Dealings in Clinigen shares are expected to commence on AIM at 8.00am on Tuesday 25 September 2012, under the ticker symbol CLIN





Clinigen is a rapidly-growing specialty pharmaceutical and services company, with one clear aim: to deliver the right drug to the right patient at the right time.




To achieve our aim, we have built a group of complementary businesses which can operate efficiently in a complex global regulatory environment and which can ensure that precious medicines are delivered securely and effectively, wherever they are needed. Through three businesses, Clinigen SP, Clinigen GAP, and Clinigen CTS, we acquire, license and revitalise niche, hospital-only critical care medicines, and source and supply our own and other pharmaceutical companies’ products, whether to meet unmet medical needs or for use in clinical trials.





Clinigen Clinical Trials Supply (CTS):

We use our global expertise, systems and relationships to source and manage the supply of commercial medicines to pharmaceutical companies for use exclusively in clinical trials. This requires excellent knowledge of the global pharmaceutical market, the regulatory processes and customs authorities of countries all over the world, along with a high tech supply chain with guaranteed quality and safety standards that can deliver swiftly.

Clinigen Global Access Programs (GAP):

On behalf of pharmaceutical and biotech companies, we manage essential programs that provide access to critical medicines for physicians and their patients all over the world. But what is a Global Access Program? Known by many terms from ‘expanded access’ and ‘named patient’ to ‘compassionate use’ and ‘early access’, a global access program enables physicians to access treatments that are not available in their own country for patients with an unmet medical need. Wherever they are, we can deliver treatments quickly, efficiently and, most importantly, ethically.

Clinigen Specialty Pharmaceuticals (SP):

We acquire niche medicines that don’t fit into the portfolio of larger pharmaceutical companies. These are typically hospital-only treatments for rare or life-threatening diseases, and we specialise in revitalising them – finding new treatment areas; new markets where we can get them licensed; or, potentially, new formulations. All the while, we’re ensuring that patients already using the medicine continue to get the treatment they need, while the company whose product we have acquired can feel confident that its reputation is being well looked after.

We are currently 100+ people, headquartered in Burton-on-Trent in the UK, with facilities in Philadelphia, US, and Tokyo, Japan, and an office in London. With a customer services team who speak over 19 languages between them, our clients from all over the world find us easy to do business with, while doctors and pharmacists find us a valuable source of information about how to access the medicines they need for their patients.




http://www.clinigen.co.uk/

18 Oct
Peel Hunt
1,000.00
Buy

7 Nov
Peel Hunt
1,000.00
Buy

7 Nov
Numis
933.00
Buy

AGM Statement
RNS
RNS Number : 9093O
Clinigen Group plc
11 November 2016
 
11 November 2016
 
 
 
 
AGM statement
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, is holding its Annual General Meeting ("AGM") at 10.00am today.
At the AGM, Peter Allen, Clinigen's Chairman will say:
"The year to 30 June 2016 marked the completion of our transformation into the global market leader in the management and supply of both unlicensed and clinical trial medicines.
"Alongside significant strategic progress, we delivered a strong financial performance with good levels of organic growth combining with acquisitions to increase adjusted EPS* by 25%. Trading for the current financial year remains in line with the Board's expectations.
"At the management level, as you know, Peter George will step down as CEO after the AGM and Shaun Chilton will now take over. We are pleased Peter will continue to work with the Group as a Non-Executive Director.
"Our focus is now fixed on leveraging our global leadership positions, and we will continue to drive organic growth supported by acquisitions and the revitalisation of products."
*Adjusted basic earnings per share is excluding share based payment costs, non-underlying costs, amortisation and associated tax credit.
 
- Ends-

Clinigen collaborates with Eisai in South Africa
RNS
RNS Number : 6197Q
Clinigen Group plc
01 December 2016
 
RNS Reach
1 December 2016
 
Halaven® (eribulin) receives registration in South Africa for treatment of women with advanced breast cancer
Collaboration between Eisai and Clinigen provides women in South Africa with access to eribulin for advanced breast cancer
Halaven® (eribulin) is now registered by the Medicines Control Council (MCC) in South Africa for the treatment of women with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Eribulin was discovered and developed by Eisai and will be available to people in South Africa through a partnership with Equity Pharma, part of Clinigen's Link Healthcare division.
Approximately 7,000 women are diagnosed with breast cancer in South Africa each year.1 Eribulin monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane unless patients were not suitable for these treatments.2
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"This is the first distribution agreement of this kind for Clinigen following our acquisition of Link Healthcare in 2015, and marks the continuation of a successful relationship with Eisai. As partners in the distribution of eribulin, we can leverage our comprehensive South African distribution network and local expertise to deliver this important medicine to eligible women across the country, marking an important moment in the fight against advanced breast cancer in the region."
Gary Hendler, Chairman and CEO EMEA & Global Chief Commercial Officer, Oncology Business Group, Eisai, said:
"Through our close partnership with Clinigen South Africa, Eisai will officially enter the South African market with the launch of eribulin and together we strive to make a meaningful difference to the lives of patients with advanced breast cancer."
Eisai is dedicated to the discovery, development and production of innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives to better understand the needs of patients and their families to increase the benefits health care provides.
- Ends -

Clinigen signs agreement with BioQ Pharma
RNS
RNS Number : 8919R
Clinigen Group plc
15 December 2016
 
15 December 2016
CLINIGEN GROUP PLC
Clinigen signs Global Access agreement for BioQ Pharma's post-operative pain management product, Ropivacaine Readyfusor
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, announces that its Idis Global Access (GA) division has signed a supply and distribution agreement with BioQ Pharma, a developer of large volume ready-to-use infusible products. The deal covers the on-demand supply and distribution of BioQ Pharma's pre-filled Ropivacaine Readyfusor for post-operative pain management in Europe, excluding France and Germany.
Under the terms of the agreement, Idis GA will make the Ropivacaine Readyfusor available, prior to it receiving its national marketing authorisation, on an exclusive on-demand basis to physicians and pharmacists in the UK. Idis GA will also supply the product to other European territories prior to approval and will manage distribution to provide ethical access to the product.
The Ropivacaine Readyfusor is a disposable, single use infusion product which is pre-filled by the manufacturer with 0.2% Ropivacaine, a non-narcotic local anaesthetic. It is a self-contained drug and administration system for delivery at the point of care, activated by a single touch. The Ropivacaine Readyfusor contains a sterile drug that is hermetically sealed until time of use.
The ready-to-use product delivers Ropivacaine at a pre-determined rate to provide pain control for at least
48 hours after surgery.
Steve Glass, Chief Commercial Officer (North America and Europe) of Clinigen said:    
"As the global leaders in providing trusted, ethical access to unlicensed medicines, this agreement means that we can enable healthcare professionals to access the Ropivacaine Readyfusor on-demand for their patients.
"This partnership with BioQ Pharma marks another important supply agreement for Idis GA. It demonstrates the continuing demand from pharmacists and physicians for a compliant route to obtain medicines that are unlicensed or unavailable in their country. There is also an increase in engagement from manufacturers to work with us to help provide continuous access to their products, to better serve patients with unmet medical needs."
Walter Cleymans, Vice President of Europe of BioQ said:                                                                  
"We are pleased to make Ropivacaine Readyfusor available to patients in Europe with the assistance of Idis GA. The Readyfusor is intended to provide effective pain relief following surgery, while providing a convenient, self-contained, and ready-to-use presentation that should reduce the number of steps needed to administer the drug to the patient."
The Ropivacaine Readyfusor comes completely ready-to-use from the manufacturer, it is intended to help avoid filling errors and breaches in sterility often associated with conventional elastomeric "pain pumps". The Ropivacaine Readyfusor's proprietary design precludes the risk of overdosing due to delivery malfunctions. The product should be prescribed post-surgically for medically appropriate procedures that require at least 48 hours of pain relief. Ropivacaine can be administered as a continuous surgical site infusion or continuous peripheral nerve block.
Healthcare professionals can obtain details about the Ropivacaine Readyfusor pre-filled infusion product by emailing customer.services@clinigengroup.com.
- Ends-

Clinigen and Cumberland enter agreement for Totect
RNS
RNS Number : 6909T
Clinigen Group plc
09 January 2017
 
9 January 2017
 
  Clinigen and Cumberland Pharmaceuticals enter exclusive U.S. commercialisation agreement for Totect®

Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global pharmaceutical and services company and Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX, 'Cumberland'), a U.S. specialty pharmaceutical company announce an exclusive agreement to commercialise the oncology support drug, Totect® (dexrazoxane hydrochloride) in the U.S.
This is the second product Clinigen has licensed to Cumberland under the strategic alliance established in 2015, following the launch of Ethyol® (amifostine) in the U.S. in September 2016.
Totect is an FDA-approved emergency oncology intervention which is indicated to reverse the toxic effects of anthracycline chemotherapy in case of extravasation. Extravasation occurs when an injected medicine escapes from the blood vessels and circulates into surrounding tissues in the body causing severe damage and serious complications. Totect can reverse such damage without the need for additional surgeries and procedures, enabling patients to continue their essential anti-cancer treatment.
Under the terms of the agreement, Cumberland has been granted an exclusive U.S. license and will manage all marketing, promotion, and distribution of Totect in the U.S. Clinigen will retain responsibility for manufacturing, regulatory and clinical management of the product. Preparations are now underway for the U.S. launch of Totect later this year.
Totect was acquired by Clinigen's Specialty Pharmaceuticals (SP) division in 2016 to expand its dexrazoxane portfolio and enter the U.S. market. Clinigen SP will continue to commercialise its existing dexrazoxane products, Savene® and Cardioxane®, in Europe and other territories outside of the U.S.
Shaun Chilton, Chief Executive Officer of Clinigen said:
"This agreement marks an important milestone for Clinigen. Totect is the second Specialty Pharmaceuticals product that we have exclusively licensed to Cumberland as part of the strategic alliance signed in 2015. Cumberland is a valuable partner, providing us with the opportunity to expand our dexrazoxane portfolio into the sizable U.S. market and enabling patients to access this vital FDA-approved emergency support therapy."
A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals said:
"It's good to see another product emerge from our strategic partnership with Clinigen, as we continue to selectively expand our line of marketed hospital brands. We are keen to help yet another group of oncology patients with Totect, which reflects our mission of delivering products that help improve patients' quality of care."
 
-Ends

Clinigen initiates program for TESARO's niraparib
RNS
RNS Number : 3742U
Clinigen Group plc
17 January 2017
 
17 January 2017

  Clinigen initiates U.S. Managed Access program for TESARO's niraparib for patients with ovarian cancer

Clinigen Group plc's (AIM: CLIN, 'Clinigen') Idis Managed Access (MA) division has partnered with TESARO Inc. (NASDAQ: TSRO), to launch a Managed Access program (also known as an expanded access program (EAP)) for the investigational PARP 1/2 inhibitor, niraparib.
Niraparib is being made available for eligible women in the U.S. with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following a complete or partial response to platinum-based chemotherapy.
Approximately 22,000 women are diagnosed each year with ovarian cancer in the U.S. Despite high response rates to platinum-based chemotherapy, 85% of women with advanced ovarian cancer will recur after first line treatment, at which point, the disease is treatable but incurable.
Most patients who recur after first or second line therapy are treated with a further round of platinum-based chemotherapy, if they responded to the previous one. However most do not receive any type of treatment post-response to the platinum-based treatment regimen and must watch and wait for the inevitable recurrence. Unfortunately, the efficacy of chemotherapy diminishes over time and most women will recur again quickly.
Niraparib is an oral, once-daily PARP 1/2 inhibitor. It is administered following a response to platinum-based chemotherapy which may address the difficult "watchful waiting" periods experienced by patients with recurrent ovarian cancer after the completion of chemotherapy, in between cycles of platinum-based chemotherapy. Niraparib has been accepted for priority review by the U.S. Food and Drug Administration.
The Managed Access program allows physicians to request niraparib for individual, eligible U.S. patients who may not be able to participate in a clinical trial nor have any other treatment option, but who may benefit from access to this investigational therapy prior to approval.
Steve Glass, Chief Commercial Officer, North America and Europe, of Clinigen said:
"As the global leader in providing access to unlicensed medicines, we have delivered over 220 Managed Access programs which have benefited thousands of patients.
"There is a clear area of unmet medical need in the treatment of ovarian cancer, the fifth most common cause of death from cancer among women in the U.S. We are pleased to be partnering with TESARO to deliver this Managed Access program for niraparib, providing women with the opportunity to gain access to this important investigational therapy at the earliest possible moment."
 
U.S. based Healthcare Professionals can obtain details about the niraparib Managed Access program by calling a Clinigen representative at: 1-877-786-4303, or emailing niraparibUSEAP@clinigengroup.com.

-Ends-

HY trading update

RNS


RNS Number : 0139V

Clinigen Group plc

25 January 2017




25 January 2017


HY trading update: strong H1 performance with gross profit up 34%



Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, today provides a trading update for the six months ended 31 December 2016.



Highlights

· Gross profit* up 34% driven by a combination of good organic growth across all divisions, a full six months contribution from Link Healthcare and currency benefits

· Excellent growth by Link Healthcare and Clinical Trial Services

· Strong growth in Managed Access and Specialty Pharma



Shaun Chilton, Group Chief Executive Officer of Clinigen, said:



"We have delivered good growth across all divisions following the successful integration of the Idis and Link Healthcare acquisitions.

"Link Healthcare has achieved an outstanding performance, demonstrating the value of its acquisition by the Group. Among the other divisions, Clinical Trials Services has again delivered a standout performance. Managed Access and Specialty Pharma also delivered strong growth.

"We are trading in line with our expectations and are well positioned to deliver good performances across all divisions in H2.

"Our priorities remain to drive organic growth by capitalising on our international market leading positions and expanded geographical footprint. We will also continue to look for selective acquisitions that meet our return criteria in order to enhance our product portfolio and / or service capabilities."



Group performance



Gross profit* increased approximately 34% compared to last year. The increase was driven by good levels of organic growth across all business divisions, a full six months contribution from Link Healthcare, which was acquired in October 2015, and favourable exchange rate effects following the depreciation of Sterling.



The Specialty Pharmaceuticals division, representing approximately 29% of Group gross profit, achieved strong growth in the first half with each of the products in the portfolio performing as expected.



The transfer of the US license for Ethyol to the Group's US strategic partner, Cumberland Pharmaceuticals, was completed in H1 of the financial year and the benefits are expected to be seen in H2. Totect, purchased last year, is on course to start generating sales in Q4 of the financial year.



Discussions with the regulator continue to move in a positive direction on Article 31 in respect of lifting the restriction of using Cardioxane with certain adult patient populations.



The Managed Access division, representing approximately 23% of Group gross profit, had a strong first half benefiting from the ramp up of a number of programmes won in the last financial year.



The Global Access division, representing approximately 12% of Group gross profit, made solid progress. The number of exclusive supply agreements increased and the first key contract converted from early access to on-demand 'point of care' access.



The Clinical Trial Services division, representing approximately 17% of Group gross profit, achieved excellent growth. Activity within its existing customer base was strong and the division achieved some important customer wins in H1. Whilst the visibility for Clinical Trial Services is always more limited, the current pipeline positions the business to complete another good year of growth.



Link Healthcare, representing approximately 19% of Group gross profit, delivered significant organic growth across all geographies and benefited from the translation effects from the depreciation in Sterling (more than 35% pro forma growth for six months versus six months last year). The launch of the Japanese business further strengthens Clinigen's presence in Asia.



Group overheads increased in line with budget as Clinigen continues to strengthen the infrastructure and management team to support its long term growth ambitions.



The implementation of the Group's ERP system, which will make the business more efficient and scalable, is progressing to plan. Cliniport, which strengthens our market proposition by providing enhanced online access to unlicensed medicines, is ready to be launched in H2 of this financial year.



Net debt



Net debt at the period end is approximately £71 million (31 December 2015: £81.5 million). As expected, net working capital increased in the first half due to the timing of cash flows around period ends and the completion of a large contract with favourable working capital characteristics. As previously guided, capital expenditure has been higher than usual due to budgeted spend on the IT system, which is currently being implemented.



Outlook



The Group is trading in line with the Board's expectations and all divisions are well positioned to drive good levels of organic growth in the second half of the financial year.





The Group expects to publish its interim results for the six months ended 31 December 2016 on Wednesday 15 March 2017.



*Gross profit growth rates include Clinigen's share of the South Africa Joint Venture and exclude the impact of the release of the fair valuation of inventory acquired with Idis and Link Healthcare. Under IFRS, the Joint Venture is excluded from revenue, gross profit and profit before tax and the Group's share of the Joint Venture's profit after tax is included in the Profit and Loss Account as 'other income'. The release of the fair value element of inventories is included in the non-underlying costs of the Group.



- Ends -

25 Jan Numis 933.00 Buy
25 Jan Stifel 900.00 Buy
25 Jan N+1 Singer 895.00 Buy
25 Jan Peel Hunt 1,000.00 Buy

Proactive investor - Clinigen, Convatec and Sinclair Pharma stand out among mid-cap pharmas says Peel Hunt
Share
12:47 24 Feb 2017
Clinigen is a core pick as a defensive GARP (growth at reasonable price) play.

Multiple headwinds have keep sector depressed
Clinigen PLC (LON:CLIN) is one of only a few bright spots in a subdued healthcare sector according to broker Peel Hunt.
Headwinds such as the outlook for US drug pricing, broader macro concerns such as taxation policy and a strengthening US Dollar have kept the yoke firmly on mid-cap pharma shares over the past year.
In response, investors have been switching out of “riskier” pharma/biotech stocks into perceived safer havens such as lab tools and services players.
The broker sees little evidence that these trends will turn soon but argues companies where growth is relatively secure but with potential for some upside surprise still have appeal.
Clinigen fits the bill suggests Peel Hunt, which has a buy rating and has upgraded its target price to 1,015p.
Since June last year the share price has risen by 58% but there is more to come argues the broker and Clinigen is a core pick as a defensive GARP (growth at reasonable price) play.
“Defensive from being pharma aligned without significant pricing risk, while delivering solid EPS growth (2016- 20: 14%).
“Growth is being driven by increasing pharma out-sourcing and deeper synergies between divisions.
“The stock also offers exposure to faster growing pharmerging markets with potential for balance sheet utilisation through specialty product acquisition.”
Other companies to consider are ConvaTec PLC ( LON:CTEC), which is a buy with a 300p target, and Sinclair Pharma PLC (LON:SPH) with a target price of 68p.
ConvaTec’s secure mid single-digit top-line growth derives from its leading positions (1-3) across medtech consumables sub-segments and geographies.
“Low working capital and capex burdens see strong cash conversion, supporting a 35-45% dividend payout for a mid single-digit yield by 2020.”
Sinclair Pharma, meanwhile, is Peel Hunt’s favourite growth story in UK small & midcap healthcare.
“We see Sinclair as a way to play the “luxury goods” consumer market through healthcare.
“Sinclair is a pure-play on aesthetic dermatology, selling next generation minimally-invasive (injectable) products that provide subtle yet noticeable cosmetic enhancement (lifting and plumping) for significantly better results vs traditional fillers.”
Share prices today were 32p fpr Sinclair, 232p for ConvaTec and 825p for Clinigen.

Halaven� (eribulin) launches in South Africa
RNS
RNS Number : 9895X
Clinigen Group plc
28 February 2017
 
28 February 2017
RNS Reach
 
Halaven® (eribulin) launches in South Africa for the treatment of women with advanced breast cancer
Eisai and Clinigen enter partnership to provide eribulin in South Africa for women with advanced breast cancer
 
Halaven® (eribulin) is now available in South Africa for the treatment of women with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens for their advanced disease. Prior therapy should have included an anthracycline and a taxane, unless patients were not suitable for these treatments1.
Approximately 7,000 women are diagnosed with breast cancer in South Africa each year and 30% will develop recurrent advanced or metastatic disease2. Metastatic breast cancer is deemed incurable and only one third of women with metastatic breast cancer will be alive five years after diagnosis2.
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"This is the first distribution agreement of its kind for Clinigen following our acquisition of Link Healthcare in 2015, and provides access to eribulin in South Africa. This launch builds on our strong relationship with Eisai allowing us to further demonstrate our local distribution knowledge and expertise."
Gary Hendler, Chief Commercial Officer Oncology Business Group, Chairman and CEO EMEA, Eisai, said:
"We are excited and pleased to launch eribulin to South Africa for patients with advanced breast cancer. Eisai discovered and developed eribulin, and have partnered with Equity Pharma from Clinigen Group's Link Healthcare division to introduce eribulin in South Africa. We hope that this launch will make a meaningful difference to the lives of patients and their families."
 - Ends -

First-in-class Fycompa� approved in South Africa
RNS
RNS Number : 0799Z
Clinigen Group plc
10 March 2017
 
10 March 2017
RNS Reach
  
First-in-class Fycompa® (perampanel) approved in South Africa for partial-onset seizures
Partnership with Clinigen to provide perampanel in the region
 
Eisai is pleased to announce that perampanel has been approved in South Africa for the adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures in patients with epilepsy aged 12 years and older.1 Perampanel is the first anti-epileptic drug to be approved in South Africa in recent years.
Perampanel is the only licensed anti-epileptic drug to selectively and non-competitively target AMPA* receptors. These receptors play a critical role in the onset and spread of seizures.2
Epilepsy affects one in every 100 people in South Africa, which amounts to an estimated half a million people living with the condition in the country.3 In addition, 20-40 per cent of people with newly-diagnosed epilepsy can become refractory to currently available treatments, which require further adjunctive medication.4
 
Dr Dave Anderson, Specialist Adult Neurologist, Wits Donald Gordon Medical Centre, said:
 "Many epileptic patients have poorly controlled seizures despite the plethora of treatments available. It is exciting to see the approval of a new treatment such as perampanel in South Africa. It will be a welcome addition to the clinician's arsenal of treatments and patients could benefit from its unique mode of action."
 
The approval of perampanel is based on three pivotal Phase III studies (304, 305 and 306)5,6,7 and an open extension study 307,8 which show consistent results in the efficacy and tolerability of perampanel as an adjunctive therapy in patients with partial-onset seizures, with or without secondary generalisation. The most commonly reported adverse events were dizziness, somnolence, fatigue, headache, falls, irritability and ataxia.8
To ensure access of perampanel to patients with epilepsy in South Africa, Eisai is collaborating with its regional partner Clinigen.
 
Johann Willemse, Chief Commercial Officer, Rest of World, Clinigen, said:
"Perampanel is the second product we are working on together with Eisai in South Africa. We have forged a strong partnership, based on Eisai's innovative products and our ability to leverage our extensive distribution network in the region and local expertise. Together, we can enable access to perampanel where it is needed most."
 
Neil West, Vice President Global Neurology Business Group, Eisai, said:
"Eisai is committed to the therapeutic area of neurology and to addressing the unmet medical needs of people with neurological conditions and their families. Ensuring patient access to new treatments underlines Eisai's human health care mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide."
*AMPA = alpha-amino-3-hydroxy-5-methyl-4-isoxazole-propionate
- Ends -

10 Mar
Numis
933.00
Buy

Half year report

HIGHLIGHTS
§ Adjusted gross profit* up 34% driven by organic growth across all divisions, a full six months contribution from Link Healthcare and currency benefits
§ Adjusted EPS* up 31% to 19.0p (2015: 14.5p)
§ Interim dividend increased 23% to 1.6p (2015: 1.3p)
§ Excellent performances by Link Healthcare and Clinical Trial Services
§ Launch of Japanese business, enhancing licensed and unlicensed presence in Asia
§ Global Access added further exclusive supply agreements
§ First contracts converted from Managed Access to Global Access

Launch of a European Patient Access programme
RNS
RNS Number : 6197Z
Diurnal Group PLC
16 March 2017
 
16 March 2017
 
Diurnal Group plc
("Diurnal" or the "Company")
 
Diurnal appoints Clinigen to launch a European Patient Access programme for Infacort® and Chronocort®
 
Infrastructure and supply chain now in place to provide Infacort® and Chronocort® as unlicensed medicines to patients on a Named Patient basis
 
 
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces a partnership with Clinigen Group plc's (AIM: CLIN) IDIS Managed Access ("IDIS") division to launch a Patient Access programme in Europe for the Company's lead products, Infacort® and Chronocort®, for patients with diseases of cortisol deficiency.   
 
The Patient Access programme will enable physicians in Europe to prescribe Infacort® and Chronocort® as unlicensed medicines on a Named Patient basis for patients who have no other treatment options, ahead of anticipated European approval and commercial launch of the products.
 
Infacort® is a preparation of hydrocortisone (the synthetic version of cortisol) specifically designed for use in children suffering from adrenal insufficiency (AI), including the related disease, congenital adrenal hyperplasia (CAH). Chronocort® is a modified release hydrocortisone preparation that has been designed to mimic the natural circadian rhythm of cortisol when given in a twice-a-day "toothbrush" regimen for the treatment of adult CAH.
 
AI and CAH are characterised by deficiency in cortisol, an essential hormone in regulating metabolism and the response to stress. AI is identified as a rare disease in Europe where there are estimated to be approximately 4,000 sufferers younger than the age of six. Poor control of the disease can result in premature puberty in young children, virilisation in girls and chronic fatigue leading to a poor quality of life in adulthood resulting in increased morbidity and mortality.
 
CAH is the most common inherited (genetic) hormone disorder affecting both men and women. Approximately two thirds of CAH patients are estimated to have poor disease control. The condition is estimated to affect approximately 51,000 patients in Europe. Poor disease control can lead to increased mortality, infertility and severe development defects including ambiguous genitalia, premature sexual development and short stature. Sufferers, even if treated, remain at risk of death through an adrenal crisis. 
 
Martin Whitaker, CEO of Diurnal, commented: 
"Our first product, Infacort®, is currently undergoing regulatory review with the EMA. Whilst this is ongoing, we are focused on putting in place the appropriate infrastructure to ensure that patients with cortisol deficiency but no other treatment options can access this medicine as efficiently as possible. As a global leader in providing unlicensed medicines to patients on a Named Patient basis, Clinigen is well placed to help us make Infacort® and Chronocort® accessible to patients ahead of their potential approval."
 
Steve Glass, Group Managing Director of Clinigen, said:
"The effective treatment of patients with CAH and paediatric AI represents a significant unmet need. As the global leader in providing Managed Access programmes, we can leverage our international reach to support these patients by enabling their physicians to access these therapies safely, ethically and quickly, ahead of approval and launch."  
 
Diurnal submitted a Paediatric Use Marketing Authorisation (PUMA) application for Infacort® to the European Medicines Agency (EMA) in late 2016. Diurnal anticipates that the EMA review process could take up to one year to complete. 
 
Chronocort® is currently in Phase III clinical development with the trial scheduled to complete in 2018. If the results of the Phase III trial are supportive, Diurnal plans to submit Chronocort® for market approval in Europe.

16:50 04/04/2017
Broker Forecast - Numis issues a broker note on Clinigen Group
Numis today upgrades its investment rating on Clinigen Group (LON:CLIN) to buy (from add) and set its price target at 951p. Story provided by StockMarketWire.com

4 Apr
Stifel
970.00
Buy

Clinigen and Onxeo initiate MA programme in Europe
RNS
RNS Number : 1822D
Clinigen Group plc
25 April 2017
 
RNS Reach
25 April 2017
Clinigen and Onxeo initiate Managed Access programme for belinostat in Europe for patients with peripheral T-cell lymphoma (PTCL)
 
Clinigen Group plc's (AIM: CLIN, 'Clinigen' or the 'Group') Idis Managed Access ('MA') division and Onxeo S.A (Euronext Paris, Nasdaq Copenhagen: ONXEO, 'Onxeo'), have agreed to launch a Managed Access programme for belinostat (Beleodaq®) in Europe. Belinostat is for use in patients with relapsed or refractory peripheral T-cell lymphoma ('PTCL').
PTCL is a form of blood cancer comprising of a group of rare and aggressive non-Hodgkin lymphomas ('NHLs'), a malignant lymphoproliferative disorder. PTCL accounts for approximately 10%-15% of all NHL cases.
Belinostat is a histone deacetylase inhibitor used to treat refractory or relapsed PTCL. The product received accelerated approval* by the US Food and Drug Administration ('FDA') in July 2014 due to the unmet medical need in this rare disease. There are no approved treatments for PTCL in Europe.
The programme allows physicians to request belinostat for individual patients for whom alternative treatment options are not currently available. This enables patients on a named patient basis in Europe** to benefit from belinostat treatment ahead of a potential European approval.
Steve Glass, Chief Commercial Officer, North America and Europe, of Clinigen said:
"There is a huge unmet need for patients with aggressive blood cancers such as PTCL. As the trusted global leader in access to unlicensed medicines, Clinigen is working in partnership with Onxeo to help patients gain access to this important medicine.
"As Clinigen and Idis MA, we have delivered over 220 Managed Access programmes to thousands of patients. We help physicians access medicines when no other treatment options are available reducing unmet clinical need. This aligns with our mission of getting the right medicine to the right patient at the right time."
Judith Greciet, Chief Executive Officer of Onxeo said:
"Consistent with our efforts to address the unmet needs of people diagnosed with relapsed or refractory PTCL, we are pleased to partner with Clinigen to establish this Named Patient programme. In selected European countries in which local health authorities permit the programme, the belinostat Managed Access programme will allow healthcare professionals to prescribe belinostat to specific patients."
Healthcare Professionals can obtain details about the belinostat Managed Access programme by calling a Clinigen representative at: +44 (0) 1283 44 347, or emailing customer.services@clinigengroup.com.
*Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
** Programme will be launched in: United Kingdom, Germany, France, Spain, Italy, Denmark, Sweden, Norway, Finland, Belgium, The Netherlands, Luxembourg, and Austria.
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Clinigen achieves positive Cardioxane CHMP opinion
RNS
RNS Number : 7353F
Clinigen Group plc
22 May 2017
 
RNS Reach
22 May 2017
Clinigen achieves positive CHMP opinion concerning Cardioxane in Europe
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, announces that its Specialty Pharma (SP) division has achieved a positive CHMP opinion in Europe to modify the current product information for Cardioxane.  It is expected that the European Commission (EC) will accept the CHMP opinion and will issue its approval later this year. This is a significant step forward in the assessment of the regulatory application which should ultimately allow physicians to consider use in paediatric patients where high dose anthracycline therapy is planned.
Since Clinigen acquired Cardioxane in March 2013, the Group has actively engaged with paediatric oncologists and cardiologists in the European Union (EU) and United States (US) to understand new data which supported a change to the product information. This work has been driven by a common desire for physicians in the EU to be allowed to use Cardioxane in children who previously did not have that option due to the paediatric contraindication introduced during the Article 31 referral (2011). 
Once final EC approval is obtained, physicians will be able to consider using Cardioxane to protect the hearts of paediatric cancer patients when they plan to administer a cumulative dose of more than 300mg/m2 of doxorubicin or the equivalent cumulative dose of another anthracycline. 
The safety profile of the product was also reassessed in the adult population. The regulatory authorities have agreed that the new data demonstrates a more favorable safety profile for Cardioxane, which will also be reflected in the updated product information.
This represents a major regulatory achievement for the Group and is a key milestone in the revitalisation of the Cardioxane brand by Clinigen SP.  Clinigen will implement appropriate safety measures to ensure the continued safe use of the product and to expand the clinical understanding in the paediatric population.
Ivo Timmermans, Chief Medical Officer of Clinigen said:
"Paediatric oncologists and cardiologists have been limited in their options to effectively manage cardiotoxicity associated with anthracycline chemotherapy when used to treat certain childhood cancers. I am proud of the fact we have been able to work with EU and US experts and the regulatory agencies to reach this positive CHMP opinion, which should result in changes to the Cardioxane product information."
Shaun Chilton, Group Chief Executive Officer of Clinigen said:
"The CHMP positive opinion on Cardioxane follows a significant international effort between Clinigen, paediatric oncologists and cardiologists. This clearly demonstrates our capabilities in revitalising our products so that they can benefit more patients. It is a significant milestone in our history to be part of a change that could offer Cardioxane as an additional option for children being treated for certain types of cancer."
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22 May
Stifel
970.00
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22 May
Numis
951.00
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