China's driving sales growth ahead of the U.S. for Big Pharma. But can it last?

fiercepharma | May 28, 2019

If you follow Big Pharma companies’ investor updates, you’ll notice China popping up frequently these days. The world’s second-largest pharmaceutical market has been turning up sales increases that continuously surpass those in the U.S. and other developed regions. In the first quarter, emerging markets growth averaged 13.3% among the Big Pharmas followed by Wolfe Pharma analysts, including AstraZeneca, Eli Lilly, Pfizer, Roche, Sanofi, Merck & Co. and GlaxoSmithKline. And in China, that number was 29%  versus 8.2% in the U.S. a growth rate that has been ticking upward since the start of 2017, Wolfe’s Tim Anderson noted in a Thursday report.Now that China's increasingly important to Big Pharma, investors are naturally tracking it closely and they wonder just how long that kind of growth can last. For good reason, too; though all of those top companies see big opportunities in China, at least four of them warn growth could be uneven in the quarters ahead. Merck’s China business grew most in Q1, at 58%, but AstraZeneca’s 28% hike is perhaps “the most meaningful” because of its sheer presence in the country. China chipped in 23% of the company's first-quarter sales, several times higher than the industry average, Anderson noted. For Merck, the driving force is HPV vaccine Gardasil and immuno-oncology star Keytruda, which recently launched in the country. There's some debate about the market for Merck’s PD-1 king in China, what with several heavily discounted domestic rivals and a high rate of lung cancer mutations, which put more patients in line for targeted therapies. But Keytruda’s “wall of data,” along with its first-mover advantage in previously untreated lung cancer, could help it do well, chief commercial officer Frank Clyburn argued on the company’s April earnings call.

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Pharmaceutical manufacturing is an industry laden with many challenges and risks due to the life-changing nature of its products—drugs that can affect millions of human lives. Manufacturers perform immensely complex research and testing daily, while facing economic challenges and regulatory requirements.


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PHARMA TECH

Zynex Submits FDA Application for its Next Generation Fluid and Blood Volume Monitor

Zynex | January 04, 2022

Zynex, Inc. an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration for the CM-1600, its next generation fluid monitoring system. "I am thrilled to announce that we have submitted a 510(k) premarket notification to the FDA for our CM-1600. We have worked diligently at adding key enhancements to our FDA-cleared CM-1500 Fluid Monitoring System, including wireless connectivity to the non-invasive wrist wearable. This 510(k) submission is an important step in the evolution of our fluid monitoring system, which we believe will become a vital tool to ensure optimal fluid management and quality care for patients at risk for hemorrhagic events." said Thomas Sandgaard, CEO "We are pleased to bring a meaningful treatment improvement to market through the submission of the CM-1600 to the FDA for 510(k) clearance," said Donald Gregg, Vice President, Zynex Monitoring Solutions. "The improved fluid and blood volume monitor will provide more accurate patient observance before, during, and after surgical procedures. We look forward to working closely with the FDA throughout the submission and clearance process to bring this next generation, first of its kind technology to the market." The Zynex Fluid Monitoring System is a 100% non-invasive solution for monitoring fluid changes throughout patient care environments. Patient fluid status is determined using an algorithm that combines the trends of several physiological parameters to generate a single Relative IndexTM (RI) value, allowing for fast interpretation of changes in fluid volume. About Zynex, Inc. Zynex, founded in 1996, markets and sells its own design of electrotherapy medical devices used for pain management and rehabilitation as well as developing noninvasive patient fluid, pulse oximetry and sepsis monitoring systems.

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BUSINESS INSIGHTS

Titan Pharmaceuticals Announces Pricing of $5.5 Million Registered Direct and PIPE Offering Priced At-The-Market

Titan Pharmaceuticals, Inc. | February 03, 2022

Titan Pharmaceuticals, Inc. announced that it has entered into a securities purchase agreement with a single institutional investor to purchase 3,374,242 shares of its common stock (or pre-funded warrants in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, Titan has also agreed to issue and sell to the investor 1,289,796 pre-funded warrants, at the same purchase price as in the registered direct offering. In addition, the Company has agreed to issue to the investor in a concurrent private placement unregistered warrants to purchase up to an aggregate of 4,664,038 shares of common stock. The combined offering price of each share or pre-funded warrant and each warrant will be $1.18. The warrants will be immediately exercisable, will expire on the five year and six month anniversary of the issuance date and will have an exercise price of $1.14 per share. The aggregate gross proceeds to the Company of both offerings is expected to be approximately $5.5 million. The offerings are expected to close on or about February 4, 2022, subject to the satisfaction of customary closing conditions. Maxim Group LLC is acting as the exclusive placement agent in connection with the offerings. The shares of common stock in the registered direct offering are being offered pursuant to a shelf registration statement on Form S-3 which was declared effective by the United States Securities and Exchange Commission ("SEC") on April 24, 2019. The pre-funded warrants and warrants issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws. This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock issued in the registered direct offering will be filed by Titan with the SEC. About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. Ultimate validation of the ProNeura® delivery system has been exemplified by approval of Probuphine in the US (FDA), EU and Canada.

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BUSINESS INSIGHTS

Qualigen Therapeutics Acquires Majority Stake in Infectious Disease Diagnostics Technology Company NanoSynex

Qualigen Therapeutics, Inc. | June 03, 2022

Qualigen Therapeutics, Inc. a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today announces it has completed the acquisition of a majority stake in NanoSynex Ltd., an Israeli-based developer of next generation diagnostics technology. NanoSynex’s award winning technology is an Antimicrobial Susceptibility Testing (AST) platform that aims to provide clinical laboratories worldwide with a rapid, accurate and personalized test for bacterial infections, especially difficult-to-treat drug resistant strains, with the goal of quickly matching the correct antibiotics at the correct concentration to treat a patient’s specific infection. Antibiotic misuse and overuse have given significant rise to more frequent and more deadly antibiotic resistant bacteria, such as Methicillin-resistant Staphylococcus aureus (MRSA). Multi-drug resistant pathogens such as these have been declared a substantial threat to U.S. public health and national security by the Institute of Medicine and a federal Interagency Task Force on Antimicrobial Resistance. According to some estimates, the global infectious disease diagnostics market is expected to reach ~$39.8 Billion by 2026 from ~$28.1 Billion in 2021. “Living through two and a half years of COVID-19 has taught us the critical role diagnostics plays in combating infectious disease, and the need to be prepared for the next wave. NanoSynex’s technology shows great promise in rapidly and accurately matching antibiotics to the target bacteria, and in doing so, quickly equipping healthcare providers with the data needed to treat their patients with the right antibiotic at the right dose at the right time. We strongly believe in the potential of this platform, and our ability to leverage our long-standing diagnostics development, regulatory and commercial expertise to help bring the NanoSynex diagnostics technology to market sooner.” Michael Poirier, Qualigen's Chairman and CEO “We are excited about beginning a new journey with Qualigen and joining forces in a common mission to develop innovative diagnostics. This partnership takes the NanoSynex AST platform to the next level," added NanoSynex Co-Founder and Chief Executive Officer, Diane Abensur Bessin. NanoSynex is led by a dynamic team of healthcare subject matter experts, microbiologists, and engineers, including its co-founders – Diane Abensur Bessin and Michelle Heymann, who were selected for Forbes’ 2020 Tech 30 Under 30 list. Qualigen’s diagnostics team, led by Shishir Sinha, Senior VP and Chief Operating Officer, will work closely alongside the Israeli-based NanoSynex team on technology development, regulatory path, and commercial preparedness. Qualigen also envisions potential synergies with its proprietary FastPack® diagnostics platform to further strengthen the Company’s diagnostics business which has seen a post-COVID-19 resurgence. Qualigen’s purchase of the controlling interest in NanoSynex was primarily accomplished via a stock-for-stock acquisition with a controlling shareholder of NanoSynex. Qualigen also provided an investment in NanoSynex at closing and will provide future milestone-based funding leading to the commercialization of this technology. NanoSynex’s Board will initially be comprised of two current NanoSynex directors – NanoSynex co-founders - and two Qualigen appointees – Mr. Poirier and Mr. Sinha. About Qualigen Therapeutics, Inc. Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for adult and pediatric cancer, as well as maintaining and expanding its core FDA-cleared FastPack® System, which has been used successfully in diagnostics for over 20 years. Our investigational QN-302 compound is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against “unwinding,” help inhibit cancer cell proliferation. Our investigational QN-247 compound inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells; QN-247 may thereby be able to inhibit the cells’ proliferation. QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (AML). The investigational compounds within Qualigen’s RAS-F family of RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. In addition to its oncology drug pipeline, Qualigen has an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems to physician offices and small hospitals for the management of prostate cancer and other diseases and health conditions. About NanoSynex NanoSynex is a MedTech company that aims at providing new solutions to improve testing quality, patient outcomes, and reduce healthcare costs by speeding up diagnostic processes. NanoSynex is focused on the development and commercialization of a rapid innovative Antimicrobial Susceptibility Test (AST). The technology is based on a purely phenotypic approach and uses a microfluidic disposable test card platform and method that optimizes bacterial growth. This disruptive development was born from exciting research discoveries at the lab of Professor Shulamit Levenberg, former Dean of the Technion Institute of Technology – Biomedical Engineering Faculty.

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PHARMACY MARKET

Entos Pharmaceuticals Announces Senior Leadership Appointments to Expand Executive Team and Accelerate Growth

Entos Pharmaceuticals | March 07, 2022

EDMONTON, Alberta Entos Pharmaceuticals a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, today announced two executive-level appointments, Dr. Steve Chen as Chief Medical Officer (CMO) and Jason Ding as Chief Business Officer (CBO). Dr. Steve Chen brings over 20 years of academic research and pharmaceutical biotechnology experience across multiple therapeutic areas to Entos. He will be responsible for the strategy, direction, and execution of Entos’ clinical development programs and medical affairs activities. Before this position, Dr. Chen served as the CMO of Cellics Therapeutics and has held leadership positions at La Jolla Pharmaceutical Company, Takeda, Eli Lilly and Company, and Amylin Pharmaceuticals. Dr. Chen also led the clinical research unit at the Center for Human Nutrition at UCLA and was a staff physician for emergency medicine at West Los Angeles Veteran Affairs Hospital. He obtained his medical degree from the Albert Einstein College of Medicine and his B.Sc. and B.A. degrees in Bioengineering and Chinese Studies from UC San Diego. “Steve Chen has a track record of working with companies developing revolutionary therapeutic approaches for complex diseases. We are thrilled to welcome him to our team at such a pivotal time as we continue to expand our footprint and grow our pipeline of Fusogenix PLV nucleic acid therapies.” John Lewis, Ph.D., Founder and Chief Executive Officer of Entos Mr. Jason Ding has almost 20 years of financial and transactional expertise in the life science and healthcare industry. He will oversee Entos’ overall business strategy, building upon the company’s foundation for sustainable, scalable growth and developing partnerships with pharmaceutical companies. Before joining Entos, Mr. Ding served as a Partner and Senior Managing Director in Deloitte’s investment banking practice and as a National Life Sciences & Healthcare Transactions Leader spearheading transactions with a cumulative value of over $1.5 billion in the last two years. He has worked with start-ups, large public companies, and global consulting companies and has been an investor and a Board member for numerous life science and industry organizations. Mr. Ding is a Fellow of the Chartered Professional Accountants of Alberta (FCPA, FCA), a Chartered Business Valuator (CBV), and ICD.D designation with the Institute of Corporate Directors. He received his BSc. and BCom. from the University of Alberta. “We’re excited to have Jason Ding join our team, bringing extensive financial and transactional expertise within the biotechnology and health tech sectors,” said John Lewis, Ph.D., Founder and Chief Executive Officer of Entos. “His insight and perspectives are invaluable as we execute on current partnerships and seek to expand our network to bring next-generation Fusogenix PLV nucleic acid therapies to patients in need.” The appointments come on the heels of exciting momentum for Entos, having entered into a collaboration with Eli Lilly in January, where Lilly acquired rights to Entos’ Fusogenix PLV nucleic acid delivery technology to research, develop and commercialize Fusogenix PLV products for central and peripheral nervous system disease indications. As part of the Alberta provincial government’s effort to grow Canada’s biomanufacturing capacity, Entos also received a commitment of $15.5 million in funding from the province in December 2021 to establish a commercial manufacturing facility in Edmonton, Alberta. About Entos Pharmaceuticals A new reality in genetic medicine lies ahead, one that will be ushered in with the advent of safe, effective, and redosable nucleic acid delivery technologies. At Entos, we develop next generation genetic medicines using our proprietary Fusogenix proteolipid vehicle (PLV) drug delivery system. Fusogenix PLVs are formulated with FAST proteins to enable the delivery of mRNA or DNA into target cells through direct fusion.

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Spotlight

Pharmaceutical manufacturing is an industry laden with many challenges and risks due to the life-changing nature of its products—drugs that can affect millions of human lives. Manufacturers perform immensely complex research and testing daily, while facing economic challenges and regulatory requirements.

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