Javelin Pharmaceuticals

Company Profile

Javelin Pharmaceuticals, Inc., together with its subsidiaries, engages in the research, development, and commercialization of products for pain relief in the United States. Its product candidates include Dyloject, which is in Phase III development stage for the treatment of post-operative pain in the United States, as well as in MAA Review stage for the treatment of acute forms of pain, including renal colic, exacerbations of osteo and rheumatoid arthritis, acute back pain, acute gout, acute trauma, and pain associated with fractures in Europe. The company's products also include Rylomine, an intranasal formulation of morphine that is in Phase III development stage for the treatment of acute moderate-to-severe pain and breakthrough pain in the United States and Europe; and PMI-150, a proprietary nasal formulation of ketamine that is under registration studies for the treatment of acute moderate-to-severe pain, including breakthrough pain in the United States. Its products also focus on treating various pain disorders, including episodic moderate-to-severe pain associated with breakthrough cancer pain; and post-trauma pain, such as orthopedic injury pain, procedural pain, and burn pain. The company was founded in 1998 and is based in Cambridge, Massachusetts.



Javelin Pharmaceuticals Completes Open Label Safety Study of Dyloject -

Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV - News) today reported that it has completed its open-label multi-dose, multi-day, observational safety study of Dyloject in the United States and that the study successfully met


New Study Shows Javelin Pharmaceutical's Dyloject Well-Tolerated in High-Risk Patients with Impaired Renal and Hepatic Function

Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV - News) today reported encouraging findings from a new Phase I pharmacokinetic (PK) and safety study of Dyloject in patients with mild to moderate renal and mild hepatic impairment. Dyloject was well tolerated in these higher risk patient populations. The elimination rate of Dyloject's active ingredient diclofenac was statistically indistinguishable in all three patient groups compared with matched healthy controls.


Javelin Pharmaceuticals First Quarter 2009 Conference Call

Javelin Pharmaceuticals, Inc. hosted a conference call today featuring CEO, Martin J. Driscoll, and Stephen J. Tulipano, CFO, discussing the Company's quarterly results for the period ending March 31, 2009.



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Javelin Pharmaceuticals to Announce First Quarter 2009 Financial Results

Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV) announced today that its CEO, Martin J. Driscoll, and Stephen J. Tulipano, CFO, will host a conference call to discuss the Company's quarterly results for the period ending March 31, 2009. The call will be held Thursday, May 7, 2009 at 10:30a.m. EDT.


Javelin Pharmaceuticals Reports Fiscal Results for the Year Ended 2008

Javelin Pharmaceuticals, Inc. (NYSE - Amex: JAV) recently reported its audited financial results for the full year and quarter ending December 31, 2008.

Javelin Pharmaceuticals Quarterly Conference Call Invitation

Javelin Pharmaceuticals, Inc. (NYSE Alternext: JAV) announced today that Martin J. Driscoll, Chief Executive Officer and Stephen J. Tulipano, CPA, CFO, will host its regular quarterly earnings conference call covering the fourth quarter and full year 2008 results. The call will be held Thursday, March 12, 2009 at 8:30 a.m. EDT.


Javelin Pharmaceuticals Signs $71 million European Commercialization Partnership for Dyloject

Javelin Pharmaceuticals, Inc. (NYSE Alternext: JAV) announced today that it has entered into an exclusive European marketing partnership for Dyloject® (diclofenac sodium for injection) with Therabel Pharma N.V. (“Therabel”), worth up to $71 million in upfront, sales, and regulatory milestone payments plus a double digit royalty on future sales.


Dyloject Significantly Reduces Moderate-to-Severe Pain in Pivotal Phase 3 Orthopedic Surgical Trial

Javelin Pharmaceuticals (AMEX: JAV - News) announced today that its US product candidate Dyloject(TM) (diclofenac sodium for injection) met primary efficacy endpoints with robust statistical significance in the second of two large pivotal US Phase 3 efficacy studies in postsurgical patients with moderate-to-severe pain.


Javelin Pharmaceuticals Announces 15 Percent Reduction in Workforce

Javelin Pharmaceuticals, Inc. (Amex: JAV - News), a leading developer of novel products for pain management, today announced that it will reduce its workforce by approximately 15 percent. The reduction is intended to reduce Javelin’s cost structure.


Javelin Pharmaceuticals Third Quarter 2008 Conference Call

Javelin Pharmaceuticals, Inc. hosted a conference call today featuring CEO, Martin J. Driscoll, and Stephen J. Tulipano, CFO, discussing the Company's quarterly results for the period ending September 30, 2008.



33:47 minutes (7.74 MB)

Javelin Pharmaceuticals, Inc. Reports Third Quarter 2008 Results and Corporate Highlights

Javelin Pharmaceuticals, Inc. (Amex: JAV - News), a leading developer of novel products for pain management, today reported its unaudited financial results for the third quarter ended September 30, 2008. The Company’s highlights in the third quarter included the following:

* Completed patient enrollment - Pivotal Phase 3 Dyloject orthopedic trial (expect to report top-line data by year end)
* Ahead of schedule - Phase 3 Ereska trial (85 percent patient enrollment achieved)
* Initiated ahead of schedule - Dyloject open-label observational safety study


Javelin Pharmaceuticals to Review Third Quarter 2008 Financial Results

Javelin Pharmaceuticals, Inc. (AMEX: JAV - News) announced today that its CEO, Martin J. Driscoll, and Stephen J. Tulipano, CFO, will host a conference call to discuss the Company's quarterly results for the period ending September 30, 2008. The call will be held Monday, November 10, 2008 at 8:30a.m. EST.


Javelin Pharmaceuticals Appoints Dr. Eric Lang Vice President of Clinical Research

Lang Previously was Global Head, Clinical Research and Development for Analgesia in Novartis' Consumer Health Division

Javelin Pharmaceuticals, Inc. (Amex: JAV - News), a leading developer of novel products for pain management, today announced that Dr. Eric Lang has been appointed Vice President of Clinical Research. Dr. Lang comes from Novartis, where he was most recently the Global Head of Clinical Research and Development for Analgesia for its Consumer Health Division. In that capacity, he was responsible for the design and implementation of the clinical strategy for its global analgesics franchise.


Javelin Enrolls First Patient in an Open Label Safety Study of Dyloject(TM)

Company Plans to submit New Drug Application to US FDA in 2009
Javelin Pharmaceuticals, Inc. (Amex: JAV - News), a leading developer of novel products for pain management, today announced that it had enrolled the first patient in a planned Phase 3, single-arm, open label observational safety study for its injectable NSAID, Dyloject™ (diclofenac sodium). The study is intended to supplement the Company’s summary of integrated patient safety data base, a part of its New Drug Application (NDA) for Dyloject in the United States, planned for submission to the FDA in 2009.


Javelin Pharmaceuticals to Present at the 2008 UBS Global Life Sciences Conference

Presentation to be Webcast Live

Javelin Pharmaceuticals, Inc. (AMEX: JAV - News) announced today that Martin J. Driscoll, the Company's Chief Executive Officer, will provide a corporate overview at the 2008 UBS Global Life Sciences Conference at the Grand Hyatt Hotel in New York City, Monday, September 22, 2008 at 12 Noon EDT.


Javelin Pharmaceuticals CEO to Provide Corporate Overview at the BioCentury NewsMakers Conference

Javelin Pharmaceuticals, Inc. (AMEX: JAV - News) today announced that Chief Executive Officer, Martin J. Driscoll, will give a corporate overview, including a discussion of the company’s commercial and clinical programs at BioCentury’s NewsMakers in the Biotech Industry Conference at 11:30am ET on September 4, 2008. The conference is being held at the Millennium Broadway Hotel – 145 W. 45th Street in New York City.

For more information on the conference, please visit the link below:

www.biocentury.com/BCApp/BioCenturyCommon/BCConferences.aspx?ss=1


Javelin Presents Successful Pivotal Phase 3 Secondary Clinical Results for Dyloject(TM) at the 12th World Congress on Pain

Javelin Pharmaceuticals, Inc. (Amex: JAV - News), a leading developer of novel products for pain management, today presented new and successful secondary endpoint data from a previously announced pivotal Phase 3 study of Dyloject™. At the 12th World Congress on Pain, held in Glasgow, Scotland. Dyloject was launched in the United Kingdom in December of last year and this year received Scottish Medicines Consortium approval.


Javelin Presents PMI-150 (Intranasal Ketamine) Data at Premier Department of Defense Scientific Meeting

Analgesic blood levels rapidly achieved, reliably sustained during repeat dosing

Javelin Pharmaceuticals, Inc. (AMEX:JAV - News), a leading developer of novel products for pain management, is presenting data today on its PMI-150 drug candidate (intranasal ketamine for acute pain) at the Department of Defense’s (DoD) 2008 Advanced Technology Applications for Combat Casualty Care (ATACCC) Conference.


Javelin Pharmaceuticals Second Quarter 2008 Conference Call

Javelin Pharmaceuticals, Inc. hosts a conference call, with CEO, Martin J. Driscoll, and Stephen J. Tulipano, CPA, CFO, discussing the Company's quarterly results for the period ending June 30, 2008.



48:08 minutes (11.02 MB)
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