Mr. Duty co-founded MPSRx with William Gatti and Steven Brody, successful entrepreneurs in the institutional pharmacy and long-term care businesses. The senior management team also includes co-founder Lena Sturgeon, a seasoned long-term care pharmacy and skilled nursing facility executive, as Chief Operating Officer; Michael Gold, Senior Vice President Marketing and Business Development , an executive with extensive experience in pharmaceutical services; and Suresh Vishnubhatla, who joined the Company in early 2007 as the Chief Technology Officer.
“We are excited about Millennium's imaginative technology-driven business model for improving the care and safety of nursing home patients and pleased to join with this proven team of entrepreneurs and managers to help them build MPSRx into an industry leader in long-term care services,” said Mark Pacala, a Managing Director at EWHV and newly appointed Director of the six-year-old company.
The equity infusion will be utilized primarily for working capital to enable the company to continue its rapid pace of uninterrupted organic growth in the traditional long term care pharmacy services market.
The company raised its first institutional round of financing, led by CHL Medical Partners and including Boulder Ventures and individuals, in September 2005. The present raise brings the total of the Company's committed growth equity capital to over $60 million since its startup in 2001.
About Millennium Pharmacy Systems
Millennium Pharmacy Systems is a pioneer in the field of medication management systems for the long term care industry. The company utilizes advanced information handling technologies and informatics-driven logistics to provide a virtually error-free environment for managing and administering medications for residents of nursing home facilities. For further information please visit www.mpsrx.com.
Two Significant Hires Round-Out VaxInnate's Core Management Team;
Newly Appointed CFO and COO Bring Extensive Experience to Support and Further the Company's Vaccine Development Programs
Cranbury, NJ – June 6, 2007
VaxInnate announced today the appointment of Andrew T. Drechsler as chief financial officer (CFO) and Edward J. Arcuri, Ph.D., as chief operations officer (COO). Mr. Drechsler, formerly CFO of Valera Pharmaceuticals, possesses the depth and breadth of financial expertise necessary to successfully guide VaxInnate's financial operations. Dr. Arcuri, formerly COO and executive vice president, Emergent Biosolutions, Inc., brings extensive, targeted experience in corporate management of the development, manufacture, and commercialization of vaccines, antibodies, and biodefense products. As part of VaxInnate's executive management team, both will play an integral role in overseeing the financial and corporate operations of the company as it advances the development of its vaccines for human and avian flu, malaria, and other therapeutic indications.
“Andy and Ed are both joining VaxInnate at the opportune time to lend their expertise to our upcoming milestones and highly-visible vaccine programs. With the science in place to move these programs forward, we rely on the strategic counsel of our management team to ensure our clinical candidates' progression toward, and success in, the marketplace,” said Alan Shaw, President and CEO of VaxInnate. “We anticipate that both Andy and Ed's expertise in biotechnology and pharmaceutical corporate management, and their collective experience in all aspects of the business including securing funding, setting up strategic transactions and partnerships, and managing clinical development and operation activities serve important functions in advancing our human and avian flu vaccine candidates, and other vaccine programs, through clinical trials and to market.”
As CFO, Mr. Drechsler will provide the financial insight and expertise in biotechnology field to maximize the company's position through investor relations and future commercial collaborations. Mr. Drechsler commented, “VaxInnate has certainly made a mark for itself in the vaccine space, substantiated by its strong financial backing by prominent investors. I look forward to maintaining those relationships, managing the funding to achieve the best possible outcomes in our clinical programs, as well as fostering the appropriate infrastructure to ensure the success of the company.”
In his role as COO, Dr. Arcuri will be overseeing the development and operations activities of clinical candidates, including QA, QC, and regulatory affairs. “VaxInnate is poised to pioneer the next generation of vaccines, and my role is to make sure that we have the proper short-term and long-term operational strategies in place to bring our clinical candidates through to commercialization.”
Mr. Drechsler and Dr. Arcuri complete VaxInnate's core management team, made up of industry-leading experts Alan Shaw, Ph.D., CEO, formerly with the Merck Vaccine Research Division; David Taylor, MD, CMO, formerly with Salix Pharmaceuticals; Jeff Powell, Ph.D., Vice President, Research, formerly with SUGEN; David Jackson, Vice President, Process Development and Manufacturing, formerly with BioReliance; and Robert Becker, Ph.D., Vice President, Business Development, formerly with Sanofi Pasteur.
Prior to serving as CFO of Valera Pharmaceuticals, Mr. Drechsler served in various senior financial positions including Corporate Controller of i-STAT Corporation which was acquired by Abbott Laboratories and Corporate Controller of Biomatrix, Inc. which was acquired by the Genzyme Corporation. He also is affiliated with several financial organizations, including the American Institute of CPAs, the New Jersey Society of CPAs, Financial Executives International, the New Jersey Tech Council, and the Association of Bioscience Finance Officers. He received his degree in accounting from Villanova University, graduating Magna Cum Laude.
Before his role as COO at Emergent, Dr. Arcuri served as Senior VP of Manufacturing, Vaccines, and then Senior VP, Manufacturing Operations, at MedImmune, Inc.; VP of Manufacturing, Senior VP of Operations, and then COO and Senior VP, at Aviron, Inc.; VP, Manufacturing Operations and Process Development, North American Vaccine, Inc.; and Senior Director, Biological Manufacturing, Merck & Co. He also held a variety of scientific and research positions at SmithKline Beecham, Merck, The Helicon Foundation, and Oak Ridge National Laboratory. Dr. Arcuri graduated with honors with a degree in biology from the State University of New York at Albany, and went on to earn both his M.S. degree and Ph.D. in Biology from Rensselaer Polytechnic Institute.
About VaxInnate
VaxInnate is a privately-held biotechnology company focused on developing novel, proprietary vaccines for both pandemic and seasonal influenza. The company's Toll-like receptor (TLR) technology platform allows for genetic engineering of the vaccines using recombinant DNA techniques. This technology physically links TLR agonists to vaccine antigens, which allows the conjugated vaccine to trigger an adaptive immune response. VaxInnate is using its TLR platform technology to enhance the immunogenicity of a series of antigens which will be combined into a number of different influenza products. The technology platform is also being investigated for development of vaccines for other diseases. For more information on VaxInnate, please visit www.vaxinnate.com.
BioRelix Rounds Up $26 Million First Round
New Haven, CT – June 4, 2007
VentureWire LifeScience – Antibiotics start-up BioRelix Inc. has closed a $25.75 million first round to
develop a novel means of fighting drug-resistant bacteria.
New investors in this round were New Leaf Venture Partners and Aisling Capital, said Ronald W.
Lennox, a partner with CHL Medical Partners. CHL led a $250,000 seed round for BioRelix in July 2006. In addition to CHL, returning investors are Novartis Venture Fund, Elm Street Ventures and
Alexandria Real Estate Equities, he said.
This round will enable BioRelix to take a drug candidate into clinical trials by late 2009 or early 2010, said Lennox, who is serving as interim chief executive. A search is on for a permanent CEO, and one may be in place this summer, he said.
BioRelix's drugs will target RiboSwitches, identified in the laboratory of Yale University researcher Ronald Breaker. RiboSwitches are short stretches of messenger RNAs that bind small metabolites and control genes essential for survival of many disease-causing microbes. Yale scientists have identified 11 different classes of RiboSwitch RNAs. They also and have found that some well-known compounds work by targeting RiboSwitch RNAs, according to the company. Research by Breaker indicates that RiboSwitch-targeted drugs may be effective against Gram-positive and Gram-negative bacteria.
With bacteria rapidly growing resistant to commonly used antibiotics, there's strong need for better drugs. Pharmaceutical companies have responded recently by acquiring biotech outfits with novel therapeutics. In 2005, Pfizer Inc. acquired Vicuron Pharmaceuticals Inc. for $1.9 billion, for example.
Dov A. Goldstein, executive vice president and chief financial officer of Vicuron until the merger,
is now an Aisling principal and has joined the BioRelix board. Also joining the board are New
Leaf Managing Director Philippe Chambon and Novartis Venture Fund Managing Director
Campbell Murray.
Amicus Therapeutics Announces Pricing of Initial Public Offering of 5,000,000 Shares of Common Stock
Cranbury, NJ – May 31, 2007
Amicus Therapeutics (Nasdaq: FOLD) announced today the pricing of its initial public offering (IPO) of 5,000,000 shares of its common stock at a public offering price of $15.00 per share. Amicus has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock to cover over- allotments, if any. All shares in the offering will be sold by the Company and are expected to begin trading today on the NASDAQ Global Market under the trading symbol "FOLD."
Morgan Stanley & Co. Incorporated and Merrill Lynch & Co. served as joint book-runners for the offering, with J.P. Morgan Securities Inc., Lazard Capital Markets LLC, and Pacific Growth Equities, LLC acting as co-managers. The offering is expected to close on or about June 5, 2007, and is subject to the satisfaction of customary closing conditions.
Amicus filed a registration statement, which has been declared effective by the Securities and Exchange Commission (SEC). A copy of the final prospectus relating to the offering may be obtained by contacting Morgan Stanley & Co. Incorporated, 180 Varick Street, New York, New York 10014, attention: Prospectus Department, or by e-mailing prospectus@morganstanley.com or contacting Merrill Lynch & Co., 4 World Financial Center, New York, New York 10080, or by calling 212-449-1000. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor shall it constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful.
About Amicus Therapeutics
Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules that selectively bind to and stabilize proteins in cells, leading to improved protein folding and trafficking, and increased activity. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus is currently conducting Phase II clinical trials of Amigal(TM) for the treatment of Fabry disease and Plicera(TM) for the treatment of Gaucher disease. The company is currently conducting Phase I clinical trials of AT2220 for the treatment of Pompe disease.
Safe Harbor Statement
This press release may contain or incorporate by reference certain statements that are not historical facts, including statements preceded by, followed by or that include the words "may," "believes," "will", "expects," "anticipates," or the negation thereof, or similar expressions, which constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Reform Act"). All statements that address events, transactions or developments that are expected or anticipated to occur in the future are forward-looking statements within the meaning of the Reform Act. Such forward-looking statements involve risks, uncertainties and other factors that may cause the actual performance or achievements of Amicus to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. For those statements, Amicus claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. Amicus will not undertake and specifically declines any obligation to publicly release the result of any revisions that may be made to any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.
Spine Wave Receives FDA Clearance for CapSure™ PS Pedicle Screw System; U.S. Sales Force Expansion Underway to Support Product Portfolio
Shelton, CT – April 17, 2007
Spine Wave, Inc., a company that develops and markets
innovative spinal surgical solutions, announced it has received FDA 510(k) clearance to
market its CapSure™ PS Spine System. The CapSure™ PS pedicle screw system will complement the Company’s StaXx® XD expandable PEEK spacer, which has also received 510(k) clearance. The Company is initiating a limited release of the CapSure™ PS System during the second quarter of 2007 and anticipates a broader market release of both products by the end of 2007.
Mark LoGuidice, Chairman and Chief Executive Officer, commented: “The CapSure™ PS System has a strong intellectual property position and a unique design which allows it
to maintain maximum polyaxial angulation even when the screw is fully seated into the
pedicle. Our innovative product portfolio, which also includes the recently cleared StaXx® FX System - a new means for treating vertebral compression fractures - and the NuCore™ Injectable Nucleus, has allowed us to recruit a very strong sales management
team which has already begun to build the foundation for a world-class sales
organization.” The sales management team is led by three executives: Nick Lake, Vice
President of Sales; Jim Skinner, Vice President of Sales Development; and Ed Traurig, Vice President of Market Development.
“With three new products and a recently announced $45 million financing, we can aggressively pursue rapid sales team expansion,” said Nick Lake. “Our goal is to build a
strong, technically-oriented sales team that provides first class customer service.”
About Spine Wave
Spine Wave is focused on the development of clinical solutions for three of the largest and fastest growing spinal market segments: nuclear replacement and augmentation, vertebral compression fracture repair and spinal fusion. The Company’s product portfolio includes the NuCoreTM Injectable Nucleus, the StaXx® FX Structural Kyphoplasty System, the StaXx® XD Expandable Device, the
CapSure™ PS Spine System and several additional products in development. For further
information, visit the Company’s website at www.spinewave.com.
Spine Wave Receives FDA Clearance for the StaXx® FX Structural Kyphoplasty System
Shelton, CT – April 16, 2007
Spine Wave, Inc., a company that develops and markets
innovative spinal surgical solutions, announced it has received FDA 510(k) clearance to
market its StaXx® FX Structural Kyphoplasty System for the treatment of vertebral compression fractures. The StaXx® FX System features innovative PEEK wafers which
are stacked in situ to simultaneously distract and support the fractured vertebral body.
The minimally invasive system is designed to provide pain relief and a controlled vertical
fracture reduction.
Mark LoGuidice, Chairman and Chief Executive Officer of Spine Wave, ommented: “The FDA’s clearance of the StaXx® FX System is a key milestone for Spine Wave. This allows us to enter a large, rapidly growing market with a very promising and highly differentiated technology. As one of three major products we will bring to the U.S. market in 2007, the StaXx® FX System will play a pivotal role in helping us to attract and build a world class direct US sales organization.”
“I have been working closely with the Spine Wave engineers on the development of this technology for several years,” stated Harvinder Sandhu, M.D., of the Hospital for Special Surgery in New York. “The system has performed well in extensive laboratory tests. In addition, the European clinical results have been very encouraging. I believe the StaXx® FX System will prove to be a tool which will allow physicians to provide immediate pain relief and meaningful sagittal correction when treating patients with vertebral compression fractures.”Dr. Marie-Helene Plais, newly elected Spine Wave Director and investor in the Company’s Series D Financing, noted, “The proprietary technologies across the Spine Wave product portfolio represent an exciting investment opportunity for our fund. Combined with a management team that is both experienced in thespinal industry and seasoned as leaders, the Company’s focus on innovation is well positioned for the betterment of spinal patients.”
Spine Wave will begin a controlled release of the StaXx® FX System during the second quarter of 2007. Physician training will be the focus throughout the remainder of 2007 with a market launch expected later in the year. About Spine Wave
Spine Wave is focused on the development of clinical solutions for three of the largest and fastest growing spinal market segments: nuclear replacement and augmentation, vertebral compression fracture repair and spinal fusion. The Company’s product portfolio includes the NuCoreTM Injectable Nucleus, the StaXx® FX Fracture Repair System, the StaXx® XD Expandable Device, the CapSure™ PS Spine System and several additional products in development. For further information, visit the Company’s website at www.spinewave.com.
Spine Wave Closes $45 Million Financing; Device Company to Expand Sales Force, Product Development and Clinical Trials
Shelton, CT – April 10, 2007
Spine Wave, Inc., a company focused on the
development and marketing of innovative spinal surgery solutions, today announced the
completion of a new $45 million round of equity financing. The Series D round was led
by the Compass Global Fund, LTD, an investment fund of the Cotrel family, along with a syndicate of individuals led by and including Ron Pickard.
Dr. Yves Cotrel, in addition to leading this investment, is one of the pioneers of modern
scoliosis surgery. His company, Sofamor, merged with the former Danek to become Sofamor Danek in 1993, creating what became the world’s leading spinal implant company. His daughter, Dr. Marie-Helene Plais, served as President of Sofamor Danek
Europe and has joined the Spine Wave Board coincident with this financing.
Ron Pickard is a current Spine Wave Board member and is the former Chairman and
CEO of Sofamor Danek. The majority of the balance of new funds was invested by Jerry
Elliott, the former CEO of Global Signal who recently joined the Spine Wave Board of
Directors and who serves as the Company’s Audit Committee Chairman.
Also participating in the financing were existing investors New Enterprise Associates,
Sprout Capital, Canaan Partners, Thoma Cressey Equity Partners, CHL Medical Partners,
Morgenthaler Venture Partners, Foundation Medical Partners, and California Technology Partners. The lead investment fund, Compass Global Fund, LTD, is managed by Compass Financial Advisors, LLC.
“It is a great privilege to be reunited with the Cotrels as we strive to bring truly unique and meaningful technologies to spinal surgeons,” commented Ron Pickard. “The Spine Wave Board of Directors welcomes Dr. Plais and looks forward to benefiting from her significant industry knowledge and global business experience.”
“2007 will be a transformational year for Spine Wave as we commercialize multiple
products both in the U.S. and Europe,” said Mark LoGuidice, Chairman and Chief
Executive Officer of Spine Wave. “This financing will allow us to continue to build our
direct U.S. sales force, establish a global distribution presence and rapidly expand our
product development, marketing and clinical teams.”
Dr. Marie-Helene Plais, newly elected Spine Wave Director and investor in the
Company’s Series D Financing, noted, “The proprietary technologies across the Spine
Wave product portfolio represent an exciting investment opportunity for our fund.
Combined with a management team that is both experienced in the spinal industry and
seasoned as leaders, the Company’s focus on innovation is well positioned for the
betterment of spinal patients.”
About Spine Wave
Spine Wave is focused on the development of clinical solutions for three of the largest
and fastest growing spinal market segments: nuclear replacement and augmentation,
vertebral compression fracture repair and spinal fusion. The Company’s product
portfolio includes the NuCoreTM Injectable Nucleus, the StaXx® FX Fracture Repair
System, the StaXx® XD Expandable Device, the CapSure™ PS Spine System and several
additional products in development. For further information, visit the Company’s
website at www.spinewave.com.
Amicus Therapeutics Files For Initial Public Offering
Cranbury, NJ – March 30, 2007
Amicus Therapeutics, Inc. today announced that it has filed a registration statement with the Securities and Exchange Commission (SEC) relating to the proposed initial public offering of shares of its common stock. All shares in the offering will be sold by Amicus Therapeutics.
The underwriters for the offering are led by Morgan Stanley & Co. Incorporated and Merrill Lynch & Co., as joint book-runners, with J.P. Morgan Securities Inc., Lazard Capital Markets LLC, and Pacific Growth Equities, LLC acting as co-managers. The number of shares to be offered and the price range for the offering have not yet been determined.
A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. When available, a preliminary prospectus may be obtained by contacting Morgan Stanley & Co. Incorporated, 180 Varick Street, New York, New York 10014, attention: Prospectus Department, or by e-mailing prospectus@morganstanley.com or Merrill Lynch & Co., 4 World Financial Center, New York, New York 10080.
About Amicus Therapeutics
Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules that selectively bind to and stabilize proteins in cells, leading to improved protein folding and trafficking, and increased activity. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus is currently conducting Phase 2 clinical trials of Amigal(TM) for the treatment of Fabry disease and Plicera(TM) for the treatment of Gaucher disease. The company is currently conducting Phase 1 clinical trials of AT2220 for the treatment of Pompe disease.
Safe Harbor Statement
This press release may contain or incorporate by reference certain statements that are not historical facts, including statements preceded by, followed by or that include the words "may," "believes," "will", "expects," "anticipates," or the negation thereof, or similar expressions, which constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Reform Act"). All statements that address events, transactions or developments that are expected or anticipated to occur in the future are forward-looking statements within the meaning of the Reform Act. Such forward-looking statements involve risks, uncertainties and other factors that may cause the actual performance or achievements of Amicus to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. For those statements, Amicus claims the protection of the safe harbor for forward-looking statements contained in the Reform Act. Amicus will not undertake and specifically declines any obligation to publicly release the result of any revisions that may be made to any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.
VaxInnate Appoints David Taylor, MD as Chief Medical Officer;
Dr. Taylor's Extensive Experience in Infectious Disease and Vaccine Research Will Support Advancement of Avian and Seasonal Influenza, Malaria Vaccines
Cranbury, NJ – March 23, 2007
VaxInnate announced today the appointment of David N. Taylor, MD as Chief Medical Officer (CMO). Formerly CMO and VP, Medical Affairs for Salix Pharmaceuticals, Dr. Taylor is an internationally-recognized authority in infectious disease and vaccine research, and brings to VaxInnate over 22 years of expertise gained from his distinguished service with the U.S. military. As VaxInnate CMO, Dr. Taylor will oversee all clinical and medical operations of the company as it advances the development of its vaccines for human and avian flu, malaria, and other prophylactic and therapeutic applications.
"David is joining VaxInnate at a pivotal time in the evolution of vaccine development, and a particularly exciting time at VaxInnate. Using recombinant DNA techniques to develop vaccines for seasonal and pandemic flu, and also malaria, VaxInnate has the potential to help tackle several key issues facing the clinical and public health communities," said Alan Shaw, President and CEO of VaxInnate. "We expect David's expertise in infectious diseases will add tremendous value to our vaccine programs as we complete pre-clinical research and prepare to advance our human and avian flu vaccine candidates through clinical trials and to market."
As CMO, Dr. Taylor will provide the clinical insight and expertise in the vaccine and infectious disease fields to advance and elevate the use of the company's TLR technology platform to produce vaccines by simple, low-cost, highly-scalable recombinant DNA techniques. The company's TLR technology enhances the immunogenicity of a series of antigens, which can be combined into a number of different influenza products. In addition, the manufacturing process for such vaccines is clean, highly efficient and scalable, and helps to avoid the pitfalls of egg-based or cell-culture influenza vaccine production.
"VaxInnate is in a position to positively impact public health through breakthroughs in vaccine development and manufacturing, so it is certainly an exciting opportunity to be able to actively drive the development of the company's vaccine programs," said Dr. Taylor. "VaxInnate's proprietary technology has the potential to dramatically improve the vaccine and infectious disease landscapes in terms of both potency and production capabilities for the national and international communities. Joining VaxInnate is a natural fit for me, as my career path in both medicine and public service aligns well with the company's goal to meet urgent public health needs."
Prior to his role at Salix Pharmaceuticals, Dr. Taylor served as Research Professor in the Department of International Health at Johns Hopkins School of Public Health. During his career with the U.S. Public Health Service and U.S. Army, he served in a number of positions in the Division of Communicable Diseases and Immunology at the Walter Reed Army Institute of Research (WRAIR), including acting Division Director, Clinical Director, Department of Enteric Infections, as well as founder and first Chief of the Department of Clinical Trials. Dr. Taylor also served at the Armed Forces Research Institute of Medical Sciences in Bangkok, Thailand, and was Director of the Cholera Vaccine Project at the Naval Medical Research Institute detachment in Lima, Peru. Dr. Taylor has authored over 200 publications, and received his medical degree from Harvard Medical School.
About VaxInnate
VaxInnate is a privately-held biotechnology company focused on developing novel, proprietary vaccines for both pandemic and seasonal influenza. The company's Toll-like receptor (TLR) technology platform allows for genetic engineering of the vaccines using recombinant DNA techniques. This technology physically links TLR agonists to vaccine antigens, which allows the conjugated vaccine to trigger an adaptive immune response. VaxInnate is using its TLR platform technology to enhance the immunogenicity of a series of antigens which will be combined into a number of different influenza products. The technology platform is also being investigated for development of vaccines for other diseases. For more information on VaxInnate, please visit www.vaxinnate.com.
Ascend Health Raises $20.1 Million Series B Financing;
New Funds to Accelerate Development of De Novo Psychiatric Hospitals in Markets with Significant Psychiatric Bed Need
New York, NY – March 26, 2007
Ascend Health Corporation, an operator of mental health and chemical dependency hospitals and residential treatment centers, today announced the closing of a $20.1 million Series B financing. The Company intends to use the proceeds to fund the development of new psychiatric hospitals. New investor Polaris Venture Partners led the round and was joined by existing investors CHL Medical Partners, Three Arch Partners and individual investors. In connection with the closing, Brian Chee, General Partner at Polaris Venture Partners, will join Ascend Health's board of directors.
“Ascend is well positioned to respond to markets with significant needs for additional psychiatric treatment facilities,” stated Mr. Chee. “Dr. Kresch and his management team have shown an ability to identify markets with unmet demand and to respond to that demand with facilities that provide not only general adult and adolescent psychiatric services, but programs that match the particular needs of the community.”
“As a seed and now repeat investor in Ascend, we are most pleased and impressed with the Company's accomplishments to date, including opening its first start-up hospital and achieving profitability for its first full year,” said Jeff Collinson, Managing Partner of CHL Medical Partners. Mark Wan, a Founding Partner of Three Arch Partners, added, “We expect the early successes will continue and are looking forward to the opening of the three new facilities Richard and his team have identified.”
“We're extremely excited about the addition of Polaris as a strategic partner,” stated Richard Kresch, M.D., President and CEO. “This new capital will allow the Company to accelerate the rollout of our innovative business model and delivery of much needed psychiatric care to patients in underserved markets across the country.”
About Ascend Health
Ascend Health Corporation is a provider of behavioral healthcare services in the United States offering inpatient care as well as a full range of outpatient services. The Company operates freestanding psychiatric facilities and provides a variety of behavioral healthcare services and programs to children, adolescents, and adults. For more information, see www.ascendhealth.net.
Amicus Therapeutics Presents Positive Results from Phase 1 Clinical Studies of
Plicera™ for Gaucher Disease;
Phase 2 Clinical Trials Initiated
Cranbury, NJ – March 21, 2007
Amicus Therapeutics, a biopharmaceutical company developing small molecule, orally-administered pharmacological chaperones for the treatment of a range of human genetic diseases, announced today that it will present positive results from its recently completed Phase 1 clinical studies of Plicera™ (isofagomine tartrate, AT2101) for Gaucher disease at the American College of Medical Genetics (ACMG) Annual Meeting on March 21-25 in Nashville, TN. The Phase 1 results show that Plicera was well-tolerated and that oral administration resulted in a significant elevation of target enzyme levels in healthy volunteers. Based on these results, Amicus announced today the initiation of two Phase 2 clinical trials of Plicera for Gaucher disease.
Plicera is designed to selectively bind to and stabilize GCase, the enzyme deficient in Gaucher disease. This deficiency leads to lysosomal accumulation of glucocerebroside inside certain cells, which is believed to cause the various symptoms of Gaucher disease. Plicera facilitates proper trafficking of the enzyme to the lysosomes, the compartments in the cell where it is needed to break down glucocerebroside.
Phase 1 Plicera data being presented at ACMG
Two double-blind, placebo-controlled, dose escalation Phase 1 studies in healthy volunteers were completed. These studies were designed to evaluate the safety, tolerability and pharmacokinetics of Plicera. In the first study, 36 subjects received a single dose of one of five dose levels of Plicera. The second study was a multiple-dose study in which 18 subjects received one of three dose levels of Plicera once daily for 7 consecutive days. In both studies, Plicera was safe and well tolerated at all doses. There were no serious adverse events and no subjects withdrew or discontinued due to an adverse event. In the multiple-dose study, a dose-dependent increase in GCase levels was observed in white blood cells from healthy volunteers receiving Plicera.
Phase 2 Clinical Trials of Plicera in Gaucher Disease
Based on the Phase 1 results, Amicus has initiated two Phase 2 clinical trials of Plicera for Gaucher disease. One is a 4-week study designed to evaluate the safety and pharmacodynamic effects of Plicera in Type I Gaucher patients who will discontinue enzyme replacement therapy for the duration of the study. The second is a 6-month study designed to evaluate the safety of Plicera and its effect on parameters that are commonly abnormal in Gaucher disease. This study will be conducted in Type I Gaucher patients who have never received enzyme replacement therapy. More information regarding these studies can be found at www.clinicaltrials.gov and www.amicustherapeutics.com.
About Gaucher Disease
Gaucher disease, the most commonly diagnosed lysosomal storage disorder, is caused by inherited genetic mutations in the GBA gene, which result in deficient activity of the enzyme acid ß-glucosidase, also known as glucocerebrosidase (GCase). Deficient GCase activity leads to lysosomal accumulation of glucocerebroside inside certain cells, which is believed to cause the various symptoms of Gaucher disease, including an enlarged liver and spleen, abnormally low levels of red blood cells and platelets and skeletal complications. In some cases there is significant impairment of the central nervous system. Gaucher disease affects an estimated 8,000 to 10,000 people worldwide. The U.S. Food and Drug Administration's Office of Orphan Products Development has granted orphan drug designation for the active ingredient in Plicera in the United States.
About Amicus Therapeutics
Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules that selectively bind to and stabilize proteins in cells, leading to improved protein folding and trafficking, and increased activity. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus is currently conducting Phase 2 clinical trials for its two lead compounds, Amigal™ for Fabry disease, and Plicera™ for Gaucher disease. The company is currently conducting Phase 1 trials with AT2220 for the treatment of Pompe disease.
Amicus Therapeutics Presents Preclinical Data from Studies of
Plicera™ for Gaucher Disease;
Studies Show Increased Enzyme Levels in Two Most Common Mutations
Cranbury, NJ – March 20, 2007
Amicus Therapeutics, a biopharmaceutical company developing small molecule, orally-administered pharmacological chaperones for the treatment of a range of human genetic diseases, announced today that it will present the results of preclinical studies of Plicera™ (isofagomine tartrate, AT2101) for Gaucher disease at the American College of Medical Genetics (ACMG) annual meeting March 21-25 in Nashville, TN. The data demonstrate the ability of Plicera to increase levels of the target enzyme in cells derived from a patient with the N370S mutation and in mice that express the L444P mutation. The N370S and the L444P are the two most common mutations associated with Gaucher disease. Additional data from both studies will also be presented.
Plicera is designed to selectively bind to and stabilize GCase, the enzyme deficient in Gaucher disease. This deficiency leads to lysosomal accumulation of glucocerebroside inside certain cells, which is believed to cause the various symptoms of Gaucher disease. Plicera facilitates proper trafficking of the enzyme to the lysosomes, the compartments in the cell where it is needed to break down glucocerebroside.
The following is a summary of the preclinical Plicera data being presented at ACMG.
- In vitro exposure to Plicera increased transport of GCase to the lysosomes in cells derived from a patient with the N370S mutation. Once in the lysosome, the enzyme was stable and active for more than 3 days after Plicera was removed. The N370S is the most common mutation associated with Gaucher disease in the Western world. These studies were published in the September 12, 2006 issue of the Proceedings of the National Academy of Sciences (PNAS).
- Oral administration of Plicera resulted in a dose-dependent increase of GCase levels in various tissues, including the brain, in mice genetically modified to produce the L444P form of the enzyme. In addition, liver and spleen weights were decreased as were plasma levels of chitin III and IgG, which are biomarkers related to Gaucher disease. The L444P is one of the most common mutations associated with Gaucher disease. Gaucher patients with two copies of this mutation typically have neurological symptoms in addition to the visceral symptoms seen in Type I Gaucher disease.
About Gaucher Disease
Gaucher disease, the most commonly diagnosed lysosomal storage disorder, is caused by inherited genetic mutations in the GBA gene, which result in deficient activity of the enzyme acid ß-glucosidase, also known as glucocerebrosidase (GCase). Deficient GCase activity leads to lysosomal accumulation of glucocerebroside inside certain cells, which is believed to cause the various symptoms of Gaucher disease, including an enlarged liver and spleen, abnormally low levels of red blood cells and platelets and skeletal complications. In some cases there is significant impairment of the central nervous system. Gaucher disease affects an estimated 8,000 to 10,000 people worldwide. The U.S. Food and Drug Administration's Office of Orphan Products Development has granted orphan drug designation for the active ingredient in Plicera in the United States.
About Amicus Therapeutics
Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules that selectively bind to and stabilize proteins in cells, leading to improved protein folding and trafficking, and increased activity. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus is currently conducting Phase 2 clinical trials for its two lead compounds, Amigal™ for Fabry disease, and Plicera™ for Gaucher disease. The company is currently conducting Phase 1 trials with AT2220 for the treatment of Pompe disease.
Amicus Therapeutics Presents Data from Preclinical and Phase 1 Studies of Amigal™ for Fabry Disease;
Studies in Mice Show Reduction of Enzyme Substrate
Cranbury, NJ – March 19, 2007
Amicus Therapeutics, a biopharmaceutical company developing small-molecule, orally administered pharmacological chaperones for the treatment of human genetic diseases, announced today that the Company will present results from studies of Amigal™ (migalastat hydrochloride, AT1001), Amicus' compound in development for the treatment of Fabry disease, at the American College of Medical Genetics (ACMG) Annual Meeting from March 21-25 in Nashville, TN. This presentation will include the first data from the Company demonstrating the reduction of globotriaosylceramide (GL-3), the lipid substrate that accumulates in Fabry disease, after oral administration of a pharmacological chaperone. These data were not available at the time of abstract submission but will be included in the presentation at the meeting.
Amigal is designed to selectively bind to and stabilize a-galactosidase A (a-GAL), the enzyme deficient in Fabry disease. This deficiency leads to lysosomal accumulation of GL-3, which is believed to cause the various symptoms of Fabry disease. Amigal facilitates proper trafficking of the enzyme to the lysosomes, the compartments in the cell where it is needed to break down GL-3.
At the ACMG meeting, Amicus scientists will present data from several studies that examined the in vitro and in vivo effects of Amigal in cell lines, mice and healthy volunteers. Among the key findings:
- In vitro exposure to Amigal increased the level of a-GAL in cells derived from healthy volunteers and from Fabry patients.
- Oral administration of Amigal resulted in a dose-dependent increase in a-GAL levels in various tissues of normal mice and Fabry mice genetically modified to produce a-GAL with a human missense mutation.
- Oral administration of Amigal to healthy volunteers in a Phase 1 clinical study resulted in a dose-dependent increase of a-GAL levels in white blood cells.
- Oral administration of Amigal significantly decreased the level of GL-3 in the skin and heart of Fabry mice and showed a trend towards reduction in the kidney.
About Fabry Disease
Fabry disease is a lysosomal storage disorder caused by inherited genetic mutations in the GLA gene, which result in deficient activity of the enzyme a-galactosidase A (a-GAL). Deficient a-GAL activity leads to lysosomal accumulation of globotriaosylceramide (GL-3), which is believed to cause the various symptoms of Fabry disease, including pain, kidney failure and increased risk of heart attack and stroke. Fabry disease is estimated to affect approximately 5,000 to 10,000 people in the developed world, but recent evidence suggests that the disease may be significantly underdiagnosed. The U.S. Food and Drug Administration's Office of Orphan Products Development has granted orphan designation for Amigal in the United States, and the European Commission has designated Amigal as an orphan medicinal product in the European Union.
About Amicus Therapeutics
Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules that selectively bind to and stabilize proteins in cells, leading to improved protein folding and trafficking, and increased activity. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus is currently conducting Phase 2 clinical trials for its two lead compounds, AmigalTM for Fabry disease, and AT2101 for Gaucher disease. The company is currently conducting Phase 1 trials with AT2220 for the treatment of Pompe disease.
Amicus Therapeutics Completes Phase 2 Enrollment
or Amigal™ for Fabry Disease
Cranbury, NJ – March 16, 2007
Amicus Therapeutics, a biopharmaceutical company developing small-molecule, orally administered pharmacological chaperones for the treatment of human genetic diseases, announced today that enrollment has been completed for all ongoing Phase 2 clinical trials of Amigal™ (migalastat hydrochloride, AT1001). Amigal is in development for the treatment of Fabry disease.
The four open-label, multi-national Phase 2 trials are examining various dose levels and frequencies of Amigal in men and women with Fabry disease. The primary objective of the studies is to evaluate the safety and tolerability of treatment with Amigal. The secondary objective is to evaluate certain pharmacodynamic measures of treatment, including effects on a-galactosidase A (a-GAL) and globotriaosylceramide (GL-3) levels in various cells and tissues of disease. An additional objective is the preliminary assessment of cardiac, renal and central nervous system function. The results of these clinical trials are expected to be available by the end of 2007.
Amigal is designed to selectively bind to and stabilize a-GAL, the enzyme deficient in Fabry disease. This deficiency leads to lysosomal accumulation of GL-3, which is believed to cause the various symptoms of Fabry disease. Amigal facilitates proper trafficking of the enzyme to the lysosomes, the compartments in the cell where it is needed to break down GL-3.
About Fabry Disease
Fabry disease is a lysosomal storage disorder caused by inherited genetic mutations in the GLA gene, which result in deficient activity of the enzyme a-galactosidase A (a-GAL). Deficient a-GAL activity leads to lysosomal accumulation of globotriaosylceramide (GL-3), which is believed to cause the various symptoms of Fabry disease, including pain, kidney failure and increased risk of heart attack and stroke. Fabry disease is estimated to affect approximately 5,000 to 10,000 people in the developed world, but recent evidence suggests that the disease may be significantly underdiagnosed. The U.S. Food and Drug Administration's Office of Orphan Products Development has granted orphan designation for Amigal in the United States, and the European Commission has designated Amigal as an orphan medicinal product in the European Union.
About Amicus Therapeutics
Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules that selectively bind to and stabilize proteins in cells, leading to improved protein folding and trafficking, and increased activity. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus is currently conducting Phase 2 clinical trials for its two lead compounds, Amigal™ for Fabry disease, and AT2101 for Gaucher disease. The company is currently conducting Phase 1 trials with AT2220 for the treatment of Pompe disease.
POINT Biomedical Appoints Thomas L. Feldman as Chief Executive Officer
San Carlos, CA – March 12, 2007
POINT Biomedical Corp. announced today that Thomas L. Feldman has joined POINT as President, Chief Executive Officer, and Member of the Board of Directors. “We are delighted that Tom has joined POINT. Tom is well qualified to lead POINT through FDA approval and commercialization of our lead product, CARDIOsphere®, as well as development of our other exciting pipeline products,” said Jon Saxe, Chairman of the Board of Directors.
“I was attracted to POINT's near-term market opportunity to commercialize CARDIOsphere,” said Tom Feldman. Mr. Feldman continued, “CARDIOsphere is designed to enable cardiologists to perform a low-cost, patient-friendly, non-radioactive office procedure to detect coronary artery blood flow. We believe, once approved, cardiologists will be eager to use CARDIOsphere because of its expected advantages to patients over current technologies.”
Mr. Feldman has over 30 years of pharmaceutical industry experience. Prior to joining POINT, Mr. Feldman was President and Chief Business Officer at COTHERIX, Inc. from 2004-2006. He was instrumental in launching that company's first product, completing its initial public offering, and negotiating the acquisition of the company by Actelion earlier this year. From 1995-2002 he was Vice President of Sales and Marketing at Scios, Inc. where he directed the successful launch of a new cardiovascular drug that led to the acquisition of Scios by Johnson & Johnson in 2002 for $2.4 billion. Mr. Feldman started his career in sales and marketing with Johnson and Johnson in 1973 and held numerous senior management positions at McNeil Pharmaceutical and Ortho Pharmaceutical. He is a graduate of North Dakota State University.
About POINT Biomedical
POINT Biomedical is developing novel technology platforms for imaging applications. The lead product, CARDIOsphere, is an ultrasound-imaging agent for assessing myocardial perfusion. It is currently in advanced clinical testing in the United States. Depending upon the outcome of the Phase 3 trials, CARDIOsphere could allow a cardiologist to determine the state of a patient's coronary artery circulation in the office setting, without the use of radioactive isotopes.
The matters discussed in this press release are forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties. The receipt of regulatory approvals, results of product development programs, and clinical efficacy of and market demand for products, among other matters, may differ significantly from the discussion of such matters in the forward-looking statements.
Ivrea Pharmaceuticals Announces Successful In Vitro Nail Penetration Results with IVR 101 and IVR 102
Quincy, MA – February 2, 2007
Ivrea Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company focused on developing and commercializing novel treatments for dermatologic conditions, announced today that its proprietary gels, IVR 101 and IVR 102, were successful in delivering fungicidal active ingredients efficiently through the human nail in a standard model.
“The Ivrea team is very encouraged that IVR 101 and IVR 102 have been shown, in this study, to deliver such high concentrations of known fungicidals through the nail,” said Dan Lynch, Ivrea's CEO. “With these results, coupled with the recently completed enrollment of our Phase II clinical trial, we remain optimistic that the combination of our proprietary gels with known highly-active fungicidal ingredients will allow Ivrea to create unique prescription products that offer an unparalleled combination of efficacy, safety and convenience for the treatment of onychomycosis.”
Ivrea, using IVR 101 and IVR 102, seeks to achieve the efficacy of oral medications and the safety of topical applications for the successful treatment of onychomycosis. IVR 101 and IVR 102 are topically applied gels which deliver active ingredients efficiently through the nail to the site of the fungal infection without the build-up of layers of lacquer on the nail, and with less likelihood of irritation.
The well-known fungicidal allylamines terbinafine and naftifine were each studied at 2% and 6% concentrations to determine the in vitro penetration and permeation through human cadaver nails. The following data are expressed as the mean +/- the standard deviation. The 21–day cumulative penetration (measured in micrograms) of terbinafine was 26.8 +/- 9.7, and 46.6 +/- 20.3. for the 2% and 6 % formulations respectively. The corresponding values for the naftifine 2% and 6% formulations were respectively, 26.0 +/- 11.7 and 38.6 +/- 11.3. The levels of the allylamines within the nail at day 21 (measured in micrograms/milligram) were 0.17 +/- 0.05 and 1.01 +/- 0.01 for the 2% and 6% terbinafine formulations, respectively. The corresponding values for the naftifine 2% and 6% formulations were 0.26 +/- 0.18 and 0.57 +/- 0.18.
The data suggest that the mean fungicidal concentrations, for each active ingredient at both the 2% and 6% concentrations, have been significantly exceeded, both in the nail, in a freely available form, and beneath the nail.
About Ivrea
Ivrea is a specialty pharmaceutical company focused on clinical development and commercialization of novel prescription pharmaceuticals for the treatment of dermatologic conditions. The company currently has two programs in clinical trials that leverage our proprietary topical delivery technologies: IVR 101/102 which combines our proprietary gels with known fungicidal active ingredients, thus creating unique dermatological prescription products for the treatment of onychomycosis that offer the safety of topical application while simultaneously providing the efficacy associated with oral medications; and IVR 103 which utilizes our proprietary platform technology to reduce the level of irritation associated with all trans retinoic acid (also called tretinoin) while uniquely maintaining efficacy in treating acne. The company's investors include Atlas Venture, Easton Capital, and CHL Medical Partners. For additional information about Ivrea Pharmaceuticals, visit the company's website, www.ivreapharma.com.
Ivrea Pharmaceuticals Appoints Daniel S. Lynch as President and Chief Executive Officer
Quincy, MA – February 1, 2007
Ivrea Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company focused on developing and commercializing novel treatments for dermatologic conditions, announced today the appointment of Daniel S. Lynch as president and chief executive officer.
Mr. Lynch spent nearly five years at ImClone Systems, Inc. as both CFO and CEO. As CEO, Mr. Lynch led ImClone through a significant turnaround, helping to restore the company's reputation and receive FDA approval of ERBITUX® (Cetuximab), an important and novel treatment for cancer patients. As CFO, Mr. Lynch led negotiations with Bristol-Myers Squibb, resulting in one of the most significant Biotech-Big Pharma transactions in history. Prior to ImClone, he held the position of chief financial officer of Derby Cycle Corporation, a private-equity portfolio company. Before that, Mr. Lynch held positions of increasing responsibility in finance at Bristol-Myers Squibb over a fifteen year period. He is a member of the board of directors of U.S. Oncology, Inc.
"Dan brings over 20 years of healthcare leadership to Ivrea including substantial experience in strategy development, operational execution, research & development, business development and finance," said Peter Barrett, of Atlas Venture and chairman of Ivrea's board of directors. "Dan's proven management ability will be invaluable as we take Ivrea to the next stage of development and leverage our proprietary technology."
"Ivrea is poised to make significant progress in the development of its pipeline of novel dermatologic treatments, including our unique, proprietary gel for the treatment of onychomycosis, a market estimated to be approximately $1.5 billion worldwide," said Lynch. "Ivrea has a combination of great people, truly unique technology, the backing of a superb investor group, unrivaled expertise on our Medical Advisory Board, and the passion to deliver new products to the marketplace."
Mr. Lynch holds an M.B.A. from the Darden Graduate School of Business Administration at the University of Virginia, and a bachelor of arts in mathematics from Wesleyan University.
About Ivrea
Ivrea is a specialty pharmaceutical company focused on clinical development and commercialization of novel prescription pharmaceuticals for the treatment of dermatologic conditions. The company currently has two programs in clinical trials that leverage our proprietary topical delivery technologies: IVR 101/102 which combines our proprietary gels with known fungicidal active ingredients, thus creating unique dermatological prescription products for the treatment of onychomycosis that offer the safety of topical application while simultaneously providing the efficacy associated with oral medications; and IVR 103 which utilizes our proprietary platform technology to reduce the level of irritation associated with all trans retinoic acid (also called tretinoin) while uniquely maintaining efficacy in treating acne. The company's investors include Atlas Venture, Easton Capital, and CHL Medical Partners. For additional information about Ivrea Pharmaceuticals, visit the company's website, www.ivreapharma.com.
Ivrea
Pharmaceuticals Announces Formation of New Medical Advisory Board
Quincy, MA – February 1, 2007
Ivrea Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company focused on developing and commercializing novel treatments for dermatologic conditions, announced today the formation of a new Medical Advisory Board, to be chaired by Seth Orlow, M.D. Ph.D., to counsel it in its drug development efforts. This world class advisory group will provide medical input to the company as it finalizes its clinical and regulatory strategy, thus improving the likelihood innovative treatments will be commercialized.
"Ivrea is fortunate to benefit from the guidance and insights provided by this distinguished group of advisors," commented Dan Lynch, CEO of Ivrea. "All of its members are experts in their respective fields within dermatology and will bring years of experience and perspective to the task of optimizing our development strategies for our products, beginning with our promising gel for the treatment of onychomycosis."
"I am excited to be able to assemble a stellar group of colleagues to assist Ivrea in developing therapies that address our patients' unmet needs. I look forward to working with Dan Lynch and his team to bring on additional MAB members in the near future," said Dr. Orlow.
Members of the new Medical Advisory Board are:
Seth Orlow, M.D. Ph.D., is a co-founder and board member of Ivrea Pharmaceuticals and serves as chairman of the company's Medical Advisory Board. He is chairman of Dermatology and a professor of Dermatology, Cell Biology, and Pediatrics at New York University School of Medicine. A venture partner with Easton Capital Partners, Dr. Orlow currently serves on the boards of Protez Pharmaceuticals and Transave, Inc. He was also a founder of the Anaderm Research Corporation, a privately held drug discovery company acquired by Pfizer. Dr. Orlow has more than 15 years of experience as a consultant to major pharmaceutical companies, biotechnology companies, OTC manufacturers, and private equity firms on early and late stage pre-clinical drug discovery, clinical development, market opportunities, in-licensing, out-licensing, and strategy. He holds an A.B. in Biochemical Sciences from Harvard College and an M.D.-Ph.D. in Molecular Pharmacology from Albert Einstein College of Medicine. Dr. Orlow trained in dermatology at Yale.
Guy Webster, M.D. Ph.D., received his degrees from the University of Pennsylvania and completed residency training in dermatology at New York University. An internationally recognized expert in acne, cutaneous infectious and inflammatory diseases and in the clinical development of dermatologic therapies, Dr. Webster has over 100 publications. Until 2005, he was professor and vice chairman in the department of Dermatology of Jefferson Medical College in Philadelphia where he also directed the clinical trials unit in the evaluation of therapeutics in dermatology. Currently, he is a clinical professor of Dermatology at Jefferson.
Lawrence Eichenfield, M.D., is chief of Pediatric and Adolescent Dermatology at Rady Children's Hospital, San Diego, and professor of Pediatrics and Medicine (Dermatology), at the University of California, San Diego (UCSD) School of Medicine. He earned his medical degree from Mount Sinai School of Medicine, was a pediatric resident and chief resident at Children's Hospital of Philadelphia, and completed dermatology training at the Hospital of the University of Pennsylvania. He is board certified in pediatrics, dermatology and pediatric dermatology. Dr. Eichenfield's clinical interests include atopic dermatitis, acne, laser surgery, and procedural pain control. He has appeared in front of FDA advisory boards and has been a principal investigator in numerous trials of topical and systemic agents for conditions including atopic dermatitis, fungal infections, acne and many others. Dr. Eichenfield serves on the board of the American Academy of Dermatology. He is editor-in-chief of Pediatric Dermatology and has published more than 150 journal articles, chapters and abstracts, and books. About Ivrea
Ivrea is a specialty pharmaceutical company focused on clinical development and commercialization of novel prescription pharmaceuticals for the treatment of dermatologic conditions. The company currently has two programs in clinical trials that leverage our proprietary topical delivery technologies: IVR 101/102 which combines our proprietary gels with known fungicidal active ingredients, thus creating unique dermatological prescription products for the treatment of onychomycosis that offer the safety of topical application while simultaneously providing the efficacy associated with oral medications; and IVR 103 which utilizes our proprietary platform technology to reduce the level of irritation associated with all trans retinoic acid (also called tretinoin) while uniquely maintaining efficacy in treating acne. The company's investors include Atlas Venture, Easton Capital, and CHL Medical Partners. For additional information about Ivrea Pharmaceuticals, visit the company's website, www.ivreapharma.com.
Amicus Therapeutics Receives Grant From Michael J. Fox Foundation for Parkinson's Research
Cranbury, NJ – January 23, 2007
Amicus Therapeutics, a biopharmaceutical company developing small-molecule, orally administered pharmacological chaperones for the treatment of human genetic diseases, announced today that it has received a grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to support research into a new treatment for Parkinson's disease using the Company's pharmacological chaperone technology.
Amicus received the funding under the Therapeutics Development Initiative, MJFF's first funding initiative open exclusively to researchers at biotech and pharmaceutical companies. The program is designed to catalyze and expand industry investment in Parkinson's drug development.
The award will further promising early research at Amicus into a new treatment for Parkinson's and will help the company rapidly advance the evaluation of its compounds in animal models of the disease. This research represents one of several initiatives at Amicus to evaluate new treatments for a broader range of diseases based on pharmacological chaperone technology.
About Michael J. Fox Foundation for Parkinson's Research
Founded in 2000, The Michael J. Fox Foundation for Parkinson's Research is dedicated to ensuring the development of a cure for Parkinson's disease within this decade through an aggressively funded research agenda. The Foundation has funded more than $90 million in research to date, either directly or through partnerships.
About Amicus Therapeutics
Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules to restore or improve biological activity in cells by selectively binding to misfolded proteins caused by genetic mutations. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus is currently conducting Phase 2 clinical trials for its lead compound, Amigal™, for Fabry disease, has completed Phase 1 clinical trials of AT2101 for Gaucher disease and is conducting Phase 1 clinical trials of AT2220 for Pompe disease.
MPSRx Featured in Assisted Living Director; Leading Long-Term Care Provider Adopts Med Management Technology Innovator
Pittsburg, PA – January 16, 2007
When Asbury Communities, Inc., the nation's ninth largest non-profit long-term care provider, decided to find a single-vendor pharmacy solution for all eight of its retirement communities, it conducted a disciplined evaluation of multiple system providers. "I've been involved in pharmacy change-overs before, and this was a very thorough selection process," Susan Boettger RN, administrator of assisted living (licensed for 164) and adult day care at Asbury Methodist Village, a continuing care retirement community in Gaithersburg, Maryland, with a total of 1,400 residents, told ALD. "The system we finally selected has everything we wanted," said Pat Sten, Asbury's director of clinical systems.
Boettger was only at Asbury a short time - she was formerly the administrator of a stand-alone assisted living facility and, earlier, a long term care nurse - when she was appointed to a multi-disciplinary task force in late spring along with Sten and ten others, including representatives from each Asbury community, every level of care, and corporate department heads.
A Request for Proposals was sent to numerous national long term care pharmacy organizations and to Millennium Pharmacy Systems, Inc. (MPSRX), a smaller regional company that was rapidly expanding its operations. Five responses were received - from Continuing Care Rx, Inc. (CCRx), Omnicare, Inc., NeighborCare, Inc. (now a subsidiary of Omnicare), PharMerica, and MPSRX. Starting in early summer each of the competing systems was numerically graded by the task force in four key areas - financial, operational, clinical, and service excellence. This critical evaluation compared the list to three finalists: Omnicare, PharMerica and MPSRX.
Members of the Asbury task force visited communities currently using the systems of the finalists. The visit to Chapel Pointe, a CCRC in Carlisle, Pennsylvania, which began using the MPSRX 360º system since 2005, was decisive. "The other systems sounded good, but they weren't ready," said Boettger.
"The deciding factor was Millennium's technology," Boettger told ALD. "I'm a nurse and I understand the medication management process. Technology is where the rubber meets the road. The MPSRX 360º system is wireless and real-time. It makes the entire process much more efficient, the quality assurance is much better, and the management reports are so much more useful." "It will really reduce or eliminate medication errors," said Sten.
A MPSRX 360º lap-top computer sits on top of the med cart, and a hand-held bar-code scanner brings up the image of the resident, as well as their medication schedule, allergies, and any special diets. "We'll know we have 'the five rights' every nurse is trained to look for - the right resident, the right medication, dosage, time, and route," Sten explained. The resident picture is especially helpful in the assisted living environment in which residents do not where ID bands, said Boettger. The MPSRX 360º system provides alerts to the care staff when follow-up is required or there is an omission in a med pass. "And I'll be able to audit our medication management productivity, look at a particular shift for example and see how long a med pass is taking, or document our one-hour before, one-hour after performance," said Boettger. "And the system will automatically generate the monthly MAR, TAR, and POS audits, freeing up considerable caregiver time."
When a physician changes a resident's prescription, because the system is updated real-time, the pharmacy knows immediately and so does the care staff, and it's recorded in the electronic medical record, said Sten. There is no redundant data entry or faxed prescriptions. "It should be error-free and paperless."
Asbury's rollout of the MPSRX 360º system begins in January at Asbury's Solomons Island, a CCRC in Southern Maryland, and then continues in February at Asbury Village. "We'll take a learning-after-doing approach after Solomon's and apply the lessons-learned in Gaithersburg and so on" until the roll-out to all eight Asbury communities is complete, says Sten.
Michael Gold, Millennium's Senior Vice President of Business Development, told ALD that "A community's implementation of the MPSRX 360 system is usually cost neutral. The fee is a per licensed bed per month charge, but cost is off set by reducing medication waste and eliminating end of month MAR and TAR recaps."
For more information about Millennium Pharmacy Systems, Inc., visit www.mpsrx.com.
Spine Wave Appoints James Skinner To Vice President of Sales Development; Spinal Industry Experience Bolsters Sales Leadership Team
Shelton, CT – January 8, 2007
Spine Wave, Inc., a company focused on the development and marketing of innovative spinal surgery solutions, announced today the appointment of James Skinner as Vice President of U.S. Sales Development. Skinner recently served as Vice President of U.S. Sales and Vice President Strategic Sales Development at NuVasive, Inc. where he was responsible for both building and transitioning that spinal device company’s distribution network to an exclusive sales force. In addition, Skinner’s career has included sales management positions at Sofamor Danek Group where he was recognized for his sales performance leadership, as well as at U.S. Surgical where he began as a sales representative and rose through the ranks to managerial responsibilities.
Mark LoGuidice, Chairman and Chief Executive Officer of Spine Wave, stated, “Jim has earned tremendous respect within the industry as a focused and capable sales executive. Nick Lake, our V.P. of U.S. Sales, and I both had the opportunity to work with Jim at each of U.S. Surgical and Sofamor Danek, and we are thrilled to have him on our team again. 2007 will be a defining year for Spine Wave as we enter the vertebral compression fracture and spinal fusion markets with our StaXxTM FX and StaXxTM XD systems. Jim’s proven track record of sales force development will be a vital component in executing our strategy.”
Skinner’s duties will encompass both sales force and market development while launching the Company’s first commercial products. Skinner stated, “Spine Wave has an exciting portfolio of innovative products and technologies and has begun to build a strong direct sales force. We, as a team, have the unique opportunity to bring these new solutions to spinal surgeons for their patients. I am very eager to join Spine Wave.”
About Spine Wave
Spine Wave, Inc., headquartered in Shelton, Connecticut, is a medical device company focused on the development of clinical solutions for three of the largest and fastest growing spinal market segments: nuclear replacement and augmentation, vertebral compression fracture repair and spinal fusion. The Company’s product portfolio includes the NuCoreTM Injectable Nucleus, the StaXxTM FX Fracture Repair System, the StaXxTM XD Expandable Device and several additional products in development. In February 2006, the Company closed its Series C financing, raising an additional $36.5 million and bringing the total funds raised to date to $90.0 million. For more information, visit www.SpineWave.com.
Spine Wave Board Adds Jerry Elliot, Chief Executive Officer of Global Signal
Shelton, CT – January 5, 2007
Spine Wave, Inc., a company focused on the development and
marketing of innovative spinal surgery solutions, announced today the election of Jerry Elliott to its Board of Directors and to the role of Audit Committee Chairman.
“We are delighted to have Jerry join our Board,” said Mark LoGuidice, Chairman and Chief Executive Officer of Spine Wave." Jerry has a unique mix of operating, financial and legal experience, which he has used to create substantial value in both the public and private markets. His insights will be invaluable as we build the Company in the years to come.”
Mr. Elliott is the CEO, President and a member of the Board of Directors of Global Signal, Inc. (NYSE: GSL), a company providing towers and communication sites to the wireless communications industry. Global Signal is in the process of a merger valued at $5.8B with Crown Castle International. Prior to joining Global Signal, Jerry was President and a member of the Board of Directors of Citizens Communications. Mr. Elliott was also Managing Director in Morgan Stanley’s Media and Communications Investment Banking Group. He received his
B.B.A. in Accounting and Finance and a J.D. from Baylor University, and an L.L.M. in Taxation from New York University School of Law.
"Spine Wave’s management team, with its truly innovative spinal technologies, is well positioned to revolutionize spinal surgery,” said Elliott. “I am excited to begin working with Mark and the Board as the Company brings these technologies to spine surgeons and their patients.”
About Spine Wave
Spine Wave, Inc., headquartered in Shelton, Connecticut, is a medical device company focused on the development of clinical solutions for three of the largest and fastest growing spinal market segments: nuclear replacement and augmentation, vertebral compression fracture repair and spinal fusion. The Company’s product portfolio includes the NuCore™ Injectable Nucleus, the StaXx™ FX Fracture Repair System, the StaXx™ XD Expandable Device, and several additional products in development. For more information, visit Spine Wave’s website at www.spinewave.com.
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