EMA approves Bayer’s NTRK-targetting Vitrakvi for children and adults

Pharmaceutical Technology | September 24, 2019

Bayer has announced that the European Medicine Agency (EMA) has licensed its Vitrakvi (larotrectinib) in adults and children with solid tumours displaying Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. The indicated patients must also have either locally advanced or metastatic disease, or be in a situation where there are no adequate treatment options or surgical resection is likely to cause severe morbidity. This makes Vitrakvi the first tumour agnostic drug to be approved in the European Union (EU), which means it can be used against multiple tumour types with the same, rare genetic alteration. NTRK gene fusion occurs when the NTRK gene fuses with an unrelated gene, leading to an altered TRK protein, which has oncogenic drivers encouraging the spread and growth of cancer cells.

Spotlight

As the managed care market pursues vertical integration and diversification, DRG sees disruptive change ahead for the U.S. healthcare system. Scroll through the infographic below to learn more about 8 drug pricing disruptors we could see in 2019.

Spotlight

As the managed care market pursues vertical integration and diversification, DRG sees disruptive change ahead for the U.S. healthcare system. Scroll through the infographic below to learn more about 8 drug pricing disruptors we could see in 2019.

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BUSINESS INSIGHTS

Hikma strengthens US Injectables business through acquisition of Custopharm

Hikma Pharmaceuticals USA Inc. | September 27, 2021

Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company and one of the largest suppliers of generic injectable medicines in the US, today announces that it has agreed to acquire Custopharm Inc. ('Custopharm') from Water Street Healthcare Partners ('Water Street'). Hikma will pay an initial cash consideration of $375 million on a debt and cash-free basis, with a further $50 million in contingent consideration payable upon the achievement of certain commercial milestones. Custopharm, a US-based generic sterile injectables company with a differentiated product portfolio and R&D pipeline, currently markets its products in the US through its commercial arm Leucadia Pharmaceuticals. Since partnering with Water Street in 2015, Custopharm has received 13 US FDA approvals, with four first-to-market Abbreviated New Drug Application (ANDA) approvals - including one with Competitive Generic Therapy (CGT) designation - and one novel 505(b)(2) NDA approval. Based in Carlsbad, California, Custopharm has 39 employees. With this acquisition, Hikma will have a differentiated US portfolio of close to 130 injectable medicines a more than fivefold increase over the last decade. Through this broad portfolio and by combining Custopharm's strong R&D capabilities with our high-quality and extensive manufacturing footprint, we will be in an excellent position to better serve the growing needs of hospitals, doctors and patients. I look forward to welcoming the team at Custopharm and Leucadia to Hikma as we continue to grow and strengthen our Injectables business. - Riad Mishlawi, President of Hikma Injectables We're excited to become part of Hikma, a global leader that shares our deep commitment to bringing generic products to market and into the hands of patients who need them. Water Street has been an outstanding partner in working with us to build an exemplary portfolio of complex generic products. We're looking forward to building on this success. - William C. Larkins, Ph.D., CEO of Custopharm and Leucadia Terms of the transaction and financial impact: The up-front consideration of $375 million is on a cash-free, debt-free basis and is being funded from Hikma's existing cash resources. The acquisition constitutes a Class 2 transaction pursuant to the UK Listing Rules.The gross assets of Custopharm at 31 December 2020 were $43 million. Losses before tax in the year to 31 December 2020 were $7.5 million. About Hikma Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. About Custopharm Custopharm is a leader in the generic injectables market. Its goal is to provide important new generic injectable products to the acute and specialty markets and to reach people and communities with underserved conditions. Custopharm invests significantly in developing and acquiring new products, including through strategic partnerships. It also launches newly approved products through its nationally recognized commercial organization, Leucadia Pharmaceuticals. Custopharm features a portfolio of highly differentiated generic products, including four first-to-market products: Calcitonin Salmon Injection, USP, Synthetic, Dihydroergotamine Mesylate Nasal Spray, Sodium Tetradecyl Sulfate (STS) Injection, 3%, and Valrubicin Intravesical Solution, USP. Headquartered in Carlsbad, California, Custopharm is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry. About Water Street Water Street is a strategic investor focused exclusively on health care. The firm has a strong record of building market-leading companies across key growth sectors in health care. It has worked with some of the world's leading companies on its investments including Humana, Johnson & Johnson, Medtronic and Walgreen Co. Water Street's team is comprised of industry executives and investment professionals with decades of experience investing in and operating global health care businesses. The firm is headquartered in Chicago.

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PHARMACY MARKET

Novartis' Sandoz spotlights importance of generic drugs in new social campaign

Novartis | December 17, 2020

Did you realize that 90% of remedies are composed for nonexclusive medications? Novartis' Sandoz is getting the news out about nonexclusive medication with such realities in its as of late dispatched "Request Generics" crusade. It's Sandoz's first significant instruction and mindfulness crusade via online media to advance the estimation of generics. The intended interest group is key partners—patients, clinicians, policymakers and payers—with messages running on LinkedIn and Twitter. Sandoz plans to run the mission through the finish of the principal quarter, perhaps more, contingent upon results. It's as of now chipping away at a second stage that will move center to biosimilar adaptations of marked biologic medications. "Generics are assuming a truly significant job, and I believe it's ideal planning currently to discuss the significant job generics play in a well-working medical care framework," said Carol Lynch, Sandoz's U.S. president and head of North America. Other than featuring the pervasiveness of generics, the online media posts promote their reasonableness and their status as firmly directed items—as protected and powerful as their image name partners. The moderateness and security messages are significant, alongside the general token of the opposition generics give in the commercial center. The duplicates of costlier marked medications help to make "a sound serious market that is directed to patients having expanded admittance to the prescriptions they need," Lynch said. Nonexclusive medications saved the U.S. medical services framework $313 billion a year ago, as per the 2020 yearly report of conventional and biosimilar access and reserve funds in the U.S. from the Association for Accessible Medicines, a generics industry exchange gathering.

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RESEARCH

Pfizer/Biontech Weren't Alone: Moderna Covid-19 Vaccine Data Aimed in Ema Cyberattack

Moderna | December 16, 2020

It would appear that Pfizer and BioNTech's COVID-19 immunization was not the sole objective of a new cyberattack at the European Medicines Agency. Moderna said Monday that reports from its pre-accommodation conversations with EMA about its shot, mRNA-1273, were "unlawfully gotten to" by programmers, refering to a warning from the organization. The assailants didn't get individual data about preliminary members, Moderna said. The organization's EMA accommodation did exclude any information recognizing people in the examination. Now, no extra insights concerning the cyberattack, for example, the size of the penetrate or the character of any suspects—are accessible, and Moderna said it anticipates results from EMA's progressing examination. The disclosure came days after the EMA initially uncovered the cyberattack, and Pfizer and BioNTech's COVID-19 immunization applicant, BNT162b2, was the principal distinguished as an objective. EMA choices on the two immunizations are moving close. Medication commentators at the EMA's Committee for Medicinal Products for Human Use are booked to evaluate BNT162b2 on Dec. 29 and mRNA-1273 on Jan. 12. Moderna was recently focused by programmers looking for its COVID-19 examination, in a cyberattack supposedly upheld by the Chinese government. The U.S. Branch of Justice in July arraigned two Chinese nationals for running a 10-year hacking effort that most as of late rotated to focusing on organizations doing COVID research. Reuters later affirmed Moderna as the antibody producer referenced in the arraignment. China has denied any function in such practices. Other than Moderna and Pfizer/BioNTech, rival COVID immunization designers AstraZeneca, Johnson and Johnson and Novavax apparently have arrived in the line of sight of North Korean programmers. In those hacking endeavors, the assailants regularly conveyed noxious reports or connections by means of email under the appearance of occupation enrollment specialists, partners or different associates of the person in question, as indicated by individuals acquainted with the issue refered to by The Wall Street Journal. Country state programmers from Iran and Russia have likewise been blamed for attempting to take COVID-related data.

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