(St. Louis, Missouri, July 31, 2013) Gallus Biopharmaceuticals, LLC (Gallus) has signed a development and manufacturing supply agreement with Genzyme, a Sanofi Company the pioneer in the development and delivery of transformative therapies for patients with rare and special unmet medical needs for over 30 years. As part of the multi-year agreement Gallus will provide process and method development, scale-up, clinical supply and preparation for commercial manufacturing for an infused protein-based therapy targeting the rare disease, Niemann-Pick type B. “Gallus is delighted to partner with Genzyme in bringing this therapy to patients in need” said Mark Bamforth, Gallus’ CEO and President. “We are confident that our deep process development expertise and over ten years of commercial, perfusion-based biomanufacturing for global markets using proprietary, flexible stainless steel bioreactors will result in successful delivery of this therapeutic molecule to advance Genzyme’s clinical program.”

Niemann-Pick type B is caused by a deficiency of an enzyme called acid sphingomyelinase, which is required for the normal turnover of sphingomyelin, a major lipid of cell membranes. The enzyme deficiency causes sphingomyelin to accumulate in patients and leads to enlargement of the liver and spleen, lung disease, low blood cell counts and in some cases a shortened lifespan.

About Gallus BioPharmaceuticals

Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. The firm, based in St. Louis, Missouri, was established in 2010 and acquired a world class commercial biopharmaceutical manufacturing facility from Johnson & Johnson’s Centocor division in 2011 and has grown its workforce by over 50% since then. In addition to process development and clinical supply services, Gallus currently produces two commercial products that are distributed globally. The St. Louis facility has been inspected and approved by every major regulatory body worldwide. For additional information on biopharmaceutical contract development and manufacturing services:

July 2013 issue of Life Science Leader magazine – Written by Rob Wright

This year there have been a number of companies announcing pharmaceutical manufacturing plant closures. For example, Catalent Pharma Solutions announced the closing of its Allendale, NJ, facility. Solgar Inc., a subsidiary of NBTY, announced the closing of its plant in Lyndhurst, NJ. These pharma manufacturing plant closings equate to 196 jobs lost for New Jersey. Jeremy Levin, CEO of Teva Pharmaceuticals, is looking at net income being down 26.7%. When income is down, companies look to cut costs. For Teva, one of the cost-cutting solutions is the proposed closure of the company’s West Rockhill Township, PA, manufacturing facility, resulting in the loss of 450 jobs. That comes on the heels of Teva’s previously announced closing of a plant in Irvine, CA and its 403 jobs. These are tough decisions and have a lasting impact on the families of 1,049 people. Having been laid off before, I know how it feels. You tell yourself it is just business and not to take it personally — this is easier said than done. The business decision to close a plant has a negative ripple effect on the economy as those who are unemployed begin spending less, stop contributing to 401K investment plans, pay fewer taxes, and draw unemployment. But what if you didn’t have to close the plant?…

(St. Louis, Missouri – April 22, 2013) – Gallus BioPharmaceuticals, LLC (Gallus) today announced performance details of its Factory of the Future today. Gallus built an 8,000 sq ft open-ballroom suite using Xcellerex 2,000 L disposable bioreactors and has been operating it for the last year. To date, four mammalian cell lines have been used in multiple bioreactor runs, demonstrating robust scale-up performance, and clinical materials have been manufactured successfully. This facility demonstrates the ability to change over products with improved sustainability with 90% lower water usage and a single operating team with reduced cross-contamination risk. The facility was completed in Q1, 2011, after less than nine months of construction.

Gallus BioPharmaceuticals is a technology pioneering CMO, offering disposable bioreactors and a unique flexible stainless steel bioreactor alternative. The company has partnered with leading upstream and downstream technology providers to establish independent performance data, making these technical solutions available to clients and enabling them to optimize their process and manufacturing methods.

Mark Bamforth, President and CEO of Gallus, said, “Our CMO model is differentiated from traditional approaches through engagement that makes tech transfer and implementation smoother, transparency and partnering that give our clients active influence, and the ability to offer substantial economic benefits through virtual suite ownership – Gallus’ SuiteSPACE™ model. Combined with the flexibility to design the desired technical platform with help from our continual evaluation of the best available technology, our model delivers very tangible benefits in terms of speed, scalability, long-term costs, and performance results.”

In addition to offering the traditional pay-per-run approach, Gallus’ virtual ownership model gives clients control of dedicated capacity without the cost of traditional capital investment. Over capacity and under capacity problems are still prevalent in the industry, and Gallus’ SuiteSPACE™ model offers the flexibility to access capacity as needed. Gallus funds the build-out of a suite that can be custom designed to the client’s needs, and the client can own the process equipment. This innovative approach offers significant economic benefits over traditional pay-per-run models.

Gallus’ world-class facility in St. Louis is distinguished by an unprecedented 27 years of biologics development and over a decade of commercial cGMP manufacturing, providing deep technical expertise and commercial proof of viability for innovative technologies. Options include flexible stainless steel, fully disposable, and hybrid technologies. Gallus has partnerships with leading providers to offer exceptional modular and portable production trains based on flexible architecture, and as a pure-play CMO, continuously evaluates leading technologies and collaborates with clients to select and optimize their technical solution for their needs.

Mark Bamforth added, “Our vision is to be the most trusted provider of world-class manufacturing and development services for the pharmaceutical and biotech industry. To fulfill this, we must be a technology pioneer and ensure that we make a significant difference to both large and small biotechs and pharma, exceeding their strategic objectives. We are also leading the industry into continuous processing based on constant perfusion, which is another area where we know we can deliver even greater results, and why we offer the Factory of the Future today.”

About Gallus BioPharmaceuticals

Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. The firm, based in St. Louis, Missouri, was established in 2010 and acquired a world- class commercial biopharmaceutical manufacturing facility from Johnson & Johnson’s Centocor division in 2011 and has grown its workforce by over 40% since then. In addition to process development and clinical supply services, Gallus currently produces two commercial products that are distributed globally. The St. Louis facility has been inspected and approved by every major regulatory body worldwide. For additional information on biopharmaceutical contract development and manufacturing services:

Life Science executive with an extensive global network adds to already deep leadership team.

(St. Louis, Missouri February 26, 2013) — Gallus BioPharmaceuticals, LLC (Gallus) announced today the appointment of Mr. Shailesh Maingi to its Board of Directors as an independent director.

Gallus is pleased to announce the addition of Shailesh Maingi to its Board of Directors. Shailesh, a life sciences executive with an extensive global network, is CEO of Kineticos Life Sciences, a management consulting practice focused on advising industry leading life sciences organizations. Shailesh also serves on 2 Advisory Boards. Prior to this, Shailesh was VP of business development for pharmaceutical development at Cardinal Health Pharmaceutical Technologies and Services (now Catalent Pharma Solutions) and VP of marketing at Sigma-Aldrich/Supelco. Shailesh obtained a Bachelor of Science in Chemistry at UNC, Chapel Hill, and an MBA (Cum Laude) from the Golden Gate University, San Francisco.

“I am very excited to join the Gallus Board. Gallus has world class operations and an industry leading quality and regulatory track record. I believe that Gallus is well positioned to capitalize on the enormous market opportunities in biopharmaceutical manufacturing” said Shailesh.

“I am delighted to have Shailesh Maingi join our Board. Gallus is building a strong industry recognition for our ability to provide high quality process development, clinical and commercial supplies of biopharmaceuticals and I look forward to this continuing with support from Shailesh who brings great experience to realizing our vision of being the CMO of choice for our industry” said Mark R. Bamforth, President and CEO of Gallus BioPharmaceuticals.

About Gallus BioPharmaceuticals

Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. The firm, based in St. Louis, Missouri, was established in 2010 and acquired a world-class commercial biopharmaceutical manufacturing facility from Johnson & Johnson’s Centocor division in 2011 and transferred a 160- strong workforce. In addition to process development and clinical supply services, Gallus currently produces two commercial products that are distributed globally. The St. Louis facility has been inspected and approved by every major regulatory body worldwide. For additional information on biopharmaceutical contract development and manufacturing services:

Leverage knowledge to promote and expand continuous processing in the biotech industry

Pine Brook, NJ and St. Louis, MO, USA: January 22, 2013 –Refine Technology, LLC (Refine), the developer and worldwide supplier to the biotech industry of the ATF™ System, a best-in-class cell retention device, and Gallus BioPharmaceuticals, LLC (Gallus), the industry leading contract bulk biopharmaceuticals manufacturer, today announced a collaboration to optimize continuous cell culture processes.

Gallus has already developed deep experience of Refine’s ATF System as the leading CMO in perfusion technology. Gallus uses the ATF System to manufacture a commercial antibody, StelaraTM, for J&J, which is distributed globally. Gallus looks to build upon this collaboration with Refine to expand the use of ATF System in perfusion, concentrated high cell density processes, and disposable processes.

“We are looking forward to deepening our involvement with Gallus, who are a skilled and flexible partner to work with,” stated Jerry Shevitz, President of Refine. “Many biopharmaceutical companies, both small and large, desire to move into high cell density and continuous production methods using our ATF System. Together, Refine and Gallus will be able to help these companies achieve their goals and deliver more robust quality and lower cost bioprocesses, building on the Gallus Center of Excellence for continuous processing for mammalian cell culture.

“With experience of developing over 40 molecules during a 26 year site history, combined with a decade of commercial manufacturing history, Gallus is strongly positioned to support clients to exploit the advantages of the ATF System in process development, clinical supply and commercial licensure for their products” said Mark R. Bamforth, President & CEO at Gallus. “We are excited to expand Gallus’ leading technology partnerships by collaborating with Refine and their best-in-class technology.”

About Refine Technology

Refine Technology develops and commercializes equipment for the enhancement of cell culture processes. Its ATF System, which scales for use in the laboratory through to commercial manufacturing, has a range of uses from simple culture maintenance and perfusion, to generation of “extreme” cultures, to complex vaccine manufacturing. Refine Technology is dedicated to quality, customer support and providing solutions to a rapidly evolving biopharmaceutical industry. Based in New Jersey, USA, Refine Technology distributes and services its products worldwide through its network of highly trained sales and support personnel.

About Gallus Biopharmaceuticals

Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. The firm, based in St. Louis, Mo., was established in 2010 and acquired a world-class commercial biopharmaceutical manufacturing facility and workforce from Johnson & Johnson/Centocor division in 2011. In addition to process development and clinical supply services, Gallus currently produces two commercial products that are distributed globally. The St. Louis facility has been inspected by every major regulatory body worldwide. For additional information on biopharmaceutical contract development and manufacturing services:

St. Louis (Dec. 6, 2011) – Gallus BioPharmaceuticals (Gallus) was recognized at the Greater St. Louis Top 50 awards ceremony on November 15th 2011 for its establishment as a new contract manufacturing business, its regional contributions, and its positive impact to the business community. The recognition involved the successful acquisition of the FDA-approved, commercially-certified biologics manufacturing plant and 160 of its employees from Centocor Biologics, LLC earlier in 2011.

Over 700 business leaders attended the awards ceremony with 50 companies being recognized for their growth. Dick Fleming, Chairman of the Regional Chamber and Growth Association, welcomed Gallus to St. Louis and said “Gallus represents the growth of the BioBelt in the Mid-west and an outstanding example of the rejuvenation of a site with a successful history.”

Gallus also announced completion of the first phase of a $20 million expansion of the site with the addition of new state-of-the-art process and analytical development laboratory suites. To supplement current process and analytical capabilities, Gallus has supplied the laboratories with a significant amount of new downstream process and analytical equipment and also partnered with Xcellerex to equip the new cell culture suites with 10L and 50L disposable bioreactors. Gallus President and CEO, Mark Bamforth, said “the expansion of the site’s development capabilities will enable Gallus to support a greater number of clients”. The addition comes as part of a larger expansion currently underway at Gallus to increase the clinical and commercial production capacity of its existing facility, which is already producing commercial products. Mr. Bamforth added “The expansion of disposable capacity at Gallus reflects the growing demand in the biopharmaceutical industry for a cost-effective development and manufacturing solution required for early phase drug development that disposables provide.” Gallus has also increased its staff by approximately 15% and will continue to grow over the next six months to support the ongoing expansion.

About Gallus Biopharmaceuticals

Gallus Biopharmaceuticals is a premier biologics contract manufacturing organization based in St. Louis, MO. Gallus operates an FDA-approved, commercially-certified facility formerly owned by Centocor Biologics, LLC. The Gallus facility has capabilities for mammalian cell culture and protein purification in both perfusion and fed-batch mode and is being expanded to offer additional development and clinical services capabilities. The plant currently produces two leading commercial biologics products, distributed globally.

Gallus Acquiring FlexFactory® Bioproduction Lines and Single-Use Bioreactors; Xcellerex Partners to Help Customers Gain Access to Commercial Biomanufacturing Facility

Marlborough, MA, and St. Louis, MO May 24, 2011 – Xcellerex, Inc. and Gallus BioPharmaceuticals, LLC today announced that they have entered into a collaboration that quickly provides Gallus with expanded cGMP biomanufacturing capacity by leveraging the key advantages of the turnkey Xcellerex FlexFactory® GMP manufacturing platform suite. The strategic collaboration will provide Gallus with world-class, scalable, flexible and cost-efficient manufacturing and laboratory technology to expand its contract manufacturing business. In addition this partnership will provide Xcellerex’s customers unprecedented access to a commercial, FDA approved, biomanufacturing facility.

Under the agreement, Gallus is acquiring several Xcellerex bioproduction systems for new suites and laboratories at its existing manufacturing facility. Along with single-use XDR bioreactors to quickly expand capabilities in an existing commercial manufacturing suite, Gallus is acquiring small scale 10L bioreactors for its expanded development laboratory and a turnkey FlexFactory cGMP manufacturing line with XDR single-use bioreactors up to 2000 liter scale for clinical supply. Such rapid capacity expansion with single-use technology not only enables Gallus to offer more services and options to its customers, but also augments Gallus’ existing, multi-suite commercial capacity with novel, proven single-use Xcellerex bioreactors. Through the collaboration, Xcellerex and Gallus will provide their customers with access to Gallus’ established biomanufacturing expertise in a world-class facility that has been inspected and approved by all major regulatory authorities.

“Gallus has a unique contract manufacturing business model that enables us to respond to clients’ changing capacity needs quickly, and achieve rapid, high quality production at a competitive price,” said Mark Bamforth, President and CEO of Gallus. “The partnership with Xcellerex allows us to leverage their single-use biomanufacturing platform. This is a strategic investment that rapidly provides us with additional manufacturing capacity and scale-up capabilities to deliver development, clinical and commercial products and services. The first manufacturing suite will be in place by the end of 2011.. Additional suites can be added to meet specific customer needs, within the existing facility at our site in St. Louis.”

Gallus is a contract biologics manufacturer that was established in 2010 and recently acquired an existing Johnson & Johnson/Centocor manufacturing facility in St. Louis, Missouri. The facility is currently producing two commercial products that are approved globally. The company’s business model includes a “condominium” concept that allows a client to “virtually-own” a manufacturing suite for its process development and production needs. This novel approach provides clients with complete flexibility in accessing capacity as needed.

Xcellerex Chief Executive Officer Guy Broadbent commented, “Gallus is capitalizing on the extraordinary flexibility afforded by the FlexFactory, along with the extensive manufacturing experience of its team, to provide innovative solutions for established as well as development-stage biopharmaceutical companies. The agreement provides us with an important path for us to offer full-scale commercial manufacturing to our customers.”

Separately, the companies announced that Mr. Broadbent will join the Gallus board of directors.

About Gallus BioPharmaceuticals

Gallus Biopharmaceuticals is a premier biologics contract manufacturing organization based in St. Louis, MO. Gallus operates an FDA-approved, commercially-certified facility formerly owned by Johnson & Johnson’s Centocor division. The Gallus facility has capabilities for mammalian cell culture and protein purification in both perfusion and fed batch mode and is being expanded to offer additional development and clinical services capabilities. The plant currently produces two leading commercial biologics products, distributed globally.

Learn More About Gallus BioPharmaceuticals »

About FlexFactory

Xcellerex’s FlexFactory is an innovative, portable biomanufacturing platform, based on the innovative application of (1) single-use technologies; (2) controlled environmental modules (CEMs); and (3) advanced and proven process automation including electronic batch records. The FlexFactory effectively eliminates clean- and steam-in-place requirements and clean room infrastructure; greatly simplifies facility design, reducing manufacturing footprint and capital investment; and creates breakthrough gains in operating efficiency, flexibility and environmental friendliness.

About Xcellerex, Inc.

Xcellerex is commercializing turnkey biomanufacturing solutions that transform the speed and economics of producing therapeutic proteins, including biosimilars and vaccines. The company’s FlexFactory® is a complete modular and portable production train based on single-use technologies, advanced process automation, and compact clean room architecture.

FlexFactory allows deployment of GMP manufacturing capacity more rapidly and at greatly reduced costs compared with traditional facilities. Through its BridgeSourcing™ services, Xcellerex manufactures a partner’s biomolecules while the partner prepares for commissioning of its own new FlexFactory. When the partner’s facility is ready, Xcellerex deploys its TransPlant™ process to install, validate and train partner personnel in their own FlexFactory. This parallel-path model both accelerates time to clinical and commercial manufacturing and allows partners to manage the development and market risks associated with adding manufacturing capacity.

Xcellerex also leverages its proprietary single use technologies through the sale of XDR bioreactors, XDM Quad Mixers, and related single-use assemblies. To date, more than 20 therapeutic proteins and vaccines have been manufactured for clinical trials using Xcellerex technology.

Based in Marlborough, Massachusetts, Xcellerex is backed by an experienced management team and top-tier venture investors including Kleiner Perkins Caufield & Byers, VantagePoint Venture Partners and SCG Capital. For more information, please visit the company’s website at http://www.xcellerex.com