Showing posts with label Javelin Pharma. Show all posts
Showing posts with label Javelin Pharma. Show all posts

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

CAMBRIDGE, Mass.-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. The Company plans to file a New Drug application for Dyloject in the United States during the fall of 2009, at the same dose used in these studies.

“Historically, IV nonsteroidal anti-inflammatory drugs (NSAIDs) such as ketorolac, the only IV NSAID approved in the US for moderate to severe pain, have been withheld from such patient populations or required major dose reductions because of concern for adverse effects” stated Daniel Carr, M.D., Javelin’s President and Chief Medical Officer. “Dyloject’s excellent tolerability in all study groups, and the insignificant changes in diclofenac distribution and clearance observed in patients with mild to moderate chronic renal insufficiency or mild hepatic impairment are most encouraging. These new PK and safety findings will be included in our NDA filing for Dyloject.”

About The Study:

This Phase I, open-label, single-dose study evaluated the safety and pharmacokinetics of Dyloject 37.5 mg given as an IV bolus over 15 seconds in subjects with mild or moderate chronic renal insufficiency and with mild chronic hepatic impairment compared to matched healthy adult volunteers. Additionally, healthy adult volunteers participated in a randomized, open-label, crossover study in which they received a single dose of Sporanox® (itraconazole 200 mg with 8 gm of the solubilizing agent HPβCD) given as an IV infusion over 60 minutes to compare the PK and safety of HPβCD in the two medications. The 37.5 mg dose of Dyloject is formulated with 0.3 gm of HPβCD. A total of 40 subjects were treated in this study including 13 patients with mild to moderate renal insufficiency (creatinine clearance 30-80 ml/min), 8 patients with mild hepatic impairment and 19 healthy adult volunteers. Patients continued to take their prescribed medications to treat hypertension, diabetes and high cholesterol.

Dodd's wife serves on health care company boards

WASHINGTON — The wife of a senator playing a lead role on a national health care overhaul sits on the boards of three health care companies, one of several examples of lawmakers with ties to the medical industry.

Jackie Clegg Dodd, wife of Sen. Chris Dodd, serves on the boards of Javelin Pharmaceuticals Inc., Cardiome Pharma Corp., and Brookdale Senior Living, their Securities and Exchange Commission filings and Web sites show.

Sen. Dodd, D-Conn., is filling in for ailing Sen. Edward Kennedy, chairman of the Health, Education, Labor and Pensions Committee, which will soon start work on a health care bill.

Dodd, who as Senate Banking Committee chairman also has been an architect of the nation's financial industry and housing rescue plans, did not file a new disclosure report outlining his personal finances as most other senators did in May. The Senate was releasing those reports Friday.

Dodd sought a 90-day extension to file his report covering last year, giving him until mid-August to submit his report.

Other publicly available documents show Mrs. Dodd last year was one of the most highly compensated non-employee members of the Javelin Pharmaceuticals Inc. board, on which she has served since 2004. She earned $32,000 in fees and $109,587 in stock option awards last year, according to the company's SEC filings.

Mrs. Dodd earned $79,063 in fees from Cardiome in its last fiscal year, while Brookdale Senior Living gave her $122,231 in stock awards in 2008, their SEC filings show.

A complaint filed by Citizens for Responsibility and Ethics in Washington, a government watchdog group, led the Senate Ethics Committee to begin looking at mortgages that Dodd and Sen. Kent Conrad, D-N.D., received from Countrywide Financial Corp.

The controversy involved a Countrywide "VIP" program for "friends of Angelo," Countrywide's then-chief executive Angelo Mozilo. The SEC filed a lawsuit this month accusing Mozilo of civil fraud and illegal insider trading.

Both senators have denied any wrongdoing. Dodd's mortgages haven't appeared in his public financial disclosure reports and didn't have to because they were for non-rental homes; Conrad disclosed a Countrywide mortgage on a rental property but not one for a vacation home.
Dodd is not the only member of the Senate health committee with ties to health care interests:
_ Sen. Jay Rockefeller, D-W.Va., reported $15,001 to $50,000 in capital gains for his wife from the sale of a stake in Athenahealth Inc., a business services company that helps medical providers with billing and clinical operations.

Rockefeller is honorary chairman of the Alliance for Health Reform, a Washington nonprofit whose board includes representatives from the UnitedHealth Group health insurance company; AFL-CIO labor union; the AARP, which sells health insurance; St. John Health, a nonprofit health system that includes seven hospitals and 125 medical facilities in southeast Michigan; CIGNA Corp., an employer-sponsored benefits company; and the United Hospital Fund of New York.

Rockefeller also serves on the advisory board of the Children's Health Fund, a New York nonprofit focused on pediatric health care, and is an honorary board member of Beckley Health Right Inc., a nonprofit community medical clinic.

_ Sen. Tom Coburn, R-Okla., is a practicing physician. He reported slight business income, $268, from the Muskogee Allergy Clinic last year; $3,000 to $45,000 in stock in Affymetrix Inc., a biotechnology company and pioneer in genetic analysis; $1,000 to $15,000 in stock in Pfizer Inc., a pharmaceutical company; and a $1,000 to $15,000 interest in Thomas A. Coburn, Md., Inc.
Under Senate ethics rules, Coburn can't accept money from his patients.

_ Sen. Judd Gregg, R-N.H., disclosed $1,000 to $15,000 each in stock in pharmaceutical companies Merck & Co., and Pfizer, the Johnson & Johnson health care products company and Agilent Technologies, which is involved in the biomedical industry.

Some members of the Senate leadership also have financial ties to the health industry.

Senate Minority Whip Jon Kyl, R-Ariz., reported $15,001 to $50,000 in stock in Amgen Inc., which develops medical therapeutics. Kyl's retirement account held stakes in several health care businesses, including the Wyeth, Bristol-Myers Squibb Co., GlaxoSmithKline, Pfizer and AstraZeneca pharmaceutical companies; medical provider Tenet Healthcare Corp.; CVS Caremark prescription and health services company; Genentech, a biotherapeutics manufacturer; and insurer MetLife Inc.

Key health care senators have industry ties

WASHINGTON — Influential senators working to overhaul the nation's health care system have investments and family ties with some of the biggest names in the industry. The wife of Sen. Chris Dodd, the lawmaker in charge of writing the Senate's bill, sits on the boards of four health care companies.

Members of both parties have industry connections, including Democrats Jay Rockefeller and Tom Harkin, in addition to Dodd, and Republicans Tom Coburn, Judd Gregg, John Kyl and Orrin Hatch, financial reports showed Friday. .

Jackie Clegg Dodd, wife of the Connecticut Democrat, is on the boards of Javelin Pharmaceuticals Inc., Cardiome Pharma Corp., Brookdale Senior Living and Pear Tree Pharmaceuticals.

Dodd is filling in for ailing Sen. Edward Kennedy, D-Mass., chairman of the Health, Education, Labor and Pensions Committee, which will soon start work on a health care bill.

Other publicly available documents show Mrs. Dodd last year was one of the most highly compensated non-employee members of the Javelin Pharmaceuticals Inc. board, on which she has served since 2004. She earned $32,000 in fees and $109,587 in stock option awards last year, according to the company's SEC filings.

Mrs. Dodd earned $79,063 in fees from Cardiome in its last fiscal year, while Brookdale Senior Living gave her $122,231 in stock awards in 2008, their SEC filings show. She earned no income from her post as a director for Pear Tree Pharmaceuticals but holds up to $15,000 in stock in Pear Tree, which describes itself as a development-stage pharmaceutical company focused on the needs of aging women.

The annual financial disclosure reports for members of Congress are less precise. They only require that assets and liabilities be listed in ranges of values.

Dodd was granted a 90-day extension to file his report covering last year, but released it to The Associated Press.

Bryan DeAngelis, Dodd's spokesman, said, "Jackie Clegg Dodd's career is her own; absolutely independent of Senator Dodd, as it was when they married 10 years ago. The senator has worked to reform our health care system for decades, and nothing about his wife's career is relevant at all to his leadership of that effort."

DeAngelis said that Mrs. Dodd has hired a personal ethics lawyer to avoid any conflicts of interest and is not a lobbyist.

Other reports showed:

_ Rockefeller, D-W.Va., reported $15,001 to $50,000 in capital gains for his wife from the sale of a stake in Athenahealth Inc., a business services company that helps medical providers with billing and clinical operations.

Rockefeller is honorary chairman of the Alliance for Health Reform, a Washington nonprofit whose board includes representatives from the UnitedHealth Group health insurance company; AFL-CIO labor union; the AARP, which sells health insurance; St. John Health, a nonprofit health system that includes seven hospitals and 125 medical facilities in southeast Michigan; CIGNA Corp., an employer-sponsored benefits company; and the United Hospital Fund of New York.

_ Coburn, R-Okla., is a practicing physician. He reported slight business income, $268, from the Muskogee Allergy Clinic last year; $3,000 to $45,000 in stock in Affymetrix Inc., a biotechnology company and pioneer in genetic analysis; $1,000 to $15,000 in stock in Pfizer Inc., a pharmaceutical company; and a $1,000 to $15,000 interest in Thomas A. Coburn, MD, Inc.
Under Senate ethics rules, Coburn can't accept money from his patients.

_ Gregg, R-N.H., disclosed $250,001 to $500,000 in drug maker Bristol-Myers Squibb Co. stock and $1,000 to $15,000 each in stock in pharmaceutical companies Merck & Co. and Pfizer, the Johnson & Johnson health care products company and Agilent Technologies, which is involved in the biomedical industry.

_ Kyl, R-Ariz., the Senate minority whip, reported $15,001 to $50,000 in stock in Amgen Inc., which develops medical therapeutics. Kyl's retirement account held stakes in several health care businesses, including the Wyeth, Bristol-Myers Squibb, GlaxoSmithKline, Pfizer and AstraZeneca pharmaceutical companies; medical provider Tenet Healthcare Corp.; CVS Caremark prescription and health services company; Genentech, a biotherapeutics manufacturer; and insurer MetLife Inc.

_ Harkin, D-Iowa, has a joint ownership stake in health-related stocks. Harkin and his wife, Ruth Raduenz, own shares of drug makers Amgen and Genentech, Inc., each stake valued at $1,001 to $15,000; Their largest health care holding, Johnson & Johnson, was valued at $50,001 to $100,000.

_ Hatch, R-Utah, a member of the Finance and Health committees, reported owning between $1,001 and $15,000 worth of stock in drug maker Pfizer Inc. He spoke to two pharmaceutical industry conferences last year. Sponsors of the conferences donated $3,500 to charities instead of speaking fees, as required by Senate rules.

Like millions of Americans, several senators took a financial hit in 2008. A sampling:
_Sen. Dick Durbin, D-Ill., lost some $100,000 in equity in his home in Springfield and $35,000 in his Chicago condominium. Durbin, who released his tax returns, reported losing $32,259 in various investments last year, including more than $10,400 in Berkshire Hathaway and $5,535 in Fidelity stock.

_Kennedy in 2007 had four trusts each valued between $5,000,001-$25 million. In 2008, only one trust was still in that category while the rest had slipped in value to $1,000,001-$5 million.
_Hatch's investments suffered from the banking crisis. In 2007, he reported assets of between $2,002 and $30,000 in Countrywide Credit Industries Inc. stock. His 2008 financial disclosure lists the value at less than $1,000.

One of Dodd's investments showed a vast improvement.

A new appraisal more than doubled the value of his vacation cottage in Ireland, which has been subject of a Senate ethics complaint filed by a conservative group questioning if the undervalued property was really a gift.

The property is valued at 470,000 euros, or about $660,000, on Dodd's disclosure report.
The previous year's report valued the seaside home, located in County Galway, at between $100,001 and $250,000.

DeAngelis, the spokesman, said Dodd and his wife decided to have the property appraised because they felt it was time to update the information.

Javelin Pharmaceuticals to Announce First Quarter 2009 Financial Results

CAMBRIDGE, Mass., - 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 8:30a.m. EDT.

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

CONFERENCE CALL ALERT
Javelin Pharmaceuticals, Inc. Q1 2009 Earnings Call
Date: May 7, 2009
Time: 8:30am E.D.T.
Those Interested in participating in the call should dial 877-419-6603 within the United States or 719-325-4847 internationally.

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