Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

, a drug development services company, reported the expansion of large molecule bioanalytical space and the addition of new members to its biologics team.

The additional space will be added at its central laboratory facility in Indianapolis, Ind.  The expansion, which is planned to open during the second half of 2014, will double the company’s large molecule capacity and is expected to add approximately 100 new positions over the next five years. 

In addition to the expansion, the company also appointed Mike Holsapple, PhD, as Covance’s executive director of global immunotoxicology. Holsapple is a member of the Academy of Toxicological Sciences and past president of the Society of Toxicology, with more than 30 years of experience.

Articles

Covance adds workspace and scientists to biologics team in Indianapolis facility.

Covance Expands Global Biologics Capabilities

 (RCA), a life-sciences consulting firm, has expanded into Europe with a new office in Warsaw, Poland.

RCA is headquartered in the US with offices in Pleasant Prairie, WI and Tampa, FL.  According to the company, RCA choose Warsaw as its next location, because of its proximity to other central eastern european biotech industries.

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RCA opens a new office in Warsaw, Poland.

Regulatory Compliance Associates Expands into Poland

 reported that it has reached a definitive agreement to acquire a minority stake in Profarma, a pharmaceutical wholesaler in Brazil. In addition, AmerisourceBergen and Profarma will establish a joint venture for specialty distribution and services. The company expects to invest a total of approximately $100 million, and the transaction is expected to close in the June quarter of 2014.

AmerisourceBergen will purchase up to a 19.9% minority stake by offering $22.50 per share for shares offered in a primary offering by Profarma. This distribution joint venture will include Profarma’s existing specialty businesses and an equity investment from AmerisourceBergen. As a result, each company will own a 50% stake in the joint venture.

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AmerisourceBergen to establish a joint venture for specialty distribution with Profarma.

AmerisourceBergen Acquires Minority Interest in Profarma

, a leader in solid-state chemistry services for drug development, has selected Freeslate, a provider of high through put research solutions, for its CM Protégé PharmD System for polymorph, salt, co-crystal, and solubility screens of APIs.
  
  The Freeslate PharmD System will be used to extend thepolymorph and solubility screens completed without increasing the time or resources required. Crystal Pharmatech will also serve as a reference site and demo lab for Freeslate, hosting customers and product demonstrations and participating in speaking engagements.
  
  Freeslate's CM Protégé PharmD System brings high-throughput solid and solubility screening to a broader range of researchers with a fully automated platform. The system can evaluate up to 384 crystallization conditions per run to quickly turn around solid-form screening projects and save users valuable material through its ability to use approximately 1 g of API per solid-form screen. Solid forms can be analyzed by birefringence, x-ray powder diffraction, and Raman spectroscopy directly from the glass universal substrate without any manual manipulation of fragile crystals. Other analyses and experiments, such as solid form stability, can also be conducted directly on the glass universal substrate. Heating, cooling, and mixing on-deck allows for simultaneous slurry, precipitation, cooling, and evaporation experiments on a single platform.
  
  The CM Protégé PharmD System uses Freeslate's Lab Execution and Analysis (LEA) software for library design, protocol development/execution, data analysis, and reporting. This allows users to design complex experiments quickly using its recipe-oriented approach. Using LEA, experimental conditions can be linked to analytical data for easy viewing and reporting.

Crystal Pharmatech selects Freeslate for its CM Protege PharmD System.

Crystal PharmaTech Collaborates with Freeslate for Solid Form Screening

 has reported that based on data generated by the SMARTag ADC platform, it has increased its minority investment in Redwood Bioscience. The proprietary SMARTag precision protein-chemical engineering platform and toxin-linker technologies developed by Redwood enables the generation of homogeneous antibody-drug conjugates (ADCs) engineered to enhance potency, safety, and stability.

Catalent announced in April 2013 that it had acquired an exclusive license to market the SMARTag technology and has subsequently collaborated with Redwood for the ongoing development and marketing of the technology. Redwood’s new, site-specific protein modification and linker technologies enable the generation of homogenous bioconjugates engineered to improve performance and ease of manufacturing. Combined with Catalent’s proprietary GPEx cell line expression system, Catalent recently completed a biomanufacturing Center of Excellence in Madison, Wisconsin and broad range of analytical and fill-finish services to develop more biologic treatments.

Redwood’s protein conjugation and linker technologies overcome the limitations associated with conventional protein chemistries that produce heterogeneous products with variable conjugate potency, toxicity, and stability, according to the company. The SMARTag technology enables site-specific, programmable drug-protein conjugation and uses naturally occurring modifications to proteins requiring minimal cell-line engineering.

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Catalent increases its minority investment in Redwood Bioscience for engineering ADCs.

Catalent Increases Investment in Redwood Bioscience

 reported that FDA has approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a rare skin disease known as chronic spontaneous urticaria (CSU) outside of the US. In the US, Xolair is indicated for CIU in adults and adolescents (12 years of age and above) who remain symptomatic despite H1-antihistamine treatment. Until now, H1-antihistamines have been the only approved therapy for CIU in the US.

FDA approval is primarily based on positive and consistent results from two phase III studies, ASTERIA I and II, which involved CIU/CSU patients not responding to approved doses of H1-antihistamines. Xolair 300 mg and 150 mg met all primary endpoints across these studies, which also showed Xolair significantly improved itch and hives, including rapid itch relief, and in many cases completely cleared symptoms. 

Results from three phase III studies for Xolair in CIU/CSU were announced in 2013. In all three studies, a significant proportion of patients became either completely free of itch and hives (range 34-44%; at 300 mg) or had their symptoms suppressed to minimal levels (52-66%; at 300 mg). In the ASTERIA II study, 44% of patients receiving Xolair 300 mg were itch-and hive-free after 12 weeks of treatment. In the ASTERIA I study, Xolair-treated patients experienced a rapid reduction in itch and hives as early as week one, with the therapeutic benefit sustained over 24 weeks of active treatment. In the GLACIAL study, more than half of patients had failed multiple therapies including H1-antihistamines (at up to four times the approved dose) and H2-antihistamines and/or leukotriene receptor antagonists (LTRAs). Patient response in GLACIAL was similar to that seen in ASTERIA I and II, leading to elimination or suppression of symptoms to minimal levels within two weeks of the start of treatment, and sustained throughout the 24 week treatment period.

Xolair was recently approved by European Commission as add-on therapy for CSU in adult and adolescent patients 12 years and above with inadequate response to H1-antihistamines. Xolair has also been approved for the treatment of refractory CSU in eight other countries: Egypt, Turkey, Guatemala, El Salvador, Bangladesh, Pakistan, Ecuador, and the Philippines. Regulatory reviews are currently ongoing in more than 20 countries, including Canada, Australia, and Switzerland. Novartis and Genentech are jointly developing Xolair.

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FDA approves Xolair (omalizumab) for the treatment of a rare skin disease known as chronic idiopathic urticarial.