lambda research newsletter · 2020-01-24 · 4. indian pharma growth at 10-12% during fy 2019-20...
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Dr. Tausif Monif President-Global operations tausifmonif@lambda-cro.com
Dr. Mrinal Kammili Executive Director–Global Head, BD
mrinal@lambda-cro.com
Lambda Research Newsletter
December 2019
Volume 12 / December 2019
2019
Volume 12 / December 2019
Contents GLOBAL NEWS 1-4
1. Discovery of new stem cells in motor neuron disease
2. Safe and cost-effective virus for vaccine production3. Novel HIV vaccine can help to reduce HIV load
4. CRIA syndrome identified by researchers
1
2 3
4 PHARMA INDIA 5-8
1. ‘Right Biotic’ to identify disease causing bacteria in blood and urine2. Belgium invites investors from Indian pharma and biotech companies
3. Discussion regarding integrated healthcare system in India4. Indian pharma growth at 10-12% during FY 2019-20
5 6
7 8
REGULATORY ROUND-UP 9-12 1. FDA replaces paper to electronic submission for medical devices
2. FDA eliminates quarterly reporting rule
3. FDA drafts guidance for drug development qualification process4. European parliament accepts second round MDR and IVDR corrigenda
9
10
11 12
MERGERS /ACQUISITIONS /COLLABORATIONS 13-16 1. Metrion and LifeArc collaborate for neuroscience drug discovery
2. Roche signs with Sarepta for DMD gene therapy3. LEO Pharma and Portal Instruments develop new drug delivery device
4. Antibe collaborates with global CMO for ATB-346 partnership
13
14 15
16 DRUGS: APPROVALS AND LAUNCHES 17-20
1. FDA approves first oral treatment for certain prostate cancers2. European Commission approves Kadcyla for HER-2 positive breast cancers
3. European Commission approves Evenity for new osteoporosis treatment4. Biosimilar infliximab approved for RA
17 18
19 20
Volume 12 / December 2019
Disclaimer: “The information compiled and published in this newsletter has been sourced, collected and derived from various resources which are in the public domain available on the web and relevant
sites. Lambda makes no claims, promises or guarantees about the accuracy, completeness, or adequacy of the contents of the newsletters and expressly disclaims liability for errors and omissions in the contents of this newsletter. The intent and object of this Newsletter is to only disseminate scientific information for knowledge up-gradation. The transmission or reproduction of any items covered in
this newsletter beyond that allowed by fair use as defined in the copyright laws may require the written permission of the copyright owners, if any. Neither Lambda, nor its employees and contractors make any warranty, expressed or implied or statutory, including but not limited to the warranties of non-infringement of third party rights, title, and the warranties of merchantability and fitness for a particular purpose with respect to content available from the newsletters. This is not a service by Lambda Therapeutic Research and it does not hold any responsibility for the accuracy of the
news/information provided herein.”
Contents DRUGS: DEVELOPMENT & CLINICAL TRIALS 21-25
1. Positive results from first-in-human trial with PVM system for ADHF 21
2. ATL1102 inhibits progression of Duchenne Muscular Dystrophy 22 3. Ibsrela shows positive data in hyperphosphatemia 23
4. Benlysta on track for regulatory submission in first half of 2020 24 PATENTS: NEW APPROVALS /LITIGATIONS /SETTLEMENTS 25-29
1. Coherus and Amgen settled lawsuit on adalimumab biosimilar 25 2. Gilead's Kite Pharma to pay $752M for CAR-T patent infringement 26
3. Takeda asks court to block sales of Mylan’s Colcrys copycat 27 4. Sun Pharma receives partial relief from generic drugs litigation 28
TECHNOLOGY/NDDS 29-32 1. Wearable iron lung for COPD patients for easy breathing 29
2. Unidose liquid device helps in epileptic seizures 30 3. JHU develops an advanced microendoscope 31 4. Nanoparticles to spot vascular calcification in atherosclerosis 32
WHAT’S NEW AT LAMBDA 33 1. Successful completion of USFDA inspection 33 2. Successful completion of EMA inspection 33
1
Volume 12 / December 2019
GLOBAL NEWS
1. Discovery of new stem cells in motor neuron disease
Motor Neuron Disease (MND) is a neurodegenerative disease of motor neurons resulting
in paralysis. The researchers at the University of St Andrews and the University of
Edinburgh have discovered “glial cells”, which usually support neurons throughout the
brain and spinal cord, but it starts damaging the motor neurons in MND.
The researchers have also found that the glial cells stop producing electrical signals
for healthy neurons that help to control muscles.
In the UK, approximately 5000 people live with MND and approximately six deaths are
reported per day. Unfortunately, there are no treatments available for MND currently.
“We hope that this new information highlights targets for the development of much -needed treatments and
ultimately a cure for MND”, said Professor Gareth Miles, Professor of neuroscience at the University of St Andrews
and a lead researcher.
Source: pharmatimes.com
2
Volume 12 / December 2019
GLOBAL NEWS
2. Safe and cost-effective virus for vaccine production
The researchers at the University of Queensland and the QIMR
Berghofer Medical Research Institute have discovered a safe virus
through their research of the Binjari virus.
This virus is unable to replicate in humans and is tolerant to genetic
manipulation. These characteristics can be used to protect humans
from infectious diseases.
The intention of this discovery was to learn more about mosquito-borne viral diseases. In laboratory, the Binjari
virus grows at high levels in mosquito cells; it is completely harmless and cannot infect humans and other species.
Important genes were swapped from pathogenic viruses into the Binjari genome.
Once the genome is modified, these viruses become physically identical to the target viruses, but they are unable
to replicate in human or animal cells. As a result, the manufacture of such vaccines is safe and does not require
bio-infrastructure to grow the target viruses and thereby reducing the cost of development.
Source: biopharma-reporter.com
3
Volume 12 / December 2019
GLOBAL NEWS
3. Novel HIV vaccine can help to reduce HIV load
The researchers at the Duke and Harvard University have developed a vaccine that can imitate
a rare process in the immune system generally seen in patients with human immunodeficiency
virus (HIV). This vaccine-led imitation process can help reduce the viral load of the body.
In HIV patients, a protein called “broadly neutralizing antibodies” (bnAbs) is produced by
immune system and these antibodies are enough to remove the viruses and its mutations.
The antibodies would be able to fight against HIV, remove them and prevent replication, but it can’t completely remove
HIV virus because some reservoirs remain within certain cells where the antibodies fail to reach them.
The study findings were published in the latest issue of the journal Science, in which the researchers report the design of
immunogens with differences in binding strength for bnAb precursors, which enable selection of rare mutations after
immunization. The immunogens promoted bnAb precursor maturation in humanized mice and macaques.
Source: news-medical.net
4
Volume 12 / December 2019
GLOBAL NEWS
4. CRIA syndrome identified by researchers
There were seven people suffering from an unknown disorder that caused fever every two to four weeks. The researchers
from Australia and the US have conducted a genetic analysis and identified the mutation causing their disease, as
cleavage-resistant RIPK1-induced auto inflammatory (CRIA) syndrome.
The researchers identified that the auto inflammatory CRIA syndrome is caused by a mutation in a cell death of RIPK1.
This finding will help in the development of cell death inhibitors for the treatment of CRIA syndrome.
Currently, interleukin-6 are mostly used as anti-inflammatory drugs for such cases, but it was not always effective, with
costs >$30,000 a year.
"RIPK1 inhibitors may be just what the doctor ordered for these patients. The discovery of CRIA syndrome also suggests a
possible role for RIPK1 in a broad spectrum of human illnesses, such as colitis, arthritis and psoriasis," said Dan Kastner,
a researcher from the National Human Genome Research Institute at the National Institutes of Health (NIH), US.
Source: news-medical.net
5
Volume 12 / December 2019
PHARMA INDIA
1. ‘Right Biotic’ to identify disease causing bacteria in blood and urine
An automatic testing equipment “Right Biotic”, which can identify bacteria in blood and urine
samples has been developed by the researchers at the Birla Institute of Technology and
Science, Hyderabad. The identification of disease-causing bacteria in blood and urine samples
is a very comprehensive and difficult process; it takes >48-72 hours.
The “Right Biotic” testing system has analyzed the disease-causing bacteria in samples in a
short period of time (within 1-3 hours), researchers have also got successful results in
identifying the pathogens in polluted water.
The Central Pollution Control Board Authorities (CPCB) had analyzed this equipment in polluted waters of Musi River in
Hyderabad and submitted the reports to the National Green Tribunal (NGT) and also suggested that the device can be
used for analyzing disease causing bacteria in all the polluted rivers across the country with permission from the Central
Science and technology Department (CSTD).
Source: pharmabiz.com
6
Volume 12 / December 2019
PHARMA INDIA
2. Belgium invites investors from Indian pharma and biotech companies
Belgium global pharma has invited Indian pharmaceutical and biotechnology companies to invest and utilize the huge
opportunities offered by the country.
Belgium, the global pharma and life science hub in Europe, provides a strategic geographical
point in Europe and gives a natural advantage in becoming a global destination for pharma
investors by providing easy access for other European countries.
The collaboration with Belgium is advantageous for Indian companies, they can use Belgium
as a global logistics and R&D hub for developing and expanding their business.
The consulate authorities of Belgium had organized a seminar in Hyderabad on “advantages of using Belgium as a Global
logistic hub”. Indian stalwarts such as Pharmexcil, Bulk Drug Manufacturers Association (BDMA), and Federation of Asian
Biotech Association and Confederation have partnered with the Consulate of Belgium.
“This is really a welcome opportunity for the Indian firms as they can utilize this to expand their network into other
European countries by making Belgium as their base,” opined Udaya Bhaskar, Director General of Pharmexcil.
Source: pharmabiz.com
7
Volume 12 / December 2019
PHARMA INDIA
3. Discussion regarding integrated healthcare system in India
The Economic Times India Leadership Council has discussed regarding the possibility
of integrated healthcare services in India through a series of interviews conducted
by Deloitte Touche Tohmatsu India LLP (DTTI LLP). In India, currently, the
healthcare services are very complex with limited wellness and prevention of
disease.
The aim of the discussion is to integrate healthcare at the community and healthcare facility level while rebalancing the
load between primary, secondary and tertiary care. There are several challenges such as lack of system integration,
standardization and mobility of health records, issues relating to data privacy, cyber security and appropriate data, lack
of awareness among consumers, and lack of adequate skilled work force.
Some technologies can be used such as machine learning, artificial intelligence (AI), and robotics which are firing the
imagination of several startups and non-traditional healthcare players-aggregators, big data and analytics companies,
social media, mobile phone and e-commerce. These technologies are improving the health care and can help in
efficiencies and improve access in a way that can have changes in the way healthcare is accessed and delivered.
These unique technologies can be advantageous to India‘s ecosystem overcoming many challenges.
Source: indianpharma.in
8
Volume 12 / December 2019
PHARMA INDIA
4. Indian pharma growth at 10-12% during FY 2019-20
According to ICRA, the FY2019-2022 compound annual growth rate (CAGR) for Indian
pharma companies is expected to be around 10-12%. ICRA has compared stable growth
for the Indian market balance sheet structure with pricing pressure in the US.
The US annual growth was 13.1% in 2018, but it has declined to 12.1% in year 2019. The
domestic Indian industry has capabilities for adequate increase in scale and generic
drug development.
The increased growth was supported by higher market share for Indian multinational companies (MNC) enhanced product
portfolios with new drug launches.
ICRA said that the US growth is expected to remain at high single digits to low double digits, due to the larger size drugs
going off patent, and generis drugs can be at a saturation level because of increased issuance of warning letters by the
US regulatory agency.
Source: financialexpress.com
9
Volume 12 / December 2019
REGULATORY ROUND-UP
1. FDA replaces paper to electronic submission for medical devices
The US Food and Drug Administration (FDA) has improved medical device submission
process to enhance medical device premarket submission system and economic net
benefits. The USFDA has replaced multiple paper submissions with a single
electronic submission. The electronic format includes CD, DVD, flash drive, and
mail.
The format has applied to all submission types that were previously listed in section 745A (b) of the FD&C Act. The final
rules improve cost savings without any additional submission burden and improve the quality of submission review.
Pharmaceutical companies will have to pay minimal administrative cost for submission.
FDA had also published a draft guidance for “both binding and nonbinding requirements regarding electronic submission
for medical devices.”
Source: raps.org
10
Volume 12 / December 2019
REGULATORY ROUND-UP
2. FDA eliminates quarterly reporting rule
The US Food and Drug Administration (FDA) has revised medical device regulations to prevent quarterly reporting approval
decision for premarket approval (PMAs) and humanitarian device exemptions (HDEs) in the Federal Register.
The rule will remove duplicating information, as the agency publishes the same information on safety and efficacy data
for PMAs and safety and probable benefits for HDEs.
FDA has issued rules for 1980s and 1990s decisions. In 1998, FDA had issued a final rule that eliminated individual federal
register notice for PMA approval and quarterly lists. The new rule would save about $10,000 over 10 years. Public have
30-days of time while decision is placed on the website.
Source: raps.org
11
Volume 12 / December 2019
REGULATORY ROUND-UP
3. FDA drafts guidance for drug development qualification process
The US Food and Drug Administration (FDA) has issued a 20 pages draft guidance for drug development tools (DDTs)
qualification process. The guidance fulfills FDA’s prescription Drug User Fee Act (PDUFA VI) commitments for improving
qualification pathway.
Cures Act has improved section 507 of the Federal Food, Drug, and Cosmetic Act and defined DDTs as biomarkers. FDA
add DDT can be used to support regulatory submissions, including investigational new drug applications (INDs), new drug
applications (NDAs) and biologics license applications (BLAs) for biologics or drugs. DDTs can be of significant use in the
development of safe and effective drugs and allow innovative technology that may greatly help drug development.
Three main DDT qualification processess which are described by the Cures Act and provide overview surrounding DDT
qualification process:
Letter of intent (LOI)
Qualification plan (QP)
Full qualification package (FQP)
Additionally, the guidance also provides some technical details, purposes of DDT qualification, where to submit electronic
documents and reference standard data.
Source: raps.org
12
Volume 12 / December 2019
REGULATORY ROUND-UP
4. European parliament accepts second round MDR and IVDR corrigenda
The corrigenda of Medical device regulations (MDR) and In Vitro Diagnostic
Regulation (IVDR) have been approved by the European Parliament Committee
in the second round.
The European Parliament’s Committee on the Environment and Public Health
and Food Safety accepted a corrigendum of certain up-classified class I
devices manufacture. The delay for some low-risk devices that require a
notified body was expected. The proposal was submitted to the committee to
change the timetable for class I reusable devices with some software and new
timeline set at 26 May 2024.
The committee has explained how the corrigenda are used to correct technicalities and also support the changes by the
MDR. Additionally, IVDR includes minor editorial changes and modifications related to Eudamed delay.
Source: raps.org
13
Volume 12 / December 2019
MERGERS /ACQUISITIONS /COLLABORATIONS
1. Metrion and LifeArc collaborate for neuroscience drug discovery
Metrion and LifeArc have agreed to continue research on
neuroscience ion channel drug discovery. The collaboration
between the two companies was started in January 2019.
The main aim of this project is to identify novel small selective molecule for a specific ion channel target, which is
involved in neurological pathogenesis.
Metrion, a biosciences contract research organization (CRO) and drug discovery company, is responsible for new chemical
entity and LifeArc, a UK-based medical research charity, is involved in ion channel screening.
According to Metrion, collaboration has completed almost 1 year, with succes. Both the companies have agreed to extend
for another 1-year collaboration to achieve mutual goals. As a result of early success, potential and effective compounds
have been identified and the companies are now preceding for a new phase “Heat to Lead” optimization for drug
discovery.
Source: outsourcing-pharma.com
14
Volume 12 / December 2019
MERGERS /ACQUISITIONS /COLLABORATIONS
2. Roche signs with Sarepta for DMD gene therapy
Roche has signed a deal with Sarepta for investigation of gene therapy ‘SRP-9001’ in
the treatment of Duchenne muscular dystrophy (DMD).
DMD is a rare X-linked degenerative neuromuscular disorder, caused by severe
progressive muscle defects and premature death.
SRP-9001 delivers micro-dystrophin-encoding gene directly to the muscle tissue for the
targeted production of the micro-dystrophin protein.
Sarepta will provide exclusive commercial rights to Roche. Under the agreement, Roche
will make an upfront payment of $1.15 billion, equity investment up to $1.7 billion in
regulatory and sales milestones and royalties on net sales to Sarepta. Additionally, Sarepta
and Roche will share global development expenses equally.
Source: pharmatimes.com
15
Volume 12 / December 2019
MERGERS /ACQUISITIONS /COLLABORATIONS
3. LEO Pharma and Portal Instruments develop new drug delivery device
LEO Pharma and Portal Instruments have jointly developed Portal’s
innovative needle-free drug delivery system. Leo pharma is a leader
in medical dermatology and Portal Instruments is a venture-backed
medical device company.
Portal Instruments has developed needle-free injector for self-
administration drugs. This technology is potentially used in
monoclonal antibodies and therapeutic proteins in drug development.
This needle–free system is a reusable software-controlled, single use and pre-filled cartridge, which is delivered through
pressurized liquid jet. This technology is advantageous for people with skin disease and allows administration of the
treatment conveniently at home.
This collaboration gives great opportunity to Leo pharma to lead innovation in the field of medical dermatology with a
needle-free drug delivery system.
Source: businesswire.com
16
Volume 12 / December 2019
MERGERS /ACQUISITIONS /COLLABORATIONS
4. Antibe collaborates with global CMO for ATB-346 partnership
Antibe, a Canada-based Therapeutics company, has collaborated with a leading global
contract manufacturing organization (CMO) for the production of ATB-346.
ATB-346 has a positive effect on pain and inflammation without any gastric side effects
associated with nonsteroidal anti-inflammatory drugs (NSAID).
Phase IIb clinical trial of ATB-346 is going on to generate more data on the efficacy and metabolism. According to the
agreement, the CMO supports by securing a reliable supply of ATB-346 to meet regulatory approval timelines and provide
manufacturing resources for the Phase III trial. While Antibe will work on business opportunities, the company acquires
rights to launch ATB-346 in the market.
According to a study, the direct cost of NSAIDs is $74bn every year including the expenditure on its side effects. Antibe
has a great opportunity to take ATB-346 to the US and Europe markets.
Source: outsourcing-pharma.com
17
Volume 12 / December 2019
DRUGS: APPROVALS AND LAUNCHES
1. FDA approves first oral treatment for certain prostate cancers The US Food and Drug Administration (FDA) has approved Xtandi (enzalutamide) for the
treatment of metastatic castration-sensitive prostate cancer.
Now, it is the first oral treatment approved by the USFDA for three different types of
advance prostate cancers including:
Non-metastatic castration-resistant prostate cancer (NCRPC)
Metastatic castration-resistant prostate cancer (CRPC)
Metastatic castration-sensitive prostate cancer (mCSPC)
The FDA has approved Xtandi based on the results of phase III ARCHES study involving 1150 patients with mCSPC and gets
positive primary endpoints with radiographic progression-free survival (rPFS) and reducing death by 61%. The safety profile
was consistent with previous clinical trials in CRPC.
Source: pharmatimes.com
18
Volume 12 / December 2019
DRUGS: APPROVALS AND LAUNCHES
2. European Commission approves Kadcyla for HER-2 positive breast cancers
The European Commission has granted approval to Roche’s Kadcyla
(trastuzumab-emtansine) for adjuvant treatment in HER2-positive early
breast cancer patients.
The EC has approval Kadcyla based on data from the Phase III KATHERINE
trial. The trastuzumab-emtansine showed an overall response rate of 88.3%
versus 77% reported with Herceptin. Kadcyla prevented the risk of disease
recurrence or death compared to Herceptin in the adjuvant setting. Safety
profile of Kadcyla was consistent with the previous studies.
Worldwide, Kadcyla is already approved in 27 countries.
Source: pharmatimes.com
88.30%
77.00%
70.00%
75.00%
80.00%
85.00%
90.00%
Kadcyla Herceptin
% p
f pati
ents
Response rate (%)
19
Volume 12 / December 2019
DRUGS: APPROVALS AND LAUNCHES
3. European Commission approves Evenity for new osteoporosis treatment
The European Commission has approved a new osteoporosis treatment ‘romosozumab’ for
post-menopausal women. Amgen and UCB’s Evenity (romosozumab) has shown increased
bone formation and declined bone loss.
Osteoporosis impacts quality of life and independence. A woman has five times more risk
to suffer another fracture within a year of her first fracture.
Evenity is a potential drug for the management of osteoporosis. It can rapidly increase bone mineral density within 12
months. The first launch of Evenity in the European Economic Area (EEA) is planned in the first half of 2020.
Source: pharmatimes.com
20
Volume 12 / December 2019
DRUGS: APPROVALS AND LAUNCHES
4. Biosimilar infliximab approved for RA
The European Commission has been granted an approval for Remsima subcutaneous
injection for the treatment of rheumatoid arthritis (RA).
Remsima is world’s first biosimilar monoclonal antibody formulation of infliximab. The
drug treatment is administered every two weeks at home.
Remsima is an anti-TNF agent that targets TNF-alpha protein, which is naturally produced in the body as a part of immune
response and fights against infection.
Remsima has been shown to have a stable potency with RA patients compared with CT-P13 IV
and has good data for both the indications (RA and IBD). The portion of patients with positive
adenosine deaminase throughout the trial was found to be slightly lower in the SC group than
the IV. In the RA study, the efficacy for SC and IV formulations was similar up to Week 54, even
after at 30 Week while switching from IV to SC treatment.
The European Medicines Agency’s (EMA) human medicines committee (CHMP) has given a
positive opinion for the subcutaneous version of the drug.
Additionally, celltrion plans to go through a new pathway for USFDA approval by 2022.
Source: pharmatimes.com
21
Volume 12 / December 2019
DRUGS: DEVELOPMENT & CLINICAL TRIALS
1. Positive results from first-in-human trial with PVM system for ADHF
Reprieve Cardiovascular has announced positive results of a first-in-human clinical trial of acute decompensated heart
failure (ADHF) using Personalized Volume Management System (PVM). The study has shown safe, effective, and long-
lasting decongestion of patients with acute heart failure. The results were presented at the Device Therapies in Heart
Failure (D-HF 2019) conference.
PVM is a second-generation, automated fluid management system, designed for the management of better diuretic
therapy for ADHF. This therapy is more precise and effective for management of fluid levels.
Potential PVM benefits include:
Speeding decongestion
Reducing shortness of breath, ascites, and swelling
Reduced time in hospital
Reduced readmission rates
Better quality of life
The clinical trial was designed to determine personalized volume management system and achieved reductions in net
volume, the average net fluid removal was -5.9 L/therapy, average weight loss -6.8 kg after mean treatment duration of
31 hours and average weight loss of -5.7 kg from baseline. Total 12 patients have completed the 30-day follow-up with
no significant adverse events reported.
Source: pharmabiz.com
22
Volume 12 / December 2019
DRUGS: DEVELOPMENT & CLINICAL TRIALS
2. ATL1102 inhibits progression of Duchenne Muscular Dystrophy
Antisense Therapeutics has performed a Phase II clinical trial of ATL1102 for
Duchenne Muscular Dystrophy (DMD). The study has shown positive effects on
progression of the disease.
ATL1102 is an alpha 4 chain inhibitor (CD49d) of T lymphocytes. High levels of
DC49b is responsible for more severity and rapid disease progression.
The aim of this trial was to evaluate the safety of 25 µg dose of ATL1102. The drug was administered in 9 young male
patients once a week via SC injection and the study evaluations included the drug immune cell number in the blood,
functional capacity, and upper limb strength.
At the end of the study, excellent safety and tolerability with no serious adverse effects were observed with the drug.
Source: smallcaps.com
23
Volume 12 / December 2019
DRUGS: DEVELOPMENT & CLINICAL TRIALS
3. Ibsrela shows positive data in hyperphosphatemia
Ardelyx has announced the positive data from its Ibsrela (tenapanor) study - PHREEDOM trial. The
study evaluated tenapanor for the treatment of hyperphosphatemia in patients with chronic
kidney disease (CKD) on dialysis.
A statistically significant difference in least square (LS) mean serum phosphorus change was reported with tenapanor
compared to the placebo arm in the PHREEDOM trial, meeting its primary endpoint. During the 26-week treatment period,
77% of tenapanor-treated patients had a decrease in serum phosphorus, with a mean reduction from baseline of 2.0
mg/dL.
This treatment will change the ways in the management of hyperphosphatemia in patients on dialysis.
Source: pharmatimes.com
24
Volume 12 / December 2019
DRUGS: DEVELOPMENT & CLINICAL TRIALS
4. Benlysta on track for regulatory submission in first half of 2020
GSK has performed Phase III BLISS-LN trial
of Benlysta (belimumab) for the
treatment of lupus nephritis (LN).
LN is the inflammation of kidney, which
is caused by systemic lupus erythematous
(SLE) and finally leads to end-stage renal
disease.
Primary endpoint:
Efficacy response rate (PERR)
Secondary endpoints:
Complete renal response (CRR)
Ordinal renal response (ORR)
Renal-related event (RRE)
The trial has demonstrated the improvements in primary and secondary endpoints compared to the placebo arm. GSK has
planned progressive regulatory submission in the first half of 2020.
Source: pharmatimes.com
43%
32%
0%
10%
20%
30%
40%
50%
Benlysta Placebo
% o
f pati
ents
Renal Response Rate
25
Volume 12 / December 2019
PATENTS: NEW APPROVALS /LITIGATIONS /SETTLEMENTS
1. Coherus and Amgen settled lawsuit on adalimumab biosimilar
Coherus BioSciences and Amgen have settled a patent lawsuit on biosimilar adalimumab.
Coherus had filed patent infringement lawsuit against Amgen, citing that Amgen’s
adalimumab biosimilar (Amgevita), referencing Humira, infringes four patents of its own
biosimilar version of the same reference.
Amgen will not launch the biosimilar until January 2023 and Coherus can’t launch until December 2023 under its
agreement.
Source: centerforbiosimilars.com
26
Volume 12 / December 2019
PATENTS: NEW APPROVALS /LITIGATIONS /SETTLEMENTS
2. Gilead's Kite Pharma to pay $752M for CAR-T patent infringement
Patent lawsuit filed between Bristol Maters
squibb (BMS) and Gilead Sciences has led to an
order by the Jury of the California after two
weeks trial that Gileads’s Kite Pharma has to
pay $752 million to BMS’ Juno Therapeutics
and its partners.
BMS has agreed with this decision, while Gilead is assertive in their opinion that the patent is not infringed. Gilead will
address its concerns post-trial.
Source: fiercepharma.com
27
Volume 12 / December 2019
PATENTS: NEW APPROVALS /LITIGATIONS /SETTLEMENTS
3. Takeda asks court to block sales of Mylan’s Colcrys copycat
Takeda has requested the federal judge to
block Mylan’s generic version of Colcrys,
which is used to treat gout flare-ups.
Takeda is accusing that Mylan has broken a license agreement according to settlement of a patent-infringement case over
Colcrys from 2017, while Mylan said copycat is licensed under the parties’ settlement and license agreements.
Takeda has also added that Mylan intentionally infringed 17 Takeda patents. Colcrys had sales of 30 billion Japanese yen
($275 million) at the end of March, which was 1.4% of Takeda’s revenue.
Source: convergenceapi.bna.com
28
Volume 12 / December 2019
PATENTS: NEW APPROVALS /LITIGATIONS /SETTLEMENTS
4. Sun Pharma receives partial relief from generic drugs litigation
Sun Pharma has received a partial relief from a US court in a litigation on delay by the company
in launching three generic drugs valganciclovir, valsartan and esomeprazole in the US market.
The complaints were filed under the Racketeer Influenced and Corrupt Organizations Act,
federal and state antitrust laws, and state consumer protection laws.
The US District Court (District of Massachusetts) has rejected in part and granting in part Sun Pharma's motion to dismiss
the claims of certain plaintiffs.
Source: business-standard.com
29
Volume 12 / December 2019
TECHNOLOGY /NDDS
1. Wearable iron lung for COPD patients for easy breathing
A clinical trial is ongoing for a wearable device for chronic obstructive pulmonary disease (COPD). This wearable device
is based on iron lungs. The basic configuration includes two shells for patient’s chest and back, and a pump that makes
the shells move back to help in breathing.
A physician from the Penn State’s Perelman School of Medicine came up with this idea. The technology is not still
commercialized, but the “Right Air” company has been involved in developing this technology. Some of the components
available such as ventilators with rubber sheeting are used to create a seal between the device and the patients’ skin,
and the attached pump can activate the shells.
The company is planning towards FDA approval for quick commercialization.
Source: medgadget.com
30
Volume 12 / December 2019
TECHNOLOGY /NDDS
2. Unidose liquid device helps in epileptic seizures
The US Food and Drug Administration (FDA) has approved NAYZILAM (midazolam)
for the treatment of acute repetitive epileptic seizures, which is based on Unidose
Liquid System as the delivery mechanism. This system requires priming, and can
be used with one hand direct administration of the drug into the nose.
AptarGroup, the developer of this drug, has designed a trainer device that mimics the real device, to help train patients
and caretakers on how to administer the drug.
“The launch of our Unidose System on the first and only U.S. FDA approved nasal rescue treatment for seizure activity
once again demonstrates Aptar Pharma’s ability to help our customers develop and launch complex treatments,” stated
Gael Touya, President, Aptar Pharma.
Source: medgadget.com
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TECHNOLOGY /NDDS
3. JHU develops an advanced microendoscope
Researchers at the Johns Hopkins University have reported a most advanced
microendoscope. This is lens-free device and can produce sharp images of very small
objects. Also, it doesn’t require movement to focus on things at different distances.
The researchers have compared their new microendoscope with existing devices and
reported remarkable results with the new device. The study was published in the
journal Science Advances.
“The new device relies on a coded aperture, which is a flat grid with a random pattern that creates a projection. Though
this image resembles noise, it allows the device to understand where the light is coming from and to reconstruct the
source of the image” said Mark Foster, the corresponding author of the study. This device can be very effective for
scientists studying the brain to observe ever smaller structures and to understand their functional interrelationships.
Source: medgadget.com
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TECHNOLOGY /NDDS
4. Nanoparticles to spot vascular calcification in atherosclerosis
Researchers at the University of Southern California have developed a new nanoparticle to
capture plaques or fatty deposits in the arteries. These nanoparticles can stick to the calcified
structures within vessels and light up, which allows their tracing.
The nanoparticles not only detect larger formations but can also detect microcalcifications.
These new nanoparticles are designed to identify hydroxyapatite, a type of calcium that is
found within arteries and plaque.
The researchers have also tried these nanoparticles on real patients and demonstrated that
these nanoparticles work with human tissues also. Researchers also reported that the new
nanoparticles are of very low toxicity.
Source: medgadget.com
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Volume 12 / December 2019
WHAT’S NEW AT LAMBDA
1. Successful completion of USFDA inspection
The US Food and Drug Administration (US FDA) completed its inspection at Lambda Ahmedabad facility for clinical aspects
of two biosimilar projects. The inspection was carried out between 09 and 13 December 2019. The inspection was
successfully completed without any 483s further reiterating the quality and processes adopted at Lambda.
2. Successful completion of EMA inspection
The European Medical Agency (EMA) completed its inspection of the Clinical Trial facility at Lambda Therapeutic Research
Limited, Ahmedabad, Gujarat. The inspection was carried out between 16 and 20 December 2019. The inspection was
conducted for one small molecule study and another biosimilar study. The inspection concluded successfully.
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