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Munich – Formycon AG, Munich, Germany, and bioeq GmbH, Holzkirchen, Germany, today announced the initiation of a pivotal Phase III clinical trial with FYB201, an investigational biosimilar ranibizumab (Lucentis®). The global clinical trial is designed to confirm biosimilarity with regard to safety, efficacy and immunogenicity of FYB201 versus Lucentis® in patients with neovascular age-related macular degeneration (nAMD). The study design was developed in consultation with the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) and is expected to support the registration in both regions.

Top selling eye drug Lucentis® is the leading treatment for nAMD and other eye diseases and had estimated sales of $4.1 billion in 2014. It inhibits vascular endothelial growth factor (VEGF) which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision. The current total market size for intraocular anti-VEGF therapy is about $6.9 billion.

Formycon had licensed FYB201 exclusively to Santo Holding GmbH, Holzkirchen, Germany end of 2013. bioeq GmbH, an affiliate of Santo Holding GmbH, acts as the sponsor of the Phase III study and will also be responsible for the global commercialization and licensing of FYB201.

Carsten Brockmeyer, Ph.D., CEO Formycon AG: “We believe that we are the first company initiating a pivotal phase III study for a biosimilar version of ranibizumab. This underlines our mission to provide high quality biologics to patients across the world. I am glad that Formycon and bioeq will jointly drive the clinical development, regulatory filings and commercialization of FYB201, which will help us to become a significant player in the field of ophthalmological diseases, one of the most rapidly growing therapeutic areas. We continue to advance our pipeline with two other biosimilar candidates already in preclinical phase.”

“Intraocular anti-VEGF agents are a cornerstone in the treatment of age related macular degeneration and other eye diseases. A high quality and clinically proven biosimilar version of Lucentis® could play an important role in broadening the access to these essential medicines and generating much needed savings” said Professor Dr. O. Findl, Chair of the Department of Ophthalmology at Hanusch Hospital, Vienna.

“The costs associated with the treatment of eye diseases have become a tremendous emerging challenge for global health care systems. I am confident that, together with our partner Formycon, we can build a strong global presence in ophthalmology. Biosimilars like FYB201 will address the need for affordable access to essential high-quality treatments for payors, prescribers and patients. We continue to expand our biosimilar portfolio in ophthalmology but also in other indications” said Nicola Mikulcik, CEO of bioeq GmbH.

* Lucentis is a registered trademark of Genentech Inc

Munich – Formycon, the biosimilars company, has closed the first half of its fiscal year 2015 with very successful financial results. Consolidated revenue for the period ending June 30, 2015, was EUR 9.8 million, an increase of EUR 2.24 million over the prior-year period. Net income for the six-month period was EUR 1.53 million, with the decrease of almost EUR 1 million from the prior-year period due largely to increased material and staff expenses related to investments in projects to develop new biosimilar drugs. As of the period closing date, Formycon Group held more than EUR 20.56 million in consolidated cash and marketable securities. The company’s equity capital ratio rose from 83.4 percent to 89.8 percent.

Formycon AG, the parent and primary operating entity, as well as the entity conducting core R&D activities, reported unconsolidated revenue of EUR 7.1 million (prior-year period: 7.4 million) and unconsolidated after-tax earnings of EUR 1.65 million (2.41 million). The company continues to anticipate a full-year profit for both the consolidated group and the unconsolidated parent entity.

“We are very satisfied with these half-year results,” said Dr. Nicolas Combé, CFO of Formycon. “Because we are investing significant amounts into the development of our biosimilar candidates and are, moreover, in a growth phase, our expense levels have increased according to plan. These are investments which are serving to build our company’s long-term future.”

With out-licensing deals now signed with Santo Holding GmbH for two of the three product candidates currently in development, Formycon has a strong partner at its side. “This has put a solid foundation into place for our product candidates and their future market launch,” explained Combé. “Furthermore, this partnership gives us the financial flexibility to proceed deliberately and confidently with our own biosimilar development efforts, as we expand our R&D pipeline step by step.”

Under the terms of the licensing agreement signed in May 2015 for FYB203, the company’s second biosimilar drug, Formycon received a multi-million-euro up-front payment from Santo. Formycon will, moreover, receiving payments for further product development all the way through to regulatory approval. Since December 2013, when the company signed its out-licensing deal with Santo Holding for FYB201, its first product candidate, Formycon has been receiving ongoing payments. Its third project under development, FYB202, is currently in pre-clinical testing.

Munich – Formycon AG, a leading independent developer of biosimilar drugs, has received a scientific advice letter from the U.S. Food and Drug Administration (FDA) regarding the preclinical and clinical development program for FYB201, the first biosimilar product candidate to emerge from its development pipeline, following the receipt of similarly favorable scientific advice from the European Medicines Agency (EMA) in December 2014. In its letter, the FDA, like the EMA, expresses its support for the company’s proposed approach to proceed with FYB201 directly to the pivotal phase III clinical trial. Based upon the scientific advices received from the EMA and FDA, Formycon and its license partner Bioeq GmbH are now in a position to carry forward with a clinical study design for a global phase III trial which will enable them to apply simultaneously for regulatory approval in both the U.S. and European Union. All preclinical activities and the preparations for the phase III trial for FYB201 are moving forward according to plan.

The market launch of FYB201 in the highly regulated markets, particularly the U.S. and European Union, is planned to begin starting from 2020.

Munich – Formycon AG has announced its financial results for the first quarter of 2015, reflecting the continued advances of its biosimilar development projects in line with plan. The group’s revenue for the period was largely attributable to its licensing and development agreement with Santo Holding GmbH for FYB201, the first of its biosimilar drug projects. Expenses consisted mainly of research and development costs for its three pending biosimilar projects. Subsequent to the end of the quarter, an important operational milestone was reached with the signing of an out-licensing agreement for FYB203, which will provide a further boost to the company’s financial flexibility. As to FYB201, the farthest advanced of its development projects, preparations and consultations with U.S. and European regulatory authorities for the commencement of phase III clinical trials essential for final regulatory approval are proceeding according to plan.

In the first quarter of 2015, Formycon reported consolidated revenues of EUR 3.0 million (1Q 2014: EUR 5.8 million). The decline was due to the fact that the prior-year period included a one-time payment following the signing of the above-mentioned licensing agreement. Consolidated EBITDA for the period was negative EUR 0.3 million (1Q 2014: EUR 4.2 million), with the decline likewise attribute to the one-time payment in the prior-year period. Based upon the recently announced successful signing of a partnership deal for FYB203, the company has raised its full-year forecast for fiscal year 2015, which it now expects to end with positive EBITDA.

Munich – Formycon AG has announced the signing of an exclusive, global out-licensing deal for its FYB203 biosimilar drug, with Santo Holding GmbH as licensing partner. The newly signed agreement will ensure that Formycon has project funding in place all the way through to market introduction.

Under the agreement, Santo Holding will assume responsibility for, and the costs of, all further development activities, production and marketing of the Formycon biosimilar drug. In return, Santo Holding will receive exclusive worldwide marketing rights for FYB203. Pharmaceutical product development through to regulatory approval will remain in the hands of Formycon, while clinical development will be carried out by Bioeq GmbH, which manages biosimilar product development activities on behalf of Santo Holding. Under the terms of the new agreement, Formycon will receive an immediate payment in the amount of several millions, along with ongoing payment for its product development activities through to regulatory approval. The company will, in addition, participate in sales revenue once the project is brought to market, receiving a percentage share in the low double digits. Based on sales projections, the agreement is thus expected to yield Formycon total cumulative revenue well over the hundred million euro mark.

“The signing of this important deal marks a further milestone for our company as well as a major success for our entire team as we work to expand our pipeline of biosimilars for the global market,” declared Dr. Carsten Brockmeyer, CEO of Formycon AG. “We are immensely pleased to have found Santo Holding as a strong, ideal partner for our first two projects. Over the past years, we have driven our company forward through our commitment to investment in long-term research – and this is a strategy which we will continue to relentlessly pursue.”

“With the out-licensing deal for FYB203, we now have financing completely in place for two biosimilar products, all the way through to market launch,” said Dr. Nicolas Combé, CFO of Formycon AG, in commenting on the newly signed agreement. “For our shareholders, this means a project financing expected to yield hundreds of millions of euros in revenue – and without shareholder dilution. This is a resounding validation of our strategy and, in particular, the superb work of our staff. The licensing agreement further strengthens our financial flexibility as we work towards our driving goal: to be the world’s leading developer for the third wave of biosimilar drugs.”

“Biosimilar drugs are making an increasingly significant contribution to patient care by making high-quality biopharmaceuticals accessible to them at a fair price,” added Nicola Mikulcik on behalf of Bioeq GmbH. “Based on our successful work together on our first joint project, likewise bringing this new product to market in partnership with Formycon is a logical step. We anticipate excellent global market opportunities for both of these products.”

Formycon currently has three biosimilar drugs under development, with Santo Holding its product partner for FYB201 and now also FYB203. The company plans to develop the third product, FYB202, through to the end of phase I clinical trials using its own resources.

Munich – Carsten Brockmeyer, CEO of Formycon AG, has been ranked No. 12 on “The Medicine Maker Power List” 2015, an index of the 100 most influential people across the globe in the field of medicine. He appears on the list alongside global leaders from the industry, including CEOs, Nobel Prize winners, and many other celebrated scientists from the pharmaceutical world.

The list also includes names like Prof. David Baltimore, Nobel Prize winner in Physiology; Robert A. Bradway, Chairman & CEO, Amgen; Joseph Jimenez, CEO Novartis; Ian C. Read, Chairman, Pfizer; Kiran Mazumdar-Shaw, Chairperson and Managing Director of Biocon; Pascal Soriot, CEO, AstraZeneca; and many more. Carsten Brockmeyer is the only Germany based business leader on the list.

“I am very glad to be part of this prestigious list of medicine makers, it is also a great recognition for the important role biosimilars have in the global access to medicine. I also like to thank the Formycon team for their commitment to develop global quality biosimilars”, says Carsten Brockmeyer.

The Medicine Maker is a UK based publication that is distributed worldwide to industry professionals. The power list has been compiled from reader nominations with the help of expert judges and is based entirely on merit. It was developed in three stages. In stage one, The Medicine Maker invited readers to nominate those who they thought deserved recognition. In stage two, a jury of four noted medicine makers selected their top 100 from the slate of nominees: the results were consolidated into a list of 100 names. In the final stage, the jury ranked the list, and the average rankings were combined to provide the final Power List. The list can be accessed here.

Munich – The Supervisory Board of Formycon AG has unanimously voted to extend the executive board appointment of Dr. Nicolas Combé, the co-founder of the company who has served with distinction as its chief financial officer since May 5, 2010. With effect from April 27, 2015, his executive appointment has now been extended for three further years, until June 16, 2018. Without this extension, his current term of office would otherwise have expired as of May 5, 2015.

“This strong vote of confidence will ensure stability and continuity as the company moves forward in its current growth phase,” noted Dr. Olaf Stiller, Chairman of the Supervisory Board. “The Supervisory Board has no doubt that Dr. Combé will continue his excellent work over the next three years.”

“I am grateful for this renewed expression of the Supervisory Board’s confidence, and I look forward to meeting the challenges which lie ahead,” said Dr. Combé. “I would also like to take this opportunity to thank the staff of Formycon and especially our CEO, my colleague on the executive board. I am highly optimistic that, working together, we will continue to be able to attain the ambitious objectives which we have set for our company.”

Munich – Formycon AG has completed a capital increase against cash contributions from its approved capital, and under exclusion of subscription rights, in the amount of 435,920 shares. With the successful completion of this transaction, the company’s registered capital rises from EUR 8,626,683.00 to EUR 9,062,603.00, an increase of EUR 435,920.00. The newly issued shares have been privately placed to selected institutional investors and family offices, notably including a U.S. healthcare fund, at a price of EUR 25.50 per share. Proceeds from the share placement in the gross amount of EUR 11,115,960.00 will flow entirely to the company and are to be used to advance and expand the company’s biosimilar development programs in accordance with its plans, thus further strengthening the market position which Formycon has already achieved. With this capital transaction, the company’s total holdings in cash and marketable securities will rise to approx. EUR 21.3 million. The entry of a major U.S. fund into the Formycon investor base underscores the high level of interest among international investors in the rapidly developing market for biosimilar drugs, as well as the strategic importance to the company of the North American market. First Berlin Securities Brokerage GmbH served as advisor to Formycon for this transaction.

Munich – Formycon AG has reported its preliminary consolidated financial results for fiscal year 2014, with sales revenue and other income totaling EUR 12.67 million (prior year: EUR 0.41 million). Operating expenses rose from EUR 1.25 million in the prior year to EUR 5.91 million due to ongoing product development activities at its Munich headquarters. EBITDA for the year was EUR 1.94 million (prior year: – EUR 6.64 million), while net income came in at EUR 0.86 million (prior year: – EUR 7.74 million). With these strong results, the company has delivered its first full-year profit in 2014, significantly ahead of its own earlier forecasts.

As of December 31, 2014, Formycon Group held a total of EUR 9.22 million in cash and marketable securities. Equity capital ended the year at EUR 13.11 million (prior year: EUR 12.25 million), leaving the company’s equity capital ratio (equity as percentage of total assets) almost unchanged from the prior-year level at 77.5 percent.

Because of the significant investments into building its drug development pipeline in 2013, Formycon had posted a loss of EUR 7.7 million for the prior fiscal year, as anticipated. These investments have now started paying out for the long term as the company successfully develops its own biosimilar products. Since December 2013, Formycon has already been earning significant income from the out-licensing of its first product to Santo Holding. As the licensed partner for this drug, Santo Holding is now financing the further clinical development, regulatory approval process and market launch of this first bioisimilar drug, towards the aim of global distribution.

Through its intensive R&D activities, Formycon has since managed to achieve a number of further milestones in the development of its three biosimilar candidates. As already announced, the company was able in December 2014 to moves its first biosimilar (FYB201) directly into the critically important phase III clinical trials on the basis of preliminary guidance received from the European Medicines Agency (EMA). Formycon is likewise now seeking scientific advice from the U.S. Food and Drug Administration (FDA). Development of the company’s two other biosimilar candidates (FYB 202 and FYB 203) continues to move forward according to plan.

Munich – Formycon AG, the biosimilar drug development company, has completed a successful GMP (Good Manufacturing Practices) inspection of its site in Munich-Martinsried by the Government of Upper Bavaria. The German GMP certificate confirms that Formycon conducts analytical testing in compliance with EU GMP regulations and underlines Formycon’s position as integrated biosimilar development company. This achievement is another important step in Formycon’s preparation of the pivotal phase III study of clinical testing for its first biosimilar candidate (FYB201) which already has been licensed out to Santo Holding GmbH back in December 2013.

Furthermore, the company has received final advice in December 2014 from the European Medicines Agency (EMA) in London for the non-clinical and clinical development of FYB201. EMA’s scientific experts are in consensus with Formycon’s approach to move FYB201 directly into phase III clinical testing, which puts Formycon almost one year ahead.

Formycon has now submitted the clinical study protocol and other documents to the U.S. Food and Drug Administration (FDA) to obtain also FDA’s expert advice before starting the pivotal global phase III study.

Background: What are biosimilars?
Since their introduction in the 1980s, biopharmaceuticals have revolutionized the treatment of diseases such as cancer, diabetes, rheumatoid arthritis and multiple sclerosis. In the coming years, many of the patents for these biotech drugs will expire – and by the year 2020, medications with revenues of more than USD 100 billion will lose their patent protection. In this way, it will become possible to launch new competing drugs, known as “biosimilars”. While the global market for these new-generation drugs is currently some USD 2.5 billion, industry experts expect this figure to grow tenfold by the year 2020. In contrast to traditional generic drugs, the development and production of biosimilars is highly complex and requires specialized expertise.