AstraZeneca revises Linzess deal with Ironwood Pharmaceuticals

Pharmaceutical Technology | September 19, 2019

AstraZeneca has revised its agreement with Ironwood Pharmaceuticals for irritable bowel syndrome with constipation (IBS-C) drug Linzess (linaclotide). Linzess is a guanylate cyclase-C (GC-C) agonist, which activates the GC-C receptor, leading to improved secretion of intestinal fluid and transit and a decrease in the activity of intestine’s pain-sensing nerves. The drug received the Chinese National Medical Products Administration approval for adult patients in January. It is expected to be commercially available in the country by the end of the year. AstraZeneca first signed an agreement with Ironwood in 2012 to co-develop and co-commercialise the drug. While the companies had joint responsibility for strategic development and commercialisation in China, AstraZeneca was primarily responsible for the implementation of local operations. Under the revised deal, AstraZeneca will carry full responsibility to develop, manufacture and commercialise Linzess in China mainland, China Hong Kong and China Macau. Ironwood will not be involved in research and development or commercialisation and will handover the manufacturing responsibility to AstraZeneca.

Spotlight

The mammalian suprachiasmatic nucleus (SCN) functions as a master circadian pacemaker, integrating environmental input to align physiological and behavioral rhythms to local time cues. Approximately 10% of SCN neurons express vasoactive intestinal polypeptide (VIP); however, it is unknown how the firing activity of VIP neurons releases VIP to entrain circadian rhythms.


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BUSINESS INSIGHTS

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

Nobel Biocare Receives FDA 510(k) Clearance for the Nobel Biocare N1™ Implant System

Envista Holdings Corporation | December 28, 2021

Envista Holdings Corporation announced that the U.S. Food and Drug Administration has cleared the Nobel Biocare N1™ implant system. Boasting a biologically driven design of components and forward-thinking treatment protocols, the N1™ implant system represents a significant step forward in patient-centric implant solutions. More than an implant, N1 is a comprehensive system of dedicated instruments, prosthetic components, and surgical protocols. New features of the system include an implant designed for immediate placement and predictable insertion torques, a trioval conical connection for the abutment to slide into place, and an emergence profile designed for soft tissue maintenance. Innovative site preparation for greater patient comfort The Nobel Biocare N1™ system includes the novel feature of the OsseoShaper™, an instrument that redefines site preparation and is set to reshape implantology with optimized workflows, greater patient comfort and faster treatment times. By gently 'shaping' the osteotomy at low speed and without irrigation, the OsseoShaper™ reduces noise and vibration compared to conventional drilling protocols. This leads to improved patient comfort and has been shown in pre-clinical studies to preserve vital bone. Embracing surface chemistry and digital workflows Fully embracing the new Mucointegration™ concept, the Nobel Biocare N1™ features the Xeal™ and TiUltra™ surface treatments. With their specially tailored surface chemistry and topography, TiUltra implants and Xeal abutments can benefit from this design to optimize tissue integration at every level. Nobel Biocare N1™ will be further integrated into the digital workflow with the DTX Studio™ suite, giving dental professionals more opportunities to provide patients with shorter time to teeth. "For over 50 years, Nobel Biocare has been a pioneering force behind implantology. The demand for high quality patient-centric solutions is higher than ever, and the Nobel Biocare N1™ system enables clinicians to set a new standard in personalizing, digitizing, and democratizing the implant treatment experience they can offer patients." Amir Aghdaei, Chief Executive Officer, Envista Patrik Eriksson, President Nobel Biocare, explained, "Drilling protocols have hardly changed over the past 50 years. However, the OsseoShaper™ provides a completely new approach designed for patient comfort, streamlined workflow, and improved predictability; while at the same time, respects biology to achieve fast osseointegration. We are excited to partner with clinicians to bring the N1 system to US-based patients." About Nobel Biocare Nobel Biocare is a world leader in the field of innovative implant-based dental restorations. The company's portfolio offers solutions from single tooth to fully edentulous indications with dental implant systems (including key brands NobelActive® and NobelParallel™ and ceramic implant NobelPearl™*) a comprehensive range of high-precision individualized prosthetics and CAD/CAM systems (NobelProcera®), digital solutions for treatment planning and guided surgery (NobelClinician® and DTX Studio™ suite) as well as biomaterials. Nobel Biocare supports its customers through all phases of professional development, offering world-class training and education along with practice support and patient information materials. The company is headquartered in Zurich, Switzerland. Production takes place at five sites located in the United States, Sweden, and Germany. Products and services are available in over 80 countries through subsidiaries and distributors. *Distributed by Nobel Biocare. Manufactured by Dentalpoint AG About Envista Envista is a global family of more than 30 trusted dental brands, including KaVo, Kerr, Nobel Biocare, and Ormco, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. With a foundation comprised of the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus, Envista is well equipped to meet the end-to-end needs of dental professionals worldwide. Envista is one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry.

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PHARMACY MARKET

Orbit Discovery and WuXi AppTec Sign Agreement to Access Peptide Discovery and Optimisation Technologies

Orbit Discovery | March 08, 2022

Orbit Discovery a ground-breaking peptide discovery company is pleased to announce the commencement of a partnership with WuXi AppTec, a leading global provider of R&D and manufacturing services that enable the global pharmaceutical and healthcare industry. Orbit will combine its leading peptide discovery platform and experience with WuXi AppTec’s downstream capabilities. Specifically, Orbit gains access to WuXi AppTec’s expertise in peptide optimisation, peptide production and manufacturing to help its Partners obtain clinically relevant data packs and materials in a rapid timeframe. Orbit will also utilise other capabilities within WuXi AppTec, in particular their expertise in cell line and assay development and biophysical analysis. Incorporating these capabilities into the Orbit platform will enable functional assays to be developed against a wider range of targets, facilitating direct functional screens using novel bead-based technologies and microfluidics. This is the first strategic technology link Orbit has penned since its formation in 2016. The partnership underlines the commitment of the new management team to deliver ground-breaking technology and broader capabilities to the Partners engaged in applying the Company’s technology for the discovery of peptide therapeutic leads. “We aim to move Orbit to the forefront of peptide discovery, and relationships such as this help us leverage expertise that would take far longer to grow organically. We see the partnership with WuXi AppTec as being a key relationship and a great asset to our current Partners, and Partners of the future.” He added: “We see particular value in the development and manufacturing platform of WuXi AppTec, that will enable us to generate peptides at small or large scale that incorporate chemical modifications to facilitate peptide optimisations and the journey towards a therapeutic candidate.” Dr Neil Butt, Chief Executive Officer of Orbit Discovery

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BUSINESS INSIGHTS

Ascletis Announces Submission of Marketing Authorization Applications for Ritonavir in Multiple European Countries

Ascletis Pharma Inc. | February 14, 2022

Ascletis Pharma Inc.announces that it has submitted marketing authorization applications for ritonavir in Germany, France, Ireland and United Kingdom through its agent in Europe. It is expected that more marketing authorization applications for ritonavir in certain other countries, including the ones in Europe, North America and Asian Pacific will soon be submitted. Ascletis has been in discussion with both domestic and international companies, including major multi-national pharmaceutical companies, for the commercial supplies of ritonavir in China and globally. Oral ritonavir tablet is a pharmacokinetic booster of multiple oral antiviral drugs targeting viral proteases and a component of oral antiviral drug Paxlovid. Ascletis aims to be one of the global commercial suppliers of oral ritonavir tablets. Ascletis owns the only authorized oral ritonavir tablet in China, which passed bioequivalence study. Ascletis' oral ritonavir tablet was approved in September 2021 by China National Medical Products Administration. Ascletis has been applying sophisticated formulation technology to significantly increase human bioavailability of ritonavir which has a very poor solubility and successfully achieved human bioequivalence with the oral ritonavir tablets produced by the originator, AbbVie. On January 3, 2022, Ascletis announced that oral ritonavir tablet annual production capacity has been expanded to 100 million tablets and can be further rapidly expanded based on market demand. About Ascletis Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange, a global platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis is committed to developing and commercializing innovative drugs in the areas of viral diseases, NASH/PBC, and cancer to address unmet medical needs both in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis targets those therapeutic areas with unmet medical needs from a global perspective, and efficiently advances the developments of pipelines with an aim of leading in global competition. To date, Ascletis has three marketed products and 20 robust R&D pipelines of drug candidates with global competitiveness, and is actively exploring new therapeutic areas.

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Spotlight

The mammalian suprachiasmatic nucleus (SCN) functions as a master circadian pacemaker, integrating environmental input to align physiological and behavioral rhythms to local time cues. Approximately 10% of SCN neurons express vasoactive intestinal polypeptide (VIP); however, it is unknown how the firing activity of VIP neurons releases VIP to entrain circadian rhythms.

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