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so is 2012 the pay date? $6 maybe per share. I bought this while in Iraq never payed attention to it. Finally emailed scottrade about the # behind the ticker. MDCO has done this allot.
Let us know when you've find the others that have not as of yet moved up!
> Btw TELK moved up nicely for the end of year run as you told me earlier, but I sold to soon
Volume tells the story for many of these small cap biotechs, sold my TARG today. Looking for others that have not as of yet moved up.
surf
Too bad, I had a feeling you might have taken more profits last day or two. Oh well. SSP and I were looking at TARG yesterday on the move, stayed out because the volume didn't excite us. LOL that's the way she goes.
Jim nice news for TARG. Unfortunately, I did sell the rest of mine at a buck. Made a nice profit, but could have more than doubled that. Rats. Can't win them all. Jim
Volume will come into the stock now:
6:53AM The Medicines Company to acquire Targanta Therapeutics for $2.00 in cash; shareholders may also receive contingent cash payments (TARG) 1.16 : MDCO announces that it has entered into a merger agreement with Targanta Therapeutics Corp (TARG) under which The Medicines Co has agreed to commence a tender offer to acquire 100% of TARG's outstanding shares. Co says, "The addition of Targanta's oritavancin, a late stage product, will be another step toward execution of our strategic plan to become a global leader in critical care medicine... Oritavancin has the potential to provide important patient outcome and economic advantages for hospitals. The growing hospital market for gram positive infections in the U.S. alone reached $1.1 bln in 2007. We believe that oritavancin can become an important anti-infective for serious infections involving difficult-to-treat bacteria in difficult-to-treat hospitalized patients. Many of those critically ill patients are the same patients treated with our existing products." Under the terms of the merger agreement, Targanta shareholders will receive $2.00 in cash up front for each common share tendered, or approximately $42 mln. Targanta shareholders may also be entitled to receive additional contingent cash payments upon the achievement of specified regulatory and commercial milestones within agreed upon time periods: 1) Upon Food and Drug Administration approval of a new drug application for oritavancin for cSSSI using a single dose infusion, $1.20 per share. If FDA approval does not include single dose infusion labeling, this payment is reduced to $0.50 per share. 2) Upon European Medicines Agency approval of a marketing authorization application for oritavancin for cSSSI during 2009, $1.00 per share. If EMEA approval occurs later, this payment is reduced to $0.75 per share if it occurs prior to June 30, 2010 or if later, $0.50 per share. 3) On achievement of worldwide net sales adding up to a total of $400 mln or more in the aggregate over four consecutive quarters, a one-time payment of $2.35 per share. Co says, "Oritavancin is a well characterized Phase 3 asset. We believe the deal terms reflect a balanced investment to expand our product portfolio and we agreed to pay for the transaction with cash to avoid share dilution. The addition of staged payments provides Targanta shareholders additional value if milestones are achieved and mitigates risk for The Medicines Company,"
The Medicines Company to Acquire Targanta Therapeutics
Acquisition Would Expand Global Critical Care Pipeline With Phase 3 Hospital Antibiotic Oritavancin for Serious Infections
Monday January 12, 2009, 10:34 pm EST
PARSIPPANY, NJ--(MARKET WIRE)--Jan 12, 2009 -- The Medicines Company (NasdaqGS:MDCO - News) today announced that it has entered into a merger agreement with Targanta Therapeutics Corporation (NasdaqGM:TARG - News) under which The Medicines Company has agreed to commence a tender offer to acquire 100 percent of Targanta's outstanding shares.
"The Medicines Company is pleased to announce our agreement to add the assets and capabilities of Targanta. The addition of Targanta's oritavancin, a late stage product, will be another step toward execution of our strategic plan to become a global leader in critical care medicine," said Clive Meanwell, M.D., Chairman and Chief Executive Officer of The Medicines Company. "Oritavancin has the potential to provide important patient outcome and economic advantages for hospitals. The growing hospital market for gram positive infections in the U.S. alone reached $1.1 billion in 2007. We believe that oritavancin can become an important anti-infective for serious infections involving difficult-to-treat bacteria in difficult-to-treat hospitalized patients. Many of those critically ill patients are the same patients treated with our existing products."
Under the terms of the merger agreement, Targanta shareholders will receive $2.00 in cash up front for each common share tendered, or approximately $42 million. Targanta shareholders may also be entitled to receive additional contingent cash payments upon the achievement of specified regulatory and commercial milestones within agreed upon time periods:
-- Upon Food and Drug Administration (FDA) approval of a new drug
application (NDA) for oritavancin for cSSSI (complicated skin and skin
structure infections) using a single dose infusion, $1.20 per share. If
FDA approval does not include single dose infusion labeling, this payment
is reduced to $0.50 per share.
-- Upon European Medicines Agency (EMEA) approval of a marketing
authorisation application (MAA) for oritavancin for cSSSI during 2009,
$1.00 per share. If EMEA approval occurs later, this payment is reduced to
$0.75 per share if it occurs prior to June 30, 2010 or if later, $0.50 per
share.
-- On achievement of worldwide net sales adding up to a total of $400
million or more in the aggregate over four consecutive quarters, a one-time
payment of $2.35 per share.
The transaction has been approved by the boards of directors of both companies, and Targanta's Board of Directors has recommended that Targanta's shareholders tender their shares into the tender offer, adopt the merger agreement and approve the merger.
"We believe that this transaction can create significant value for our shareholders and further expand our portfolio of critical care products. It adds a late stage product, with global rights, and the potential for near-term revenue, and could contribute significantly to our long-term growth. Oritavancin is a well characterized Phase 3 asset. We believe the deal terms reflect a balanced investment to expand our product portfolio and we agreed to pay for the transaction with cash to avoid share dilution. The addition of staged payments provides Targanta shareholders additional value if milestones are achieved and mitigates risk for The Medicines Company," said Glenn Sblendorio, EVP & Chief Financial Officer.
Targanta's lead product, oritavancin, is an innovative, investigational hospital-based antibiotic with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria including staphylococcal strains with resistance to methicillin (MRSA) and vancomycin. Oritavancin has the potential to provide significant clinical advantages, including superior dosing options over current IV antibiotics that treat serious infections in the hospital setting. While conventional daily dosing with oritavancin would provide hospitals with a new treatment option, the potential for oritavancin to be a single dose product could deliver significant cost advantages and treatment benefits to the health-care system. Initial use of oritavancin is expected in critical care settings within the hospital including the ICU, surgical suite and the emergency department, where The Medicines Company sales representatives promote our current products.
Oritavancin has been studied in two pivotal Phase 3 trials in the treatment of cSSSI (complicated skin and skin structure infections). Phase 2 trials have successfully studied the compound in gram positive bacteremia and have examined efficacy and safety of a single dose infusion in cSSSI (SIMPLIFI trial). Pre-clinical studies have shown unique anti-microbiological activity in Clostridium Difficile infection, a rapidly growing problem, which causes severe and occasionally life-threatening colitis in the hospital.
Invasive MRSA infection is a serious and growing public health care concern. In the U.S. over 94,000 patients suffered invasive infection in 2005, and, of these, almost 19,000 cases were associated with death (Klevens, RM et al., JAMA. 2007 Oct 17). As a result of this epidemic, the lack of efficacy provided by existing older drug treatments, and the availability of novel antibiotics similar to oritavancin delivered with conventional dosing, the US market for sales of gram-positive antibiotics grew to more than $1 billion in 2007, up 17% since 2006.
In December 2008, the U.S. Food and Drug Administration (FDA) issued a complete response letter to Targanta's New Drug Application (NDA) indicating that it could not approve the NDA in its present form and that it would be necessary for Targanta to perform an additional adequate and well-controlled study to demonstrate the safety and efficacy of oritavancin in patients with cSSSI before the application may be approved. A Market Authorisation Application (MAA) for oritavancin is undergoing review by the European Medicines Agency (EMEA).
Following consummation of the transaction, The Medicines Company plans to consult with regulatory authorities with a view to initiating a confirmatory Phase 3 study, in the United States, of oritavancin given as a single dose infusion before the end of the year.
The tender offer will expire at midnight Eastern Time on the 20th business day following and including the commencement date, unless extended in accordance with the terms of the merger agreement and the applicable rules and regulations of the Securities and Exchange Commission. The tender offer, if successful, will be followed by a second-step merger in which any shares of Targanta not tendered into the offer will be converted into the right to receive the same per share consideration paid to Targanta shareholders in the tender offer. The Medicines Company has entered into agreements with Targanta shareholders representing approximately 36% of the voting shares outstanding to tender their shares in the tender offer.
The consummation of the tender offer is subject to the satisfaction or waiver of certain conditions, including: (i) a majority of outstanding Targanta shares on a fully diluted basis having been tendered into the offer, (ii) the absence of litigation by any governmental agency relating to the transaction or any other litigation that would reasonably be expected to succeed and in which a judgment adverse to Targanta would reasonably be expected to result in a material adverse change with respect to Targanta, (iii) there not having been a material adverse change with respect to Targanta, and (iv) other customary conditions. The tender offer is not subject to a financing condition.
The Medicines Company plans to announce fourth quarter and full year 2008 financial results in February 2009. At that time, the Company will provide expected 2009 full-year net sales and net income estimates based upon completion of the valuation of the transaction and transition costs.
The Medicines Company management will host a conference call on Tuesday, January 13th at 8:30 a.m. Eastern Time to discuss the proposed Targanta acquisition and its anticipated impact on ongoing operations. The conference call will be available via phone and webcast. Dial in details are as follows -- domestic dial in 800-561-2601; international dial in 617-614-3518; participant passcode 32479308. A replay of the call will be available until 12:00 a.m. EST on January 26 by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 93634023. The webcast can be accessed at The Medicines Company website at http://www.themedicinescompany.com/.
Advisors
J.P. Morgan acted as financial advisor and WilmerHale acted as legal advisor to The Medicines Company for this transaction. Leerink Swann acted as financial advisor and Ropes & Gray acted as legal advisor to Targanta Therapeutics Corporation.
About Oritavancin
Oritavancin is a novel, semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria. The oritavancin NDA submission included data from 19 clinical trials, including two pivotal Phase 3 clinical trials examining the safety and efficacy of oritavancin in the treatment of cSSSI, both of which met their primary endpoints. The NDA dossier also included the data from more than 2,100 individuals and in vitro activity data on oritavancin against more than 9,000 clinical bacterial isolates, including a broad range of gram-positive strains resistant to commonly used antibiotics such as oxacillin, methicillin, vancomycin, daptomycin, and linezolid.
About Targanta Therapeutics
Targanta Therapeutics Corporation (NasdaqGM:TARG - News) is a biopharmaceutical company focused on developing and commercializing innovative antibiotics to treat serious infections in the hospital and other institutional settings. The Company's pipeline includes an intravenous version of oritavancin, a semi-synthetic lipoglycopeptide antibiotic currently awaiting EU regulatory approval, and a program to develop an oral version of oritavancin for the possible treatment of Clostidium difficile-related infection. The Company has operations in Cambridge, MA, Indianapolis, IN, and Montreal, Quebec, Canada. For more information on Targanta, visit http://www.targanta.com/.
MDCO-G
About The Medicines Company
The Medicines Company (NasdaqGS:MDCO - News) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiomax® (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, and Cleviprex® (clevidipine butyrate) injectable emulsion in the United States for the reduction of blood pressure when oral therapy is not feasible or not desirable. The Company also has an investigational antiplatelet agent, cangrelor, in late-stage development and a serine protease inhibitor, CU-2010, in early-stage development. The Company's website is http://www.themedicinescompany.com/.
Cautionary Note regarding Forward-Looking Statements
Statements in this press release regarding the proposed transaction between the Company and Targanta, the expected timetable for completing the transaction, future financial and operating results, benefits and synergies of the transaction, future opportunities for the combined company, new product development, including obtaining regulatory approvals, and any other statements about the Company managements' future expectations, beliefs, goals, plans or prospects constitute forward-looking statements. Any statements that are not statements of historical fact (including statements containing the words "believes," "plans," "anticipates," "expects," "estimates" and similar expressions) should also be considered to be forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include uncertainties as to the timing of the tender offer and merger; uncertainties as to how many of Targanta's stockholders will tender their stock in the offer; the risk that competing offers will be made; the possibility that various closing conditions for the transaction may not be satisfied or waived; the effects of disruption from the transaction making it more difficult to maintain relationships with employees, licensees, other business partners or governmental entities; transaction costs; whether results obtained in clinical studies or in preclinical studies such as the studies referred to above will be indicative of results obtained in future clinical trials; whether, if the Company consummates the acquisition, the Company can advance oritavancin through the contemplated Phase 3 trial on a timely basis or at all and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies for the product; whether, if oritavancin receives approval, the Company will be able to successfully distribute and market the product and in that regard, whether physicians, patients and other key decision-makers will accept clinical trial results; whether the Company will be able to obtain regulatory approvals and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on November 10, 2008, which are incorporated herein by reference. The forward-looking statements are made only as of the date of publication. Except as otherwise required by law, the Company specifically disclaims any obligation to update any of these forward-looking statements.
Additional Information
This press release is neither an offer to purchase nor a solicitation of an offer to sell shares of Targanta. Boxford Subsidiary Corporation (the "Merger Sub"), a wholly owned subsidiary of The Medicines Company, has not commenced the tender offer for the shares of Targanta stock described in this press release.
Upon commencement of the tender offer, the Merger Sub will file with the SEC a tender offer statement on Schedule TO and related exhibits, including the offer to purchase, letter of transmittal, and other related documents. Following commencement of the tender offer, Targanta will file with the SEC a tender offer solicitation/recommendation statement on Schedule 14D-9. These documents will contain important information about The Medicines Company, Targanta, the transaction and other related matters. Investors and security holders are urged to read each of these documents carefully when they are available.
Investors and security holders will be able to obtain free copies of the tender offer statement, the tender offer solicitation/recommendation statement and other documents filed with the SEC by The Medicines Company and Targanta through the web site maintained by the SEC at http://www.sec.gov/. In addition, investors and security holders will be able to obtain free copies of these documents from The Medicines Company or Targanta by contacting: Robyn Brown of The Medicines Company at 973-290-6000 or investor.relations@themedco.com, or Susan Hager of Targanta at 617-577-9020 x217 or shager@targanta.com.
Contact:
Contact:
Emily Poe
WeissComm Partners
Phone: (212) 301-7183
Email Contact
Robyn Brown
The Medicines Company
Phone: (973) 656-1616
Email Contact
I am hedging on this one. Sold half today for a nice gain. Will hold the rest for a buck should no news come. With news, holding/selling plans change. Jim
I am waiting for the volume to come into TARG before selling, with over 400k shares short and low volume, we should get a volume spike soon.
surf
Nice movement since last week. From around .50 to .93 now. Jim
Targanta Announces Corporate Restructuring
Thursday December 18, 4:05 pm ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Targanta Therapeutics Corporation (Nasdaq: TARG - News) today announced a strategic restructuring including a staff reduction of 86 employees, approximately 75% of the company's total workforce. Following the restructuring, the company expects to have 27 employees. The Company expects the majority of the plan to be implemented by the end of December 2008.
The restructuring and corresponding reduction in workforce is meant to preserve capital, while maintaining key personnel needed to support the regulatory approval process for oritavancin in the European Union, while simultaneously clarifying the regulatory pathway for oritavancin with the U.S. Food and Drug Administration (FDA) and developing the protocol for an additional Phase 3 study of oritavancin for the treatment of complicated skin and skin structure infections (cSSSI).
Mark Leuchtenberger, President and CEO of Targanta, commented, "Targanta has transitioned from a company preparing for the commercial launch of its lead drug candidate to a late-stage clinical development company since receiving the FDA’s Complete Response Letter to our New Drug Application (NDA) for oritavancin. Targanta’s management team and its Board of Directors are in alignment that our best path forward to achieving our corporate goals and preserving shareholder value is to restructure the Company and focus our resources and capital in a way that efficiently advances oritavancin for the treatment of cSSSI. This restructuring in no way reflects the tireless efforts and tremendous contributions of the Targanta team who have worked so hard to advance this much needed antibiotic therapy.”
As part of the restructuring and to further reduce costs, Chief Development Officer, Pierre E. G. Etienne, M.D.; Chief Commercial Officer, Mona Haynes; and, Vice President of Operations and Head of Targanta’s Indianapolis, Indiana site, Roger D. Miller, will be leaving the company.
Employees affected by the reduction have been offered severance benefits. The company expects to incur restructuring charges of approximately $5.8 million.
Targanta's Oritavancin MAA Accepted for Review by EMEA
Wednesday June 25, 5:58 am ET
Company Seeking Approval for the Treatment of Complicated Skin and Soft Tissue Infections in Europe
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Targanta Therapeutics Corporation (Nasdaq: TARG - News) today announced that the European Medicines Agency (EMEA) has accepted for review its Marketing Authorization Application (MAA) for oritavancin, Targanta’s novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria. Targanta is seeking approval of intravenous oritavancin in the European Union for the treatment of complicated skin and soft tissue infections (cSSTI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Targanta announced the submission of its MAA for oritavancin to EMEA on June 9, 2008.
“With the acceptance for review of our United States regulatory filing for oritavancin earlier this year, closely followed by this EMEA acceptance for review, we are proud to have achieved these planned operational milestones and we are now in the position of planning for the commercial launch of oritavancin in the U.S. and European markets," said Mark Leuchtenberger, President and CEO of Targanta. “If regulatory discussions progress as anticipated and approval is received, we expect to launch oritavancin in the U.S. in the first half of 2009. Given the standard regulatory review times in the EU, we hope to receive approval for oritavancin in late 2009.”
Mona Haynes, Targanta’s Chief Commercial Officer, commented further on the need for new agents in the EU: “As in the U.S., serious gram-positive infections are increasing and provide challenges to healthcare professionals. We are excited at the possibility of bringing clinicians another option to use in patients with these difficult-to-treat infections.”
The oritavancin MAA includes data from 19 clinical trials, including two pivotal Phase 3 clinical trials examining the safety and efficacy of intravenous oritavancin in the treatment of cSSTI (known in the U.S. as complicated skin and skin structure infections, or cSSSI), both of which met their primary endpoints. The MAA dossier also includes data from more than 2,100 individuals and in vitro activity data on oritavancin against more than 9,000 clinical bacterial isolates, including a broad range of gram-positive strains resistant to commonly used antibiotics such as oxacillin, methicillin, vancomycin, daptomycin, and linezolid.
About Oritavancin
Oritavancin is a novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria. In its intravenous (IV) formulation, the product candidate has been tested in over 2,400 individuals and has completed two Phase 3 studies for the treatment of complicated skin and skin structure infections (cSSSI) in which the primary endpoints were met. Targanta submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in February 2008 seeking to commercialize oritavancin for the treatment of cSSSI; the FDA accepted the NDA submission for standard review, establishing an action date of December 8, 2008. Targanta’s Marketing Authorization Application (MAA) for oritavancin was accepted for review by the European Medicines Agency (EMEA) in June 2008. Targanta is also developing an oral version of oritavancin for possible treatment of Clostridium difficile-related conditions.
Targanta Completes Enrollment in Phase 2 Oritavancin Infrequent Dosing Study
Tuesday May 20, 7:58 am ET
SIMPLIFI Examining Single- and Infrequent-Dosing Regimens in cSSSI
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Targanta Therapeutics Corporation (Nasdaq: TARG - News) today announced that enrollment has been completed in its Phase 2 trial investigating the safety and efficacy of oritavancin at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (cSSSI), or SIMPLIFI. Oritavancin is Targanta’s lead antibiotic candidate targeting gram-positive infections.
Mark Leuchtenberger, President and Chief Executive Officer of Targanta, commented on the event: “We are very pleased to have completed enrollment in SIMPLIFI on schedule and are looking forward to locking the database and analyzing the results over the next few months. We are optimistic that we will have data ready to submit to one of the major infectious disease meetings this fall and will be using these data to determine whether to pursue Phase 3 registration trials for infrequent dosing of oritavancin in the treatment of cSSSI.”
“As discussed previously,” Mr. Leuchtenberger continued, “we believe that, if demonstrated effective in pivotal, controlled trials and subsequently approved by regulatory authorities, a less frequent dosing regimen for oritavancin could be a major advantage to the infectious disease community by providing flexible patient treatment options and could also confer pharmacoeconomic benefits through shorter hospital stays and reduced use of hospital resources.”
Targanta submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in February 2008 seeking to commercialize oritavancin for the treatment of cSSSI; the FDA has accepted the NDA submission for standard review, establishing an action date of December 8, 2008.
About SIMPLIFI
This Phase 2 study is an international, multi-center, randomized, double-blind, controlled study in patients with cSSSI presumed or proven to be caused by gram-positive pathogen(s). The study consisted of three treatment arms in which patients received either:
* 200 mg oritavancin delivered by intravenous (IV) administration daily for a minimum of 3 days and up to a maximum of 7 days (the dosing regimen used in the larger of the two completed Phase 3 studies of oritavancin in cSSSI and currently under review by U.S. regulatory authorities);
* A single dose of 1200 mg oritavancin IV; or
* A single dose of 800 mg oritavancin IV, with a further dose of 400 mg IV on Day 5, if needed.
As its primary endpoint, SIMPLIFI is measuring clinical response (either cure or improvement versus failure) in clinically evaluable patients. As a secondary endpoint, this study is examining safety data in all intent-to-treat patients. Over 300 patients were enrolled in the study.
Targanta Reports First-Quarter 2008 Financial Results
Tuesday May 13, 7:58 am ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Targanta Therapeutics Corporation (Nasdaq: TARG - News) today reported financial results for the quarter ended March 31, 2008.
Targanta reported a net loss of $17.6 million for the three months ended March 31, 2008, compared to a net loss of $18.7 million for the same period in 2007. Net loss for the first quarter of 2007 included $9.5 million of expense related to the Company’s achievement of certain milestones under its agreement with InterMune, Inc. Excluding this expense, the increase in net loss period over period was primarily due to increases in research and development expenses related to advancement of the Company’s lead intravenous antibiotic candidate, oritavancin, for which Targanta submitted a New Drug Application to the U.S. Food and Drug Administration in the first quarter and on which the Company is conducting additional clinical trials. The calculation of net loss for the first quarter ended March 31, 2008 includes stock-based compensation expense of $0.5 million.
The Company had cash, cash equivalents and short-term investments totaling $73.3 million as of March 31, 2008 and had 21.0 million shares outstanding.
Targanta Announces Highlights of Oritavancin Data to Be Presented at the 18th ECCMID
Saturday April 19, 1:00 am ET
Presentations Highlight Candidate Antibiotic's In Vivo and In Vitro Activity
BARCELONA, Spain--(BUSINESS WIRE)--Targanta Therapeutics Corporation (NASDAQ: TARG - News) today announced the presentation of data further detailing the in vivo and in vitro activity of its lead intravenous antibiotic candidate, oritavancin, at the 18th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) taking place in Barcelona, Spain, April 19th through the 22nd. Oritavancin is currently awaiting U.S. regulatory approval for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus, or MRSA.
Thomas Parr, Jr., Ph.D., Targanta’s Chief Scientific Officer commented on the Company’s presence at the meeting: “We are delighted that oritavancin is the focus of so many poster and oral presentations at this important European infectious disease conference. We believe it could not come at a better time, as we prepare for a mid-2008 Marketing Authorization Application (MAA) submission seeking approval of oritavancin in the European Union for the treatment of complicated skin and soft tissue infections, the European term for cSSSI. We would like to thank our international collaborators and commend the Targanta researchers for their contributions to the impressive body of work being presented at ECCMID this year.”
Highlights of the presentations focused on oritavancin follow.
Oritavancin Active Against Small Colony Variants (SCVs)
Persistence of S. aureus infection has been associated with the presence of SCVs in a variety of clinical situations including cystic fibrosis, osteomyelitis, and device-associated infections. These SCVs are thought to be protected from the effects of antibiotics due to their intracellular location. Two posters are being presented at ECCMID that suggest oritavancin’s potential utility in the eradication of these persistent infections.
Poster 1058 (P-1058) concludes that when used at high concentrations, oritavancin shows the most rapid and substantial effect of the agents studied (gentamicin, rifampicin, vancomycin, moxifloxacin, linezolid and tigecycline) against an SCV strain that was isolated from a cystic fibrosis patient in a human airway model, while P-1059 concludes that the combination of oritavancin with either moxifloxacin or rifampicin may prove useful for eradicating intracellular SCVs; indeed, the oritavancin-rifampicin combination was the only combination tested that eradicated the infecting strain from the human cell line.
Data Support Study of Short-Course Oritavancin for cSSSI
Targanta is currently testing a single/infrequent dosing regimen for oritavancin in the treatment of cSSSI in a Phase 2 clinical trial. In an oral presentation (O-152), pharmacokinetic and pharmacodynamic data will be presented that provided the basis for this trial. Due to oritavancin’s long half life and demonstrated concentration-dependent bactericidal activity, the approach presented here proved useful in selecting the dosing regimen for the study. Further, the speaker postulates that front-loaded regimens are likely to result in improved response rates for patients with cSSSI relative to other antibiotic regimens previously studied. Targanta believes, if clinical development of oritavancin with a single/infrequent dosing regimen is successful, that oritavancin could play a role in changing the treatment paradigm for cSSSI as a result of possible patient convenience and pharmacoeconomic benefits through shorter hospital stays and reduced use of hospital resources.
Broad, Rapid and Potent In Vitro Activity Demonstrated
Six posters are being presented today at ECCMID detailing oritavancin’s activity in vitro against a variety of strains of susceptible and resistant gram-positive bacteria:
Data from the study summarized in P-537 suggest that oritavancin activity is differentiated from other glycopeptide antibiotics, such as vancomycin, due to its ability to rapidly kill MRSA by affecting the coordination of cell division, and vancomycin-resistant Enterococcus faecalis (VRE) by breaking down the cell wall.
P-538 and P-539 conclude that oritavancin maintains potent in vitro activity against clinical European bacterial isolates including: strains of staphylococci resistant to oxacillin or multiple drugs, coagulase-negative staphylococci non-susceptible to linezolid and daptomycin; both vancomycin-susceptible and –resistant enterococci (VSE and VRE) whether E. faecalis or E. faecium; and against all streptococci, regardless of penicillin, macrolide or multi-drug resistance phenotypes.
In the study summarized in P-584, researchers demonstrated oritavancin activity against S. aureus that showed hetero-vancomycin-intermediate resistance (hVISA); hVISA isolates are thought to be the precursors of VISA strains and associated with failure in treatment with vancomycin.
P-544 concludes that under the conditions tested, which mimicked physiologically relevant antibiotic concentrations for oritavancin and the comparators (vancomycin, teicoplanin, linezolid and daptomycin), oritavancin was the only antibacterial agent tested that displayed concentration-dependent killing of all tested strains of MRSA, VRSA and hVISA in vitro. Furthermore, oritavancin cell eradication activity was rapid, killing at least 99.9% of viable cells of the tested strains within 6 hours.
Poster 597 details oritavancin’s activity against biofilms of Staphylococcus epidermidis , as well as biofilms of VSE and VRE, which are prominent in infections of indwelling devices and infective endocarditis and thought to be a major cause of relapse.
About Oritavancin
Oritavancin is a novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria. The product candidate has been tested in over 2,100 individuals and has completed two Phase 3 studies for the treatment of complicated skin and skin structure infections (cSSSI) in which the primary endpoints were met. Targanta submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in February 2008 seeking to commercialize oritavancin for the treatment of cSSSI and believes oritavancin's properties may give it distinct advantages in the treatment of patients with serious gram-positive skin infections, if approved.
Targanta Announces FDA Acceptance of Oritavancin New Drug Application
Wednesday April 9, 7:58 am ET
Targanta to Host Conference Call & Webcast at 4:30 pm ET TODAY
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Targanta Therapeutics Corporation (Nasdaq: TARG - News) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review its New Drug Application (NDA) for its lead antibiotic candidate, oritavancin. The Company also announced it will hold a conference call and webcast today at 4:30 pm ET to discuss recent corporate achievements.
By granting standard review status to oritavancin, the FDA has established a target date to act on the NDA filing by December 8, 2008. The oritavancin NDA was submitted in early February seeking approval of the intravenous antibiotic for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus, or MRSA. These types of resistant infections have created a market that IMS Health estimated to be over one billion dollars in the U.S. in 2007 and growing rapidly.
“With an expected FDA response date in December, we have begun the exciting task of building a commercial infrastructure to position the company to begin marketing oritavancin in the U.S. in the first half of 2009," said Mark Leuchtenberger, President and CEO of Targanta. “In the meantime, we will continue to work closely with the FDA to facilitate its review of our NDA while preparing for an advisory committee meeting in the fall of 2008. In addition, we are on track to submit a Marketing Authorization Application for European Union approval of oritavancin by mid-2008 for the treatment of complicated skin and soft tissue infections, the European name for cSSSI, and, given our preliminary discussions with EU regulatory authorities and standard review times, we hope to receive approval of oritavancin in the EU in late 2009.”
Mona Haynes, Targanta’s Chief Commercial Officer commented on the news as well: “We are very excited about the possibility of bringing a new choice to physicians treating patients with serious gram-positive skin and skin structure infections. We believe that the unique combination of characteristics of oritavancin could make it an attractive option for clinicians in both the hospital and outpatient settings, should it gain approval.”
The oritavancin NDA submission includes data from 19 clinical trials, including two pivotal Phase 3 clinical trials examining the safety and efficacy of oritavancin in the treatment of cSSSI, both of which met their primary endpoints. The NDA dossier also includes data from more than 2,100 individuals and in vitro activity data on oritavancin against more than 9,000 clinical bacterial isolates, including a broad range of gram-positive strains resistant to commonly used antibiotics such as oxacillin, methicillin, vancomycin, daptomycin, and linezolid.
Targanta Reports Fourth-Quarter and Full-Year 2007 Financial Results
Monday March 24, 7:58 am ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Targanta Therapeutics Corporation (Nasdaq: TARG - News) today reported financial results for the quarter and full year ended December 31, 2007.
Targanta reported a net loss of $10.7 million for the three months ended December 31, 2007, compared to a net loss of $8.7 million for the same period in 2006. This increase is primarily due to increases in research and development expenses related to advancement of the Company’s lead antibiotic candidate, oritavancin, for which Targanta recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and on which the Company is conducting additional clinical trials. For the full year ended December 31, 2007, the Company reported a net loss of $63.3 million compared to a net loss of $30.1 million for the same period in 2006. The calculation of net loss for the fourth quarter and full year ended December 31, 2007 includes stock-based compensation expense of $0.5 million and $2.2 million, respectively.
The Company had cash, cash equivalents and short-term investments totaling $90.3 million as of December 31, 2007 and 21.0 million shares outstanding.
On October 9, 2007, the Company completed its initial public offering, issuing 5.75 million shares of its Common Stock at a price of $10.00 per share. Net proceeds to the Company were approximately $51.1 million after deducting underwriting discounts and commissions and offering expenses.
“2007 was a year of great accomplishment at Targanta, culminating in our recent first regulatory submission for oritavancin,” said Mark Leuchtenberger, President and Chief Executive Officer of Targanta. “With our Series C fundraising early in 2007, our successful IPO in October, and key additions to our senior management team, we believe we are well positioned to bring oritavancin to market, should we gain approval, providing physicians and hospitals with a new tool to fight resistant bacterial skin infections.”
Targanta Submits Oritavancin New Drug Application
Monday February 11, 8:15 am ET
Candidate Represents Potential New Short-Course Treatment Option for Serious Gram-Positive Skin Infections, Including MRSA
CAMBRIDGE, Mass., Feb. 11 /PRNewswire-FirstCall/ -- Targanta Therapeutics Corporation (Nasdaq: TARG - News) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead antibiotic candidate, oritavancin, a novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria.
Targanta Submits Oritavancin New Drug Application
Monday February 11, 8:15 am ET
Candidate Represents Potential New Short-Course Treatment Option for Serious Gram-Positive Skin Infections, Including MRSA
http://biz.yahoo.com/prnews/080211/nym038.html?.v=101
CAMBRIDGE, Mass., Feb. 11 /PRNewswire-FirstCall/ -- Targanta Therapeutics Corporation (Nasdaq: TARG - News) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead antibiotic candidate, oritavancin, a novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal (killing) activity against a broad spectrum of gram-positive bacteria.
Targanta to Participate in BIO CEO & Investor Conference
Tuesday February 5, 8:00 am ET
Participation Includes Corporate Presentation and Antibiotic Panel; Corporate Presentation to be Webcast Live
CAMBRIDGE, Mass., Feb. 5 /PRNewswire-FirstCall/ -- Targanta Therapeutics Corporation (Nasdaq: TARG - News) today announced its participation in the Biotechnology Industry Organization's CEO & Investor Conference, taking place from February 11th through February 13th at the Waldorf~Astoria Hotel in New York City.
http://biz.yahoo.com/prnews/080205/nytu029.html?.v=101
Targanta Reports Third-Quarter 2007 Financial Results
Thursday November 15, 8:00 am ET
CAMBRIDGE, Mass., Nov. 15 /PRNewswire-FirstCall/ -- Targanta Therapeutics Corporation (Nasdaq: TARG - News) today reported financial results for the quarter and nine months ended September 30, 2007.
Targanta reported a net loss of $21.8 million for the three months ended September 30, 2007, compared to a net loss of $6.9 million for the same period in 2006. This increase is primarily due to increases in research and development expenses related to advancement of the Company's lead antibiotic candidate, oritavancin, for which Targanta is currently preparing a U.S. regulatory submission and on which the Company is conducting additional clinical trials. For the nine months ended September 30, 2007, the Company reported a net loss of $52.7 million compared to a net loss of $21.5 million for the same period in 2006.
The Company had cash, cash equivalents and short-term investments totaling $48.7 million as of September 30, 2007.
On October 9, 2007, the Company completed its initial public offering, issuing 5.75 million shares of its Common Stock at a price of $10.00 per share. Net proceeds to the Company were approximately $51.4 million after deducting underwriting discounts and commissions and estimated offering expenses.
In connection with the initial public offering, all outstanding exchangeable shares issued by the Company's Canadian subsidiaries and all outstanding shares of Series A Convertible Preferred Stock, Series B Convertible Preferred Stock and Series C Convertible Preferred Stock were converted into 15.2 million shares of the Company's Common Stock. After the initial public offering, the Company has 21.0 million shares outstanding.
On a pro forma basis, when including the net proceeds of approximately $51.4 million from the initial public offering in October, Targanta would have had $100.1 million in cash, cash equivalents and short-term investments as of September 30, 2007.
http://biz.yahoo.com/prnews/071115/nyth010.html?.v=101
Targanta Therapeutics Announces Pricing of its Initial Public Offering
CAMBRIDGE, Mass., Oct. 10 /PRNewswire-FirstCall/ -- Targanta Therapeutics Corporation (Nasdaq: TARG) today announced the pricing of its initial public offering of 5,750,000 shares of its common stock at a price to the public of $10.00 per share. All of the shares are being offered by Targanta. Targanta has granted to the underwriters a 30-day option to purchase up to an additional 862,500 shares of common stock at the initial offering price, less underwriting discounts and commissions, to cover over-allotments, if any. Targanta's common stock is scheduled to commence trading on The Nasdaq Global Market on October 10, 2007 under the symbol 'TARG.'
Credit Suisse is acting as the sole book-running manager for the offering. Cowen and Company, Lazard Capital Markets, and Leerink Swann are acting as co- managers.
Copies of the final prospectus relating to this offering may be obtained from Credit Suisse, Prospectus Department, One Madison Avenue, Level 1B, New York, NY 10010 (telephone number: (212) 325-2580).
A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on October 9, 2007. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Targanta Therapeutics
Targanta Therapeutics Corporation is a biopharmaceutical company focused on developing and commercializing innovative antibiotics to treat serious infections in the hospital and other institutional settings.
SOURCE Targanta Therapeutics Corporation
Source: PR Newswire (October 10, 2007 - 7:30 AM EST)
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