Laureate Pharma has officially opened its newly constructed Pilot Plant in Princeton, NJ for pre-clinical biopharmaceutical manufacturing. The plant is now available for early engineering runs and product production for uses such as formulation and toxicological testing.
The plant is designed for process development, production and purification of early-phase preclinical proteins. The facility features two separate production suites and two expanded purification suites to support preclinical production of recombinant proteins from mammalian-cell culture. The plant includes stainless steel, stirred-tank bioreactors and disposable, single-use bioreactors. The purification suites feature the same process chromatography and filtration technologies used in Laureate's larger scale cGMP facility.
"The equipment in our pilot plant facility is designed to facilitate a direct, seamless scale-up from development to cGMP production for our clients' projects," said Robert Broeze, Ph.D., Laureate's president and chief executive officer. "With the new pilot plant in operation, we can accelerate our manufacturing of preclinical material and save on several months' worth of critical product development time."
Riccardo Trecroce has been appointed chief executive officer of
Patheon, Inc. Mr. Trecroce was initially appointed to this position on an interim basis in September 2006.
"Since joining Patheon in 2000, Mr. Trecroce has played a key role in the development and execution of Patheon's business strategy," said Peter Green, chairman of Patheon. "Riccardo's in-depth knowledge of the company, strong client focus and vision are qualities that will serve Patheon well as we move forward to advance Patheon's positioning as a global leader in our sector."
Also, Patheon has entered into an agreement with J.P. Morgan Securities Inc. and GE Commercial Finance for new credit facilities to refinance its North American and UK debt. The refinancing is based on the completion of the $150 million convertible preferred share investment by JLL Partners Fund V, L.P., which is expected to close, together with the JLL Partners investment, by April 30th.
The new credit facilities total $225 million, comprising a seven-year $150 million term loan facility and a five-year $75 million revolving facility. The proceeds of the term facility, together with the proceeds of the JLL Partners investment, will be used to repay the company's obligations under its existing North American and U.K. credit facilities.
"Today's agreement with JPMorgan and GE Commercial Finance marks the next major milestone in our capital restructuring process," said John Bell, chief financial officer, Patheon. "With the investment by JLL Partners and the new long-term debt facilities, we will have the appropriate long-term financial structure in place to operate and grow our business effectively."
"The JLL investment and bank refinancing are important to the future of Patheon and represent the culmination of an extensive strategic and financial alternatives review process undertaken over the past six months," said Mr. Trecroce.
The Toronto Stock Exchange has granted approval for the issuance of the convertible preferred shares to JLL Partners. However, the TSX requires Patheon's common shareholders have the right to elect six of the nine members of Patheon's board of directors, but will not be entitled to vote to elect the three directors who will be JLL Partners' representatives under the terms of the agreement.
Hollis-Eden Pharmaceuticals, Inc. filed an IND application with FDA to begin a Phase I trial with its next-generation drug candidate, HE3286, for the treatment of metabolic disorders, which include diabetes, obesity and dyslipidemia. The trial program, designed to assess the safety of HE3286 in healthy volunteers, could support both a Phase II study in type 2 diabetes, and a Phase II study in rheumatoid arthritis under a separate IND the company plans to file for autoimmune disorders later this year.
In preclinical studies, HE3286 has been shown to regulate signaling pathways of inflammation common to both metabolic and autoimmune disorders. In preclinical models of type 2 diabetes, HE3286 produced glucose lowering activity and increased insulin sensitivity when administered orally. These findings suggest that HE3286 may be the first in a new class of insulin sensitizers with a novel mechanism of action, since it appears to regulate the pro-inflammatory NF-kappa B pathway without acting on the PPARgamma receptor, which is the target of insulin sensitizing drugs currently prescribed today. This new pathway appears to avoid the side effect of weight gain commonly seen with these existing therapies.
HE3286 has also demonstrated a benefit in rodent models of both initial-onset and established rheumatoid arthritis. Potential mechanisms of action for HE3286 in this indication include regulation of NF-kappa B and increasing the production of regulatory T cells, or Treg cells, which play a key role in keeping the immune system from attacking the body.
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