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/

Clinigen GAP to Manage Raptor's PROCYSBI Program
RNS
RNS Number : 1615F
Clinigen Group plc
18 February 2015



Clinigen Group Adds New Named Patient Program to
Global Access Portfolio

Burton-on-Trent, UK - 18 February 2015 - Clinigen Group plc ('Clinigen' or the 'Group', AIM:CLIN) announces the latest program to be managed by Clinigen Global Access Programs (Clinigen GAP). The program will provide access to Raptor Pharmaceuticals Corp.'s PROCYSBI® (cysteamine bitartrate) for individual patients with nephropathic cystinosis. Through the program PROCYSBI® will be available worldwide, except for the USA where the drug is already commercially available, LATAM and a small number of European territories.

Nephropathic cystinosis is a rare, inherited condition caused by a build up of cystine that affects every cell in the body. Without treatment, patients can suffer from kidney and eye problems and eventually severe and irreversible damage to the heart, central nervous system and muscles. Approximately 2,000 people worldwide are currently diagnosed with the disorder1.

PROCYSBI® is a delayed-release form of cysteamine bitartrate that can be used to manage cystinosis by continually reducing the toxic levels of cystine in the cells. This can help to prevent cellular damage and delay the progression of cystinosis and its complications.

Mark Corbett, Senior Vice President, Clinigen GAP said: "Nephropathic cystinosis is a serious, progressive disease and the initiation of this program for PROCYSBI® is a key step in getting an important new therapeutic option to patients with limited treatment options. We are very proud that Raptor have selected Clinigen GAP as their partner to manage this global access program. We are able to utilize our extensive international expertise in project management, regulatory advice and logistics in order to ensure Raptor can effectively address this area of unmet medical need."

1Gahl WA, Kuehl EM, Iwata F, Lindblad A, Kaiser-Kupfer MI. Corneal crystals in nephropathic cystinosis: natural history and treatment with cysteamine eyedrops. Mol Genet Metab. 2000;71:100-120.

- Ends -

18 Feb Oriel... 650.00 Buy
18 Feb N+1 Singer 549.00 Buy
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UPDATE - Clinigen drug access programme gaining traction with second deal in a week

By Ian Lyall

February 18 2015, 1:26pm
This morning Clinigen said it had signed a deal with Raptor Pharmaceuticals, the US firm, to distribute PROCYSBI, a delayed-release form of cysteamine bitartrate used to treat nephropathic cystinosis.
This morning Clinigen said it had signed a deal with Raptor Pharmaceuticals, the US firm, to distribute PROCYSBI, a delayed-release form of cysteamine bitartrate used to treat nephropathic cystinosis.


---ADDS SHARE PRICE AND BROKER COMMENT---

Speciality pharma group Clinigen (LON:CLIN) is gaining significant traction for its global access programme, which provides patients with the opportunity to receive drugs not yet on the market.

This morning Clinigen said it had signed a deal with Raptor Pharmaceuticals, the US firm, to distribute PROCYSBI, a delayed-release form of cysteamine bitartrate used to treat nephropathic cystinosis.

This is a rare inherited condition, affecting 2,000 people worldwide, and is caused by the build-up of an amino acid called cysteine.

Untreated it can lead to kidney and eye problems and eventually severe and irreversible damage to the heart, central nervous system and muscles.

Clinigen will run its global access programme outside the US and a number of other territories where the drug already has full regulatory approval.

"Nephropathic cystinosis is a serious, progressive disease and the initiation of this programme for PROCYSBI is a key step in getting an important new therapeutic option to patients with limited treatment options,” said Mark Corbett, senior vice president of Clinigen GAP.

“We are very proud that Raptor have selected Clinigen GAP as their partner to manage this global access programme.

“We are able to utilise our extensive international expertise in project management, regulatory advice and logistics in order to ensure Raptor can effectively address this area of unmet medical need."

Last week Clinigen said had been appointed by AstraZeneca to manage a global access programme for its new antibiotic.

The Anglo-Swedish pharma giant is developing ceftazidame-avibactam, or CAZ-AVI for short, to combat drug-resistant Gram-negative bacterial infections.

It is still under investigation by scientists assessing its potential to tackle these tough-to-treat infections.

However, the Clinigen-run programme will offer certain patients with complicated urinary tract infections, complicated intra-abdominal infections and nosocomial pneumonia the opportunity to access the next-generation antibiotic.

It is the first time it has managed such an operation for AstraZeneca.

The shares, up 35% in the past six months, marked time at 537p.

Oriel Securities pointed out the stock trades at a discount to its peers while having “superior” growth prospects at it repeated its ‘buy’ advice.

Also a ‘buyer’ of the stock is N+1 Singer, whose analyst Elizabeth Klein said:

“This is the second win for the Clinigen GAP business in a few weeks, and we expect more business wins over the rest of this year.

Clinigen Signs Distribution Agreement with MSD
RNS
RNS Number : 0338G
Clinigen Group plc
27 February 2015



Clinigen Group Signs Distribution Agreement with MSD UK for Clinical Trial Supply Services

MSD Products Further Strengthen Clinigen's Clinical Trial Supply Services

Burton-on-Trent, UK - 27 February 2015 - Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN) today announces that its Clinical Trials Supply business (Clinigen CTS) has entered into an agreement with Merck Sharp & Dohme Limited ('MSD'), to distribute their human health products for use in clinical trials carried out in Europe. This agreement now represents the fourth arrangement Clinigen CTS has with manufacturers to distribute products.

Under the terms of the agreement, Clinigen CTS will be a preferred distributor and manage enquiries, order receipts and distribution of MSD's products to manufacturers, contract research organizations (CROs), clinical trial contract packagers and other specialist service providers looking to source pharmaceutical products as comparators, rescue and adjunctive drugs for use in clinical trials.

Steve Glass, Senior Vice President Clinigen CTS said: "The addition of this agreement further strengthens our position within the clinical trial supply market as we continue on our path to become the no.1 global clinical trial supply service provider."

- Ends -

About Clinigen Group

The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group, dedicated to delivering 'the right drug, to the right patient at the right time', has three operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). Clinigen CTS sources commercial medical products for use in clinical studies only. These include comparator drugs, where existing medical treatments are used as benchmarks to assess the effectiveness of investigative products, adjuvant drugs, which improve the effectiveness of the product being trialed, and rescue therapies, which help patients who have experienced a worsening of symptoms or insufficient therapeutic benefit during a trial.

For more information, please visit www.clinigengroup.com

Interim results for 6 months end 31 December 2014
RNS
RNS Number : 3140G
Clinigen Group plc
03 March 2015



Clinigen Group plc

Half year revenues up 17% to £72.6m, underlying EBITDA up 8% to £13.5m

Burton-on-Trent, UK - 3 March 2015 - Clinigen Group plc (AIM: CLIN, Clinigen or the Group), the global specialty pharmaceuticals and pharmaceutical services business, has today published its half year results for the six months ended 31 December 2014.

Financial highlights

- Group revenue up 17% to £72.6m (H1FY14: £61.8m); on a constant exchange rate basis up 21%

- Gross profit up 11% to £22.0m (H1FY14: £19.9m)

- Underlying EBITDA* up 8% to £13.5m (H1FY14: £12.5m), despite significant additional new product integration investment

- Adjusted underlying earnings per share** up 12.6% to 12.5p (H1FY14: 11.1p). Reported earnings per share up 5.7% to 9.2p (H1FY14: 8.7p)

- Interim dividend up 10% to 1.1p per share (H1FY14: 1.0p per share)

- Net cash of £12.9m at 31 December 2014 (30 June 2014: £5.3m)

Business highlights

- CTS: 28% revenue growth, 14 new customers, underlying activity up (requests up 11%, medicines supplied up 13%)

- GAP: 51% increase in units shipped, seven new programs to start in CY15 including first program for AstraZeneca for their product CAZ-AVI. Fycompa program extended for a further 18 months

- SP: SP sales and gross profit up 21% driven by new products and underlying volume growth in Foscavir. Ethyol acquisition (August 2014) already contributing to revenues. Revitalisation plans for dexrazoxane portfolio of products, Cardioxane and Savene on track. Final Marketing Authorisations for Cardioxane transferred from Novartis, in February 2015.

* Underlying EBITDA is defined as earnings before interest, tax, depreciation and amortisation excluding share based payments and associated Employer's National Insurance

** Underlying earnings exclude share based payments, associated Employer's National Insurance costs, amortization and are adjusted for associated tax

Peter George, Chief Executive Officer, said:

"After another strong first half, with all three divisions making good profit contributions, we are in a great position to continue our ambitious pursuit to become the world leaders in Clinical Trial Services, Global Access Programs and have a Specialty Pharmaceutical portfolio with 10 revitalized products.

"For the second half of the year gaining regulatory clearance for our dexrazoxane portfolio of drugs is a priority, along with the constant drive to convert the pipeline of new business and extend current customer relationships within CTS and GAP. In addition, we continue to explore opportunities to extend our global footprint and unlicensed supply market position.

"We anticipate another busy six months ahead."

-Ends-

An analyst briefing will be held at 9:30am today at the offices

3 Mar Investec N/A Hold
3 Mar Numis 770.00 Buy

Clinigen Extends Foscavir US Distribution Contract
RNS
RNS Number : 0764H
Clinigen Group plc
11 March 2015



Clinigen Group Extends Exclusive Foscavir® US Distribution Agreement
with Hospira to 2019

Burton on Trent, UK - 11 March 2015 - Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN) today announces the extension and renegotiation of the exclusive license and distribution agreement with Hospira, Inc ('Hospira') for its anti-viral product Foscavir® (foscarnet sodium) in the US. This is expected to be beneficial to both parties.

The original distribution agreement with Hospira established in July 2011 was due to expire in May 2017. The new agreement is for five years extending the term to 31 December 2019.

Foscavir® is Clinigen's lead product. Foscavir® received FDA approval in May 2012 for the treatment of HIV/AIDS-related cytomegalovirus infections and herpes. In September 2014, the FDA recognized the determined efforts made by Clinigen in providing Foscavir® to patients in the US by awarding Clinigen the first Drug Shortage Assistance Award.

Peter George, Chief Executive Officer, Clinigen Group said: "Hospira has been an excellent partner in the US, working closely with Clinigen since we acquired Foscavir®. The new five year agreement recognizes the strength of this partnership and shows the commitment of both Hospira and Clinigen to the continued supply of Foscavir® to US patients."

- Ends

UPDATE - Clinigen extends US distribution agreement for lead product

By John Harrington

March 11 2015, 4:39pm
The original distribution agreement with Hospira expired in May 2017, but this has now been extended until the end of 2019.



---ADDS BROKER COMMENT---

Clinigen (LON:CLIN) has renegotiated and extended its exclusive licence and distribution agreement with Hospira for its Foscavir treatment for HIV.

The agreement was due to expire in May December but not runs to the end of 2019 in a move that Clinigen said is expected to be beneficial to both parties.

Peter George, Clinigen’s chief executive, said: "Hospira has been an excellent partner in the US, working closely with Clinigen since we acquired Foscavir. The new five year agreement recognizes the strength of this partnership and shows the commitment of both Hospira and Clinigen to the continued supply of Foscavir to US patients."

Broker N+1 Singer reiterated its ‘buy’ recommendation and said: “Last week, in our sector piece, we upgraded our target price on Clinigen to 590p. At the time, we highlighted that we expected its portfolio of Specialty Pharma therapies to see good ongoing growth. Today’s announcement supports this.”

11 Mar N+1 Singer 590.00 Buy

Finally some appeal returning here. A new 52 week high today and more importantly we've broken the Nov14 high. Next stop 650P? - and perhaps quite rapidly after not having done much since the autumn.

Peel Hunt - buy - 717p
Investec - hold - 546p
N+1 Singer - buy - 590
Numis - buy - 770p

17 Apr Investec 550.00 Hold

Broker spotlight - Investec has put a hold rating on drugs distributor Clinigen (LON:CLIN).

A review of its competitive situation and key products suggests it can continue to grow its portfolio, but services is not growing as fast as expected so the broker downgrading earnings estimates down the road. Target price is 550p. Hold is the view.

Acquisition

£225 million Acquisition of Idis and £135 million Vendor Placing

It had to come soon, next shift upwards. Great news - haven't digested it all yet.

Blue sky coming...

Numis target price 860p

ROUNDUP – Clinigen shares jump as investors give £225mln acquisition the thumbs-up

By Ian Lyall

April 24 2015, 2:51pm
Some £2.5mln of revenue and cost synergies have been identified


---ADDS BROKER COMMENT---

Shares in the speciality pharma group Clinigen (LON:CLIN) jumped over 7% after it unveiled the £225mln acquisition of Idis Group - a deal that will create a market leader in the ethical unlicensed supply of medicines.

The purchase will be funded from Clinigen’s new debt facility and a £135mln vendor placing and is expected to be ‘significantly’ earnings enhancing in the first full year after the transaction.

Some £2.5mln of revenue and cost synergies have been identified.

But chief executive Peter George told Proactive Investors: “The real savings in this business are about driving growth through the business and changing some of the commercial terms in our business.

“So I think we will drive profit through the gross profit line much faster than we would through synergy savings because this is about a growth plan, not a cost saving plan.

“We want to hit the ground running and take the market by storm. This isn’t going to be done by making cuts in the business. That’s not what this is about.”

The companies will be filling a gap in the market by bringing potentially life-saving medicines to countries where they are not currently licensed.

A quirk of the current system is that many drugs and treatments that might have regulatory and safety clearance in the major developed or developing countries, remain unsanctioned in other territories.

“We want to become the healthcare professional solution for hospital pharmacies and clinicians to access unlicensed medicines in an ethical and completely controlled way,” George said.

Clinigen believes there is a major growth opportunity in combining the two businesses to create the biggest player in the ethical unlicensed supply market, which is estimated to be worth in excess of US$5bn a year.

“On completion, Clinigen, as the market leader, will be well placed to shape and define this fast growing and critically important market,” the company told investors.

Following the news, broker Numis repeated a 'buy' rating and upgraded its price target by 12% to 860p.

Meanwhile, broker Stifel said the acqusition would diversify Clinigen's business away from its over dependence on the antiviral drug Foscavir.

"However, Clinigen has retained the flexibility to make further bolt-on acquisitions of specialty pharma products. The deal clearly makes financial sense since it is earnings enhancing from the start as well as making Clinigen by far the largest player in the supply of unlicensed medicines."

Headquartered in Weybridge, in Surrey, Idis has established a significant business over the past 25 years supplying drugs predominantly on an exclusive basis through managed access programmes and on-demand through its general access division.

In the year ended February its revenues were just under £197mln, while earnings before interest, tax, depreciation and amortisation were £15.6mln.

“This acquisition satisfies a number of our key strategic goals - achieving the market leader position in the $5bn-plus unlicensed medicine supply sector and strengthening our leading position in the $2bn clinical trial supply market,” George said.

"The acquisition will also accelerate our growth and gives us a much better balanced portfolio of businesses, whilst extending our unique business model.

"The enlarged entity creates an incredibly exciting business with tremendous opportunities for growth.

“I am confident that, together with Idis, we have the right people to define and shape the unlicensed medicine supply market - an increasingly important health care sector for patients with unmet needs."

The deal is a particularly good one for CBPE, the private equity owner of Idis, which invested £9.4mln buying the business in 2005.

Idis managing director Tony Dutta said: “IDIS is now the clear market leader in a market with highly attractive long term growth fundamentals.

“CBPE have been an outstanding, partner, fully supporting us as we have grown the business over the long term.

“The acquisition by Clinigen marks the beginning of a new and exciting chapter in the continued development of the business.”

Clinigen’s investors reacted positively to the acquisition, helping push the stock up 47p to 572.5p, valuing the business at £466mln.

We've not seen the 6 big figure for some time. Rapidly up to life highs now?

Stifel new buy today, tp 650p

Yehaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa

Nice write-up in this week's IC before Idis acquisition.