life sciences - JLT Specialty

LIFE SCIENCES LIFE SCIENCE NEWSLETTER MARCH 2016

REGULATORY & LEGAL UPDATE

Page 4

MERGER & ACQUISITIONS NEWS

Page 5

NEW PRODUCT DEVELOPMENT

ALSO IN THIS ISSUE Clinical trials

10

Company news

14

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The era of orphan drugs and their inherent risks and challenges Orphan drugs are prescribed for rare diseases, largely affecting less than 200,000 patients in the US or less than five in 10,000 patients in the EU. The patient pool for orphan drugs is small, but their relatively low development cost, high price point and food and drug administration (FDA) approvals have interested manufacturers. Non-orphan drugs usually take an

• Small patient base: the primary

a relatively weaker clinical trial

additional three months for FDA approval

challenge is to find sufficient patients

requirement for orphan drugs

versus orphan drugs. The shifting of

to produce statistically significant

(one-ninth the number of patients

balance to orphan drugs can be gauged

data as the developed drugs are

in a common disease drug trial)

from the 22.3% compound annual

intended for a subset of a small

and result in subsequent product

growth rate (CAGR) in FDA orphan drug

population; for example, Kalydeco,

approvals, which grew from 15% to 41%

which is used to treat cystic fibrosis

during the financial years (FY) 2010 to

(30,000 patients in the US), only

continued manufacturer interest in

2015.

works on 1,200 of those patients due

the orphan drug market coupled with

to a particular genetic mutation.

increasing revenue and market size

Orphan drug manufacturing may appear very appealing, but it faces some serious inherent risks and challenges such as:

• Weaker clinical trials: potential adverse events can arise due to

liabilities. • Regulatory and legal challenges:

could lead to enhanced regulatory requirements or legal challenges from Continued on page 2 

FOREWORD

2 LIFE SCIENCE RISK PRACTICE | LIFE SCIENCES | March 2016

Welcome to our latest life science newsletter covering topical insurance and risk management issues in the industry. In this issue, we look at orphan drugs and their inherent risks and challenges. We also have our usual features including a clinical trials update, mergers and acquisitions news from across the sector and a look at regulatory and legal developments. This year we will be holding our ninth JLT Life Science Conference, The Science of Risk Management. 2015 was another challenging year for life science

 Continued from page 1

companies, merger and acquisition activity was unrelenting, although there was an

advocacy groups. For example, the

by 2020. The global orphan drugs’ market

unusually high number of products achieving

Department of Health and Human

growth is expected to be two times higher

regulatory approval to somewhat offset the

Services had tried to include orphan

than the global prescription market for the

well-publicised pipeline difficulties that many

drugs under the 340B discount

period staring from FY 2015 to FY 2020.

companies faced.

program. However, this was

In 2015, the global orphan drugs’ market

challenged by the Pharmaceutical

accounted for approximately 16% of the

The JLT Life Science 2016 Conference is our

Research and Manufacturers

global prescription market and is expected

ninth such event and topics to be discussed

of America (PhRMA) and was

to reach 20.2% by FY 2020.

and debated this year include:

overthrown in court in October 2015.

• Legal and regulatory changes that affect first and third party exposures, plus sessions on preparing and responding to some of these issues • How data and analytics can be used to aid decision making. For more information and to register your interest in attending please visit www.jltspecialty.com/lifescience2016

• Manufacturing issues: risks relating to manufacturing complexity are inherent in orphan drugs as more than 60% of orphan drugs are biological rather than small molecule one. Therefore, their manufacturing process is more complex and any small change in the manufacturing process could lead to significant changes in immunogenicity.

The manufacturers’ benefit from the ODA because it provides them with seven years of marketing exclusivity, 50% tax credits on research and development costs and exemption from prescription drug user fee, which was more than USD 1.3 million per application in FY 2015. Additionally, the off-label use of the drug also benefits the manufacturer; for example, Rituxan (made by Roche) was initially approved for the treatment of follicular non-Hodgkin’s

Despite these risks and challenges, the

lymphoma, but is currently used to treat a

I hope you find this publication useful,

favourable regulatory environment in

number of conditions and has generated

please let me know if there are any

the form of the Orphan Drug Act (ODA)

more than USD 3.7 billion through US

topics you would like to see covered in

1983 in the US and the Orphan Product

sales (2014). These factors, coupled with

future issues.

Designation (OPD) 2000 in the EU has

the possibility of high prices which are

helped to expand the market. According

sometimes as high as USD 200,000 to

to EvaluatePharma, the global orphan drug

USD 300,000 per year/per patient, have

prescription sales was estimated at USD

caught the manufacturers’ attention.

102 billion in 2015 and is expected to James Bird Head of Life Science Risk Practice JLT Specialty Limited

grow at 11.7% CAGR to USD 174 billion

www.jltspecialty.com | LIFE SCIENCES 3

MANUFACTURING RISKS – HOW YOUR BROKER CAN HELP JLT Specialty’s Life Science Practice understands the functioning of life science companies and can help companies mitigate their manufacturing risks by providing them consultancy services and risk transfer solutions.

as the control in terms of the production is lost which is causing serious quality issues. Until August 2015, US FDA had issued a total of 1,901 import alerts, with China, Mexico, Canada, India and Hong Kong having the most. Mexico, India and China are the top three countries to have received import refusals of 208, 192 and 178 respectively. How do we support our clients? Our specialist brokers understand clients’ business and seek

What are the key risks related to manufacturing for pharma companies?

comprehensive coverage based on their needs. We deliver advanced, customised insurance policies which can provide cover not only for damage, but also for fear of loss (suspected

Identification and quantification of risks itself has become one

damage), and cover for loss of revenue caused by non-physical

of the key tasks for companies. There has been a high disparity

damage such as site closure/shutdown at a client’s own or

with some companies able to identify and quantify where their

supplier site.

risks are, whereas others are unable to. On the other hand risks related to regulations are increasing as companies have to follow changing good manufacturing process at each stage of the process. Outsourcing the process has led to reduced costs but with an associated loss of control. Outsourcing activity on the rise

How do we help quantify the risks for our clients? We provide specialised consultancy services to identify and quantify the key risks and the downside associated with them. Once the risks are quantified, clients have more visibility whether risks need mitigation. They can decide whether the risks are to be retained or mitigated. Our specialised software

Outsourced activities in the sector are on an upward trend.

SCAIR ™ help clients assess and quantify the loss of revenues

According to a contract pharma survey of 375 industry

and increased costs associated with possible interruptions they

professionals, companies are increasing by outsourcing

may face in their business. The software with its web based

activities in the areas of analytical and testing services (37%),

interface can help clients to measure the key risks associated

clinical trials (34%), solid dosage manufacturing (28%) and

with suppliers, own sites or processes across an entire portfolio

formulation development (20%). This has lead to a higher risk,

or selected products, product groups and therapy areas. 


for finished pharmaceuticals. Following the FDA‘s action Cadila has discontinued production of narrow therapeutic index drug warfarin at the Moraiya plant. This could raise financial challenges for Cadila as Moraiya plant represents almost 60% of the company’s US business which was USD 500 million in 2014-15. • Recently, IPCA Laboratories Ltd. has been issued warning letters for three of its manufacturing plants located at Piparia, Indore and Ratlam by the FDA. The letters cite manufacturing quality lapses at the three factories. These three sites also supply drugs within India, the UK and Canada. Johnson & Johnson (J&J) has been facing a tough time on account of ongoing legal issues. • J&J has been ordered to pay USD 124 million for Risperdal marketing. J&J had sought a successful outcome at the US Supreme Court.

Regulatory & legal update US FDA kept its strict stance on Indian pharma companies as a series of warnings were given in January and February. • Wockhardt’s new plant which the company considers as ‘one of the kind in Asia’ will not be allowed to export the products to the US, the largest pharma market. This is due to the shortcomings found by the FDA during a recent inspection at the new sterile injectables plant which revealed nine observations. • On first week of January 2016, Cadila received a warning letter from the FDA for two of its facilities (Moraiya formulation facility and Zyfine API plant) due to the violations of current good manufacturing practice (CGMP) regulations

• J&J and its subsidiary, McNeil, face a USD 140 million judgment in a lawsuit over the side effects caused by children’s Motrin. The jury had awarded the plaintiff Samantha Reckis and her parents USD 63 million which amounted to USD 140 million with interest. Lawmakers in the US have been trying to bring some essential bills for approval to improve consumer safety. • Members of congress, federal officials and health policy experts are of opinion that the FDA’s surveillance systems for devices are inadequate and have resulted in serious infections. The lawmakers are thus looking to reduce the threat of tainted medical devices. • Issues between the Republican and Democratic party members has delayed the new bill to speed up the approval of new drugs and medical devices. • Legislation introduced added the Zika virus to the FDA priority review programme. 

TOP STORIES

1.

Partisan split threatens progress on the bill to spewed drug approvals: The rift between Democrats and Republicans has delayed passing of the bill. The Republicans want the bill to be passed for getting new drugs and medical devices on the market at faster pace, however Democrats fear that passing of the bill might result in neglect towards consumer safety and protection.

2.

Time for J&J to pay USD 124 million risperdal case as Supreme Court of the United States (SCOTUS) deflects final appeal: The U.S. Supreme Court declined to take up J&J’s last appeal in the case, putting the company up for a USD 124 million penalty. The penalty however is significantly lowered from USD 327 million that the jury had ordered the company to pay in 2011.


TOP STORIES Merger & acquisitions news

1.

diagnostics, medical device and diabetes drugs space. Some of the major deals include:

2.

• Stryker has agreed to acquire Sage Products from the private equity firm Madison Dearborn Partners for USD 2.7 billion. The deal will help Stryker to expand its position as a major player in the market for products aimed at helping hospitals control the spread of infection. • Panasonic announced that it has closed its USD 1 billion acquisition of Bayer’s diabetes care business. The new units will operate as a stand alone company, named Ascensia Diabetes Care. It will develop, manufacture, market and sell blood glucose monitoring meters and strips across 125 countries. Pfizer looks to strategically focus on its core operations and its geographical presence through acquisitions, sell-off and partnerships. • Pfizer, through the Allergan deal, will reduce its tax rate. The movement of its headquarters from New York to Ireland will help the company save approximately USD 1.2 billion in taxes. • Pfizer is planning to sell off its pumps and devices business it acquired in last year’s purchase of Hospira Inc. The selloff will fetch the company USD 2 billion. • Pfizer is planning to increase its presence in Russia by forming a joint venture with Russian drug-maker Polysan. Big pharma players are expanding their business in the oncology segment by acquiring small size companies. • Merck acquired IOmet Pharma for an undisclosed amount. The acquisition will help Merck to add therapies into their pre-clinical pipeline that targets indoleamine 2,3-dioxygenase (IDO) / tryptophan 2,3-dioxygenase (TDO) pathways. It was help in developing new cancer treatments. • Roche has invested USD 175 million in Flatiron, the oncology software player. This will help Roche enhance its research and development team by giving them access to a larger dataset. 

of the year: The deal will help Abbot to boost its

of deal, Abbott is expected to bring in more than USD 7 billion in revenues.

takeover will be completed by mid-year after the approval of

to increase its presence in the diagnostic testing industry.

company, Alere for USD 5.8 billion by the end

4.65 billion in revenues last year. After the closure

provider of therapies for rare diseases. It is believed the

enhance its diagnostics business. The deal will help Abbott

Abbott Labs will acquire the medical test

medical testing business which had bought in USD

Baxalta Inc. The deal is expected to form the biggest

• Abbott has agreed to acquire Alere for USD 5.8 billion to

business. The combined pipeline will contribute 2020.

• Shire PLC unveiled a USD 32 billion agreement to buy

regulators in multiple countries.

billion deal: Deal will enhance Shire’s rare-disease approximately USD 5 billion to the annual sales by

The start of 2016 has seen an increase in merger and acquisition (M&A) deals on a global scale in the biotech,

Shire and Baxalta to merge with a USD 32

3.

Sage Products, a medical products company, will be acquired by Stryker Corp. for USD 2.8 billion: The deal is expected to close by the second quarter.


New product development GlaxoSmithKline to

fosaprepitant dimeglumine, along with

Pharmaceuticals’ chronic liver disease

develop flu vaccines

other antiemetic medications, has been

drug, with a sales forecast of USD 2.6

with Valneva

approved by the FDA as a preventive

billion in 2020, and Gilead Sciences’

February 08, 2016, Smart Brief

therapy for delayed chemotherapy-

(GILD.O) new fixed dose HIV drug

GlaxoSmithKline has signed a research

induced nausea and vomiting in patients

emtricitabine plus tenofovir alafenamide.

and development deal with Valneva to

treated with moderately emetogenic

produce flu vaccines based on their

chemotherapy. The approval was

EU approves AstraZeneca

EB66 cell line. Under the terms of the

granted based on late-stage trial data.

first-in-class lung cancer

agreement, Valneva will create upstream processes to be used in vaccine production and is eligible for undisclosed

drug Drug companies likely to

February 03, 2016, Pharma Times

launch seven drugs to 2016

Patients in Europe with a certain form of lung cancer could soon get access to a

research payments. The Biomedical Advanced Research and Development Authority will be involved in financing and overseeing the advanced development programme.

February 03, 2015, Reuters

new, first-in-class treatment option after

Drug companies are likely to launch

regulators waved through AstraZeneca’s

seven drugs in 2016, each with USD 1

targeted therapy, Tagrisso.

billion-plus annual sales potential, led by new treatments for liver disease and

TapImmune’s ovarian

New dosage of Merck’s

HIV, according to analysis by Thomson

cancer vaccine gains

CINV drug receives FDA

Reuters. The assessment means the

FDA fast-track status

approval

pharmaceuticals industry is on track

February 03, 2016, Seeking Alpha

February 04, 2016, Smart Brief

for another productive year, although

The FDA designates Taplmmune’s

Merck’s supplemental new drug

not as good as 2015, which saw the

(OTCQB:TPIV +0.8%) lead therapeutic

application for the single-dose

arrival of 11 new drugs. The two main

cancer vaccine candidate, TPIV 200,

administration of injectable Emend,

ones for 2016 are tipped to be Intercept

for Fast Track review for the treatment


of ovarian cancer. Specifically, the fast

Merck sets USD 54,000 list

on humans could begin as early as

track tag applies to the use of TPIV

price for hep C combo as

August. If successful, that may allow the

200 (multiple-epitope Folate Receptor

it prepares for battle with

vaccine to be used during a public health

Alpha Peptide Vaccine), with (GM-CSF)

Gilead, AbbVie

emergency in October or November.

adjuvant, for maintenance therapy

January 29, 2016, Fierce Pharma

in patients with platinum-sensitive

Industry watchers have long been

advanced ovarian cancer who npw

speculating on how Merck would take on

have stable disease or partial response

Gilead and AbbVie when it priced its new

following the completion of standard-of-

hep C regimen.


The New Jersey pharma giant, which

generation diabetes treatment Tresiba

FDA clears ARIAD

received FDA approval for its combo pill,

in the US post approval by the FDA last

Pharmaceuticals’ application

Zepatier, late on Thursday, announced

September. The Danish drug-maker

for lung cancer treatment

it would set the drug’s list price at USD

expects robust sales, but the long-

February 02, 2016, Fierce Medical Device

54,600 for a 12-week regimen. It is

acting insulin faces new competitors

ARIAD Pharmaceuticals, Inc.

expected to help broaden and accelerate

that could get in the way of those

announced that the FDA has cleared its

patient access to treatment and move

ambitions. Tresiba will go up against

investigational new drug application for

them closer to their shared goal of

Sanofi’s market standby Lantus and its

its tyrosine kinase inhibitor, AP32788.

reducing the burden of chronic HCV in

newly approved follow-up Toujeo. Plus,

It is being developed as a targeted

the US.

as of December, it faced lower-priced

care chemotherapy.

treatment of patients suffering from

AstraZeneca to collaborate

non-small cell lung cancer (NSCLC) with

with Allergan on

specific mutations in EGFR or HER2.

combination antibiotic

ARIAD expects to initiate a phase I/ II study on AP32788 in patients with NSCLC in the second quarter of 2016

Novo Nordisk rolls out long-awaited Tresiba

Novo Nordisk launched its next

competition from Eli Lilly and Boehringer Ingelheim, in the form of their Lantus biosimilar Basaglar.

January 29, 2016, Smart Brief

GeneOne, Inovio team up

AstraZeneca will work with Allergan

to develop vaccine for Zika

on the development and marketing of

virus

German firm develops

a fixed-dose antibiotic compound for

January 22, 2016, Bio Prep Watch

rapid Dx test for Zika virus

use against metallo-beta-lactamase-

GeneOne Life Science has teamed up

producing gram-negative bacterial

with Inovio Pharmaceuticals to further

January 31, 2016, Tele SUR TV

infections. Under the terms of the deal,

develop a vaccine that is based on DNA.

Researchers in Germany have

AstraZeneca will have marketing rights

The vaccine will be used to combat the

developed a diagnostic test that can

to the compound, which combines

Zika virus, which is hitting several Latin

accurately detect the Zika virus in

aztreonam and avibactam, in all

American countries. “We are moving

humans with test kits already sent

countries except the US and Canada.

rapidly with Inovio and our academic

to Brazil. Previously the mosquito

Financial terms of the deal were not

collaborators to test a vaccine for this

borne virus could only be detected if

disclosed.

fast-spreading viral disease causing

someone showed some of the disease’s distinctive symptoms, making the fever extremely difficult to track – especially

Zika virus vaccine could be ready this year

as the majority of people do not show symptoms. However the tests, developed by German biotechnology company, Genekam, not only reveal the presence of Zika pathogens in a blood sample but also provide information on the quantity in the patient’s blood.

major birth defects in newborns,” says GeneOne Life Science CEO, Young Park. “We aim to be on the front line of defence against major emerging

January 29, 2016, Reuters A vaccine for the Zika virus, which has been linked to severe birth defects in

infectious disease such as Ebola, MERS and now the Zika virus.”

thousands of infants, could be ready for

Medtronic Launches

emergency use before year-end, one

OsteoCool System for

of its lead developers said, a timetable

Spinal Metastasis

well ahead of estimates by US officials.

January 18, 2016, Zacks

Canadian scientist Gary Kobinger, part

In an attempt to expand its product

of a consortium working on the vaccine,

portfolio that addresses pain therapeutic

mentioned that the first stage of testing

solutions, Medtronic plc recently


launched its OsteoCool radiofrequency

Big question for Pfizer: Will

Elocta is the first haemophilia A

(RF) Ablation System in the US market,

Enbrel’s EU biosim bring on

treatment approved in Europe that

subsequent to the receipt of FDA

the pain?

offers prolonged protection against

approval. The OsteoCool System


bleeding episodes through prophylactic

is designed to treat cancer patients

Amgen and Pfizer’s Enbrel officially has

injections every three to five days instead

suffering from painful spinal metastasis.

a biosimilar rival in Europe. And if the

of every other day, as is necessary with

rollout goes anything like the recent EU

conventional therapies.

Anti-hepatitis Harvoni to be released in market soon

launch of Remicade copy Remsima,

Boston Scientific

the brand will be in trouble. Approved

Corporation launches the

by the European Commission, the

January 17, 2015, Egypt Independent Mohie Ebeid, head of the Pharmacists’ Syndicate, announced that the antihepatitis C Harvoni drug, made by the US company Gilead, will be available in the Egyptian market within days. He further added that each packet will sell for LE1,100 in comparison to the “smuggled” packets that used to sell for LE120,000. Egypt’s Health Ministry plans to treat 300,000 hepatitis patients in 2016. It has embarked on importing foreign-made medications, most notably Gilead-made Sovaldi, before producing locally-made versions at cheaper rates.

LithoVue single-use digital

Enbrel knockoff from Samsung Bioepis

flexible ureteroscope

will be sold by US-based Biogen. The Cambridge, MA, company plans to roll it out gradually across the 28 EU member states plus Norway, Iceland and Liechtenstein.

January 12, 2016, Boston Scientific Boston Scientific Corporation announced the US and european launch of the LithoVue single-use digital flexible ureteroscope for minimally invasive

Long-acting Haemophilia

endoscopic procedures to diagnose and

A drug hits UK shores

treat stones and other conditions of the kidney, ureter and bladder. By providing

January 15, 2016, Pharma Times

a single-use flexible ureteroscope for

UK patients with Haemophilia A can now

urologists, the LithoVue System is

access a new, longer-acting treatment

designed to address the inconsistent

to keep bleeds under control, following

performance, one to four operational

the launch of Sobi and Biogen’s Elocta

challenges and costs associated with

across the country.

TOP STORIES

1.

Acceleration towards countering Zika virus: •The German firm Genekam has developed a Dx test for identifying Zika virus accurately in humans. The test will assist in determining the quantity of Zika pathogen’s in the patient’s blood, which could help an early detection of the disease. •A consortium involving Canadian scientist Gary Kobinger working towards the cure of Zika virus (vaccine), claims that the vaccine may be available by October or November this year.

2.

Regulatory approvals for cancer related drugs is on the rise: •Several companies working towards cancer treatment drugs observed increases in approvals from US and EU regulatory bodies. •The FDA has cleared ARIAD Pharmaceuticals’ application for lung cancer treatment and the FDA has provided a fast track status to TapImmune’s ovarian cancer drug. •The EU has granted approval to AstraZeneca’s first in class lung cancer drug.


widely used reusable scopes that

The new test will be based on Philips’

million for each potential hit. Oncodesign

require maintenance, sterilization and

Minicare I-20 system, and will be useable

is responsible for identifying drug

reprocessing one to seven.

at the point of care. The I-20 system

candidates and handing over projects

consists of a handheld analyser and

to its partner to handle preclinical and

ImpediMed launches L-Dex

software and a single use, disposable

clinical development. Bristol-Myers will

non-invasive lymphedema

cartridge for the test.

hold commercialisation rights to any

assessment system

resulting products with Oncodesign in

January 11, 2016, MedBuzz Today

Mylan launches Hep C

line for tiered royalties and milestone

ImpediMed, a medical technology

drug in India

payments tied to future sales.

company, based out of Carsbad, California, has launched its L-Dex

January 07, 2015, Business Standard

Hemophilia A treatment

lymphedema assessment system in

Mylan Pharmaceuticals Private Limited,

now available

the US. Lymphedema is a condition

the Indian subsidiary of Mylan NV,

of localised fluid retention and tissue

has launched their generic Hepatitis C

January 04, 2016, MPR

swelling caused by a compromised

medicine under brand name MyHep

Octapharma USA announced that Nuwiq

lymphatic system. Though the disease is

LVIR in India. This Ledipasvir/Sofosbuvir

(antihemophilic factor [recombinant])

frequently caused by cancer treatments

combination product is indicated for the

is now available for the treatment

and by parasitic infections, it can be

treatment of Hepatitis C infection and

and control of bleeding, perioperative

inherited or caused by a birth defect.

offers a simplified treatment regimen

management, and routine prophylaxis to

that eliminates the need for interferon

reduce bleeding episodes in patients with

Sanofi and Regeneron line

injections and ribavirin tablets. The

hemophilia A. The treatment was initially

up for FDA approval with

product is also a single-tablet regimen

approved by the FDA in September

arthritis treatment

and requires a therapy course of just 12

2015. Nuwiq is the first 4th generation

January 08, 2015, Fierce Biotech

weeks, compared with 24 to 48 weeks

recombinant Factor VIII derived from a

Sanofi and Regeneron are moving

involving interferon and ribavirin.

human cell-line without any chemical

towards FDA approval with what could

modification or protein fusion. Nuwiq

be their second big collaboration,

CEO Frazier expects Merck

temporarily replaces the missing clotting

preparing to make the case for a new

to be player in Hepstitis C

Factor VIII that is needed for effective

treatment for rheumatoid arthritis.

market this year

hemostasis.

The FDA accepted the pair’s application for sarilumab, an antibody targeting an inflammation-related protein called interleukin-6, and has promised to hand down a final decision by October 30th. Across Seven Phase III trials, the injection beat out placebo in tamping down arthritis symptoms in more than 2,500 patients, including those who can’t

January 06, 2015, Fierce Pharma Merck & Co.’s CEO Kenneth Frazier

Samsung unveils

expects his company to be a player in

multisensory processor to

the lucrative hepatitis C market again

move mHealth beyond heart

with the anticipated approval this month

rate tracking

of its hep C candidate. That, along with

January 02, 2015, Fierce BiotechIT

some M&A deals and growth in oncology

Samsung has unveiled a processor,

should propel the world’s fourth largest

which they hope will become the

drug maker forward for some time.

cornerstone of the next-generation of wearable devices. The chip is designed

tolerate market-leading therapies like

Bristol-Myers recruits

AbbVie’s Humira and Amgen’s Enbrel.

to gather and process data on body fat,

Oncodesign to find new

skeletal muscle mass, heart rate rhythm,

ways of attacking tumors

skin temperature and stress, setting it

Philips and Banyan developing handheld blood test for concussions January 08, 2015, Fierce Medical Device Royal Philips and blood test developer Banyan Biomarkers together are developing a handheld blood test for concussions.


up to power devices with capabilities

Bristol-Myers Squibb recruited French

beyond those of the current generation

biotech Oncodesign to help find new

of wearables.

ways of attacking tumors. Under the deal, Oncodesign gets USD 3 million up front to begin screening some proprietary molecules against a group of Bristol-Myers-selected targets, and the company is in line for up to USD 80


Clinical Trials Cynata to trial

hematopoietic cell transplantation (HCT)

US ‘orphan status’ for

Cymerus

in mid-2016. The study will evaluate

Immunocore’s eye cancer

ProTmune’s tolerability and safety and

drug

January 28 , 2016, News.com

its potential to prevent cytomegalovirus

January 25 , 2016, Pharma times

Cynata Therapeutics will conduct clinical

(CMV) infection and acute graft-versus-

The US FDA has granted Immunocore’s

trials on its Cymerus mesenchymal

host disease (GvHD) – both are leading

IMCgp100 orphan drug designation

stem cell product, CYP-001, after

causes of mortality and morbidity in

for the treatment of uveal melanoma.

confirmation from the UK medicines and

patients undergoing HCT.

The move qualifies the UK biotech for

healthcare products regulatory agency. The company proposes a phase I clinical trial for Cymerus in patients with graft versus host disease. Centres in the EU, including the UK and Australia will be used, with additional countries targeted

FDA action date approaches for Merck’s HCV single tablet combo January 26 , 2016, Seeking Alpha The FDA’s PDUFA date for its priority

a number of development incentives and will enable a fast-track registration for the drug, which is currently in Phase IIa clinical trials for the treatment of late stage cutaneous and uveal melanoma.

review of Merck’s once-daily, single-

Merck & Co and Affimed

tablet combination therapy, grazoprevir/

to test Hodgkin lymphoma

Fate to move ProTmune

elbasvir (100 mg/50mg), for the

combo

into phase I/II study

treatment of chronic hepatitis C infection

January 25 , 2016, Pharma Times

(HCV) genotypes one, four or six

Merck & Co has signed a clinical

was Thursday.

trials deal with German biopharma

as discussions continue.

January 27 , 2016, Zacks Fate Therapeutics, Inc. announced that the FDA has cleared its investigational new drug (IND) application for ProTmune. Fate plans to initiate a controlled, randomised multi-center phase I/II study in adult patients with hematologic malignancies undergoing mobilised peripheral blood (mPB) and

The breakthrough therapy-tagged product candidate is a combination of an NS3/4A protease inhibitor (grazoprevir) and an NS5A replication complex inhibitor (elbasvir). In clinical studies, it demonstrated HCV cure rates as high as 100% after eight weeks of treatment.

Affimed that will test a combination of two immunotherapies for Hodgkin lymphoma. Under the deal, Affimed will fund and conduct a Phase Ib clinical trial to assess the potential of combining Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) with Affimed’s experimental AFM13


for the treatment of patients whose

testing and add to the manufacturing

Human trials set to begin

disease has relapsed or is refractory to

costs of the devices. The guidance

on Ebola vaccine

chemotherapy.

classifies sterilisation techniques into two categories - ‘established’ and ‘novel’

Amgen’s Kyproli’s

-- and requires additional information

backbone therapy

from companies using novel methods,

approved by FDA

because the chemicals or processes

January 22 , 2016, fierce biotech

being used have not been evaluated or

Back in March 2015, Amgen’s Kyprolis

cleared by the FDA.

posted impressive results in a head-

January 19, 2016, Technical.ly Whether it’s making headlines or not, the quest to discover an Ebola vaccine continues for biotech companies, including Profectus Biosciences. The Ebola outbreak was back in the news

to-head trial with Takeda behemoth

Unexplained death of two

recently as a new case was reported

Velcade-and now, those results have

patients, Zafgen says

in Sierra Leone only one day after the

helped it grab an important thumbs up

obesity drug cut weight in

outbreak was declared over.

Phase III

The East Baltimore company, which

med in tandem with dexamethasone


received new funding for its vaccine

or with dexamethasone plus Celgene’s

With its clinical development program

candidate as the recent Ebola outbreak

Revlimid to treat patients with relapsed

for a new obesity drug in limbo following

was raging in West Africa, is set to begin

or refractory multiple myeloma who have

the unexplained deaths of two patients,

clinical trials on humans, the company

already received between one and three

Zafgen reported that the troubled

announced.

other treatments.

Phase III study hit its co-primary efficacy

from the FDA. The agency approved the

endpoints in treating a rare eating Glenmark Pharma gets

disorder.

January 21, 2016, prhex Glenmark Pharmaceuticals Inc has

receives FDA approval for new Sapien 3 trial

US FDA approval for two generic drugs

Edwards Lifesciences

Lilly, Incyte file baricitinib in the US for rheumatoid arthritis

January 15 , 2016, Mass Device Edwards Lifesciences said that the FDA approved a new trial of its Sapien 3

been granted final approval by the US

January 19, 2015, Pharma Times

replacement heart valve. The Sapien 3

FDA for Potassium Chloride extended

Lilly and Incyte have filed for US

transcatheter aortic valve replacement

release capsules USP, 10mEq, of Actavis

approval of the experimental JAK

was approved last year by the federal

Laboratories FL, Inc.

inhibitor baricitinib as a treatment for

safety watchdog for patients at high risk

moderately-to-severely active rheumatoid

of death from open surgical procedures

arthritis. The drug is the only once-daily

to replace their aortic valve. The new

oral selective JAK1 and JAK2 inhibitor

investigational device exemption for the

currently in late-stage clinical studies for

Partner III trial is designed to evaluate

inflammatory and autoimmune diseases

the Sapien 3 TAVR in patients with a low

January 21, 2016, TheStreet

and so, if approved, would offer patients

K2M Group Holdings, Inc. announced it

mortality risk from open surgical valve

a new treatment option.

replacement.

K2M receives CE Mark for its next-generation RHINE(TM) cervical disc system

has received a CE Mark for the RHINE ™ Cervical Disc System, allowing for sale

Sorrento’s RA biosimilar

Janssen starts phase

and distribution of the product within

candidates successful in

I/III trial of imetelstat in

Europe and other countries.

Phase III

myelodysplastic syndromes

January 19, 2016, The PharmaLetter

January 15, 2016, PBR

Sorrento Therapeutics’ investigational

Janssen has started research and

biosimilars STI-001 and STI-002 for

development on the phase I/III clinical

treating advanced colorectal cancer and

trial to evaluate imetelstat in patients

January 21 , 2016, Smart Brief

rheumatoid arthritis have met primary

AdvaMed said the final guidance

with myelodysplastic syndromes (MDS).

endpoints in pivotal Phase III trials, the

issued by the FDA addressing sterile

Imetelstat, discovered by Geron,

Californian biotech firm confirmed.

is a potent and specific inhibitor of

FDA’s medtech sterilisation guidance increases testing requirements

medical devices submitted for 510(k) clearance would mean increased

telomerase that is administered by intravenous infusion.


The clinical trial, also referred to as the

for patients with chronic obstructive

increases drug potency by enhancing

IMerge study, is the second study to

pulmonary disease.

delivery of the drug to its target tissue,

be started under the global imetelstat license and collaboration agreement between Geron and Janssen Biotech Pluristem (PSTI) Gets FDA Approval for Phase I PLXR18 Trial

FDA: duchenne muscular dystrophy drug not ready for approval

which for this drug is the liver. Ionis and GSK are also collaborating on the development of IONIS-HBVRx, a generation 2.0+ antisense HBV drug.

January 14, 2016, healio.com

Both IONIS-HBVRx and IONIS-HBV-LRx

The US FDA issued a complete response

are part of Ionis’ alliance with GSK.

letter to BioMarin Pharmaceutical Inc.,

EC grants expanded

January 14 , 2016, Zacks

the maker of drisapersen, branded as

Pluristem Therapeutics Inc. announced

Kyndrisa, a drug to treat duchenne

that the FDA has cleared its

muscular dystrophy, indicating it has

investigational new drug (IND) application

not met requirements for efficacy. The

January 12 , 2015, FDA News

to begin a phase I trial on PLX-R18 cells

denial has drawn the ire of researchers

Irish device maker Medtronic has

for treating incomplete hematopoietic

and members of the duchenne patient

scored the CE Mark for its IN.PACT

recovery following hematopoietic cell

community who anxiously await the

Admiral drug-eluting balloon with an

transplantation (HCT).

approval of drisapersen and another

expanded indication for the prevention of

drug, eteplirsen, which was on the

restenosis. The device helps to provide

subject of an FDA committee meeting on

arteriovenous access to help maintain

January 22.

hemodialysis access in patients with

Mylan Seeks approval for generic advair diskus January 14, 2015, Pharmacytimes Mylan has submitted an abbreviated new drug application to the FDA for a generic

GSK initiates Phase I study of IONIS-HBV-LRx; Ionis gets milestone payment

indication to medtronic’s balloon device

end-stage renal disease by opening the artery and delivering paclitaxel to the vessel wall. A new 40 centimeter catheter specifically designed for AV

equivalent to GlaxoSmithKline’s advair

January 13 , 2016, European

access will also be available in Europe

diskus. If approved, Mylan would be able

Pharmaceutical Review

under the expanded indication

to manufacture and market fluticasone

Ionis pharmaceuticals has announced

propionate 100, 250, and 500 mcg and

that GSK has initiated a Phase 1 study

salmeterol 50 mcg inhalation powder.

of IONIS-HBV-LRx. IONIS-HBV-LRx

Advair Diskus is currently indicated for patients four years and older who have asthma or who need maintenance treatment of airflow obstruction. Advair Diskus can also reduce exacerbations

(previously referred to as ISIS-GSK6LRx) is a drug Ionis is developing with GSK for the treatment of patients with hepatitis B virus (HBV). IONIS-HBV-LRx incorporates Ionis’ LIgand Conjugated Antisense (LICA) technology that

Incyte and AstraZeneca announce new lung cancer trial collaboration January 11 , 2015, European Pharmaceutical Review Incyte and AstraZeneca are to evaluate the efficacy and safety of Incyte’s INCB39110 in combination with


AstraZeneca’s Tagrisso (osimertinib)

FDA clears Glaukos Phase

Merck KGaA, Pfizer

as a second-line treatment for patients

II iDose drug-eluting eye

Advance Phase III Trials of

with EGFR mutation-positive non-small

implant trial

Avelumab

cell lung cancer (NSCLC), who have

January 07, 2016, Mass Device

January 05, 2015, FDA News

been treated with a first generation

Glaukos said it won a nod from the FDA

German drugmaker Merck KGaA and

EGFR tyrosine kinase inhibitor (TKI) and

for an investigational new drug Phase II

Pfizer are moving ahead with a Phase

subsequently developed the T790M

study of its Travoprost intraocular implant

3 study of the immunotherapy agent

resistance mutation.

utilizing the company’s iDose delivery

avelumab as a maintenance treatment

system for patients with glaucoma

for patients with bladder cancer. The

Health Canada

FDA gave the o.k. to advance the trial

Blesses RPS Diagnostics’ FebriDx Test January 08 , 2016, FDA News Health Canada has issued a device license to RPS Diagnostics for its FebriDx test. The diagnostic helps to identify a pathogen-induced immune response to viral or bacterial acute febrile respiratory infection with a fingerstick blood sample. Results are available in 15 minutes, enabling the establishment of an effective patient treatment plan, RPS says

NAID’s dengue vaccine

for maintenance treatment in the first line

TV003 enters phase III trial

setting for patients with locally advanced

in Brazil

or metastatic urothelial cancer. It will

January 06 , 2016, NIH

assess treatment with avelumab plus

A large-scale clinical trial to evaluate

best supportive care versus BSC alone in

whether a candidate vaccine can prevent

roughly 670 patients.

the mosquito-borne illness dengue fever has been launched in Brazil. The vaccine, TV003, was developed by scientists in the laboratory of Stephen Whitehead, Ph.D., at NIH’s National Institute of Allergy and Infectious Diseases (NIAID).

TOP STORIES

1.

Clinical trials related to cancer drugs are being undertaken by companies to evaluate efficacy: •Merck KGaA and Pfizer are advancing with the phase III study of the immunotherapy agent avelumab (treatment for patients with bladder cancer). •Immunocore’s IMCgp100 which is undergoing phase IIa clinical trials has received orphan drug status.

2.

EBOLA still on the minds of the bio-tech companies: Profectus Biosciences is commencing clinical trials on humans. The company is looking to conduct phase I clinical trials on 39 people.

JLT Specialty Limited provides insurance broking, risk management and claims consulting services to large and


comes from focusing on sectors where

Company Specific News

we know we can make the greatest

As the fastest growing pharmaceutical

Big pharmaceuticals companies

difference – using insight, intelligence

market, Chinese pharma companies

teamed up with Britain’s top

and imagination to provide expert advice

are realising opportunity to tap

universities to increase medical

and robust – often unique – solutions.

increasing demand and thus investing

research:

We build partner teams to work

in rising healthcare market.

• Astra Zeneca, GlaxoSmithKline

side-by-side with you, our network and

Companies such as Jiangsu Hanosh

and Johnson & Johnson tied up

the market to deliver responses which

Pharmaceutical, China Resources

with Cambridge university, Imperial

are carefully considered from all angles.

Pharmaceutical, and Hutchison China

College London and University

MediTech are planning to spend

College London to developed a GBP

heavily on expansion and research and

40 million apollo therapeutics fund for

development for higher-value products:

new medicines research.

international companies. Our success

For more than a decade we have been the leading liability broker for larger life science companies, working with the majority of the leading players in

• Jiangsu Hansoh Pharmaceutical

the sector, from pharmaceutical and

Company is planning to extend its

agricultural to chemical and

reach by developing facilities and

research institutes.

• Each of the three companies will contribute GBP 10 million to Apollo over six years while each of the three universities will put in GBP 3.3

therefore it has planned to go public

million.

and raise over USD 3 billion. • China Resources Pharmaceutical

• Apollo will employ its own team of drug discovery experts to work

Group, China’s second-largest

with academics and the individual

pharma and a subsidiary of

companies may also contribute

state-owned China Resourc

additional resources

es (Holdings), is planning an IPO in Hong Kong to raise at USD

Chanelle Pharmaceuticals is in the

1 billion.

process to revamp its operations. The

• Hutchison China MediTech is filing a

CONTACT James Bird Head of Life Science Risk Practice JLT Specialty +44 (0)20 7558 3580 [email protected]

company has plans to increase its work

prospectus for its USD 1 billion IPO

force:

in the US.

• The company is planning to bring

Additionally, companies such as

EUR 70 million investment to double

Simcere Pharmaceuticals, Xiuzheng

its production, with addition of

Pharmaceutical, and Zhejiang Starry

175 new jobs in Loughrea, Galway

Pharmaceutical are in line to raise money

(Ireland).

from capital markets, to increase domestic

• The company also has plans to

capability and expand their presence.

expand into new markets, including the US, Central and South America.

This publication is for the benefit of clients and prospective clients of JLT Specialty Limited. It is not legal advice and is intended only to highlight general issues relating to its subject matter but does not necessarily deal with every aspect of the topic. If you intend to take any action or make any decision on the basis of the content of this newsletter, you should first seek specific professional advice. JLT Specialty Limited The St Botolph Building 138 Houndsditch London EC3A 7AW www.jltspecialty.com Lloyd’s Broker. Authorised and regulated by the Financial Conduct Authority. A member of the Jardine Lloyd Thompson Group. Registered Office: The St Botolph Building, 138 Houndsditch, London EC3A 7AW. Registered in England No. 01536540. VAT No. 244 2321 96. © March 2016 271633

TOP STORIES

1.

Chinese Pharmaceutical companies are raising funds through IPOs: Several promising Chinese drug developers are preparing to raise money from stock markets to improve presence in China’s expanding medical research base.

2.

Global Pharma giants formed a GBP 40 million Joint Venture with British universities: AstraZeneca, GlaxoSmithKline and Johnson & Johnson Innovation formed joint venture’s with Imperial College London, University College London and the University of Cambridge to perform scientific research into new medicines.

3.

Ireland’s largest pharmaceuticals manufacturer Chanelle Group are to invest EUR 70 million: The company will expand its production facility and plans to come up with dozens of new products. Company expects to increase sales by 65% over the next five years.