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Boehringer Ingelheim, Gubra to validate new Peptides for obesity

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Boehringer Ingelheim has entered into a new research and licensing agreement with biotech company Gubra to identify and validate innovative peptides to treat obesity.

Boehringer Ingelheim and Gubra partnered to develop innovative Peptides to treat obesity. (Credit: Tumisu from Pixabay.)

Boehringer Ingelheim has entered into a new research and licensing agreement with biotech company Gubra to identify and validate innovative peptides to treat obesity.

The new partnership builds upon the companies’ previous successful relationship and combines Gubra’s streaMLine platform with Boehringer Ingelheim’s lead optimisation and clinical development expertise.

The agreement further expands Boehringer Ingelheim’s research into approaches with first in class potential for obesity treatment.

Under the partnership, Gubra is responsible for the early discovery activities.

Boehringer Ingelheim will further develop the projects and bring promising candidates into non-clinical and clinical development.

Gubra CEO Henrik Blou said: “Over the past four years our two companies have built a strong drug discovery relationship. In this third collaboration, Gubra is responsible for the early discovery of peptides – now applying our proprietary target and drug discovery platform streaMLine.

“After initial maturation, projects are handed over for further development to Boehringer Ingelheim. This approach, we believe, has the potential to take obesity treatment to the next level for the benefit of patients around the world.”

According to Boehringer Ingelheim, approximately half of the US population is estimated to have obesity by 2030.

Obesity is a complex chronic disease which requires long-term management and is among the leading risk factors for several cardio-metabolic diseases including heart disease, ischemic stroke, liver diseases.

With growing global prevalence, the disease has limited treatment options which are also not sufficiently effective or are associated with adverse events.

Gubra and Boehringer Ingelheim share the goal to provide new obesity therapies with increased tolerability which support greater weight loss compared to therapy options that are currently available.

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EMA validates Pfizer and OPKO’s somatrogon marketing application for review

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The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for Pfizer and OPKO’s somatrogon, for review.

The European Medicines Agency has validated for review the marketing authorization application for Pfizer and OPKO’s somatrogon. (Credit: Coolcaesar/Wikipedia.org.)

The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for Pfizer and OPKO’s somatrogon, for review.

Somatrogon is a long-acting human growth hormone (hGH) molecule, which is intended to be injected once-weekly for the treatment of paediatric patients with growth hormone deficiency (GHD).

GHD is a rare disease which is identified by the inadequate secretion of growth hormone from the pituitary gland and affects one in about 4,000 to 10,000 people.

The molecule consists of the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) of the human chorionic gonadotropin hormone.

Pfizer Global Product Development Rare Disease chief development officer Brenda Cooperstone said: “If approved in the EU, somatrogon will represent an important advancement, as this long-acting, weekly treatment may reduce the burden of daily injections on children, their loved ones, and caregivers.

“We look forward to continuing to work with the EMA to evolve the treatment paradigm for pediatric patients with growth hormone deficiency.”

The latest MAA submission is supported by the results of Phase III safety and efficacy evaluation of somatrogon injectable once-weekly to paediatric patients with GHD.

The randomised, open-label, active-controlled study was conducted in more than 20 countries.

If approved by European Commission, which is expected in 2022, somatrogon will serve as a once-weekly treatment option for GHD.

The company noted that somatrogon was well tolerated during the study compared to that of GENOTROPIN (somatropin) injected once-daily with respect to the types, numbers and severity of the adverse events observed between the treatment arms.

Pfizer and OPKO signed a worldwide agreement in 2014 to develop and commercialise somatrogon.

OPKO agreed to conduct the clinical programme and Pfizer is responsible for registering and commercialising the product.

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Merck signs agreement to purchase Pandion Therapeutics

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World’s leading biopharmaceutical firm Merck has announced that it has entered into a definitive agreement to purchase Pandion Therapeutics through a subsidiary, for a total equity value of about $1.85m.

The office of Merck, located in Upper Gwynedd Township, Montgomery County, Pennsylvania. Credit: Montgomery County Planning Commission

Biopharmaceutical firm Merck has announced that it has entered into a definitive agreement to purchase Pandion Therapeutics through a subsidiary, for a total equity value of about $1.85m.

Through its subsidiary, Merck will initiate a tender offer to acquire all outstanding Pandion shares, under the terms of the acquisition agreement. The tender offer closes subject to certain conditions. Merck’s subsidiary will be merged into Pandion once the tender offer is completed successfully. Close of transaction is expected to occur in the first half of 2021.

Clinical-stage biotechnology company Pandion develops novel therapeutics that are designed to address the unmet needs of patients suffering from autoimmune diseases.

Merck Research Laboratories president Dean Y. Li said: “This acquisition builds upon Merck’s strategy to identify and secure candidates with differentiated and potentially foundational characteristics. Pandion has applied its TALON technology to develop a robust pipeline of candidates designed to re-balance the immune response with potential applications across a wide array of autoimmune diseases.”

Pandion is developing precision immune modulators that target critical immune control nodes. Heading this strike force is Pandion’s lead candidate PT101, an engineered IL-2 mutein fused to a protein backbone.

PT101 selectively activates and expands regulatory T cells (Tregs) and can be utilised for the potential treatment of ulcerative colitis and other autoimmune diseases.

Pandion announced earlier this year that PT101 had completed a Phase 1a clinical trial, achieving its primary objective of safety and tolerability.

Pandion Therapeutics CEO Rahul Kakkar said: “Pandion grew out of our founders’ personal and scientific mission to change the way patients living with autoimmune diseases are treated. In just a few years, we have taken that mission from idea to clinical proof of mechanism with PT101, our lead IL-2 mutein. We are proud that Merck has recognised our team’s innovation and drive in creating a pipeline of diverse candidates that activate natural immune regulatory mechanisms and thereby have the potential to achieve better clinical responses for patients.

“We believe Merck is well positioned to bring our novel approach to the millions of those living with autoimmune diseases, and we look forward to seeing these molecules progress in the clinic.”

Merck’s financial advisor is Credit Suisse Securities (USA) LLC, while its legal advisor is Covington & Burling LLP.

Pandion’s financial advisor is Centerview Partners LLC, while Skadden, Arps, Slate, Meagher & Flom LLP acted as legal advisor.

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Moderna to boost global Covid-19 vaccine manufacturing capacity

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Moderna has announced plans to increase its global manufacturing capacity for Covid-19 vaccine by making additional capital investments.

Moderna plans to increase global 2022 capacity to about 1.4 billion doses of Covid-19 vaccine at 100μg dose. (Credit: Marco Verch Professional Photographer.)

Moderna has announced plans to increase its global manufacturing capacity for Covid-19 vaccine by making additional capital investments.

The investments will be made at the company’s owned and partnered manufacturing facilities and will increase global capacity for next year to approximately 1.4 billion doses at 100μg dose.

Enabling additional production of existing Moderna Covid-19 Vaccine, the investments will also allow the production of vaccine boosters which would be needed to address the emerging variants of SARS-CoV-2.

Moderna estimates that it would take about 12 months to make the additional production available.

Moderna CEO Stephane Bancel said: “We believe from our discussions with governments around the world that there will continue to be significant demand for our COVID-19 vaccine and we now are committed to materially increasing our manufacturing capacity.

“Because of the high efficacy of our COVID-19 vaccine and our ability to quickly develop variant vaccines to help boost the immune system of vaccinees, there is increased demand.

“We are investing in this additional capacity to help us increase production and allow for flexibility in manufacturing potential vaccine boosters to address emerging variants of the virus.”

The company is also set to increase base plan for this year to manufacture 700 million doses globally and is exploring other approaches to improve its throughput.

Moderna plans to potentially supply nearly one billion doses this year by optimising its operations.

It the company’s variant vaccine booster needs a less dose, such as 50μg, it could deliver more than two billion doses next year.

For this, Moderna plans to study a dose range of 50μg and lower for variant-based boosters and an additional booster of mRNA-1273. If this is successful, the company can supply more than 1.4 billion doses next year.

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ViiV Healthcare seeks USFDA approval to expand Cabenuva use for HIV-1 infected adults

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Specialist HIV company ViiV Healthcare has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) to expand the use of Cabenuva.

ViiV Healthcare seeks USFDA approval to expand use of Cabenuva to every two-month dosing. (Credit: Darwin Laganzon from Pixabay.)

Specialist HIV company ViiV Healthcare has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) to expand the use of Cabenuva.

Cabenuva is a complete long-acting regimen to treat HIV-1 infected adults and consists of two separate injectable medicines, Janssen Sciences’ rilpivirine and ViiV Healthcare’s cabotegravir.

It helps to replace the current antiretroviral regimen in people who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen without any known or suspected resistance to either cabotegravir or rilpivirine.

The sNDA is to expand the Cabenuva’s label to include administration every two months dosing to treat HIV-1 infection in virologically suppressed adults.

Last month, the FDA has approved Cabenuva as a once-monthly, long-acting regimen for the treatment of HIV-1 infection in virologically suppressed adults.

An oral dosing of cabotegravir and rilpivirine should be administered for about one month, before initiating the treatment of Cabenuva, to assess the tolerability of each therapy.

ViiV Healthcare Research and Development head Kimberly Smith said: “Today’s submission of Cabenuva dosed every 2-months marks another meaningful step forward in our ongoing commitment to bring innovative HIV treatments to the community.

“This first-of-its-kind regimen reflects the evolving needs of people living with HIV, and, if this expanded use is approved, could allow adults living with HIV to maintain virologic suppression with six dosing days per year.

“At ViiV Healthcare, we will continue to advance new approaches to care as part of our mission of leaving no person living with HIV behind.”

The company stated that the submission of application is based on the pivotal Phase 3b ATLAS-2M (Antiretroviral Therapy as Long-Acting Suppression) study results, which showed the similar safety of taking Cabenuva every 2-months when compared to once monthly administration.

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UCB expands partnership with Microsoft to speed up drug development

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Belgium-based biopharmaceutical firm UCB has expanded its collaboration with technology company Microsoft to accelerate discovery and development of drugs for people living with severe diseases in immunology and neurology.

Microsoft’s platform helps UCB’s scientists and data scientists to analyse data sets or multi-modal unstructured information to discover new medicines. (Credit: Coolcaesar.)

Belgium-based biopharmaceutical firm UCB has expanded its collaboration with technology company Microsoft to accelerate discovery and development of drugs for people living with severe diseases in immunology and neurology.

As part of a new multi-year strategic collaboration, Microsoft’s computational services, cloud, and artificial intelligence (AI) will be combined with UCB’s drug discovery and development capabilities.

UCB stated that Microsoft’s platform helps its scientists and data scientists to analyse high-dimensional data sets or multi-modal unstructured information to discover new medicines more efficiently and innovatively.

The collaboration builds on work UCB completed along with Microsoft on the COVID Moonshot project, a worldwide open-science project.

UCB CEO Jean-Christophe Tellier said: “By amplifying the power of scientific innovation through digital transformation, we hope to have a better understanding of what makes a patient’s journey unique so that we can provide personalised and differentiated medicine in a sustainable way.”

The two companies are planning to explore the combination of diverse research data sets while improving a patient’s overall journey, increasing the treatment impact, providing better research data-driven insights and accelerating clinical development timelines.

Microsoft Global Sales, Marketing & Operations executive vice-president and president Jean-Philippe Courtois said: “Together, UCB and Microsoft are taking on some of healthcare’s greatest challenges to find connected, innovative ways to create better experiences, insights, and more personal and more effective care.

“With the deep knowledge that UCB offers in drug discovery and the knowledge of human biology, together with Microsoft’s unmatched expertise in computer science and AI, we have a unique opportunity to reinvent the way new medicines are created.”

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USFDA accepts priority review for Pfizer’s TicoVac

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Pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for priority review for TicoVac, a tick-borne encephalitis (TBE) vaccine.

Pfizer said that TicoVac will help reduce the risk of TBE virus for adults and children who are travelling to or living in endemic areas. (Credit: Coolcaesar/Wikipedia.org.)

Pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for priority review for TicoVac, a tick-borne encephalitis (TBE) vaccine.

This vaccine is for active immunisation to prevent TBE in individuals aged one year and older.

TBE is a viral infection that affects the brain and spine, and is transmitted to humans mostly through infected tick bites. It also infects humans, although less frequently, by ingestion of unpasteurised milk or milk products from infected animals.

Pfizer noted that the ticks infected with the TBE virus have been identified in over 35 countries across Europe and Asia until now.

Currently, the TBE vaccination has been recommended by the European Centre for Disease Prevention and Control (ECDC) for people who live in or are travelling to these risk areas.

If approved, TicoVac will be the first vaccine in the US, which would help reduce the risk of TBE virus for adults and children travelling to or living in endemic areas; including military personnel posted in these locations.

Pfizer Vaccines global president Nanette Cocero said: “For many years, our TBE vaccine has helped protect millions of people in Europe from this potentially serious disease.

“We are proud that today’s US FDA Priority Review acceptance acknowledges the potential value that our vaccine candidate can bring.

“If approved in the US, we hope this vaccine will help protect those traveling to or residing temporarily in at-risk locations, potentially including military personnel who are serving overseas.”

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AstraZeneca withdraws Imfinzi indication in US for bladder cancer

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AstraZeneca has voluntarily withdrawn the Imfinzi (durvalumab) indication for adult patients who received treatment earlier in the US for locally advanced or metastatic bladder cancer.

AstraZeneca has voluntarily withdrawn Imfinzi (durvalumab) indication for bladder cancer. (Credit: D Wells/Wikipedia.org.)

AstraZeneca has voluntarily withdrawn the Imfinzi (durvalumab) indication for adult patients who received treatment earlier in the US for locally advanced or metastatic bladder cancer.

The company has made this decision for withdrawal in consultation with the US Food and Drug Administration (FDA).

AstraZeneca’s Imfinzi is a human monoclonal antibody which binds to PD-L1 and blocks its interaction with PD-1 and CD80, thereby countering the immune-evading tactics of the tumour and releasing the inhibition of immune responses.

The antibody secured an accelerated approval from FDA in May 2017 depending on the tumour response rates as well as the duration of response data from Study 1108, a Phase I/II trial.

This trial evaluated the safety and efficacy of Imfinzi in advanced solid tumours, including previously treated bladder cancer.

Continued approval of the antibody was dependent on the DANUBE Phase III trial results in the first-line metastatic bladder cancer setting, which failed to meet its primary endpoints last year.

Imfinzi’s withdrawal aligns with FDA guidance to evaluate indications with accelerated approvals which it did not meet post-marketing requirements, as part of a broader evaluation across the industry.

AstraZeneca stated that the withdrawal does not affect the other approved Imfinzi indications within or outside the US.

AstraZeneca Oncology Business Unit executive vice-president Dave Fredrickson said: “The science of immunotherapy has moved swiftly over the past few years, bringing new options to patients at an unprecedented pace.

“While the withdrawal in previously treated metastatic bladder cancer is disappointing, we respect the principles FDA set out when the accelerated approval pathway was founded and remain committed to bringing new and innovative options to patients.

“In the last three years, Imfinzi has become an important standard of care in multiple lung cancer settings, an area of considerable focus for AstraZeneca.”

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Dynavax secures EC marketing authorisation for hepatitis B vaccine

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Biopharmaceutical company Dynavax Technologies (DVAX) has secured marketing authorisation from the European Commission (EC) for Heplisav B, a two-dose adult hepatitis B adjuvanted vaccine.

EC grants marketing authorisation for Heplisav B vaccine. (Credit: EmDee/ wikipedia.)

Biopharmaceutical company Dynavax Technologies (DVAX) has secured marketing authorisation from the European Commission (EC) for Heplisav B, a two-dose adult hepatitis B adjuvanted vaccine.

The vaccine is used for the active immunisation against hepatitis B virus infection (HBV), which is caused by all known subtypes of hepatitis B virus in adults aged 18 years and above.

Heplisav B combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist adjuvant CpG 1018 to improve the immune response.

The approval from EC follows the recommendation for marketing authorisation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

It was based on the positive benefit-risk for the vaccine demonstrated by the safety and immunogenicity results of three Phase III clinical trials.

Dynavax CEO Ryan Spencer said: “Hepatitis B is a highly infectious and potentially deadly virus with increasing infection rates, and over 250 million people infected worldwide. Thankfully, it can be prevented with effective vaccination.

“With a two-dose regimen that takes only one month to complete and a statistically significantly higher seroprotection rate in head-to-head clinical trials, HEPLISAV B provides a unique opportunity to address known challenges with compliance, while delivering higher levels of protection compared to the three-dose regimen of the comparator vaccine.

“We are pleased that HEPLISAV B has received this latest approval and look forward its launch in Europe expected later this year.”

As per the EC marketing authorisation approval, Heplisav B can be sold in all EU as well as EEA-European Free Trade Association (EFTA) states including Norway, Iceland and Liechtenstein.

The company stated that the new vaccine is now approved in the US and EU.

USFDA grants FTD to efanesoctocog alfa for hemophilia A treatment

Fast Track Designation is a process for facilitating the development and expediting the review of drugs to treat serious medical conditions. The novel and investigational factor VIII therapy

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