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Alphatec Spine and Cross Medical Products Settle License Agreement Dispute
PrintAlert
Alphatec Holdings, Inc. (MM) (NASDAQ:ATEC)
Intraday Stock Chart
Today : Friday 6 January 2012
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, today announced that it has reached a global settlement agreement of two pending lawsuits. In the first lawsuit, Cross Medical Products, Inc. (a subsidiary of Biomet, Inc.) claimed that Alphatec Spine had breached the April 23, 2003 license agreement with Cross Medical by failing to make certain royalty payments. In the second lawsuit, Alphatec Spine claimed that a subsidiary of Biomet, Inc. EBI, LLC, infringed a patent owned by Alphatec Spine.
Under the terms of the settlement, all parties obtained a release of all claims that were the subject of the disputes. No party has admitted liability in connection with the settlement. The settlement also includes an amendment to the April 23, 2003 License Agreement.
"While we continue to believe in the strength of our position in this dispute, we felt it served the best interests of our stockholders to proactively settle the matter to eliminate ongoing legal costs resulting from the litigation and remove any uncertainty that is inherent in the litigation process," said Dirk Kuyper, President and Chief Executive Officer of Alphatec Spine. "This settlement provides certainty and will allow us to more fully focus our time and resources on executing our 2012 business plan."
As part of the settlement, Alphatec Spine will pay Cross Medical an initial payment of $5 million dollars. In addition to the initial payment, Alphatec Spine shall make thirteen payments of $1 million, with the payments made quarterly, and the first payment being due on August 1, 2012, and each subsequent payment due three months thereafter until the final payment, which is due August 1, 2015, is made. The total cash impact of $18 million will be dispersed in the following amounts: $7 million in 2012, $4 million in 2013, $4 million in 2014 and $3 million in 2015. In addition, pursuant to the settlement, the parties have exchanged covenants not to sue for patent infringement with respect to products that each respective company had on the market as of December 30, 2011.
Conference Call
Alphatec Spine will host a conference call on January 6, 2012 at 6:00 a.m. PT / 9:00 a.m. ET to discuss the settlement. To participate in the conference call, please visit the investor relations section of the Alphatec Spine website at www.alphatecspine.com. The dial-in numbers are (877) 556-5251 for domestic callers and (720) 545-0036 for international. A live webcast of the conference call will be available online from the investor relations section of the Alphatec Spine website at www.alphatecspine.com. The webcast will be recorded and will remain available on the investor relations section of Alphatec Spine's website for at least 30 days.
Great movement and Volume today, can we keep this pig up?
Lots of moderators on this board, damn, think more mods then post this month, lol, think we all should be a mod, lets have the board with the most mods. Haw many can we get. Sheeesh, got to have some fun waiting on the boat to come to dock
AVI BioPharma Receives NASDAQ Notice of Minimum Bid Price Non-Compliance
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Avi Biopharma (NASDAQ:AVII)
Intraday Stock Chart
Today : Wednesday 14 December 2011
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, announced today that it received a letter from the listing qualifications department staff of The NASDAQ Stock Market LLC, notifying AVI that for the last 30 consecutive business days the bid price of its common stock had closed below $1.00 per share, the minimum closing bid price required by the continued listing requirements set forth in Listing Rule 5450(a)(1). The notice has no effect at this time on the listing of AVI's common stock, which will continue to trade under the symbol "AVII."
Pursuant to Listing Rule 5810(c)(3)(A), AVI has 180 calendar days, or until June 11, 2012, to regain compliance with the minimum bid price requirement. If at any time before this date AVI's common stock has a closing bid price of $1.00 or more for a minimum of 10 consecutive business days, NASDAQ staff will notify AVI that it has regained compliance.
If AVI cannot demonstrate compliance with Rule 5450(a)(1) by June 11, 2012, NASDAQ will provide notice to AVI that its securities may be delisted. At that time, AVI may appeal NASDAQ's decision to a Listing Qualifications Panel. Alternatively, AVI may submit an application to transfer its securities to The NASDAQ Capital Market. Following submission of the application, AVI may be eligible for an additional 180-day period to regain compliance with the minimum bid price requirement if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards, with the exception of the bid price requirement, for The NASDAQ Capital Market.
I think it will go back to the 60s, gonna wait to get back in untill then
gl bull, i got lucky, got in last week at 59
up .43 already premarket
By the sound of the tweets, it seems to be going well for us. Fingers staying crossed
THanks, Appreciate it
December 12, 2011: Psychopharmacologic Drugs Advisory Committee Meeting Announcement
Center Date Time Location
CDER December 12, 2011 8:00 a.m. to 5:00 p.m. Marriott Inn and Conference Center
University of Maryland University College (UMUC)
3501 University Blvd. East
Adelphi, Maryland
Telephone: (301) 985-7300
Agenda
On December 12, 2011, the committee will discuss safety and efficacy issues with new drug application (NDA) 022549, ADASUVE (loxapine) inhalation powder, Alexza Pharmaceuticals, Inc., for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Particular issues for discussion are concerns regarding pulmonary safety.
Meeting Materials
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
Background Material
2011 Meeting Materials, Psychopharmacologic Drugs Advisory Committee1
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before November 28, 2011
Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before November 17, 2011.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by November 18, 2011.
Webcast Information
CDER will not be providing a webcast of the December 12, 2011 Psychopharmacologic Drugs Advisory Committee meeting.
Contact Information
Philip A. Bautista, Pharm.D.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, Maryland 20993-0002
Telephone: 301-796-9001
Fax: 301-847-8533
E-mail: PDAC@fda.hhs.gov
FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)
Code: 3014512544
Please call the Information Line for up-to-date information on this meeting
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Philip A. Bautista at (301) 796-9001 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings2 for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).
Interesting day today sice that report, what do u make of it? Hope it keeps going till the EOD
Can this Bounce
why the pre-market big drop, was away 2 days, what happen????
UPDATE: JAL President Sees No Change In Joint Ops With American AirlinesLast update: 12/8/2011 2:47:34 AM-- JAL president shrugs off concerns the bankruptcy protection filing of American Airlines will have a negative impact on cooperation between the two carriers -- JAL president says the airline can help American's restructuring in customer service -- JAL expects delivery of Boeing 787 in February (Recasts, adds comments by JAL president in 4th-9th paragraphs) Yoshio Takahashi OF DOW JONES NEWSWIRES TOKYO (Dow Jones)--The president of Japan Airlines Corp. shrugged off concerns Thursday that the bankruptcy protection filing of American Airlines Inc. will have a negative impact on cooperation between the two carriers, and said American should make a successful comeback. It is unlikely American will reduce or scrap routes between major cities in the U.S. and Japan, as their trans-Pacific business "is generating favorable results," JAL President Masaru Onishi said at a press conference. Both members of the Oneworld alliance, JAL and American jointly operate several trans-Pacific routes, and there should be no change in that cooperation despite the bankruptcy protection filing, he said. The tie-up is a crucial to JAL's rebuilding efforts, with the carrier having filed for Japan's biggest non-financial bankruptcy protection in 2010. JAL operates a total of nine trans-Pacific routes under a joint agreement with American, whose parent AMR Corp. (AMR) filed for bankruptcy protection last week amid stiff cost competition and surging fuel costs. Onishi said there doesn't seem to be much JAL can do to help its U.S. partner, as the focal issue remains talks with American's labor unions to reduce costs. JAL's restructuring, meanwhile, gives it little room to support its partner financially, he said. Still, there are ways JAL can support American, he added. For instance, JAL could help train its flight attendants, Onishi said--an idea endorsed recently retired AMR chairman Gerard Arpey. Onishi also said American Airlines should be able to return to healthy operations under court protection, just as many U.S. carriers have done. Meanwhile, Onishi said he expects the first delivery of the new Boeing 787 in February, slightly later than the previously expected December or January. But the later delivery won't affect JAL's plans to use the jet on a route between Tokyo's Narita Airport and Boston from April, or on three other routes--Narita to Moscow, Narita to New Delhi, and Tokyo's Haneda Airport to Beijng--he said. -By Yoshio Takahashi, Dow Jones Newswires; 813-6269-2791; yoshio.takahashi@dowjones.com (END) Dow Jones NewswiresDecember 08, 2011 02:47 ET (07:47 GMT
JAL Pres:No Change In Joint Ops With American Airlines After AMR Chapter 11 FilingLast update: 12/8/2011 1:01:25 AMTOKYO (Dow Jones)--The president of Japan Airlines Corp. said Thursday that the bankruptcy protection filed by American Airlines Inc.'s parent company won't alter the Japanese carrier's alliance with its U.S. partner. JAL also could help support its struggling U.S. peer in some operations such as customer services, the president said. It is hard to believe that American Airlines will trim or scrap routes to connect major cities between the U.S. and Japan as "their trans-Pacific business is generating favorable results," said JAL President Masaru Onishi at a press conference. JAL operates a total of nine trans-Pacific routes under a joint agreement with American Airlines, whose parent company AMR Corp. (AMR) filed for bankruptcy protection last week amid stiff cost competition and surging fuel expenses. -By Yoshio Takahashi, Dow Jones Newswires; 813-6269-2791; yoshio.takahashi@dowjones.com (END) Dow Jones NewswiresDecember 08, 2011 01:01 ET (06:01 GMT)
Bama, Why did you step down from Mod? You were the best, hope this is just for a short time
Flagstar Completes the Sale of Its Indiana Retail Bank Franchise
PrintAlert
Flagstar Bancorp (NYSE:FBC)
Intraday Stock Chart
Today : Friday 2 December 2011
Flagstar Completes the Sale of Its Indiana Retail Bank Franchise
PR Newswire
TROY, Mich., Dec. 2, 2011
TROY, Mich., Dec. 2, 2011 /PRNewswire/ -- Flagstar Bancorp (NYSE:FBC) (the "Company"), the holding company for Flagstar Bank, FSB (the "Bank"), today announced that the Bank has completed the sale of its 22-branch Indiana retail bank franchise to First Financial Bank, N.A. ("First Financial"), a wholly owned subsidiary of First Financial Bancorp (Nasdaq:FFBC), pursuant to the previously announced agreement between the parties.
At the closing, the Bank sold its branches in Indiana and the associated deposits. First Financial paid the Bank a premium for the consumer and commercial deposits it assumed plus the net book value of the real estate and personal assets associated with the branches. First Financial also assumed the existing leases on 14 of the branches.
Flagstar Bancorp's chairman and chief executive officer, Joseph P. Campanelli, said, "We sold approximately $340 million of consumer and commercial deposits and approximately $120 million of government and municipal deposits in the transaction. Based upon the estimated deposit premium of $22.5 million, we anticipate recording a gain of approximately $22 million on the transaction."
"The consummation of this transaction allows Flagstar to focus our resources on the markets where we see the greatest return and growth potential," Mr. Campanelli said. "We've invested significant resources in transforming Flagstar into a full-service commercial bank, and our ultimate goal is to continue to grow our retail and commercial lines of business to complement our strong market presence in national mortgage banking."
Drug Candidates From Alexza and BioSante Pharmaceuticals Inch Closer to Decision Day
PrintAlert
Alexza (NASDAQ:ALXA)
Intraday Stock Chart
Today : Thursday 1 December 2011
2012 is shaping up to be a big year for the biotechnology industry with several drug candidates facing FDA advisory panels. The drug approval rate in the United States has been falling in recent years -- studies released this year courtesy of the Biotechnology Industry Organization peg the country's overall success rate at close to ten percent -- which have led to volatile swings in shares throughout the biotechnology sector. The Bedford Report examines the outlook for companies in the biotechnology industry and provides investment research on Alexza Pharmaceuticals, Inc. (NASDAQ: ALXA) and BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX). Access to the full company reports can be found at:
www.bedfordreport.com/ALXA
www.bedfordreport.com/BPAX
In its third quarter report, BioSante Pharmaceuticals said that its Bio-T-Gel, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals, has been assigned an FDA approval decision date of February 14, 2012. Male hypogonadism generally characterized by impotence, a lack of sex drive, muscle weakness and osteoporosis. BioSante says that the transdermal testosterone market for men in the US was over $1.2 billion in 2010.
BioSante is also developing LibiGel to treat female sexual dysfunction, specifically hypoactive sexual desire disorder, in postmenopausal women, for which there is no Food and Drug Administration-approved product. Shares of the company got a boost last month after it said a study shows its LibiGel increased free-testosterone levels in postmenopausal women.
The Bedford Report releases regular market updates on the biotechnology industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at www.bedfordreport.com and get exclusive access to our numerous analyst reports and industry newsletters.
Alexza Pharmaceuticals is a development stage company focused on the research, development, and commercialization of novel proprietary products for the acute treatment of central nervous system conditions. Alexza is meeting with an FDA advisory panel this month to review the company's inhalation product candidate Adasuve for the rapid treatment of agitation in patients with Schizophrenia or Bipolar Disorder. The FDA had initially rejected Adasuve in October 2010 due to concerns over lung safety. Alexza resubmitted the drug to FDA last August. According to Alexza's website, the NDA PDUFA goal date is Feb. 4, 2012.
The Bedford Report provides Market Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. The Bedford Report has not been compensated by any of the above-mentioned companies. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at: http://www.bedfordreport.com/disclaimer
Contact:
The Bedford Report
hmmmm have no clue, still scratching my head
HMMM new waters, in the 50's, where to now
thats ok, hang tough, it will be ok
Well I waited and waited and got my .75.... Now iam in good.. NOw just hope iam right and it goes up :)
Inching closer to my .75 cents, then its time to buy
Alphatec Spine to Present at the 23RD Annual Piper Jaffray Health Care Conference
PrintAlert
Alphatec Holdings, Inc. (MM) (NASDAQ:ATEC)
Intraday Stock Chart
Today : Tuesday 22 November 2011
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, today announced it will present at the 23rd Annual Piper Jaffray Health Care Conference on Tuesday, November 29, 2011 at 12:00 p.m. ET at The New York Palace Hotel in New York City, New York.
During such presentation, Michael O'Neill, Alphatec Spine's Chief Financial Officer, will provide an overview of the Company's activities. A live audio webcast of the presentation at the Annual Piper Jaffray Health Care Conference will be accessible through the Company's investor relations website at www.alphatecspine.com. An archived edition of the presentation will be available later that day and will be available for at least 30 days afterwards.
Thanksgiving Week 2011 Contest Pick -AMR-
well 20 days and we got a trade (lmao) , guess someone needed cab fare
That is amazing. 48$ - commisions = yikes
hmmmm someone bailed this morning very cheaply
Flagstar Bancorp Raised To Buy From Hold By Cantor Fitzgerald >FBCLast update: 11/17/2011 8:45:34 AM
thanks for that OB
AVI Enters Into Collaborations for the Development of Two Additional Exon-Skipping Products for Duchenne Muscular Dystrophy (...
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Avi Biopharma (NASDAQ:AVII)
Intraday Stock Chart
Today : Tuesday 15 November 2011
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, today announced collaborations for the development of two additional exon-skipping drugs, one for exon 45 and one for exon 50, to support AVI's broad-based development program for the treatment of DMD. AVI's collaboration with Children's National Medical Center in Washington, D.C. and the Carolinas Medical Center (CMC) will support certain IND-enabling activities for an exon 45-skipping therapeutic. AVI's collaboration with the National Institutes of Health (NIH) will support IND-enabling activities for an exon 50-skipping therapeutic and will be supported through in-kind research conducted either by the Therapeutics for Rare and Neglected Diseases (TRND) program or by contract research organizations. AVI is currently conducting a Phase IIb trial of eteplirsen, its exon 51-skipping therapeutic candidate for the treatment of DMD.
"The initiation of these additional programs, with the financial support of, and in collaboration with, leading institutions, is a validation of AVI's exon-skipping drug platform and will help to accelerate the development of our DMD program," said Chris Garabedian, President and CEO of AVI BioPharma. "These collaborations will lay the foundation for AVI's pan exon strategy for the development of therapeutics to treat a majority of the DMD population."
Exon 45-Skipping Collaboration
The collaboration with Children's National and CMC will be funded primarily through two grants, one from the U.S. Department of Defense's (DoD) Congressionally Directed Medical Research Program to Children's National and the other from the National Institute of Neurological Disorders and Stroke to CMC. This funding is intended to pursue the most promising treatments for DMD. The collaboration will support a series of GLP toxicology studies for an exon 45-skipping drug candidate based on AVI's phosphorodiamidate morpholino oligomer (PMO) chemistry. The details of the research plan associated with this collaboration, as well as the details of the funding from the NIH and the DoD, will be finalized by the parties over the next few months.
"Children's National is committed to finding an effective treatment for Duchenne muscular dystrophy patients," said Eric Hoffman, PhD, Director of the Center for Genetic Medicine Research at Children's National Medical Center. "Working with partners like AVI and their PMO-based exon-skipping therapeutics may accelerate the clinical development of a specific exon 45-skipping therapeutic that could improve the care and quality of life for more boys with this disease."
Dr. Qi Long Lu, director of the McColl-Lockwood Laboratory at Carolinas Medical Center, added, "A strong pre-clinical GLP toxicology package is a critical part of a robust drug development program. Our collaboration with AVI is designed to help support the IND-enabling work necessary to advance AVI's exon-skipping drug candidates into the clinic."
Exon 50-Skipping Collaboration
The TRND program is a new initiative by NIH designed to assist in the development of new drugs for rare and neglected diseases. To develop new medicines, TRND establishes partnerships with leading academic, government, biopharmaceutical and patient advocacy groups to focus on the discovery, optimization and pre-clinical testing of new drugs. AVI was selected for the award through a national competitive process. Definitive details of the collaboration will be finalized upon execution of a Cooperative Research and Development Agreement (CRADA) between the two parties.
"TRND collaborates with researchers and companies with an aim of helping companies like AVI advance TRND's mission of accelerating the development of therapeutics for rare diseases like DMD," said John McKew, PhD, Chief of TRND's Therapeutic Development Branch. "TRND selected AVI because its innovative platform technology has the potential to move forward into later stage clinical trials in this disease for which there is little or no therapy."
About Duchenne Muscular Dystrophy
DMD is one of the most common fatal genetic disorders to affect children around the world. Approximately one in every 3,500 boys worldwide is affected with DMD. A devastating and incurable muscle-wasting disease, DMD is associated with specific inborn errors in the gene that codes for dystrophin, a protein that plays a key structural role in muscle fiber function. Progressive muscle weakness eventually spreads to the arms, neck and other areas. Eventually, this progresses to complete paralysis and increasing difficulty in breathing due to respiratory muscle dysfunction requiring ventilatory support as well as cardiac muscle dysfunction leading to heart failure. The condition is terminal, and death usually occurs before the age of 30.
About AVI BioPharma
AVI BioPharma is focused on the discovery and development of novel RNA-based therapeutics for rare and infectious diseases, as well as other select disease targets. Applying pioneering technologies developed and optimized by AVI, the Company is able to target a broad range of diseases and disorders through distinct RNA-based mechanisms of action. Unlike other RNA-based approaches, AVI's technologies can be used to directly target both messenger RNA (mRNA) and precursor messenger RNA (pre-mRNA) to either down-regulate (inhibit) or up-regulate (promote) the expression of targeted genes or proteins. By leveraging its highly differentiated RNA -based technology platform, AVI has built a pipeline of potentially transformative therapeutic agents, including eteplirsen (the non-proprietary name for AVI-4658), which is in clinical development for the treatment of Duchenne muscular dystrophy, and multiple drug candidates that are in clinical development for the treatment of infectious diseases. For more information, visit www.avibio.com.
About Eteplirsen
Eteplirsen is AVI's lead drug candidate that is systemically delivered for the treatment of a substantial subgroup of patients with DMD. Data from clinical studies of eteplirsen in DMD patients have demonstrated a broadly favorable safety and tolerability profile and restoration of dystrophin protein expression.
Eteplirsen uses AVI's novel phosphorodiamidate morpholino oligomer (PMO)-based chemistry and proprietary exon-skipping technology to skip exon 51 of the dystrophin gene. By skipping exon 51, eteplirsen may restore the gene's ability to make a shorter, but still functional, form of dystrophin from mRNA. Promoting the synthesis of a truncated dystrophin protein is intended to improve, stabilize or significantly slow the disease process and prolong and improve the quality of life for patients with DMD. AVI is also developing other PMO-based exon-skipping drug candidates intended to treat additional patients with DMD.
About Children's Research Institute / Children's National Medical Center
Children's National Medical Center in Washington, DC, has been serving the nation's children since 1870. Home to Children's Research Institute and the Sheikh Zayed Institute for Pediatric Surgical Innovation, Children's National is consistently ranked among the top pediatric hospitals by U.S. News & World Report and the Leapfrog Group. With 303 beds, more than 1,330 nurses, 550 physicians, and seven regional outpatient centers, Children's National is the only exclusive provider of acute pediatric services in the Washington metropolitan area. Children's National has been recognized by the American Nurses Credentialing Center as a Magnet® designated hospital, the highest level of recognition for nursing excellence that a medical center can achieve. For more information, visit ChildrensNational.org, receive the latest news from the Children's National press room, or follow us on Facebook and Twitter.
About the Carolinas Medical Center
Carolinas Medical Center (www.carolinasmedicalcenter.org) is an 874-bed tertiary care hospital located in Charlotte, N.C. It is one of 33 hospitals currently affiliated with Carolinas HealthCare System (www.carolinashealthcare.org) one of the nation's leading and most innovative healthcare organizations. CHS provides a full spectrum of healthcare and wellness programs throughout North and South Carolina. Its diverse network of more than 650 care locations includes academic medical centers, hospitals, healthcare pavilions, physician practices, destination centers, surgical and rehabilitation centers, home health agencies, nursing homes and hospice and palliative care. CHS works to improve and enhance the overall health and wellbeing of its communities through high quality patient care, education and research programs, and a variety of collaborative partnerships and initiatives.
About the Therapeutics for Rare and Neglected Diseases (TRND) Program
The Therapeutics for Rare and Neglected Diseases (TRND) program (currently administered by the NIH Center for Translational Therapeutics, an intramural program of the National Human Genome Research Institute) is part of a congressionally mandated program to encourage and speed the development of new drugs for rare and neglected diseases. This program is specifically intended to stimulate drug discovery and development research collaborations between NIH and academic scientists, non-profit organizations, and pharmaceutical and biotechnology companies working on rare and neglected illnesses. The TRND program provides an opportunity to partner with and gain access to rare and neglected disease drug development capabilities, expertise, and clinical/regulatory resources in a collaborative environment with the goal of moving promising therapeutics into human clinical trials. TRND uses an application and evaluation process to select collaborators. Selected investigators provide the drug project starting points and ongoing biological/disease expertise throughout the project.
Forward-Looking Statements and Information
In order to provide AVI's investors with an understanding of its current results and future prospects, this press release contains statements that are forward-looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "will," "intends," "potential," "possible" and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements about the development of AVI's product candidates and their efficacy, potency and utility in the treatment of rare and infectious diseases, AVI's expectations regarding future success, and the ability of the exon 45 and exon 50 collaborations to accelerate AVI's DMD program and result in additional open INDs.
These forward-looking statements involve risks and uncertainties, many of which are beyond AVI's control. Known risk factors include, among others: preclinical studies may not result in open INDs; clinical trials may not demonstrate safety and efficacy of any of AVI's drug candidates and/or AVI's antisense-based technology platform; and any of AVI's drug candidates may fail in development, may not receive required regulatory approvals, or be delayed to a point where they do not become commercially viable.
Any of the foregoing risks could materially and adversely affect AVI's business, results of operations and the trading price of AVI's common stock. For a detailed description of risks and uncertainties AVI faces, you are encouraged to review the official corporate documents filed with the Securities and Exchange Commission. AVI does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.
AVI Media and Investor Contact:
Erin Cox
425.354.5140
Email Contact
AVI Media Contact:
David Schull
212.845.4271
Email Contact
18 Day and Counting
My 75 cent buy in is getting closer
we are do for TRADE, last trade oct 28, geeeesh
thanks for sharing ei
AVI BioPharma Announces Third Quarter 2011 Financial Results and Recent Corporate Developments
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Avi Biopharma (NASDAQ:AVII)
Intraday Stock Chart
Today : Thursday 3 November 2011
AVI BioPharma, Inc. (NASDAQ: AVII)
Completed Enrollment With All Patients Receiving Ongoing Doses in Phase IIB Study of Eteplirsen, the Company's Lead Exon-Skipping Therapeutic Candidate for the Treatment of Duchenne Muscular Dystrophy
Completed Final Dosing Following Positive Safety Results in Initial Cohorts of Phase I Trials of AVI-6002 and AVI-6003, AVI's Lead Drug Candidates for the Treatment of Ebola and Marburg, Respectively
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based therapeutics, today reported financial results for the three and nine months ended September 30, 2011, and provided an update of recent corporate developments.
"In the past quarter, significant developments have taken place for our DMD and infectious diseases programs, including continued dosing of our fully-enrolled Phase IIB clinical study of eteplirsen in DMD patients and the promising interim safety data reported for our Ebola and Marburg therapeutic candidates," said Chris Garabedian, President and CEO of AVI. "These accomplishments validate our unique PMO-based chemistries and continue to enable the development of our therapeutics to treat life-threatening diseases."
Financial Results
For the third quarter of 2011, AVI reported an operating loss of $11.3 million compared with an operating loss of $3.8 million in the third quarter of 2010. The increase in the quarterly operating loss was primarily the result of increased research and development expenses of $6.5 million and lower government contract revenue of $1.2 million.
Research and development expenses were $15.6 million in the third quarter of 2011 compared to $9.1 million in the third quarter of 2010, an increase of $6.5 million. The increase was primarily due to a $4.4 million increase in DMD-related program costs, a $3.4 million increase in spending related to the Ebola Marburg government contract and a $1.6 million increase in other non-government projects. These increases were partially offset by $2.6 million in reduced spending for the H1N1 government contracts which concluded in 2011.
General and administrative expenses in the third quarter of 2011 were $3.2 million, compared to $3.4 million in the third quarter of 2010.
Revenue for the third quarter of 2011 decreased $1.2 million to $7.5 million from the third quarter of 2010 as a result of $5.8 million in lower revenue from the H1N1 contracts and the 2006 government contracts. This decrease was partially offset by a $4.6 million increase in revenue from the Ebola Marburg government contract.
In the first nine months of 2011, the operating loss was $26.9 million, compared with an operating loss of $19.2 million in the first nine months of 2010. The increase in the operating loss was the result of increased research and development expenses of $26.1 million and increased general and administrative costs of $1.1 million, partially offset by increased revenue of $19.5 million.
Research and development expenses were $48.2 million in the first nine months of 2011, compared to $22.1 million in the first nine months of 2010, an increase of $26.1 million. The increase was primarily due to a $20.5 million increase in spending related to the Ebola Marburg government contract, a $5.3 million increase in DMD-related program costs and $3.3 million in non-government projects and other research and development costs. This increase was partially offset by a $3.0 million decrease in spending on AVI's H1N1 and 2006 government contracts.
General and administrative expenses in the first nine months of 2011 were $12.1 million, compared to $11.0 million in the first nine months of 2010, an increase of $1.1 million. The increase is primarily due to $3.3 million in salaries, severance and employee related costs, $0.4 million in higher costs for professional services, and $0.3 million in increased costs for facilities. These increases were partially offset by a $2.6 million decrease in severance related costs for the former chief executive officer that were incurred in the first nine months of 2010 and $0.3 million in lower legal fees in the first nine months of 2011.
Revenue for the first nine months of 2011 increased to $33.4 million from $13.9 million in the first nine months of 2010 primarily as a result of the increased revenue associated with the Ebola Marburg government contract.
The net loss for the third quarter of 2011 was $4.0 million, or $0.03 per share, compared to a net loss for the third quarter of 2010 of $7.3 million, or $0.07 per share. The $3.3 million decrease was due to a $10.6 million variance resulting from the decrease in the valuation of certain warrants described below, offset by a $7.5 million increase in the operating loss. The net loss for the first nine months of 2011 was $0.9 million, or $0.01 per share, compared to a net loss for the first nine months of 2010 of $24.5 million, or $0.22 per share. The $23.6 million decrease was due to a $31.1 million variance resulting from the decrease in the valuation of certain warrants described below, offset by a $7.7 million increase in the operating loss.
In connection with prior equity financings, AVI issued warrants that are classified as current liabilities and are adjusted to fair value on a quarterly basis with the change in fair value being included in net income (loss). The amount of the warrant liability is primarily affected by changes in AVI's stock price during each financial reporting period which causes the warrant liability to fluctuate as the market price of AVI's stock fluctuates. In the third quarter of 2011, the warrant valuation decreased by $7.1 million compared to an increase in the warrant valuation of $3.6 million in the third quarter of 2010. In the first nine months of 2011, the warrant valuation decreased by $25.6 million compared to an increase in the warrant valuation of $5.5 million in the first nine months of 2010.
AVI had cash and cash equivalents of $46.4 million as of September 30, 2011, an increase of $12.8 million from December 31, 2010. This increase was primarily due to the $32.1 million in net proceeds raised in the April 2011 equity financing partially offset by cash used in operations during the first nine months of 2011 of $18.0 million, and cash used for property and equipment purchases and patent-related costs of $1.5 million.
Recent Corporate Developments
Duchenne Muscular Dystrophy (DMD) Program
Completed enrollment of the Phase IIB trial of eteplirsen with all patients receiving multiple doses in this placebo-controlled study in ambulatory DMD patients taking place at Nationwide Children's Hospital in Columbus, Ohio.
Presented comparative pharmacokinetics (PK) data in primates and humans from AVI's lead drug candidate, eteplirsen, for treating DMD patients, at the 16th International World Muscle Society Congress.
Infectious Disease Programs
Completed dosing of 9.0 mg/kg in the sixth and final cohorts of healthy volunteers following positive safety results from the first five cohorts, which evaluated doses from 0.01 mg/kg to 6.0 mg/kg in these Phase I single ascending dose trials of AVI-6002 and AVI-6003, AVI's lead drug candidates for the treatment of Ebola and Marburg viruses, respectively.
Presented efficacy data in oseltamivir-resistant H1N1 infected ferrets and toxicity and toxicokinetic data from its lead therapeutic candidate AVI-7100, at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) Annual Meeting.
Presented data from AVI-6003 single ascending-dose study program for Marburg at the 49th Annual Meeting of Infectious Diseases Society of America.
2011 Guidance
AVI anticipates that its full year 2011 revenue will be in the $40 million to $50 million range due to the requirement to finalize the Ebola and Marburg contract modification with respect to costs and timing of activities, which was signed September 26, 2011. This modification, though it does not impact the total revenue AVI expects to receive under the contract, resulted in a delay of certain third party manufacturing, preclinical and clinical activities, which shifted some revenue from the latter part of 2011 into 2012. This deferral of revenue impacts the expected overall net contribution from the government contracts in 2011 and, therefore, AVI is increasing its 2011 cash burn guidance to the $30 million to $35 million range. AVI believes it will continue to receive funding from government contracts and has assumed certain revenue from these awards in providing this guidance. If AVI does not continue to receive the funding from its current contracts, its guidance may change.
Conference Call
AVI BioPharma will hold a financial results and corporate update conference call today at 5:00 p.m., Eastern Time (2:00 p.m., Pacific Time). The conference call may be accessed by dialing 866.314.5050 for domestic callers and 617.213.8051 for international callers. The passcode for the call is 97800942. Please specify to the operator that you would like to join the "AVI BioPharma third quarter 2011 earnings call." The conference call will be webcast live under the events section of AVI's website at www.avibio.com, and will be archived there following the call for 90 days. Please connect to AVI's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. An audio replay will be available through November 10, 2011 by calling 888.286.8010 or 617.801.6888 and entering access code 42274933.
Chase Packaging Declares 10% Stock Dividend on Its Preferred Stock
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Chase Packaging Corp Tex (QB) (USOTC:CPKA)
Intraday Stock Chart
Today : Tuesday 1 November 2011
Chase Packaging Corporation, which trades over-the-counter under the symbol "CPKA" (PINKSHEETS: CPKA), today announced that its Board of Directors declared a ten percent (10%) stock dividend on its outstanding Series A 10% Convertible Preferred Stock ("Preferred Stock"). Shareholders of record as of November 15, 2011, will receive the stock dividend for each share of Preferred Stock owned on that date, payable on December 1, 2011. The dividend will be paid in kind (i.e., in additional shares of Preferred Stock) based on the stated value of $100 per share.
The Board's declaration is in accordance with the provisions of the Statement of Resolution Establishing the Preferred Stock which provides that the Board of Directors may, in the exercise of its sole discretion, declare and pay a ten percent (10%) annual dividend on the stated value, such dividend payable either in cash or in kind, or any combination thereof. The Board of Directors approved the declaration and payment of this ten percent 10% stock dividend by unanimous written consent of the Board of Directors of the Corporation dated October 20, 2011.
Fractional shares will be accumulated until whole shares can be issued. As of November 1, 2011, Chase Packaging had 18,775 shares of Preferred Stock outstanding.
Chase ceased its prior specialty packaging business operations as of December 31, 1997, and since that time the Company's existence has been as a publicly traded development stage shell corporation. Management of the Company is seeking to secure a suitable merger partner wishing to go public or to acquire private companies to create investment value for the Company. However, there is no assurance that a transaction will be concluded.
This press release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward looking statements are based on our current expectations and projections about future events. All statements other than statements of historical fact included in this press release regarding the Company are forward looking statements. There can be no assurance that those expectations and projections will prove to be correct.
CONTACT:
Chase Packaging Corporation
Ann C.W. Green
(732) 741-1500
Chief Financial Officer
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Alphatec Spine Announces New Products at Upcoming North American Spine Society (NASS) Meeting in Chicago
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Alphatec Holdings, Inc. (MM) (NASDAQ:ATEC)
Intraday Stock Chart
Today : Tuesday 1 November 2011
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced today that it will be introducing three new products at the upcoming North American Spine Society (NASS) meeting in Chicago, IL, which will be held from November 2nd to 4th, 2011
The Company is pleased to make the following new product introductions, and to announce the release of Alphatec Solus to its international beta sites:
-- The Trestle LuxeTM Anterior Cervical Plating System is the Company's next-generation anterior cervical fixation system. It combines a proprietary zero-step locking mechanism, low-profile flush-fit design, large graft window, and a comprehensive offering of implants and instrumentation to provide the surgeon with confidence in the system's performance and comfort to their patients.
-- The AvalonTM Occipito-Cervico Plating System, which is used in connection with the Solanas® Posterior Cervico-Thoracic Fixation System, provides the surgeon with an innovative and comprehensive posterior solution for occipito-cervico-thoracic fixation. The unique buttress design of the Avalon plate allows the surgeon to ideally place and secure bone graft in the optimal midline location to help promote fusion and improve graft stability without adding profile to the overall surgical construct.
-- The Epicage® Minimally Invasive Posterior Interbody Spacer can be used for either TLIF or PLIF procedures. In its resting state the cage has a crescent shape; but due to its unique geometry and design, it can be flexed into a straight and narrow shape. The cage can be delivered in a minimally invasive, low- profile manner, which upon delivery reshapes to cover a large surface area. Additionally, it is delivered through a portal that is designed to reduce the potential of nerve injury to the patient, and to ensure that the cage is delivered to a precise location upon each implementation.
-- The Alphatec SolusTM Anterior Lumbar Interbody Fusion (ALIF) System provides a biomechanically proven, industry leading design in treating spinal column stability for internal fixation ALIF devices. Four points of fixation combined with what we believe is the largest competitively available graft volume support rapid and robust arthodesis potential. Deployment of the internal fixation blades is performed in one step, and is designed to decrease incision size, operative time and blood loss.
"Alphatec Spine is extremely proud to have designed, manufactured and introduced each of these products to the US and international markets", said Dirk Kuyper, President and CEO. "These products are on the cutting edge of spinal instrumentation and implants. Each incorporates our philosophy of being focused on the aging spine, being minimally invasive in their approach and compatible with Biologics solutions. Each of these systems is in a significantly sized market segment, and as next-generation designs, each has the potential to impact our future positively".