January 2021

Transformative Drug Manufacturer On Demand Pharmaceuticals Chooses Montgomery County, MD for Its New Headquarters

Company revolutionizes medicine manufacturing to allow production whenever and wherever needed

Rockville, Md. — On Demand Pharmaceuticals (ODP), an innovative pharmaceutical manufacturing company, has selected Rockville in Montgomery County, Maryland, for its new GMP manufacturing, research, development and headquarters facility.

ODP recently signed a $20 million contract with the Department of Defense (DOD) and the Department of Health and Human Services (HHS) to develop a domestic production capability for critical active pharmaceutical ingredients (API) and medicines using its proprietary Pharmacy on Demand (PoD) technology. PoD is a modular manufacturing machine the size of a small household refrigerator that can be quickly customized to produce pharmaceuticals from key starting materials to API and final formulated drugs.

ODP’s on demand manufacturing approach will enable a more resilient domestic medicine production capability and create secure alternatives to KSMs (key starting materials) and APIs currently sourced from offshore manufacturers. PoD’s small-scale, adaptive and distributed manufacturing has the ability to provide an adequate, safe and reliable supply of medicines to communities around the world.

ODP is creating a state-of-the-art 44,500 square foot facility in Rockville. The company selected Montgomery County for its first commercial location over Boston, Princeton, NJ, and other locations around the country. It expects to have up to 75 employees by the end of 2021 and potentially hundreds at the end of five years.

“Montgomery County is ideal for government partners who need to be in Washington, D.C. regularly and want to access the experienced talent here,” said Dr. Geoffrey Ling, CEO and co-founder of ODP. “Our physical needs were critical as we needed to scale up our operations quickly in response to the COVID-19 crisis, and Montgomery County had a site that worked for our use, a flexible landlord experienced with life sciences, and local officials who helped to expedite the move.”

Dr. Ling views ODP’s technology as a crucial breakthrough for healthcare workers in some of the world’s most difficult environments. A key advantage of the PoD system is its flexibility; the same machines can be easily switched to make different medicines and in various formulations. This versatility has the potential to produce low volume drugs, such as those for rare diseases, at the fraction of their current cost.

“On Demand Pharmaceuticals will feel right at home here in Montgomery County, MD, where they join a wide array of ground-breaking innovators,” said County Executive Marc Elrich. “Our county is the place for diverse and highly capable businesses to nurture ideas and see them come to fruition.”

“This technology is revolutionary for the pharmaceutical industry in some of the same ways that iconic IT brands designed around the end user have been revolutionary,” said Benjamin H. Wu, MCEDC President & CEO. “On Demand’s PoD technology has the potential to produce life-saving medicines within reach of every American while also safeguarding our nation’s security through greater domestic manufacturing production.”

MCEDC connected the company with the City of Rockville for expedited permitting review. “The City of Rockville changed its permitting systems in the last few years to be more business friendly and was ready to nimbly meet the needs for this project,” said Cindy Rivarde, CEO of Rockville Economic Development Inc. “The City also gave ODP high priority in processing due to the pressing public health needs and ODP’s strong positive economic impact to our community.”

MCEDC also connected ODP with Facility Logix, a Montgomery County company that specializes in the design and construction of biotech manufacturing and R&D facilities.  “As a member of the local life sciences community, we were pleased to work closely with ODP to help them with their commercial facility design and implementation. We helped them avoid costly overruns so they could focus on their core and unique mission to change pharmaceutical delivery,” said Pat Larrabee, CEO of Facility Logix.

ODP, as a Maryland company, is eligible for state tax credits through the More Jobs for Marylanders (MJM) and Job Creation Tax Credits (JCTC) programs, as well as a Partnership for Workforce Quality (PWQ) grant.

Dr. Ling developed the ODP concept while serving as a Lieutenant Colonel in the U.S. Army. When Dr. Ling was deployed at a combat hospital in Afghanistan, a wounded American soldier needed a life-saving treatment that was not available onsite. The treatment was flown in from a base in Germany, a time-consuming and costly undertaking. Dr. Ling turned frustration into inspiration when he realized he could have made the drug himself with some simple starting ingredients. His idea came to fruition through work at MIT funded by the Defense Advanced Research Projects Agency (DARPA).

ODP recently received a number of federal contracts. In addition to the DOD/HHS contract to further develop PoD, ODP received a DARPA contract in June to produce key starting materials in a GMP space. Read more about the present and future plans for On Demand Pharmaceuticals.

ABOUT MCEDC

The Montgomery County Economic Development Corporation (MCEDC) is the official public-private economic development organization representing Montgomery County, Maryland. Created in 2016, MCEDC is led by a Board of Directors of business executives. Its mission is to help businesses start, grow and relocate in Montgomery County by helping them gain access to top talent, business and market intelligence and prime locations. For more information, visit our website. Follow us on Twitter, Facebook and LinkedIn.

ABOUT ODP

On Demand Pharmaceuticals (ODP) is an innovative pharmaceutical manufacturing company creating new reconfigurable medicine production systems that enable rapid response when conditions are uncertain and changing. Our mission is to provide an adequate, safe, and reliable supply of medicines to every community across the world. ODP is led by an experienced team of chemical engineers, materials science experts, pharmacists, pharmacologists, and organic chemists. www.ondemandpharma.com

Aurinia Pharmaceuticals’ Rockville, Maryland commercial center is about to get a whole lot busier following the U.S. Food and Drug Administration’s approval of the company’s treatment for adult patients with active lupus nephritis (LN).

The FDA greenlit Aurinia’s Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen for LN, a serious progression of systemic lupus erythematosus (SLE), a chronic, complex and autoimmune disease. The approval not only marks the first medication in the United States specifically approved for active LN, but it also marks the first for Aurinia, which is headquartered in Canada and last year opened its 30,000 square-foot commercialization facility in the BioHealth Capital Region.

Recent challenges around preparing, transporting, and administering COVID-19 vaccines have received national and international attention. As part of our ongoing COVID-19 response, the U.S Pharmacopeia (USP) rapidly engaged stakeholders and convened experts to identify and help address operational efficiency gaps to help increase COVID-19 vaccinations.

The new USP COVID-19 Vaccine Handling Toolkit provides critical information to pharmacists, doctors, nurses, nurse practitioners, physician assistants, health profession students, and others who are involved in handling COVID-19 vaccines. These resources facilitate operational efficiencies that can help accelerate delivery and support safe handling of COVID-19 vaccines while maintaining quality and ultimately the public’s trust.

When complete in early 2021, it will include operational strategies in three key areas:

Preparation and labeling

Storage, handling and transport

Waste and disposal

https://www.usp.org/covid-19/vaccine-handling-toolkit

2020 was an interesting year for the biotech industry and the BioHealth Capital Region as we adjusted to continue moving forward during the COVID-19 Pandemic. While the biggest stories in terms of dollars were related to the Coronavirus and funding to create a vaccine in record time, that didn’t stop other biotech companies from working hard to develop their research, science, and/or devices.

As we begin 2021, we ask the same question this time every year:
Who’s the next big success story that could emerge in the new year?

To answer that question, we looked back at our stories from 2020 to review the companies in our ecosystem poised for transformative funding transactions or collaborations in 2021.

Here are the six life science companies to keep an eye on in 2021 and beyond.

Click here to read more via BioBuzz

A nonprofit is considering Montgomery County as the site of a global pandemic center that would focus on prevention, research and response.

The Global Pandemic Prevention and Biodefense Center would serve as the “world’s epicenter” for pandemic prevention and biodefense ecosystem coordination.

Click here to read more via Bethesda Magazine

Immunomic Therapeutics Inc. has raised another $16 million following a mammoth raise in the spring of 2020.

The Rockville vaccine company secured the new capital to support its oncology programs, the company said in an email Friday to the Washington Business Journal. That’s after it surpassed its initial $50 million target with a total $61.3 million in new funding in April. The company disclosed the latest raise Thursday in a filing with the Securities and Exchange Commission.

Click here to read more via WBJ.

With a phase 3 data readout on its COVID-19 vaccine looming, Novavax has already started stockpiling doses ahead of an authorization. Now, thanks to a fresh manufacturing tie-up, the company’s ex-U.S. supplies just got a little more secure.

Novavax tapped Baxter BioPharma Solutions to handle commercial-scale vaccine manufacturing at its facility in Halle, Germany. Once production work kicks off, Baxter will be on deck to crank out supplies for the European and U.K. markets, the companies said.

The Deerfield, Illinois-based CMO will tackle fill-finish work on Novavax’s recombinant nanoparticle adjuvanted vaccine, a Novavax spokeswoman said via email. The company’s candidate, NVX-CoC2373, is still in phase 3, though it’s eyeing a phase 3 data readout sometime during the first quarter.

Click here to read more via FiercePharma

FREDERICK, Md – January [XX], 2021 – Veralox Therapeutics, a biotechnology company developing first-in-class small molecule therapeutics that treat the underlying pathologies of diseases with significant unmet medical needs, today announced it submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for initiation of a Phase 1 clinical trial of VLX-1005, a first-in-class small molecule inhibitor of 12-Lipoxygenase in development for the treatment of heparin-induced thrombocytopenia (HIT).

HIT is an immune complication of heparin therapy resulting in low platelet counts caused by antibodies to complexes of platelet factor 4 (PF4) and heparin. Currently, one third of hospitalized patients in the U.S., or about 12 million a year, receive heparin. HIT is the most important and most frequent drug‐induced type of thrombocytopenia.

“This IND submission is a key milestone for Veralox and a tribute to the hard work and dedication of our team to advance VLX-1005 to first in human studies,” said Jeffrey Strovel, Ph.D., Chief Executive Officer of Veralox Therapeutics, Inc.
“We are excited to continue our efforts to further develop this groundbreaking new therapy for patients suffering from HIT,” David Maloney, Ph.D., Chief Scientific Officer of Veralox Therapeutics.

About VLX-1005

VLX-1005 is a first-in-class and selective small molecule inhibitor 12-Lipoxygenase, a key target within the arachidonic acid pathway. Preclinical data has demonstrated that VLX-1005 halts immune driven platelet activation and thrombosis thus offering the potential of a lifesaving treatment for patients with HIT.

About Veralox Therapeutics

VERALOX Therapeutics Inc. (Veralox Website) is developing first-in-class therapeutics that target the underlying pathologies of diseases with unmet medical needs. The company’s lead candidate, VLX-1005, will be developed initially to treat patients with heparin-induced thrombocytopenia (HIT). Second generation therapeutic products are under development for T1D and other immune-mediated and inflammatory diseases.

Contact:
Jeffrey Strovel, CEO
Jeff@veralox.com