Frost & Sullivan Names Javelin Pharmaceuticals Entrepreneurial Company of the Year for Intranasal Therapeutics

Date : 10/25/2006 @ 7:45AM
Source : PR Newswire
Stock : Javelin Pharmaceutic (JAV)
Quote : 2.28  -0.08 (-3.39%) @ 8:00PM
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Frost & Sullivan Names Javelin Pharmaceuticals Entrepreneurial Company of the Year for Intranasal Therapeutics

PALO ALTO, Calif., Oct. 25 /PRNewswire/ -- Javelin Pharmaceuticals (AMEX:JAV) has received the 2006 Frost & Sullivan Award for Entrepreneurial Company of the Year for its role as an emerging leader in intranasal therapeutics. Formal presentation of this award will take place at Frost & Sullivan's annual Excellence in Pharmaceuticals & Life Sciences Awards Banquet in October.

Each year Frost & Sullivan presents this Award to a company that has demonstrated superior entrepreneurial ability in its industry. This Award signifies the company's identification of a unique and revolutionary product solution with significant market potential. Additionally, the Award certifies that the company's marketing strategy appears sound and poised for success.

Javelin Pharmaceuticals receives this award in recognition of its position as an emerging leader within the intranasal drug delivery market. Javelin, until 2006 a company of fewer than 20 full time employees, is developing three pain management products. The lead product, Dyloject(TM) (a novel injectable diclofenac formulation for acute pain treatment) may enter the marketplace next year pending European regulatory approval, with the potential of at least two of its products entering the US marketplace as early as 2008. The award recognizes and honors Javelin's ability to drive the development of multiple product candidates with limited personnel and financial resources for both the US and worldwide markets.

"Presently, Javelin Pharmaceuticals has two late-stage intranasal pain management products, Rylomine and PMI-100/150, in development," notes Frost & Sullivan Research Analyst Jason McKinnie. "Rylomine(TM) is currently in Phase III clinical trials, and PMI-150 is in late phase II trials. Both products are reformulations of well-known, well-characterized drugs. Morphine is the active ingredient in Rylomine, and ketamine the active ingredient in PMI- 100/150. Also in Phase III clinical trials is their lead product Dyloject(TM), an injectable nonselective NSAID for the treatment of postoperative pain."

While the primary goal of the company is to produce medications that address unmet medical needs through reformulation, expansion of the label, or other proprietary means, the business strategy of Javelin Pharmaceuticals focuses on several key areas within the specialty pharmaceutical model. Building upon the strength and diverse skills of its seasoned management and drug development teams, Javelin is optimizing its portfolio by selecting analgesic candidates that maximize revenue while limiting clinical development risk.

Morphine is the "gold standard" medication used to manage moderate-to- severe pain in conditions spanning cancer, orthopedic injury, burn trauma and postsurgical pain. Intravenous (IV) and oral formulations are available but both have limitations. IV morphine requires application via injection and often is provided using an expensive, patient-controlled pump, while oral administration of morphine has a slow onset and variable effectiveness owing to individual differences in absorption and commonly, nausea and vomiting. Intranasal administration of Javelin's proprietary morphine formulation Rylomine(TM) addresses these shortfalls. Intranasal Rylomine(TM), employing the ChiSys(TM) delivery platform, combines the simplicity of oral formulations with the rapid onset of analgesia seen with IV drug delivery.

Ketamine, a nonopioid, is currently FDA-approved for use only at high doses sufficient for general anesthesia during surgery. However, clinicians' experience points to its value at low doses as an alternative to morphine for pain relief in patients with nerve injury or after surgery. Ketamine as a general anesthetic is most commonly delivered via injection or IV pump, but Javelin's PMI-100/150 offers the non-invasive alternative of nasal administration. The company is seeking its approval as a needle-free alternative to morphine for the relief of moderate-to-severe pain in certain civilian and military patients in whom morphine administration is ineffective or may pose risks. Such risks can include worsening shock in casualties with blood loss, or exacerbating breathing problems after chest trauma. In July 2006, Javelin was awarded a grant from the National Cancer Institute to extend its pilot studies showing the efficacy of this same product candidate for treating brief episodes of 'breakthrough' cancer pain in patients with cancer.

"Javelin Pharmaceuticals has produced a strong portfolio of products that are poised to serve important unmet clinical needs," says McKinnie. "Their expertise is positioning the company as a leader in the intranasal drug delivery market and makes them the deserving recipient of Frost & Sullivan's 2006 Entrepreneurial Company of the Year Award in the Intranasal Drug Delivery Market."

Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.

About Javelin Pharmaceuticals

Headquartered in Cambridge, MA, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the pain management market. For additional information, please visit the website at http://www.javelinpharmaceuticals.com/ .

About Frost & Sullivan

Frost & Sullivan, a global growth consulting company, has been partnering with clients to support the development of innovative strategies for more than 40 years. The company's industry expertise integrates growth consulting, growth partnership services and corporate management training to identify and develop opportunities. Frost & Sullivan serves an extensive clientele that includes Global 1000 companies, emerging companies, and the investment community, by providing comprehensive industry coverage that reflects a unique global perspective and combines ongoing analysis of markets, technologies, econometrics, and demographics. For more information, visit http://www.awards.frost.com/ .

Contact: Stacie Jones 210.247.2450

Corporate: June Gregg 212.554.4291

Media Bryan Murphy - LaVoie Group 781.596.0200, x-105

DATASOURCE: Frost & Sullivan

CONTACT: Stacie Jones of Frost & Sullivan, +1-210-247-2450, or

; or corporate, June Gregg of Javelin Pharmaceuticals,

+1-212-554-4291, or ; or media, Bryan Murphy

of LaVoie Group, +1-781-596-0200, ext.105

Web site: http://www.frost.com/

http://www.awards.frost.com/

http://www.javelinpharmaceuticals.com/

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