Brand Strategies

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Shire submits NDA for investigational ulcerative colitis treatment Shire Pharmaceuticals Group Plc submitted a New Drug Application to the Food and Drug Administration for Mesavance (mesalamine), formerly known as SPD476, an investigational treatment for active, mild to moderate, ulcerative colitis.

Although mesalamine, the active ingredient in Mesavance, is contained in other drugs available to treat ulcerative colitis, Shire said its formulation uses a different drug delivery technology that enables the delayed and extended release of the active compound throughout the colon. If approved, Mesavance will be the first once-daily mesalamine, according to Shire.

"The timely filing of our Mesavance NDA represents the fourth new product submission in 2005 for Shire and our partners," said Matthew Emmens, the firm's chief executive officer.

Shire licensed the rights for Mesavance in the United States, Canada, the Pacific Rim and Europe, excluding Italy, from Giuliani SpA. Giuliani retains the right to develop and commercialize the drug in Italy.

The MMX Multi Matrix System drug delivery technology used in Mesavance was developed by Cosmo SpA.

Shire plans to apply for European approval of the drug in the first quarter of next year.

Brand Strategies Endo completes NDA filings for two formulations of oxymorphone Endo Pharmaceuticals Inc. filed responses to the Food and Drug Administration's approvable letters regarding the company's New Drug Applications for oxymorphone extended-release (ER) and immediate-release (IR) tablets.

The FDA has 60 days to decide whether the submissions meet the agency's criteria for a complete response. If the response is deemed complete, Endo expects to receive an action letter for each NDA within 180 days.

The responses included data from two separate randomized, double-blind, parallel-group trials that evaluated oxymorphone ER, a semisynthetic mu-opioid agonist formulated for extended release using Penwest Pharmaceuticals Co.'s proprietary TimeRx delivery system, in opioid-naive and -experienced patients with chronic low back pain.

Additionally, the responses contained previously disclosed data from a placebo-controlled Phase III trial of oxymorphone IR in the treatment of acute post-operative pain.

"We believe that oxymorphone is the most extensively studied oral opioid, including a data set of more than 3,000 patients," said Peter Lankau, Endo's chief executive officer. "We also believe oxymorphone ER will give physicians an important new option for treating patients with moderate to severe chronic pain who require around-the-clock opioid therapy for longer than a few days."

If the products are approved, Lankau said the company will be ready to launch them in the second half of 2006.

Brand Strategies

BMS, Merck define final agreement terms to end collaboration on Pargluva Bristol-Myers Squibb Co. and Merck & Co. Inc. reached an agreement regarding the termination of their collaborative efforts to develop Pargluva (muraglitazar), an investigational oral diabetes treatment. Under the agreement, all rights to the drug revert to BMS.

On Oct. 18, the Food and Drug Administration issued an approvable letter for Pargluva in which the agency requested more information on the drug's cardiovascular safety profile. This notice spurred discussions between the two companies regarding possible termination of the drug's development.

BMS said it is still discussing its options for Pargluva with the FDA. The company may choose to conduct additional studies, which it said could take up to five years, or it could dissolve the Pargluva development program altogether.

Separately, Icagen Inc. issued an update on its atrial fibrillation program, in which BMS had been conducting a Phase I, proof-of-concept trial. BMS decided to discontinue the study, which was initiated in 2004, because of slow enrollment. According to Icagen, BMS is "considering alternative trial designs."

Brand Strategies

Wyeth submits NDA for depression drug Wyeth Pharmaceuticals Inc. submitted a New Drug Application to the Food and Drug Administration for desvenlafaxine extended release (DVS-233), an investigational treatment for major depressive disorder.

The NDA included data from a clinical development program that assessed use of the drug in patients with emotional and somatic symptoms of depression.

Wyeth Research discovered and developed the drug, a serotonin/norepinephrine reuptake inhibitor. According to Reuters, it is a "tweaked version" of Wyeth's antidepressant Effexor (venlafaxine hydrochloride).

"We know from clinical studies as well as clinical practice that there remain significant unmet needs in treating depressed patients," said Dr. Gary Stiles, Wyeth's chief medical officer. "If approved, desvenlafaxine extended release will offer physicians a new clinically proven option for treating depression."

Brand Strategies

AstraZeneca, AtheroGenics enter into license agreement regarding cardiovascular product candidate AtheroGenics Inc. entered into a licensing agreement with AstraZeneca Plc for the global development and commercialization of AtheroGenics' oral anti-inflammatory cardiovascular product candidate, AGI-1067, which is intended to treat atherosclerosis.

Based on the agreement, if the product candidate is commercialized successfully, AtheroGenics could receive a total of $1 billion. This sum includes a $50 million up-front payment and as much as $300 million in development and regulatory milestone fees. Additional payments of up to $650 million are tied to "progressively demanding sales performance-related milestones."

AtheroGenics will continue to be responsible for the ongoing Phase III clinical trial of the drug and for U.S. regulatory filings. AstraZeneca will be responsible for pre-commercialization activities, which AtheroGenics said would begin immediately, and for regulatory filings in countries other than the United States. AstraZeneca will also oversee marketing, sales and distribution activities associated with AGI-1067.

If the compound is successfully commercialized, AstraZeneca will fund the formation and operation of a 125-person AtheroGenics specialty sales force for a minimum of three years. This sales force would focus on the U.S. cardiology field and would co-promote AGI-1067 and another of AstraZeneca's key cardiovascular drugs.

"The benefit of this collaboration goes well beyond the obvious financial rewards and gives us the opportunity to access AstraZeneca's commercial expertise as we establish our own sales and marketing group in preparation for the next phase of our corporate growth," said Dr. Russell Medford, AtheroGenics' chief executive officer.

Shares of AtheroGenics closed at $19.74, up $3.24, or 19.6 percent, in heavy trading on the Nasdaq.

Brand Strategies

Medicare Part D enrollment off to strong start, HHS says; Humana anticipates large Medicare enrollment More than 21 million seniors and people with disabilities will be covered under Medicare's new drug benefit as of Jan. 1, 2006, according to Mike Leavitt, secretary of the Department of Health and Human Services.

"With more than 21 million participating in coverage as of Jan. 1, we are well on the way of meeting our goal of 28 million to 30 million enrolled in the first year of the program," he said.

Humana Inc. said it expects to have enrolled more than 1.7 million people in its Medicare plans as of Jan. 1. At the end of September, the firm had approximately 503,000 Medicare members.

For its Medicare stand-alone prescription drug plans, Humana expects enrollment to be between 1.1 million and 1.2 million as of Jan. 1. By the end of 2006, the company anticipates enrollment in these plans to increase to between 1.7 million and 2.2 million members.

"We're pleased by the volume of response to all [of] our Medicare products, both existing and new," said Michael McCallister, chief executive officer of Humana.

Based on its results thus far, Humana confirmed its earnings guidance for 2006 and said it expects to earn at least $2.70 per diluted share.

In separate news, Humana acquired behavioral health care management firm Corphealth Inc. for approximately $54 million in cash. Humana said it does not expect the transaction to have a material effect on its 2006 earnings.

Humana shares closed at $55.29, up $6.97, or 14.4 percent, in heavy trading on the New York Stock Exchange.

Brand Strategies

Brand Strategies
Wyeth Pharmaceuticals Inc. Wyeth Pharmaceuticals Inc. signed a license agreement with Exelixis Inc. for compounds that target a nuclear hormone receptor known as farnesoid X receptor, which is thought to play a role in various metabolic and liver disorders. Under the agreement, Wyeth will be responsible for the compounds' preclinical and clinical development, as well as associated regulatory, manufacturing and commercialization activities. In exchange, Exelixis will receive $10 million up front and may receive up to $147.5 million in additional development and commercialization milestone payments, along with royalties.

Brand Strategies

Brand Strategies
Wyeth Consumer Healthcare Inc. Wyeth Consumer Healthcare Inc. and SCOLR Pharma Inc. entered into a licensing agreement granting Wyeth worldwide rights to SCOLR's proprietary, patented Controlled Delivery Technology drug delivery platform for potential use in an unspecified over-the-counter formulation. Under the agreement, Wyeth will pay SCOLR an up-front licensing fee, as well as milestone and royalty payments. The agreement also allows for further collaboration between the two companies on other products that may use the technology. Additional details of the agreement were not disclosed.

Brand Strategies

Brand Strategies
CVS Corp. CVS Corp. confirmed that it has been in talks with Albertson's Inc. regarding the possibility of acquiring Albertson's stand-alone Osco and Sav-on drugstores, noting that the companies have not reached any agreement. The New York Times, citing a source familiar with the discussions, reported that Albertson's recently ended discussions with a group of investors that considered buying the entire company for $9.6 billion.

Brand Strategies

Brand Strategies
BioCryst Pharmaceuticals Inc. BioCryst Pharmaceuticals Inc. said the Food and Drug Administration has given the company approval to begin human testing of its influenza neuraminidase inhibitor, intravenous peramivir. Preclinical studies have demonstrated the drug's broad-spectrum activity against multiple influenza strains, including the avian influenza H5N1 virus. In addition to the intravenous formulation, which is intended to treat infected patients who are acutely ill, the company said it is conducting preclinical studies with intramuscular formulations, which would be used in patients in the earlier stages of influenza infection. BioCryst shares closed at $17.59, up $2.38, or 15.7 percent, in heavy trading on the Nasdaq.