Formycon AG signs licensing agreement for its FYB203 biosimilar

  • Second biosimilar drug to be out-licensed from Formycon product pipeline
  • Important milestone strengthens position as world’s leading independent biosimilars developer
  • Formycon to receive success-based payments in the triple-digit millions of euros

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.

Carsten Brockmeyer belongs to the top 20 most influential people in the Global ‘Medicine Maker Power List’ 2015

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.

Reappointment of board member Dr. Nicolas Combé

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.”

Formycon AG successfully completes capital increase from approved capital

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.

Formycon Group announces preliminary results for fiscal year 2014

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.

Formycon AG announces successful GMP inspection and the start of US FDA scientific advice procedure for its out-licensed biosimilar FYB201

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.

Formycon AG moves planned start of pivotal phase III study for its first biosimilar product (FYB201) forward to 3Q 2015

Munich – Formycon AG, the biosimilar drug development company, is planning to begin the pivotal phase III study of clinical testing for its first biosimilar product (FYB201) already in the third quarter of 2015. The company has brought its schedule forward on the basis of preliminary guidance received from the European Medicines Agency (EMA) in London, with which Formycon is working closely to define the regulatory approval pathway and design of phase III clinical studies for FYB201. The company expects to receive the EMA’s final position as to its scientific advice in December. This is a service through which the EMA provides consultation and recommendations to drug developers on study design and clinical trials reflecting the consensus of the EMA’s scientific experts, in order to facilitate subsequent regulatory approval.

For Formycon AG, the favorable response to its proposed plan for clinical studies means a significant shortening of its development and approval schedule. “This puts us almost exactly one year ahead. The opportunity to jump directly to phase III serves as further confirmation of the high quality of our work,” says Dr. Carsten Brockmeyer, CEO of Formycon AG.

Following the company’s successful capital raising and its partnership deal for its first biosimilar drug signed with Santo Holding in 2013, this marks yet another key milestone for Formycon. Marketing launch for FYB201 in the USA and European Union is planned starting in 2020 – and in certain selected countries should be possible starting already in 2018. The two other biosimilar drugs currently in Formycon’s development pipeline continue to move forward according to plan and remain the subject of discussions with various pharmaceutical and generic companies.

Formycon AG releases nine-month figures for 2014

Munich – Formycon AG, the German biosimilars company which in December 2013 licensed out its first product candidate to Santo Holding GmbH, has reported positive financial results in line with expectations. For the first nine months of 2014, the company posted revenues of EUR 8.98 million (2013: EUR 0.33 million). Its operating profitability likewise improved markedly, with EBITDA of EUR 2.64 million for the period from January through the end of September. In the same period last year, the company had posted an EBITDA loss of EUR 4.33 million.

In terms of net income, the company earned EUR 1.81 million for the first nine months. During the same period in 2013, the company had reported a loss of EUR 5.16 million. Formycon has, moreover, confirmed its expectation for ending the fiscal year with positive EBITDA. The company’s total liquidity (including credit balances with banks, cash, checks and marketable securities) as of the end of September was EUR 10.44 million, compared to EUR 3.11 million at the same time last year.

Operational work continues as planned on the company’s three currently pending biosimilar projects, with each project advancing in line with its respective development schedule. As a developer of biosimilar drugs, Formycon is benefiting from the explosion of interest from the pharmaceutical industry in the so-called “third wave” of biosimilars, biotech drugs which replicate existing biopharmaceuticals, and is thus in discussions with a number of pharmaceutical corporations and generic drug producers about further development projects.

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.

Formycon AG announces its results for the first half of 2014

Munich – The first half of 2014 has been marked by the expansion of the company’s research and development activities. The company has started with the development of a third product, which, like the two previous products, is intended to mimic a biopharmaceutical active ingredient of the third wave of biosimilars. The company has also already licensed a biosimilar candidate out to Santo Holding GmbH and is currently in discussions with national and international pharmaceutical and generics companies about licensing out further product candidates.

In the first half of 2014, Formycon AG recorded a turnover of 7.4 million euros (2013: 0.2 million euros). This increase is substantially due to the high revenues achieved as a result of the above mentioned licence agreement and the resulting development alliance. The company’s EBITDA amounted to 3.2 million euros in the first half of 2014 (first half of 2013: -3.0 million euros). Overall, the company expects to achieve positive EBITDA for the business year 2014. The company’s liquid assets, comprising cash on hand, bank credit balances and financial securities, amounted to 11.2 million euros at the end of June 2014.

Formycon AG commences development of its third product, seeing this as confirmation of its pioneering position in the "third wave" of biosimilar drugs

Munich – Formycon, the independent biosimilar development company, today announced that the development of its third product has now commenced, which like its first two products aims to replicate an established biopharmaceutical drug. These products will be part of the so-called “third wave” of biosimilars, referring to the major, multi-billion-dollar blockbuster drugs created through biotechnology for indications in the areas of ophthalmology, autoimmune disease, and metabolic and blood clotting disorders for which patent protection will expire beginning in 2020. According to information from FirstWord Pharma, a respected provider of industry information, many of the biosimilar development teams within the major pharmaceutical groups are still concentrating their efforts on the first and second waves of biosimilars, where there is strong competition. Formycon, in contrast, has been able to position itself as the clear global leader within the highly lucrative market for biosimilar drugs for patents expiring starting in 2020.

Formycon sees a strong validation of its positioning, in particular, through recent remarks made by Teva, the world’s largest generics producer, whose top management has, in speaking to analysts, expressed its strong interest in this third wave of biosimilars. In the view of FirstWord Pharma, the remarks point to a shift in paradigm affecting the entire industry, as the firm writes in a recent report: “Teva is one of the first companies to openly discuss biosimilar opportunities beyond 2020, but due to limited opportunity within the current crop of biosimilar targets, it certainly won’t be the last.” There is, according to the report, broad agreement among all of the surveyed experts that it is, in view of the development lead times, far too late for investments into the second wave of biosimilars, and that companies need to focusing on biopharmaceuticals for which patents will be expiring in the year 2020 or beyond.

“The development of biosimilar drugs, and the building of a product portfolio therefrom, for the period starting in 2020 is precisely the business model of Formycon. We are gratified to hear that the market leader in generics has likewise put this ‘Agenda 2020’ for biosimilars on its radar. It demonstrates that the work we are doing is very closely aligned to market needs, and it validates the strategic direction that we put into place already one and a half years ago. Since the start of 2013, we have been working on the most significant biosimilar products of the third wave, enabling us to gain a significant head start. We see further confirmation of this in the strong interest in our product developments,” explains Dr. Carsten Brockmeyer, CEO of Formycon AG.

Formycon AG has already licensed out the first of the third-wave biosimilar candidates which it has developed to Santo Holding GmbH (Bioeq GmbH) and is currently in discussions for the out-licensing of further product candidates.