Merck to spin off women’s health and biosimilar drug businesses

The Globe and Mail | February 05, 2020

Merck & Co Inc said on Wednesday it will spin off its women’s health, biosimilar drugs and older products into a separate publicly traded company as it tightens its focus on growth drivers like cancer drug Keytruda and vaccines. The new company’s assets currently make up around 15 per cent of Merck’s total sales and around half of its drugs that treat people. Merck will retain its animal health business, as well as drugs used for acute care in hospitals such as Bridion, which reverses the effects of anesthesia. Merck shares fell 3.7 per cent to $85.12 after the U.S. drugmaker also reported quarterly Keytruda sales below Wall Street’s lofty estimates. The spinoff is a culmination of the drugmaker’s strategy of concentrating on a few key areas, particularly oncology, where Merck has turned the immunotherapy Keytruda into one of the world’s top selling drugs, Merck Chief Executive Ken Frazier said in an interview.

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PHARMACY MARKET

AIkido Pharma Reports Improved Manufacturing Process and New United States Patent for Pancreatic Drug

AIkido Pharma Inc. | March 04, 2022

AIkido Pharma Inc.reported an improvement in the manufacturing process for its pancreatic cancer drug, DHA-dFdC, licensed from the University of Texas at Austin. The Company also reported the issuance of an additional U.S. patent covering the drug, and the filing of a continuation patent application intended to expand patent coverage to other facets of the drug. With respect to manufacturing process, the Company reported the successful development of a new means for the scaled production and isolation of the key intermediate compound in the manufacture of DH-dFdC. The Company has now executed a further contract with its contract manufacturing organization, Parimer Scientific, to employ the new process to produce several thousand milligrams of the drug for use in formulation development and stability studies. The Company also reported that the U.S. Patent Office recently issued new U.S. Patent No. 11,219,633, which provides additional intellectual property protection for the drug compound. The term of the patent is expected to continue until May of 2035 with the payment of required maintenance fees. Prior to the patent issuance, the Company authorized the timely filing of a patent continuation application, U.S. Serial No. 17/539,682, in which additional claims related to various aspects of the drug and formulation will be pursued. "This new process significant step forward in the development of our pancreatic cancer drug and should permit production of the drug on a commercial scale at a lower cost. I am also pleased that we can continue to report expansion of the patent estate." Anthony Hayes, CEO of AIkido Richard T. Pace, Owner and Principal Scientist of Parimer Scientific, stated, "The newly developed manufacturing method is a large step forward for this innovative technology. I believe it will reduce cost per unit and at the same time increase batch production volumes." About AIkido Pharma Inc. AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics. The Company's platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus and Marburg virus.

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PHARMA TECH

CSL Limited announces tender offer to acquire Vifor Pharma Ltd

Vifor Pharma Group | December 15, 2021

Global biotechnology leader CSL Limited and Vifor Pharma Ltd, a global specialty pharmaceutical company with leadership in iron deficiency, nephrology & cardio-renal therapies, announced that they have entered into a definitive agreement for CSL to acquire Vifor Pharma for an aggregate equity value for Vifor Pharma of US$ 11.7 / CHF 10.9 billion. CSL has offered to acquire Vifor Pharma in an all-cash tender offer of US$179.25 per share, payable in U.S. dollars.1 The offer assumes a dividend of CHF 2 expected to be declared at the AGM of 26 April, consistent with past practice. The tender offer represents an implied premium of approximately 61% to the unaffected closing price of Vifor Pharma on 1 December 2021 and a 47% premium to Vifor Pharma’s unaffected 1-month VWAP as of 1 December 2021.2 Patinex AG, Vifor Pharma’s largest shareholder holding 23.2% has agreed to tender its shares into the offer. The Transaction remains subject to the conditions and further terms including: Minimum acceptance rate of 80% of all Vifor Pharma shares on a fully diluted basis; and further customary offer conditions, including regulatory approvals. The tender is currently expected to commence around 18 January 2022 and the transaction is expected to complete around mid-2022. The Board of Directors of Vifor Pharma considers that the proposed transaction respects the interests of all stakeholders and is unanimously recommending the offer to shareholders. There is committed financing for the deal and a strong commitment to pursue regulatory clearances. “Vifor Pharma's strategy has been to focus towards continuing being a market leader in iron deficiency, nephrology and cardio-renal therapies. The offer provides an excellent strategic opportunity for Vifor Pharma to optimize future market opportunities from a position of strength and to create substantial value for all stakeholders.” Jacques Theurillat, Chairman of the Board of Directors Vifor Pharma Group The transaction will enable Vifor Pharma to leverage CSL’s global reach, balance sheet and capabilities to bring more products to patients within its key categories. The transaction also enables Vifor Pharma to accelerate growth in cardiovascular-metabolic, renal and transplant. Centerview Partners UK LLP is acting as exclusive financial advisor to Vifor Pharma on the transaction. IFBC have been retained as Fairness Opinion providers by the Vifor Pharma Board of Directors. About Vifor Pharma Group Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange About CSL CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses, CSL Behring and Seqirus- provides life-saving products to more than 100 countries and employs more than 25,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

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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

Novartis announces new organizational structure to accelerate growth strengthen pipeline and increase productivity

Novartis Pharma AG | April 04, 2022

Novartis announced the introduction of a new organizational structure and operating model designed to support the company’s innovation, growth, and productivity ambitions as a focused medicines company in the coming decade. “The simpler organizational model we are unveiling today is central to our growth strategy as it will make us more agile and competitive, enhance patient and customer orientation, unlock significant potential in our R&D pipeline and drive value-creation through operational efficiencies. With our portfolio of in-market medicines and up to 20 major pipeline assets that could be approved by 2026, Novartis is in a strong position to deliver above-peer-median sales and margin growth in the mid- and long-term.” Vas Narasimhan, CEO Novartis Integrating Pharmaceuticals and Oncology business units Novartis will integrate the Pharmaceuticals and Oncology business units and create two separate commercial organizations with a stronger geographic focus—Innovative Medicines US and Innovative Medicines International. The two units will have full P&L responsibility across all therapeutic areas and ownership of customer experience, marketing and sales, and market access for their respective markets. The elevation and establishment of an independent US commercial organization strengthens Novartis’s ability to achieve its goal of becoming a top-five company in the US in terms of sales while maintaining and growing its leadership position internationally. The new model will also help Novartis bring increased focus and commitment to its core therapeutic areas of Cardiovascular, Hematology, Solid Tumors, Immunology and Neuroscience. Marie-France Tschudin, currently President, Novartis Pharmaceuticals, will become President, Innovative Medicines International and Chief Commercial Officer. In her capacity as Chief Commercial Officer, Marie-France Tschudin will oversee global marketing, medical affairs and value and access across all therapeutic areas. Victor Bulto, currently Head of US Pharmaceuticals, will become President, Innovative Medicines US. They will both report to Vas Narasimhan effective immediately. New Strategy & Growth Function Novartis will create a new Strategy & Growth function combining corporate strategy, R&D portfolio strategy and business development. This function will help drive the company’s growth strategy end-to-end and will look across internal and external opportunities to strengthen Novartis’s pipeline with medicines that are both transformational and can make significant contributions to growth. This new function will be led by a Chief Strategy & Growth Officer who will become a member of the ECN and report to the CEO. The search is currently underway for this new leader, and in the interim the function will be led by Lutz Hegemann, M.D., Ph.D., President, Global Health. Integrated Operations and Global Functions Novartis will also combine its Technical Operations and Customer & Technology Solutions units to create a new Operations unit. This new unit will provide a stronger and simpler operational backbone that can accelerate multiple technology transformation initiatives more efficiently, create novel digital solutions at scale and increase productivity, while maintaining industry-leading quality and service levels. Effective immediately, Steffen Lang, currently Global Head of Novartis Technical Operations, will become President, Operations reporting to Vas Narasimhan. In addition, all G&A functions—Finance, People & Organization, Ethics, Risk & Compliance, Legal, and Communications & Engagement—will be integrated on global and country levels. Change in Global Drug Development (GDD) Leadership Novartis has appointed Shreeram Aradhye, M.D., as President, Global Drug Development and Chief Medical Officer effective May 16th, 2022. Dr. Aradhye, who is returning to Novartis, was most recently Executive Vice President and Chief Medical Officer at Dicerna Therapeutics where he led the development of multiple clinical stage RNAi assets. Previously, he was Chief Development Officer at Axcella Health. Dr. Aradhye has dedicated his entire professional career to improving patient lives, first as an academic clinician and then as a drug developer and business leader. He brings significant experience in global clinical development of innovative medicines across several therapeutic areas and has played a key leadership role in the development of multiple innovative therapeutics. During his 20-year tenure at Novartis, he held several global leadership roles including as development head for the company’s Neuroscience franchise and Global Head of Medical Affairs for the Pharmaceuticals business unit. Dr. Aradhye will report to Vas Narasimhan and join the ECN. With the changes in organizational structure and operating model, John Tsai, M.D., has decided to pursue opportunities outside Novartis effective May 15th, 2022. “I would like to extend my deep gratitude to Susanne, Robert and John for their invaluable contributions to the company. Susanne has been an inspiring and dedicated leader at the company for 25 years, and she has played a pivotal role in strengthening our global Oncology business. Over the last four years, Robert has led a successful transformation of our business services and technology operations and helped create a strong Customer & Technology Solutions unit. Since taking over as Head of GDD in May 2018, John has played a key leadership role in advancing our mid-stage pipeline and delivering 18 major drug approvals to patients around the world. I wish them the very best in their future endeavors,” added Vas Narasimhan, CEO Novartis. “I would like to congratulate Marie-France, Shreeram, Steffen and Victor on their new roles, and extend a warm welcome back to Shreeram. I look forward to working closely with them as we embark on this new phase of our journey to reimagine medicine together.” About Novartis Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments.

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Spotlight

Microorganisms inevitably inhabit our food as they do every other corner of the Earth. Many exist there harmlessly, and some can even be beneficial. However, there is also a subsection that can make us ill or even kill. Consequently, food microbiology has become a worldwide public health concern.

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