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BioPharma

Vial and syringe with a vaccine

Clover Biopharmaceuticals, a clinical-stage firm developing a Covid-19 vaccine with potential manufacturing and distribution advantages over other vaccine technologies, has raised $230 million as it prepares to advance its lead candidate into pivotal testing.

Chengdu, China-based Clover said Tuesday that it expects to start a global Phase 2/3 clinical trial for its vaccine candidate, SCB-2019, in the first half of this year. The company added that it has already started planning for the production of potentially hundreds of millions of vaccine doses.

The Clover Covid-19 vaccine is protein-based. SARS-CoV-2, the virus that causes Covid-19 infection, is an enveloped RNA virus—the outer coating is dotted with spike proteins that bind to a receptor on the host cell. These spikes are trimeric, meaning they’re formed by three proteins.

Using its Trimer-Tag technology, Clover developed a trimeric spike protein that resembles the one found on the outer envelope of the novel coronavirus. The vaccine uses an adjuvant, an ingredient that boosts immune response, supplied by Dynavax Technologies.

As a protein-based vaccine similar to many of the vaccines developed for influenza, shingles, and hepatitis B, Clover said production can use manufacturing processes that are already well established. The company added that this production can be rapidly scaled up to large quantities.

Another advantage of the Clover vaccines are the temperature requirements. The company said its vaccines and adjuvant should be stable for long periods at refrigerator temperatures of 2 to 8 degrees Celsius. At room temperature, Clover has said its vaccines are stable for at least two months. Those temperature and storage requirements stand in contrast to messenger RNA vaccines, which must be distributed frozen and stored at temperatures well below what medical-grade freezers can achieve. Last week, Pfizer and BioNTech asked the FDA to approve a change in the storage temperatures permitted once vaccines reach a vaccination site.

The new financing follows publication in The Lancet earlier this month of peer-reviewed results from an early-stage test of two Clover Covid-19 vaccine candidates. The 150-patient study showed that the vaccines were well tolerated and safe. Both vaccines also induced neutralizing antibodies at levels comparable to or higher than those found in the blood of those who have recovered from Covid-19.

Clover said that its research includes vaccines that could address multiple variants of the novel coronavirus. In addition to supporting its Covid-19 vaccines, Clover said the new capital will support plans to advance multiple programs into human testing later this year. Other vaccines in the Clover pipeline include programs for rabies and influenza. The company also said it plans to expand its manufacturing and capabilities.

GL Ventures and Temasek both led the Series C financing. Oceeanpine Capital, OrbiMed, and Delos Capital also invested. Clover said it has raised more than $400 million in the past year.

Clover also has financial support from the Coalition for Epidemic Preparedness Innovations (CEPI), which has committed to finance development of the company’s Covid-19 vaccine candidate up through licensure with a total investment of $328 million. Some of that cash will fund the global Phase 2/3 study. If the Clover vaccine is shown to be safe and effective, it would be distributed through Covid-19 Vaccines Global Access, or COVAX, the World Health Organization’s initiative to ensure equitable vaccine access throughout the world.

Public domain photo by Flickr user Alachua County

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Pfizer and BioNTech are asking the FDA to approve a change that would permit storage of their Covid-19 vaccine within a temperature range found in medical-grade freezers.

To be clear, this proposed change doesn’t eliminate the need for ultra-cold temperatures as the vaccine moves throughout the supply chain—temperatures that require specialized equipment. Those storage requirements are a barrier to its distribution because not all facilities have equipment that can achieve the required temperatures. What Pfizer and BioNTech are proposing is that when the vaccine reaches its destination, such as a hospital or pharmacy, it could be stored for up to two weeks at (relatively) warmer freezer temperatures.

The FDA granted emergency use authorization to the messenger RNA vaccine, named Comirnaty, last December. According to the product’s label, the vaccine must be stored in ultra-cold temperatures between minus 112 degrees and minus 76 degrees Fahrenheit (minus 80 degrees and minus 60 degrees Celsius). At those temperatures, the vaccine can last up to six months. Pfizer ships the vaccines in specially designed containers that can be refilled with dry ice every five days. Those containers can serve as temporary storage for up to 30 days.

The vaccine can be stored at refrigerator temperatures for up to five days. Pfizer and BioNTech are asking the FDA to approve an additional option to store the vaccine at minus 13 degrees to 5 degrees Fahrenheit (minus 25 degrees to minus 15 degrees Celsius) for two weeks. That range would put it closer to the storage requirements for the mRNA vaccine from Moderna. The temperature range Pfizer and BioNTech are proposing would be in addition to the five days at refrigerator temperatures that is currently permitted under the authorization.

“If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply,” Pfizer CEO Albert Bourla said in a prepared statement.

Pfizer and BioNTech are proposing the additional temperature option based on new data about their vaccine’s stability. The data span from the earliest clinical trials up to batches currently in production.

Messenger RNA vaccines are a new technology that employ a snippet of genetic material from the novel coronavirus. This mRNA serve as a blueprint that a cell’s protein-making machinery use make the characteristic spike protein found on the surface of the novel coronavirus. That protein is what triggers an immune response and confers immunity.

Though mRNA vaccines are administered at room temperature, they must be kept at ultra-cold temperatures in the supply chain because mRNA is fragile. The extremely cold temperatures keep the components of the vaccine from breaking down. As mRNA companies study the storage data they have for vaccines, they are getting a better understanding of how long these vaccines can last at certain temperatures. Last November, Moderna released data that it said supported storage of its vaccine at refrigerator temperatures for up to 30 days.

Temperature requirements can be a barrier to the distribution of the vaccine to rural areas, which may not have facilities with appropriate freezers. In that regard, the Johnson & Johnson Covid-19 vaccine is seen as offering an advantage. In addition to requiring only a single shot (both authorized mRNA vaccines require two), the J&J vaccine can be stored at standard refrigerator temperatures. An FDA advisory committee is scheduled to hold a hearing about that vaccine on Feb. 26.

Photo by BioNTech

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Paula Soteropoulos

Gene therapy may offer potential cures, but its promise comes with a price. Some experimental approaches require a multi-step process to prepare stem cells for the procedure—a burden to a patient and to the healthcare system, according to Paula Soteropoulos, executive chair of startup Ensoma.

Soteropoulos’s company is proposing an alternative. The Boston-based biotech is developing technology that won’t require hospitalization in a specialized medical center. Furthermore, the Ensoma technology does its therapeutic work in vivo—inside the patient. These features could make genomic medicine more accessible, turning a lengthy hospital process into a single visit to a doctor’s office.

“Our hope with our technology is to be able to do it outpatient,” Soteropoulos said. “It’s an injection that can be done anywhere, it doesn’t require specialized centers.”

Ensoma emerged last week with details about its technology and $70 million in Series A financing. The company also revealed something unusual for a preclinical startup coming out of stealth: a research partnership with a large pharmaceutical company. Takeda Pharmaceutical is collaborating with Ensoma on up to five disease targets.

Soteropoulos, the former CEO of rare-disease drug developer Akcea Therapeutics, said Takeda and others that want to be in gene therapy are looking for in vivo innovations. Ex vivo approaches, in which a patient’s cells are removed and manipulated in a lab before being reintroduced, pose complexities and challenges for companies trying to commercialize them and to healthcare facilities that will provide them, she said.

Gene therapies reach target cells as cargo carried on engineered viruses. But these viruses come with limitations. Adeno-associated virus (AAV), a commonly used vector, can trigger an immune response. AAV also has limited capacity, which makes it hard to deliver a therapy consisting of a larger gene.

An alternative vector, lentivirus, has more capacity but is still limited in its ability to carry a big payload. This approach requires collecting a patient’s stem cells and engineering them outside the body. Before the stem cells are reintroduced, patients must undergo conditioning, comprised of chemotherapy. This step helps the stem cells carrying a therapeutic gene to be taken up by bone marrow, where they will proliferate. But conditioning can lead to side effects such as greater susceptibility to infection and bleeding. Avrobio and bluebird bio are among the biotechs developing lentiviral stem cell gene therapies that require patient  conditioning.

Soteropoulos describes Ensoma’s engineered adenoviruses as “gutless.” On the inside, they’re stripped of viral DNA or RNA that could trigger an immune response. On the outside, the viruses are engineered to specifically target hematopateic stem cells in the bone marrow. They can also target the cells that arise from these stem cells, such as T cells, B cells, and myeloid cells.

There’s another benefit to Ensoma’s gutless viruses. Removing their DNA or RNA creates more room for the genetic payload—more than three times as much as what the viruses used to deliver the current generation of gene therapies can carry. With that extra space, Ensoma’s vectors can carry larger genes as well as gene-editing tools, such as CRISPR or zinc finger nucleases.

“It allows us to do things that other gene therapies cannot,” Soteropoulos said.

Ensoma’s science is based on 20 years of research from the company’s scientific co-founders, Hans-Peter Kiem of the Fred Hutchinson Cancer Research Center, and André Lieber of the University of Washington School of Medicine. In the past five years, that research started forming the foundations of a company. In 2017, the scientists published research showing how their cells were taken up by the bone marrow in a monkey study. Last year, they published study results showing how their approach corrected two genetic disorders, beta thalassemia and sickle cell disease, in mice.

Ensoma was founded about 18 months ago, backed by seed financing from 5AM Ventures, Soteropoulos said. The startup licensed technology from Fred Hutch and UW, then added to the research, building on the intellectual property surrounding it. She said the research reached the point where additional financing was needed to support the next step of selecting which diseases to pursue.

Along the way, the startup drew interest from larger companies that had followed the science of its founders, Soteropoulos said. One of those companies was Takeda. In addition to investing in Ensoma’s Series A financing, the Tokyo-based pharmaceutical giant is also a research partner. The collaboration grants Takeda an exclusive global license to Ensoma’s technology for up to five rare diseases. That alliance could lead to up to $100 million in upfront and preclinical research payments to Ensoma. If all five programs reach the market, Ensoma could receive as much as $1.25 billion in milestone payments plus royalties from sales.

The Ensoma technology offers the potential to go beyond rare diseases. Soteropoulos said that the in vivo approach does away with all the complexity of working with a therapy outside of the body, making these therapies simpler to manufacture and easier to administer. She added that the fact that these therapies won’t require conditioning or stem cell donors helps extend the reach of these genetic medicines to common diseases.

Ensoma is pursuing rare diseases first. The technology is new, so regulators will need time to understand it, Soteropoulos said. Takeda and Ensoma aren’t disclosing the disease targets they have in mind and Soteropoulos said it’s too soon to say when the technology will reach human testing. But she added that because Ensoma’s approach holds promise to address many diseases, there are plenty to choose from. The startup may look for other collaborators in the future but in the near term, the company will focus on developing its own therapies in addition to working with Takeda.

“There are some rare diseases where there is already validation from being able to make these modifications and cure,” Soteropoulos said. “We would be working off of that for our first indications and then see how we can explore other areas.”

5AM led Ensoma’s Series A financing. Besides Takeda, the new round of funding included the participation of F-Prime Capital, Viking Global Investors, Cormorant Asset Management, RIT Capital Partners, Symbiosis II, and Alexandria Venture Investments.

Photo by Ensoma

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Johnson & Johnson has formally asked the FDA to allow emergency use of its Covid-19 vaccine as the company seeks to add a third option to the U.S. lineup of vaccines for the novel coronavirus.

The application comes a week after J&J released preliminary data showing 66% overall efficacy in a Phase 3 clinical trial. Those results fall short of the efficacy marks of messenger RNA (mRNA) vaccines from Moderna and Pfizer. But the J&J jab offers advantages compared to those vaccines.

Unlike mRNA vaccines, which are given as two doses weeks apart, J&J’s vaccine is a single shot. Also, the J&J vaccine can be kept at refrigerator temperatures. Both the Moderna and Pfizer vaccines must be kept frozen—Pfizer’s at ultra-cold temperatures. They’re then thawed and temporarily stored at refrigerator temperatures before dosing.

J&J’s vaccine storage requirements are the same as those for most vaccines, making it an easier fit vaccine distribution channels already in place. The company said that if authorized, its vaccine will ship using the same cold chain technologies it uses for transporting other medicines. Of the vaccine candidates that have advanced to late-stage testing, J&J’s is the only one given as a single dose.

Before the FDA decides whether to grant emergency use authorization to the J&J vaccine, the pharma giant’s candidate must be evaluated by an independent advisory committee to the agency that will evaluate the clinical data and discuss the efficacy and safety risks of the shot. The vaccines from both Moderna and Pfizer went through the same step. The J&J meeting is scheduled for Feb. 26.

J&J’s vaccine, developed by the company’s Janssen division, employs a version of the virus that causes the common cold. That virus is modified so it does not cause illness. It’s used to deliver to cells a snippet of the genetic code for the spike protein, which is prominent on the surface of the novel coronavirus. The cells of the body read that genetic material and make copies of the spike protein. The immune system responds to those copies by making antibodies that protect against Covid-19.

AdVac is the same platform Janssen used to develop an Ebola vaccine that was approved by the FDA in 2019. The technology is also the foundation of experimental Zika, RSV, and HIV vaccines. J&J said that the safety profile observed with its Covid-19 vaccine was consistent with other experimental vaccines based on AdVac.

J&J evaluated its Covid-19 vaccine in a Phase 3 study enrolling 43,783 patients. The main goal was to show protection from moderate to severe disease. There were geographic differences in efficacy rates. The vaccine candidate was most protective in the U.S., where efficacy was 72%, the company said. In Latin America, efficacy was 66%; in South Africa, it was 57% effective. While those marks fell short of the efficacy rates demonstrated by the Moderna and Pfizer vaccines, cross trial comparisons are tricky. Also, the J&J studies were done when more variants of the novel coronavirus were circulating compared to when the Moderna and Pfizer vaccines were tested.

Paul Stoffels, J&J’s chief scientific officer, said in a prepared statement that the company has vaccines ready to ship immediately upon receiving emergency authorization.

“With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible,” he said.

In addition to the submission to the FDA, J&J is seeking similar authorizations from health agencies in other countries. The company said an application to the European Medicines Agency will be submitted in coming weeks.

Photo: Teka77, Getty Images

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Voyager Therapeutics is losing Neurocrine Biosciences as a research partner on an experimental Parkinson’s disease treatment, the latest in a string of setbacks for the biotech’s efforts to develop gene therapies addressing neurological disorders.

Cambridge, Massachusetts-based Voyager disclosed late Tuesday that Neurocrine provided a termination notice on the Parkinson’s candidate NBlb-1817, which is currently in mid-stage clinical testing. The decision follows the FDA’s December decision to place a clinical hold on that program due to safety concerns.

Termination of the partnership on the Parkinson’s gene therapy will be effective Aug. 2. The collaboration agreement requires Neurocrine to provide 180 days written notice of a termination. The San Diego biotech acknowledged providing that notice in its own regulatory filing. Three other programs covered by the agreement, one for Friedreich’s ataxia and two others in the discovery stage, are not affected by Tuesday’s decision and will continue, Voyager said.

The alliance began in 2019 when San Diego-based Neurocrine pledged $165 million in cash and stock to Voyager. Of the four programs covered by the pact, the Parkinson’s candidate was the most advanced. According to the deal terms, Neurocrine was responsible for funding Phase 2 clinical development. After the study produced data, Voyager held the option to split the rights to the gene therapy with Neurocrine, sharing in further development costs. Alternatively, Voyager could grant its partner full global rights in exchange for milestone payments pegged to sales.

Prior to the Covid-19 pandemic, Neurocrine anticipated advancing the Parkinson’s gene therapy to a pivotal study in the second half of 2020, the company said in its annual report. The pandemic and the clinical hold stalled that timeline.

Voyager uses engineered viruses to deliver gene therapies to the brain. Parkinson’s is characterized by a lack of dopamine, a brain chemical that’s key to controlling muscle movement. Standard treatment includes prescriptions of levodopa, which is converted by a brain enzyme into dopamine.

As Parkinson’s progresses, a patient has less of that key enzyme in parts of the brain where it is needed to convert levodopa to dopamine, Voyager states in its filings. The Parkinson’s candidate is designed to deliver a gene directly into the neurons where dopamine receptors are located, providing the instructions the brain needs to make the key enzyme.

The Parkinson’s gene therapy is administered via a direct injection into the brain. For its amyotrophic lateral sclerosis and Friedreich’s ataxia programs, the company is exploring other approaches, including spinal or intravenous injections.

In its announcement of the end of the partnership in Parkinson’s, Voyager said Neurocine based its decision on a review of its portfolio and the prioritization of other programs in its pipeline. No mention was made about the safety of the Parkinson’s gene therapy. When Voyager disclosed the clinical hold in December, it said that a Neurocrine safety report noted MRI abnormalities in some study participants. It also said the independent board responsible for monitoring the safety of study participants requested a pause on dosing of patients until it could review additional data.

Until the alliance on NBIb-1817 is officially terminated in August, Neurocrine is the company of record for the clinical program. Voyager said that last month, the FDA informed Neurocrine of the information needed to respond to the clinical hold. In addition to an assessment of how the therapy may have contributed to the adverse findings, Voyager said the agency wants a mitigation plan to manage them along with supportive data to justify that the benefit of the therapy outweighs its risks.

Voyager said it will support Neurocrine on any imaging or clinical assessments requested by data safety monitors of the study, as well as any information sought by the FDA. The company added that it is evaluating the financial effect the termination will have on the company and the future of the Parkinson’s program.

The end of the partnership on the Parkinson’s gene therapy marks the second time a company has passed up the opportunity to advance that program. Sanofi was Voyager’s first partner on the experimental therapy, committing $100 million up front in 2015 for rights to several gene therapies for brain disorders. At the time of the deal, the Parkinson’s gene therapy was in early-stage testing. In 2017, Sanofi returned the therapy to Voyager after the biotech declined to amend the original deal to grant the pharma giant a share of the U.S. rights to the program.

The loss of Neurocrine as a partner in Parkinson’s comes a little more than six months after an alliance with AbbVie ended. That partnership focused on developing gene therapies for Alzheimer’s and Parkinson’s. AbbVie terminated the alliance before either program reached Phase 1 testing, at which point Voyager would have become eligible for additional payments from the North Chicago, Illinois-based pharma company.

Photo: SIphotography, Getty Images

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For decades, scientists have known that viruses can kill cancer cells. The challenge has been harnessing that power safely and effectively.

Buoyed by advances in immunotherapy and drug discovery, a new wave of researchers and companies is poised to make a run at that challenge over the next few years with a class of therapies known as oncolytic viruses.

“We’re just on the brink of some really exciting developments in our field,” said Charlotte Casebourne, CEO of Theolytics. Based in Oxford, England, the company hopes to move its lead oncolytic virus candidate into clinical trials over the next two to three years.

The field is based on a relatively simple premise. A virus is injected into tumor cells; the virus replicates and blows up – or lyses – the tumor cells; the immune system recognizes the remaining tumor cells and clears them out.

The premise was discovered decades ago in patients who came down with viruses alongside cancer. The viruses attacked the cancer but they also could harm patients.

Early research focused on attenuated viruses, which generally proved too weak to do much. Recent advances are solving that challenge while addressing new ones, such as preventing the immune system from turning on the virus.

“Right now, it’s about finding that Goldilocks, that perfect happy medium,” said Greg Delgoffe, a cancer immunologist and associate professor at the University of Pittsburgh.

The field got a shot in the arm in 2015 when Amgen won approval from the U.S. Food and Drug Administration for an oncolytic virus therapy called T-VEC. Based on a genetically modified herpes simplex virus and marketed as Imlygic, it is used to treat melanomas that cannot be surgically removed.

“We have this example which provides us with really nice clinical proof of concept that efficacy is possible with oncolytic viruses as a technical approach,” Casebourne said in a Zoom interview.

T-VEC, however, is injected directly into a tumor. Some of the newer therapies are designed to be injected intravenously, allowing them to move through the body to clear cancer.

Theolytics’ lead candidate is TheoAd281, an adenovirus-based therapy that targets ovarian cancer. Clinical trials will focus on its safety and efficacy as a monotherapy, delivered intravenously, before delving into its potential in combination with other therapies, Casebourne said.

The company was founded in 2017 by Casebourne and researchers Margaret Duffy, Kerry Fisher and Len Seymour. It raised $6.8 million in a Series A round in early 2021 led by Epidarex Capital and Taiho Ventures, with participation from existing investor Oxford Sciences Innovation.

In addition to Amgen’s approved therapy, the field has benefited from advances in drug discovery and gene sequencing, Casebourne noted. Theolytics uses a proprietary phenotypic platform to figure out which virus variants might be effective against particular tumors, Casebourne said. The platform speeds up the discovery process to between 12 and 18 months, she added.

Valo Therapeutics also is banking on a platform approach. Its platform incorporates peptides to create oncolytic viruses that do not linger in the body after they turn the immune system against tumor cells. Its lead candidate, PeptiCRAd 1, is expected to enter phase 1 trials this year, most likely for treating melanoma and non-small cell lung cancer, according to Paul Higham, CEO of Valo, which is based in Oxford, England.

The use of peptides is based on research by Vincenzo Cerullo, a professor and head of the drug research program at Helsinki University in Finland.

“Because it’s actually a simple process to attach peptides on the surface of the oncolytic virus, we can be extremely flexible in terms of what we attach to the viruses,” Higham said. “We can select all different kinds of peptides to stimulate all different kinds of immune responses.”

Different tumors may require different peptides, he said. “The most effective therapies in the future are going to be those that are most specific to the patient being treated, and our platform really allows to do that.”

Another contender in the space is CG Oncology, based in Irvine, California. In December, the company raised $47 million in a Series D round led by Kissei Pharmaceutical Co. Ltd. CG’s main oncolytic virus candidate, CG0070, is being examined in several clinical trials.

A phase 3 trial is testing the candidate as monotherapy for a form of bladder cancer. A phase 2 trial is studying CG0070 for the same indication but in combination with Merck’s Keytruda, a checkpoint inhibitor. The candidate is injected directly into the tumor.

Checkpoint inhibitors release the brakes on the immune system while the oncolytic virus strengthens the immune response, said Arthur Kuan, CG’s CEO. “I think oncolytic viruses will continue to emerge as one of the best combination partners with checkpoint inhibitors.”

The company is planning to move into other cancers this year, Kuan said in a phone interview. He and others expect that future oncologists will have a range of viruses to choose from based on a range of factors, including the type and location of the cancer.

It may be years before therapies win approval, Kuan said. But he believes the oncolytic virus field is coming into its own.

“We’re definitely in a rising-tide environment with many catalysts coming up in the next 12 to 18 months,” he said.

The field’s challenges over the years have made investors somewhat leery, said Dr. Mark McCamish, CEO of San Diego-based IconOVir Bio.

For its part, IconOVir was able to overcome investor skepticism by explaining how the field has overcome some of its earlier challenges, McCamish said. Those challenges have included creating an oncolytic virus that could escape detection by the immune system and confer lasting immunity against a tumor. IconOVir Bio raised $77 million earlier this year in Series A funding to advance its platform for creating oncolytic virus therapies. The platform is based on more than a decade of research by company co-founder Clodagh O’Shea of the Salk Institute for Biological Sciences.

“It’s data-driven. It’s not just a story,” said McCamish, who previously led immune-oncology company Forty Seven before it was bought last year by Gilead Sciences.

IconOVir is hoping to start clinical trials of its lead candidate, IOV-1042, in the first half of 2022. Derived from the common cold virus, IOV-1042 has been shown in preclinical research to infect and kill a range of tumor cells, including head and neck, bladder, lung and breast.

“I think it’s an exciting field and an exciting time,” said McCamish. “And if the science comes to fruition, it’s a great opportunity.”

Photo: Main_sail, Getty Images

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When he worked part-time one summer in a Brooklyn pharmacy, Rahul Kavuru made occasional sweeps of the store’s inventory to find nearly expired drugs and dispose of them.

The high school student suspected the drugs could have been put to better use. Conversations with his peers reinforced the notion and eventually prompted action on what is, in fact, a costly problem for pharmaceutical companies.

In early 2020, Kavuru, his sister and a friend started a nonprofit, Altrui Rx, and built a technology platform to match drug companies with nonprofits that help patients in need.

“The biggest problem is that it costs money to destroy the medication and it costs money to hold the product,” said Kavuru, a junior at St. Paul’s School in New Hampshire. His co-founders are his sister, Shreya Kavuru, a senior at St. Paul’s, and Sourish Jasti, a freshman at The Wharton School at the University of Pennsylvania.

Their research into the problem led them to conclude that roughly $5 billion worth of medication is destroyed each year at a cost of between $1 and $3 per pound, Rahul Kavuru said in a phone interview.

Drug companies often collaborate with charities to distribute medications they might otherwise destroy. But it is hard for manufacturers to work with more than a handful of charities, said Jasti, who plans to pursue studies in entrepreneurship and innovation.

Altrui’s platform makes it easier to find charities and learn what they need, Jasti said. Drug companies sign in, upload inventory that is near expiration and then pick from a list of organizations where they can send it. The charities are all vetted by Altrui.

Drug companies can then download packing slips and tracking numbers to send their products to the selected charities.

“We are an intermediary in the process,” Kavuru said. “The goal is to bring out more impact and create an accessible portal for these medications.”

Within a few months after its founding, Altrui had redirected nearly $12.3 million worth of medication. Its pharmacy partners include Aurobindo Pharma, Ingenus Pharmaceuticals and Rising Pharmaceuticals, where Altrui’s founders had an inside connection through a neighbor in their hometown of Holmdel, New Jersey. Rahul and Shreya now live in Rumson, New Jersey.

The founders initially spent their own money to build and host their website. But they have gotten subsequent funding from Aurobindo, the New Jersey Health Foundation and the BEN Health Innovation Summit, which is sponsored by Rutgers University. BEN stands for Biomedical Entrepreneurship Network.

They also have started a companion nonprofit, Altrui Education. It provides college counseling services to disadvantaged students. The two charities are staffed by a team of 15 volunteers.

In addition to their work at Altrui, Jasti and Rahul Kavuru run a blog called CompanyRoots, which interviews business experts and entrepreneurs about their experiences.

Altrui’s founders have impressed Paul Moore II, president and CEO of CitiHope Relief and Development in Margaretville, New York.

Over the past three decades, CitiHope has delivered more than $1.5 billion worth of donated medication to people and organizations around the world. The nonprofit has existing relationships with drug companies, but decided to give Altrui a try, Moore said in a phone interview.

This led CitiHope to get connected to new donors using Altrui’s platform. Moore, whose own philanthropic career began when he was a teenager, was heartened to find that the founders of the nascent startup have worked hard to learn more about this charitable niche.  

“Every interaction I’ve had with them has been, ‘Can we do this better? How have you managed this in the past?’” Moore said.

Photo: cagkansayin, Getty Images

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Metoprolol (muh•tow•pruh•laal). Eszopiclone (es•zoe•pik•lone). Hydrochlorothiazide (hy•dro•klor•oh•thi•a•zide). Amitriptyline (a•muh•trip•tuh•leen). Canagliflozin (kan•a•gli•floe•zin).

Are you able to recognize or pronounce any of these commonly prescribed medications? If so, you might be a pharmacist, or at least have experience providing patient care. It’s fair to say that most people find it challenging to pronounce drug names, and it may be even more challenging for the elderly.

It’s not uncommon for elderly patients to be prescribed multiple medications to treat multiple chronic conditions, and sometimes these medications come from multiple providers. In my experience, I have seen many patients fail to understand what, why and how to take their prescriptions. Some have the help of family or caregivers while others may not, which makes it even more challenging to manage. Many factors can contribute to these challenges including vision problems, memory loss, swallowing problems and or hearing loss. Medications can be extremely helpful in treating and preventing disease, or they can cause a major health setback if not taken appropriately.

As a pharmacist by training, or “pharmist” as my Grandpa likes to call me, I spend my time reviewing his medications when I’m in town to visit. He loves to sit down with me and tell me all about the medications he’s taking and what he takes them for.  At 87 years old, he’s impressively taking only three (3) medications. Up until last year, he was taking only taking one (1). He’s incredibly sharp and has never needed any extra assistance. My Grandpa is the perfect patient. He’s highly adherent and takes his medications every day, at the same time, right before his morning coffee. I understand the importance of adherence and adherence to the right medications, but I have never personally experienced or witnessed the challenges that come with adherence following discharge from a hospital stay, until now.

Covid-19 hit close to home and affected both of my grandparents this past Thanksgiving. After a few days, it was apparent they were unable to weather this virus alone. It severely affected their cognitive status and caused weakness so severe they were unable to stand or walk on their own. While staying with them during this time, a decision was made to take my Grandpa to the E.R., which led to a six-day hospital stay. Because I know he visits multiple providers and pharmacies, I knew the hospital wouldn’t have a complete record of all the medications he takes….and I was right.  I made sure he went with an updated med-list so that the doctors could give him his regular medications while in the hospital.  I knew this med-list would likely change following his discharge.

Upon discharge, I was provided with a long list of instructions from multiple people on the care team that was difficult to follow along even for me. First came a call from the nurse,  then a call from the provider, then a call from the pharmacist, and lastly a call from the company who would be dropping off his home oxygen. The pharmacist’s call was helpful, but not appropriately timed — I had no discharge papers to reference.  The provider called again, to go over the medications with us. The review was fast. Medications were discontinued. Medications were added. Some medications were named in their brand name while others were listed generically.

Who could possibly follow along? No one expressed to us the duration of these medications. When could they be stopped? Will they ever be stopped? Were refills needed, what doctor would continue to prescribe them? What if I had not been around to help?

Following my Grandpa’s return, I immediately sat down to review and organize all of his medications, new and old. One medication was discontinued, while 4 were added. My Grandpa went from taking 3 medications to 7 overnight, and each medication came with its own set of directions:

  1. Take this tablet with food.
  2. Take this tablet on an empty stomach.
  3. Take this tablet every day and skip on Saturdays.
  4. Take this tablet on Monday, Wednesday, and Friday.
  5. Skip this tablet for two days. Restart on Sunday.
    1. 2 days later* “Actually, take this medication every other day starting Tuesday.”
  6. Take this tablet every day.
  7. Take this tablet three times a day and make sure not to eat too much sugar or salt with this med.

With all of this information, I created a “Fridge Report” for when I’m not around. A Fridge Report is a simple and easy to read medication list. It displays all medications a patient is taking and how to take them in a nice visual display that is easy to follow. I also called and spoke with his primary care provider (PCP) and cardiologist to confirm his active medications and to notify them of the newly added and discontinued medications. I can’t imagine my grandparents, or anyone else’s grandparents, managing this without the help of a pharmacist. The Fridge Report was highly appreciated by my family.

“We need that (Fridge Report). It’s very detailed. No mixing up or second-guessing of medications. Now I know what to give and when to give it.” – Lorraine Armenta, My Aunt

According to the World Health Organization (WHO), care transitions threaten patient safety as they can increase the possibility of losing critical clinical information and require an increased degree of coordination. I believe a multifaceted approach is needed to improve care transitions and is especially needed for vulnerable and high-risk individuals. The transition between inpatient and community settings, in particular, is prone to medication errors related to a lack of communication between health care providers, missed patient follow-up, inadequate patient education, incomplete medication reconciliation, and the absence of patient involvement in medication management. Pharmacists can and should take a more active role in improving medication safety during care transitions; this could lead to a reduction in hospital readmissions and improved quality of care.

Pharmacists serve as quarterbacks of a patient’s at-home-care team, providing essential help to those who are taking multiple medications. We are medication safety experts and have access to sophisticated and innovative tools to better manage the medication-related needs of patients and mitigate adverse drug events (ADEs). Ultimately, engaging with your local pharmacist can reduce the burden placed on a patient’s family and the primary caregiver, while making the transition to at-home care manageable.  

Photo: JohnnyGreig, Getty Images

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A major hurdle to quick and efficient vaccine distribution could be the proliferation of “pharmacy deserts” across the country.

There are 56,802 local and chain pharmacies, which evens out to about 1.83 pharmacies per 10,000 people on average, according to a new report from GoodRx. But these facilities are unevenly distributed leaving many residents in “pharmacy deserts.” These are areas where people have to drive a long distance to reach the closest pharmacy or areas with too many people sharing the same pharmacy.

Pharmacy deserts may have dire implications for the Covid-19 vaccine rollout, according to a report from GoodRx, which tracks U.S. prescription drug prices and provides free discount coupons. Since pharmacies are playing a key role in administering the vaccine, living in a pharmacy desert may prevent Americans from getting vaccinated in a timely manner.

Two vaccines have been approved in the U.S., one developed by Pfizer and BioNTech, and the other by Moderna. Both are two-dose vaccines. So far, the rollout has been characterized by missteps and is moving slowly, with only 17 million vaccine doses administered out of nearly 38 million distributed as of Thursday, according to data from the Centers for Disease Prevention and Control. But President Joe Biden has promised to speed up the process — vowing to administer 100 million Covid-19 vaccine shots in the first 100 days of his administration.

GoodRx examined pharmacy deserts using information from the National Council for Prescription Drug Program’s DataQ and the GoodRx databases. Researchers also used data from the American Community Survey to calculate population per county.

Both rural and urban areas can have pharmacy deserts, according to the report.

Pharmacy deserts in rural counties are more likely to be characterized by a lack of pharmacy resources. About 177 U.S. counties have zero pharmacies, leaving 635,000 residents with no choice but to drive a long distance to access one.

On the other hand, pharmacy density is a bigger issue for Urban Americans, the report shows. For example, there are 10 million people living in Los Angeles County in California, but there are only 1.61 pharmacies per 10,000 residents. Cook County in Illinois, which has 5.2 million residents, has only 1.50 pharmacies per 10,000 residents. Both fall below the national average of 1.83 pharmacies per 10,000 residents.

Many pharmacy deserts are also vaccination deserts, the report states.

For instance, assuming the promised 100 million vaccines are distributed, only 11.2% of the population in San Mateo County, California, will receive both doses of the Covid-19 vaccine, researchers estimate, as the county only has 1.06 pharmacies per 10,000 residents.

Other similar vaccine deserts include Shelby County, Tennessee, El Paso County, Texas and Pinal County, Arizona.

The researchers conclude that administering the Covid-19 vaccine through pharmacies alone “is not going to cut it.” Additional mass vaccination sites are going to be needed as well as support services in more rural counties, like transportation or in-home vaccinations.

Biden’s administration has already heeded the call for more vaccination sites. The president’s vaccine distribution plan, unveiled in a speech last week, includes plans to mobilize the Federal Emergency Management Agency and the National Guard to ramp up distribution, according to STAT News.

Photo: LarisaBozhikova, Getty Images

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Before they ever make a dime, biotech startups incur steep costs to research and develop new therapies.

But despite a business model that relies heavily on upfront capital, biotech is no riskier than other industries, at least as measured through the lens of initial public offerings, or IPOs.

That’s the conclusion of a study published this month in PLOS ONE by a team of researchers at the Center for Integration of Science and Industry at Bentley University in Waltham, Massachusetts.

Biotech firms may not be making money. But they are still generating value, said Dr. Fred Ledley, the center’s director and a professor in the departments of management and natural and applied science at Bentley.

“These companies are creating real value by doing what they do, by advancing the science, by advancing the pipeline, by establishing the foundation on which real, traditional value will be recognized at some point,” Ledley said in a phone interview.

The study examined 319 biotech companies that went public between 1997 and 2016, a period that covers advances in genomics, precision medicine and other fields. The companies were compared to a similarly sized control group of non-biotech companies that went public on the same dates.

The biotechs made fewer sales, lost money and spent more on research and development, the study found. But the stock market did not value them much differently over time.

The market capitalization of biotech companies overall grew by $127 billion during the study period, while the control group’s market cap rose by $133 billion. And the two groups had relatively similar records when it came to producing high-value and low-value companies.

Among biotechs, 134 companies reached a valuation of $1 billion, compared to 129 in the control group. Failures, defined as companies whose market cap fell below $100 million, totaled 45 among biotechs and 41 among non-biotechs.

The non-biotech group, however, did better when it came to delivering net value, defined as a company’s end valuation relative to net capital. Net capital is the total capital raised by a company minus capital returned to shareholders as dividends or stock buybacks. The control group’s net value grew by a combined $411 billion, compared to $93 billion for the biotechs.

The difference reflects the heavier capital requirements of biotech companies, the study said.

Other differences arose in the traditional metrics used to evaluate companies.

Biotech companies generated significantly lower sales, for example. Median annual revenue for biotechs was $10.1 million, compared to $192 million for the control group, according to the study.

The difference could be explained, in part, by the fact that biotech companies with successful products are often bought before they generates significant sales, the study said. Only four biotech companies in the study period reached $1 billion in annual revenue: United Therapeutics, Jazz Pharmaceuticals, Biomarin Pharmaceutical and Horizon Pharma. Only one cracked $500 million, Acorda Therapeutics, according to the study.

Annual R&D spending also was much higher: a median of $32.9 million for biotechs compared to $1.6 million for the control group. In addition, biotechs lost a median $36.2 million per year, versus a median profit of $2.86 million for the control group.

“Together, these data point to the institutionalization of a distinctive business model for public biotechnology companies in which the measure of company success is less likely to be sustained revenues or profits, but rather acquisition,” the study concluded. “In this model, the risk of investment is mitigated both by pursuing multiple product opportunities and through a portfolio that includes some products in later-stage development.”

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