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Contract manufacturing news in brief

By staff reporter, 24-Jan-2008

Related topics: Processing & QC

KBI Biopharma, Helix BioMedix and Azopharma have all recently announced new contract manufacturing news.

Canada's Helix BioPharma has contracted US firm KBI Biopharma to develop a process for preparing L-DOS47 in a lyophilised vial format that would allow the drug to become suitable for clinical testing.

L-DOS47 is a combination of Helix's DOS47 new drug candidate, with a highly specific single domain antibody, to form a potential new targeted treatment for adenocarcinoma of the lung, the most common form of cancer in the world today.

Helix said it intends to seek approval this year from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study of the experimental medicine in lung adenocarcinoma patients.

"This new arrangement advances the Company closer to its objective of initiating clinical testing with L-DOS47", said John Docherty, Helix's president.

"The lyophilised packaging format will provide for optimum stability of L-DOS47 while in storage so that individual vials may be reconstituted in liquid form immediately prior to patient administration".

Meanwhile, a firm with a similar name (but no relation), Helix BioMedix, has entered into a manufacturing and supply agreement with Peptisyntha, an affiliate of Solvay.

Under this contract, Peptisyntha will manufacture and supply certain peptides at specified prices for Helix for an initial term of two years.

Helix is a biopharmaceutical company with over 50 patents supporting a library of peptides that are diverse in structure, sequence, and bioactivity.

Stephen Beatty, president and CEO described the agreement as "significant" because it "addresses several critical components that are important to the company both now and in the future".

He said that the relationship with Peptisyntha is a "major step" towards ensuring that the firm can supply commercial quantities of peptides once products are developed and will "immediately" provide peptide supplies to its marketing partners for the company's consumer product segment, which Beatty described as rapidly growing.

"As a result of this agreement, our partners will have a readily available peptide supply for the significantly higher order volume that we are now beginning to experience," he said.

Privately-held Azopharma Product Development has inked a five-year deal with Accu-Break Pharmaceuticals (ABP) whereby Azopharma will become the "center of excellence" for developing products based on ABP's patented tablet technologies.

Dr. Allan Kaplan, CEO of ABP said that the company's tablet technologies create an inactive break layer in tablets, allowing them to be broken into accurate partial doses.

"By breaking at the inactive layer, accurate dose splitting can be guaranteed, since the active layer remains undisturbed," he said.

It is claimed that this will allow doctors to provide patients with a more accurate, flexible and individualised dosage adjustment.

According to the two firms, ABP's technology also provides pharma firms with a solution for formulation challenges such as separating incompatible active ingredients to allow for the development of unique combination therapy products.

"These new patented technologies will help pharmaceutical companies in many ways, from creating new products utilising these novel technologies, to gaining competitive market share by modifying existing products", said Phil Meeks, CEO of Azopharma.