POLICY AND REGULATION
EpiEndo Pharmaceuticals | August 19, 2021
EpiEndo Pharmaceuticals , a privately held biopharmaceutical company focused on a novel barrier enhancing approach to the treatment of chronic inflammatory airway diseases such as chronic obstructive pulmonary disease (COPD), announces the closing of a €20m Series A financing round led by Flerie Invest and Iðunn Venture Fund, with existing investors ABC Ventures participating, along with the European Innovation Council (EIC) Fund joining the round. The financing secures funds to advance clinical development of EpiEndo’s lead compound EP395, which entered phase I clinical trials in April, through Phase IIa, targeting COPD as a primary indication. EpiEndo’s development rationale is based on a newly acknowledged therapeutic paradigm, that loss of integrity of epithelial barriers plays a critical role in propagating chronic inflammatory diseases in lungs and contributes to vulnerability to infections associated with acute exacerbations of airway diseases.
“I am delighted to announce the closing of this new investment round,” commented Maria Bech, CEO of EpiEndo Pharma. “We are very pleased to welcome such well-reputed investors as Flerie Invest and Iðunn Venture Fund to help us build our company and are honoured that the European Innovation Council Fund has chosen EpiEndo as its first follow-on investment. We are also grateful for the continued support of our existing investors. This financing is a major step for EpiEndo, not only funding our lead compound through clinical development in patients with COPD, but also enabling exploration of other important potential therapeutic application areas such as dermatology and gastrointestinal disorders, where compromised epithelial integrity is known to contribute to disease pathophysiology.”
Macrolide antibiotics such as azithromycin have been known for decades to exhibit good disease modifying efficacy against many chronic inflammatory airway diseases in addition to their antibacterial properties, in which their long-term use reduces the frequency and severity of inflammatory flare-ups and exacerbations. Although beneficial for overall health and prognosis, their off-label use in these patient populations has led to the emergence of macrolide resistance in the host flora.
EpiEndo’s lead compound EP395 is a new chemical entity in which the epithelial regenerative properties and anti-inflammatory effects seen with macrolides have been augmented, and the anti-bacterial properties removed. Using this Series, A funding, EpiEndo aims to advance the clinical development of EP395 towards approval as the first disease modifying non-antibiotic macrolide that can be prescribed safely and effectively as a long-term treatment for patients with COPD.
“We have followed EpiEndo for some time and have seen impressive progress towards clinical phase of their lead compound EP 395. We are proud to take part in their continuing journey with the aim to deliver substantially improved treatment of COPD,” said Carl-Johan Spak, Senior Advisor at Flerie Invest.
“EpiEndo is an attractive investment opportunity for Iðunn and a good fit for our fund’s investment strategy. We are looking forward to work with the company in the coming years to develop its lead candidate through the coming clinical phases. It is important for Iðunn to participate in the translation of new scientific discovery into clinical practice,” commented Hilmar Bragi Janusson, Managing Director of Iðunn Venture Fund.
“ABC is thrilled to obtain, in this round, a group of new investors to co-lead with us and support EpiEndo´s quest to create a solution to some of the most problematic diseases,” commented Ivar Gudjonsson, Managing Director of ABC Venture and a board member of EpiEndo.
“EpiEndo Pharmaceuticals’ challenge is to develop a new class of drugs and we are delighted to take part in this scale up journey,” said José Fernando Figueiredo, EIC Fund Investment Committee member, “The EIC Fund is taking part in this financial round to help this great example of a life science company to develop and deploy breakthrough treatment of chronic obstructive inflammatory pulmonary disease.”
About EpiEndo Pharmaceuticals
EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to inflammatory disorders that focuses on enhancement of epithelial barrier integrity as a critical pathophysiological factor underlying the etiology of a number of major diseases. Epithelial cells are a key component of the barrier that makes up human lung tissue and other organs such as the gut and skin. Compromised integrity of this barrier is implicated in the progression and non-resolution of several chronic inflammatory diseases. EpiEndo is developing a proprietary portfolio of orally available macrolide drugs with promise as first-in-class disease-modifying therapeutics, to address the huge global burden of chronic diseases of the lung and other organs where there is other significant unmet medical need. EpiEndo’s lead drug candidate, EP395, aims to be the first on-market oral, non-antibiotic, barrier strengthening and anti-inflammatory macrolide for the treatment of COPD.
Cancer Prevention Pharmaceuticals, CPP-1X/sul | June 29, 2020
Cancer Prevention Pharmaceuticals, Inc. (CPP), a private biotech company developing novel therapeutics to prevent cancer and other diseases, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for CPP-1X/sul for treatment of adults with familial adenomatous polyposis (FAP).
FAP is a rare genetic disease that if left untreated progresses to colorectal cancer in nearly 100% of patients. The clinical development of CPP-1X/sul was designed to establish this fixed dose combination product as a potential pharmaco-preventive drug treatment specifically for FAP patients.
“The NDA submission for our lead drug candidate, CPP-1X/sul, represents a significant milestone for FAP patients and their families,” said CPP CEO Jeff Jacob. “For most FAP patients, current medical practice involves a lifetime of periodic monitoring as well as highly invasive surgical procedures. If approved, CPP-1X/sul could provide an alternative to surgery for many patients, significantly improving their quality of life.”
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.