Prescription Drug News and Research

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First Edition: August 12, 2010

Some of today's headlines highlight how the new health reform law is playing beyond Washington, D.C.'s beltway.

12 Aug 2010

Bristol-Myers Squibb, ACTF announce enhanced agreement to support ADAPs

Bristol-Myers Squibb Company and the ADAP Crisis Task Force today announced an enhanced agreement to support the efforts of AIDS Drug Assistance Programs to provide antiretroviral medicines to people living with HIV and AIDS. Building on an agreement signed in March of 2010, today's announcement marks a multi-year enhancement to assist ADAPs in meeting the challenges of increasing patient case loads and strained government funding.

12 Aug 2010

FDA advisory committee votes in favor of investigational anti-epileptic drug ezogabine

GlaxoSmithKline and Valeant Pharmaceuticals International announced today that a U.S. Food and Drug Administration advisory committee voted unanimously that clinical studies had provided substantial evidence of the effectiveness of ezogabine as adjunctive treatment for adults with partial-onset seizures.

12 Aug 2010

More Medicare Part D checks in the mail

The Department of Health and Human Services has mailed out a third round of $250 checks to help seniors who enter the Medicare Part D coverage pay gap for prescription drugs, WCAX [in Vermont] reports. "The one-time payment aims to close a gap in coverage for prescription medication. The rebates will go to about 9,000 Vermonters whose out-of-pocket expenses already total more than $940 for the year" (8/11).

12 Aug 2010

Third round of tax-free $250 rebate checks mailed to eligible Medicare beneficiaries

Today, U.S. Department of Health and Human Services Secretary Kathleen Sebelius announced that the third round of one-time, tax-free $250 rebate checks have been mailed to eligible Medicare beneficiaries whose drug costs are so high they have reached the Medicare Part D prescription drug coverage gap known as the "donut hole."

11 Aug 2010

U.S. Senators introduce legislation to encourage R&D aimed at neglected pediatric diseases

"New bipartisan legislation was introduced in the U.S. Senate last week which seeks to encourage innovative [research and development] R&D by drugmakers aimed at treating rare and neglected pediatric diseases," PharmaTimes reports.

11 Aug 2010

Education, changes in reimbursement practices can reduce inappropriate antibiotic usage: Study

Improved drug coverage under Medicare Part D has led to an increase in the use of antibiotics by seniors, particularly of brand-name and more expensive drugs, according to a University of Pittsburgh Graduate School of Public Health study. Published in the Aug. 23 issue of Archives of Internal Medicine and the first to explore spending on antibiotics under Medicare Part D, the study suggests recent changes in drug coverage improved the use of antibiotics for pneumonia, but could lead to unnecessary spending on expensive broad-spectrum antibiotics and the overuse of inappropriate antibiotics.

11 Aug 2010

FDA grants Orphan Drug Designation to YM BioSciences' JAK1/2 inhibitor

YM BioSciences Inc., announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration has granted Orphan Drug Designation to the Company's highly-selective JAK1/2 inhibitor, CYT387, for the treatment of myelofibrosis, a chronic debilitating unmet medical need, in which a patient's bone marrow is replaced by scar tissue, and for which treatment options are limited or unsatisfactory.

10 Aug 2010

Study suggests reimbursements can address inappropriate antibiotic usage

Antibiotic use appears to have increased among older adults whose prescription drug coverage improved as a result of enrolling in Medicare Part D, with the largest increases for broad-spectrum, newer and more expensive drugs, according to a report in the August 9/23 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

10 Aug 2010

Measurable medical errors cost U.S. economy $19.5 billion in 2008: Report

Findings from a new study released today estimate that measurable medical errors cost the U.S. economy $19.5 billion in 2008. Commissioned by the Society of Actuaries (SOA) and completed by consultants with Milliman, Inc., the report used claims data to provide an actuarially sound measurement of costs for avoidable medical injuries. Of the approximately $80 billion in costs associated with medical injuries, around 25 percent were the result of avoidable medical errors.

9 Aug 2010

FDA accepts Salix's XIFAXAN550 sNDA for Priority Review

Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Company's efficacy supplement to the New Drug Application (NDA) for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating.

9 Aug 2010

Clinical Data first-quarter gross revenue increases 52% to $6.2 million

Clinical Data, Inc. today announced operational and financial results for the first quarter ended June 30, 2010, noting key accomplishments including the acceptance of the Company's new drug application (NDA) for vilazodone by the U.S. Food and Drug Administration (FDA) and the successful completion of a public offering .

9 Aug 2010

Rite Aid announces proposed $650 million senior secured notes offering

Rite Aid Corporation announced today its intention to offer $650 million aggregate principal amount of senior secured notes due 2020. The notes will be unsecured, unsubordinated obligations of Rite Aid Corporation and will be guaranteed by substantially all of Rite Aid's subsidiaries. The guarantees will be secured on a senior lien basis.

9 Aug 2010

WellCare Health Plans reaches agreement on material terms of settlement

WellCare Health Plans, Inc. announced today that it has reached an agreement on the material terms of a settlement which will resolve the claims asserted against the Company in the previously disclosed putative securities class action consolidated complaint filed against the Company.

9 Aug 2010

WellCare reports $128.9 million net loss for second-quarter 2010

WellCare Health Plans, Inc. today reported results for the three and six months ended June 30, 2010. As determined under generally accepted accounting principles, the Company reported a second quarter 2010 net loss of $128.9 million, or $3.05 per diluted share, compared with net income of $37.0 million, or $0.88 per diluted share, for the prior year period.

9 Aug 2010

Orexigen second-quarter net loss decreases to $11.9 million

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the second quarter of 2010. For the quarter ended June 30, 2010, Orexigen reported a net loss of $11.9 million, or $0.25 per share attributable to common stockholders, as compared to a net loss of $17.8 million, or $0.51 per share attributable to common stockholders, for the second quarter of 2009.

7 Aug 2010

Alkermes reports $42.3 million revenue for first-quarter fiscal 2011

Alkermes, Inc. today reported financial results for its first quarter of fiscal 2011, which ended on June 30, 2010.

7 Aug 2010

AVANIR Pharmaceuticals reports net loss of $5.7M for third-quarter fiscal 2010

AVANIR Pharmaceuticals, Inc. today reported unaudited financial results for the three and nine months ended June 30, 2010.

7 Aug 2010

Biovail second-quarter total revenues increase 23% to $238.8 million

Biovail Corporation today announced financial results for the three-month and six-month periods ended June 30, 2010.

5 Aug 2010

Alexza to raise $18.0M in registered direct offering

Alexza Pharmaceuticals, Inc. today announced that it has entered into definitive agreements with a select group of institutional investors to raise approximately $18.0 million in gross proceeds in a registered direct offering through the sale of common stock and warrants. The Company agreed to sell a total of 6,685,183 units, each unit consisting of (i) one share of common stock and (ii) one warrant to purchase 0.5 of a share of common stock, at a purchase price of $2.70 per unit.

5 Aug 2010