PHARMACY

Lilly completes acquisition of Avid

BY Allison Cerra

INDIANAPOLIS — One month after announcing it would acquire a leader in molecular imaging development, Eli Lilly announced it has completed its acquisition of Avid Radiopharmaceuticals.

Under the terms of the definitive merger agreement, Lilly acquired all outstanding shares of Avid for an upfront payment of $300 million, subject to adjustment based on existing cash on hand at closing. Avid stockholders also will be eligible for up to $500 million in additional payments contingent upon potential future regulatory and commercial milestones for florbetapir, a molecular imaging agent under investigation for detecting the presence of amyloid plaque in the brain.

The Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee will hold a meeting to discuss florbetapir’s new drug application on Jan. 20.

The impact of the acquisition will be reflected in Lilly’s fourth-quarter 2010 financial statements, but is not expected to be substantial, Lilly said.

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Dey Pharma settles DoJ suit

BY Allison Cerra

BASKING RIDGE, N.J. — A Mylan subsidiary has settled a lawsuit brought on by the Department of Justice four years ago.

Dey Pharma — which was involved in the suit prior to begin acquired by Mylan from Merck KGaA in 2007 — said that it agreed to pay $280 million to the DoJ in exchange for a release of claims, which dealt with Medicare and Medicaid reimbursements paid by the federal government to pharmacists and other healthcare providers. Dey added that Merck KGaA is responsible for paying the full amount of this settlement, as well as all costs and other expenses associated with pending and future-related lawsuits.

The settlement agreement confirmed that the resolution of the case does not constitute an admission, finding or evidence of fault, liability or wrongdoing by Dey, the drug maker said.

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FDA releases annual ‘Generic Drug Roundup’

BY Alaric DeArment

SILVER SPRING, Md. — Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

The roundup is an annual highlighting of what the agency considers the most significant generic drug approvals.

One of the most important was enoxaparin sodium injection, approved in July. The drug, a generic version of Sanofi-Aventis’ anti-clotting drug, Lovenox, is marketed by Sandoz, the generics arm of Swiss drug maker Novartis. While the FDA approved Lovenox as a pharmaceutical, its chemical complexity and production process place it in league with biologics, and many analysts said the special circumstances under which the agency approved it could influence regulations governing biosimilars in the future. Lovenox had sales of $2.7 billion in 2009, according to Sanofi-Aventis financial data.

June saw the approval of Roxane Labs’ anastrozole tablets, a generic version of AstraZeneca’s breast cancer treatment Arimidex, which had sales of $916.8 million, according to IMS Health. Roxane, based in Columbus, Ohio, is the generics arm of German drug maker Boehringer Ingelheim.

Also in June, the FDA approved Teva’s venlafaxine hydrochloride extended-release capsules, a generic version of Wyeth’s major depressive disorder treatment Effexor XR, which has annual sales of around $2.75 billion, according to IMS.

In October, the FDA approved Actavis’ losartan potassium tablets, a generic version of Merck’s Cozaar, used to treat hypertension. Losartan potassium tablets had sales of around $940 million for the 12-month period ended in June, according to IMS.

In July, the agency approved APP Pharmaceuticals’ injected drug aztreonam, a generic version of Bristol-Myers Squibb’s antibiotic Azactam, which had sales of around $86 million in 2009, according to IMS.

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