Lambda Research Newsletter · 2020-01-24 · 4. Indian pharma growth at 10-12% during FY 2019-20...

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Lambda Research Newsletter

December 2019

Volume 12 / December 2019

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


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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


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


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


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


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


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


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.


7


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


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


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


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


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


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

https://www.raps.org/news-and-articles/news-articles/2019/11/second-mdr-corrigendum-targets-class-i-devices

https://www.raps.org/news-and-articles/news-articles/2019/11/second-mdr-corrigendum-targets-class-i-devices

13


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



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.


15



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



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


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.


https://ascopubs.org/doi/abs/10.1200/EDBK_200967

https://ascopubs.org/doi/abs/10.1200/EDBK_200967

18



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.


88.30%

77.00%

70.00%

75.00%

80.00%

85.00%

90.00%

Kadcyla Herceptin

% p

f pati

ents

Response rate (%)

19



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.


20



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.


21


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.


22



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



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.


24



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.


43%

32%

0%

10%

20%

30%

40%

50%

Benlysta Placebo

% o

f pati

ents

Renal Response Rate

25


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

https://news.bloomberglaw.com/pharma-and-life-sciences/coherus-amgen-settle-patent-suit-on-arthritis-biosimilar-drug-1

26



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



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



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

https://www.business-standard.com/topic/sun-pharma

29


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


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.


https://www.ptcommunity.com/wire/ucb-announces-availability-nayzilam-midazolam-nasal-spray-civ-first-and-only-nasal-rescue

31


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.


32


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.


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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.

Lambda Research Newsletter · 2020-01-24 · 4. Indian pharma growth at 10-12% during FY 2019-20...

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Transcript of Lambda Research Newsletter · 2020-01-24 · 4. Indian pharma growth at 10-12% during FY 2019-20...