The Future of Pharma: Technology's Opportunity to Improve Patient Care

Inside Digital Health | October 18, 2019

The Future of Pharma: Technology's Opportunity to Improve Patient Care
Tech innovation is impacting everyone, everywhere — including those in need of specialty medical care. Although there has been robust innovation across the healthcare industry as a whole, patient services and engagement tools, specifically in pharma, are lagging behind. The idea that doctors can simply write a prescription and send patients on the path to healing just isn’t the reality. People, especially those with a chronic condition or comorbidities necessitating multiple medications, require well-rounded, ongoing support to be successful in their medical treatment. Healthcare relationship management and patient engagement platforms can provide that level of support. More and more people are being diagnosed with chronic conditions. In fact, research shows that chronic diseases like heart disease will affect an estimated 164 million Americans by 2025. Additionally, the consumption and spend on prescription medication continues to climb, with 2018 data revealing that 5.8 billion prescriptions were dispensed at a total cost of $344 billion. However, only 30 to 50% of those medications were taken as prescribed. On top of this, physicians are stretched increasingly thin and not always able to dedicate the time required to help patients manage their increasingly complex medication regimens.

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PHARMA TECH

SciNeuro Pharmaceuticals and Mabylon AG to Collaborate on Development of Novel Therapeutics for Neurological Diseases

SciNeuro Pharmaceuticals | October 26, 2021

SciNeuro Pharmaceuticals a leader in the discovery and development of innovative therapeutics for the treatment of neurological diseases, and Mabylon AG, a leader in the discovery and characterization of human-derived antibodies against therapeutic targets, today announced the establishment of a multi-program collaboration and license agreement. Under the collaboration, MabSciNeuro and Mabylon will collaborate on multiple targets that encompass serious neurological diseases including TAR DNA binding protein-43 (TDP-43) and Apolipoprotein E (APOE) for neurodegenerative diseases for which there are currently no effective treatments. Both TDP-43 and APOE have human genetic evidence causal to ALS and Alzheimer’s disease. SciNeuro will have rights to develop and commercialize resulting product(s) within Greater China, and an option to expand such rights to become worldwide. “We are excited to be collaborating with Mabylon, a leading biotech company with deep expertise and capabilities for identification and characterization of native human antibodies with therapeutic potential. Their platform enables a deeper exploration of human immunology for therapeutic discovery Native human antibody-based approaches have proven successful for the treatment of infectious diseases including COVID-19. Discovery of auto-antibodies to treat other diseases has been more challenging, due in part to the availability of sufficiently large and high-quality sample collections. By working with companies such as Mabylon, possessing both proprietary antibody screening and cloning technology coupled with large, re-contactable patient sera repositories, we are in a strong position to test the hypothesis and exploit human immune responses for novel and differentiated therapeutic candidates for CNS diseases.” Dr. Min Li, Founder and CEO, SciNeuro Pharmaceuticals “Collaborating with SciNeuro and its R&D team allows full exploitation of Mabylon’s human antibody platform by seamlessly bringing our discovery research products forward to pivotal proof of concept. We are thrilled about this collaboration, which combines innovation in drug discovery with great expertise in drug development in the neurological disease area,” added Dr. Alcide Barberis, CEO, Mabylon. About Mabylon AG Mabylon AG is a leading Swiss biotechnology company harnessing the therapeutic potential of naturally occurring human antibodies to treat neurodegenerative diseases and allergies. Access to over 100,000 patients per year allows the discovery of extremely rare target-specific human antibodies, additionally providing information about the target’s human biology and safety profile.. About SciNeuro Pharmaceuticals SciNeuro Pharmaceuticals is a leading neuromedicine company focused on elevating the standard of care for patients suffering from neurological diseases. With R&D capabilities located in the major life sciences hubs of Shanghai, China and Rockville, Maryland, SciNeuro is establishing a robust CNS product pipeline through internal innoylon and SciNeuro will work together to discover and develop human auto-antibodies against targets of mutual interest with a goal to develop differentiated biologic therapeutics to treat neurological diseases.

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PHARMACY MARKET

Boston Scientific Announces partnership Definitive Agreement to Divest BTG Specialty Pharmaceuticals Business

Boston Scientific | December 02, 2020

Boston Scientific Corporation today declared that it has gone into a conclusive concurrence with Stark International Lux S.A.R.L., and SERB SAS, partners of SERB, an European strength drug gathering, to sell its BTG Specialty Pharmaceuticals business for $800 million in real money. SERB, supported by private value firm Charterhouse Capital Partners since 2017, possesses an expanded arrangement of doctor prescribed prescriptions zeroed in on uncommon and hazardous infections. "This exchange will help the BTG Specialty Pharmaceuticals business upgrade its potential as a completely coordinated forte drugs stage," said Anthony Higham, president, BTG, Specialty Pharmaceuticals. "We accept our capacities and portfolio firmly supplement those of SERB, and we anticipate this next section as we keep on emphatically sway the lives of patients and the individuals who care for them." The BTG Specialty Pharmaceuticals business creates, fabricates and markets life-sparing cures utilized in clinics and crisis care settings, including the clinically demonstrated and driving items CroFab®, DigiFab®, and Voraxaze®. The three establishments are required to produce roughly $210 million in income for the entire year 2020. "In the wake of obtaining BTG in 2019 for around $3.7 billion net of money available, and following the end of this exchange, we will have stripped the two BTG non-clinical gadget parcels – Pharmaceutical Licensing sovereignties in the final quarter of 2019 and Specialty Pharmaceuticals declared today – for more than $1.0 billion in net continues," said Jeff Mirviss, chief VP and president, Peripheral Interventions, Boston Scientific. "We keep on being satisfied with the presentation of the center Interventional Medicines business, the essential driver of the BTG securing, which has conveyed solid development and is required to surpass our unique objective of $175 million in collaborations." The arrangement incorporates the exchange of five offices and roughly 280 workers around the world. The exchange is relied upon to shut in the primary portion of 2021, subject to standard administrative endorsements and other shutting conditions.

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BUSINESS INSIGHTS

Recro Announces Acquisition of San Diego-based IRISYS, Creating Bi-Coastal, Full Service CDMO

Recro Pharma, Inc. | August 16, 2021

Recro Pharma, Inc. a contract development and manufacturing organization dedicated to solving complex formulation and manufacturing challenges for companies developing oral solid dose drug products, today announced its acquisition of IRISYS, a San Diego-based CDMO that possesses capabilities that complement and expand those of Recro. Recro acquired IRISYS for approximately $50 million in a combination of cash, shares of Recro common stock and a seller promissory note. With its acquisition of IRISYS, Recro has transformed itself into a full service CDMO with operations on both the East and West Coast of the U.S. capable of offering its now expanded global client base access to services spanning from pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for wide range of dosage forms. “Today’s acquisition of IRISYS is truly a transformative transaction for Recro. The joining of these two companies creates an organization that is ideally positioned to achieve Recro’s previously disclosed four-pronged strategy for growth, which includes strengthening the organization’s leadership and talent, expanding and diversifying our client base, fortifying our financial position, and enhancing our capabilities and competencies,” said David Enloe, president and chief executive officer of Recro. “Adding the personnel, facilities, capabilities and global customer base of IRISYS advances each of these goals and positions Recro for sustainable, profitable growth moving forward. We welcome the members of the IRISYS team to the Recro family and are eager to begin implementing the integration of the companies.” IRISYS is a full service CDMO based in San Diego, CA with capabilities that range from formulation development to commercial manufacturing for various dosage forms including oral liquids, sterile injectables, tablets, topicals, liquid/powder filled capsules, ophthalmic droppers, liposomes and nano/microparticles. IRISYS serves a diverse, global client base within the biopharmaceutical industry with its nearly 40 clients located in six different countries around the world. This includes manufacturing support for four commercial and near-commercial products. Importantly, IRISYS recently added automated, aseptic fill/finish and lyophilization capabilities to its existing facility, offering a new key avenue for significant near-term growth. IRISYS expects to generate $15.4 million in revenue for full year 2021 and has approximately $23 million spanning its contracted backlog and vetted sales pipeline. Strategic Rationale Recro’s acquisition of IRISYS was driven by a number of compelling factors covering the four prongs of the company’s ongoing growth strategy. Enhances Capabilities and Competencies: Expands technical focus beyond oral solid dose to include sterile injectables oral liquids, tablets, topicals, liquid/powder filled capsules, ophthalmic droppers, liposomes and nano/microparticles; Adds new capabilities in the areas of aseptic fill/finish and lyophilization; and Establishes bi-coastal footprint from which to better serve clients within the U.S., as well as globally. Expands and Diversifies Client Base: Adds more than three dozen clients spanning six countries, reducing Recro’s customer dependency risk; Provides greater balance between our clinical and commercial project mix; and Diversifies portfolio from exclusively oral solid dose to a balance of multiple advanced dosage forms and oral solid dose. Fortifies Financial Position: Adds profitable business with IRISYS full year 2021 estimated revenues of $15.4 million, net income of $2.1 million and EBITDA* of $2.8 million; the corresponding anticipated improvement in Recro’s EBITDA will be beneficial to Recro’s debt covenants under its credit agreement. Recro intends to provide updated financial guidance when it releases third quarter 2021 earnings; Offers significant revenue diversification, reducing financial reliance on any particular client or service offering; Becomes accretive by the fourth quarter of 2021, excluding integration costs; and Enables transaction-related paydown of credit facility and an extension of the due date, leading to improved cash flow. In addition to the advancement of the company’s four-pronged growth strategy, the acquisition was also driven by key synergies between Recro and IRISYS within business development, clinical development and commercial scale-up, as well as a strong cultural alignment and fit between the companies. Transaction Details Under terms of the agreement, Recro has acquired 100% of the equity interests of IRISYS in exchange for consideration having an aggregate value of approximately $49.850 million. The purchase price was paid through: (i) $25.5 million of cash at closing; (ii) 9,302,718 shares of common stock of Recro to be issued in six months; and (iii) a seller promissory note of $6.1 million. The seller note has a three (3) year maturity date from the date of closing and bears interest at a rate of 6% annually. The seller note is expressly subordinated and unsecured in right of payment and priority to Recro’s existing debt with Athyrium Capital Management. Bailey Southwell & Co. served as the exclusive financial advisor to IRISYS. William Blair & Company, L.L.C. represented Recro on the transaction. Non-GAAP Financial Measures Certain financial measures of IRISYS presented in this press release, including EBITDA, were not calculated using U.S. generally accepted accounting principles (“GAAP”). We believe these financial measures are helpful in understanding IRISYS’ business because it allows for greater transparency of supplemental information used by Recro’s management in connection with the acquisition of IRISYS. These measures are used by investors, as well as Recro’s management, in assessing IRISYS’ past and potential future performance. Non-GAAP financial measures should be considered in addition to, but not as a substitute for, reported GAAP results. Further, Non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared. Please see the section of this press release titled “IRISYS, LLC Reconciliation of GAAP to Non-GAAP Financial Measures” for a reconciliation of Non-GAAP EBITDA, to its most directly comparable GAAP measure. About Recro Recro is a contract development and manufacturing organization with capabilities from early feasibility to commercial manufacturing. With an expertise in solving complex manufacturing problems, Recro is a CDMO providing oral solid dosage form development, end-to-end regulatory support, clinical and commercial manufacturing, and packaging and logistics services to the global pharmaceutical market. In addition to our experience in handling DEA controlled substances and developing and manufacturing modified release oral solid dosage forms, Recro has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 120,000 square feet, in Gainesville, Georgia.

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Not only the most accurate cartridge filling system but it is also the most consistent, versatile, and dynamic.