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/

HAEi Global Access Program for RUCONEST� Now Live
RNS
RNS Number : 5738T
Clinigen Group plc
21 July 2015

HAEi Global Access Program for RUCONEST® Now Live

Unique patient organization-driven program is enabling people with HAE who cannot access effective treatments to receive medication for the first time

Clinigen Group plc ("Clinigen" or the "Group", AIM: CLIN) and Pharming Group N.V. ("Pharming" or the "Company"), Euronext: PHARM) today announce that their global collaboration to provide access to Pharming's RUCONEST® (conestat alfa) is now live. The unique access program was initiated by HAEi, the International Patient Organization for C1- Inhibitor Deficiencies.

RUCONEST is a recombinant human C1- inhibitor, approved by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for the treatment of acute attacks of hereditary angioedema (HAE). The "HAEi GAP" program enables patients in all countries where RUCONEST is not commercially available to gain access to the drug through an ethical and regulatory compliant "Named Patient Program" mechanism.

Physicians wishing to request RUCONEST through the HAEi GAP program should contact the Clinigen customer services team at customer.services@clinigengroup.com or on 0044 1283 494340.

"HAEi is committed to securing access to HAE medications for patients across the globe," said Anthony J. Castaldo, President of HAEi. "We are extremely proud to have established HAEi GAP with our current partners and to be able to announce that, from today, physicians are able to request RUCONEST to meet the needs of their patients."

Simon Estcourt, Managing Director, Managed Access, Clinigen Group said: "We are very pleased to work with Pharming to help HAEi realize their mission to ensure that sufferers of hereditary angioedema worldwide can access this effective and potentially life-saving treatment. The ground-breaking program provides RUCONEST to patients in an ethical and compliant way, removing the need and the risk for patients to resort to other less reliable or even illegal sources of the drug."

Sijmen de Vries, CEO, Pharming said: "As the first pharmaceutical company to partner with HAEi and provide access to RUCONEST through HAEi GAP, we are leading the charge to improve the lives of those HAE patients that otherwise would continue suffering from this debilitating and unpredictable disease."

- Ends -

Year end trading update
RNS
RNS Number : 7047T
Clinigen Group plc
22 July 2015

22 July 2015

Year end trading update

Strong profit growth with underlying EBITDA up at least 20%; integration of Idis well underway



Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN), the global pharmaceutical and services company, today provides a trading update for the year ended 30 June 2015.



Highlights

· Revenues increased in excess of 45% to not less than £183.6m (2014: £126.6m).

· Gross profit increased in excess of 30%, mainly driven by greater than 25% growth in Specialty Pharmaceuticals (SP) gross profits and the acquisition of Idis.

· Underlying EBITDA up at least 20% to not less than £32.2m (2014: £26.8m).

· Notable year for acquisitions:

o August 2014, SP strengthened the oncology support portfolio with the acquisition of Ethyol® (amifostine) from AstraZeneca.

o April 2015, acquired Idis for £225m, establishing the enlarged Group as the market leader in the ethical supply of unlicensed medicines.

o Both acquisitions are performing strongly in line with expectations.

· Strong cash generation and, as at 30 June 2015, closing net debt was £78.0m (2014: net cash £5.3m).



Group performance

Clinigen continues with its strategy of organic growth supplemented with acquisitions.



The acquisition of Idis, with its established Global Access (GA) and Managed Access (MA) businesses, has positioned the Group as market leader in the ethical supply of unlicensed medicines. These businesses are being integrated into the Group and the operational and financial benefits are already clearly apparent.



The Group's Clinical Trial Services (CTS) and SP businesses delivered organic revenue growth in excess of 30% and 25% respectively.



All divisions have shown revenue and gross profit growth in H2 compared to H1, with Group full year gross profit increasing by in excess of 30%.



Group underlying EBITDA growth was more than 20% to not less than £32.2m, of which half the growth was due to acquisitions and the other half was organic.



Peter George, Chief Executive Officer, Clinigen said,

"This has been another tremendous year for Clinigen. Organic growth has been significant and the £225m acquisition of Idis has propelled us into market leader position in the fast growing ethical supply of unlicensed medicines and strengthened our CTS business.



"Ethyol has strengthened the SP portfolio and we are seeing further product acquisition and complementary opportunities which supports our strategy to focus on niche, hospital-only, specialty drugs.



"The enlarged Group of four operating businesses is integrating well and the Idis businesses are already contributing to the overall strong trading performance. Strategically, the focus for the current financial year is to strengthen our global footprint."



Acquisition of Idis

The acquisition of Idis on 24 April 2015 was financed by a vendor placing raising gross proceeds of £135.0m and £105.8m drawn down under new debt facilities.



Clinigen now operates as four synergistic businesses across the full spectrum of supply for unlicensed and licensed medicines - from early stage products still in clinical trials to approved products that may not be accessible due to lack of regional licenses or market withdrawal.



Acquisition and integration costs relating to Idis will be shown as non-underlying costs. Taking these costs into account, the reported profit before tax and earnings per share is expected to be lower than the prior year.



Operational businesses

· Clinical Trial Services (Clinigen's Clinical Trials Supply and Idis' Clinical Trial Procurement businesses)

CTS is performing well against the parameters by which it is measured. There has been significant growth in sales for FY15 compared with the prior year, with revenue growth in excess of 30% driven by the US.



The business has also seen in excess of 10% growth in the number of medicines delivered and the number of customers has increased from 73 to 85. The number of customers with sales greater than £5.0m has risen from five to seven. Overall, absolute gross profit has grown in excess of 5%.



· Managed Access (Clinigen's Global Access Programs and Idis' Managed Access Programs)

This business has grown significantly over the year. The key measure that reflects this growth is the number of drug units delivered. Combining Clinigen and Idis for a full year, MA has seen an increase of deliveries to 418,000 units delivered through 62,000 shipments; this is up from 263,000 units across 40,000 shipments in the previous year on a comparable basis.



Clinigen is now the global market leader of the exclusive managed access market which is valued at c.$500m-$600m.



· Global Access (Idis' General Access)

The business has shown solid growth in gross profits, with margins in excess of 20%.



The ethical unlicensed medicine market is estimated at $8-$10 billion. The Idis GA business provides a stable footing for Clinigen to secure a large proportion of this ethical market. Clinigen plans to build on the Idis brand and relationships beyond the UK into Europe. Over time the Group will move into the global space through strategic acquisition.



Clinigen also intends to develop the Idis e-commerce system - an online platform that is essential to the GA business and will be instrumental in driving global reach.



· Specialty Pharmaceuticals (Clinigen's SP)

SP remains the largest contributor to the Group's gross profits accounting for in excess of 50%, and showed gross profit growth of over 25% in the year.



All five products in the portfolio contributed to revenue and gross profit growth, notably Ethyol, where its revitalisation is on track. The SP team also continues to pursue overturning Article 31 with respect to the dexrazoxane portfolio and progress so far is positive.



Overall, Clinigen continues to deliver on its objective of building its SP portfolio and is on track to have 10 products over the next three to four years.



Management Team

In light of the Idis acquisition, Clinigen has taken the opportunity to review and restructure its management team to ensure effective management across the enlarged business. Consequently, Shaun Chilton has been promoted from COO to Deputy CEO of the Group. As previously announced, Martin Abell will join at the beginning of August 2015 as a director, and CFO elect during a period of handover from Robin Sibson.



Additionally the Group now has significant leadership experience in all four divisions. The managing directors of each business are as follows: Simon Estcourt (MA), Mark Corbett (GA), Steve Glass (CTS) and David Moran (SP).



The information contained in this statement has not been audited and may be subject to further review. The Group expects to publish its final results for the year to 30 June 2015 on Tuesday 22 September 2015.



-Ends-

Going great guns here, soon to be breaking the 700p. Broker target prices:

23/07 Edison 871p
22/07 Stifel 740p
22/07 Numis 840p
05/06 Peel Hunt 1000p

Nicely breaking £7 now.

29 Jul N+1 Singer 800.00 Buy

A quick romp higher to 800p looks quite possible before a pause.

Strong performance again today.

Jim Slater - Clinigen

Following its game-changing acquisition of a rival firm, Idis, for £225m, Clinigen is now a market leader in the supply of ethical unlicensed medicines – which have the potential to become a very large international market. The deal, which was financed by a £135m share sale and debt, will be earnings-enhancing in the first full year, with cost savings to come in later years.

A trading update on July 22 for this financial year was very positive.

At 761p Clinigen shares are on a forward p/e ratio of 24 with a forecast growth rate in earnings per share of 26pc and a further 20pc increase to follow in 2017.

Numis Securities, the company’s broker, has a target price of 840p and Peel Hunt is more optimistic with £10.

The shares are expensive but they are a strong hold.

1 Sep Numis 840.00 Buy

Notification of Full Year Results Date
RNS
RNS Number : 9190X
Clinigen Group plc
03 September 2015

3 September 2015



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 2015 on Tuesday, 22 September 2015.



A group analyst briefing will be held at 9:30am on Tuesday, 22 September 2015 at Instinctif Partners' offices at 65 Gresham Street, London EC2V 7NQ.



Analysts who wish to participate should contact Instinctif Partners on +44 (0)20 7457 2020 or email clinigen@instinctif.com to register

New alliance with Cumberland Pharmaceuticals
RNS
RNS Number : 3074Z
Clinigen Group plc
17 September 2015

17 September 2015



Clinigen Group signs strategic alliance with Cumberland Pharmaceuticals



Partnership strengthens Clinigen's global footprint

and gives Cumberland Pharmaceuticals access to new international markets



Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN), the global pharmaceutical and services company, has agreed to a strategic alliance with Cumberland Pharmaceuticals Inc. ('Cumberland', NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care. The alliance will combine Clinigen's and Cumberland's respective strengths, expertise and geographical footprints to maximize the commercial potential of future products.



As part of Clinigen's continuing strategy to extend its global presence, this collaboration will build on Clinigen's existing North American relationships by providing complementary support from Cumberland in the development, marketing, promotion and distribution of future products in the US.



Clinigen will be responsible for the marketing, promotion, distribution and sale of selected Cumberland pharmaceutical products, enabling Cumberland to use Clinigen's strong international reach to enter in to new markets outside of the US.



Peter George, CEO of Clinigen Group plc, said:

"A key strategic initiative this year has been to develop our Group's global distribution footprint. The US is a particular area of focus where we are looking to initiate a long term strategic partnership and Cumberland was a natural fit as a partner. Working together is a logical move for both companies as we will mutually benefit from each other's distribution expertise and capabilities in our respective regions."



AJ Kazimi, Chairman and CEO of Cumberland, added:

"This alliance with Clinigen creates a new growth driver for both companies that builds on our strengths. We look forward to working closely with Clinigen to bring its future products to patients in the US through our established commercial infrastructure. In turn, our products will gain access to new markets in other parts of the world."



Clinigen is focused on delivering the right drug to the right patient at the right time by providing medicines to patients with high unmet needs through clinical trials, licensed and ethically unlicensed supply. As part of this it acquires and revitalizes essential niche medicines to ensure pharmacists and doctors can continue to use the treatments their patients rely on and the business is always looking for new products to develop the pipeline.



Cumberland Pharmaceuticals acquires, develops and commercializes branded prescription products designed to improve quality of care and address unmet medical needs. The company focuses on underserved niche markets in the US and currently markets five FDA approved products. These products include Acetadote® (acetylcysteine) injection for the treatment of acetaminophen poisoning and Vaprisol® (conivaptan) injection, for the treatment of hyponatremia. Cumberland also has a development pipeline with candidates in Phase II studies.



-Ends-

Final results - Tues 22 Sept

Good results and heading back towards the highs. Some good business alliances being formed too.

New MA program with Neuraltus Pharmaceuticals
RNS
RNS Number : 5825Z
Clinigen Group plc
21 September 2015

21 September 2015



Clinigen Group and Neuraltus Pharmaceuticals Announce Partnership to Initiate a Managed Access Program for Investigational ALS Therapy in Europe

Clinigen Group plc's ('Clinigen' or the 'Group', AIM: CLIN) Idis Managed Access (MA) division and Neuraltus Pharmaceuticals, Inc., a privately-held biopharmaceutical company focused on the development of drugs to treat neurodegenerative diseases, announced today that the companies are partnering to initiate a Managed Access program for NP001, Neuraltus' investigational therapy for amyotrophic lateral sclerosis (ALS). The partnership makes the Managed Access program immediately available in selected European countries and is expected to gradually expand over the next year.



ALS, or Lou Gehrig's disease, is a rare and fatal neurodegenerative disease characterized by the degeneration of motor neurons in the spinal cord and brain. There are approximately 400,000 ALS patients worldwide, including 50,000 patients in Europe. Most patients and physicians report only modest slowing of ALS progression from existing treatments for ALS, underscoring the need for new and effective drug therapy.



"By partnering with companies like Neuraltus, Idis Managed Access plays a vital role in providing ethical access to unapproved medicines, like NP001, for patients with unmet medical needs," said Simon Estcourt, Managing Director, Idis Managed Access, Clinigen Group. "Our global regulatory and logistical expertise mean that we can deliver a fast and efficient response to physician inquiries. We look forward to working with both Neuraltus and the ALS community, to help patients in Europe who have no other available treatment options."



"Managed Access programs are about giving patients timely access to potential new therapies for devastating diseases, before the therapies are approved for general use," said Rich Casey, President and Chief Executive Officer at Neuraltus Pharmaceuticals, Inc. "We have received numerous inquiries from physicians, patients and their families regarding access to and inclusion in clinical studies for NP001. The planned Phase 2 study in the United States, coupled with our ability to provide NP001 to qualifying patients under a Managed Access program in Europe, underscores our commitment to the ALS community."



Access to NP001 will be provided by Idis MA to individual ALS patients who meet the established eligibility criteria via a regulatory compliant mechanism, following a physician request. European healthcare professionals can obtain details about the NP001 Managed Access program by calling +44 (0)1932 824 123 or via email at global@idispharma.com. Additional information can also be found on Neuraltus' website.



- Ends -

7% fall today - Director's dealings

07 Oct 2015 Clinigen Group Peter Allen 91,464 0 0
07 Oct 2015 Clinigen Group Peter Allen 91,464 685 626,528
07 Oct 2015 Clinigen Group Peter George 825,556 0 0
07 Oct 2015 Clinigen Group Peter George 825,556 685 5,655,059
07 Oct 2015 Clinigen Group Robin Sibson 1,000,000 685 6,850,000
07 Oct 2015 Clinigen Group Shaun Chilton 412,778 0 0
07 Oct 2015 Clinigen Group Shaun Chilton 412,778 685 2,827,52

Looks overdone, on director sales. Hopefully will hold the gains today.

So the gains didn't last long, back to the 200 day moving average. I took my profits out not so long ago but still running my initial outlay, which might also be coming out very soon.

Is that another "knifecatcher"?

I don't believe so, the business is doing well but when the CFO realises £6m...
You could also argue that a good price to get in at this level.

Some useful reasons:
Is now on a dowtrend
I do not like shares on a forward PE of 15 though is on a good growth path and although it has come down a lot recently is still on a prospective of 20
There is always a "cat bounce " but the trend is your friend also.
take it or leave it the choice is yours @ 623.25p