Columbia: Our mission,your dream

In the News

12/06/2010
PROCHIEVE Vaginal Progesterone Gel Achieves Primary Endpoint in Phase III Study to Reduce Risk of Preterm Birth

PREGNANT Study Top-line Results Call

11/30/2010
Columbia Laboratories Amends Stockholder Rights Plan to Preserve Use of Net Operating Losses under Section 382

11/04/2010
CBRX Reports Q3 2010 Financial Earning

10/21/2010
Columbia Laboratories to Discuss Q3 2010 Financial Results on Nov. 4 Cconference Call

http://www.columbialabs.com/index.htm  

+1,32%rt

GrB  

wer will die Plette mal drauflegen(GD38)

GrB  

 

DB-Nsdq100

GrB  

sieht so aus(EUR)/GrB  

rt1,69 €-FFM
hier mal der interessante Chart/Nasdaq,da wird gespielt  

Euro/dollar so um die 1,38/GrB/zieht schon sehr nach oben/Eile sei geboten ;-)  

bin gespannt auf den SK  

Chart-Kurs im Ganzen top *freu*  

Added to NASDAQ Biotechnology Index
LIVINGSTON, NJ — May 16, 2011 — Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced the Company will be added to the NASDAQ Biotechnology Index® (Nasdaq: NBI). The semi-annual re-ranking of the index will become effective when the market opens on Monday May 23, 2011.

The NASDAQ Biotechnology Index is designed to track the performance of a set of NASDAQ listed securities that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The Index is re-ranked semi-annually in May and November, and serves as the basis for the iShares NASDAQ Biotechnology Index FundSM (IBB). For more information about the NASDAQ Biotechnology Index, including eligibility criteria, visit www.nasdaq.com.


About Columbia Laboratories

Columbia Laboratories, Inc. is developing products that utilize its novel bioadhesive drug delivery technologies to optimize drug delivery in a controlled, sustained manner. The Company has developed and sold six products for the U.S. market including CRINONE® (progesterone gel) for which Columbia receives royalties on annual net sales from Watson Pharmaceuticals. CRINONE is commercialized outside the U.S. by Merck Serono. The Company submitted a New Drug Application (NDA) to the Food and Drug Administration for PROCHIEVE® (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy on April 26, 2011.
Columbia's press releases and other company information are available online at www.columbialabs.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words “may,” “will,” “plans,” “believes,” “expects,” “intends,” “anticipates,” “potential,” “should,” and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: the successful marketing of CRINONE® by Watson Pharmaceuticals, Inc., in the United States; the successful marketing of CRINONE by Merck Serono outside the United States; successful development of a next-generation vaginal progesterone product; acceptance for filing by the United States Food and Drug Administration (“FDA”) of the New Drug Application (“NDA”) for PROCHIEVE® in the preterm birth indication; the decision of the FDA on Columbia's request for Priority Review for this NDA; the outcome of further statistical analyses by the FDA of the clinical data generated during the PREGNANT Study; success in obtaining timely FDA approval of PROCHIEVE in the preterm birth indication; the ability of our third-party manufacturers to supply CRINONE and PROCHIEVE; the impact of competitive products and pricing; the timely and successful negotiation of partnerships or other transactions; the strength of the United States dollar relative to international currencies, particularly the euro; competitive economic and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the SEC. Columbia does not undertake any responsibility to revise or update any forward-looking statements contained herein.

CRINONE® and PROCHIEVE® are registered trademarks of Watson Pharmaceuticals, Inc.




Contact:  
Lawrence A. Gyenes
Senior Vice President, CFO & Treasurer
(973) 486-8860  Seth Lewis
Vice President The Trout Group LLC
(646) 378 2952



http://www.columbialabs.com/...f/investors-press-releases-details.htm  

geht es in Richtung Winterhimmel.So muss das auch sein.Heute bereits über 9% zu diesem kurs ist das mehr wie heftig *freu*  

Shares of Columbia Laboratories plummeted more than 50 percent Tuesday after federal drug reviewers said the company's hormone-based gel appears to be ineffective for preventing premature birth.

Shares of the Livingston, N.J.-based company fell $1.30, or 54 percent, to close at $1.10.

The Food and Drug Administration said in an online review that Columbia Labs' drug failed to show a significant reduction in preterm birth among U.S. women tested in the company's trial. The company has submitted the progesterone-based gel, called Prochieve, as a treatment to reduce instances of non-full-term births by women with abnormally short cervixes. The company estimates the problem affects 10 to 12 percent of all pregnancies in the U.S.

On Friday, the FDA will ask a panel of outside experts to vote on the effectiveness and safety of the drug. The FDA is not required to follow the group's advice, though it often does. The FDA will make its final decision on the drug later this year.

Quelle: http://finance.yahoo.com/news/...plummets-negative-fda-215521447.html  

isss klaaaaaaaaaaar  

Shares of Columbia Laboratories /quotes/zigman/70216/quotes/nls/cbrx CBRX +3.54% plunged nearly 60% to 65 cents on Monday. Late Friday, an advisory panel of the U.S. Food and Drug Administration voted against recommending approval of the company's progesterone gel to help prevent premature deliveries in pregnant women with short cervixes, citing insufficient data. While the agency is not bound to the recommendations of its panels, it generally follows them. The product, which is co-marketed by Watson Pharmaceuticals /quotes/zigman/191341/quotes/nls/wpi WPI -0.10% , is already on the market to treat progesterone deficiencies in women undergoing certain fertility treatments. The FDA is expected to make a final decision by Feb. 26  

Columbia Laboratories Inc. (CBRX) and Watson Pharmaceuticals Inc. (WPI), Friday said their progesterone vaginal gel was not recommended for approval by an advisory panel of the Food and Drug Administration. According to the panel, data provided by the company was insufficient to prove the product to be efficient in reducing the risk of preterm birth in women with short cervical length. Following the news, shares of Columbia tumbled down over 62 percent in extended hours trading. The members of Advisory Committee for Reproductive Health Drugs generally agreed that progesterone vaginal gel is safe, however the panel voted 13-4 stating they needed more information to support approval. The FDA is expected to take a final decision on the gel by February 26, 2012. Although the regulatory agency considers the recommendations of its advisory panels, such recommendations are not binding. Frank Condella, CEO of Columbia Laboratories, said, 'We will work with the FDA to address the Advisory Committee's comments as the Agency finalizes its review of our NDA. We remain confident in the Pregnant study results that showed the administration of progesterone vaginal gel 8% is a safe and effective treatment for patients at risk for preterm birth due to short uterine cervical length in the mid-trimester of pregnancy.' CBRX closed Friday's regular trading session at $1.58 on the Nasdaq. However, the stock lost $0.98 or 62.28% in after-hours trade.  

eine zulassung wäre eine überraschung  

 

zum glück ist die cash burn rate nicht so hoch  

immer noch, aber mehr Volumen, hmm...  

einiges an shares aufgesogen worden letzten Tage, hmm... news ahead?  

Anzeige Frankfurt am Main RT  

Drive Paediatric Formulation Development
11:05 19.12.13

PR Newswire

NOTTINGHAM, England, Dec. 19, 2013

NOTTINGHAM, England, Dec. 19, 2013 /PRNewswire/ --A collaborative pharmaceutical project focused on improving the pathway for developing paediatric formulations has been given the go-ahead after successfully securing an innovation grant.

The UK-wide consortium, led by Astra Zeneca, received a £660k grant from the UK's innovation agency, the Technology Strategy Board, to help fund a £1million project aimed at accelerating paediatric formulation development through smart design and predictive science.

The consortium is comprised of pharmaceutical analytical development specialist Molecular Profiles along with Pfizer, Bristol Myers Squibb, GlaxoSmithKline and academic institutions including University College London, University of Bath, University of Birmingham, Aston University and the Academy of Pharmaceutical Sciences (a not-for-profit organisation).

Paediatric formulation development is more complex than the associated adult medicines. In addition to considering the differences in physiology and anatomy, paediatric formulations must offer flexible dosing and provide effective taste-masking.

This project will address the need to improve the speed, cost and quality of paediatric formulation development by drawing on the combined expertise of the consortium members. The goal is to deliver a novel, commercially available, regulatory-approved platform to identify the most appropriate delivery strategy.

Molecular Profiles' chief executive officer Nikin Patel said: "This collaborative project is an ambitious venture aimed at developing a strategic pathway to expedite the development of paediatric formulations, establishing the UK as a global leader in this area. Receipt of the Technology Strategy Board grant will enable us to move forward with this multi-partner project.

"To be involved with such credible consortium members from both large pharmaceutical companies and academia is exciting for Molecular Profiles. Our team is ready to apply our expertise to assist the consortium in achieving its collective goals," concluded Dr. Patel.

The government-backed Technology Strategy Board has awarded over £9.2 million to support 35 collaborative projects to advance the UK's capabilities in formulated products. The funding allocated through the Formulated products - meeting the product and process design challenge was shared across 19 feasibility projects and 16 collaborative R&D projects. The initial funding was increased by 50% due to the strength of submissions.

Molecular Profiles works with leading pharmaceutical companies across the globe and specialises in advanced characterisation, R&D, formulation development and clinical manufacturing services. Its team has specialist knowledge on developing challenging molecules and manufacturing a range of dosage forms spanning solids, liquids, semi-solids and inhaled products, including highly potent compounds.  Molecular Profiles is a wholly-owned subsidiary of Columbia Laboratories, Inc. (Nasdaq: CBRX).

www.molprofiles.co.uk/ | enquiry@molprofiles.co.uk | https://twitter.com/MolProfiles

Notes for editors:

The Technology Strategy Board is the UK's innovation agency. Its goal is to accelerate economic growth by stimulating and supporting business-led innovation. Sponsored by the Department for Business, Innovation and Skills (BIS), the Technology Strategy Board brings together business, research and the public sector, supporting and accelerating the development of innovative products and services to meet market needs, tackle major societal challenges and help build the future economy. For more information please visit www.innovateuk.org.

About Columbia Laboratories

Columbia Laboratories, Inc. is a profitable company with a rich heritage in drug development. The Company's revenue streams include sales and royalty revenues from CRINONE® 8% (progesterone gel), which is marketed by Actavis, Inc. in the United States and by Merck Serono S.A. in over 60 other countries worldwide, and revenues from its wholly-owned subsidiary Molecular Profiles Ltd., a UK-based provider of pharmaceutical formulation development and manufacturing services. For more information, please visit www.columbialabs.com.

Molecular Profiles™ is a registered trademark of Molecular Profiles Ltd.

SOURCE Columbia Laboratories, Inc.


Quelle: PR Newswire  

Fourth Quarter and Year-End 2013 Results
12:05 09.01.14

PR Newswire

BOSTON, Jan. 9, 2014

BOSTON, Jan. 9, 2014 /PRNewswire/ -- Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced preliminary, unaudited financial results of the fourth quarter and year ended December 31, 2013.

For the fourth quarter of 2013, the Company expects to report:

Total revenues in the range of $7.4 to $8.0 million, as compared with $7.1 million in the fourth quarter of 2012.
Services revenues from Molecular Profiles in the range of $2.6 to $3.1 million.
Product revenues from Merck Serono in the range of $3.4 to $3.7 million, as compared with $4.9 million in the fourth quarter of 2012.  This result is in line with the Company's stated expectations.  
Cash and cash equivalents increased to $20.6 million at December 31, 2013, an increase of $1.8 million from September 30, 2013.
For fiscal 2013, the Company expects to report:

Total revenues of $28.8 to 29.4 million dollars, as compared with $25.8 million in 2012.
Services revenues from Molecular Profiles in the range of $3.2 to $3.7 million since its acquisition by Columbia on September 12, 2013.
Product revenues from Merck Serono in the range of $21.2 to $21.6 million, as compared with $17.2 million in 2012.
"Our year-on-year fourth quarter revenue growth was largely driven by the contributions of our world-class pharmaceutical development subsidiary, Molecular Profiles," said Frank Condella, Columbia's president and CEO.  "We are well positioned for continued growth within the $21.5 billion-and-growing global outsourced pharmaceutical development market."

As previously disclosed, Merck Serono was building inventory of CRINONE® (progesterone gel) during the first three quarters of 2013 in one of its higher-volume, higher-margin markets ahead of a routine license renewal.  During the renewal period, which is expected to continue through the first half of 2014, Merck Serono is not expected to ship CRINONE into this market.  As a result, product revenue from Merck Serono was lower for the fourth quarter of 2013; this is expected to continue through the first half of 2014.  CRINONE revenues fluctuate from quarter-to-quarter and year-to-year based in part on the timing of product batch shipments to Merck Serono.  However, underlying CRINONE worldwide in-market sales are expected to continue to increase throughout 2014 and beyond driven by Merck Serono's continued growth in emerging markets and entry into new markets.

Columbia's updated investor presentation is now available on its website, www.columbialabs.com. Columbia Laboratories' management will be conducting meetings in San Francisco the week of January 13 at the Trout Group's Annual 1x1 Management Access Event.

The results disclosed in this press release are preliminary and unaudited.  The Company will report full, audited results for the fourth quarter and year ended December 31, 2013 in early March 2014.

About Columbia Laboratories

Columbia Laboratories, Inc. is a publicly traded company with a rich heritage in drug development. The Company's revenue streams include sales and royalty revenues from CRINONE® 8% (progesterone gel), which is marketed by Actavis, Inc. in the United States and by Merck Serono S.A. in over 60 other countries worldwide, and revenues from its wholly-owned subsidiary Molecular Profiles™ Ltd., a world-class pharmaceutical development company providing formulation development, clinical trial manufacturing, high-end analytics and IP support to multinational pharmaceutical companies. For more information, please visit www.columbialabs.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words "may," "will," "plans," "believes," "expects," "anticipates," "potential," "should," and similar expressions. These include all statements relating to expected financial performance, including, without limitation, statements involving projections of revenue, margin, and the Company's future growth prospects.  Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: completing the financial reporting closing process and financial audit, which could necessitate changes to these preliminary results; the effect of converting Molecular Profiles' financial statements from U.K. to U.S. GAAP; Actavis' and Merck Serono's success in marketing CRINONE for use in infertility in their respective markets; the successful launch by Actavis of the next-generation vaginal progesterone product for the U.S. market; Molecular Profiles' ongoing ability to retain current and attract new customers; difficulties or delays in manufacturing; the availability and pricing of third-party sourced products and materials; successful compliance with FDA, MHRA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; changes in the laws and regulations; the ability to obtain and enforce patents and other intellectual property rights; the impact of patent expiration; the impact of competitive products and pricing; the strength of the United States dollar relative to international currencies, particularly the euro, British pound and the Swiss franc; competitive, economic, and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the SEC, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2012.  Columbia does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.

CRINONE® is a registered trademark of Actavis, Inc. in the U.S. and of Merck Serono S.A. outside the U.S.

Molecular Profiles™ is a trademark of Molecular Profiles Ltd., a wholly-owned subsidiary of Columbia Laboratories, Inc.

Contact:

Jonathan Lloyd Jones

Tricia Truehart

Vice President & CFO

Senior Associate

Columbia Laboratories, Inc.

The Trout Group LLC

(617) 639-1500

(646) 378-2593



SOURCE Columbia Laboratories, Inc.


Quelle: PR Newswire  

Under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are indicated by the words "may," "will," "plans," "believes," "expects," "anticipates," "potential," "should," and similar expressions. These include all statements relating to expected financial performance, including, without limitation, statements involving projections of revenue, margin, and the Company's future growth prospects.  Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. Factors that might cause future results to differ include, but are not limited to, the following: completing the financial reporting closing process and financial audit, which could necessitate changes to these preliminary results; the effect of converting Molecular Profiles' financial statements from U.K. to U.S. GAAP; Actavis' and Merck Serono's success in marketing CRINONE for use in infertility in their respective markets; the successful launch by Actavis of the next-generation vaginal progesterone product for the U.S. market; Molecular Profiles' ongoing ability to retain current and attract new customers; difficulties or delays in manufacturing; the availability and pricing of third-party sourced products and materials; successful compliance with FDA, MHRA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; changes in the laws and regulations; the ability to obtain and enforce patents and other intellectual property rights; the impact of patent expiration; the impact of competitive products and pricing; the strength of the United States dollar relative to international currencies, particularly the euro, British pound and the Swiss franc; competitive, economic, and regulatory factors in the pharmaceutical and healthcare industry; general economic conditions; and other risks and uncertainties that may be detailed, from time-to-time, in Columbia's reports filed with the SEC, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2012.  Columbia does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.

CRINONE® is a registered trademark of Actavis, Inc. in the U.S. and of Merck Serono S.A. outside the U.S.

Molecular Profiles™ is a trademark of Molecular Profiles Ltd., a wholly-owned subsidiary of Columbia Laboratories, Inc.

Contact:

Jonathan Lloyd Jones

Tricia Truehart

Vice President & CFO

Senior Associate

Columbia Laboratories, Inc.

The Trout Group LLC

(617) 639-1500

(646) 378-2593



SOURCE Columbia Laboratories, Inc.


Quelle: PR Newswire