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Tag: pharmaceutical

Pharma company invests $1.5M on Prince William expansion

Pharmaceutical manufacturer Granules Consumer Health, a subsidiary of Granules India, will invest $1.5 million into expanding its operations in Prince William County, Gov. Glenn Youngkin announced Monday. 

The company plans to install new manufacturing lines at its existing Manassas facility, with an aim of creating nearly 100 new jobs. 

“Granules’ decision to expand their operations reinforces Virginia’s position as a cutting-edge hub for advanced pharmaceutical manufacturing,” Youngkin stated in a news release. “This investment … underscores the Commonwealth’s commitment to supporting businesses that drive innovation in healthcare and life sciences.”

In 2022, Granules Consumer Health announced plans to invest $12.5 million to establish a facility on Cushing Road in Manassas for pharmaceutical packaging and distribution. The operation currently has Our Chantilly location is Granules Pharmaceuticals Inc. where the manufacturing occurs. The Manassas operation currently has about 105 full-time workers, according to Bret Svedberg, head of human resources for the company’s North America operations. 

“Since its opening in early 2023, we have nearly doubled our workforce by hiring local talent,” Krishna Prasad Chigurupati, chairman and managing director of Granules India, stated in a news release. “This is a big step forward for us, and we are glad to be growing alongside the community.” 

Founded in 1991, Granules India has a presence in more than 80 countries.

Granules has 323 employees in North America, including about 185 who work at Granules Pharmaceuticals, a manufacturing facility, in Chantilly, according to Svedberg.

Granules Consumer Health launched in 2014 to manufacture over-the-counter, generic pharmaceutical products. 

The Virginia Economic Development Partnership worked with Prince William to secure the project. Granules Consumer Health will receive support through the state-funded Virginia Jobs Investment Program, which provides services and funding to support employee recruitment and training.

Editor’s note: This story has been updated. 

Afton Scientific announces $200M Albemarle expansion

Afton Scientific, a manufacturer of sterile injectable pharmaceuticals, plans to invest over $200 million to expand its manufacturing facility in Albemarle County, Gov. Glenn Youngkin announced Wednesday.

The expansion is projected to create more than 200 jobs.

Founded by Thomas Thorpe in Charlottesville in 1991, Afton Scientific is a contract development and manufacturing organization (CMDO), providing comprehensive services including drug development and manufacturing. At its facility at Avon Court, Afton Scientific offers a range of services including sterile manufacturing, packaging and labeling, analytical and micro lab and pharmaceutical support services.

“This announcement represents an exciting advancement in providing critical, life-saving therapies to more Americans, and Afton Scientific is thrilled about our expansion in Central Virginia, where we’ve grown the company since day one,” Thorpe, CEO of Afton Scientific, stated in the announcement.

In January, Arlington Capital Partners, a Washington, D.C.-area private investment firm that specializes in government regulated industries and works to close gaps in sectors like health care, announced it had made a majority investment in Afton Scientific.

“Companies like Afton are mission critical to the safety and well-being of America, and their importance is only going to increase as we continue to onshore and reinforce our pharmaceutical supply chain,” Malcolm Little, a partner at Arlington Capital Partners, said in a statement. “Ensuring systemically important domestic manufacturing is well-optimized has always been a focus of ours and since partnering with Afton nearly a year ago, we have worked hand-in-hand with Thomas, his strong management team and Gov. Youngkin to help meet the ever-increasing demand for its aseptic CDMO services.”

The expansion will allow Afton Scientific to implement new manufacturing technologies and increase manufacturing capacity.

Virginia competed with “several” states for the project, according to Youngkin’s office. The Virginia Economic Development Partnership worked with Albemarle County and the Central Virginia Partnership to secure the expansion for the commonwealth.

Youngkin approved a grant from the Commonwealth’s Opportunity Fund to assist Albemarle County with the project. Additionally, Afton Scientific will receive support through the Virginia Talent Accelerator Program, a VEDP service provided in collaboration with the Virginia Community College System and other higher education partners. Launched in 2019, the program provides direct delivery of recruitment and training services at no cost to companies.

Afton Scientific is a current participant – and a 2012 graduate – of the Virginia Leaders in Export Trade Program, which provides assistance to Virginia exporters.

Norfolk biopharma company appoints CEO, chief R&D officer

Norfolk-based biopharma company ReAlta Life Sciences has appointed David Marek its CEO and Paolo Martini its chief research and development officer, the company announced Thursday.

“I am confident that David and Paolo are the ideal leaders for these two pivotal roles,” Edward A. Heidt Jr., chairperson of ReAlta’s board of directors, said in a statement. “David has a strong track record of success driving business transformation including leading an organization with one of the most successful buyouts in recent years, while Paolo’s deep expertise in leading-edge drug discovery and development across an array of therapeutic areas, including rare diseases, will position ReAlta well as we look ahead to delivering potentially life-saving medications for patients with rare and acute inflammatory diseases.”

Marek was previously CEO and a member of the board of directors for Myovant Sciences, where he led its shift from clinical stage to commercial stage with three commercial launches of therapeutics focused on hormone-sensitive oncology and women’s health, according to a news release. Sumitovant Biopharma closed its approximately $1.7 billion acquisition of the company in March 2023.

“It’s rare to find a company so well-positioned with a novel scientific approach to take on one of the great challenges in human health — inflammation,” Marek said in a statement. “I am excited to bring my energy and experience to serve as the CEO of ReAlta and am proud to work alongside team members who work tirelessly to break new ground in advancing our mission on behalf of patients.”

Before joining Myovant, Marek was chief commercial officer of Axsome Therapeutics, leading the buildout of commercial capabilities for anticipated product launches. Prior to that, he was general manager of the neuroscience business unit at Amgen, a position in which he led the U.S. launch of the Aimovig medication for migraine prevention.

Paolo Martini, chief research and development officer of ReAlta Life Sciences
Paolo Martini, chief research and development officer of ReAlta Life Sciences

Marek also previously held roles with WebMD Health, Saatchi & Saatchi Healthcare Advertising, Eli Lilly and Co., and AstraZeneca. He holds a bachelor’s degree in business administration from Washington State University.

Now ReAlta’s chief research and development officer, Martini has more than 25 years of experience in drug discovery and development. He previously served as chief scientific officer and founder of Moderna Rare Diseases at Moderna. In those roles, he led a team focused on identifying novel therapies and applying translational approaches for drug development in rare diseases and hematological disorders.

Before that, Martini was senior director of discovery biology and translational research at Shire Pharmaceutical, where he helped launch VPRIV for Gaucher disease and Firazyr for hereditary angioedema.

Martini has authored more than 50 journal articles. He has a doctorate in molecular endocrinology from the University of Milan in Italy. Martini is a member of Certa Therapeutics’ scientific and clinical advisory board for nephrology and Ginkgo Bioworks’ biopharma advisory board.

Launched in 2018, ReAlta is a clinical mid-stage biotech company that focuses on addressing life-threatening acute inflammatory and rare diseases. It has locations in Norfolk and in Aguadilla, Puerto Rico.

Reports: Novo Nordisk in talks to buy Petersburg Ampac plant

Two South Korean media outlets have reported that the South Korean owner of Ampac Fine Chemicals may sell its manufacturing plant in Petersburg to Novo Nordisk, the Danish global pharmaceutical company.

Sources told The Korea Economic Daily that the Seoul-based manufacturing conglomerate SK Group, which purchased Ampac in 2018 for a reported $576 million, is in “final-stage talks” to sell the 600,000-square-foot plant for $216 million to Novo Nordisk, with the deal possibly completed by the end of August, according to a June 25 article.

The Korea Herald reported June 26 that the potential sale could be part of a push on the Danish drugmaker’s part to increase production of its popular weight-loss drugs Wegovy and Ozempic. In late June, Novo Nordisk announced plans to invest $4.1 billion to build a second manufacturing facility in Clayton, North Carolina, adding 1,000 jobs.

A U.S. spokesperson for Novo Nordisk said Wednesday that the company has not yet announced any plans in Petersburg.

“SK Pharmteco does not discuss potential business transactions, whether rumored or confirmed,” Audrey Greenberg, the company’s chief marketing and communications officer, said in a statement Thursday. “However, we are constantly exploring strategic opportunities to strengthen our leading position as a CDMO. Our commitment lies in expanding our capabilities in small molecule APIs, cell and gene therapies, and analytical services. By doing so, we aim to offer our clients a broader range of solutions and, ultimately, improve patients’ lives worldwide.”

SK Pharmteco is SK Group’s contract drug-making subsidiary, with contract development and manufacturing organization (CDMO) plants in California, Texas and Virginia. In 2018, SK Holdings purchased California-based Ampac Fine Chemicals, then owned by H.I.G. Capital, a private equity firm. H.I.G. had owned the company since 2014 and was responsible for acquiring the Petersburg plant reportedly under consideration for sale to Novo Nordisk. In 2019, SK Group consolidated Ampac Fine Chemicals with its biotech divisions in South Korea and Ireland to form SK Pharmteco.

Ampac, founded in 1945, arrived in Petersburg in 2019, restarting a former pharmaceutical plant that had been closed for five years. Between 2020 and 2022, Ampac doubled production capacity and tripled its employee base to 150 workers. Currently, the company has three production buildings and 16 manufacturing lines making active pharmaceutical ingredients in Petersburg.

Ampac’s presence was a draw for other pharmaceutical companies — notably Phlow and Civica Rx — now with facilities in Petersburg. Civica, a Utah-based nonprofit generic drugmaker, is set to begin producing medications for general and local anesthesia, pain management and antibacterial therapies created with ingredients produced by Ampac and Phlow by late 2024. The three companies, along with Virginia Commonwealth University’s Medicines for All Institute, are partners on a federally funded $354 million contract to reduce U.S. dependence on foreign supply chains and promote domestic medication production. The contract, awarded in May 2020, finished its initial four-year phase in May, and is now in the first of six potential one-year renewal options.

In 2022, the 16-partner Alliance for Building Better Medicine, which includes the three pharma companies, won a $52.9 million Build Back Better Regional Challenge grant from the U.S. Commerce Department’s Economic Development Administration to address the national need for domestically produced drugs. In October 2023, the EDA designated the Richmond-Petersburg metropolitan statistical area an Advanced Pharmaceutical Manufacturing Tech Hub, qualifying it to apply for additional funding, but the region missed out on $502 million in federal grants announced in July.

Briggman leaving post as CEO of Activation Capital

Chandra Briggman is leaving her position as president and CEO of Activation Capital, the Richmond tech incubator announced Monday. Her last day is Friday.

Briggman joined Activation Capital, an accelerator arm of the Virginia Biotechnology Research Partnership Authority, in May 2020; the organization includes a biotech park, startup development and cluster accelerator for pharmaceutical research and manufacturing. During her time at Activation Capital, Briggman played significant roles in raising $31 million to build an innovation center in the Virginia Bio+Tech Park, launching the Alliance for Building Better Medicine, and winning a $53 million federal grant in the Build Back Better Regional Challenge, among other achievements.

According to Monday’s announcement, Briggman plans to “pursue new opportunities to build innovation ecosystems and drive economic development,” but her specific plans were not disclosed.

“At heart, I’m a builder, and what I do well, I have done,” Briggman said in a statement. “The opportunity to contribute to Activation Capital and the Central Virginia community has been a highlight of my career. It gave me an opportunity to sharpen the organization’s strategy, secure the growth capital necessary to flourish and align every action with a mission-centric outcome. Together, we built a team of experts who are focused on execution and excellence during the next phase of Activation Capital. My goal was always to create the team, prove our model and then transition to the next opportunity to build.”

The organization plans to launch a search for Briggman’s replacement, but in the meantime, Kipton Currier, vice president of operations, will lead day-to-day operations, and Activation Capital’s executive team will oversee key initiatives, a spokesperson said.

“Chandra Briggman’s pivotal time at Activation Capital has been defined by impact, and her impressive body of work has energized our region,” said Virginia Commonwealth University President Michael Rao, also chairman of the Virginia Biotechnology Research Partnership Authority Board. “In 2020, Chandra was recruited from Boston/Cambridge, Massachusetts, to grow the economic impact of Activation Capital. In four years, two of which were at the height of the COVID-19 pandemic, she helped reenergize the organization with a new vision and strategy. Chandra executed a bold roadmap that has since grown our regional innovation economy and strengthened Activation Capital’s sustainability model for the future.”

VCU launches pharmaceutical sciences undergrad degree

Graduate school isn’t a prerequisite for a career in the pharmaceutical industry. 

Virginia Commonwealth University’s new Bachelor of Science in Pharmaceutical Sciences (BSPS) degree will prepare students to step into pharma jobs like quality assurance technicians, research technologists and laboratory technicians, according to Kelechi “K.C.” Ogbonna, dean of VCU’s School of Pharmacy. 

VCU will be the first public university in Virginia to offer the BSPS degree when it begins enrolling students in the fall, according to an announcement the university made Thursday. Hampton University, a private university, also offers the BSPS degree. Nationally, several institutions offer the degree. 

“What’s different about this program is many of those programs were designed as feeder programs for a professional degree or a graduate degree,” Ogbonna said. “A lot of those programs were not focused on … being a standalone program that is hands on, where they’re actually translating what they learned in the classroom and in internships and externships and getting familiarity and understanding with certain tools and instruments, assurance methodologies.”

When students graduate, Ogbonna said, they should be “well-equipped to jump immediately into a pharmaceutical company, for example, and be able to begin doing that work.” 

VCU leaders were propelled to develop the undergraduate program at the school because of real-world problems, according to Ogbonna. 

In the first quarter of this year, there were 323 active medication shortages according to the American Society of Health-System Pharmacists. A report by the U.S. Food and Drug Association, updated in 2020, identified complicated root causes for the shortage, including a lack of economic incentive to produce less profitable drugs and a failure to reward manufacturers for investing in manufacturing quality. 

A need for employees to run Central Virginia’s thriving hotbed of pharmaceutical manufacturing companies also propelled the university’s leaders to offer the degree, according to Ogbonna. 

In October, the Richmond and Petersburg region received a federal designation as an Advanced Pharmaceutical Manufacturing (APM) Tech Hub that could lead to millions in future federal funding . 

“There’s federal and state support to say, ‘Are there ways we can be more efficient about drug discovery and manufacturing? And if so, can Virginia really be the epicenter for that?’” Ogbonna said. “In order for this to work, there’s got to be a really intentional and strategic focus on workforce development.” 

Eric Edwards, co-founder and CEO of Phlow, a Richmond-based, public benefit corporation that develops and domestically manufactures active pharmaceutical ingredients and finished pharmaceutical products, said VCU’s BSPS degree will be “fantastic [for students] who are seeking to contribute beyond just a basic science field in biology or chemistry or physics and trying to move more into an applied career pathway that may involve building medicines, or pharmaceutical products or treatments.”

Previously, these students would have needed to obtain a master’s degree or doctoral degree in pharmaceutical sciences or a doctor of pharmacy degree.

“I think what’s going to happen here is this program is going to unlock and equip students to really gain momentum and move beyond just a foundation that would serve them well into graduate studies, but actually a foundation that will enable and equip them to enter into the pharmaceutical industry and gain experience earlier,” Edwards said.

There’s plenty of work for these students in Richmond, according to Edwards. “This is definitely going to be another piece of that puzzle to really strengthen the future pipeline,” he said.

Sandro da Rocha, director of pharmaceutical engineering at VCU’s School of Pharmacy, will serve as inaugural director of the undergraduate pharmaceutical sciences program. 

Ogbonna feels confident students will be gravitate toward the degree. After all, they saw firsthand the impact scientists who quickly developed a vaccine for COVID-19 made on the world. 

“There’s renewed interest amongst the public about how medications are made,” he said. 

Forty applicants vying for Shenandoah medical marijuana license

Forty complete applications were received for conditional permits to operate as the state’s sole licensed pharmaceutical processor of medical cannabis for a region including the Shenandoah Valley, as well as the cities of Charlottesville and Fredericksburg and the counties of Spotsylvania and Stafford, according to the Virginia Cannabis Control Authority.

Each company paid an $18,000 fee for the opportunity to be granted the sole medical marijuana license to serve the CCA’s health service area 1 (HSA 1), which has been tied up in litigation for years. The HSA 1 region has not had a licensed medical marijuana dispensary available since the state began issuing pharmaceutical processor licenses in 2018.

“This is a pay to try-to-play,” said Eric Postow, Fairfax County-based managing partner for Holon Law Partners. “That really just kind of demonstrates the interest in the business community wanting to service the cannabis sector.” Postow led a team that helped put together an application for Albemarle County-based Integra Vertical to be considered for the HSA 1 license.

The competition also reflects the lucrative nature of the license, which allows licensees to open and operate dispensaries within their designated HSA region. While the CCA doesn’t track sales revenues, the state’s dispensaries made 3.4 million medical cannabis dispensations in 2023. Virginia patients paid an average $14 per gram for medical cannabis flower at dispensaries, compared with $10 in Florida and Pennsylvania, according to a November 2023 market study conducted for the authority.

Virginia Cannabis Control Authority Chief Officer Jeremy Preiss, the agency’s acting head, provided Virginia Business a chart listing the names of applicants on Tuesday. It began with AYR Virginia, which lists a principal address that is shared by AYR Wellness, a Miami-based multistate cannabis business.

Another applicant for the HSA 1 license, Curaleaf Compassionate Care VA, lists a principal address that is also used by Massachusetts-based Curaleaf Holdings, the largest U.S. cannabis company, according to Stash, a New York-based financial services firm. 

CLVA, another HSA 1 applicant, lists a Chicago principal address that is also used by Cresco Labs, which Stash ranks as the sixth largest U.S. cannabis company. Another application, Trulieve Virginia, shares an address with Tallahassee, Florida-based Trulieve Cannabis, which Stash lists as the fourth largest U.S. cannabis company. 

Pure Virginia, a company connected to Pure Shenandoah, an Elkton-based, family-run CBD and hemp products business is also included on the list. Pure Virginia CEO Tanner Johnson said 40 applicants was on the higher end of what he’d expected, but he’s still optimistic about the chance of his family’s business being selected. 

“To us, it didn’t really come down to the competition we were against but how good of an application we could put in, and I think that we put in a really, really good one,” he said. “So, if they want a company from Virginia for Virginians, then it’s going to be hard to pick anyone besides us.”

Mike Tabor, CEO of Integra Vertical in Albemarle County, got his start in medical cannabis two decades ago when a friend was diagnosed with cancer. “I started growing medicine for him, and it all just kind of ballooned from there,” he said. Greenwood-based Jackpot 777 Farms, the company behind Integra Vertical, currently produces hemp flower and CBD-infused products.

“When the opportunity came up and Virginia decided to put HSA 1 up for application, it seemed like an opportune time to make the shift into cannabis,” Tabor said. “I think [that is] a lot of people’s long-term goal in the hemp business anyway.”

The state Cannabis Control Authority plans to name the selected applicant at the end of June, according to Preiss.

Virginia is divided into five health service areas, or HSAs, for regulating medical marijuana.

In September 2018, the Virginia Board of Pharmacy issued five regional pharmaceutical processor licenses for medical cannabis dispensaries.

Dharma Pharmaceuticals opened Virginia’s first dispensary in Bristol in 2020, with three other Virginia HSAs following. 

The processor initially given a conditional permit for HSA 1 was PharmaCann Virginia, originally a subsidiary of Illinois-based PharmaCann. However, that permit was revoked in 2020 after the company failed to build a facility by the December 2019 deadline.

PharmaCann Virginia filed suit against the Virginia Board of Pharmacy in Henrico County Circuit Court in September 2020. New applications for conditional permits for pharmaceutical processors in HSA 1 were put on hold during litigation. 

In April 2023, Virginia’s Court of Appeals agreed with the circuit court, which rejected PharmaCann Virginia’s argument that the Board of Pharmacy treated it differently than the four other pharmaceutical processors in the state.

The current landscape

Virginia currently has four pharmaceutical processors of medical marijuana owned by three out-of-state companies. 

Maryland-based Green Leaf Medical was selected to serve patients in HSA IV, which includes Richmond, while New York-based Columbia Care was tapped to serve HSA V, which includes the Hampton Roads area. 

In 2021, Columbia Care bought Green Leaf Medical for $240 million. Columbia Care, which rebranded as the Cannabist Co. in September 2023, has operations in 15 states. It had more than $511 million in revenue in 2023 and reported that Virginia operations made up $16.5% of that number. 

Abingdon-based Dharma Pharmaceuticals received the processing license for HSA III, which encompasses Southwest Virginia. Chicago-based Green Thumb Industries purchased Dharma Pharmaceuticals in 2021, reportedly paying about $80 million in cash and stocks. With operations in 14 states, Green Thumb Industries reported a revenue of $1.05 billion in 2023.

Alexandria-based Dalitso received the permit to operate in Health Service Area II, which includes Northern Virginia. In December 2020, Florida-based Jushi Holdings announced it had acquired the 100% of the issued and outstanding equity of Dalitso. In 2019, it reported having paid about $16 million for 62% of the company. 

Jushi had a total revenue of $269.4 million in 2023. A spokesperson for Jushi declined to disclose state-by-state revenues. 

Messages to Green Thumb Industries asking what percentage of their total revenue came from Virginia operations were not immediately returned. 

The Cannabist Co. operates 10 dispensaries in Virginia, while Jushi and Green Thumb Industries both operate six each.

Tabor said he’d like to see the last service area go to a Virginia-owned company and “have some of the revenue directly contribute back into our local economy.”

The CCA contracted with Massachusetts-based Cannabis Public Policy Consulting to complete a report on Virginia’s medical marijuana program, which was released in November 2023. A key finding of the report was that Virginia does not have a track-and-trace system, which allows states to track cannabis from the moment a seed is planted to when a retail sale is made. 

In 2022, there were 1,846,313 medical cannabis “dispensations” reported to the Prescription Monitoring Program, according to a spokesperson for the Virginia Department of Health Professions. In 2023, there were 3,356,376 medical cannabis dispensations in the commonwealth.

The CCA has issued a request for proposals for a seed-to-sale tracking system that’s due May 12, with an expedited six-month implementation timeline.

“Once we have seed-to-sale tracking software in place, we will track medical marijuana sales,” Preiss wrote in an email Tuesday.