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/

AGM Statement
RNS
RNS Number : 4909D
Clinigen Group plc
27 October 2015

27 October 2015

AGM Statement

Clinigen Group plc (AIM: CLIN, "Clinigen" or the "Group"), the global specialty pharmaceuticals business, is holding its Annual General Meeting ("AGM") at 10.00am today at Instinctif Partners' offices, 65 Gresham Street, London EC2 7NQ.

At the meeting Peter Allen, Clinigen's Chairman, and Peter George, Group Chief Executive Officer, will cover the following areas:

This has been a strategically transformational year for the Group. During the year, Clinigen has doubled the size of the business, strengthened its global capabilities, become the global market leader in the ethical supply of unlicensed medicines and continued the revitalization of its speciality products portfolio.

Through the acquisition of Idis, the Group has extended its unique, synergistic business model and created a better balanced portfolio of businesses. Clinigen is now the market leader in the $5+ billion unlicensed medicine supply sector and the $2 billion clinical trial supply market. The proposed acquisition of Link, due to complete shortly, will also substantially broaden the Group's international distribution footprint across the AAA region - Asia, Africa and Australasia.

As reported at Clinigen's full year results in September, all of its newer specialty pharma assets - Cardioxane, Savene and Ethyol - continue to progress to plan. The lifting of the EMA Article 31 referral for Cardioxane also remains on track.

Having completed the CFO handover period, described previously, Robin Sibson will step down from the role of CFO after the AGM and Martin Abell will now assume that role with immediate effect. The Board welcomes Martin and thanks Robin for the important role that he has played in the success and development of the Group. Robin will continue to work with the Group in his new role as a Non-Executive Director of Clinigen.

Clinigen's strong financial performance demonstrates its strengthened international position in growing markets. The Group is on track in advancing its underlying philosophy of getting the right drug to the right patient at the right time, regardless of where they are in the world.



-Ends-

products-the-priority-for-clinigen-says-deputy-chief-after-transformational-2015

Half yearly report


HIGHLIGHTS

§ Adjusted gross profit* doubled, reflecting change in scale following acquisitions

§ Adjusted EPS* up 21% to 15.1p (2014: 12.5p)

§ Interim dividend up 18% to 1.3p (2014: 1.1p)

§ £22.1m cash generated from operations, up 96%

§ Revitalisation of newer products has driven strong Specialty Pharmaceuticals performance

§ All commercial and most of operational integration complete for Idis

§ Link Healthcare acquisition builds global footprint, adding capability in Australia, Africa and Asia

§ Further extension of Dexrazoxane product line with the acquisition of Totect from Biocodex, opening up the US market for Clinigen (see separate announcement for further details)

§ Positioned for good growth in H2, in line with Board expectations

2 Mar Stifel 800.00 Buy
2 Mar Numis 916.00 Buy
2 Mar Peel Hunt 1,000.00 Buy

Trading statement Wed 20th

Trading update

RNS


RNS Number : 6704E

Clinigen Group plc

20 July 2016




20 July 2016





Year end trading update



Strong second half performance completes transformational year for Clinigen



Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, today provides a trading update for the 12 months ended 30 June 2016.



Highlights



· Revenue and gross profit up 87% and 90% respectively driven by acquisitions and organic growth*

· Significant step up in performance in H2, driven by Clinical Trial Services, Specialty Pharma and Managed Access

· Specialty Pharma portfolio enhanced by acquisition of Totect and product line extension for Foscavir

· Integration of Idis and Link acquisitions substantially complete



Peter George, Chief Executive Officer of Clinigen Group said:



"The integration of Idis and Link Healthcare has transformed the Group into the global market leader in the management and supply of both unlicensed and Clinical Trial medicines.



"We had a strong second half performance, completing a transformational year. The newer products in our Specialty Pharma portfolio are making good progress, demonstrating the effectiveness of our revitalisation model and we saw another excellent year in the Clinical Trial Services division.



"We are entering the new financial year in an excellent position, having delivered on our key strategic objectives. A major focus for FY17 will be to develop our Global Access on-demand unlicensed offering to hospital pharmacists, an exciting opportunity for the Group.



"Our priorities now are to capitalise on our market leader positions, drive organic growth and continue to progress the revitalisation of our products."





Group performance



Revenue and gross profit increased by 87% and 90% respectively versus last year. The growth has been delivered by a combination of the acquisitions of Idis in April 2015 and Link Healthcare in October 2015, as well as organic growth in the underlying business.



The Specialty Pharma division, representing 31% of Group gross profits, achieved good growth. Foscavir performed as expected during the year and the Foscarnet in bags product line extension, announced in May 2016, enhances the product and is expected to extend its lifecycle.



The newer products, Cardioxane, Savene and Ethyol made excellent progress in the year, collectively increasing gross profits by over 30%. The expansion of the Dexrazoxane franchise saw the addition of Totect in March 2016. Totect provides an important entry into the US and is expected to start providing revenues in the second half of FY17.



The Managed Access division, representing 26% of Group gross profits, had a good year after taking account of a complex integration following the Idis acquisition. As expected, the start of a number of important new programs resulted in a stronger performance in the second half, positioning the division well going into FY17.



The Global Access division, representing 14% of Group gross profits, recorded gross profits marginally ahead of last year. This is after taking account of the planned disposal of the low margin commercial contract discussed following the acquisition of Idis. The Group's market leading positions in the Managed Access space and the local capability and expertise provided by the Link acquisition, will enable us to capitalise on the considerable long term international opportunity in the 'on-demand' unlicensed medicine market.



The Clinical Trial Services division, representing 19% of Group gross profits in the year, delivered excellent growth combining strong activity within its existing customer portfolio with some important new customer wins through the year. Good levels of clinical trial activity, a widening customer base and the continued roll out of our value added services are expected to drive further strong growth in FY17.



Link Healthcare, representing 10% of Group gross profits in the year, had a solid underlying performance with the strongest growth coming from the developing Asian business. Whilst reported results for Link Healthcare have been affected this year by the depreciation of local currencies, particularly in South Africa, these effects are expected to reverse in the current financial year following the recent depreciation in sterling.



Integration of acquisitions



The integration of both the Idis business and Link Healthcare is substantially complete. Acquisition and integration costs relating to Idis and Link will be shown as non-underlying costs.



Net debt



Net debt has decreased from £76.2 million as at 30 June 2015 to around £67 million as at 30 June 2016 with the cash consideration for the Link Healthcare acquisition and the product acquisitions funded from the free cash flow of the Group.





EU Referendum



Brexit is not expected to have any adverse effects on the Group in the short term. Whilst the outcomes are not yet clear, the Group's flexible operating model, the team's deep understanding of multinational regulatory process and with around 85% of revenues being from International markets, it is expected that any medium to long term implications will be manageable.



Outlook



Overall the Group has traded in line with the Board's expectations and all divisions are well positioned for good growth next year.



The Group expects to publish its final results for the year ended 30 June 2016 on Wednesday 28 September 2016.



*Revenue and 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.



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20 Jul Stifel 800.00 Buy
20 Jul Numis 916.00 Buy
20 Jul Peel Hunt 1,000.00 Buy

Notice of Results

RNS


RNS Number : 8709I

Clinigen Group plc

07 September 2016




7 September 2016



Notification of full year results date



Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN), the global pharmaceutical and services company, will announce its full year results for the year ended 30 June 2016 on Wednesday, 28 September 2016.

Final results wed 28 Sept

Should be an upbeat set of results according to Shares.

Proactive investor -Clinigen/Cumberland launch oncology treatment in US
Share
14:56 26 Sep 2016
Shaun Chilton, Clinigen’s deputy chief executive said Ethyol’s US launch formed a key part of its global revitalisation strategy for the drug.

Drug will be Cumberland's first oncology treatment
Clinigen Group PLC (LON:CLIN) and its US partner Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX) have launched the first product following their strategic licence last year.
Ethyol (amifostine) for injection is one of Clinigen’s key Specialty Pharmaceuticals brands and as well as being the first product Cumberland has licensed through the alliance, it is also its first oncology product in the US.
Ethyol helps to reduce xerostomia or dry mouth in patients receiving post-operative radiation treatment for head and neck cancer.
It can also reduce toxicity in women receiving cistplatin chemotherapy for ovarian cancer.  
Cumberland will distribute and market the drug and provide support services.
Shaun Chilton, Clinigen’s deputy chief executive said Ethyol’s US launch formed a key part of its global revitalisation strategy for the drug.
 AJ Kazimi, Cumberland’s chief executive, added: “We have worked diligently to prepare for the introduction of Ethyol and are excited to expand our activities into hospital-based oncology and this new patient population."

Full year results


HIGHLIGHTS
·     Adjusted gross profit* up 90%, driven by acquisitions and organic growth
·     Adjusted EPS* up 25% to 35.0p (2015: 28.0p)
·     Net debt decreased £8.1m to £68.1m, after £28.5m spent on acquisitions
·     Full year dividend increased 18% to 4.0p (2015: 3.4p)
·     Strongest performances by Specialty Pharmaceuticals, driven by revitalisation of newer products, and CTS
·     Integration of Idis and Link acquisitions substantially complete
·     Acquisition of Totect and Foscavir bag line extension enhances Specialty Pharmaceuticals portfolio
·     Shaun Chilton to become CEO on 11 November 2016, when Peter George steps down
(see separate announcement)

28 Sep
Stifel
800.00
Buy

28 Sep
Numis
933.00
Buy

28 Sep
N+1 Singer
800.00
Buy
28 Sep
Peel Hunt
1,000.00
Buy

Clinigen launches Japanese business
RNS
RNS Number : 7557M
Clinigen Group plc
18 October 2016
 
18 October 2016

Clinigen launches Japanese business to strengthen Asian presence
Clinigen Group plc (AIM: CLIN, 'Clinigen' or 'the Group'), the global pharmaceuticals and services group, has launched its Japanese business with the opening of an office in Tokyo, Japan. The establishment of Clinigen KK further expands the Group's presence in Asia, following Clinigen's acquisition of Link Healthcare in 2015.
Alongside the launch, Clinigen KK will transfer the Marketing Authorisation for its lead Specialty Pharmaceutical (SP) product Foscavir® (foscarnet sodium) back from Nobel Pharma on 1 November 2016. Nobel Pharma has been the distribution partner for Foscavir in Japan since 2011.
Foscavir is indicated to treat cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) or Cytomegalovirus viremia and cytomegalovirus disease in hematopoietic stem cell transplant (HSCT) patients. Japan was the first market where Clinigen successfully achieved a new license extension for HSCT patients in 2011.
Japan remains an important market for Foscavir with more than 2,000 patients treated annually. Clinigen will assume full marketing and distribution responsibility for Foscavir from November, to supply the product to healthcare professionals and patients across Japan. 
Clinigen KK is a significant milestone for the Group in expanding its global footprint as Japan is the second largest pharmaceutical market globally. The Japanese business will allow the Group to supply and distribute both licensed and unlicensed medicines in the country, providing additional infrastructure to support Clinigen's mission to deliver the right medicine to the right patient at the right time.
Clinigen employs over 500 people globally, across 11 locations. The opening of the Japanese office further expands its international supply chain and operational network.
Shaun Chilton, Chief Executive Officer-designate, said:
"We are focused on building our market leadership positions by expanding in key geographic regions to drive sustained organic growth and better address unmet patient needs for access to critical medicines.
"The opening of our Japanese business helps support our goals and will enable us to effectively serve the Japanese market by supplying our own products, beginning with Foscavir.
"At a time when many pharmaceutical and biotechnology companies are looking for specialist partners to work with them in Asia, the opening of our Japanese office gives us more opportunities to provide customers with our global expertise combined with local knowledge."


- Ends -

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.
 
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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.
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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.
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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