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 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."
- Ends-
 

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."
 
-Ends-

Final results

HIGHLIGHTS
§ Adjusted gross profit up 22% - driven by organic growth, full year's contribution from Link Healthcare ('Link') and currency benefits
§ Adjusted EPS up 25% to 41.8p (2016: 33.4p)
§ Strong cash flow performance with cash generated from operations of £54.7m (2016: £49.4m)
§ Net debt substantially decreased by £33.1m to £35.0m (2016: £68.1m)
§ Full year dividend increased 25% to 5.0p (2016: 4.0p)
§ Strong growth across all operations
§ Outstanding performance in Africa and Asia Pacific
§ Dexrazoxane portfolio revitalisation significantly enhanced by EC approval to update product information for Cardioxane, and launch of Totect in US
§ New simplified reporting structure comprising Clinical Trial Services ('CTS'), Unlicensed Medicines and Commercial Medicines

Broker Forecast - Peel Hunt issues a broker note on Clinigen Group
BFN
Peel Hunt today upgrades its investment rating on Clinigen Group (LON:CLIN) to buy (from add) and raised its price target to 1350p (from 1200p).

Story provided by StockMarketWire.com

Clinigen acquires IMMC in Japan
RNS
RNS Number : 2527U
Clinigen Group plc
23 October 2017
 
RNS Reach
 
23 October 2017
  
Clinigen acquires Japan's largest supplier of unlicensed medicines
 
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has today acquired International Medical Management Corporation ('IMMC'), Japan's largest supplier of unlicensed medicines, for an undisclosed sum.
The acquisition will add to Clinigen's existing footprint in the country following the launch of its Japanese business in October 2016. The acquisition of IMMC is part of Clinigen's strategy to become the 'go to' global leader in ethical access to unlicensed medicines and will allow the Group to better address unmet patient needs.
IMMC, established in 2006, operates throughout Japan in sectors including niche vaccine, oncology and IVF. It currently has relationships with more than 850 hospitals and clinics, which will now be able to benefit from the broader access to medicines available as part of Clinigen.
Japan is the world's second largest pharmaceutical market. The unlicensed medicines market in Japan is underdeveloped, highly regulated and well controlled leading to a high unmet medical need. For instance, from the 154 new drugs launched globally between 2008 and 2012, two thirds still remained unavailable in Japan by 2013, illustrating the difficulties patients in Japan have in accessing approved medicines.
The threat of counterfeit medicines entering the supply chain in Japan, also remains an issue. Japan is the second-largest target of illegal online medicine sellers in the world behind the US.
IMMC was acquired for an upfront cash payment followed by certain potential milestone-based instalments over 12 months.
In the year ended 30 September 2017 the unaudited IMMC gross profit was ¥352m (£2.4m).
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"This acquisition represents another strategic development, extending our geographical footprint and another step to becoming the global leader in ethical access to unlicensed medicines. The enlarged Japanese operation adds further capability in this high growth market which is crucial to our customers and a key part of Clinigen's global offering."
Yoshiyuki Kudo, President, IMMC, said:
"Clinigen's global expertise and our local knowledge will allow us to better address the unmet patient need in Japan, further benefiting our customers and increasing our offering in access to unlicensed medicines."
- Ends -

Ex-Dividend
09 Nov 17 Clinigen Group [CLIN] (3.4 p)

12:10 29/11/2017
Broker Forecast - N+1 Singer issues a broker note on Clinigen Group
N+1 Singer today reaffirms its buy investment rating on Clinigen Group (LON:CLIN) and set its price target at 1225p. Story provided by StockMarketWire.com

Wed 17th Jan - Trading statement

HY trading update
RNS
RNS Number : 0600C
Clinigen Group plc
17 January 2018

17 January 2018

HY trading update: good H1 performance with profits up over 10%

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 2017.

The Group has traded well in the first half, in line with the Board's expectations.

Group revenues increased around 28%. This is higher than the growth in gross profit due primarily to an increased level of pass through costs within the early access part of Unlicensed Medicines.

Gross profit*, viewed by the Board as the best measure of top line growth, increased by around 10% compared to last year. Growth has been driven by a combination of a strong performance by Commercial Medicines and two months contribution from Quantum Pharma plc ('Quantum').

Commercial Medicines, representing around 49% of Group gross profit and including the commercial business of Quantum, delivered excellent growth, with all products across the portfolio performing strongly.

Unlicensed Medicines, representing around 41% of Group gross profit, benefited from two months contribution from the related business within Quantum and IMMC. In early access, performance was affected by a number of larger programmes coming to the end of their lifecycle. There are a significant number of new programmes now starting that are expected to drive stronger second half performance.

Clinical Trial Services, representing around 10% of Group gross profits, was below last year following two years of double digit growth. Performance is expected to step up in the second half.

The Group acquired IMMC, Japan's largest supplier of unlicensed medicines, on 23 October 2017 and Quantum on 1 November 2017. Both businesses performed well in the two months following their acquisition.

Following a period of investment last year, underlying Group overheads are expected to grow at a slower pace than gross profit.

The Group has achieved another good cash flow performance. Following the acquisitions and the payment of the final scheduled deferred consideration on the Link acquisition, net debt increased to around £142m as at 31 December 2017 (31 December 2016: £70.9m).

Shaun Chilton, Group Chief Executive Officer of Clinigen, said:

"We have delivered good growth and made strong progress against our strategic priorities, which have been enhanced by the acquisition of Quantum and IMMC.

"Our strategic priorities remain unchanged. We have and will continue to drive organic growth and search for selective acquisitions to complement our existing offering and capabilities.

"We are well positioned to deliver another good year of progress."


The Group expects to publish its interim results for the six months ended 31 December 2017 on Tuesday 27 February 2018.

*Gross profit growth rates exclude the release of the fair valuation on inventory from business acquisitions.


- Ends -

17 Jan
N+1 Singer
1,225.00
Buy
17 Jan
Peel Hunt
1,350.00
Buy
17 Jan
Numis
1,208.00
Add

15:50 18/01/2018
Broker Forecast - Berenberg issues a broker note on Clinigen Group
Berenberg today upgrades its investment rating on Clinigen Group (LON:CLIN) to buy (from hold) and raised its price target to 1220p (from 1200p). Story provided by StockMarketWire.com

AIM company Clinigen enters the 1 billion + club

1 Feb
Peel Hunt
1,350.00
Buy

Interims Tues 27 Feb 18

Interims Tues 27 Feb 18

Half year results
HIGHLIGHTS
§ Adjusted gross profit up 10% driven by strong performance by Commercial Medicines and two months contribution from Quantum Pharma plc ('Quantum')
§ Adjusted EPS up 13% to 21.2p (2016: 18.8p)
§ Strong cash flow performance with cash generated from operations of £34.3m (2016: £7.7m)
§ Interim dividend increased 10% to 1.76p (2016: 1.6p)
§ All products across Commercial Medicines portfolio performing strongly
§ Good growth in Africa and Asia Pacific region
§ Acquisition of Quantum adds complementary capability in Unlicensed Medicines and provides pipeline of products and in-house development capabilities
§ Unlicensed Medicines capability and geographical footprint further enhanced by acquisition of IMMC in Japan

28 Feb
Peel Hunt
1,350.00
Buy

Clinigen and Jazz Pharma initiate MA programme
RNS
RNS Number : 0522I
Clinigen Group plc
19 March 2018

RNS Reach
19 March 2018


Clinigen appointed by Jazz Pharmaceuticals to manage Managed Access Program for Vyxeos® (CPX-351) outside the United States
Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global pharmaceutical and services company, has been appointed by Jazz Pharmaceuticals plc (NASDAQ: JAZZ, 'Jazz') to distribute Vyxeos® (daunorubicin and cytarabine) liposome for injection via a Managed Access Program ('MAP') outside the United States.
This MAP is for the treatment of adults aged 60-75 with newly-diagnosed, therapy-related, acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos® is a dual-drug liposomal encapsulation of daunorubicin and cytarabine combined in a 1:5 molar ratio respectively.
Initially, the program is being launched in the United Kingdom, Ireland, Germany, Poland, Belgium, Switzerland, Portugal, Spain and Canada.
In August 2017, the U.S. Food and Drug Administration ('FDA') approved Vyxeos® liposome for injection for the treatment of adults with newly-diagnosed t-AML or AML-MRC. Vyxeos® is not approved for use outside of the U.S.
AML is a rapidly progressing and life-threatening blood cancer that starts from young white blood cells called granulocytes or monocytes which build up in the bone marrow - the soft inner part of the bones where new blood cells are made. It is relatively rare with approximately 21,000 people in the United States and 19,000 in the European Union diagnosed each year.1 However, it is the most common type of acute (aggressive) leukemia in adults with variable treatment options and outcomes depending on the subtype of AML and the age of the patient. It has one of the lowest survival rates of all types of leukemia.
John Lagus, Head of Managed Access, Clinigen, said:
"There is a huge unmet need for adults with AML where treatment options to date have been very few. Vyxeos® provides the first FDA approved chemotherapy treatment for patients with certain types of high-risk AML in more than 40 years."

09:20 23/05/2018
Broker Forecast - Berenberg issues a broker note on Clinigen Group
Berenberg today reaffirms its buy investment rating on Clinigen Group (LON:CLIN) and cut its price target to 1160p (from 1220p). Story provided by StockMarketWire.com Broker Forecasts data provided by www.sharesmagazine.co.uk