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IndustryWeek -- Abbott Laboratories -- IW 1000 2008 Profile
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Boston Scientific gets FDA approval for new stent (AP)
biz.yahoo.com | Sep 25, 2008
Boston Scientific gets FDA approval for new stent. - NATICK, Mass. (AP) -- Boston Scientific Corp. said Thursday the Food and Drug Administration approved the medical device maker's new Taxus drug-coated stent.
http://biz.yahoo.com/ap/080925/boston_scientific_fda.html?.v=1
Angioplasty for chest pain is no bargain: study
uk.reuters.com | Sep 25, 2008
CHICAGO (Reuters) - People who get surgery to ease chest pain from a blocked heart artery pay $10,000 more for about the same level of relief they can get from taking a combination of pills, U.S. researchers
http://uk.reuters.com/article/healthNews/idUKTRE48N8E120080925?feedType=RSS&feedName=healthNews
$21M settlement ironed out for drug cost lawsuit
www.dailyreportonline.com | Sep 12, 2008
The Daily Report is Fulton County’s official legal organ and Georgia’s leading source for legal news and information. Only the Daily Report offers comprehensive coverage of Georgia’s legal affairs.
Texas settles case against Abbott Labs for $28 million
feeds.bizjournals.com | Sep 9, 2008
The Texas Attorney General’s office has reached a $28 million civil settlement with Abbott Laboratories Inc. over charges that the drug maker falsely reported pharmaceutical prices to Texas and federal Medicaid programs.
http://feeds.bizjournals.com/~r/vertical_36/~3/387879640/daily17.html
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Anesiva Announces Appointment of William Houghton, M.D. as Senior Vice President and Chief Medical
SOUTH SAN FRANCISCO, Calif., Sept 02, 2008 /PRNewswire-FirstCall via COMTEX/ --
Anesiva, Inc. (Nasdaq: ANSV) today announced that William Houghton, M.D. has joined the company as senior vice president and chief medical officer. Dr. Houghton will lead Anesiva's clinical and regulatory functions.
"Bill brings to Anesiva deep commercial and product development expertise with pain management products, and a medical background in anesthesiology," said Mr. Kranda. "He fills a key role as we proceed with the clinical development of Adlea for the management of acute pain following orthopedic surgeries, pursue approval of the adult indication for Zingo, and evaluate strategies to increase the clinical and commercial potential of these products. I also look forward to working with Bill to evaluate opportunities to expand Anesiva's portfolio of pain management products."
Dr. Houghton has more than 20 years of clinical development and regulatory affairs experience. Prior to joining Anesiva, he was chief medical officer of Eleos, Inc., a private company. From 2005 to 2007 he was vice president, clinical and regulatory affairs for Alexza Pharmaceuticals, Inc., where he was responsible for the development and conduct of clinical trials for a novel Fentanyl formulation, among others. From 1998 to 2005, Dr. Houghton was associated with Orphan Medical, Inc., where he directed regulatory and clinical development strategies, and provided scientific support of commercialized products. He began his career in industry with Abbott Laboratories, Inc. in 1984 where he worked until 1995. Most recently, from 1992 to 1995, he was medical director of Abbott's hospital products division, providing medical support to the business units for anesthesia and pain management, including both pharmaceutical and device aspects. Prior to joining industry, Dr. Houghton was a practicing physician in Australia. He received his M.D. degree from the University of Sydney (Australia).
"I am pleased to join Anesiva at this exciting time, with Zingo on the U.S. market for treating pain associated with peripheral venous access procedures in children, and Adlea advancing in clinical development," said Dr. Houghton. "These products form a strong foundation upon which to build a leading pain management franchise."
About Anesiva and its Pipeline of Pain Products
Anesiva, Inc. is a commercial-stage specialty pharmaceutical company that seeks to be a leader in the development and commercialization of novel pharmaceutical products for pain management. The company's first commercial product, Zingo(TM), is available in the U.S. for the reduction of pain associated with peripheral venous access procedures in children ages three to 18. For full Zingo prescribing information and other information, visit http://www.zingo.com. An application is under FDA review to expand the Zingo label indication to include adults.
The next product in Anesiva's pipeline, Adlea(TM), is currently being evaluated in multiple clinical trials for the management of acute pain following orthopedic surgeries. Adlea has been shown in Phase 2 trials to reduce pain after only a single administration for weeks to months in multiple indications for site-specific, acute and chronic, moderate-to-severe pain.
Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development and commercialization of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com.
SOURCE Anesiva, Inc.
http://www.anesiva.com
Tags: appointment australia california career children clinical commercial fda foundation hospital market medical nasdaq pharmaceuticals pipeline president product development products science sydney
Companies: Anesiva Inc (ANSV)
NOTICE OF INTENT TO AWARD - Zibb.com
Aug 11, 2008 (FedBizOpps via COMTEX) --
NOTICE TYPE: Special Notice
DATE POSTED: 08-AUG-08
AGENCY: Department of the Army
OFFICE ADDRESS: WESTERN REGIONAL CONTRACTING OFFICE, ATTN: MCAA W BLDG 9902, 9902 LINCOLN STREET, TACOMA, WA 98431-1110
SUBJECT: Notice of Intent to Award
CLASSIFICATION CODE: 00 - None
SOLICITATION NUMBER: YMECSG82181401
CONTACT: ANGELA DEXTER, 253-968-4912 MAILTO:ANGELA.DEXTER@AMEDD.ARMY.MIL [WESTERN REGIONAL CONTRACTING OFFICE]
SETASIDE: N/A
NOTICE TEXT: Department of the Army U.S. Army Medical Command WESTERN REGIONAL CONTRACTING OFFICE MEDCOM, Western Regional Contracting Office, Tacoma, Washington, intends to award a contract to Abbott Laboratories in amount of $50,000.00 for Vascular Implants products in accordance with FAR Part 6.302.1. The Surgeon has determined that that these products will best meet the patients specific medical needs/requirements. SEE NOTE 22
INTERNET ADDRESS: https://www.fbo.gov/spg/USA/MEDCOM/DADA13/YMECSG82181401/listing.html Provided by Federal Information & News Dispatch, Inc. (FIND) 202-429-5944
253-968-4912
Tags: army contract federal internet medical note products washington
Follica Announces $11M in New Financing and Expanded Team - Zibb.com
BOSTON, Aug 12, 2008 /PRNewswire via COMTEX/ --
Follica Inc., a privately held developer of novel therapies for androgenetic alopecia and other hair follicle disorders, today announced an $11 million Series B financing round. Polaris Venture Partners led the financing and existing investors InterWest Partners and PureTech Ventures participated.
Androgenetic alopecia is male and female pattern hair loss in genetically susceptible men and women.
The company also announced several new additions to its team. Two new members joined the Follica board, including Mr. G. Kirk Raab, former CEO Genentech, COO Abbott, and chairman, Connetics. Mr. Raab will serve as Follica's chairman. The other new board member is Dr. Kevin Bitterman, principal at Polaris Venture Partners. Raab and Bitterman will join existing board members Daphne Zohar, Follica CEO and PureTech Ventures managing partner, and Mr. Chris Ehrlich, general partner, InterWest Partners.
"Polaris is thrilled to join PureTech and InterWest in helping to build Follica," said Bitterman. "The cutting-edge biology on which the company was founded allows Follica to address hair loss and multiple other conditions with an entirely novel mechanism of action. The combination of world-class founders George Cotsarelis, Rox Anderson and Vera Price, and the enormous unmet need in the aesthetic dermatology space make this a tremendously exciting company."
In addition, Dr. Samir Mitragotri of the University of California at Santa Barbara (UCSB), a leading expert in transdermal drug delivery, will join Follica's Scientific Advisory Board. The company also welcomed Mr. Scott Kellogg (formerly of Sontra Medical, Ultracision, and Ethicon Endosurgery) as vice president of operations and promoted Dr. Stephen Prouty (formerly of Johnson & Johnson's skin biology group) to vice president of research.
Follica was co-founded by PureTech Ventures and a group of academic dermatologists from Harvard, UCSF and the University of Pennsylvania to address the critical issue of alopecia. The company recently announced a Series A round of financing in January 2008.
In a paper published in May 2007 in the journal Nature, technology licensed by Follica from the University of Pennsylvania School of Medicine was used to generate completely new hair follicles for the first time in normal adult mammals.
Unlike currently available treatments that attempt to retain or re-activate existing follicles, this technology provides for the first time, the potential to stimulate entirely new hair follicles. New hair follicles that form after disruption function normally, cycle through the normal stages of hair growth and exhibit normal architecture, including a full complement of stem cells.
About Polaris Venture Partners:
A national venture capital firm with over $3 billion under management, Polaris (www.polarisventures.com) invests in seed, early stage and growth equity businesses in the life science, technology, digital media, enertech and consumer sectors. Through a philosophy of lead investing and active, long-term partnering with entrepreneurs and management teams, Polaris has helped a number of companies achieve outstanding success. Among them are: Accordant Health Services, Acusphere, Advanced Inhalation Research (acquired by Alkermes), Alnylam Pharmaceuticals, Aspect Medical Systems, Cubist Pharmaceuticals, deCODE genetics, GlycoFi (acquired by Merck), Momenta Pharmaceuticals and TransForm Pharmaceuticals (acquired by J&J).
About InterWest Partners
InterWest Partners (www.interwest.com), founded in 1979, is a leading diversified venture capital firm focused on building long-term relationships with entrepreneurs and portfolio companies. Currently investing its tenth fund, IW X, a $650 million fund, InterWest has raised more than $2.8 billion of capital since inception. InterWest has 14 investing partners in Menlo Park, CA and Dallas, TX, who bring together deep domain knowledge in life sciences and information technology. The firm's investments in life sciences include: ArthroCare, Aspreva Pharmaceuticals Corporation (acquired by Galenica group), Cor Therapeutics (acquired by Millennium Pharmaceuticals), Corixa (acquired by GlaxoSmithKlein), Coulter Pharmaceutical (acquired by Corixa Pharmaceuticals), Cubist Pharmaceuticals, Epicor Medical (acquired by St. Jude Medical), Inspire Pharmaceuticals, IntraLase, Myogen, Spinal Dynamics (acquired by Medtronic), TheraSense (acquired by Abbott Labs) and Ventritex (acquired by St. Jude Medical).
About PureTech Ventures
PureTech Ventures (www.puretechventures.com) is a Boston-based venture creation firm specializing in translating breakthrough research from top tier academic institutions into therapies that will impact human health. PureTech's partners include entrepreneurs and leaders from the top echelon of pharma, biotech and academia including Dr. Ronald Cape (founder, Cetus), Dr. Robert Langer (renowned MIT professor), Dr. Frank Douglas (former chief scientific officer, Aventis), Dr. Bennett Shapiro (former EVP worldwide basic and External research, Merck), Dr. John Zabriskie (former CEO Pharmacia & Upjohn), and Daphne Zohar (PureTech founder and managing partner).
About Follica
Follica Inc. (www.follicabio.com), a privately held medical device company, was co-founded by PureTech Ventures and a group of world renowned experts in hair follicle biology and medicine. In addition to hair loss, Follica has intellectual property and development programs in various skin and follicle related indications.
SOURCE Follica Inc.
http://www.follicabio.com
Tags: academic architecture biology biotechnology california ceo consumer dermatology equity genetics health information technology medical medicine men millennium pennsylvania pharmaceuticals president property research science technology venture capital women
WaferGen Announces Second Quarter 2008 Financial Results - Zibb.com
FREMONT, Calif., Aug 13, 2008 /PRNewswire-FirstCall via COMTEX/ --
WaferGen Biosystems, Inc. (OTC Bulletin Board: WGBS), a leading developer of state-of-the-art gene expression, genotyping, cell biology and stem cell research systems, today highlighted the company's recent developments and milestones and announced financial results for the quarter and six months ended June 30, 2008.
Recent Corporate Developments and Milestones:
-- Initiation of alpha testing of WaferGen's SmartChip(TM) Real-Time PCR
System and proprietary oncology gene panel assays by the University of
Pittsburgh Medical School.
-- Close of private placement in the U.S. for a total of $3.6 million to
be used for general corporate purposes including the continued
advancement of the company's SmartChip(TM) Real-Time PCR System, as
well as the expansion of the company's global commercialization
campaign for its SmartSlide(TM) Micro-Incubation System.
-- Initial close of private placement by WaferGen's wholly owned Malaysian
subsidiary, WaferGen Biosystems (M) Sdn. Bhd to Malaysian Technology
Development Corporation Sdn. Bhd for a total of $1 million. An
additional $1 million is contingent on the subsidiary reaching certain
agreed upon milestones. Proceeds will be used to support the
high-volume manufacturing of the company's SmartChip(TM) Real-Time PCR
System in Malaysia.
-- Establishment of exclusive agreements for distribution of WaferGen's
SmartSlide(TM) Micro-Incubation System by leading distributors of
innovative products and services to cell biologists and stem cell
researchers in Switzerland, Taiwan, Germany and the Nordic Region
(Denmark, Sweden, Norway and Finland).
"During the second quarter of this year, we made significant progress in the development of our SmartChip Real-Time PCR System as evidenced by the initiation of alpha testing by Dr. Steven Shapiro and his team at the University of Pittsburgh Medical School," stated Alnoor Shivji, WaferGen's chairman and chief executive officer. "We look forward to working closely with Dr. Shapiro through the alpha testing process, and expect to announce results in the second half of this year."
Second Quarter and Six Month 2008 Financial Results
At June 30, 2008, WaferGen had cash, cash equivalents and marketable securities of $4.3 million, compared to $5.2 million at December 31, 2007. This balance includes the approximately $3.6 million in new financing secured during the quarter.
WaferGen's net revenues were $177,000 for the quarter ended June 30, 2008, compared to $300 for the quarter ended June 30, 2007. For the six months ended June 30, 2008, net revenues were $358,000, compared to $61,000 for the six months ended June 30, 2007. For the quarter and six-month periods, the increases resulted primarily from WaferGen's signing of multiple international SmartSlide distributorships and the expansion of its internal sales team.
Research and development expenses totaled $1.3 million for the quarter ended June 30, 2008, compared to $362,000 for the quarter ended June 30, 2007. Research and development expenses totaled $2.3 million for the six months ended June 30, 2008, compared to $762,000 for the same period of 2007. For the quarter and six-month periods, the increases resulted primarily from an increase in headcount, an increase in research and development materials and supplies used for product development and testing, the company's move to a new facility and associated expenses, and an increase in stock-based compensation associated with the issuance of stock options.
Sales and marketing expenses totaled $296,000 for the quarter ended June 30, 2008, compared to $138,000 for the quarter ended June 30, 2007. Sales and marketing expenses totaled $681,000 for the six months ended June 30, 2008 compared to $290,000 for the six months ended June 30, 2007. For the quarter and the six-month periods, the increases resulted primarily from an increase in stock-based compensation associated with the issuance of stock options, and additional expenses incurred as a result of an increased headcount.
General and administrative expenses totaled $634,000 for the quarter ended June 30, 2008, compared to $384,000 for the quarter ended June 30, 2007. For the six months ended June 30, 2008, general and administrative expenses totaled $1.3 million, compared to $809,000 for the six month period ended June 30, 2007. For the quarter and six-month periods, the increases resulted primarily from an increase in stock-based compensation associated with the issuance of restricted common stock and stock options, additional expenses incurred as a result of an increased headcount, and legal and professional fees.
WaferGen reported a net loss applicable to common stockholders of $2.1 million, or ($0.09) per share, for the quarter ended June 30, 2008, compared to a net loss applicable to common stockholders of $1.0 million, or ($0.10) per share, for the quarter ended June 30, 2007. For the six months ended June 30, 2008, WaferGen reported a net loss applicable to common stockholders of $4.0 million, or ($0.17) per share, compared to a net loss applicable to common stockholders of $2.0 million, or ($0.30) per share in the same period of 2007.
Goals for 2008
During the balance of 2008, WaferGen will continue to work toward the creation of corporate and shareholder value through the achievement of key milestones, including:
-- Completion of SmartChip(TM) alpha testing at University of Pittsburgh
Medical School
-- Initiation of SmartChip(TM) beta testing and collaboration with other
academic and/or genome centers and/or pharmaceutical company
-- Publication/presentation of SmartChip(TM) alpha test results
-- Continued expansion of SmartSlide(TM) worldwide distribution channels
-- Expansion of SmartSlide(TM) distribution through strategic reagent
and/or instrument partners
-- Development and commercialization of one or more new SmartSlide(TM)
applications such as in-vitro fertilization, cancer stem
cell/chemotherapy monitoring, infectious disease monitoring,
bioprocessing
-- Establishment of manufacturing and production in Malaysia
About WaferGen
WaferGen Biosystems Inc. is a leader in the development, manufacture and sale of state-of-the-art systems for gene expression, genotyping, cell biology and stem cell research for the life science and pharmaceutical industries. The company is actively developing its SmartChip(TM) product for the gene expression and genotyping markets. SmartChip(TM) is being developed as the first whole genome, high throughput gene expression real-time polymerase chain reaction (PCR) platform and promises to deliver significant speed and cost advantages to researchers in the gene expression and genotyping markets. WaferGen currently markets its SmartSlide(TM) family of products to companies and organizations involved in stem cell and cell biology research. SmartSlide(TM), which was launched in 2006, represents the first fluidics integrated micro-incubators enabling cell biology and stem cell research. Representative SmartSlide(TM) customers include Harvard University, Mayo Clinic, California Institute of Technology (CalTech), Abbott Labs, and the National Institutes of Health (NIH).
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
This press release contains certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Such statements include statements relating to the company's goals in 2008, the intended use of any proceeds received in the company's financings, the expected timing of any announcement of the results of the alpha testing with Dr. Shapiro and the University of Pittsburg Medical School, and other statements that are not historical facts, including statements which may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. For such statements, the company claims the protection of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the control of the company. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include the risks that: (i) the company may be unsuccessful in commercially developing its products or in achieving market acceptance of new and relatively unproven technologies; (ii) the company will need to raise additional capital to meet its business requirements in the future and the company may not be able to do so on reasonable terms or at all; (iii) the company's proprietary intellectual property rights may not adequately protect its products and technologies; and (iv) the company expects intense competition in its target markets, including from companies that have much greater resources than the company, and there can be no assurance that the company will be able to compete effectively. More detailed information about the company and the risk factors that may affect the realization of forward-looking statements is set forth in the company's filings with the Securities and Exchange Commission, including the company's Quarterly Report on Form 10-Q filed with the SEC on May 15,2008. Investors and security holders are urged to read this document free of charge on the SEC's web site at http://www.sec.gov. The company does not undertake to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Contact:
Vida Communication (on behalf of WaferGen)
Stephanie Diaz (investors) Tim Brons (media)
415-675-7400 415-675-7402
sdiaz@vidacommunication.com tbrons@vidacommunication.com
WAFERGEN BIO-SYSTEMS, INC. AND SUBSIDIARIES
(A Development Stage Company)
Condensed Consolidated Statements of Operations (Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2008 2007 2008 2007
Revenues $176,851 $300 $358,491 $60,760
Cost of sales 57,048 - 132,065 21,774
Gross margin 119,803 300 226,426 38,986
Operating expenses:
Sales and marketing 295,506 137,788 680,680 289,970
Research and
development 1,345,621 361,948 2,298,062 761,706
General and
administrative 633,764 384,495 1,322,807 809,156
Total operating
expenses 2,274,891 884,231 4,301,549 1,860,832
Operating loss (2,155,088) (883,931) (4,075,123) (1,821,846)
Other income and
(expenses):
Interest income 18,064 15,781 49,781 15,781
Interest expense (3,252) (143,724) (7,225) (186,526)
Foreign exchange
(loss) (2,941) - (2,941) -
Total other income
and (expenses) 11,871 (127,943) 39,615 (170,745)
Net loss before
provision for
income taxes (2,143,217) (1,011,874) (4,035,508) (1,992,591)
Provision for income
taxes - - - -
Net loss (2,143,217) (1,011,874) (4,035,508) (1,992,591)
Accretion on Series B
Preferred Stock - (20,799) - (51,998)
Net loss applicable
to common
stockholders $(2,143,217) $(1,032,673) $(4,035,508) (2,044,589)
Net loss per share -
basic and diluted $(0.09) $(0.10) $(0.17) $(0.30)
Shares used to compute
net loss per share -
basic and diluted 23,965,978 10,107,941 23,591,912 6,886,433
WAFERGEN BIO-SYSTEMS, INC. AND SUBSIDIARIES
(A Development Stage Company)
Condensed Consolidated Balance Sheets (Unaudited)
June 30, December 31,
2008 2007
Assets
Current assets:
Cash and cash equivalents $4,257,597 $5,189,858
Accounts receivables 241,620 139,827
Inventories 129,300 62,521
Prepaid expenses and other
current assets 100,375 87,487
Total current assets 4,728,892 5,479,693
Property and equipment, net 829,355 321,159
Other assets 12,788 54,016
Total assets $5,571,035 $5,854,868
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $643,233 $560,641
Accrued rent 30,508 19,340
Accrued payroll 159,576 414,519
Accrued vacation 186,554 156,234
Accrued other expenses 123,684 -
Current portion of capital
lease obligations 72,472 32,443
Total current liabilities 1,216,027 1,183,177
Capital lease obligations,
net of current portion 84,423 73,451
Commitment and contingencies - -
Stockholders' equity :
Preferred Stock, $0.001 par
value; 10,000,000 shares
authorized; no shares issued
and outstanding - -
Common Stock: $0.001 par value;
300,000,000 shares authorized;
24,830,932 shares issued and
outstanding at June 30, 2008
and December 31,2007 24,831 23,218
Additional paid-in capital 20,228,253 16,527,929
Accumulated other comprehensive
income 5,916 -
Accumulated deficit (15,988,415) (11,952,907)
Total stockholders' equity 4,270,585 4,598,240
Total liabilities and
stockholders' equity $5,571,035 $5,854,868
SOURCE WaferGen Biosystems, Inc.
http://www.wafergen.com
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Companies: WaferGen Bio-systems Inc (WGBS)
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