PHARMACY MARKET

Bushu Pharma's Partnership with Suzuken Group Increases Specialty Pharmaceutical Services

Bushu Pharmaceuticals Ltd. | April 28, 2021

Bushu Pharmaceuticals Ltd. has entered into a business partnership arrangement with Suzuken Co., Ltd. to provide specialty pharmaceutical producers looking to enter the Japanese market with extensive support for new product releases.

In recent years, the market has seen an increase in the number of innovative specialty pharmaceuticals, such as biopharmaceuticals, regenerative medicines, and orphan drugs for rare diseases, that require strict temperature, inventory, and security control. In line with this trend, the number of pharmaceutical companies planning to bring these types of drugs to Japan has grown. These pharmaceutical manufacturers, on the other hand, often lack the necessary infrastructure, such as production facilities, delivery centers, and networks, to reach the Japanese market with minimal resources, and must therefore outsource these functions to trusted partners.

Suzuken, Bushu Pharma's partner, has played an industry-leading role in Japan's pharmaceutical distribution market. Suzuken, one of the leading organizations in the industry, has a distribution network in Japan capable of supporting the international shipping of specialty pharmaceuticals. Bushu Pharma, on the other hand, has been in the contract manufacturing industry in Japan for over 20 years, holds GMP certifications from all over the world, and has a track record of exporting to over 43 countries. Bushu Pharma will establish a platform that provides one-stop holistic assistance for pharmaceutical producers seeking to penetrate the Japanese market by aligning functions and capabilities with Suzuken.

About Bushu Pharmaceuticals Ltd.
Bushu Pharma manufactures solid reparations, solid preparation primary packaging, injection manufacturing, and injection packaging not just for domestic pharmaceuticals but also for multinational pharmaceutical manufacturers, drawing on its expertise and understanding as a contract development and manufacturing organization (CDMO) cultivated over 20 years. Bushu Pharma has a diverse product and service offering, ranging from clinical trial supplies to commercial product development support to commercialization, as well as various production facilities and technologies.

Bushu Pharma is a leading domestic contract manufacturing company in Japan that can offer optimum solutions such as technology transfer, production, packaging, and logistics from project start to project approval.

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BUSINESS INSIGHTS, PHARMACY MARKET

TherapeuticsMD Announces Definitive Agreements to License its Products to Mayne Pharma

TherapeuticsMD, Inc. | December 05, 2022

TherapeuticsMD, Inc. an innovative, leading women’s healthcare company, announced that it has entered into definitive agreements to license its products to an affiliate of Mayne Pharma Group Limited an ASX-listed specialty pharmaceutical company focused on commercializing novel and generic pharmaceuticals, for commercialization in the United States. In addition, TXMD has agreed to sell certain assets to Mayne Pharma to allow Mayne Pharma to commercialize the products. At closing of the transaction, TXMD will receive an upfront cash payment of $140.0 million for the license grant and sale of certain assets, plus an additional approximately $13.1 million, subject to customary adjustments, for acquired net working capital. In addition, TXMD will receive a 20-year royalty stream tied to Mayne Pharma’s net sales of the products. The upfront payment to be made by Mayne Pharma, along with cash on hand, will allow TXMD to repay its outstanding indebtedness with Sixth Street Partners and to redeem its outstanding preferred equity, with TXMD continuing as a pharmaceutical royalty company with the potential to create value for stakeholders over time from the resulting net cash flows. "After completing a thorough evaluation of several strategic alternatives, our Board of Directors concluded that this transaction with Mayne Pharma would create the most value for TherapeuticsMD’s stakeholders. This transaction will allow us to repay in full our debt to Sixth Street Partners and redeem our preferred stock from Rubric Capital Management, while also establishing a future royalty revenue stream for our common shareholders. We believe that Mayne Pharma has the experience necessary to fully realize the promise of our products as we work together to improve patient care.” The Honorable Tommy Thompson, Executive Chairman of TherapeuticsMD Upon completion of the transaction, which is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Act of 1976, Mayne Pharma will be responsible for development, regulatory filings, manufacturing, and commercialization of the Products. TXMD will receive an upfront payment of $140.0 million for the sale of the assets and the grant of the licenses, plus a payment of approximately $13.1 million for the acquisition of net working capital, subject to certain customary adjustments. In addition, Mayne Pharma will make one-time, milestone payments to the Company of (i) $5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $100.0 million, (ii) $10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $200.0 million and $15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $300.0 million. Further, Mayne Pharma will pay to the Company royalties on net sales of all licensed Products in the United States at a royalty rate of 8.0% on the first $80.0 million in annual net sales and 7.5% on annual net sales above $80.0 million, subject to certain adjustments, for a period of 20 years following the closing. The royalty rate will decrease to 2.0% on a Product-by-Product basis upon the earlier to occur of the expiration or revocation of the last patent covering a Product and a generic version of a Product launching in the United States. Mayne Pharma will pay to the Company minimal annual royalties of $3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3%, subject to certain further adjustments. In connection with entering into the transaction, the lenders and administrative agent under the Company’s Financing Agreement with Sixth Street Partners have agreed to extend the maturity date of the Financing Agreement to December 31, 2022, allowing the Company to complete the transaction with Mayne Pharma on or before that date. The maturity date of the Financing Agreement may be further extended to January 31, 2023, upon payment of an amendment fee, in the event the definitive agreements in connection with the transaction remain in effect and the waiting period under the HSR Act has not expired or terminated. The Company will retain its existing licensing agreements with Knight Therapeutics, Inc. and Theramex HQ UK Limited. The transaction is not subject to any financing conditions and is expected to close at the end of 2022, pending satisfaction of customary closing conditions. About TherapeuticsMD, Inc. TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. TherapeuticsMD’s products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. TherapeuticsMD is committed to advancing the health of women and championing awareness of their healthcare issues.

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BUSINESS INSIGHTS, PHARMACY MARKET

Shields Health Solutions Increases Specialty Pharmacy Services Nationwide

Shields Health Solutions | January 12, 2023

Shields Health Solutions (ShieldsRx), one of the leading specialty pharmacy accelerators, informed that the company has now collaborated with more than 850 hospitals at over 75 health systems after adding four more health systems. ShieldsRx health system partners are well-positioned to improve therapy management and care coordination for critical patients, improving outcomes through high-quality care. Its health systems serve 1 million patients in 44 states. Matt Conway, Chief Commercial Growth Officer of ShieldsRx stated, "As the foremost expert in health system specialty pharmacy, Shields has proven successful in partnering with health system leaders to develop integrated programs that deliver superior experiences and outcomes for complex patients." He further stated, "Not only do these programs deliver measurable clinical results but integrating specialty pharmacy within the health system also creates the net operating income health systems need to succeed. These proven clinical and financial results are why so many leading health systems trust Shields to elevate access, outcomes and growth within specialty pharmacy." (Source- PRNewswire) ShieldsRx's expansion with new health system partnerships includes MyMichigan Health: Midland-based MyMichigan Health serves 25 counties. Its urgent care, home health, virtual care, and medical offices offer a broad spectrum of care in over 30 specialties and subspecialties. Nemours Children's Health: Nemours Children's Health, the nation's most extensive multistate pediatric health system, has two free-standing children's hospitals and over 70 general and specialized care practices. Solution Health: Phoenix Children's Care Network, Arizona's leading children's hospital, offers over 1,175 pediatric primary care professionals and specialists in over 75 subspecialties. Traditional specialty pharmacy patients had to tackle administrative difficulties like prior authorization and expensive medical bills alone. Shields' expansion facilitated value-based reimbursement. About Shields Health Solutions Shields Health Solutions is a leading specialized pharmacy accelerator. Its Performance Platform is designed to improve payer and drug access for specialty pharmacies, improve health outcomes for complex patients, and promote growth across the entire health system. The company has access to over 80% of limited distribution medications (LDDs) and major health insurance payers in the U.S. along with a clinical strategy that lowers the total cost of treatment by 13%. ShieldsRx has collaborated with more than 70 health systems to deliver measurable clinical and financial benefits.

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BUSINESS INSIGHTS, PHARMA TECH

Xtalpi Partners with Singapore's Drug Discovery Platform to Find Better Cancer Treatments

XtalPi Inc. | December 29, 2022

One of the pioneering pharmaceutical technology companies - XtalPi, powered by artificial intelligence (AI) and automation, has recently announced a strategic collaboration with Singapore's national platform for drug discovery and development, the Experimental Drug Development Centre (EDDC), which is hosted by the Agency for Science, Technology, and Research of Singapore (A*STAR). The goal of this partnership is to find novel treatment candidates for non-small cell lung cancer (NSCLC). “According to Research and Markets, the size of the global market for NSCLC treatments will surpass USD 20 billion by 2027” Lung cancer is the second-most prevalent cancer worldwide and the leading cause of cancer-related mortality. NSCLC accounts for more than 80% of all lung cancer occurrences, while its incidence continues to rise worldwide. Despite growing interest and investment in drug research, there is a substantial unmet demand for effective targeted therapeutic alternatives for NSCLC patients to improve outcomes. In this partnership, EDDC and XtalPi will work together to find promising candidates against an NSCLC target chosen by EDDC. XtalPi will use its AI technology, automation platform, and expert domain knowledge. It will also use quantum physics and an AI-driven platform to create and test millions of molecules for the De-novo drug design. Iterations will be used in its robotics-powered synthesis and testing lab to confirm and improve the predicted top-performing molecules with desirable drug properties. EDDC will give helpful information and data about the new NSCLC target, which will speed up the process of finding new drugs and carry the program forward. XtalPi said in a statement that it is delighted to work with EDDC. It intends to help people all over the world by using AI and automation to improve the speed, size, variety, and success rate of drug research and development. In line with this, EDDC stated that it is excited to collaborate with XtalPi to translate science and research into practical and targeted cancer therapies. Furthermore, EDDC is confident that this collaboration will accelerate the development of much-needed targeted therapies for NSCLC patients due to XtalPi's experience in AI and automation technologies. About XtalPi XtalPi is a quantum physics-based, AI-powered drug R&D firm aiming to improve the speed, scale, novelty, and success rate of drug discovery. To meet the needs of its clients and partners, the company has offices in China and the United States. Frost & Sullivan cites the company as one of the world's first AI-powered drug R&D companies, with an iterative feedback loop between dry and wet lab capabilities.

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