Pharmaceutical Technology Editors

UK-based crystal and particle-engineering company, Crystec, and Argentinian company, Biosidus, have joined forces to enhance the delivery and performance of biotherapeutics, it was announced in an Oct. 19, 2021 press release.

Using Crystec’s proprietary modified supercritical antisolvent (mSAS) supercritical fluid particle engineering platform on selected Biosidus products, the companies hope to be able to generate a range of innovative, differentiated medicines. Initially, the partnership will focus on accelerating the development of a dry powder preparation of teriparatide for the treatment of osteoporosis.

Currently, teriparatide typically needs to be administered by daily injections over a two-year period. Crystec and Biosidus are hoping to be able to eliminate the need for daily injections by developing the dry preparation of the drug that can be used in formulations for administration via alternative routes, such as the nose.

“We are passionate about making our vital therapies accessible and convenient for those who require them. Our ultimate ambition is to eliminate the need for daily injections meaning that men, women, and children who suffer from long-term and chronic illnesses are not subjected to additional discomfort in the course of their treatment,” said Marcelo Criscuolo, scientific director at Biosidus, in the press release. “Working with Crystec’s innovative mSAS technology opens up the possibility of maximizing the therapeutic potential of these drugs through retaining improved biological activity levels and enabling ‘needle free’ delivery options for our patients.”

“We are delighted to work with Biosidus in this important area of drug delivery,” added Paul Thorning, CEO, Crystec, in the press release. “Our collaboration provides significant potential to demonstrate the power of the mSAS platform in simplifying biopharmaceutical processing, whilst facilitating the accelerated development of inhaled and nasal products that could be truly transformative for patients.”

Articles

Crystec and Biosidus have joined forces to enhance the delivery and performance of biotherapeutics.

Crystec, Biosidus Collaborate on Enhanced Delivery and Performance of Biotherapeutics 

International pharmaceutical company, Ferrer, and clinical-stage biotechnology company, Treeway, have entered into a license agreement for the development and commercialization of an oral formulation of edaravone (TW001/FNP122).

According to an Oct. 20, 2021 press release, the medicine will be used for the treatment of Amyotrophic Lateral Sclerosis (ALS) in certain territories, which will include Europe and some Asian countries. Ferrer will be responsible for advancing the development and commercialization of the drug and will make royalty payments to Treeway once certain milestones have been met.

“Guided by patients, we have developed TW001/FNP122 through the early stages of development,” said Inez de Greef, CEO at Treeway, in the press release. “We are therefore delighted that Ferrer has committed to advance our lead product to the required pivotal Phase III trial and make it available for ALS patients in large parts of the world.”

“Driven by our purpose of bringing transformative products to patients the world over, we are pleased to enter the agreement with Treeway and look forward to patients benefiting from improved treatment options,” added Oscar Pérez, Ferrer’s chief business development and licensing officer, in the press release. “TW001/FNP122 is the perfect fit for Ferrer’s strategy to bring new molecules to late-stage clinical development, registration and market entry in the field of neurological disorders and strengthen our pipeline for the coming years.”

Ferrer and Treeway, have entered into a license agreement for the development and commercialization of an oral formulation of edaravone (TW001/FNP122).

Ferrer, Treeway Partner on Development and Commercialization of ALS Treatment

The European Medicines Agency (EMA) has recommended the marketing authorization of a first-in-class medicine, Trodelvy (sacitusumab govitecan), to treat patients with an aggressive form of breast cancer.

More specifically, it was revealed in an Oct. 15, 2021 press release that the recommendation is for Trodelvy to be used in the treatment of adult patients with unresectable or metastatic triple-negative breast cancer who have already received two or more systemic therapies, with at least one of those treatments being for advanced disease. As patients with this aggressive form of breast cancer tend to be unresponsive to the standard treatment, chemotherapy, there is a high unmet medical need for new treatments in this area to improve patients’ outcomes.

Trodelvy combines a humanized antibody with a type of an antineoplastic agent called topoisomerase I inhibitor, which are intended to inhibit cancer growth, division, and spread. The marketing authorization application for the treatment has been evaluated under an accelerated process in efforts to speed up patient access to the medicine.

The regulatory authority’s recommendation was based on the data from a Phase III clinical trial that evaluated the safety and efficacy of Trodelvy in 529 patients. In the trial, it was found that the therapy helped to prolong the overall survival of patients by approximately five months and progression-free survival by approximately three months.

This recommendation will now be sent to the European Commission for a final decision on marketing authorization for the European Union. If a positive final decision is made, each European member state will make decisions on price and reimbursements for the medicine

EMA has recommended the marketing authorization of Trodelvy (sacitusumab govitecan) to treat patients with an aggressive form of breast cancer.

Trodelvy Gains EMA Nod for Treatment of Aggressive Form of Breast Cancer

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has approved two new manufacturing sites and a ready-to-use formulation of the BioNTech-Pfizer COVID-19 vaccine, Comirnaty.

Announced in an Oct. 18, 2021 press release, the two new manufacturing sites are both located in Italy—one in Monza, operated by Patheon, and the other in Anagni, operated by Catalent Anagni. Both sites are set to manufacture finished product and are expected to be able to produce up to 85 million addition doses of the COVID-19 vaccine to the European Union before the end of 2021.

The ready-to-use formulation that has been approved by CHMP does not require dilution prior to administration and will be available in a 10-vial (60 dose) pack size. The new formulation can be stored at 2–8 °C for up to 10 weeks. Currently, the concentrated formulation of Comirnaty needs to be diluted before use and can only be stored for up to one month at 2–8 °C. So, the new formulation should provide better storage, transport, and logistic options for distribution and administration.

According to the press release, the new formulation will be rolled out in a phased way commencing in early 2022.

EMA's CHMP has approved two new manufacturing sites and a ready-to-use formulation of Comirnaty.

EMA Approves Two New Manufacturing Sites and a New Formulation for Comirnaty

The European Medicines Agency (EMA) has commenced its evaluation of the BioNTech-Pfizer COVID-19 vaccine, Comirnaty, in children who are aged between five years and 11 years old, to determine if it can be authorized for further expanded use.

According to an Oct. 18, 2021 press release, EMA’s Committee for Medicinal Products for Human Use (CHMP) will review available data on the vaccine, which include results from a clinical study involving children between five and 11 years old that is ongoing. Once CHMP has formed a decision on whether or not an extension of the use of Comirnaty is appropriate it will forward all information onto the European Commission for a final decision.

EMA has specified in the press release that it will “communicate on the outcome of its evaluation, which is expected in a couple of months unless supplementary information is needed.”

EMA has started its evaluation of further expanded use of Comirnaty in children aged between five years and 11 years old.

EMA Starts Evaluation of Comirnaty in Children

The government of the United Kingdom has secured two new antiviral treatments for COVID-19, it was revealed in an Oct. 20, 2021 press release. The deals were made by the government’s Antivirals Taskforce and could be rolled out through a national clinical study before the end of 2021.

“I am delighted to confirm we may soon have a new defense in our arsenal with two new antiviral drugs that we have secured,” said Sajid Javid, health and social care secretary for the UK government, in the press release. “Our work is far from done though—and we’ll continue our tireless work to secure more innovative treatments so we can protect as many people as possible from the virus, its variants, and future diseases.”

Primarily, the antivirals—Molnupiravir (MSD) and PF-07321332/ritonavir (Pfizer)—will be used for the most vulnerable patients, including the elderly and those with weakened immune systems. Both treatments will need to be evaluated by the UK’s regulatory body the Medicines and Healthcare products Regulatory Agency (MHRA) before they are authorized.

“This is a very important development in our mission to find antivirals for those exposed to COVID-19, supporting the renowned vaccination program and the [National Health Service] over the coming months,” added Eddie Gray, chair of the Antivirals Taskforce, in the press release. “Should they be approved by the medicines regulator, we could see these treatments rolled out to patients this winter, providing them with vital protection.”

In response to the government’s announcement, Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry commented in a press statement, “Vaccines have already done so much to help break the link between infections and hospitalizations. Antivirals are another line of defense for the most clinically vulnerable and patients who are seriously ill with COVID-19. This is good news, and another example of the pharmaceutical industry and government working together to make sure we have as many effective tools as possible to tackle this pandemic.”

UK government has secured two new antiviral treatments for COVID-19, which may be rolled out in a national clinical study before the end of 2021.