AMRI, New River Pharmaceuticals Enter Manufacturing Pact

Posted on July 25, 2006 @ 09:52 am

AMRI has entered a multi-year drug substance manufacturing agreement with New River Pharmaceuticals, Inc. Under the agreement, AMRI will manufacture the API in New River's compound, NRP104, a treatment for attention deficit hyperactivity disorder (ADHD) that is currently under review with the FDA. AMRI participated with New River in the development of the chemical process to manufacture NRP104. Financial terms were not disclosed.

"AMRI is delighted to continue its relationship with New River Pharmaceuticals," said AMRI chairman, president and chief executive officer Thomas E. D'Ambra, Ph.D. "We are well positioned to manufacture this compound based on our long history of manufacturing, as well as our strength in chemical development. Our expertise and specialized capabilities in the area of active ingredient manufacturing provide a unique and value-added capability to AMRI customers."

Krish Krishnan, New River's chief financial officer and chief operating officer, commented, "We are confident that AMRI is a solid choice for manufacture. AMRI has the current capability of delivering a quality product in a timely manner, leading us to conclude that it is the best candidate for manufacturing NRP104 for an expected product launch in the first quarter of 2007."

Financial Report: Covance

Posted on July 25, 2006 @ 09:50 am

Covance

2Q Revenues: $335 million (+14%)

2Q Earnings: $35 million (+32%)

YTD Revenues: $656 million (+14%)

YTD Earnings: $68 million (+32%)

Comments: The company achieved record net orders of $555 million in the quarter, driving its backlog up 31% to nearly $2 billion. Early development revenues for the quarter grew 11% to $156 million and operating income increased 16% to $39 million in the quarter. Late-stage development revenues were up 16% to $179.5 million and operating income increased 6% to $28.5 million.

Enzon's ALL Onco-Drug Approved

Posted on July 25, 2006 @ 09:48 am

Enzon Pharmaceuticals received approval from the FDA for its sBLA for Oncaspar, an oncology product for use as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia (ALL). Oncaspar had previously been indicated for patients with ALL who require L-asparaginase in their treatment, but developed hypersensitivity to the native forms.

The FDA approved the new first-line indication for Oncaspar based on data from two studies conducted by the Children's Cancer Group (CCG), CCG-1962 and CCG-1991, with safety data from more than 2,000 pediatric patients.

Acute Lymphoblastic Leukemia is an aggressive blood cancer, which will affect almost 4,000 people in 2006, according to the American Cancer Society. ALL is the most common form of cancer in children, representing 23% of cancer diagnoses among those younger than 15 years of age.