By Christopher Valasek, Joshua Cole, Frank Hensel, Pei Ye, Michael A. Conner, and Michiel E. Ultee

Mmunoglobulin G (IgG) antibodies have been used to treat cancer for many years. Another class of antibodies — immunoglobulin M (IgM) — has been overlooked in spite of offering unique advantages that make them highly desirable as cancer therapeutics. Serving a valuable function in our innate immune system, IgM antibodies are the first to be secreted when an abnormal cell is present. These antibodies play a critical role in recognition and elimination of infectious particles, in removal of intracellular components, and in immunosurveillance mechanisms against malignant cells. IgMs also can bind to multiple copies of a target on a cancer cell surface. Such high avidity leads to cross-linking and more effective cell killing.

DPx Holdings B.V., privately owned by JLL Partners and Royal DSM and the parent company of Patheon, announces that it has completed the transaction to acquire Gallus BioPharmaceuticals, LLC, a leading contract manufacturing company specializing in biologics. Patheon’s biologic drug substance business, a unit of DPx Holdings, now spans four global facilities in Europe, Australia and North America and includes more than 550 employees.

“We are pleased to have closed this transaction within such a short period of time so that we can begin providing customers with an even higher level of service with our expanded service offerings and dedicated biologics presence in the U.S.,” says Jim Mullen, CEO of DPx Holdings. “This acquisition allows us to better serve the biologics segment in our industry and aligns with our strategy to continue to bring our customers an industry leading end-to-end service offering.”

The Patheon pharma services business provides commercial manufacturing, pharmaceutical product development services for a full array of solid and sterile dosage forms, and biologic and chemical drug substance development and manufacturing. With the Gallus BioPharmaceuticals acquisition, Patheon is now a leading provider of process development as well as clinical and commercial scale manufacturing of mammalian cell culture derived products. Patheon offers customers a broad array of disposable manufacturing technology, as well as commercial scale production, throughout its expanded global network. In addition, Patheon is able to leverage its expertise in disposable technology to expedite manufacturing as well as broaden its capabilities in mid-scale flexible manufacturing. These enhanced capabilities further support the Patheon end-to-end integrated offering providing small-scale API and biologic drug substance through to commercial manufacturing.

The two existing Gallus sites in St. Louis, Mo. and Princeton, N.J. are the first Patheon biologic drug substance sites in the U.S. and complement the two existing sites in Groningen, the Netherlands and Brisbane, Australia. Three of these four global sites each have nearly three decades of mammalian cell culture experience, while the fourth site in Brisbane was opened within the last year and is considered a facility of the future for biologics. Under the Patheon brand, these sites will support the company’s continued expertise in biologics and support the needs of Patheon’s customers in this growing segment of the industry.

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DPx Holdings B.V. Media Relations

Tel: +1 (919) 226-3200

Email: moc.noehtap@aidem

About DPx Holdings B.V.
DPx Holdings B.V. is the privately held parent company of the Patheon, DPx Fine Chemicals and Banner Life Sciences businesses. The company is a leading provider of CDMO services, pharmaceutical products and products for other industries. DPx Holdings B.V. was founded in 2014 as a result of the merger of Patheon and DSM Pharmaceutical Products and is owned 51% by JLL Partners and 49% by Royal DSM. With a global headquarters in Durham, N.C., DPx Holdings B.V. has a footprint of more than 20 locations across North America, Europe, Latin America and Australia with more than 8,000 employees. DPx Holdings B.V. offers customers unsurpassed quality, end-to-end services and value through its three business units. For more information, visit www.patheon.com/DPx .

About Patheon®
Patheon®is a leading provider of contract development and commercial manufacturing (CDMO) services to the global pharmaceutical industry for a full array of solid and sterile dosage forms, including small molecule API and biologic drug substances. Patheon, a business unit of DPx Holdings B.V., encompasses the combined commercial manufacturing capabilities and pharmaceutical product development services, as well as offers a full array of biologic services and pharmaceutical active pharmaceutical ingredients (API) development. Patheon is #1 in product development services, #2 in commercial scale product manufacturing and is #1 in quality. For more information, visit http://www.patheon.com .

Durham, N.C. and St. Louis–(August 27,  2014)–DPx Holdings B.V., privately owned by JLL Partners and Royal DSM, is pleased to announce that it has reached a definitive agreement to acquire all shares of Gallus BioPharmaceuticals, LLC, a leading contract manufacturing company specializing in biologics and current portfolio company of Ridgemont Equity Partners. Following the transaction, Patheon’s biologic drug substance business, a unit of DPx Holdings, will span four facilities in Europe, Australia and North America and include 550 employees globally.

DPx Holdings is the parent company of Patheon, DSM Fine Chemicals and Banner Life Sciences. The Patheon pharma services business provides commercial manufacturing, pharmaceutical product development services for a full array of solid and sterile dosage forms, and biologic and chemical drug substance development and manufacturing. The addition of Gallus BioPharmaceuticals makes Patheon a leading provider of process development as well as clinical and commercial scale manufacturing of mammalian cell culture derived products. Patheon can offer its customers a broad array of disposable manufacturing technology, as well as commercial scale production, throughout its global network.

“We are pleased to expand our biologics business with the acquisition of Gallus BioPharmaceuticals,” says Jim Mullen, CEO of DPx Holdings. “This transaction is in line with our strategy. We can now further support the needs of our customers with biologics projects by providing flexibility, leading technology solutions, commercial operations and an expanded footprint with two U.S. sites.”

Once the transaction is complete the two Gallus sites in St. Louis, Mo. and Princeton, N.J. will be the first Patheon biologic drug substance sites in the U.S. and will complement the two existing sites in Groningen, the Netherlands and Brisbane, Australia. Three of the four global sites each have nearly three decades of mammalian cell culture experience, while the fourth site in Brisbane was opened within the last year and is considered a facility of the future for biologics. Together these sites will support Patheon’s ongoing growth in biologics and will continue to support the needs of Patheon’s customers in this growing segment of the industry. In addition, Patheon will be able to leverage its expertise in disposable technology to expedite manufacturing as well as expand its capabilities in mid-scale flexible manufacturing.

“This is an exciting time as we join a world-class company and expand our offerings as one global team specializing in biologics,” says Mark R. Bamforth, president and CEO, Gallus BioPharmaceuticals. “We have built deep commercial and clinical manufacturing and process development capabilities that are highly complementary to Patheon’s biologics organization. We look forward to the ongoing success and growth by combining our knowledge, skills, technical expertise and capabilities to serve customers’ product needs.”

Subject to receipt of regulatory approvals, the transaction is expected to close in the fourth quarter of 2014. Wells Fargo Securities served as lead financial advisor to Gallus, with William Blair & Company and Frontier Management, Inc. serving as co-advisors. Goodwin Procter LLP served as legal advisor to Gallus, the Gallus management team and Ridgemont Equity Partners. Skadden, Arps, Slate, Meagher & Flom LLP served as legal advisor to DPx Holdings.

About DPx Holdings B.V.

DPx Holdings B.V. is the privately held parent company of the Patheon, DSM Fine Chemicals and Banner Life Sciences businesses. The company is a leading provider of CDMO services, pharmaceutical products and products for other industries. DPx Holdings B.V. was founded in 2014 as a result of a deal between JLL Partners and Royal DSM. With a global headquarters in Durham, N.C., DPx Holdings B.V. has a footprint of more than 20 locations across North America, Europe, Latin America and Australia with more than 8,000 employees. DPx Holdings B.V. offers customers unsurpassed quality, integrated offerings and value through these three business units.

About Patheon

Patheon is a leading provider of contract development and commercial manufacturing (CDMO) services to the global pharmaceutical industry for a full array of solid and sterile dosage forms. Patheon, a DPx Holdings B.V. business unit, encompasses the combined CMO capabilities and pharmaceutical product development services (PDS), as well as the Biosolutions and Biologics (BIO) business.

About Gallus BioPharmaceuticals

Gallus BioPharmaceuticals, a portfolio company of Ridgemont Equity Partners, is a leading contract manufacturing company offering exceptional contract services to its clients. Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacturing of Stelara® and Remicade® for Janssen Pharmaceuticals. Gallus’ facility in Princeton, New Jersey, has three decades of experience in process development and clinical manufacturing of bulk and aseptic-filling of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs and collagens, plus over 20 years of experience of commercial manufacture including the supply of ProstaScint®. Both sites maintain exemplary quality and regulatory records.

(St.Louis, Missouri, August 21, 2014)– Gallus BioPharmaceuticals, LLC, a premier, full service biopharmaceutical contract development and manufacturing organization (CMO) announced today that it has been selected by Progenics Pharmaceuticals, Inc., an oncology company focused on the development of innovative approaches to targeting and treating cancer, to manufacture the anti-prostate specific membrane antigen (PSMA) monoclonal antibody used in Progenics’ PSMA ADC product candidate. Under the agreement the antibody will be produced in Gallus’ commercial manufacturing facility in  St. Louis, Missouri for use in ongoing clinical trials.

“Our extensive commercial manufacturing experience and proven quality systems make Gallus an ideal partner to support Progenics in the manufacture of their anti-PSMA antibody,” said Mark R. Bamforth, President & CEO of Gallus. “We look forward to working with Progenics as they advance this treatment for patients with prostate cancer.”

PSMA ADC is a fully human monoclonal antibody-drug conjugate designed to deliver chemotherapeutic drug selectively to prostate cancer cells. It does so by targeting the three-dimensional structure of PSMA, a protein that is a clinically validated biomarker of prostate cancer which is expressed on the surface of prostate cancer cells. The PSMA antibody produced at Gallus is designed to internalize into the cancer cell, release active anti-cancer drug, and destroy the malignant cell.

“Gallus has impressed us with their ability to meet our high standards, combined with the experience and expertise necessary to manufacture our anti-PSMA antibody,”said Nitya Ray, PhD, Sr. Vice President, Manufacturing of Progenics. “We look forward to a productive partnership with Gallus as we develop this product for patients in need of this therapy.”

About Gallus BioPharmaceuticals

Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional development and manufacturing services to its clients. Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacturing of Stelara^® and Remicade^® for Janssen Pharmaceuticals. Gallus’ facility in Princeton, New Jersey, has three decades of experience in process development and clinical manufacturing of bulk and aseptic-filling of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs and collagens, plus over 20 years of experience of commercial manufacture including the supply of ProstaScint^®. Both sites maintain exemplary quality and regulatory records. For additional information, please visit www.gallusbiopharma.com.

About Progenics

Progenics Pharmaceuticals, Inc. is developing innovative medicines for oncology, with a pipeline that includes several product candidates in late-stage clinical development. Progenics’ first-in-class PSMA targeted technology platform includes an antibody drug conjugate therapeutic in a two-cohort phase 2 clinical trial and a small molecule targeted imaging agent that has completed patient dosing in a phase 2 trial. Among other assets in its pipeline of targeted radiotherapy and molecular imaging compounds is Azedra™, an ultra-orphan radiotherapy candidate also in a phase 2 study under an SPA. Progenics’ first commercial product, Relistor® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with and marketed by Salix Pharmaceuticals, Inc. For additional information, please visit www.progenics.com.

This press release may contain projections and other forward-looking statements regarding future events. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the cost, timing and results of clinical trials and other development activities; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; and possible safety or efficacy concerns, general business, financial and accounting matters, litigation and other risks. Information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the U.S. Securities and Exchange Commission. Information on or accessed through its website is not included in its SEC filings.

(St. Louis, MO, April 29, 2014) – Gallus BioPharmaceuticals, LLC (Gallus), a premier pure-play biologics contract development and manufacturing organization (CMO), and Omni Bio Pharmaceutical, Inc. (Omni Bio) (OMBP.ob), a biopharmaceutical company focused on the commercialization of alternative uses of alpha-1 antitrypsin (AAT) for the treatment of a variety of indications and the development of next-generation recombinant forms of AAT, jointly announced finalization of a multi-stage manufacturing services agreement.

The agreement includes cell line optimization, analytical development and manufacturing scale-up activities for Omni Bio’s leading AAT Fc fusion protein with the goal of providing cGMP product to support animal toxicology studies and early clinical trials of the molecule. Under the agreement, Omni Bio has selected the commercially available CHOZN® GS Cell line commercially available from Sigma-Aldrich’s custom manufacturing and services business unit SAFC® Commercial, as the expression system. In addition, SAFC® will perform the cell line development and safety testing services, in conjunction with Gallus’ overall management of the process development and manufacturing services program for Omni Bio.

“Gallus is delighted to partner with Omni Bio in the cell line optimization, process development and clinical supply of their AAT Fc protein” said Mark R. Bamforth, Gallus’ President & CEO. “We are confident that our deep process development expertise and direct experience with Fc fusion molecules will result in high quality material effectively delivered to meet Omni Bio’s goals.”

“We are also quite pleased to be entering into this relationship with Gallus, a very experienced CMO with an excellent track record of manufacturing both early-stage and commercial-stage biopharmaceutical products” commented Dr. Bruce Schneider, CEO, Omni Bio. “We look forward to working with the Gallus technical team to advance our recombinant AAT molecule into the clinic as efficiently and effectively as possible.”

About Alpha-1 Antitrypsin (AAT)

AAT is the most abundant circulating serine protease inhibitor in the body and an acute phase reactant. Systemic deficiency in AAT due to genetic mutations can result in debilitating liver failure and chronic lung disease such as emphysema. Lifelong treatment with plasma-derived AAT, intravenously administered, is indicated for such patients. Recent evidence suggests that AAT plays an important role in modulating immunity, inflammation and apoptosis. AAT protects various cell types from cell death, inhibits caspases-1 and -3 activity and has been shown to be effective in a wide variety of animal models of human disease, including diabetes, graft versus host disease (rejection reactions following bone marrow or other transplantation procedures), refractory gout, myocardial infarction and inflammatory bowel disease.

About Omni Bio Pharmaceutical, Inc.

Omni Bio Pharmaceutical (www.omnibiopharma.com) is a biopharmaceutical company that is focused on alternative uses for AAT and on developing new recombinant forms that can be applied to the treatment of a broad range of indications as noted above. The Company holds licenses to patents and patent applications licensed from the University of Colorado and a privately held company. Since its formation, Omni Bio has supported research using animal models and human clinical studies that demonstrate that AAT is a promising agent for ameliorating these conditions. The Company is now focused on the development of a recombinant AAT Fc fusion molecule as a new biological entity.

About Gallus BioPharmaceuticals

Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacturing of Stelara® and Remicade® for Janssen Pharmaceuticals. Gallus’ facility in Princeton, New Jersey, has three decades of experience in process development and clinical manufacturing of bulk and aseptic-filling of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs and collagens, plus over 20 years of experience of commercial manufacture including the supply of ProstaScint®. Both sites maintain exemplary quality and regulatory records.

Forward-Looking Statements

Some of the statements made in this press release are forward-looking statements that reflect Omni Bio management’s current views and expectations with respect to future events. These forward-looking statements are not a guarantee of future events and are subject to a number of risks and uncertainties, many of which are outside our control, which could cause actual events to differ materially from those expressed or implied by the statements. These risks and uncertainties are based on a number of factors, including but not limited to the business risks disclosed in our SEC filings, especially the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended March 31, 2012. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

(St. Louis, Missouri – February 25, 2014)– Gallus BioPharmaceuticals, LLC (Gallus), a premier pure-play biologics contract manufacturing organization (CMO) has signed a manufacturing agreement with Symphogen, A/S (Symphogen), a private biopharmaceutical company developing recombinant monoclonal antibody (mAb) mixtures for the treatment of cancer.

This agreement includes process transfer and clinical stage cGMP manufacturing of Symphogen’s antibody mixture product candidates. Gallus will employ the GE Healthcare Life Sciences Flex Factory™, a flexible single-use biomanufacturing platform, at their headquarters in St. Louis to manufacture product candidates for Symphogen.

“Gallus is delighted to partner with Symphogen in the process development and clinical supply of their antibody mixture candidates. Symphogen has developed unique technologies for the controlled, reproducible production of highly characterized mAb mixtures manufactured in a single batch. Gallus’ expertise in process development and scale-up will ensure high quality molecules are delivered to the clinic,” said Mark R. Bamforth, Gallus’ President & CEO.

“We are pleased to work with Gallus, a very experienced CMO with an extensive background in the cGMP manufacture of antibodies, ranging from early stage clinical programs to the commercial supply of approved therapeutics. We look forward to working together to advance our innovative cancer therapeutic programs” said Kirsten Drejer, CEO of Symphogen A/S.

About Symphogen A/S

Symphogen is developing next-generation antibody therapeutics for the treatment of cancer and is dedicated to bringing truly innovative oncology products to the market.

The Company has advanced the frontier of antibody discovery by creating well-characterized antibody mixtures that address multiple oncology targets in a single drug product. The Company has matured its oncology pipeline and has currently brought two product candidates into the clinic. The Company’s productive technology suite – capable of identifying, selecting and manufacturing optimal antibody mixtures – fuels Symphogen’s oncology pipeline.

The lead oncology product, Sym004, was out-licensed to Merck KGaA in 2012 following phase 2 clinical data in late stage cancer patients.

In total, the Company has raised €249 million in equity capital from premier international investors including Novo, Essex Woodlands Health Ventures and PKA, and employs 100 people, most of whom are based at Symphogen’s facilities in Copenhagen.

About Gallus BioPharmaceuticals

Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacture of Stelara® and Remicade® for Janssen Pharmaceuticals. Gallus’ facility in Princeton, New Jersey, has three decades of experience in process development and clinical manufacturing of bulk and aseptic-filling of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs, and collagens, plus over 15 years of experience in commercial manufacture of ProstaScint®. Both sites maintain exemplary quality and regulatory records.

For additional information visit www.gallusbiopharma.com or email: *protected email*.

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Contact Information:

Gallus BioPharmaceuticals, LLC

Claire Ruzicka, Sr. Marketing Manager

4766 LaGuardia Drive, St. Louis, MO 63134-3117

Phone no.: +1 314 562 5755

Email: moc.amrahpoibsullag@akcizur.erialc

Symphogen A/S

Gayle Mills, Chief Business Officer

Elektrovej, building 375, DK-2088 Lyngby, Denmark

Phone no.: +1 650 464 3656

Email: moc.negohpmys@mmg

Gallus BioPharmaceuticals, LLC (Gallus), a premier pure-play biologics contract manufacturing organization (CMO) announces the appointment of Claudette Kile as Vice President of Quality & Regulatory. This addition to the highly experienced Gallus leadership team supports the continued growth of Gallus’ contract manufacturing services.

Ms. Kile will be responsible for the planning, implementation and daily operations of the Quality & Regulatory organization at Gallus headquarters in St. Louis and the Princeton, New Jersey facility. “Gallus has a strong track record in process development, clinical and commercial manufacturing of licensed biopharmaceuticals at both sites, and the addition of Claudette Kile to our team strengthens our commitment to maintaining exemplary compliance for our pharma and biotech clients as their products mature through the clinic towards licensure” stated Mark Bamforth, President and Chief Executive Officer of Gallus.

Ms. Kile brings 27 years’ of industry experience in medical devices, biologics, and pharmaceuticals, with specialized expertise in building global compliant quality systems. She has experience with all phases of clinical trials and strong leadership, risk-based decision making, flexibility, compliance, project management, and organizational skills.

Most recently, Ms. Kile was Senior Director of Quality at Jazz Pharmaceuticals where she led the oversight of global clinical trials and drug safety and pharmacovigilance activities. Previous roles in Quality include; Director, Quality Assurance at Emergent Biosolutions, where she oversaw the supply of vaccines and antibody therapy products from pre-clinical through commercial and managing her own consultancy focusing on regulatory affairs, compliance, and quality assurance. Earlier in her career, Ms. Kile held roles with increasing responsibility at Abbott Labs, as Director, Global Clinical Quality, EV3, Inc. (now part of Covidien) and an extended period at Guidant where she managed 4 clinical departments and had a variety of hands-on quality roles.

About Gallus BioPharmaceuticals

Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients.  Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacture of Stelara^® and Remicade^® for Janssen Pharmaceuticals. Gallus’ facility in Princeton, New Jersey, has three decades of experience in process development and clinical manufacturing of bulk and aseptic-filling of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs, and collagens, plus over 15 years of experience in commercial manufacture of ProstaScint^®. Both sites maintain exemplary quality and regulatory records.

For additional information visit www.gallusbiopharma.com or email .moc.amrahpoibsullag@ofni

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Contact information:

Gallus BioPharmaceuticals, LLC

Claire Ruzicka

Sr. Marketing Manager

4766 LaGuardia Drive

St. Louis, MO 63134-3117

USA

+1.314.562.5755

moc.amrahpoibsullag@akcizur.erialc

By Michiel E. Ultee, Ph.D., CSO

Laureate Biopharma cell-culture scientists routinely develop cell-culture processes to produce higher titers of the desired recombinant protein over the original processes given to them by our clients. Increasing titer is one of the most effective routes to lower cost of goods for our clients. This is because titers can often be increased two to five fold, meaning that any given bioreactor run will produce that much more protein product. In contrast, improvements in downstream yields are typically less than two fold, such as increasing recovery from 50 to 70%.

Three case studies will be presented to demonstrate different cell lines and types of proteins. These include CHO, PER.C6, and hybridoma cell lines, and IgG and IgM antibodies. In each case the existing process was improved to result in higher final titers in the bioreactor. With these improved processes, our manufacturing team has successfully produced clinical material to enable our clients to advance these protein therapeutics in clinical evaluation.

By Douglas W. Rea, Michiel E. Ultee, Sharon X. Chen, Thomas P. Loisel

Platform processes are valuable tools in process development. Applying them to complex fusion molecules made up of different structures, however, can lead to unexpected results. EA2 is a unique engineered molecule, and it did not fit well into a platform process. It does, however, have three potential affinity and pseudo-affinity sites, each target site having a platform purification unit operation. One site is the antibody Fc region for Protein A binding, but the product was too sensitive to low pHs for typical Protein A elution conditions, so a high pH elution process was developed instead. The other two pseudo-affinity sites proved to be unusable, as did ion exchange chromatography. The final process that was developed added hydrophobic interaction and mixed mode (HIC and AEX) chromatography polishing, with a solvent and detergent (S/D) treatment instead of the typical lowpH virus inactivation.This product points out the need for innovation and flexibility in cases where platforms do not work.

(St. Louis, Missouri – October 1, 2013) – Gallus BioPharmaceuticals, LLC (Gallus), a leading biologics contract manufacturing organization (CMO), today announced its acquisition of Laureate Biopharmaceutical Services, Inc. (Laureate), a full service biologics CMO located in Princeton, New Jersey. This acquisition doubles Gallus’ process development (PD) and clinical drug substance manufacturing capacity, adds full protein characterization, testing and clinical fill-finish capability and offers a seamless development pathway for clients – from early stage PD and clinical manufacturing to commercial manufacturing.

United by a common mission to deliver outstanding clinical and commercial CMO services, the merged companies combine two organizations with proven track records and offer clients two Centers of Excellence for manufacturing therapeutic proteins using mammalian cell-culture: The Princeton site is a Center of Excellence for PD solutions and manufacture of clinical-stage products, including fill-finish; the St. Louis site is a Center of Excellence for PD, clinical and commercial manufacture of biopharmaceutical products. Both sites are FDA approved, while the St. Louis site is also licensed by every major regulatory authority globally.

Gallus, a pure-play CMO, now has multiple clinical and commercial suites at the two sites, with 50L to 2,000L GMP single-use platforms from XcellerexTM and HyCloneTM in addition to 50L to 2,000L fixed and flexible stainless steel bioreactors and associated downstream purification for drug substance. Additionally, clinical fill-finish capabilities are part of the Princeton site. All of these services will be delivered by the combined team of 350 experienced and dedicated staff.

Michael A. Griffith, Laureate CEO, who will support the transition for several months, stated that, “The merger of Laureate into Gallus benefits our clients and our employees by creating a more secure and diverse platform including important additional technologies and capabilities. Our client portfolio includes late-stage clinical programs advancing towards launch that will immediately benefit from the commercial readiness of the Gallus St. Louis site. Importantly, we believe that the service mindsets of Gallus and Laureate are well matched.”

Mark R. Bamforth, Gallus President and CEO, stated “This acquisition is another important step towards realizing Gallus’ vision to be the most trusted provider of world class biologics manufacturing and development services for the pharmaceutical and biotechnology industry. By combining Laureate and Gallus, we double the development and clinical capacity of Gallus with a uniquely flexible combination of stainless steel and single use technologies and capacities to suit every client’s process needs. Critically, we have an established, reliable commercial pathway for late stage molecules and expect to continue to grow our organization and make further capital investments to serve client needs.” Financial details of the acquisition are confidential. Laureate was a portfolio company of Saints Capital, LLC. Gallus is a portfolio company of Ridgemont Equity Partners.

About Gallus BioPharmaceuticals

Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacture of Remicade® and Stelara® for Janssen Pharmaceuticals. Gallus’ new facility in Princeton, NJ, has three decades of experience in process development and clinical manufacturing of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs and collagens, plus over 15 years of experience in commercial manufacture of ProstaScint®. Both sites maintain an exemplary quality and regulatory record.