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/

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.
- Ends -

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."
- Ends-

22 May
Stifel
970.00
Buy
22 May
Numis
951.00
Buy

Broker Forecast - Peel Hunt issues a broker note on Clinigen Group
BFN
Peel Hunt today reaffirms its buy investment rating on Clinigen Group (LON:CLIN) and raised its price target to 1200p (from 1015p).

Story provided by StockMarketWire.com

Clinigen and Cumberland: FDA approval for Totect
RNS
RNS Number : 6070K
Clinigen Group plc
10 July 2017
 
RNS Reach
10 July 2017
 
  Clinigen and Cumberland Pharmaceuticals obtain
FDA approval for Totect® in the U.S.
 
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company and Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX, 'Cumberland'), a U.S. specialty pharmaceutical company, today announce they have obtained FDA approval for Totect® (dexrazoxane hydrochloride) in the U.S.
Totect is an 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.
In January 2017, Clinigen and Cumberland entered an exclusive U.S. agreement to commercialise Totect, the second such agreement under their Strategic Alliance, established in 2015. The FDA approval of Totect is an important milestone in the preparation for the U.S. launch of the product later this year.
Totect was acquired by Clinigen's Specialty Pharmaceuticals (SP) division in March 2016 to expand its dexrazoxane portfolio for the U.S. market. Clinigen SP also continues 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:
"Totect is the second SP product that we have exclusively licensed to Cumberland as part of the Strategic Alliance, and the FDA approval of Totect is an important milestone in its revitalisation strategy.
"Approval paves the way for launch, which will enable patients to access this vital FDA-approved emergency support therapy."
A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals said:
"We are delighted by the FDA approval of Totect for the United States, and we are looking forward to expanding the number of patients that will benefit from this important oncology support product.
"This is a significant next step for Cumberland as we build our position in oncology supportive care and further strengthen our Strategic Alliance with our partner, Clinigen."
 
-Ends-

Year End Trading Update
RNS
RNS Number : 3083L
Clinigen Group plc
18 July 2017
 
18 July 2017
              
 
Year end trading update
 
Strong full year performance with profits up over 20%
 
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 2017.
 
Highlights
 
§ Gross profit* expected to be up 22% driven by a combination of organic growth across all operations, a full year's contribution from Link Healthcare and currency benefits
§ Strong growth across Clinical Trial Services (CTS), Unlicensed Medicines, and Commercial Medicines
§ Outstanding performance in Africa and Asia Pacific
§ Dexrazoxane portfolio revitalisation significantly enhanced by positive CHMP** opinion on Cardioxane and Totect US approval
§ New simplified operating and reporting structure comprising CTS, Unlicensed Medicines and Commercial Medicines
 
Shaun Chilton, Group Chief Executive Officer of Clinigen Group said:
 
"This has been another excellent year with all three operations, CTS, Unlicensed Medicines and Commercial Medicines, performing strongly.
 
"We have made significant progress in our strategy to build scale and capability in high growth geographies in Africa and Asia Pacific. Now that Link's earn-out period has been completed, we will be able to further integrate and develop our complementary portfolio of businesses worldwide.
 
"Our priorities in the current financial year remain unchanged. We will drive organic growth across all parts of the Group and search for selective acquisitions to complement our existing offering and capabilities."
 
Group performance
 
Overall the Group has traded in line with the Board's expectations and all operations are well positioned to drive good growth in the current financial year.
 
Following the completion of the Link earn-out and subsequent closer integration of Link into the Group, the performance of the business will be reported as three operations; CTS, Unlicensed Medicines, and Commercial Medicines. This structure reflects how Clinigen operates in practice and will allow the Group to better capitalise on our market leading positions and expanded geographical footprint.
 
Gross profit, viewed as the best measure of top line growth, is expected to increase by around 22% compared to last year, driven by organic growth across all operations, a full year's contribution from Link Healthcare ('Link') and currency benefits following the depreciation of Sterling.
 
Revenues increased around 7% excluding the effect of the change in mix in Managed Access towards programmes where the product is provided by the pharmaceutical client free of charge, and the termination of a large Global Access low margin commercial contract, which was inherited with the Idis acquisition. This revenue growth is lower than the growth in gross profit primarily due to the change in mix in CTS towards higher margin products and activity. Reported revenue decreased around 11%.
 
CTS
CTS, representing around 19% of Group gross profits, delivered another year of excellent growth. It continues to add complementary services to the core business to respond to the increased demand from clients requiring more global and complex solutions.
 
Unlicensed Medicines
Unlicensed Medicines, encompassing the Managed Access, Global Access and the unlicensed business within the Link division, represents around 42% of Group gross profit. This part of the business delivered strong growth with the highlight being outstanding growth in the Africa and Asia Pacific region.
 
Commercial Medicines
Commercial Medicines, encompassing the Specialty Pharma division and the commercial business of the Link division, representing around 39% of Group gross profits, delivered another excellent year of progress.
 
Foscavir was an important driver of growth and Ethyol stepped up in the second half benefiting from the strategic partnership with Cumberland in the US. The Group's dexrazoxane portfolio comprising Cardioxane, Savene and Totect, performed as expected, with Totect achieving FDA approval in the final quarter in the US.
 
As announced in May 2017, a key development was the positive CHMP** opinion to modify the current product information for Cardioxane. It is expected that the European Commission will accept the CHMP opinion and will issue its approval shortly. As a result of the approval, physicians will be able to consider use of Cardioxane in paediatric patients where high dose anthracycline therapy is planned. The approval is expected to step up usage of Cardioxane in the medium term and further demonstrates Clinigen's ability to revitalise acquired products.
 
Excellent progress was made in the Africa and Asia Pacific region, building sales from Link's existing commercial portfolio and from the strategy of converting unlicensed medicines to licensed medicines.
 
Group overheads are expected to increase in line with budget as the Group 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.
 
Cash flow performance was significantly stronger in the second half of the year.  As a result, net debt has decreased to around £35 million as at 30 June 2017 from £70.9 million as at 31 December 2016. It is estimated that the deferred cash consideration on the Link acquisition, payable in October 2017, will be in the region of £40m.
 
The Group expects to publish its final results for the year ended 30 June 2017 on Thursday 28 September 2017.
 
*Gross profit growth rate includes 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.
 
**The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines.
 
- Ends -
 

Clinigen Group: A billion pound AIM company
Share
13:35 18 Jul 2017
Gross profit in the half year to December was up by 34%

INVESTMENT
OVERVIEW: CLIN
The Big
Picture
Clinigen saw strong growth across all divisions
There are not many £1bn market cap companies on AIM, but Clinigen PLC (LON:CLIN) is one and Shaun Chilton, chief executive, couldn’t be happier.
Speaking to Proactive Investors after a bumper year for the pharma services and drug group, he said business currently was very good.
Organic growth, a currency boost and full contribution from recent acquisition Link Healthcare helped gross profits rise by 22% in the year to June.
Chilton was especially pleased that all three of its divisions, clinical trial services, unlicensed medicines and commercial medicines, had made good progress.
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WATCH: Clinigen's Shaun Chilton 'couldn't be happier' with full year performance
There was an outstanding performance in Africa and Asia Pacific from the unlicensed medicines business, he added, where with recent acquisition Link's infrastructure it started to distribute drugs for epilepsy and breast cancer in partnership with Japanese firm Eisai.
In the commercial division, Foscavir, for HIV sufferers with herpes, and chemotherapy relief Ethyol benefited from the strategic partnership with Cumberland in the US. 
Approval is also expected soon in Europe for a reformulated version of Cardioxane, a chemotherapy toxicity treatment for children based on Dexrazoxane, while Totect, another in the Dexrazoxane portfolio, has now received the green light in the US.
READ: Clinigen Group set for European approval for Cardioxane
Clinigen 'cash as usual'
Debts halved over the year to £35mln with strong cashflow in the second half of the year and Chilton says that the business is still generating £1 of cash for every £1 of underlying profit [EBITDA].
Clinigen estimates it will pay a further £40mln as the final consideration for Link in October and following that will be on the look-out for more acquisitions. 
These may be either through more products, adding to its geographic footprint or else pushing deeper into the unlicensed medicines to licensed arena, he said.
Deals were more likely to be bolt-ons such as Link rather than deals on the scale of its £200mln acquisition of Idis.
£1bn valuation
Even though Clinigen is now worth well over £1bn Chilton in insists the company is still happy to remain on AIM.
It’s [AIM] been very good for us, he said and a move to the main market is not something it’s been discussing.
At 923p, or just shy of its all-time high, Clinigen is worth £1.06bn.

Clinigen receives EC approval for Cardioxane
RNS
RNS Number : 3337N
Clinigen Group plc
08 August 2017
 
8 August 2017
Clinigen receives EC approval for updates to Cardioxane product information
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, announces that its Commercial Medicines operation received a European Commission (EC) approval to update the current product information for Cardioxane.  
Cardioxane is an oncology support drug that prevents chronic cumulative cardiotoxicity caused by high dose anthracycline chemotherapy. In 1992, it was licensed for international markets but its label was revised in Europe as a result of an Article 31 referral in 2011. This restricted its indication and introduced a paediatric contraindication.
The EC approval follows a positive opinion issued by the EMA Committee for Medicinal Products for Human Use (CHMP) in May 2017, which was highlighted in the Group's trading update on 18 July, 2017.
Approval will enable physicians to consider the use of Cardioxane in paediatric patients where high dose anthracycline therapy is planned. The product information will also be updated to reflect a more favourable safety profile for Cardioxane in adult populations at the same time.
Since Clinigen acquired Cardioxane three and a half years ago, a multi-disciplinary team at Clinigen has actively engaged with an extensive group of international paediatric oncologists and cardiologists. The aim was to achieve updates to the product information, especially concerning the paediatric population, to align with new data.
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 and will submit amendments to the labelling in countries where Cardioxane licences are held.
Merav Edan, Head of Regulatory Specialty Pharmaceuticals of Clinigen said:
"EC approval is the final step to ensuring that the paediatric oncologists can effectively manage cardiotoxicity associated with anthracycline chemotherapy by using Cardioxane when needed. Not only that, the additional changes to the Cardioxane product information will extend its use in the adult population."
Shaun Chilton, Group Chief Executive Officer of Clinigen said:
"Final approval to enable Clinigen to implement the label change is a milestone achievement. This decision has been the work of many years, driven by a dedicated Clinigen team with the growing support of healthcare professionals. The impact for Cardioxane usage will not be immediate but this is a major regulatory achievement for us and demonstrates our ability to revitalise products so that they can benefit more patients over the long term."
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Quantum leaps after receiving takeover proposal from Clinigen
Wed, 16 August 2017




(ShareCast News) - UK pharmaceutical developer Quantum Pharma announced it had received an indicative proposal of a possible offer for the company from Clinigen Group.
The proposal from Clinigen and would be satisfied through a combination of new ordinary shares in its fellow London-listed company and cash.

Quantum's board did emphasise that the proposal was non-binding and is subject to preconditions including the customary due diligence.

It noted a further announcement would be made in due course.

Shares in Quantum had advanced 16.71% to 76.15p as of 1245 BST, while Clinigen was up 1.4% to 1,024p.

Clinigen and Cumberland launch Totect
RNS
RNS Number : 7306R
Clinigen Group plc
25 September 2017
 
RNS Reach
 
25 September 2017
Clinigen and Cumberland launch Totect® in the U.S. for emergency oncology intervention
 
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company and Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX, 'Cumberland'), a U.S. specialty pharmaceutical company, announced today the promotional launch of Totect® (dexrazoxane hydrochloride), in the U.S.
Totect is an FDA-approved hospital based emergency oncology intervention drug, indicated to treat 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 limit such damage without the need for additional surgeries and procedures and enable patients to continue their essential anti-cancer treatment.
In preparation for Totect's launch, Cumberland has completed the training of its sales and medical organization, stocked the product at wholesalers serving hospitals nationwide, and recently introduced the product website. Totect will be supported by Cumberland's hospital sales force.
Totect is Cumberland's second oncology support product and complements its current portfolio of specialty pharmaceuticals. Cumberland entered into an exclusive agreement with Clinigen to commercialize Totect in the U.S. earlier this year. Cumberland is managing all marketing, promotion, and distribution of the product in the U.S. Clinigen is responsible for manufacturing, regulatory, and clinical management of the product.
Totect was acquired by Clinigen in March 2016 to expand its dexrazoxane portfolio and enter the U.S. market. Clinigen will continue to commercialize its existing dexrazoxane products, Savene® and Cardioxane®, in Europe and other territories outside of the U.S.
Simon Clayton, Commercial Director, Specialty Pharmaceuticals of Clinigen said:
"The commercial launch of Totect in the U.S. is an important milestone in the dexrazoxane revitalization strategy at Clinigen. It will ensure that patients in the U.S. can access this vital FDA-approved emergency support therapy."
A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals said:
"This is a significant next step for Cumberland as we build our position in oncology supportive care while improving the quality of care for patients in the U.S."
 
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