First patient dosed in Astellas late-stage menopause trial

PharmaTimes | August 07, 2019

Astellas Pharma has announced the initiation and dosing of the first patient in its SKYLIGHT1 Phase III pivotal trial for fezolinetant. The investigational oral, non-hormonal compound is being studied for the treatment of moderate-to-severe menopause related vasomotor symptoms VMS, such as hot flashes and night sweats. The first trials of the programme will evaluate the efficacy and safety of 30 and 45 mg once-daily (QD) doses of fezolinetant in reducing VMS frequency and severity. “There are currently limited non-hormonal options for managing vasomotor symptoms, which can be quite disruptive and often interfere with daily life,” said Salim Mujais, senior vice president and therapeutic area head, medical specialties, Astellas. “With the initiation of our Phase III fezolinetant program, we move further towards our goal of providing women with a non-hormonal treatment for moderate-to-severe hot flashes.” The global BRIGHT SKY program will launch with three Phase III clinical trials overall; SKYLIGHT 1, SKYLIGHT 2 and SKYLIGHT 4, which will each enroll approximately 450 women with moderate-to-severe VMS and will be double-blinded and placebo-controlled for the first 12 weeks followed by non-controlled 40-week extension periods.

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The threat posed by pandemics grows alongside increased globalization and technological innovation. Distant cultures can now be connected in a day’s time, and international trade links global health and economic prosperity. In this report, the Scowcroft Institute of International Affairs at the Bush School of Government and Public Service at Texas A&M University details nine priority areas and accompanying action items that will help to address current pandemic response problems.


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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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Optomed signs an industrial partnership with a French AI company OphtAI

Optomed Oyj | March 21, 2022

Optomed and a French artificial intelligence company OphtAI have signed a commercial collaboration agreement, where both parties sell OphtAI artificial intelligence for screening of most common eye diseases together with Optomed Aurora handheld cameras as a complete solution for eye screening. The agreement is focusing mostly on European countries and Canada, where OphtAI has a strong presence. OphtAI offers artificial intelligence for detection of diabetic retinopathy, glaucoma and AMD, which is CE-marked for use in Europe and also regulatory authorization for commercialization in Canada. This collaboration supports both companies in their goals to provide more accessible and easier screening of various eye diseases. "The partnership with OphtAI supports Optomed's vision to bring AI enabled eye screening to primary care. We are happy to work with OphtAI who have a strong clinical validation and existing market approvals for EU and Canada." Optomed Vice President Devices, Laura Piila OpthAI CTO, Bruno Lay, comments: "This partnership with Optomed will bring OphtAI to the next level of its growth. OphtAI has been successfully integrated in the Optomed Aurora camera and the software suite, validated by key ophthalmologists, and it is now used on a daily basis for mass screening of diabetic retinopathy. This portable solution is easy to use, intuitive, and quite powerful for end-users. We are really excited to work with the leading company of portable cameras".

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PHARMACY MARKET

The McQuade Center for Strategic Research and Development and Mindset Pharma Collaborate to Develop Psychedelic Medicines

McQuade | January 06, 2022

The McQuade Center for Strategic Research and Development, LLC, a member of the global Otsuka family of pharmaceutical companies, and Mindset Pharma Inc. announce a collaboration that will support the development of psychedelic medicines. MSRD has made a strategic investment to support the discovery and development of novel chemical entity assets of Mindset, a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs. “Exploring multiple paths is essential as we work to address the unique needs of individuals living with mental health conditions. We look forward to collaborating with Mindset on these assets and are hopeful that medical psychedelics could be approved to treat mental illness in the future.” Robert McQuade, Ph.D., president, McQuade Center for Strategic Research and Development, LLC, and chief strategic officer, Otsuka Pharmaceutical Development & Commercialization, Inc MSRD, which identifies and supports early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders, will financially and operationally support the development of two families of Mindset’s novel medical psychedelic compounds through Phase 1a and Phase 1b clinical trials. MSRD has made an upfront cash payment of $5 million USD to Mindset and under the terms of the agreement, MSRD and Mindset may agree to expand the collaboration to continue to develop the compounds as pharmaceutical products. In addition, Mindset has granted MSRD a right of first refusal with respect to any asset sale, exclusive licensing or collaboration opportunities pertaining to the drugs and a right of first negotiation with respect to a merger, acquisition or asset sale related to Mindset, both in exchange for the upfront payment, further collaboration, and funding of the development of Mindset’s novel compounds. MSRD also has the ability to potentially receive single-digit percentage royalty payments under certain circumstances when the right of first refusal is not consummated or the agreement is terminated. “It is our great pleasure to collaborate with MSRD, a member company of Otsuka, to further the development of two of our families of novel psychedelic compounds. We look forward to leveraging their extensive experience in drug development and CNS indications to accelerate and de-risk our development pathway as we prepare to launch clinical trials,” said James Lanthier, chief executive officer of Mindset. “There is a high unmet need for innovative treatments of mental illness. This collaboration further validates our belief that optimized and patentable next-generation psychedelic compounds will be the future of treatments for mental illness.” Mr. Richard Patricio, chairman of Mindset’s board, added, “This transformational transaction is a validation of what our team has accomplished over the last several years. We are ecstatic that Otsuka has chosen to collaborate with Mindset in the novel psychedelic drug development space and see this as a pivotal moment in Mindset’s maturation. Our team is excited to work closely with MSRD to help meet the unmet needs of millions of people worldwide suffering with a variety of mental disorders. The future is truly exciting.” About Mindset Pharma Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds. For further information on Mindset, About the McQuade Center for Strategic Research and Development (MSRD) Established in 2019, by the Otsuka pharmaceutical business in the U.S., the mission of MSRD is to search for, identify, and fund innovative early-stage research and development programs that have the potential to build the future portfolio of Otsuka products. Otsuka is dedicated to investing in innovative and creative products in areas of unmet need and MSRD was created as an extension of this commitment to support and identify early-stage opportunities that can change the landscape of treatments for mental illness and renal disorders. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

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OPTEL ACQUIRES PHARMA TRACK-AND-TRACE UNIT OF KÖRBER

OPTEL Group | January 12, 2022

OPTEL GROUP, already a world leader in supply chain traceability, is expanding its expertise and global reach with the recent acquisition of the track-and-trace unit of the Körber Business Area Pharma, formerly known as Traxeed, based in Germany. Körber is a leading international technology group. The acquisition, announced today, will allow OPTEL to leverage the unit's expertise in pharmaceutical and agrochemical track-and-trace technologies, provide the company with a second foothold in the European marketplace and contribute to its diversification plans. "Creating a strong presence in the German market is key to the success of our strategic objectives because Germany is a well-established manufacturing hub, with a strong history of developing innovative manufacturing efficiency solutions and Industry 4.0 technologies," Louis Roy, founder and president of OPTEL "We are pleased that we have found a solid and future-oriented new owner with a broad international market access, from whose global network and years of experience in the highly specialized track-and-trace sector customers will clearly benefit. We are furthermore convinced that the new strategic owner can open up attractive development opportunities for the team," said Dr. Jürgen Krebs, Chief Technology Officer and Chief Operating Officer in the Körber Business Area Pharma. The acquisition allows OPTEL to welcome highly skilled pharma track-and-trace experts from Körber, complementing OPTEL's existing strengths in traceability, vision technologies, software and hardware. Furthermore, it will solidify and expand the company's presence in the European market by providing a second base of operations after Limerick, Ireland. In addition to the acquisition, a close collaboration between OPTEL and Körber's Business Area Pharma is planned in the future. The two companies plan to sign a partnership agreement whereby OPTEL becomes Körber's preferred partner for track-and-trace solutions for the pharmaceutical industry. Since its founding in 1989, OPTEL has become the world's foremost provider of track-and-trace solutions to the pharmaceutical industry. Its acquisitions in recent years have positioned it as the only company with the ability to provide complete, full-stack supply chain traceability. The Canadian multinational has since diversified into other industries, including consumer-packaged goods, metals and minerals, and agrochemicals. The acquisition of the track-and-trace unit of the Körber Business Area Pharma is expected to accelerate further expansion. ABOUT OPTEL OPTEL is a leading global provider of traceability systems whose goal is to use its innovative technologies to build a sustainable world through the Intelligent Supply Chain. OPTEL is the only company with the ability to offer complete end-to-end traceability, providing granular data at every step of the supply chain – from raw materials to the consumer and beyond. Founded in 1989, OPTEL is a Certified B Corporation headquartered in Canada, with facilities in Ireland, India and Brazil, as well as employees worldwide. ABOUT KÖRBER We are Körber – an international technology group with about 10,000 employees, more than 100 locations worldwide and a common goal: We turn entrepreneurial thinking into customer success and shape the technological change. In the Business Areas Digital, Pharma, Supply Chain, Tissue and Tobacco, we offer products, solutions and services that inspire. We act fast to customer needs, we execute ideas seamlessly, and with our innovations we create added value for our customers. In doing so, we are increasingly building on ecosystems that solve the challenges of today and tomorrow. Körber AG is the holding company of the Körber Group.

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Spotlight

The threat posed by pandemics grows alongside increased globalization and technological innovation. Distant cultures can now be connected in a day’s time, and international trade links global health and economic prosperity. In this report, the Scowcroft Institute of International Affairs at the Bush School of Government and Public Service at Texas A&M University details nine priority areas and accompanying action items that will help to address current pandemic response problems.

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