Monthly Archives

June 2019

Novavax Signs Strategic Partnership with Catalent’s Paragon BioServices, Secures Company Future and 100’s of Jobs

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Montgomery County Maryland’s Novavax has had a rocky road to say the least, and the latest failed Phase III RSV trial earlier this year put the company in a difficult position to recover from. Aside from the turbulent clinical path, the company is well known for the high caliber cGMP manufacturing assets, especially its talented workforce. For Catalent Biologics new Paragon BioServices division, this was exactly what they needed to aid their rapid expansion.

Paragon BioSevices has made many headlines this year with strategic moves that have propelled the company into a leading position within the gene therapy market. Therefore, this new strategic partnership with Novavax is right in line with their playbook.

The Baltimore-based CDMO has been hiring as fast as they can to meet the demand for their expertise in gene therapy, hiring around 90 in the first quarter along this year. Projections of 100-200 additional jobs at Paragon seemed almost impossible to fill in the current, competitive job market, so this acquisition for manufacturing assets and talent may have been the best way to meet their increasing workforce needs.

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NanoCellect® and QIAGEN streamline single-cell RNA-Seq by sorting directly into RNAseq-ready plates

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A non-exclusive collaboration between NanoCellect and QIAGEN aims to accelerate adoption and ease of use of single-cell RNAseq by combining the power of NanoCellect’s WOLF® Cell Sorter with QIAGEN’s QIAseq® UPX 3′ Transcriptome Kit

SAN DIEGO and GERMANTOWN, Md. and HILDENGermanyJune 24, 2019/PRNewswire/ — QIAGEN N.V. and NanoCellect Biomedical, Inc., a leader in cell analysis and sorting technology, announced today a scientific collaboration to improve the cell sample prep upstream of QIAGEN’s QIAseq® UPX 3′ Transcriptome Kit through the utilization of NanoCellect’s WOLF Cell Sorter technology, which allows for individual cells to be gently sorted into RNAseq- ready 96-well plates.

Single-cell RNA-seq analysis focuses on the individual contribution of every cell, highlighting a specific biological response otherwise obscured when assessed in bulk. The greatest bottleneck to single-cell analysis is the lack of easy-to-use methods for precisely isolating single cells from a heterogeneous cell population and debris, without damaging the cells, and dispensing them into 96- or 384-well plates. Combining the power of NanoCellect’s WOLF Cell Sorter with QIAGEN’s QIAseq UPX 3′ Transcriptome Kit provides a high-tech, synergistic Sample to Insight® workflow solution.

The two parties are working together to optimize a solution that simplifies the workflow and accessibility to precisely aliquot single (or up to 100) of cells per well. Customers will be able to leverage the dispensed cells with the high-performance and sensitivity of the QIAseq UPX 3′ kits and thereby achieve the goal of enabling high-throughput 3′ transcriptome NGS from ultralow amounts of RNA. The combination of cell IDs and sample IDs enables up to 18,432 libraries to be sequenced together, providing users with an innovative solution to many NGS challenges.

Click here to read the entire Press Release.

QIAGEN Inks Distribution Deal With Mckesson Medical-Surgical

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QIAGEN N.V. QGEN recently announced that it has inked an agreement with McKesson Medical-Surgical Inc. Mckesson Corporation’s MCK affiliate will serve as the exclusive distributor of QIAGEN’s QIAstat-Dx syndromic testing solution in the acute market segment of U.S. hospitals, which have 200 beds or less. Mckesson Medical-Surgical will also distribute the solution in other select segments. This will enable QIAGEN to expand its reach within the healthcare market.

More About the Agreement

Through the agreement, McKesson becomes a non-exclusive distributor for future expansion of QIAstat-Dx into the non-acute retail clinics in U.S. retail pharmacies. The distribution relationship reinforces QIAGEN’s sales and marketing focus on the growing syndromic market in the larger hospitals and clinical laboratories setting.

The agreement with McKesson comes after the QIAstat-Dx syndromic testing system attained 510(k) approval from the FDA. The multiplex QIAstat-Dx Respiratory Panel for simultaneous qualitative detection and identification of multiple respiratory viral and bacterial pathogens also received FDA’s nod. This comprehensive respiratory panel identifies more than 20 pathogens and is the first test in a wide array of assays planned for QIAstat-Dx in the United States. Moreover, this includes the addition of a comprehensive gastrointestinal panel later in 2019.

Click here to read the entire release.

Viela Bio Closes $75 Million Series B Financing

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Funding to support regulatory filing and pre-commercial planning for lead product candidate, inebilizumab, and to advance development of additional clinical candidates targeting autoimmune and inflammatory diseases

Financing led by HBM Healthcare Investments

Gaithersburg, MD—June 17, 2019 – Viela Bio today announced the successful completion of a $75 million private placement of its Series B preferred stock, bringing the total capital raised since the Company’s launch in February 2018 to more than $300 million. The financing round was led by HBM Healthcare Investments, and additional new investors participating included Viking Global Investors, Cormorant Asset Management, Terra Magnum Capital Partners, Goldman Sachs, and Barer & Son Capital. Existing investors participating included Temasek.

“We are pleased that our ongoing development of our clinical programs continues to attract capital from leading healthcare investors. This financing will support our upcoming regulatory milestone—the anticipated filing of our Biologics License Application with the U.S. FDA for our lead product candidate, inebilizumab, for the treatment of neuromyelitis optica spectrum disorder, or NMOSD,” said Bing Yao, Ph.D. Executive Chairman and Chief Executive Officer. “NMOSD is a severe, debilitating, and sometimes fatal neurological disease for which there is currently no approved treatment. While our priority is to serve this patient population through the successful approval and launch of inebilizumab, we believe this financing also puts us in a strong position to pursue additional new indications with inebilizumab. Furthermore, we believe this financing will allow us to advance the entirety of our clinical pipeline, which is comprised of several additional clinical candidates for a range of rare autoimmune and inflammatory diseases.”

Click here to read more via Viela Bio.

Maryland and UK Sign Two New Partnerships to Grow Life Science Businesses

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Last week two new partnerships were formed between Maryland and the United Kingdom. Biohealth Innovation, a MD based public-private nonprofit focused on accelerating commercialization for biohealth, will be collaborating with Catalyze, an Amsterdam based company dedicated to bringing non-dilutive funding for biomedical innovations.

Another alliance was formed across the pond at the 2019 BIO International Convention in Philadelphia as Maryland Commerce Secretary Kelly M. Schulz and Sir John Peace, chairman of the Midlands Engine, signed a Memorandum of Understanding (MoU). These new partnerships speak to the collaborative approach Maryland is taking to continue to grow its life sciences industry and expand growth opportunities for the hundreds of Maryland-based companies.

The MoU is a mutually beneficial agreement that will help bring investors to the table to help life science companies in Maryland and the Midlands thrive. This new union seeks to promote economic growth for both economies through opportunities like an exchange program that will be implemented by the two countries. Life science companies from Maryland and the Midlands will visit the other country to seek opportunities for expansion into the local market. One such trade mission already took place this past March with participation by eleven life science companies

Click here to read more via BioBuzz.

Altimmune Announces Successful Pre-IND Meeting with FDA

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Meeting on HepTcell Phase 2 program for treatment of chronic hepatitis B (HBV)

GAITHERSBURG, Md., June 10, 2019 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its Phase 2 trial design and manufacturing plans for HepTcell. The FDA did not object to the planned study design and patient populations, as well as plans for manufacturing and product testing, and did not recommend any additional studies in preparation for an IND submission and initiation of Phase 2 trials. A recently completed Phase 1 study in chronically infected subjects was performed in the United Kingdom and South Korea. Altimmune intends to conduct a Phase 2 study in the United States and the pre-IND meeting was held to obtain feedback from the FDA on our intended development path.

“We are pleased to have completed the pre-IND meeting with the FDA and will move forward with our plans to file the IND and initiate a Phase 2 trial of HepTcell,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “We appreciate the FDA’s guidance as we endeavor to find a cure for chronic hepatitis B.”

HepTcell is an immunotherapeutic product candidate composed of nine synthetic peptides chosen from across the HBV proteome with a proprietary T-cell epitope identification method. In a Phase 1 clinical study conducted under clinical trial agreement in the United Kingdom and South Korea, three monthly injections at two dose levels of HepTcell peptides were given with and without IC31® adjuvant (Valneva) as add-on therapy to entecavir or tenofovir in patients with HBe antigen negative chronic infections. All arms were well tolerated, and both high and low peptide doses given in combination with IC31® resulted in increased cellular immune responses against HBV antigens.

Breaking immune tolerance against HBV antigens is the key to clearance of infection. This occurs naturally in the majority of acute HBV infections through a T-cell immune response. However, in chronically infected patients immune tolerance prevents the clearance of the virus and these patients can progress to cirrhosis and are at risk of developing liver cancer. Currently licensed treatments do not clear infection and require lifelong therapy to control the disease. The goal of all HBV therapeutics currently in development is to achieve functional cure by reactivating the T-cell immune response, either indirectly by further lowering the HBV antigen expression, or directly, as is the goal of HepTcell.

In the planned Phase 2 trial, Altimmune will evaluate immune responses after a 6-month treatment course of HepTcell in an expanded population of HBV infected patients. The Phase 2 trial is anticipated to start in 2020.

Click here to read the entire press release.

Emergent BioSolutions Awarded 10-Year HHS Contract Valued at Approximately $535 Million to Deliver Vaccinia Immune Globulin Intravenous (VIGIV) in Support of Smallpox Preparedness

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GAITHERSBURG, Md., June 03, 2019 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced a contract award by the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) valued at approximately $535 million over 10 years for the continued supply of Vaccinia Immune Globulin Intravenous (VIGIV) into the U.S. Strategic National Stockpile (SNS) in support of smallpox preparedness.

“Emergent is pleased to continue its successful track record of being a solutions provider to governments to help address serious public health threats such as smallpox,” said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. “VIGIV is the only product licensed by the U.S. Food and Drug Administration (FDA) for the treatment of complications due to smallpox vaccination. We look forward to delivering on this long-term $535 million contract to supply VIGIV, which, together with our ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) smallpox vaccine, are integral to the government’s overall preparedness and response strategy to have a sustainable and sufficient supply of medical countermeasures in the SNS to protect the U.S. population against the threat of smallpox.”

The contract consists of a one-year base period of performance valued at $23 million and nine option years that, when exercised, would bring the total contract value to approximately $535 million. The scope of work under the contract includes the collection of plasma, manufacturing, and delivery of finished drug product. During year one, Emergent will use plasma provided by the U.S. government to manufacture VIGIV doses, while all subsequent years will involve Emergent-led plasma collection and production efforts resulting in higher annual revenue potential. VIGIV is the only therapeutic licensed by the FDA for the treatment of complications due to smallpox vaccination and has been stockpiled at a ratio of one dose of VIGIV per 10,000 doses of first or second generation smallpox vaccine ( This multi-year contract follows the conclusion of a one-year, $26 millionprocurement contract signed with the U.S. government in February 2018.

“Through this 10-year contract with HHS, Emergent is honored to continue its long-term partnership with the U.S. government, whose support of the VIGIV program reflects its commitment to protect the population against serious public health threats,” said Dr. Laura Saward, senior vice president and antibody therapeutics business unit head at Emergent. “The VIGIV product has been a critical component of the government’s preparedness strategy, dating back to 2002 when it was first procured for inclusion in the stockpile.”

Click here to read the entire release.

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