Biofrontera AG is a biopharmaceutical company specializing on the development of drugs and medicinal cosmetics for the treatment of skin diseases and the regenerative care of damaged skin.

In February 2012 Biofrontera launched the prescription drug Ameluz® for the treatment of actinic keratosis on the German market. In other European countries Ameluz® is marketed through various local representatives. Ameluz® is applied in Photodynamic Therapy requiring a powerful source of red light. For this Biofrontera has developed the BF-RhodoLED® lamp, which was CE marked in November 2012.

As a cosmeceutical product Biofrontera markets Belixos® creme for the regenerative care of reddened and inflamed skin. It is Biofrontera’s intention to develop a line of cosmeceutical products for damaged skin under the Belixos brand.

Biofrontera AG operates as an administrative holding company with four wholly-owned subsidiaries, Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, Biofrontera Development GmbH and Biofrontera Neuroscience GmbH. While the first two cover the operational business of Biofrontera group, the latter allow structured funding of individual clinical development projects. The companies occupy fully equipped, modern lab facilities with sufficient space for growth, an own GMP-certified laboratory and a GMP-certified medicament storage room.
Biofrontera group was founded in 1997 by Prof. Dr. Hermann Lübbert, the current CEO, and is located in Leverkusen, Germany.
Since 2006 Biofrontera is listed in the regulatory market under the ISIN DE0006046113, the company currently employs 35 people.

http://www.biofrontera.com/en/

3rd Quarter Results - 9mnths to 30 Sept 2014

RNS


RNS Number : 9012W

Biofrontera AG

13 November 2014






Biofrontera publishes report on the third quarter of 2014



· Significant progress in business operations: excellent results in the phase 3 clinical study on the broad area therapy of actinic keratosis and completion of the safety studies required by the FDA

· Patient recruitment for phase 3 study on basal cell carcinoma is in progress in Germany and the United Kingdom

· Growth in sales of 31% in Germany compared to the nine-month period of the previous year

· Other international sales remain slow ahead of the planned basal cell carcinoma trial



Leverkusen, 13 November 2014 - Today, Biofrontera AG (FSE/AIM: B8F), the biopharmaceutical company focusing on skin cancer, presents the company results for the first nine months of 2014. The quarterly report now published on the company's website (at http://biofrontera.com/en/) goes into detail in particular on the clinical development activities surrounding Biofrontera's skin cancer drug, Ameluz®, and the preparations for the approval process in the US. In addition, the report covers national and international sales activities.



Development of the key financial figures in the first nine months of 2014



In the third quarter of the 2014 financial year, Biofrontera achieved a significant increase in revenue of 61% compared to the same period of the previous year. In Germany, where Biofrontera manages sales activities itself, sales grew by 54% compared to the same quarter of the previous year. The first nine months of the year resulted in revenue of EUR 1,992 thousand. While this was 7% higher overall than in the period for the previous year, sales in Germany increased significantly by 31% to EUR 1,399 thousand, which exceeded the revenue growth target for Germany. In contrast to this, the development in revenue outside Germany was still slow; in the first nine months, revenue from sales to foreign licensing partners fell from EUR 798 thousand in the first nine months of the previous year to EUR 523 thousand. Although revenue increased sales in the individual countries, the majority of these sales were fulfilled from existing inventory previously purchased by Biofrontera's local distribution partners. At this stage, it remains challenging to position Ameluz@ in hospitals while the medicine is only approved for the treatment of actinic keratosis but not for the treatment of basal cell carcinoma. Consequently, we are expecting sales to increase as approval is extended for the treatment of basal cell carcinoma and the phase 3 clinical study required for this is under way.

Our gross margin has improved to 56% compared to 31% in the same period of the previous year. This was due both to systematic cost management and to a considerable reduction in expenditures incurred in 2013 for the qualification of new production methods and manufacturers carried out upon request by the EMA, which have not yet been completed but were reduced considerably in 2014.

Research and development costs increased from EUR 1,950 thousand in the previous year to EUR 3,146 thousand in the first nine months of 2014. The increase is due to clinical activities in connection with extending the range of indications for basal cell carcinoma and the work undertaken towards the approval of Ameluz® in the US. As a result of savings, however, R&D costs remain below the projected amount. As planned, sales and administration costs increased from EUR 3,773 thousand to EUR 5,588 thousand compared with the same period of the previous year as a result of the approval process in the US and the setting up of an internal company infrastructure to meet the requirements of pharmaceutical companies.

The loss before tax was EUR 7,955 thousand; in the previous year it was EUR 6,022 thousand. As at 30 September 2014 cash and cash equivalents amounted to EUR 9,962 thousand.

On 30 September 2014, Biofrontera employed 41 employees, compared to 39 employees on 30 September 2013.



Study results, preparation of the approval of Ameluz® in the US



Three clinical trials have been conducted in preparation for the submission of the approval dossier to the FDA (US Food and Drug Administration). As expected, the two safety studies required by the FDA did not reveal any critical aspects in respect of drug safety. In a third, recently completed phase 3 study, in which the combination of Ameluz® was tested with Biofrontera's PDT lamp BF-RhodoLED®, 91% of the patients treated with Ameluz® and 94% of the individual actinic keratoses were completely cured at the end of the study. In this study, photodynamic therapy (PDT) was tested on larger areas (fields) of skin for the first time in a phase 3 trial, although this therapy is actually recommended in the dermatological guidelines for field therapy. In field therapy, the significant effect of skin rejuvenation which occurs with PDT proves to be particularly beneficial.



The submission of the approval dossier in the US is scheduled for March 2015, after a combined analysis of all clinical results has been performed. The approval is expected to be issued around one year later.



The pre-NDA (new drug application) meeting, at which significant issues relating to the approval dossier were discussed again, took place shortly after the reporting date of this report, on 08 October 2014. Due to the few remaining outstanding questions following the FDA's examination of the documents submitted, this meeting was held as a conference call on the recommendation of the FDA. At this meeting, any remaining outstanding questions were also clarified.





Extension of indications to basal cell carcinoma



A recently published meta-analysis of all clinical trials already carried out for the treatment of actinic keratosis clearly showed that Ameluz® is by far the most effective form of treatment for mild and moderate actinic keratosis on the face and scalp. Despite this, the lack of approval for the indication of basal cell carcinoma (BCC), for which there are several competing drugs, has proven to be a challenge in the marketing of Ameluz®.



Therefore, Biofrontera has begun the implementation of a phase 3 trial in order to have Ameluz® European approval extended to include the treatment of BCC. BCCs are the most common invasive tumors to affect humans and account for approximately 80% of all invasive skin cancers in Caucasians. About 30% of all Caucasians develop at least one BCC in their lifetime, and cases are increasing rapidly worldwide due to increased exposure to UV light. Surgical removal is the most frequent treatment currently used in Germany but this can lead to clearly visible scarring, whereas treatment with photodynamic therapy (PDT), which is an alternative particularly in the treatment of thin, nonaggressive BCCs, is not only a highly effective treatment method, but also produces excellent cosmetic results.



The recruitment of the 360 planned patients began in Germany in early February and in the UK in May 2014. Because patient recruitment has been slower than expected, Biofrontera has included 8 further centers in Germany in the trial, which has increased the number of study centers involved to a total of 27. It is expected that the recruitment process will be completed at the end of this year or the beginning of next year, which will mean that the expansion of indications can probably take place in early 2016. The expansion of the European approval to include BCC will be of particular importance for sales development in European countries outside Germany.





The management board of Biofrontera AG will outline the main developments in the period under review in a telephone conference.

The telephone conference for shareholders and potential investors begins in German at 9:00 AM.

Ameluz International Approval Procedure

RNS


RNS Number : 9859X

Biofrontera AG

26 November 2014








Biofrontera AG

("Biofrontera" or "the Company")

Further progress in international approval processes of Biofrontera's Ameluz®



Highlights



· Successful filing of waivers in the US

· Ameluz® applied for registration in Switzerland



Leverkusen, Germany, xx. November, 2014 - Biofrontera (FSE / AIM: B8F), the specialist for sun-induced skin cancer, has taken important steps towards further international approvals of Ameluz®. As part of the approval process for Ameluz® in the US, Biofrontera had discussed with the FDA to submit the "Pediatric Waiver" and the "User Fee Waiver" before submitting the complete registration dossier. These filings have now occurred. An approved Pediatric Waiver avoids the obligation for conducting studies with children. The User Fee Waiver is given to small enterprises and allows them to apply for their first drug approval without the need to pay further FDA fees, which would otherwise amount to the payment of fees by Biofrontera of in excess of US$2 million. PreviouslyBiofrontera had obtained a similar status by the European Medicines Agency.



In Switzerland, the Company's licensing partner, Louis Widmer SA has, in collaboration with Biofrontera, submitted the registration dossier of Ameluz® to the local health authorities, the Swissmedic. After a technical validation of the application the authority has now accepted Ameluz® for registration, by which the next step of the approval process was initiated. Within the scope of the authorization procedure, Swissmedic assesses the quality, safety and efficacy of the drug on the basis of the comprehensive scientific documentation submitted, and approves the information provided to healthcare professionals and patients.



Prof. Dr. Hermann Lübbert, CEO of the Biofrontera: "In a close cooperation between Louis Widmer and Biofrontera the European drug approval dossier has been adapted to the Swiss regulations. In Switzerland Biofrontera's drug for photodynamic treatment of actinic keratosis will, as in all other European countries, be marketed under the brand name Ameluz®. The market authorization in Switzerland will represent another important milestone in the international expansion of the business with Ameluz®. The application of the two waivers is another important step within the scope of the US registration process."

Belixos(R) Gel addition to derma product range

RNS


RNS Number : 9566Y

Biofrontera AG

05 December 2014






Biofrontera AG

("Biofrontera" or "the Company")



Biofrontera launches Belixos® Gel as new addition to its derma-cosmetic line



Leverkusen, Germany 05 December 2014 - Biofrontera (FSE / AIM: B8F), the specialist for sun induced skin cancer, has this week launched the third product of its derma-cosmetic line Belixos®, a cooling and cleaning day care gel designed for situations of increased sebum production.



Belixos® Gel was developed for the special needs of inflamed, reddened skin prone to impurities, the ideal basic care for rosacea and acne. To minimize the risk for sensitive reactions and skin irritations the gel formulation was reduced to just a few high-value ingredients. The formulation causes a cooling sensation and combines the extracts of cinnamon bark in the Sepicontrol A5 complex and mahonia aquifolium with Biofrontera's innovative Biocolloid technology.



The extract of mahonia relieves inflammation, redness and itching, typical signs of rosacea. The active ingredient complex Sepicontrol A5 with cinnamon bark has antibacterial activity and removes callused skin, regulates sebum and clears congested sebaceous glands.



As with the other products in the Belixos® dermo-cosmetic series in cream and liquid formulations, the underlying biocolloid technology causes an optimized penetration of this unique ingredient combination from traditional medicinal plants extracts.



Commenting, Prof. Dr. Hermann Lübbert, CEO of Biofrontera, said: "The new Belixos® Gel compliments the Company's existing derma-cosmetic products which successfully bring together the benefits of natural ingredients, already recognized for their efficacy, and Biofrontera's innovative biocolloid formulation, effectively delivering excellent cosmetic properties to the skin."



Ends.

Ameluz Belgium launch and Clinical Trials Update
RNS
RNS Number : 0653D
Biofrontera AG
26 January 2015



Biofrontera prepares market launch in Belgium

for its non-melanoma skin cancer drug Ameluz®



· First sales in Belgian market expected in Q1 2015

· Continuous progress in approval procedures and clinical trials



Leverkusen, 26 January 2015 - Biofrontera AG (FSE/AIM: B8F), the biopharmaceutical company focusing on skin cancer, has completed almost all preparations for its launch of Ameluz® in Belgium.



Pricing has been agreed for the Belgian market and Biofrontera anticipates that it will generate first sales in the first quarter of 2015. It is particularly beneficial that the therapy will be fully reimbursed by the Belgian health care system. An add-on payment, as is required through public health insurance in Germany, will not be required in Belgium. Distribution will be undertaken by Bipharma N.V. which is successfully distributing Ameluz® in the Netherlands already.



Prof. Hermann Lübbert, CEO of Biofrontera, commented: "Ameluz® has been well received in Belgium, receiving recognition of the high efficacy and economic viability of the therapy with Ameluz® for actinic keratosis, also in comparison to competing products. This will not only give us a head-start in Belgium but should also serve as a positive signal towards other markets in Europe".



There is also notable progress in Biofrontera's other activities. During the course of this year, Ameluz® will be launched in further markets in Europe. More than two thirds of the required 360 patients have been recruited in the Phase III study for the approval of basal cell carcinoma. This study is of great importance for the further growth of Biofrontera in Europe. Preparations for the FDA-filing in the USA are well progressing. All required tests, reports and documents should be finalised within the next eight weeks.

Sales and Marketing of Ameluz� in Spain
RNS
RNS Number : 3628I
Biofrontera AG
25 March 2015





Biofrontera starts Sales and Marketing of Ameluz® in Spain



· Key Account Manager transfers from Allergan to Biofrontera

· Biofrontera will capture full margin of Ameluz® sales with immediate effect

· International launch event with leading dermatologists in Valencia - 27/28 March



Leverkusen, 25 March 2015 - Biofrontera AG (FSE: B8F), the biopharmaceutical company focusing on skin cancer, has now taken over marketing and sales activities for Ameluz® and BF-RhodoLED® in Spain as planned in line with its announcement made on 7 November 2014. Previously, these functions were performed by distribution partner Allergan Pharmaceuticals.



The successful transition has been prepared over several months in cooperation with Allergan. In addition, Biofrontera is pleased to announce that Antonio Lopez Belda, former Key Account Manager for dermatology at Allergan, has transferred to Biofrontera, with immediate effect. Mr. Lopez led the launch of Ameluz in Spain and has successfully developed the market since. This will allow for continuity with all established contacts within hospitals and physicians.



"Spain is one of the most important European markets for photodynamic therapy," said Prof. Dr. Hermann Lübbert, CEO of Biofrontera. "In the new structure, we can now collect the entire margin of the Ameluz® sales for Biofrontera. Thus, our profitability in Spain will increase significantly. It is anticipated that the additional investment in sales and marketing should pay off within one year."



The new Biofrontera subsidiary will be named 'Biofrontera Pharma GmbH, sucursal en España' and is based in Cornellá de Llobregat near Barcelona. In the current year Biofrontera expects sales in the mid six-digit Euro range in Spain.



On the occasion of the launch, Biofrontera will hold an international symposium in Valencia from March 27 to 28, and expects some 50 dermatologists from all over Spain to attend the event.



Ends

Final Results
RNS
RNS Number : 8016J
Biofrontera AG
10 April 2015



Biofrontera AG

("Biofrontera" or "Company" or "Group)



Final Results



Leverkusen, Germany, 10 April 2015 - Biofrontera AG (FSE/AIM:B8F), the biopharmaceutical company focusing on skin cancer, announces final results for the year ended 31 December 2014.



Highlights

· Increase in revenues by nearly 30% in Germany

· Major investment in R&D in order to extend product indications and to prepare for marketing approval in the USA

· Successful completion of US Phase III study for the combination of Ameluz® and BF-RhodoLED® lamp in field therapy of actinic keratosis was carried out and completed in the reporting period:

o 91% of patients were completely cured of keratoses

o 94 % individual lesions were completely eradicated

· Phase III trial continues on the expansion of indications to include basal cell carcinoma

· Positive pre-NDA meeting with the FDA regarding the submission of approval documents for Ameluz® in the USA

· Final report on the Ameluz® safety trials to be filed with the FDA

· Licensing agreement with Perrigo for Ameluz® in Israel

· Licensing agreement for Ameluz® in Switzerland and Liechtenstein with Louis Widmer SA

· Agreement with Allergan with regard to Biofrontera taking over sales activities in Spain

· Launch of new products in the Belixos® range

· Upgraded to Prime Standard on the Frankfurt stock exchange, and shares listed on the AIM Market of the London stock exchange (AIM)

· Successful capital increase with proceeds of EUR 15.3 million



Commenting, Professor Hermann Lübbert, Chief Executive Officer, said: "We will continue to strive assiduously to realise the enormous potential of Ameluz® in order that Biofrontera becomes a more established independent pharmaceutical company. We achieved important milestones in 2014 and are now in a stronger position to lay the groundwork to tap into our products' full potential and make Biofrontera a highly successful company in the medium term."

Publication of PIII Study for Actinic Keratosis
RNS
RNS Number : 3027M
Biofrontera AG
06 May 2015





Biofrontera delivers excellent results from the Phase III study for field therapy of actinic keratosis for publication



· Excellent clearance rates with 90.9% of patients cleared from all actinic keratoses

· Details of skin quality assessment illustrate strong skin rejuvenation effect

Leverkusen, 06 May 2015 - Biofrontera AG (AIM/FSE: B8F), the biopharmaceutical company focussing on sun induced skin cancer, has prepared a scientific publication about the results of the multi-centre, placebo-controlled phase III study for field therapy of actinic keratosis using the combination of Biofrontera's prescription drug Ameluz® and PDT-lamp BF-RhodoLED®. Field therapy involves treating entire fields on the face or scalp covered with mild to moderate actinic keratosis with photodynamic treatment (PDT) with an entire tube of Ameluz® in combination with Biofrontera's PDT-lamp BF-RhodoLED®. Preliminary results of the phase III trial were first published in October 2014 and comprise a key component of the clinical program executed for the approval of Ameluz® in the US.

With 90.9% of all patients fully cleared from all actinic keratoses, the combination of Ameluz® and BF-RhodoLED® provided excellent efficacy. After a maximum of two treatments clearance of the non-hyperkeratotic Olsen Grade I lesions1 reached 99.1%, that of the moderately hyperkeratotic Olsen Grade II lesions 91.7%. Completely eliminating all Olsen Grade I lesions is of particular importance since up to 63.8% of all squamous cell carcinomas originate from the less suspicious Olsen Grade I lesions2.

The cosmetic outcome of the treatment was assessed by the clinical investigators without taking the removal of the keratotic lesions into consideration. All tested parameters improved significantly during the treatment. The number of patients left without skin roughness, dryness, and scaliness increased from 14.8% to 63% after Ameluz® treatment. Patients without hyperpigmentation or hypopigmentation increased from 40.7% to 57.4% and 53.7% to 70.4%, respectively. Mottled pigmentation, including both hyper- and hypopigmentation within the treatment area, decreased from 48.1% of the patients to 29.6% of the patients, respectively. Before treatment, 22.2% of the patients displayed mild scarring, which after treatment was reduced to 14.8% of the patients. Atrophic skin tissue was apparent in 31.5% of the patients before, and in 16.7% of the patients after treatment.

The study is an important component of the application that is currently prepared by Biofrontera to obtain approval for Ameluz® and BF-RhodoLED® in the USA. No other phase III trial applying PDT in the field-directed approach has ever been conducted, rendering Biofrontera's study an important contribution to the field. The application for approval in the USA is expected to be made by the end of Q2, and approval is anticipated 12 months after application.

For Biofrontera's strategically evenly important study in Basal Cell Carcinoma the number of enrolled patients is now sufficient for a statistical power of greater than 90%, and Biofrontera's request for completion of patient recruitment is currently evaluated by the responsible federal agency.

Commenting on findings of the study, CEO Prof. Hermann Lübbert said: "Field therapy with PDT should be the standard of care for patients with multiple actinic keratoses because of the extremely high efficacy rates, the potent skin rejuvenation effect documented in this study, and the potential to prevent new neoplastic lesions. The latter effect will be documented further during the ongoing follow-up phase of the study, but the fact that no patient presented with new tumours in the treatment field after Ameluz® treatment, while one patient with new lesions was in fact present in the twice smaller placebo group, may, even though not statistically relevant, indicate the prophylactic effect of field therapy using Ameluz® PDT."

References:



1. Olsen EA, Abernethy ML, Kulp-Shorten C et al. A double-blind, vehicle-controlled study evaluating masoprocol cream in the treatment of actinic keratoses on the head and neck. J Am Acad Dermatol 1991; 24:738-43.



2. Fernandez-Figueras MT, Carrato C, Saenz X, Puig L, Musulen E, Ferrandiz C, et al. Actinic keratosis with atypical basal cells (AK I) is the most common lesion associated with invasive squamous cell carcinoma of the skin. J Eur Acad Dermatol Venereol. 2014.

Ends

FDA New Drug Application submitted for Ameluz�
RNS
RNS Number : 8481S
Biofrontera AG
13 July 2015



Biofrontera submits New Drug Application for Ameluz® to FDA



· Comprehensive dossier filed with FDA on Friday

· FDA 'Acceptance to file' response within next 60 days

· Submission represents outstanding milestone, achieved by very few biotech companies worldwide

Leverkusen, Germany, 13 July 2015 - Biofrontera AG (AIM/FSE: B8F), a biopharmaceutical company focusing on sun induced skin cancer, has completed a major milestone by submitting a New Drug Application ('NDA') to the US Food and Drug Administration ('FDA') for its combination prescription drug Ameluz® and medical device BF-RhodoLED®. The combination of both products shall be applied in photodynamic therapy in the USA.

Unlike the US which requires combination approval, Ameluz® and BF-RhodoLED® were listed under separate filings in the EU. Ameluz® was granted marketing authorization by the European Medicines Agency ('EMA') in December 2011 for the treatment of mild and moderate actinic keratosis on the face and scalp. Biofrontera's PDT lamp BF-RhodoLED® was approved as a medical device in the EU.

The FDA combination drug and device application is extremely complex and required additional phase III testing prior to submission. The phase III actinic keratosis field therapy study with the drug/light combination reported complete clearance in over 90% of treated patients, along with a strong skin rejuvenation effect. The filing also includes results from two additional Phase III studies as well as results from two drug safety studies requested by the FDA. The comprehensive dossier was submitted to FDA on Friday July 10th. It comprises of more than 1,000 text files and documents, covering more than 50,000 pages, and data sets representing a multiple of these.

Biofrontera has been in close dialogue with FDA since July 2012 in order to prepare the NDA in coordination with the authority. The positive review during the pre-NDA meeting in October 2014 gives the company great confidence in the application.

According to US guidelines FDA has 60 days to respond as to whether the application will be accepted ('acceptance to file'). During this initial review period, FDA confirms completeness of the application and upon 'acceptance to file' FDA conducts a thorough review that is normally completed within 9-12 months after submission. FDA provides a mid-term review about six month after 'acceptance to file', which could provide a strong indication that approval will be granted.

Prof. Hermann Lübbert, CEO of Biofrontera commented: "A New Drug Application in the US, in particular a combination drug/medical device submission, is a huge endeavour and it involves every single employee in our small company. Worldwide, only very few small biotech companies have accomplished such a milestone with an in-house developed drug. We believe we delivered excellent clinical data and are therefore very confident in our application. If approved, this product will generate outstanding growth potential for Biofrontera as well as a significant increase in shareholder value."

Ends

Belixos� Protect product launch
RNS
RNS Number : 4460T
Biofrontera AG
20 July 2015



Belixos® Protect product launch: Biofrontera adds a daily skincare product for sun-damaged skin to its Belixos® dermo-cosmetic line



Leverkusen, Germany, 20 July 2015 - Biofrontera (FSE/AIM:B8F), the biopharmaceutical company focusing on sun-induced skin cancer, is launching another product in its Belixos® dermo-cosmetic line. Belixos® Protect, a regenerative daily skin care product for sun-damaged skin, complements the Belixos® dermo-cosmetic line and bridges the gap between Biofrontera's medicinal product Ameluz® for the treatment of sun-induced skin cancer and the Belixos® line.



Combining skin regenerating niacinamide with sun protection factor 15, Belixos® Protect was developed specifically for the needs of sun-damaged skin and provides ideal daily care for skin that already shows signs of damage by UV light.



UV light damages the genetic material of skin cells and may eventually transform them into cancer cells. Skin cells can repair damage caused by UV light but for this, they require a large amount of energy. The highly concentrated niacinamide in Belixos® Protect provides skin cells with additional energy for these repair procedures. Thereby, Belixos® Protect helps the skin to regenerate itself and to reduce existing signs of skin ageing. Scientific studies have demonstrated that niacinamide reduces the fine lines that are perceived as withered skin.



In addition, the cream contains a nurturing lipid matrix consisting of biocolloids, ceramides, and shea butter. It is pleasant to apply, absorbed rapidly and is also ideal for sensitive skin types. An active ingredient complex of vitamin B3 and vitamin E smoothes the skin, protects against moisture loss and reduces pore size and hyperpigmentation. The carefully chosen sun protection factor 15 is adequate for most daily sun exposure scenarios and therefore avoids unnecessarily high dosing of UV filters.



Belixos® Protect is the fourth product in Biofrontera's medical skincare line and complements Belixos® cream, Belixos® liquid hair tonic, and Belixos® gel that meet the special needs of reddened and itchy skin on different skin types of the body, whereas Belixos® Protect was prepared for everybody aware of the dangers of UV irradiation who cast about a daily protective and nurturing skin care. The new product is available in a pump dispenser containing 50ml. Like all other Belixos® products, Protect is available online through Amazon with immediate effect.



Ends

Half Year Results
RNS
RNS Number : 0447W
Biofrontera AG
14 August 2015



Biofrontera AG



("Biofrontera" or "the Company")



Half Year Results



Good progress made in first half of 2015



Leverkusen, 14 August 2015 - Biofrontera (FSE/AIM:B8F), the biopharmaceutical company focusing on sun-induced skin cancer has published its unaudited consolidated results for the six month period ended 30 June 2015, reporting an increase in revenues by 29% to EUR 1.57 million (2014 H1: EUR 1.22 million). The published half-yearly report is available in full on the Company's website www.biofrontera.com.

Financial highlights

· Significant growth in sales revenue of 29% compared to the same period in the previous year

· Improving sales performance in European countries outside German home market

· Consolidated profit/loss before tax: EUR -7.3 million, reflecting FDA submission fee

· Cash and cash equivalents of EUR 4.1 million as at 30 June 2015

· Capital raise for FDA submission fee successfully completed

Operational highlights

· Approval application for Ameluz® and BF-RhodoLED® submitted to the FDA in the USA

· Patient recruitment for the phase III trial on basal cell carcinoma completed

· Successful takeover of sales and distribution in Spain from Allergan

· Preparations for marketing in the USA initiated, own US subsidiary founded, Monica L. Tamborini appointed CEO of US Operations

The majority of revenues were again recorded in Germany with EUR 1.19 million (2014 H1: EUR 915,000), which represents an increase of 30%. Product revenues in other European countries also developed well with EUR 382,000 being achieved, which represents an increase of 65% compared to the first half of the previous year.

The Company reported a net loss before tax of EUR 7.3 million (2014 H1 loss: EUR 5.4 million) which includes development costs of EUR 4.5 million (2014: EUR 2.1 million). The increase was primarily as a result of the application fee of EUR 2.1 million which was paid to the FDA. This amount may be repaid by the FDA as Biofrontera may be eligible for a waiver for small businesses.

Milestone Approaching - US filing for Ameluz®

One of Biofrontera's most important strategic goals is entering the US market with its combination prescription drug Ameluz® and PDT-lamp BF-RhodoLED®. Both products are used together in photodynamic therapy for the treatment of mild and moderate actinic keratosis. As announced during the period, the Company's phase III actinic keratosis field therapy study with the drug/light combination reported complete clearance in over 90% of treated patients, along with a strong skin rejuvenation effect.

During the first half of 2015, results from all clinical studies were analysed in the format requested by the FDA and the dossier was finalised. Submission to the FDA was initiated on 10 July 2015. This represents an outstanding milestone in the history of Biofrontera. Management believes that globally there are very few biotech companies that have been able to initiate an approval process with the FDA for a drug developed in-house.

Marketing authorization will provide Biofrontera access to the largest pharmaceutical market in the world with the associated significant and transformational revenue potential for the Company.

European Approval Process for Ameluz® for the treatment of BCC

Biofrontera has also made good progress in its second project of strategic importance, the label extension of the European approval of Ameluz® for the treatment of basal cell carcinoma, one of the most frequently occurring forms of skin cancer. Patient recruitment for this study was completed in May. The study will therefore be finished by the end of 2015 and the extended approval is expected to be achieved by mid-2016. This approval will, in management's view, provide further revenue opportunities to the company far greater than with the existing label.

Prof. Hermann Lübbert, Chief Executive Officer, commented: "We are well in line with our targets for revenue development and can confirm our annual growth expectation of 30% with revenue of EUR 4 to 5 million for the full year to 31 December 2015. We have also made great progress with the submission of the application in the US as well as with completion of patient recruitment in our Phase III study for basal cell carcinoma. Biofrontera is well underway to become a much larger and much more prominent company in the short to medium term and we will work very hard to secure significant value for all our shareholders".

Ends

FDA accepts filing of Ameluz� and BF-RhodoLED�
RNS
RNS Number : 8954Y
Biofrontera AG
14 September 2015







Biofrontera AG - FDA accepts filing of Ameluz® and BF-RhodoLED® application



Leverkusen, 11 September 2015 - Biofrontera AG (FSE/AIM:B8F), the biopharmaceutical company focusing on sun-induced skin cancer, has today been informed that the Food and Drug Administration (FDA), the responsible US government agency, has accepted filing of the New Drug Application (NDA) of Biofrontera's anti-skin cancer drug Ameluz® combined with the PDT lamp BF-RhodoLED®. This constitutes the first key step in the approval process of Ameluz® and BF-RhodoLED® in the USA. Successfully passing this stage is a major milestone in the approval process and one of the most important steps in the history of the company.



With the positive decision, an FDA Review team is assigned to evaluate the research Biofrontera has performed on the drug's safety and effectiveness as well as the control measures in place to warrant the quality of the products. Within 5-6 months, the FDA will now prepare the mid-term review that will identify any outstanding issues and therefore provide a good indication for the timely approvability of the products.

FDA shortens review period for Ameluz
RNS
RNS Number : 0089B
Biofrontera AG
02 October 2015



FDA determines May 10, 2016 as PDUFA* date for Ameluz®



· 74-day letter received from FDA

· No potential review issues were identified in filing review

· FDA to provide interim report with suggested labelling by 30 March 2016

· PDUFA* action date is 10 May 2016



Leverkusen, Germany, 2 October 2015 - Biofrontera (FSE/AIM:B8F), the biopharmaceutical company focusing on sun-induced skin cancer, announces that it has received the 74-day letter from the Food and Drug Administration (FDA) in the approval process of Ameluz® in the USA. In its filing review, FDA did not identify any potential review issues and set the PDUFA date, the day of the approval letter, to 10 May 2016. Thus, FDA intends to use two months less than in most drug approvals for its review process.

FDA will now enter into its substantive review, which is expected to take six months. By 30 March 2016, FDA will release its interim report that will include suggested labelling and, if necessary, any post marketing commitment requests. Final labelling and potential commitments will be agreed upon between FDA and Biofrontera between 30 March 2016 and 10 May 2016. The suggested timing is based on the assumption that FDA does not identify any major issues during its substantive review.

Commenting on this milestone, Prof. Hermann Luebbert, CEO of Biofrontera said: "The choice of 10 May 2016 as PDUFA date is great news. FDA has not made use of their maximum 12-month review period, thereby potentially reducing time-to-market by two months".

* PDUFA - Prescription Drug User Fee Act



Ends

Who Should Attend?Date:

Wednesday 4th November 2015

Venue:

Novotel Tower Bridge, London EC3N, 10 Pepys Street, London, EC3N 2NR

Event Timings:Sponsored by: