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A report launched by pharmaceutical company Takeda UK reveals that, despite heightened public and media attention on the industry’s efforts to develop vaccines and treatments, the COVID-19 pandemic has had little positive impact on perceptions of pharmaceutical companies.

The Pharma: Repurposed report explores the importance of ‘purpose’ to the pharmaceutical industry and provides recommendations on how the sector can convey a stronger purpose to build trust and ultimately improve the lives of patients.

For the report, Takeda UK commissioned Ipsos MORI to conduct online interviews among adults ages 16-75 from the United Kingdom. A total of 1104 interviews were conducted in October 2020 and key findings include: Only 17% of respondents said their impression of pharmaceutical companies had improved, based on how the industry had reacted to the coronavirus pandemic over the previous six months. Over half (54%) said their impression had stayed the same and 16% said their impression had got worse.

The pandemic has had a positive impact on UK adults’ perceptions of healthcare professionals, with 44% of respondents saying their impression had improved. In contrast, UK adults’ impression of politicians has got markedly worse, with 51% of respondents saying their opinion of government ministers had worsened over the last six months.

When respondents were asked to express their opinion on a range of organisations and roles within the sector, just 38% had a total favourable opinion of pharmaceutical companies.

As per the survey, Over a third of respondents (36%) had neither a favourable nor unfavourable view of the pharmaceutical sector, suggesting that the industry has more work to do to engage the public with its role and activities. The survey revealed a high total favourable result for healthcare professionals (74%), and for healthcare charities (58%). Scientists within the pharmaceutical industry (53%) were also well regarded.

Total unfavourable views of Government ministers stood at 55% and other politicians at 54%. Less than half (48%) of respondents trust the pharmaceutical industry to act in the best interest of society. In contrast, 82% of respondents trust healthcare professionals to act in society’s best interests and over 70% trust healthcare charities to do so.

Jon Neal, MD UK and Ireland at Takeda, said: “The pharmaceutical industry has faced several reputational challenges over the years. However, perhaps now more than ever, the development of new treatments relies on cross-sector collaborations and public trust and willingness to engage with the sector. Therefore, we need to address perceptions of the industry to improve the future of healthcare and ultimately save lives.

“We hope this report will lead to further discussion about how the industry can convey a stronger purpose to build trust with both patients and other healthcare organisations. Employees in pharma companies such as Takeda are completely committed to improving the lives of patients and yet this research shows our commitment to patients and our purpose is not widely understood or accepted. We need to do more and I hope this report will lead to further discussion and opportunities to work with others from across the industry to increase understanding of our role in society and how we operate.”

Ben Page, Chief Executive of Ipsos MORI, commented: “Our research with Takeda suggests that the public have a higher opinion of roles or organisations that articulate a strong purpose around their role in and value to society. The pharmaceutical industry has historically struggled to clearly articulate what it does and what it stands for. If the sector wants to better connect with the public, it needs to start talking much more openly about its activities and values.

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US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 12 to 1 that the data presented support the use of Entresto® (sacubitril/valsartan) in treatment of patients with heart failure with preserved ejection fraction (HFpEF). This was based on data supporting the benefit of Entresto in reducing worsening heart failure (total heart failure [HF] hospitalizations and urgent HF visits) in patients studied in PARAGON-HF. If approved by the FDA, Entresto could become the first therapy indicated for use in treatment of patients with HFpEF, as well as the first medication approved for both major types of chronic heart failure, HFpEF and heart failure with reduced ejection fraction (HFrEF), both based on trials that included active comparators (valsartan and enalapril, respectively).

With no approved therapies for HFpEF to address the prevention of HF hospitalizations and urgent visits, a significant unmet medical need exists for a treatment to reduce the burden associated with this debilitating condition. The FDA is expected to make a decision on the supplemental New Drug Application (sNDA) in the first quarter of 2021.

“Managing HFpEF has historically been a clinical and scientific challenge due to the heterogeneity of the condition,” said Scott Solomon, MD, Professor of Medicine at Harvard Medical School and Brigham and Women's Hospital, and PARAGON-HF Executive Committee Co-Chair. “Today’s vote represents much needed progress in this area of unmet need and is a positive step toward bringing a potential therapy to millions of patients suffering from this type of heart failure.”

The Committee’s positive decision is based on the totality of evidence from efficacy and safety analyses, including findings presented from a pre-specified subgroup analysis of PARAGON-HF, the largest and only Phase III active-controlled study to date in patients with HFpEF and additional evidence from PARAMOUNT (a Phase II trial in HFpEF), as well as PARADIGM-HF (a Phase III trial in HFrEF). Data from PARAGON-HF demonstrated a favorable safety profile for Entresto in patients with HFpEF, which is in line with the vast clinical and post-marketing experience in HFrEF, and showed clinical benefit of Entresto in HFpEF patients.

“Our commitment to reimagine medicine through our extensive clinical trials program on heart failure has been unwavering, and we are encouraged by the Committee’s response today,” said David Soergel, MD, Global Head of Cardiovascular, Renal and Metabolic Drug Development, Novartis. “We appreciate the valuable insights shared by the patient and advocacy community about this devastating disease, and we look forward to FDA’s decision on the potential approval of this new indication.”

HFpEF affects more than 3 million Americans, and is increasing in prevalence as the population ages. It is a complex disease for which it is difficult to develop treatments due to its heterogeneous pathophysiology and the varied impact of symptoms among patients, despite decades of research. HFpEF can change the structure of the heart and occurs when the muscle tissue of the heart thickens and stiffens so that it cannot expand to fill with enough blood to meet the body’s needs. HFpEF is associated with high rates of recurring heart failure hospitalizations, emergency room visits and urgent doctor’s office appointments. Each hospitalization event is associated with worsening long-term prognosis, and approximately one in four patients are re-admitted for heart failure within one year of discharge.

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Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 200 μg/50 mL and 400 μg/100 mL Single Dose flexible containers (Bags).

Aurobindo’s Dexmedetomidine HCl in 0.9% Sodium Chloride Injection is a therapeutic equivalent generic version of Hospira’s Precedex® in 0.9% Sodium Chloride Injection. The product will be launched in January 2021.

Dexmedetomidine Hydrochloride in 0.9% sodium chloride injection is a relatively selective alpha2 -adrenergic agonist indicated for a) sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting; b) sedation of non-intubated patients prior to and/or during surgical and other procedures. The approved product has an estimated market size of US$ 228 million for the twelve months ending October 2020 according to IQVIA.

This is the 79th ANDA to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing injectable & ophthalmic products. Aurobindo now has a total of 459 ANDA approvals (431 Final approvals and 28 tentative approvals) from USFDA.

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The Russian Direct Investment Fund, (RDIF) Russia’s sovereign wealth fund, announces RDIF. Healthcare – an investment channel with a strategic focus on the implementation of projects in the healthcare sector. The fund has formed a specialized team of healthcare professionals to lead in developing the channel.

RDIF has been actively involved in fighting COVID-19 through working on healthcare projects. Before the pandemic, a number of healthcare projects have been launched as part of the fund’s investment strategy aimed at improving general quality of life. Further development of healthcare investment is the next stage in the process.

Regarding this, RDIF announces the appointment of Nina Kandelaki as a Director at RDIF. Healthcare. Mrs Kandelaki joined RDIF from GE Healthcare, one of the leading manufacturers of medical equipment globally, where she held a position of Regional Manager for Russia and the CIS.

Nina Kandelaki will lead a team of top-tier international healthcare professionals at RDIF, who have been tasked to develop existing initiatives and launch new investment projects in this strategic area.

Since the start of 2020, RDIF has focused its efforts on three key areas in fighting COVID-19: testing systems, treatment drugs and a vaccine. Thanks to an international partnership network and accumulated internal expertise, RDIF has achieved great results in all the three areas.

RDIF started production (from scratch) of a unique Russian-Japanese COVID-19 diagnostics system called EMG, which provides highly-accurate results in 30 minutes, both in stationary laboratories as well as in mobile mini-labs, which does not have an international equivalent. Thanks to the EMG diagnostics system, Russia has become one of the global leaders in terms of the number of COVID-19 tests conducted.

Together with ChemRar Group, one of the leaders in the Russian pharmaceuticals industry, RDIF launched mass production of Avifavir, one of the two registered COVID-19 drugs in the world. Avifavir has already been supplied to 15 countries.

Together with The National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya (the Gamaleya Center), RDIF is developing industrial production of Sputnik V, the world’s first registered vaccine against coronavirus based on the well-studied platform of human adenoviral vectors. Based on the analysis of data obtained from 18,794 clinical trial volunteers 28 days after administering the first dose (7 days after the second dose), the efficacy of the Sputnik V vaccine is 91.4%. Requests for more than 1.2 billion doses of Sputnik V vaccine have already been received from over 50 countries.

These investments have been made possible thanks to RDIF’s previous experience in the implementation of the following projects:
• Mother and Child’s network of clinics and hospitals and the company’s transformation into the leading private medical company in Russia;
• Russia’s first public-private partnership project in nuclear medicine;
• Reorganization and expansion of Russia’s leading pharmaceutical companies Gerofarm, R-Farm and Alium;
• The launch of Doctis, an online medical services platform, and its development into a key player in Russia’s booming online medical services market;
• Investments in AST, a developer of surgical robots based on artificial intelligence (AI);
• Investment in Motorica, Russia’s leading developer and producer of prostheses which incorporate artificial intelligence (AI)

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, commented:
“In working on projects focused on fighting the COVID-19 pandemic, we saw huge demand for new investments in the healthcare sector in Russia and all over the world. These investments will help us defeat the current pandemic we are facing in the near term, but also to provide a platform for us to be better prepared to deal with potential threats to human health in the more distant future. We are ready to form new partnerships and provide investments in telemedicine, production of new drugs, treatment of oncological diseases, research and production of new vaccines, as well as education of doctors and medical workers. RDIF has formed a new team of market-leading professionals with experience of working in international markets. Soon, the share of healthcare investments in RDIF’s portfolio will reach 15%, and the total number of customers being serviced by the companies in RDIF’s healthcare portfolio will reach 20 million people”.

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Zydus Cadila announced that it had received an approval from the Drugs Controller General of India (DCGI) to start the Phase 3 clinical trial in CoVID-19 patients with its biological therapy, Pegylated Interferon alpha-2b, ‘PegiHepTM’. The trials which will commence in December will be conducted on 250 patients across 20-25 centres in India. In the Phase II clinical trials study established the early safety, efficacy and tolerability of PegiHep TM and has indicated that Pegylated Interferon alpha-2b having statistical clinical beneficial impact on the patient suffering from moderate COVID 19 disease by reducing their viral load helping in better disease management such as reduced duration of oxygen support. Moreover, a single dose therapy will improve compliance and also make it highly affordable for patients. Pegylated Interferon alpha-2b, ‘PegiHepTM is an approved drug and is being re-purposed for the treatment of COVID-19.

Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said, “We are encouraged by the results of Phase II study of Pegylated Interferon alpha 2-b which has shown the potential to reduce virus titres when given earlier in the disease. Our efforts are to look at possible treatment options to fight COVID-19 which are safe, can be administered easily and also reduce the disease burden.”

In the Phase 2 clinical trial which was open-label, randomized, comparator controlled study, involving 40 adult patients with moderate COVID-19 disease, 95% subjects in the test arm who received a single dose of PegiHepTM along with the Standard Of Care (SOC), became virus free as assessed by RT-PCR on day 14 and showed a statistically significant clinical improvement over the patients in the reference arm, who received only the standard of care and where only 68% patients showed an improvement in clinical symptoms and became RT-PCR negative.

In the test arm 16 subjects were RT-PCR negative as early as day 7 of treatment which was an improvement over the reference arm. Clinical improvement was assessed using a seven point ordinal scale where the patients were assessed on multiple criteria such as requirement and duration of hospitalization, ventilation, supplemental oxygen etc.

Zydus Cadila is also conducting a similar Phase 2 trial in Mexico. The Company is also working with the USFDA to open an Investigational New Drug (IND) application for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in US.

Pegylated Interferon alpha-2b is not a new therapy. The product was first approved internationally in 2001 and is also included in WHO’s Essential Medicines List. Zydus Cadila’s Pegylated Interferon alpha-2b, PegiHepTM, was originally approved for Hepatitis C and was launched in the Indian market in 2011. Since then safe and efficacious drug use for this product has been demonstrated in thousands of patients. Given that type I interferons including Interferon alpha have been implicated as crucial in the protection against SARS-CoV-2 in the recent publications in the leading journal Science (Hadjadj et al, Bastard et al and Zhang et al), the findings in Zydus Cadila’s Phase 2 study are not surprising. In this study, a single dose of PegiHep at 1 mcg/kg body weight was tested to find out whether the drug could be repurposed for treating moderate COVID-19 patients. In 19 out of 20 patients, a single 1 mcg/kg dose of the drug demonstrated viral clearance as assessed by RT-PCR and a significant improvement in clinical symptoms.

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Dr. Reddy’s Laboratories Ltd and Russian Direct Investment Fund (RDIF) announced today that they have commenced adaptive phase 2/3 clinical trials for Sputnik V vaccine in India after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli, India. This will be a multicenter and randomized controlled study, which will include safety and immunogenicity study.

The clinical trials are being conducted by JSS Medical Research as the clinical research partner. Further, Dr. Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support and to use BIRAC’s clinical trial centres for the vaccine.

Recently, RDIF announced the second interim analysis of clinical trial data, which showed 91.4% efficacy for the vaccine on day 28 after the first dose; vaccine efficacy over 95% 42 days after the first dose. Currently, 40,000 volunteers are taking part in Phase III of Sputnik V clinical trials, out of which over 22,000 have been vaccinated with the first dose of the vaccine and more than 19,000 - with both the first and second doses of the vaccine.

G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories said, “This is another significant step as we continue to collaborate with multiple entities along with the government bodies to fast-track the process for launching the vaccine in India. We are working towards making the vaccine available with a combination of import and indigenous production model.”

In September 2020, Dr. Reddy’s and RDIF entered into a partnership to conduct clinical trials of the Sputnik V vaccine and the rights for distribution of the first 100 million doses in India.

On August 11,2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the World’s first registered vaccine against COVID-19 based on the human adenoviral vector platform.

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Pharma major Lupin Limited (Lupin) announced that it has received approval for its Penicillamine Tablets USP, 250 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Depen® Tablets, 250 mg, of Mylan Specialty, L.P. The product would be manufactured at Lupin’s Nagpur facility and is expected to be launched shortly.

Penicillamine Tablets USP, 250 mg, are indicated in the treatment of Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.

Penicillamine Tablets USP (RLD: Depen®) had an annual sales of approximately USD 4 million in the U.S. (IQVIA MAT September 2020).

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Alembic Pharmaceuticals Limited (Alembic) announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received tentative approval from the US Food & Drug Administration

USFDA approved for its Abbreviated New Drug Application (ANDA) for Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation). The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), AndroGel 1.62%, of AbbVie Inc. (AbbVie).

Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired).

Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) has an estimated market size of US$ 107 million for twelve months ending September 2020 according to IQVIA.
Alembic has a cumulative total of 136 ANDA approvals (117 final approvals and 19 tentative approvals) from USFDA.

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