Merck’s oral MS drug finally gets FDA okay

Merck | April 03, 2019

The US approval for relapsing/remitting and secondary progressive MS comes a couple of years after Merck won European approval for Mavenclad (cladribine), and several years after the first generation of oral MS therapies emerged to steal market share for older, injectable therapies such as Merck’s own Rebif beta interferon brand. Despite its late appearance, analysts think Merck could finally have a blockbuster on its hands, now that safety concerns behind the regulatory days in both the US and Europe seem to have been overcome. Merck KGaA fought for years to get the drug approved after rejection by the FDA and EMA, which was concerned that the drug could be linked to cancer. As it turns out, the drug has been approved in the US with a black box warning for an increased risk of cancer and birth defects, as well as a label that only supports second-line use of the drug. GlobalData suggested recently that Mavenclad has good efficacy compared to rivals such as Biogen’s Tecfidera (dimethyl fumarate), Novartis’s Gilenya (fingolimod) and Sanofi’s Aubagio (teriflunomide), as well as a favourable dosing regimen and several years of additional safety data from its protracted clinical trials programme.

Spotlight

If you want a roller coaster ride full of ups, downs, twists, and turns, move a portion of your portfolio to the pharmaceutical or biotech sector. Every day, including weekends, newswires are full of press releases from these companies outlining the results of clinical trials conducted on new and experimental drugs and compounds.

Spotlight

If you want a roller coaster ride full of ups, downs, twists, and turns, move a portion of your portfolio to the pharmaceutical or biotech sector. Every day, including weekends, newswires are full of press releases from these companies outlining the results of clinical trials conducted on new and experimental drugs and compounds.

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PHARMA TECH

Piramal Pharma Solutions Announces Sterile Fill/Finish Program Theratechnologies Inc

Piramal Pharma Solutions, Theratechnologies Inc. | January 25, 2021

Piramal Pharma Limited's Pharma Solutions business, a leading contract development and manufacturing organization (CDMO), today declared that it is giving Theratechnologies Inc. with GMP manufacturing of sterile fill/finish drug item to help their developmental item as it goes into a first-in-people clinical investigation. The clinical material is being created at the Piramal Pharma Solutions (PPS) manufacturing site in Lexington, Kentucky, which is perceived around the world for its skill in sterile fill/finish administrations. It will be utilized in a Phase I preliminary for TH1902, Theratechnologies' lead peptide-drug conjugate (PDC) (docetaxel conjugate). The Phase I preliminary plan incorporates a portion acceleration study to assess the security, pharmacokinetics, most extreme endured portion (MTD) and fundamental enemy of tumor movement of TH1902 managed once at regular intervals in patients with cutting edge strong tumors headstrong to accessible enemy of malignant growth treatments. According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, "Our Lexington team went the extra mile to provide solutions to ensure timely formulation development and production of the material. It's yet another example of how we are focused on working with our customers to reduce the burden of disease on patients." About Piramal Pharma Solutions Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. We also offer specialized services like development and manufacture of highly potent APIs and antibody drug conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve innovator and generic companies worldwide. About Piramal Pharma Limited Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 14 global facilities and a global distribution network in over 100 countries. PPL includes an integrated contract development and manufacturing (CDMO) business, Complex hospital generics business, and India Consumer Products business, selling over-the-counter products in India. In addition, it has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market. In October 2020, PPL received 20% strategic growth investment from the Carlyle Group. About Theratechnologies Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

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CNS Pharmaceuticals Announces US Drug Manufacturing Milestones

CNS Pharmaceuticals | September 03, 2020

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, today provides an update on progress for the U.S. manufacturing of Berubicin, the Company's lead drug candidate, in preparation for upcoming clinical trials. As previously announced, the Company implemented a dual-track drug product manufacturing strategy and engaged U.S.-based Pharmaceutics International, Inc. ("Pii") and Italy-based BSP Pharmaceuticals S.p.A. ("BSP") for the production of Berubicin. By engaging two separate manufacturers on two separate continents, CNS expects to mitigate COVID-19-related delay risks, diversify its supply chain and provide for localized availability of Berubicin.

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POLICY AND REGULATION

EpiEndo Pharmaceuticals Secures Funding to Advance Clinical Development of its Non-Antibiotic Macrolide for the treatment of COPD

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.

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