U.S. FDA Accepts Biohaven's Supplemental New Drug Application (sNDA) Of NURTEC™ ODT For The Preventive Treatment Of Migraine

Biohaven Pharmaceutical Holding Company Ltd. | October 14, 2020

Biohaven Pharmaceutical Holding Company Ltd. today announced that the U.S. Food and Drug Administration (FDA) has filed and accepted for review its recently submitted supplemental New Drug Application (sNDA) for NURTEC™ ODT (rimegepant) for the preventive treatment of migraine. The Prescription Drug User Fee Act (PDUFA) goal date for completion of the FDA review of the preventive sNDA is set for 2Q2021. Vlad Coric, M.D., Chief Executive Officer of Biohaven commented, "Patients with migraine deserve the simplicity of managing their disease with a single medication that alleviates acute episodes and also works to prevent future attacks. Our goal with the NURTEC ODT development program has been to offer a fast acting, quick-dissolve oral tablet with "dual-acting" properties --acute and preventive-- to treat migraine across its full spectrum.  We believe that the ease of use associated with a single oral medication will benefit people with migraine so that they can take back their days, and also provides the health care system with a cost-effective approach as opposed to paying for two separate drugs for acute and preventive treatment."

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Harbour BioMed Announces IND Approval for Next-Gen Anti-TSLP Fully Human Monoclonal Antibody

Harbour BioMed | February 22, 2022

Harbour BioMed announced that China National Medical Products Administration had approved its investigational new drug (IND) application for HBM9378 a next-gen fully human antibody targeting thymic stromal lymphopoietin for the treatment of moderate-to-severe asthma. HBM9378/SKB378 is a co-development project conducted by HBM and Kelun-Biotech, who together equally share the global rights in respect of HBM9378. The IND approval of HBM9378 is an achievement of the strategic collaboration between the parties. According to the strategic collaboration and license agreement between HBM and Kelun-Biotech, the parties will jointly explore innovative therapies of monoclonal antibodies and antibody-drug conjugate. Building on HBM's innovative business model leveraging its productive R&D platform to lead the next generation of valuable and innovative therapies and its mission to address the unmet medical needs, HBM will continue to expand its collaboration with industry leading partners and further leverage on the combined capabilities of HBM and its collaborators. "HBM9378/SKB378, a next-gen fully human monoclonal antibody, is developed from HBM's H2L2 platform. Its long half-life optimization and outstanding biophysical properties support the favorable dosing advantage. The approval of this IND application once again proves HBM's powerful innovation capability. Unleashing the power of our unique R&D engine, we are highly confident and determined to defeat intractable diseases across the world." Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed About HBM9378/SKB378 HBM9378/SKB378 is a fully human monoclonal antibody against TSLP generated from two heavy chains and two light chains (H2L2) platform. It inhibits the TSLP mediated signaling pathway by blocking the interaction between TSLP and TSLP receptor. TSLP plays important roles in DC cell maturation, T helper 2 (Th2) cell polarization and inflammation, particularly in both eosinophilic and non-eosinophilic inflammation asthma. About Asthma Asthma is a heterogeneous disease defined by the history of respiratory symptoms that vary over time and in intensity, together with variable expiratory airflow limitation. The disease is estimated to affect more than 300 million people worldwide and affect more than 45.7 million adult people (≥20 years) in China. Approximately 5-10% of those afflicted with asthma have severe disease that is poorly controlled. Despite the use of medium to high dose inhaled corticosteroids (ICS) in combination with a long-acting β2-agonist (LABA), currently available biologic therapies and oral corticosteroids (OCS), many severe asthma remain uncontrolled. Current biologics are mainly targeting Type 2 severe asthma which manifests clinically with a combination of peripheral eosinophilia, sputum eosinophilia and/or elevated fractional exhaled nitric oxide (FENO). Severe asthma patients experience frequent exacerbations, significant limitations on lung function and a reduced quality of life. The healthcare burden associated with care for these patients is also high. Therefore, there are still significant unmet needs to develop safer and broader therapies for severe asthma. About Harbour BioMed Harbour BioMed is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions.

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BUSINESS INSIGHTS

Sandoz targets growth opportunities in respiratory and complex generics through acquisition of respiratory device company Coalesce

Novartis Pharma AG | March 14, 2022

Sandoz, a Novartis division, announced that it has successfully acquired the UK-based medical and drug delivery device development company, Coalesce Product Development Limited. Through this deal, Sandoz has acquired the significant capabilities and assets of Coalesce, which will help it build on its existing portfolio of respiratory medicines and further improve patient access to these high-quality, complex therapies. “Respiratory and complex generics are areas of relatively high unmet medical need, due largely to their comparatively high technical complexity,” Sandoz CEO, Richard Saynor “At Sandoz, we have the experience and expertise to succeed in these fields and this acquisition offers us a significant new growth platform, particularly in the US and Europe, reinforcing our commitment to pioneer access for patients.” Respiratory diseases are leading causes of death and disability worldwide.1 Asthma is a major non-communicable disease affecting both children and adults, and in 2019 it affected an estimated 262 million people.2 In the same year, about 3.23 million deaths were attributed to chronic obstructive pulmonary disease (COPD).3 The resulting burden of respiratory diseases on healthcare systems and productivity amounted to more than USD 380 billion per year across 28 EU member states.4 With an existing portfolio of six in market-products and nearly twice as many more in the pipeline, Sandoz sees respiratory as a key pillar of its ambitious long-term growth strategy and intends to actively explore further opportunities both in-house and externally. More generally, Sandoz is determined to grow its portfolio in the complex generics space, including complex injectables. About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world’s leading and most valued generics company. Our broad portfolio of high-quality medicines, covering major therapeutic areas, accounted for 2021 sales of USD 9.6 billion.

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MedAvail Announces Pricing of $50 Million Private Placement

MedAvail | April 01, 2022

MedAvail Holdings, Inc. a technology-enabled retail pharmacy company, announced it has entered into a definitive securities purchase agreement for the sale of common stock and warrants to purchase common stock in a private placement with certain institutional and other accredited investors for gross proceeds to MedAvail of $50 million, before deducting placement agent commissions and other offering expenses. Pursuant to the terms of the securities purchase agreement and following the completion of all closings of the private placement, MedAvail will issue approximately 47.1 million shares of common stock and warrants to purchase approximately 23.5 million shares of common stock. The shares of common stock will be sold for a price of $1.0625 per share. Each purchaser will also receive a warrant to purchase 50% of the number of shares purchased under the securities purchase agreement by such purchaser. The warrants will have a per share exercise price of $1.25 and will be exercisable by the holder at any time on or after the issuance date for a period of five years. In addition, the warrant terms provide MedAvail with a call option to force the warrant holders to exercise up to two-thirds of the warrant shares subject to each warrant, with one-third of the warrant shares being callable beginning on each of the 12 month and 24 month anniversaries of the warrant issuance dates, in each case until the expiration of the warrants, and subject to the satisfaction of certain pricing conditions relating to the trading of MedAvail’s shares. If all warrants that are sold and issued in the private placement following the completion of all closings are fully exercised, then MedAvail would receive gross proceeds of approximately $29.4 million. The private placement is expected to have a first close on or about April 1, 2022, subject to the satisfaction of customary closing conditions. Additional details regarding the private placement will be included in a Form 8-K to be filed by MedAvail with the Securities and Exchange Commission. MedAvail intends to utilize the net proceeds for general corporate purposes and to fund its strategic initiatives. The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended or any state or other jurisdiction’s securities laws, and may not be resold absent registration under, or exemption from registration under, the Securities Act. MedAvail has agreed to file a registration statement with the SEC registering the resale of the shares of common stock to be issued and sold in the private placement, together with the shares of common stock underlying the warrants issued in the private placement, within 60 days of the applicable closing of the private placement in which such securities were purchased. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. Cowen acted as the placement agent for the private placement. Lake Street acted as financial advisor. About MedAvail MedAvail Holdings, Inc. is a technology-enabled pharmacy organization, providing turnkey in-clinic pharmacy services through its proprietary robotic dispensing platform, the MedAvail MedCenter, and home delivery operations, to Medicare clinics. MedAvail helps patients to optimize drug adherence, resulting in better health outcomes.

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PHARMACY MARKET

Twelve Consulting Group Announces Partnership with Celonis to Help Customers Identify and Eliminate Process Inefficiencies

Twelve Consulting Group, | February 11, 2022

Twelve Consulting Group, a consultancy firm specializingin designing and delivering cloud-based solutions, has formalized its partnership with Celonis, the global leader in execution management. This partnership combines Twelve CG’s technology consulting expertise with Celonis’ market leading process mining and execution management capabilities, enabling customers to optimize their business operations, identify inefficiencies and unlock their full execution capacity. The Celonis Execution Management System (EMS) provides companies with a modern way to understand and execute their business processes, eliminating billions of dollars in inefficiencies. The EMS powers all facets of business execution, including real-time data ingestion, process and task mining, planning and simulation, visualization and daily management, and targeted action flows to course correct in real-time. “By partnering with Celonis, we’ll be able to help our customers identify broken processes and execution gaps. And in addition, we can use the Celonis platform to fix those process issues and unlock efficiencies and value. This collaboration brings together the strengths of both organizations to deliver exceptional business outcomes and improve performance for our joint customers.” Jon Howard, Director of Solution Innovation at Twelve CG “Today’s businesses need to be able to see and understand processes before they can effectively act. Our Execution Management System helps customers identify and fix failing business processes, and addresses every facet of execution management from analytics, to strategy and planning, management, actions and automation,” said Nicole Gallant, VP Partner Management North America at Celonis. “Partnering with Twelve CG will help enterprises close the execution gaps that have been holding them back from achieving full execution capacity.” About Twelve Consulting Group Founded in 2013 by Jill King, Twelve Consulting Group leverages leading cloud-based technologies to help customers unlock potential with smarter data. Twelve CG works with 100+ customers across the CPG, Pharmaceutical and Technology industries to solve mission critical business challenges with speed, accuracy and agility.

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