Jazz, Lundbeck and Alexion settle with feds for $122M-plus over charity contributions

Jazz, Lundbeck and Alexion | April 05, 2019

The federal government’s probe into pharma’s co-pay assistance charities has snared some of the biggest names in the business, and Thursday the Department of Justice said three drugmakers have inked settlements totaling $122.6 million. Jazz, Lundbeck and Alexion each struck deals with the DOJ—worth $57 million, $52.6 million and $13 million, respectively—to resolve allegations of using payments to charities as “conduits” to help Medicare and other patients afford their drugs. The companies previously disclosed the settlements in securities filings and releases. The settlements don't include admissions of liability, but Jazz and Lundbeck are entering five-year corporate integrity agreements as part of their deals. The DOJ says Jazz asked a patient foundation in 2011 to establish a fund to pay Medicare patients’ co-pays on narcolepsy med Xyrem. Jazz was the sole donor to the fund, the government says. Each company blocked Medicare patients from participating in their free drug programs. Instead, drugmakers referred patients to the charities, which helped pay co-pays and allowed patients to access the drugs in a way that generated sales, the government said.

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VIEWS AND ANALYSIS

Altamira Therapeutics Provides Business Update and First Half 2022 Financial Results

Altamira Therapeutics Ltd | December 01, 2022

Altamira Therapeutics Ltd. a company dedicated to developing therapeutics that address important unmet medical needs, today provided a business update and reported its first half 2022 financial results. “We continue to make good progress with the transformation of Altamira into an RNA delivery technology company. We are optimistic of reaching an agreement to divest or partner our Bentrio nasal spray for key markets in North America and Europe by year end. Last month, we agreed to divest part or all of our inner ear therapeutics programs to a European family office. Following some delay and under slightly amended terms, we expect that transaction to close in December. Thomas Meyer, Altamira Therapeutics’ founder, Chairman and CEO “Heading towards 2023, we look forward to focusing exclusively on the many emerging opportunities in the fast-growing RNA therapeutics market. We are increasingly well positioned to advance our RNA delivery technology throughout 2023.” As Altamira is going through the final stages of a major corporate transformation, management intends to hold its next investor call upon finalization of its partnering / divestiture projects. On that call, the Company will also provide its outlook for 2023. RNA delivery platform update Altamira continued to make solid progress with the development of its patented, peptide-based platform for RNA delivery to extrahepatic tissues. In recent months, the RNA team led by Chief Development Officer Covadonga Pañeda, Ph.D., and Chief Scientific Officer Samuel Wickline, MD, have advanced various projects, including selection and optimization of siRNA sequences, formulation, process development and manufacturing. Starting with project AM-401 for the treatment of KRAS-driven tumors, the Company added a second project, AM-411 for the treatment of rheumatoid arthritis. AM-411 nanoparticles comprise siRNA targeting NF-kB a key checkpoint in RA inflammation. The Company is developing both AM-401 and AM-411 with the objective of out-licensing the drug products at a later stage. They serve as a “showcase” for the application of Altamira’s RNA delivery technology; the Company’s strategy will be to out-license the technology to pharma and biotech companies for use with their own RNA molecules. In this context, Altamira has been intensifying its efforts to raise awareness about OligoPhore/SemaPhore within science and industry. In recent months, members of Altamira’s leadership team gave oral presentations at multiple international conferences, highlighting the ability to deliver RNA molecules to extrahepatic tissues and achieve efficient and rapid endosomal release inside target cells. Concurrently, further data on RNA delivered with Altamira’s delivery technology has been published by independent research groups in peer-reviewed scientific journals. Altamira anticipates entering into its first partnering agreements in 2023. Bentrio Update Earlier today, Altamira reported that its licensee and distribution partner Nuance Pharma has launched Bentrio nasal spray in Hong Kong to help provide protection against airborne viruses as well as allergens. This will be the first step to distributing Bentrio in the other Nuance-licensed territories which is comprised of mainland China, Macau and South Korea. As part of its strategy to focus exclusively on RNA delivery, Altamira has been in discussions with several well-established OTC consumer health companies for the partnering of Bentrio. Those discussions intensified following the 510(k) clearance of the product by the FDA and have advanced well, including due diligence by interested parties. The Company anticipates entering into a partnering transaction before year end. In the context of those partnering discussions, Altamira suspended preparations for launching the product in the US on its own as well as pausing major marketing initiatives in Europe. This restraint provides the prospective strategic partner for Bentrio with maximum flexibility to fit the product into its business plan. Beginning in early October, the Bentrio nasal spray was relaunched in Europe for allergic rhinitis. Previously, the Company had ceased marketing the product for the indication of viral infection in the EU and Switzerland although Bentrio’s mode of action is the same regardless of whether it provides a barrier against airborne virus or allergen particles. This had been demonstrated in various relevant in vitro assays. However, certain countries and regions require specifically clinical performance data to clear Bentrio for this indication, in particular related to COVID-19. Such data are expected to become available through the COVAMID trial. In September, Altamira announced that it had reached its extended enrollment target of 160 confirmed subjects in its COVAMID clinical investigation to evaluate the safety, tolerability, and efficacy of its Bentrio nasal spray in patients with acute COVID-19. The read-out of top-line data remains on track for the current quarter. The Company plans to seek an expansion of its product label to also include viral infections in those countries requiring supportive clinical data. In September, the Company also announced that its “NASAR” clinical trial in seasonal allergic rhinitis (SAR) resumed enrollment as the new pollen season started in Australia. The NASAR trial is expected to enroll a total of 100 patients suffering from SAR and is designed to compare the safety and efficacy of Bentrio against a (control) saline nasal spray. The primary endpoint will be the comparison of the reflective Total Nasal Symptom Score under treatment with Bentrio against control. The NASAR trial was initiated in the fall of 2021. It was suspended in spring 2022 as the pollen season came to an end before the enrollment target could be met. Interim data from the trial were used in support of the 510(k) clearance of Bentrio by the US FDA. Unless an interim analysis performed upon reaching 50% of the enrollment target to check the validity of the statistical powering assumptions requires a change to the target size of 100 patients, the Company expects to complete enrollment into the NASAR trial by year-end or in early 2023 with a read-out of top-line data in late 1Q-23.

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VIEWS AND ANALYSIS, PHARMACY MARKET

Soligenix Initiates Phase 2 Clinical Trial of SGX302 (synthetic hypericin) for the Treatment of Mild-to-Moderate Psoriasis

Soligenix, Inc. | December 20, 2022

Soligenix, Inc. a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that patient enrollment has been opened for its Phase 2a study evaluating SGX302 in the treatment of mild-to-moderate psoriasis. Psoriasis is an ongoing unmet medical need, with as many as 7.5 million people in the U.S. and 60-125 million people worldwide affected by this incurable disease. "We are excited to expand synthetic hypericin's development into different cutaneous T-cell diseases such as psoriasis, as a component of our long-term strategy to enhance the value of this unique compound. Given our promising published results with hypericin to date, including a small Phase 1/2 proof of concept clinical trial in mild-to-moderate psoriasis, and the Phase 3 FLASH study in cutaneous T-cell lymphoma, where we filed a New Drug Application this month, we are hopeful synthetic hypericin will have a role to play in helping patients suffering from this difficult to treat and chronic disease." Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix The Phase 2a clinical trial will target enrollment of up to 42 patients ages 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of their body. In both Parts A and B, all patients will apply the study drug twice per week and will activate the drug with visible light 24 ± 6 hours later using the supplied visible light devices and according to the manufacturer's instructions. Patients will undergo treatments for a total of 18 weeks and, on completion, will be followed for a 4-week follow-up period in which patients will not receive other psoriasis treatments. In Part A, 5-10 patients will be assigned open-label SGX302 at the time of enrollment. Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to placebo ointment. Active dermatologic assessment of treated lesions for adverse events will be performed immediately before and during light treatments. Patients will be assessed for overall disease status through 4 weeks of follow-up. Efficacy endpoints will include the extent of lesion clearance and patient reported quality of life indices. Routine safety laboratories also will be collected. About Synthetic Hypericin Visible light-activated synthetic hypericin is a novel, first-in-class, photodynamic therapy that is expected to avoid much of the long-term risks associated with other PDT treatments. Synthetic hypericin is a potent photosensitizer that is topically applied to skin lesions and taken up by cutaneous T-cells. With subsequent activation by safe, visible light, T-cell apoptosis is induced, addressing the root cause of psoriasis lesions. Other PDTs have shown efficacy in psoriasis with a similar apoptotic mechanism, albeit using ultraviolet light associated with more severe potential long-term safety concerns. The use of visible light in the red-yellow spectrum has the advantage of deeper penetration into the skin potentially treating deeper skin disease and thicker plaques and lesions, similar to what was observed in the positive Phase 3 FLASH study in CTCL. Synthetic hypericin or HyBryte™ was demonstrated in this study to be equally effective in treating both plaque and patch lesions in this orphan disease caused by malignant T-cells. In a published Phase 1/2 proof of concept clinical study using synthetic hypericin, efficacy was demonstrated in patients with CTCL. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with both the frequently used DNA-damaging drugs and other phototherapies that are dependent on UV A or B exposure. The use of synthetic hypericin coupled with safe, visible light also avoids the risk of serious infections and cancer associated with the systemic immunosuppressive treatments used in psoriasis. The Phase 3 FLASH trial enrolled a total of 169 patients with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly in 6-week cycles. In the first double-blind treatment cycle, 116 patients received HyBryte™ treatment and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (using the standard Composite Assessment of Index Lesions Severity [CAILS] score) compared to only 4% of patients in the placebo group after just 6 weeks of treatment (p=0.04). Further treatment with HyBryte™ increased the number of treatment successes to 40% and 49% after 12 and 18 weeks, respectively (p<0.0001 for both). Additional analyses also indicated that HyBryte™ is equally effective in treating both plaque (42% treatment response rate after 12 weeks treatment, p<0.0001 relative to placebo treatment in Cycle 1) and patch (37%, p=0.0009) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions. This is also relevant to psoriasis where the lesions can be thicker than the patches observed in CTCL. In a subset of patients evaluated during their third treatment cycle, it was demonstrated that HyBryte™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions. About Psoriasis Psoriasis is a chronic, non-communicable, itchy and often painful inflammatory skin condition for which there is no cure. Psoriasis has a significantly detrimental impact on patients' quality of life, and is associated with cardiovascular, arthritic, and metabolic diseases, as well as psychological conditions such as anxiety, depression and suicide. Many factors contribute to development of psoriasis including both genetic and environmental factors. The lesions develop because of rapidly proliferating skin cells, driven by autoimmune T-cell mediated inflammation. Of the various types of psoriasis, plaque psoriasis is the most common and is characterized by dry, red raised plaques that are covered by silvery-white scales occurring most commonly on the elbows, knees, scalp, and lower back. Approximately 80% of patients have mild-to-moderate disease. Mild psoriasis is generally characterized by the involvement of less than 3% of the body surface area (BSA), while moderate psoriasis will typically involve 3-10% BSA and severe psoriasis greater than 10% BSA. Between 20% and 30% of individuals with psoriasis will go on to develop chronic, inflammatory arthritis (psoriatic arthritis) that can lead to joint deformations and disability. Studies have also associated psoriasis, and particularly severe psoriasis, with an increased relative risk of lymphoma, particularly CTCL. Although psoriasis can occur at any age, most patients present with the condition before age 35. Treatment of psoriasis is based on its severity at the time of presentation with the goal of controlling symptoms. It varies from topical options including PDT to reduce pain and itching, and potentially reduce the inflammation driving plaque formation, to systemic treatments for more severe disease. Most common systemic treatments and even current topical photo/photodynamic therapy such as UV A and B, carry a risk of increased skin cancer. Psoriasis is the most common immune-mediated inflammatory skin disease. According to the World Health Organization Global Report on Psoriasis 2016, the prevalence of psoriasis is between 1.5% and 5% in most developed countries, with some suggestions of incidence increasing with time. It is estimated, based upon review of historic published studies and reports and an interpolation of data that psoriasis affects 3% of the U.S. population or more than 7.5 million people. Current estimates have as many as 60-125 million people worldwide living with the condition. The global psoriasis treatment market was valued at approximately $15 billion in 2020 and is projected to reach as much as $40 billion by 2027. About Soligenix, Inc. Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. With a successful Phase 3 study completed, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the U.S. Development programs in this business segment also include expansion of synthetic hypericin into psoriasis, our first-in-class innate defense regulator technology, dusquetide for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation including pediatric Crohn's disease.

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VIEWS AND ANALYSIS, PHARMA TECH

Anaqua and PatSnap Team Up to Deliver an End-to-End Pharma IP Management Solution

Anaqua and PatSnap | December 08, 2022

Anaqua, the leading provider of innovation and intellectual property management technology announced it is partnering with innovation intelligence platform PatSnap. The collaboration will deliver an enhanced IP management solution to provide Anaqua’s pharmaceutical industry clients with a more detailed and informed view of the market and competitive landscape for key use cases. The combined Anaqua AQX® Pharma and PatSnap Synapse solutions will help AQX Pharma clients further enhance competitiveness, keep up with the fast-paced requirements of the current market, eliminate duplicated work across functions, as well as identify and realize new areas of investment. PatSnap is a platform for innovation intelligence, utilizing AI technology – including machine learning, computer vision and Optical Character Recognition that facilitates access to an unrivaled breadth of data that is connected in a meaningful way. PatSnap’s Synapse solution will give AQX Pharma users access to millions of data points, sourced utilizing best-in-class algorithms and expert manual curation, providing a comprehensive 360-degree market view and adding strategic value to drug development processes and strategy. The new integration is in response to client requests to access more pharmaceutical market data within the AQX platform to improve internal team efficiency and streamline processes. The integration will support sharing deeper intelligence between clients and partners and simplify the route of administration through features such as docket personalization that will allow teams to focus on their most strategic initiatives. Specifically, the combined system will address the use case of conducting stage gate reviews and automatically kick off relevant workflows. “AQX Pharma helps clients manage the business aspects of pharmaceutical IP management, while Synapse powers the external aspects of drug discovery through external and competitor drug discovery processes. Together, we’re using our unique capabilities to enable best practices in Life Science lifecycle stage gate reviews. We’re pleased to offer a complete pharma innovation solution, which can be further complemented by leveraging Anaqua’s strategic integrations, such as its innovation management solution, ideaPoint.” Vincent Brault, SVP of Product & Innovation at Anaqua Ray Chohan, Co-founder and VP of Corporate Development at PatSnap, said, “PatSnap is thrilled to team up with Anaqua, who are true innovators in life sciences IP management. Synapse will empower users of AQX Pharma to comb through millions of data points to discover and commercialize new therapies.” About Anaqua Anaqua, Inc. is a premier provider of integrated intellectual property management technology solutions and services for corporations and law firms. Its IP management software solutions, AQX® and PATTSY WAVE®, both offer best practice workflows with big data analytics and tech-enabled services to create an intelligent environment designed to inform IP strategy, enable IP decision-making, and streamline IP operations, tailored to each segment’s need. Today, nearly half of the top 100 U.S. patent filers and global brands, as well as a growing number of law firms worldwide, use Anaqua’s solutions. Over one million IP executives, attorneys, paralegals, administrators, and innovators use the platform for their IP management needs. The company’s global operations are headquartered in Boston, with offices across the U.S., Europe, Australia, and Asia. About PatSnap PatSnap’s AI-powered innovation intelligence platform transforms billions of innovation data points into actionable intelligence for over 10,000 global customers in more than 50 countries. With an unrivaled breadth of data, including patents, drug information, technology news, market reports, scientific literature, and more, PatSnap breaks barriers to connect innovators with insights.

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PHARMA TECH

Three iA Employees Honored with Top Women in Health Awards

iA | November 18, 2022

iA, a provider of software-enabled pharmacy fulfillment and automation solutions, celebrated three of its employees being recognized at Drug Store News’ Fourth Annual Top Women in Health, Wellness & Beauty Awards held in Chicago, Illinois. Rachael Clark, Vice President of Commercial Sales, received a Rising Star award. As Vice President of Commercial Sales, Rachael works with large-scale retail chain grocery stores, mainstream pharmacies, and digital pharmacies, as well as independent mom-and-pop operations. Rachael is responsible for a team of account executives that work to promote iA’s technology across North America and globally by developing long-term strategies, while also organizing and maintaining sales operations. Bobbi Jamriska, Senior Vice President, Product Management, received an award for Business Excellence. Bobbi leads the Product Management team at iA that is responsible for the iA portfolio of solutions, where she manages the strategy, development, and go-to-market planning. She has been a pharmacy tech for 12 years, and has led global product management initiatives as well as new product development experiences. Stacey Weber, Senior Director of Customer Operations, received an award for Business Excellence. Stacey oversees the customer support division, where she manages a team of 35 remote technicians who assist customers in using iA’s Rx fulfillment solutions, which include automated prescription filling robots and innovative warehouse management systems. In addition to ensuring customers receive timely and helpful assistance, she also oversees standardization and process improvement for iA’s call center and for the customers that use iA solutions. “We are incredibly proud of our team members. Rachael, Bobbi, and Stacey all represent the best of iA, and we are very lucky to be able to work with them every day.” Tom Utech, President and Chief Operating Officer About iA iA is a leading-edge provider of software-enabled pharmacy fulfillment solutions. With over 30 years in pharmacy fulfillment, iA has invented and developed a suite of software-driven pharmacy automation solutions. From NEXiA software to automated modular hardware and sophisticated counting and collation devices, iA pharmacy automation solutions and technology empower pharmacists. iA can run the prescription fulfillment process from end to end, helping pharmacies manage fulfillment and inventory to help lower costs, improve efficiency and provide comprehensive Rx tracking and real-time support.

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