HollisterStier Contract Manufacturing and sister organization, Draxis Pharma, have appointed Steven Rowan as vice president of business development, Jubilant Organosys Contract Manufacturing North America. Mr. Rowan will oversee a HollisterStier-Draxis corporate business development team.

The two companies have a partnership joining their capabilities and services under the ownership of Jubilant Organosys. Mr. Rowan will be responsible for global business development activities for HollisterStier and Draxis, as well as establishing strategic partnerships to strengthen the companies’ presence throughout Europe and Asia.

Mr. Rowan has more than 20 years of experience in the pharmaceutical and biopharmaceutical industries. His in-depth knowledge, extensive scientific background and experience implementing Six Sigma methodologies will benefit the organizations as they align their manufacturing services.

“I look forward to being a part of this team as we transition into having a more heightened global presence,” said Mr. Rowan. “Together, we offer a level of technical expertise, multiple dosage forms, and understanding of the entire life cycle that proves to be very competitive in the outsourcing industry ─ this is an exciting opportunity for me to help showcase our competitive advantages and strategically position HollisterStier and Draxis Pharma as leading industry players.”

Cephalon, Inc. and BioAssets Development Corp. (BDC) have signed an agreement that will provide Cephalon with an option to acquire BDC. Cephalon will pay $30 million upfront and an additional payment if it exercises its option. BDC stockholders could also receive additional future payments related to regulatory and sales milestones. The agreement is subject to customary closing conditions.

BDC, a privately held biopharmaceutical company, is currently conducting a Phase II placebo-controlled proof of concept study with the tumor necrosis factor (TNF) inhibitor, etanercept, epidurally administered to patients with sciatica. Sciatica is a neuropathic inflammatory pain condition that occurs when the sciatic nerve is compressed, injured or irritated. Results are expected to be available in 2H10. BDC has secured rights for use of TNF inhibitors for sciatic pain in patients with intervertebral disk herniation, as well as other spinal disorders.

"BioAssets offers an estate of intellectual property and scientific expertise that will allow us to evaluate our own domain antibody tumor necrosis factor inhibitor, CEP-37247 (formerly known as ART-621), for the treatment of sciatica," said Frank Baldino, Jr., Ph.D. chairman and chief executive officer of Cephalon. "Combining these two innovations helps fulfill our strategy to address unmet patient needs, while focusing on specialty physicians."

"Development of an improved non-surgical therapy for sciatica presents a pressing unmet medical need and a potentially significant commercial opportunity," commented James Gorman, M.D., Ph.D., chief executive officer of BioAssets. "Cephalon combines an innovative TNF inhibitor pipeline with a well established pain therapeutic franchise. I believe these capabilities uniquely position Cephalon to develop and commercialize a novel biologic therapy for these patients."

Exelixis and Bristol-Myers Squibb achieved positive Phase II data showing that XL184 demonstrated activity in patients with glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer. The study evaluated the safety, tolerability, and clinical activity of XL184 at daily doses of 175 mg or 125 mg in 46 patients with previously treated GBM, including some patients who had received prior antiangiogenic therapy.

The overall rate of confirmed partial response in the patients treated at 175 mg was 17%. Among patients without prior antiangiogenic therapy, 21% achieved confirmed responses. In patients who had received prior antiangiogenic therapy, 8% progressed on vandetinib and achieved a confirmed partial response. Of the 46 patients treated at the 175 mg dose level, 21% attained 6-month progression-free survival (PFS) rate with 35% of patients censored for PFS at the time of analysis. The median duration of response was 5.9 months. The median PFS interval was 3.7 months.

“The updated data from patients treated with the 175 mg dose of XL184 is consistent with what we have reported previously and continue to demonstrate that the compound is clinically active,” said Michael M. Morrissey, Ph.D. president of R&D at Exelixis. “While the data from the 125 mg dose cohort are still early, they are encouraging and we will continue to evaluate the suitability of this dose and potentially others for future clinical studies. This trial in its totality is providing important information that will enable future decision making with respect to designing and implementing trials of XL184 in this patient population.”

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