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 Enrolls First Patient in Pivotal Trial for PMI-150

Javelin Pharmaceuticals, Inc. (AMEX: JAV - News) announced dosing of the first patient in its pivotal Phase 3 clinical study of PMI-150 (intranasal ketamine) for acute pain. The trial is expected to enroll approximately 200 patients and is designed to confirm the analgesic efficacy of PMI-150 in treating postoperative pain following orthopedic surgery. Prior randomized, double-blind, placebo-controlled, phase II clinical studies of PMI-150 have demonstrated rapid, statistically significant relief of moderate-to-severe postoperative and breakthrough pain.

"This pivotal Phase 3 efficacy study is a multi-dose efficacy study to support the New Drug Application (NDA) for PMI-150 in the US," said President and CMO, Dr. Daniel Carr. "We are pleased to start this key trial and plan to expedite the study by quickly increasing the number of clinical sites, so that we can file a high quality NDA with the FDA next year."


Javelin Pharmaceuticals' Founder and President Transitions to Executive Director

Dr. Daniel Carr Takes on Role of President

Javelin Pharmaceuticals, Inc. (Amex: JAV - News), a leading developer of specialty pharmaceutical products for pain management, today announced that Dr. Daniel Carr, Vice Chairman and Chief Medical Officer, has become President. Fred Mermelstein, Ph.D., Javelin’s Founder and President, has assumed the role of Executive Director and continues to work actively for Javelin. Both Drs. Carr and Mermelstein will report to Javelin’s CEO, Martin J. Driscoll.


Javelin Pharmaceuticals, Inc. Announces New Patent Covering PMI-150 (Intranasal Ketamine)

Issuance of PMI-150 European Patent Extends European Exclusivity into 2023 Enhancing Global Value

Javelin Pharmaceuticals, Inc. (Amex: JAV - News), a leading developer of specialty prescription medications for pain management was today granted a commercially important patent in the European Union that extends patent protection for Javelin's PMI-150 (intranasal ketamine) drug candidate into 2023. European Patent No. 1 562 566 B1, entitled: "Analgesic Compositions Comprising NMDA Receptor Antagonists and Benzalkonium Chloride," will cover the major EU market countries (G5) as well as an additional 20 Member States of the European Patent Convention. This new patent is the European counterpart to Javelin’s U.S. Patent No. 7,273,889 that issued in September, 2007.


Javelin Pharmaceuticals First Quarter 2008 Conference Call


37:03 minutes (8.48 MB)

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 March 31, 2008.

About Javelin Pharmaceuticals, Inc.:

Javelin is a specialty pharmaceutical company that applies proprietary technologies to develop new drugs and improved formulations of existing drugs for pain management. Specialty pharmaceutical analysts from six investment firms cover Javelin Pharmaceuticals, Inc. Javelin's headquarters are located in Cambridge, Massachusetts with European offices in Cambridge, England and Cologne, Germany. For additional information, visit www.javelinpharmaceuticals.com.


Javelin Pharmaceuticals, Inc. Reports First Quarter 2008 Results

Javelin Pharmaceuticals, Inc. (Amex: JAV - News), a leading developer of specialty pharmaceutical products for pain management, recently reported its unaudited financial results for the first quarter ended March 31, 2008.


Javelin Pharmaceuticals to Announce First Quarter 2008 Financial Results

Javelin Pharmaceuticals, Inc. (AMEX: JAV - News) announced today that its CEO, Martin J. Driscoll, and Stephen J. Tulipano, CPA, CFO, will host a conference call to discuss the Company's quarterly results for the period ending March 31, 2008. The call will be held Wednesday, May 14, 2008 at 8:30 a.m. EDT.

The Company invites all interested parties to participate. The call will be web cast and accessible live through the following URL: http://ir.javelinpharmaceuticals.com/events.cfm. The call will be archived on the Company's website www.javelinpharmaceuticals.com.


Javelin Pharmaceuticals, Inc. to Raise $27.6 Million through Registered Direct Offering

Javelin Pharmaceuticals, Inc. (Amex: JAV - News), a leading developer and marketer of specialty pharmaceutical products for pain management, has received commitments from selected investors to purchase up to 11,450,000 shares of its common stock at a purchase price of $2.41 per share.

The purpose of the offering is to enhance our balance sheet as we proceed in our ongoing partnership discussions.

Certain officers and directors of Javelin will participate in this offering.

The closing of the offering is expected to take place on May 13, 2008, subject to customary closing conditions. The total number of shares to be sold in the offering are up to 11,450,000 with the gross proceeds of up to $27.6 million. The company estimates that net proceeds from the offering will be approximately $25.7 million, after deducting placement agent fees and estimated offering expenses.


Javelin Pharmaceuticals Appoints John C. Taylor as Vice President of Business Development

Javelin Pharmaceuticals, Inc. (Amex: JAV - News), a leading developer and marketer of specialty pharmaceutical products for pain management, has appointed John C. Taylor as Vice President, Business Development. Mr. Taylor will report to Javelin’s recently appointed CEO Martin J. Driscoll and will be responsible for daily execution of Javelin’s global partnership initiatives for its late stage product pipeline.

“I have placed a high priority on Business Development initiatives as a strategic element of Javelin’s new commercialization strategy. Our first commercial partnership will be structured to accelerate the market uptake for our brand, reduce our exposure to early commercialization risk, and augment our growth capital while providing future upside. John will play an essential role in assisting us as we complete this effort,” said Martin Driscoll, Chief Executive Officer.


Javelin CEO to Present at the 8th Annual Fortis Biotechnology Conference

Javelin Pharmaceuticals, Inc. (Amex: JAV - News)— announced today Martin J. Driscoll, Chief Executive Officer, will present at the 8th Annual Fortis Bank Biotechnology Conference on Thursday, April 3, 2008 at 2:00 p.m. GMT in Ballroom A at the Four Seasons Hotel London, England.

About Javelin Pharmaceuticals, Inc.


Javelin Pharmaceuticals CEO to Present at Cowen & Company's 28th Annual Health Care Conference

Presentation to be webcast live

Javelin Pharmaceuticals, Inc. (Amex: JAV - News) today announced that CEO Martin J. Driscoll will present a corporate overview to investors at the 28th Annual Cowen & Company Health Care conference. Mr. Driscoll’s presentation will take place on Monday, March 17, 2008 at 4:00pm in the Regis Room on the Third Floor at the Boston Marriott Copley Place.


Javelin Pharmaceuticals' Dyloject Accepted by Scottish Medicines Consortium (SMC)

Market Potential for Dyloject Expands in UK

Today Javelin Pharmaceuticals Inc. (AMEX: JAV - News) announced that Dyloject® (diclofenac sodium solution for injection) has been accepted by the Scottish Medicines Consortium (SMC) for use within the National Health Service (NHS) Scotland, for the treatment or prevention of postoperative pain by intravenous injection, in supervised healthcare settings at the NHS Tariff Price of £48 per pack (10 x 75mg/2ml vials).


Javelin Pharmaceuticals Reports Results for the Year Ended 2007

Javelin Pharmaceuticals, Inc. (Amex: JAV - News) recently reported its audited financial results for the full year and quarter ending December 31, 2007.

Financial Highlights for the Year Ended December 31, 2007:

  • Ended the year with $37.3 million in cash, cash equivalents and short term investments.

  • Net loss increased to approximately $31.0 million or $0.68 per share for the 12 months ended December 31, 2007, from $17.8 million or $0.44 per share for the same period in 2006.
  • Net loss increased to approximately $9.7 million or $0.20 per share in the fourth quarter ended 2007, from $5.5 million or $0.14 per share in the fourth quarter of 2006.
  • Non-cash stock based compensation expense for the year ended December 31, 2007 was approximately $3.5 million or $0.08 per share impact on operations, in accordance with Statement of Financial Accounting Standard 123R, compared to $2.8 million or $0.07 per share impact on operations for 2006.
  • Javelin Pharmaceuticals 2007 Year End Conference Call


    37:48 minutes (8.65 MB)

    Javelin Pharmaceuticals, Inc. hosts a conference call, with Dr. Daniel B. Carr, CEO and CMO, and Stephen J. Tulipano, CPA, CFO, discussing the Company's annual results for the period ending December 31, 2007.

    About Javelin Pharmaceuticals, Inc.:

    Javelin is a specialty pharmaceutical company that applies proprietary technologies to develop new drugs and improved formulations of existing drugs for pain management. Specialty pharmaceutical analysts from six investment firms cover Javelin Pharmaceuticals, Inc. Javelin's headquarters are located in Cambridge, Massachusetts with European offices in Cambridge, England and Cologne, Germany. For additional information, visit www.javelinpharmaceuticals.com.


    Javelin Pharmaceuticals Board Appoints Industry Veteran Martin Driscoll as Chief Executive Officer

    Dr. Daniel B. Carr Becomes Vice Chairman and will Continue as Chief Medical Officer

    Javelin Pharmaceuticals Inc. (AMEX: JAV - News) today announced that its Board of Directors has appointed Javelin Director and veteran pharmaceutical executive Martin J. Driscoll to the position of Chief Executive Officer, effective immediately. Dr. Daniel B. Carr has become Vice Chairman of the Board of Directors and will continue in his role as Chief Medical Officer.

    Javelin’s Board of Directors has also established a Strategic Commercialization and Partnership Committee consisting of members with significant experience in creating partnerships and commercial ventures. The Committee will consist of Directors Peter D. Kiernan III, Neil W. Flanzraich, and Georg Nebgen.


    Javelin Pharmaceuticals, Inc. Vice President to Assume Consultant Role

    Javelin Pharmaceuticals, Inc. (AMEX: JAV - News) announced today it has accepted the resignation of Dr. Curtis Wright, its Executive Vice President for Risk Management and Regulatory Affairs, for personal reasons. Dr. Wright will pursue a business opportunity outside the field of pain drug development that offers him the opportunity to work closer to his home and continue as a consultant to Javelin.


    Javelin Pharmaceuticals Regains Compliance with Amex Director Independence Rules

    Javelin Pharmaceuticals (AMEX: JAV - News) announced today that the Company recently advised the American Stock Exchange (“Amex”) that it has regained compliance with Sections 121A and 802(a) of the Amex Company Guide and is currently in compliance with the Amex Rules regarding director independence.

    The deficiency was first reported on February 7, 2008, when Javelin filed a Current Report on SEC Form 8-K stating that the Company no longer complied with Amex Rules regarding director independence. This deficiency resulted from the determination that a company director, Mr. Martin Driscoll, no longer qualified as independent.

    On February 18, 2008, Javelin’s Board of Directors elected Mr. Peter D. Kiernan, III, as a director and qualified him as independent under the Amex Rules. At the time of his appointment, the Board had not yet determined the total number of directors who qualified as independent.


    Javelin Pharmaceuticals Completes Subject Accrual for all Pharmacokinetic Clinical Studies of PMI-150

    Javelin Pharmaceuticals (AMEX: JAV - News) announced today that it recently completed accrual of subjects in the last of four planned Phase 1 human pharmacokinetic (PK) studies needed to support its intended filing of a New Drug Application (NDA) next year for its intranasal ketamine product candidate, PMI-150.


    Javelin Pharmaceuticals to Host Year End Conference Call

    Javelin Pharmaceuticals, Inc. (AMEX: JAV - News) announced today that Dr. Daniel B. Carr, CEO and CMO, and Stephen J. Tulipano, CPA, CFO, will host a conference call to discuss the Company's annual results for the period ending December 31, 2007. The call will be held Thursday, March 6, 2008 at 4:15 p.m. EST.

    The Company invites all interested parties to participate. The call will be webcast and accessible live through the following URL: http://ir.javelinpharmaceuticals.com/events.cfm. The call will be archived on the Company's website at: www.javelinpharmaceuticals.com.


    Javelin Pharmaceuticals Names Peter Kiernan to Board of Directors

    Former Goldman Sachs Veteran Financial Expert Joins Javelin Board

    Javelin Pharmaceuticals Inc. (AMEX: JAV - News) today announced that its Board of Directors recently voted to increase the size of the Board from seven members to eight, and that it has elected Peter D. Kiernan, III, to fill the newly created directorship. Mr. Kiernan was qualified by the Board as an independent director.


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