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CombinatoRx Incorporated


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CombinatoRx, Incorporated's Synavive (CRx-102) Maintains Efficacy Throughout 12 Month Phase 2 Knee

www.biospace.com | Oct 21, 2009

CAMBRIDGE, Mass.--(BUSINESS WIRE)--CombinatoRx, Incorporated (NASDAQ: CRXX - News) today announced the results of a 12 month knee osteoarthritis (OA) Phase 2 extension trial for Synavive™ (CRx-102) at the American College of Rheumatology (ACR) 2009 Annual Meeting in Philadelphia.

http://www.biospace.com/news_story.aspx?StoryID=159856&full=1

CombinatoRx narrows loss on deep R&D cuts

boston.bizjournals.com | Nov 3, 2009

Drug developer CombinatoRx Inc. narrowed its loss in the third quarter on aggressive cost cutting that resulted in a 36 percent reduction in its workforce. The Cambridge, Mass.

http://boston.bizjournals.com/boston/stories/2009/11/02/daily25.html?ana=from_rss

Nasdaq halts CombinatoRx trading pending FDA review - Boston Business Journal:

boston.bizjournals.com | Sep 23, 2009

Drug developer CombinatoRx Inc. said Nasdaq Stock Market Officials have halted trading of the company’s common shares pending a regulatory review of the company’s new drug application for its Exalgo pain medication. The Cambridge, Mass.

http://boston.bizjournals.com/boston/stories/2009/09/21/daily36.html?ana=from_rss

 

CombinatoRx Oncology Programs to Be Highlighted at ASH 2009 - Zibb.com

CombinatoRx, Incorporated (NASDAQ: CRXX) today announced that two abstracts highlighting data on its A2A and Beta-2 Adrenergic Receptor Agonist oncology programs have been accepted for presentation at the American Society for Hematology (ASH) 2009 Annual Meeting in New Orleans on December 5-8, 2009.

Poster Presentation:

Abstract #3762, Poster Board III-698, Monday, December 7, 2009, 6:00 PM-8:00 PM,

"Adenosine A2A and Beta-2 Adrenergic Receptor Agonist Synergy in B-Cell Malignancies: Selectivity, Breadth of Activity and Effects of Chronic Exposure", Rickles, et.al., Ernest N. Morial Convention Center, Hall E.

Abstract #3831, Poster Board III-767, Monday, December 7, 2009, 6:00 PM-8:00 PM,

"A2A or Beta-2 Adrenergic Receptor Agonist Synergies Induce Distinct Patterns of Gene Expression Relevant to Multiple Myeloma Cell Survival", Rickles, et.al., Ernest N. Morial Convention Center, Hall E.

About CombinatoRx

CombinatoRx, Incorporated (CRXX) is pioneering the new field of synergistic combination pharmaceuticals. Going beyond traditional combinations, CombinatoRx creates product candidates with novel mechanisms of action, striking at the biological complexities of human disease. The CombinatoRx proprietary drug discovery technology provides a renewable and previously untapped source of novel drug candidates. The Company was founded in 2000 and is located in Cambridge, Massachusetts. To learn more about CombinatoRx, please visit www.combinatorx.com.

Forward-Looking Statement:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning CombinatoRx and its B-cell malignancy programs. These forward-looking statements about future expectations, plans and prospects of CombinatoRx, and its B-cell malignancy programs involve significant risks, uncertainties and assumptions, including risks related to CombinatoRx's ability to further develop and obtain regulatory approval for its B-cell malignancy programs and those other risks that can be found in the "Risk Factors" section of the CombinatoRx Annual Report on Form 10-K on file with the Securities and Exchange Commission and the other reports that CombinatoRx periodically files with the Securities and Exchange Commission. Actual results may differ materially from those CombinatoRx contemplated by these forward-looking statements. These forward looking statements reflect management's current views and CombinatoRx does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release.

(c) 2009 CombinatoRx, Incorporated. All rights reserved.

SOURCE: CombinatoRx, Incorporated

CombinatoRx, Incorporated 
Robert Forrester, 617-301-7575 
Interim President and Chief Executive Officer 
rforrester@combinatorx.com 
or 
Gina Nugent, 857-753-6562 
gnugent@combinatorx.com

Read more...

Tags: annual report   massachusetts   nasdaq   pharmaceuticals   securities   technology  

Companies: Combinatorx Inc (CRXX)

 

FDA Extends NDA Review for Exalgo(TM) Extended-Release Tablets - Zibb.com

CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo(TM) (hydromorphone HCl) extended-release tablets by three months. The extended Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review of the Exalgo NDA has been set for February 22, 2010. The FDA stated in its letter extending the PDUFA date that the purpose for the extension is to allow the FDA more time for a full review of Neuromed's submission, including a recent amendment by Neuromed to the Exalgo NDA.

Neuromed will continue to work with Mallinckrodt Inc., who owns the commercial rights to Exalgo, to obtain FDA approval of the Exalgo NDA under Section 505(b)(1) of the Food Drug and Cosmetic Act of 1938, as amended (FDCA). Neuromed and Mallinckrodt may be successful in these efforts and the FDA may approve the Exalgo NDA in its current form on or before the new PDUFA date. However, the Exalgo NDA in its current form may not be sufficient to form the basis for approval of Exalgo under Section 505(b)(1) of the FDCA. If that is the case, the FDA may issue a complete response letter to Neuromed, and Neuromed and Mallinckrodt may choose to provide additional data or information to provide a basis for approval of Exalgo or may resubmit the Exalgo NDA under Section 505(b)(2) of the FDCA. At this time, the outcome of any of these efforts or actions is not certain.

The U.S. rights to Exalgo tablets were acquired from Neuromed by Mallinckrodt Inc., a Covidien company, in June, 2009. Under the agreements between Neuromed and Mallinckrodt, Neuromed has received milestone payments totaling $15 million, and if Exalgo is approved by the FDA, Neuromed is eligible to a milestone payment of $30 million, which could potentially increase to $40 million. Mallinckrodt has also agreed to fund certain clinical development and regulatory activities of Neuromed, up to a cap of $16 million.

CombinatoRx and Neuromed entered into a definitive merger agreement on June 30, 2009. CombinatoRx and Neuromed have each adjourned their annual and special meetings of stockholders relating to the merger until, in the case of CombinatoRx, 9:00 a.m. ET on November 30, 2009, at the offices of Goodwin Procter LLP, 53 State Street, Boston, MA 02109, and in the case of Neuromed, 8:00 a.m. PT on November 30, 2009, at Neuromed's offices, 301 -- 2389 Health Science Mall, Vancouver, BC V6T1Z3. Additional information regarding the CombinatoRx and Neuromed stockholders meetings and the proposed merger will be provided to stockholders of CombinatoRx and Neuromed.

About CombinatoRx

CombinatoRx, Incorporated (CRXX) is pioneering the new field of synergistic combination pharmaceuticals. Going beyond traditional combinations, CombinatoRx creates product candidates with novel mechanisms of action, striking at the biological complexities of human disease. The CombinatoRx proprietary drug discovery technology provides a renewable and previously untapped source of novel drug candidates. The Company was founded in 2000 and is located in Cambridge, Massachusetts. To learn more about CombinatoRx, please visit www.combinatorx.com.

About Neuromed

Neuromed is a privately held biopharmaceutical company in business to develop new and improved pain medicines. Neuromed has multiple programs aimed at addressing this important unmet medical need. The rights to its lead product candidate, Exalgo(TM) (hydromorphone HCL) extended-release tablets, which has a proposed indication for once daily administration in the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time, was recently acquired by Mallinckrodt Inc., a Covidien company. Neuromed is also developing oral drug candidates to block N-type and T-type calcium channels, an important target directly involved in pain signaling, and includes candidates for potentially treating pain, epilepsy and hypertension. For more information visit Neuromed's website at http://www.neuromed.com.

Forward-Looking Statement:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning CombinatoRx and Neuromed, Neuromed's product candidate Exalgo(TM), and its potential and the timing and regulatory strategy for obtaining FDA approval, the timing of the closing of the merger of CombinatoRx and Neuromed, the CombinatoRx drug discovery technology, and the business plans of both CombinatoRx and the combined company. These forward-looking statements about future expectations, plans and prospects of CombinatoRx, Neuromed and the combined company involve significant risks, uncertainties and assumptions, including risks related to the ability of Neuromed or Mallinckrodt to obtain regulatory approval for the sale and marketing of its Exalgo(TM) product candidate, the unproven nature of the CombinatoRx drug discovery technology, the Company's ability to obtain additional financing or funding for its research and development and those other risks that can be found in the "Risk Factors" section of the CombinatoRx Annual Report on Form 10-K on file with the Securities and Exchange Commission and the other reports that CombinatoRx periodically files with the Securities and Exchange Commission. Actual results may differ materially from those CombinatoRx contemplated by these forward-looking statements. These forward looking statements reflect management's current views and CombinatoRx does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

Important Additional Information Available

This press release does not constitute an offer of any securities for sale. In connection with the merger with Neuromed, CombinatoRx has filed with the U.S. Securities and Exchange Commission (SEC) a registration statement on Form S-4 (File No. 333-161146) (S-4), which, as amended, was declared effective on October 22, 2009. The joint proxy statement/prospectus of CombinatoRx and Neuromed included in the S-4 was filed with the SEC under Rule 424(b)(3) of the Securities Act of 1933 on October 22, 2009 and mailed to CombinatoRx and Neuromed stockholders. Investors and security holders of CombinatoRx are urged to read the S-4 and the joint proxy statement/prospectus (including all amendments and supplements thereto) and the other relevant material because they contain important information about CombinatoRx, Neuromed and the proposed transaction. The S-4, joint proxy statement/prospectus and other relevant materials, and any and all documents filed by CombinatoRx with the SEC, may be obtained free of charge at the SEC's web site at www.sec.gov. In addition, investors and security holders may obtain free copies of the documents filed with the SEC by CombinatoRx by directing a written request to CombinatoRx, Incorporated, 245 First Street, Third Floor, Cambridge, MA 02142, Attention: Secretary. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND THE OTHER RELEVANT MATERIALS BEFORE MAKING ANY VOTING OR INVESTMENT DECISION WITH RESPECT TO THE PROPOSED TRANSACTIONS.

(c) 2009 CombinatoRx, Incorporated. All rights reserved.

SOURCE: CombinatoRx, Incorporated

CombinatoRx, Incorporated 
Robert Forrester, 617-301-7575 
Interim President and CEO 
rforrester@combinatorx.com 
or 
Gina Nugent, 857-753-6562 
gnugent@combinatorx.com

Read more...

Tags: annual report   business   clinical   fda   health   investment   law   marketing   massachusetts   medical   merger   nasdaq   pharmaceuticals   research and development   science   sec   securities   security   technology   vancouver   web  

Companies: Combinatorx Inc (CRXX)

 

Neuromed Gets FDA Feedback on NDA for Exalgo Extended-Release Tablets - Zibb.com

CombinatoRx, Inc. and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, announced that on November 13, representatives of Neuromed discussed the pending New Drug Application (NDA) for the product candidate Exalgo (hydromorphone HCl extended release) tablets.

CombinatoRx said that it is seeking FDA approval for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time, with staff from the United States Food and Drug Administration (FDA).

In a release, the Company noted that in these discussions, the FDA staff indicated that the NDA in its current form would not be sufficient to form the basis for approval of Exalgo under Section 505(b)(1) of the Food, Drug and Cosmetic Act of 1938, as amended (FDCA). Based on these discussions with the FDA, Neuromed is working with Mallinckrodt, Inc., who owns the commercial rights to Exalgo, to determine the appropriate actions to be taken based on the discussions with the staff of the FDA, which actions may include amending the existing NDA, or potentially resubmitting the NDA under Section 505(b)(2) of the FDCA, which utilizes different criteria to determine the basis for approval of a new drug candidate.

So that each company's stockholders can be provided with additional information regarding these developments, CombinatoRx and Neuromed said that they each plan to convene their respective stockholders meetings at the previously scheduled times and then adjourn these meetings until, in the case of CombinatoRx, 9 a.m. ET on November 30, at the offices of Goodwin Procter, Boston, and in the case of Neuromed, 8 a.m. PT on November 30, at Neuromed's offices, Vancouver, BC.

The U.S. rights to Exalgo were acquired by Mallinckrodt, Inc., a Covidien company, on June 11. CombinatoRx and Neuromed entered into a definitive merger agreement on June 30.

((Comments on this story may be sent to health@closeupmedia.com))

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Tags: fda   health   merger   pharmaceuticals   vancouver  

Companies: Combinatorx Inc (CRXX)

 

xtremepicks.com: www.Xtremepicks.Com: Xtremepicks Alerts November 20, 2009 : CRXX, RENT, KIRK and

Xtremepicks.com Alerts include CombinatoRx, Incorporated (NASDAQ: CRXX), Rentrak Corporation (Nasdaq: RENT), Kirkland's, Inc. (Nasdaq: KIRK) and Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC)

CombinatoRx, Incorporated (NASDAQ: CRXX) trading at $0.911 per share on trading volume of 172,349 shares.

In a press release out on November 20, FDA Extends NDA Review for Exalgo(TM) Extended-Release Tablets

CAMBRIDGE, Mass. & VANCOUVER, British Columbia, Nov 20, 2009 -- CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo(TM) (hydromorphone HCl) extended-release tablets by three months. The extended Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review of the Exalgo NDA has been set for February 22, 2010. The FDA stated in its letter extending the PDUFA date that the purpose for the extension is to allow the FDA more time for a full review of Neuromed's submission, including a recent amendment by Neuromed to the Exalgo NDA.

About CombinatoRx

CombinatoRx, Incorporated (CRXX) is pioneering the new field of synergistic combination pharmaceuticals. Going beyond traditional combinations, CombinatoRx creates product candidates with novel mechanisms of action, striking at the biological complexities of human disease. The CombinatoRx proprietary drug discovery technology provides a renewable and previously untapped source of novel drug candidates. The Company was founded in 2000 and is located in Cambridge, Massachusetts. To learn more about CombinatoRx, please visit www.combinatorx.com.

Rentrak Corporation (Nasdaq: RENT) trading at $15.50 per share on trading volume of 8,518 shares.

In a press release out on November 20, Rentrak Announces Top Ten Movies-on-Demand Titles for Week Ending November 15, 2009

---- Rentrak's OnDemand Essentials Measures Video-On-Demand Television at a Full Census Level--

PORTLAND, Ore., Nov 20, 2009 -- Rentrak Corporation (Nasdaq: RENT), today announced the top ten movies-on-demand (VOD) titles based on consumer transaction rate. Movies-on-demand are transactional (pay-per-purchase) films available through cable and telco providers.

About Rentrak Corporation

Rentrak Corporation, based in Portland, Oregon, is an information management company serving clients in the media, entertainment, retail and advertising industries. The company's Entertainment Essentials(R) suite of services is redefining media measurement in the digital broadband era. Entertainment Essentials provides customers with near-real-time, actionable insight into performance of content distributed over a wide variety of modern media technologies. Available by license or subscription, each Entertainment Essentials application allows executives to analyze detailed industry-wide and title-specific data to make decisions that enhance the bottom line and provide competitive advantage. For further information, please visit Rentrak's corporate website at http://www.rentrak.com.

Kirkland's, Inc. (Nasdaq: KIRK) trading at $15.22 on a volume of 984,129 shares

In a press release out on November 20, Kirkland's Reports Third Quarter Results

NASHVILLE, Tenn., Nov 20, 2009 -- Highlights:

-- Comparable store sales increase 11.3% -- Reports EPS of $0.27 versus loss of $0.07 a year ago -- Total sales increased 7.6% despite 30 fewer stores from a year ago

-- Raises guidance assumptions for fiscal 2009

Kirkland's, Inc. (Nasdaq: KIRK) today reported financial results for the 13-week and 39-week periods ended October 31, 2009.

Kirkland's, Inc. was founded in 1966 and is a specialty retailer of home decor in the United States. Although originally focused in the Southeast, the Company has grown beyond that region and currently operates 298 stores in 32 states. The Company's stores present a broad selection of distinctive merchandise, including framed art, mirrors, candles, lamps, picture frames, accent rugs, garden accessories and artificial floral products. The Company's stores also offer an extensive assortment of gifts, as well as seasonal merchandise. More information can be found atwww.kirklands.com.

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) trading at $1.08 on a volume of 2.45M shares

In a press release out on November 20, Cell Therapeutics Wins Federal Appeal to Pursue $22.8 Million Claim Against The Lash Group

--CTI to seek recovery from The Lash Group for damages including reimbursement of prior expenses from the 2007 settlement with United States government concerning TRISENOX

SEATTLE, Nov 20, 2009 -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the Ninth Circuit Court of Appeals reversed a U.S. District Court order and ruled that CTI should be allowed to pursue all of its claims against The Lash Group, sending the case back to the District Court for trial. CTI filed a complaint against The Lash Group, CTI's former third-party reimbursement consultant for CTI's product TRISENOX, in 2007 seeking $22.8 million in damages for expenses already incurred related to the investigation, defense and a settlement of claims by the U.S. government concerning Medicare reimbursement for TRISENOX and other business losses.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com.

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Companies: Combinatorx Inc (CRXX), Kirkland's, Inc. (KIRK), Rentrak Corp. (RENT)

 

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CombinatoRx

CombinatorRx - See Us. See the Future. Company Products Discovery Investors & News Careers Contact CombinatoRx Singapore Investor Events Video: Our Technology Our Pipeline 06/18/08 CombinatoRx to Present at the Third Annual Piper Jaffray Europe Conference 05/30/08 CombinatoRx to Present at the

http://www.combinatorx.com/

Boston Millennia Partners

Boston Millennia Partners' portfolio reflects Millennia's commitment towards building enduring, large-scale businesses that have the potential to provide superior financial returns to our investors.

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EvaluatePharma - CombinatoRx Sample Information

EvaluatePharma provides historic and forecast sales from 1986 to 2010 for worldwide and US Rx (prescription drugs) and OTC drugs. EvaluatePharma analysts continuously update company models from SEC filings, annual reports, investor/analyst presentations, company press releases, FDA and USPTO.

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CombinatoRx, Incorporated - Google Finance

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CombinatoRx, Incorporated (CRXX): Stock Quote & Company Profile ...

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CRXX: Summary for CombinatoRx, Incorporated- Yahoo! Finance

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CombinatoRx, Incorporated Stock Trading Halted Today; FDA Advisory ...

www.biospace.com

CombinatoRx, Incorporated Stock Trading Halted Today; FDA Advisory Committees Meet to Discuss Exalgo 9/24/2009 CAMBRIDGE, Mass. & VANCOUVER--(BUSINESS WIRE)--CombinatoRx ...

http://www.biospace.com/news_story.aspx?StoryID=156845&full=1