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 acquires Savene

RNS


RNS Number : 5151D

Clinigen Group plc

31 March 2014






Clinigen Group Acquires Oncology Support Therapy SAVENE®
(dexrazoxane) from SpePharm AG

Acquisition strengthens Clinigen's position in dexrazoxane market

Burton-on-Trent, UK - 31 March 2014 - Clinigen Group plc ('Clinigen' or the 'Group') (LSE: CLIN) (AIM: CLIN) the specialty global pharmaceutical company today announces the acquisition of SAVENE® (dexrazoxane) from SpePharm AG, a majority owned affiliate of Norgine B.V. The Financial terms of the acquisition are not being disclosed.

SAVENE is indicated for the treatment of extravasation in anthracycline chemotherapy in adults. Extravasation occurs when anticancer drugs, normally injected into a vein, leak or are accidentally injected into tissue surrounding the vein where they can cause serious damage. SAVENE is the only authorized treatment of its kind available. Its use within the first six hours of extravasation occurring is crucial and enables affected patients to continue their anticancer treatment.

SAVENE has Orphan Drug status and protection until late 2016 with a worldwide method of use patent until 2020. In 2013 the sales were approximately €3.8million.

Under the terms of the agreement, Clinigen will assume full responsibility for SAVENE's manufacturing, registration, distribution, and commercialization in all markets globally excluding the Americas, Israel and South Africa. In Japan, Clinigen will provide SAVENE through an existing supply and license agreement with Kissei Pharmaceutical Co. Ltd, the marketing authorization holder.

In 2013 the Group also acquired Cardioxane® from Novartis which, like SAVENE, has dexrazoxane as its active substance and is also an oncology support therapy; used to prevent the cardiotoxicity of anthracyclines for patients with advanced and/or metastatic breast cancer. The acquisition of SAVENE allows Clinigen to exploit synergies between the two products.

Peter George, Chief Executive Officer, Clinigen Group, said: "In acquiring both SAVENE and Cardioxane, Clinigen will expand its strategic options in oncology support and consolidate its supply chain. The acquisition was a natural move for us and is in line with our stated strategy to expand our specialty pharmaceuticals portfolio."

David Bryant, Senior Vice President, Clinigen SP, said: "This is the fourth product to be added to our specialty pharmaceuticals portfolio. This acquisition has helped strengthen our position in the oncology support area, adding SAVENE to Cardioxane and Foscavir®. We continue to focus on the acquisition of niche, hospital-only therapies which have the potential to save the lives of critically ill patients."

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Clinigen Group: Numis takes target price from 620p to 650p upgrading to buy

Went long again today, its a certainty for a write up in tip sheet SCSW either this sat or the sat after.

Cheers gf.

Think its this saturday DC ill be keeping an eye out on advfn this coming weekend.

Dont have to subscribe just look for the leaks.

CLIN could be in for a very bullish phase. Ive added this afternoon. When this one rises it rises fast. looking for upside to previous highs. as featured on the chart.

Excelent financial news for CLIN..........

RCS - Clinigen Group plc - Clinigen agrees new £35 million banking facility

04 Apr 2014 - 07:00
For best results when printing this announcement, please click on the link below:
http://pdf.reuters.com/Regnews/regnews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20140404:nRSD0321Ea
RNS Number : 0321E
Clinigen Group plc
04 April 2014
Clinigen agrees a new £35 million banking facility
Burton-on-Trent, UK - 04 April 2014 Clinigen Group plc ("Clinigen" or the
"Group") (AIM: CLIN) has agreed a new four year £35 million multi-currency revolving credit facility. An accordion option has also been agreed under which Clinigen can request an additional £15 million on the same terms.
The facility, provided by the Group's existing bankers, The Royal Bank of Scotland PLC, replaces the existing £20 million facility. It is secured on the tangible and intangible assets of the Group.
Robin Sibson, Clinigen's Chief Financial Officer, said: "This significantly increased facility will provide us with the flexibility to continue to deliver our strategy of adding to our SP product portfolio whilst we continue to drive the business forward through organic growth."
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Acquisitions should keep coming.

Should do now yep.

Hoping it gets tipped tomorrow.

Think tip sheet SCSW is out and cant see it not reporting the new drugs.

Monday COULD be explosive.

don't think it's out for another week gf

DRAT...............double drat.

Out now.

Is it........good. Bet its got a mention.

Good full page article in today's Shares mag - buy.

Clinigen to manage Nerixia named patient program

RNS


RNS Number : 7288E

Clinigen Group plc

14 April 2014














Clinigen Group to Manage International Named Patient Program for
Abiogen Pharma's Nerixia® (Neridronic Acid)


Burton-on-Trent, UK and Pisa, Italy - 14 April 2014 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN) and Abiogen Pharma SpA ('Abiogen') jointly announced today the initiation of a Named Patient Program, managed by Clinigen Global Access Programs (Clinigen GAP) to provide Nerixia® (neridronic acid), owned by Abiogen to individual patients with Osteogenesis imperfecta (OI) through their Healthcare Professional.

Clinigen GAP will supply the drug to countries within the European Union (EU), except for in Italy where the drug is currently licensed and commercially available. Nerixia, an aminobisphosphonate, is indicated for the treatment of OI, a congenital disorder characterized by brittle bones that are prone to fracture, which is estimated to affect 1-9 people per 100,000 worldwide1. No other bisphosphonate is currently licensed for the condition in Europe.

Nerixia is not licensed outside of Italy but under the Named Patient Program, Healthcare Professionals in the EU will be able to request the drug for individual patients suffering from OI who have no other approved therapeutic option.

Dr. Massimo Di Martino, President and CEO of Abiogen said, "Securing a trusted, specialist partner to manage access for Nerixia is key. Our collaboration with Clinigen GAP will ensure responsive, efficient supply of the drug to those patients who need it until we can make Nerixia commercially available. Clinigen GAP has extensive experience in the design and management of access programs on a global scale and we look forward to working with the team."

Mark Corbett, Senior Vice President, Clinigen GAP said, "Nerixia has the potential to make a huge difference to the lives of individual patients and we are very pleased to be able to implement an access program for this important therapy. With an expanding client base of international pharmaceutical companies and over thirty access programs ongoing we have the expertise, capabilities and regulatory know-how to deliver this bespoke program."

1 Orphanet portal for rare disease and orphan drugs www.orpha.net
Search: Osteogenesis Imperfecta
Accessed on 10 March 2014

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Clinigen raised to buy at Investec. Not sure of price target.

7 Jul Investec 497.00 Buy

Clinigen shares upgraded by Investec

By Ian Lyall

July 07 2014, 11:38am
Investec's new price target points to significant upside.


Investec said it was time to buy shares in speciality pharma group Clinigen (LON:CLIN) after the broker upgraded from ‘hold’ and revised its earnings targets.

Analyst Nicholas Keher tweaked down his earnings per share (EPS) forecast by 3% and 7% respectively for the next two financial years.

The valuation was also shaved back - to 497p a share - to reflect the change.

“Even against our lower target price, we think the shares offer an attractive opportunity,” said Keher.

Clinigen is a three-wheeled hybrid of a business that is unique, not just on AIM and in the UK, but across the world, but the business model works and has synergies that will be the catalyst for growth for some years to come.

The first wheel, which generates around 65% of revenues, is Clinical Trials Supply (CTS).

Big pharma and the large contract research firms, when carrying out clinical studies on new blockbuster treatments, require comparator drugs and medicines that ensure patient safety. Clinigen sources and supplies these products.

The second business, Global Access Programs, which provides access to drugs that are still in clinical trials but are showing encouraging signs of efficacy.

It also has a growing speciality pharma arm.

Shares in the business, which is valued at £317mln, were changing hands this morning for 385p each.

11 Jul Numis 650.00 Buy

year end trading update

RNS


RNS Number : 1683N

Clinigen Group plc

24 July 2014






Year end trading update

Profit growth strong; underlying EBITDA up at least 17%

Burton-on-Trent, UK - 24 July 2014 - Clinigen Group plc ('Clinigen' or the 'Group', AIM: CLIN), the specialty global pharmaceutical company, today provides the following trading update for the year ended 30 June 2014.

Highlights

· Like for like revenues* on a constant currency basis up in excess of 7% on prior year and reported revenues not less than £126m.

· Gross margins increased to over 30% delivering growth in excess of 17% on prior year.

· Underlying EBITDA up at least 17% on prior year.

· Closing net cash position of £5.3m; combined with the borrowing facility of £35m, provides opportunity for continued expansion.

· Significant growth in GAP; good new business pipelines for both GAP and CTS.

· Acquisition of Savene complements Cardioxane, and strengthens dexrazoxane market position for SP.

* Like for like sales represent revenues adjusted for Foscavir stock fill (£3m) in FY13.

Group performance

Clinigen continues to drive strong organic growth, demonstrated by in excess of 50% growth in GAP revenues, greater than 10% growth in SP revenues and revenues up more than 11% in H2 on H1 in CTS. This, combined with improved gross margins and lower than expected administrative costs, has resulted in over 17% growth in underlying EBITDA.

Foscavir in-market sales are matching the global growth of the transplant market. The integration of two new products during FY14, Cardioxane and Savene, is running to plan and they are expected to complete their transition to Clinigen during FY15. Both of these brands are formulated from the active ingredient dexrazoxane, and going forward Clinigen's revitalization opportunities are enhanced by acquiring both of these products.

The Group continues to have strong cashflows, which this year have funded the acquisition of Savene and the second staged payment for Cardioxane. The closing net cash position combined with the bank facility provides funding for further product acquisitions.

Peter George, Chief Executive Officer, Clinigen said,

"This has been another great year for Clinigen. All three operating businesses have contributed to a strong trading performance and we have seen good organic growth, especially in GAP. We're particularly pleased with the increased gross margins and, yet again, the excellent growth of EBITDA.

"We are also seeing good acquisition and complementary product opportunities for SP, which supports our strategy to focus on niche, hospital-only, specialty pharmaceutical products. This strategy plays well in the current environment where big pharmaceutical companies are looking to divest more mature products.

"At this early stage, we are confident of another strong year ahead and we remain on track to be the leading provider of CTS and GAP services."



Operational businesses

· CTS

CTS continues to be the main revenue generator of the Group albeit the revenues are lumpy. Revenues in FY14 will be lower than the prior year due to the previously explained anti-viral studies in FY13 which were not repeated this year.

A recent market research report estimates the clinical trial supply market to be $1.5-2.0bn globally, with spend on individual clinical trial comparators ranging from $200K to $20m. Clinigen is in a good position, with its regulatory and global distribution expertise, to target this large market. The goal for the Group is to become the global leader in clinical trial supply and continued growth is supported by the division's strong sales pipeline.

· GAP

GAP continues to be the fastest growing Clinigen business. A measure that reflects this significant growth is the number of drug units delivered, which has increased to 58,000 in FY14 from 31,000 in the prior year.

As previously announced, H1FY14 saw the winding down of one large high revenue, lower margin program which has not been replicated in the second half of the year. Despite this, GAP has maintained its gross profits.

Clinigen GAP's growing reputation in the delivery of global access programs places it in a strong position to increase market share in the outsourced global access market, estimated to be in excess of $500m. This position is reflected in the division's robust new business pipeline.

· SP

Revenues have been boosted as a result of a full year's ownership of Cardioxane and a small contribution from newly acquired Savene in the final quarter of this year. SP remains the largest contributor to the Group's gross profits.

Foscavir continues to be a reliable generator of revenue and profits. Year on year revenues and volumes were impacted last year by stock fills and this year by new bulk supply distribution agreements, which benefit cashflow but mean actual sales do not accurately reflect in-market sales. For the full year results, the Group will report on underlying in-market sales which are expected to reflect the growth of the transplant treatment area. There has also been improvement in the average selling price of Foscavir.

Under the agreement for Cardioxane with Novartis, sales are not recognized at the market value until the Marketing Authorization (MA) for the specific territory has been transferred. All MAs for Cardioxane have now been transferred, apart from Latam and South Korea which are on schedule. The integration of Savene into the operational business also remains on track. More detail on the revitalization plans for these two dexrazoxane products will be provided at the full year results.

The lifting of the suspension on the European Marketing Authorisation for the antibiotic Vibativ, in March 2014, was an important milestone in the development of the European launch of the product. This launch is now anticipated to be October/November this year following unforeseen delays in product availability and sensitivity testing.

Overall, Clinigen continues to deliver on its objective of building its specialty pharmaceutical portfolio and is on track to have ten products over the next four to five years.



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 2014 on Wednesday 24 September 2014.



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