Pfizer and Lilly claim win for NGF pain drug in osteoarthritis

Pfizer and Eli Lilly’s nerve growth factor (NGF) inhibitor tanezumab has inched closer to becoming the first alternative to opioid analgesics for severe pain after hitting the mark in a phase 3 trial.

Two subcutaneous doses of tanezumab—given eight weeks apart—met all the objectives in the trial in patients with osteoarthritis pain, significantly improving pain, physical function and patients’ assessment of their symptoms compared to placebo over the 16-week study.

It’s an important win for the drug, which was held back for years in development by concerns over NGF inhibitor safety, and particularly accelerated joint destruction that required replacement surgery in some cases. That resulted in the FDA applying a clinical hold on NGF drugs in 2012 that wasn’t relaxed until 2015.

Pfizer and Lilly say safety data from the phase 3 trial showed that rapidly progressive osteoarthritis was seen in “less than 1.5%” of tanezumab-treated patients and wasn’t observed in the placebo group, and there were no cases of bone destruction or osteonecrosis—another toxicity previously linked to NGF drugs.

The results keep the two partners on course for a filing in 2019 and represent an important milestone for the NGF field given that Regeneron halted some arms in its phase 3 program for NGF rival fasinumab in osteoarthritis in May after the independent data monitoring committee called the risk-benefit profile of the drug at higher doses unfavorable.

Meantime, another NGF inhibitor—Amgen’s fulranumab—seems to have been shelved after former partners Johnson & Johnson and Takeda both handed rights to the drug back in 2016, while AbbVie also gave up on its candidate earlier in the decade.

Pfizer and Lilly’s persistence with the project over many years may be about to pay off, assuming their big phase 3 program, including six studies across osteoarthritis, chronic low back pain and cancer pain, continues to deliver results. The high-risk gamble has a big prize in the offing, given the pressing need for nonopioid drugs for severe and chronic pain without the addictive properties and side effects of opioid painkillers. The U.S. is currently in the grip of an opioid addiction epidemic, with an estimated 11.5 million people misusing these drugs, according to Department of Health and Human Services (DHHS) data. It’s widely thought that an effective nonopioid drug for severe, chronic pain could quickly become a blockbuster and, prior to the FDA’s clinical hold, analysts had predicted that NGF inhibitors could become an $11 billion product category in their own right.

Pricing will of course be an issue given that current opioid analgesics are very cheap; however, it’s worth noting that opioids often don’t work very well in challenging indications like osteoarthritis. That’s one reason Pfizer and Lilly picked up fast-track status from the FDA for tanezumab last year for osteoarthritis and chronic low back pain.

Link: https://www.fiercebiotech.com/

The European Federation of Pharmaceutical Industries and Associations statement on antimicrobial resistance problem

The European Federation of Pharmaceutical Industries and Associations (EFPIA) strongly welcomes the approval of their own initiative report on “A European One Health Action Plan against Antimicrobial Resistance” by the Environment, Public Health and Food Safety (ENVI) Committee of the European Parliament on the 20th June 2018.

The Committee of the European Parliament appeals to the European Commission and the Member States encouraging them to support and adopt new economic models and experimental pilot projects so that to stimulate the development of new antimicrobials, vaccines and rapid diagnostic tests. These aspects are the main measures that should be taken to effectively combat with antimicrobial resistance.

Therefore, EFPIA and its’ members especially support any activities which aim to boost the development of new antimicrobial drugs, vaccines and rapid diagnostic tools. The Federation is positive that European policy makers should work in conjunction with public and private researchers in order to find ways to increase the number of antimicrobials under development.

It is pointed out in the report that correct and prudent use of antimicrobials is crucial for controlling the resistance. They also do believe that the European Commission should manage and share practical guidelines among Member States and stimulate EU countries to implement resolute national strategies against antimicrobial resistance.

The ENVI Committee is calling the European Commission and EU members to join their efforts together and coordinate monitoring and reporting of any new information on antimicrobial resistance problem.

 

Link: EFPIA

In Europe withdraw some drugs valsartan because of security issues

The European medicines Agency (EMA) is examining medicines containing valsartan supplied by one of the companies in China, after they have been detected by an impurity that potentially causes cancer, according to PharmaTimes.

Chinese company Zhejiang Huahai was found N-nitrosodimethylamine (NDMA) in some batches of the active substance (API) valsartan, supplied to a number of manufacturers of valsartan drugs, circulating in the EU market.

These drugs are used in patients with high blood pressure to prevent heart attack and stroke, as well as in patients with heart failure or who have experienced acute coronary syndrome.

According to the EMA experts, the presence of NDMA in the active substance, which is a potential carcinogen, was a surprise. The reason for the appearance is associated with a change in the production process of API.

Currently, drugs delivered by the company Zhejiang Huahai containing valsartan, Supervisory authorities revoked Tran the EU. In parallel with this, analyzes of the NDMA content in the drugs begin.

Source: pharmvestnik.ru

X7 Research takes part in the DIA 2018

Colleagues, X7 Research company takes part in the five-day conference “DIA 2018 Global Annual Meeting”, which will be held from June 24 to 28, 2018, in Boston Convention & Exhibition Center, 415 Summer Street, Boston, USA.

Designed to drive insights into action by connecting key policy discussions to real-world knowledge that you need to do your job every day, your attendance will accelerate your growth and your organization’s performance in the development ecosystem. Sessions will include distinguished speakers and expert panelists from regulatory, industry, patient advocacy, and academia. Engage with global decision-makers and influencers in the biotechnology hub of 2018 that you would not otherwise have access to. Advance healthcare product development globally and grow your career while doing so.

More information you can find by clicking on the link on the official website.

Contact us by email info@x7research.ru. We will be glad to see you at this event!

X7 Research cooperates with universities, providing internships to foreign students

Colleagues, X7 Research has been having international students of Moscow International University and The Herzen State Pedagogical University of Russia interning at our offices in Saint Petersburg and Moscow.

At our offices, interns are having hands on experience in training, medical writing, consulting and marketing. During their time at X7 Research interns are an integral part of our daily business by being put in a position where their past knowledge and experience are being put at work while simultaneously gaining a valuable work experience in a different language and culture. Student-interns excel in their knowledge of business Russian language and all other fields of our services that they are interested in.

Moscow International University was opened in the capital of Russia in 1991 and is an established educational institution for many domestic and international students pursuing a degree in law, journalism, languages and management to name a few.

The Herzen State Pedagogical University of Russia (Herzen University) is one of the oldest educational institutions in the country, located in the heart of Saint Petersburg. Founded in 1797 by Emperor Paul I, today the university welcomes students to 57 educational programs from all over the world.

Thus, X7 Research team through internships helps to develop the necessary practical skills, which will later be useful for graduates in their work and promotion on the career ladder. We are happy to continue being a great place for all international students looking for a valuable experience while studying at one of the top Russian universities.

Development of a universal shot against influenza

Imutex has reported their phase 2b data of their universal flu shot “FLU-v” showing strong signs of boosting immune responses while simultaneously lowering rate of infection. This true “universal” shot is designed to protect against all influenza A and influenza B strains in humans and animals.

Imutex, now a well established joint venture between clinical research specialist “hVIVO” and drug development organization “SEEK Group” has their team working on its universal flu vaccine candidate for the past 14 years, as Gregory Stoloff CEO of “SEEK Group” reported to FiercePharma. Giving the urgency for better flu shots, U.S. and Europe have helped fund this phase 2 work, and at this pace, the vaccine should be on the market in 2 years. Before that, testing needs to proceed to phase 3, for which Stoloff added their team is ready to head into and are in discussions with Big Pharma players seeking a partnership for a more efficient testing giving that a large drug maker would already have late-stage testing capabilities well established.

Such a vaccine would create quite a market, as it would serve as a global vaccine for a target population of 7 billion people generating $10 billion to $20 billion annually over a period of 20 years. After the reported 2b data results hVIVO share prices have doubled, which comes at no surprise giving that many other companies including global giants Sanofi and Johnson & Johnson, are also working on advancing flu vaccine technology.

Source: Fiercepharma.

X7 Research will take part in the practical forum “Clinical Trials in the EAEU 2018”

Colleagues, X7 Research company is going to visit the two-day conference “Clinical Trials in the EAEU 2018”, which will take place from 21 to 22 June 2018, in Skolkovo, Moscow region, Russia.

The Practical Forum “Clinical Trials in the EAEU” brings together clinical research professionals who share their practical cases, ideas, useful information about new developments, implementations and services.

The main topics of this year’s conference are:

  • Regulation of CT implementation in the EAEU: recent changes, peculiarities and practice of preparing the dossier, deadlines for issuing CT permits, mutual recognition of research results conducted in countries outside the EAEU.
  • Will the process of obtaining permission to conduct a clinical study according to the EAEU standards from the national procedure differ?
  • Will there be scientific advice for applicants?
  • Replacement of trials in the EAEU by inspections of clinical sites. When will the inspectorate and how will it be conducted?

More information you can find by clicking on the link on the official website.

Contact us by email: info@x7research.ru. We will be glad to see you at this event!

Changes in the registration dossier for influenza vaccines

At a meeting of the Eurasian Economic Commission (EEС) on June 14, unified approaches to the procedure for amending the registration vaccines’ documents for the prevention of influenza were adopted. Uniform requirements to the structure, content, format and scope of the registration dossier, procedures for amending the dossier, its expertise, and the timing of applications for registration were also established.

The flu is caused by the smallest biological fractions – viruses. It belongs to the group of RNA-containing viruses, that is, viruses that store genetic information in the RNA molecule. In total, three types of the virus are known – A, B and C, within which virologists isolate individual strains and serotypes, depending on which proteins contain the influenza virus.

The composition of vaccines varies annually, which is due to the variability of this virus. A characteristic feature of the influenza virus is its ability to permanently mutate. And this means that every year new strains appear, and if a person has had flu and acquired resistance to infection with one strain, it does not mean that he or she will not be able to catch the disease caused by another strain of the virus next year.

The current requirements for the production of vaccines and vaccination of the population in order to prevent epidemics and pandemics of influenza do not allow the standard procedure for 210 days to be applied to the registration of these drugs, as well as the introduction of changes therein. That is why a reduced order of evaluation of this vaccines group was introduced when making adjustments to the registration dossier related to the change in the strain of influenza. Now the term of the procedure for making changes to the registration dossier should not exceed 40 calendar days.

Source: Pharmvestnik.

X7 Research will take part in the oncology forum

Colleagues, X7 Research company is going to visit the 4th St. Petersburg international oncology forum, which will take place 5-8 July 2018, in the PARK INN BY RADISSON PRIBALTIYSKAYA HOTEL, Russia, St. Petersburg, 14 Korablestroiteley str.

The Forum “White Nights” is one of the largest events in the field of oncology that unites a wide range of specialists from Russia, CIS, and far-abroad countries; the main objective of the Forum is to consolidate the forces of the medical community to share the latest professional information in order to improve health care quality and reduce cancer incidence and mortality rates.

More information you can find by clicking on the link on the official website.

Contact us by email: info@x7research.ru. We will be glad to see you at this event!

FDA has released new guidance on liposomes

In April 2018 the FDA has released the final guidance for pharmaceutical industry on liposome drug products. The new guidance incorporates the finalized recommendations on liposome drug products manufacturing and includes the following main chapters: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics: Bioavailability and Bioequivalence; and Labeling.

According to the definition given in the guidance “Liposomes are vesicles composed of a bilayer (uni-lamellar) and/or a concentric series of multiple bilayers (multi-lamellar) separated by aqueous compartments formed by amphipathic molecules such as phospholipids that enclose a central aqueous compartment. In a liposome drug product, the drug substance is generally contained in liposomes.”

There may be parenteral, oral and topical routes of administration of liposome drugs.  For injectable liposome medications, it is necessary to prove that the drug is sterile and that it does not contain pyrogens or bacterial endotoxins.

The new guidance is based on the Quality by Design (QbD) principles according to ICH Q8(R2) Pharmaceutical Development. It means that it includes the control of critical variables (Critical Quality Attributes [CQAs] are chemical, physical, biological and microbiological attributes that can be defined, measured, and continually monitored to ensure final product outputs remain within acceptable quality limits) and establishment of a Design Space. It is also recommended to include a detailed process flow diagram as well as the description of unit operations with specifying process parameters and process controls documentation. The ranges of process parameters must be proved by pharmaceutical development investigations. Liposomes are very sensitive to any alterations in the conditions of production as well as changes in scale (batch sizes). Therefore, it is necessary to ensure a proper control of product development and manufacturing process. The manufacturing process parameters that may influence the quality of liposome drug products are a shear force, pressure, pH, temperature, batch-size-related hold times, lyophilization parameters, etc.

It is expected that implementation of new guidance allows to define more specific requirements for the manufacturing and quality control of liposome products and facilitates a more standardized electronic registration dossier (that will hopefully result in fewer questions from the regulatory bodies) for these products.

Sources: GMP, FDA.