Berlin, June 7, 2013 - INJEX Pharma AG announces that the Executive Board under the direction of Dr. Thomas Klaue will publish a letter to the shareholders on Friday of next week. The letter intents to fully inform the shareholders about the current situation of the company and planned measures.
Berlin, May 17, 2013 - INJEX Pharma AG announces the appointment of Dr. Thomas Klaue as member of the Executive Board with immediate effect. He will serve as the CEO of INJEX Pharma AG. Andy Rösch, the founder and CEO to date, will retire at the end of June 2013. However, he will further support the company in the future as a consultant and as a main shareholder.
The Chairman of the Supervisory Board of INJEX Pharma AG, Dr. Peter Heinrich, commented: "On behalf of the Supervisory Board, I would like to thank Mr Andy Rösch for the impressive job he has done as a visionary founder and CEO in the start-up phase. His accomplishments are the basis for the growth phase we are facing now. And we are glad having been able to attract Mr Thomas Klaue, an experienced manager with capital markets expertise and with senior management experience in the technology and life science industry. He is the CEO to lead the company into the next growth stage and to the stock market.”
"After completion of the start-up phase I am looking forward to develop this company into the next stage. We will first reinforce our equity base and second increase our production capacity to supply our global distributor network", concluded the newly appointed Executive with regard to his new assignment.
The Harvard Business School graduate Thomas Klaue has more than two decades of experience as senior executive in the technology (EADS, Infineon Technologies) and biotech/healthcare industry, i. e. with MediGene AG. Since 2007 he served as CFO in listed companies and was appreciated by analysts and investors for his transparent communication with the capital market.
INJEX Pharma AG is currently preparing its listing in segment General Standard at the Frankfurt Stock Exchange.
INJEX Pharma AG
Investor Relations
t: +49 89 24 41 18 - 223
f: +49 89 24 41 18 - 499
ir@injex.com
INJEX Pharma AG:
INJEX Pharma Aktiengesellschaft and its subsidiaries INJEX Pharma GmbH and INJEX Vertrieb Deutschland GmbH are specialized in the development, manufacturing and marketing in the medical technology segment and in the cosmetics and beauty markets. The Group’s core business areas are the needle-free INJEX30 system and the product line SHIREEN in the beauty market. The main markets of the Group are North America, China, India, Russia and Europe.
Berlin, May 06, 2013 – INJEX Pharma AG announces a change to its Supervisory Board. On April 23, 2013 Mr Till Andreesen was appointed a member of INJEX Pharma AG's Supervisory Board by order of the local court of Charlottenburg / Berlin according to section 104 German Companies Act (AktG) with immediate effect. A replacement became necessary because the former member of the Supervisory Board, Mr Roland Knoll stepped back for personal reasons on March 22, 2013.
Mr Till Andreesen is an auditor since 2008 and in private practice since 2011 in Berlin. The legal requirements according to section 100 clause 5 German Companies Act (AktG) are fulfilled by the appointment of Mr Andreesen. He is an independent member of the Supervisory Board and, as a result of his education and professional experience, has appropriate accounting and auditing expertise.
For further information on INJEX Pharma AG and its subsidiaries, please refer to www.injex.com. For further questions please contact our Investor Relations team directly:
INJEX Pharma AG
Investor Relations Team
t: +49 89 24 41 18 - 223
f: +49 89 24 41 18 - 499
ir@injex.com
INJEX Pharma AG:
INJEX Pharma Aktiengesellschaft and its subsidiaries INJEX Pharma GmbH and INJEX Vertrieb Deutschland GmbH are specialized in the development, manufacturing and marketing in the medical technology segment and in the cosmetics and beauty markets. The Group’s core business areas are the needle-free INJEX30 system and the product line SHIREEN in the beauty market. The main markets of the Group are North America, China, India, Russia and Europe.
China, April 16, 2013 – INJEX Pharma AG is pleased to announce that yesterday its wholly owned subsidiary INJEX Pharma GmbH has successfully registered the INJEX30 needle free injection system with the Chinese State Food and Drug Administration (SFDA), supported by its exclusive distributor Hangzhou Hema Medical Equipment Co. Ltd. The SFDA is responsible for regulating the market access of medical devices in the People’s Republic of China. The arduous approval process took more than 1.5 years and has required a detailed documentation.
The registration is a significant milestone in the Company's efforts to expand its offerings in key markets. One area of application is the use of insulin for persons with diabetes. According to figures in the recent Diabetes Atlas (5th edition, 2012) published by the International Diabetes Federation, about one fourth of the 371 million people with diabetes live in China. Hangzhou Hema Medical Equipment can immediately start marketing the INJEX30 system.
For further information on INJEX Pharma AG and its subsidiaries, please refer to www.injex.com.
For further questions please contact our Investor Relations team directly:
INJEX Pharma AG
Investor Relations Team
t: +49 89 24 41 18 - 223
f: +49 89 24 41 18 - 499
ir@injex.com
INJEX Pharma AG:
INJEX Pharma Aktiengesellschaft and its subsidiaries INJEX Pharma GmbH and INJEX Vertrieb Deutschland GmbH are specialized in the development, manufacturing and marketing in the medical technology segment and in the cosmetics and beauty markets. The Group’s core business areas are the needle-free INJEX30 system and the product line SHIREEN in the beauty market. The main markets of the Group are North America, China, India, Russia and Europe.
Berlin, March 18, 2013 – INJEX Pharma AG announces that the timetable of the securities prospectus, that was approved on February 26, 2013, is changing. The approval decision of the Frankfurt Stock Exchange and the commencement of share trading which should have taken place today are postponed.
According to the German Prospectus law, if a significant new factor arises during the relevant period, the company shall submit a supplementary prospectus containing details of the new factor to the Federal Financial Supervisory Authority (BaFin) for its approval. The relevant period begins when the prospectus is approved by the BaFin and ends when trading in the securities on the regulated market begins. After the approval of the prospectus on February 26th, 2013, a significant new factor arose which leads to a supplementary prospectus.
The approval decision of the Frankfurt Stock Exchange and the commencement of share trading are postponed due to the obligation to write a supplementary prospectus. The postponement was initiated at the request of INJEX Pharma AG.
INJEX Pharma AG will set up as fast as possible the supplementary prospectus. As long as the supplementary prospectus is not filed with BaFin, the approval decision of the Frankfurt Stock Exchange and the commencement of share trading will not take place. We endeavour to produce the draft within a reasonable timeframe, but more importantly will make sure, that all new events will be addressed appropriately.
For further questions please contact our Investor Relations team directly:
INJEX Pharma AG
Investor Relations Team
t: +49 89 24 41 18 - 223
f: +49 89 24 41 18 - 499
INJEX Pharma AG is pleased to announce about the progress of the review process of the share prospectus. The prospectus was filed on November 07, 2012 with the German Financial Supervisory Authority (Bafin). The management is contented with the development of the process.
INJEX Pharma AG had decided to move to the Regulated Market (segment General Standard) of Frankfurt Stock Exchange - one of the crucial prerequisites for this is an approved share prospectus by Bafin. On November 30, 2012, the Management Board has provided application via ACON Actienbank AG for inclusion of the INJEX Shares for trading on the regulated market at the Frankfurt Stock Exchange.
Andy Rösch, CEO, commented: “We ask our shareholders for their continued understanding that there has been little available information about the current review process of the share prospectus. As soon as information comes to light which may be published by INJEX, we will inform our shareholders and the capital market immediately. We therefore strive to keep the general public, and our shareholders in particular, informed about the review process at Bafin."
Berlin - Newly founded '21 Medical Technologies LLC.,' (21 MT) located in Fort Lauderdale, Florida, will exclusively market and distribute INJEX30 Systems in the United States. INJEX30 syringes without a needle may be used in multiple medical, cosmetic and anesthetic applications and marketed via traditional pharmaceutical and emerging life science modalities. INJEX30 targeted disease states and delivery systems include diabetes, local and dental anesthetics, allergy and fertility treatments, vaccinations, erectile dysfunction and growth hormones. '21 MT' is a perfect partner in the US and it's an exciting time for INJEX Pharma AG as we continue to execute on our global mission while simultaneously introducing the SHIREEN Beauty Kit utilizing a 'Poring method' in the United States.' Andy Rösch, CEO INJEX Pharma AG.
The signed distributor agreement includes a minimum volume of 70,000 INJEX30 Systems, 25,000 SHIREEN Beauty Kits and 300,000 SHIREEN Fluid Units. The First shipment will commence during the month of September.
'Product launches in the United States must be carefully orchestrated across many modalities including direct to the consumer. The United States' healthcare industry appears to be in early stages of its transformation which presents an opportune time to align our innovative technology with a 'High profile personality.' '21 MT' has the ability to raise immediate awareness for both INJEX30 Systems and SHIREEN Beauty Kits through its media reach and seasoned team of professionals. We look forward to working closely with '21 MT' as they prepare to deploy significant resources across modalities. This multi-faceted approach will be necessary to build brand awareness with an emphasis on 'service excellence.' This agreement is a 'Home run' for the end users who will benefit from a syringe delivery system without a needle.' Sylwin Grinman, Director International Sales and Marketing at INJEX Pharma AG.
'We are excited to begin marketing our innovative 'Poring method' with SHIREEN Beauty Kits in the world's biggest beauty market. '21 MT' was founded with an appreciation for challenges when dealing with big markets and we are comfortable '21 MT' will exceed distribution expectations and establish new benchmarks for 'service excellence' in this industry. We will be increasing our production capacities in the short-term and developing necessary logistical contingencies to meet future demand. '21 MT' will consummate this agreement in the days ahead, with payments on the way, triggering exclusivity, as terms for initial shipments are met. Shortly thereafter, we expect to conduct a press conference with 21 Medical Technologies LLC, elaborating on our vision, steps for executing in the US and defining details related to this agreement.' Andy Rösch, CEO INJEX Pharma AG.
Medical Marketing Canada (MMC) Inc. is pleased to announce it has successfully navigated the complex registration process for INJEX30 in Canada. INJEX Pharma AG and their exclusive international partners continue to enter new countries via national registrations in numerous countries including China and India which offer significant growth opportunities for this innovative technology while delivering solutions’ to help improve the quality of life.
INJEX Pharma AG will deliver its initial shipment of 2500 INJEX30 System and all disposable ancillaries to “MMC” in accordance with the contract which includes: 75% prepayment and remaining monies to be paid within several business days of shipment.
“Registration in Canada is one of the more challenging processes associated with International distribution and we are pleased our strategic partner “MMC” met all necessary requirements. In concert with our previously announced FDA 510 K we are well positioned to execute on our sales strategy in these regions. In addition to our North American Regions we anticipate additional key registrations as we continue to execute on our vision.“ stated Andy Roesch, CEO of INJEX Pharma AG
INJEX Pharma AG markets and sells their INJEX30 System and ancillaries products worldwide. The INJEX30 technology offers needle free technology which is cost effective and painless. INJEX30 is a syringe without a needle used in multiple medical, cosmetic and anesthetic applications and may be marketed via traditional pharmaceutical and emerging life science modalities. INJEX30 targeted disease states and delivery systems include diabetes, local and dental anesthetics, allergy and fertility treatments, vaccinations, erectile dysfunction and growth hormones.
INJEX Pharma AG is introducing the SHIREEN Beauty system focused on the rejuvenation of the skin. SHIREEN is being formulated to remove initial wrinkles and provide natural glow to the skin. The “Poring method” is an innovative international cosmetic treatment for the skin. The liquid crème SHIREEN Fluid is sprayed with high pressure and within a small distance of the skin via the SHIREEN pore-jet allowing the fluid open access to pores stored in the upper layers of the skin.
New York Investment Groups recommends – listing on NASDAQ.
The Management of INJEX Pharma AG, a health care company based in Berlin, Germany, visited New York for a financial road show in the first week of June and presented the innovative products, INJEX and ROJEX, needle free and painless injection systems to selected investment groups.
The CEO, Mr. Andy Rösch and the Director for international sales, Mr. Sylwin Grinman, are convinced that the technology, which was introduced more than ten years ago, has great worldwide market potential today. We offer our worldwide network of distributors exclusive signed agreements. The start of marketing and sales in the US market is just ahead. At the end of May the company received the FDA 510(k) registration for marketing and sales of the INJEX products in the United States of America. This is an important milestone especially for the New York financial community.
INJEX Pharma AG impressed by presenting the beauty kit SHIREEN with the new Poring – Method for a soft wrinkle treatment. This new method combined with the SHIREEN Fluid has -big market potential and shall acquire the market between the skin creams and the injection method with different products.
Sylwin Grinman, INJEX Pharma USA in Miami says; “We will offer more as we plan for the future. We have an innovative concept, we are going new ways, entering new markets and are seeking new market potentials. INJEX for the medical markets and SHIREEN for the cosmetic markets will yield market share with our new marketing and sales concept. “
New York investment bankers recommended after the presentation a listing on the NASDAQ and offered their services to accompany INJEX Pharma AG. The CEO and the supervisory board will check the opportunities for such a listing with selected investment bankers in New York.
According to Andy Rösch, “This was a ground - breaking experience for our us to have the chance to present the company, the history and the future potential in New York. American bankers are focusing on the future and we were able to present and convince in a reliable manner. We are diversifying and entering new markets like the profitable cosmetic market. The proposal for a NASDAQ listing definitely amazed us. We want to take this American challenge, because this would be a huge opportunity for the company and the shareholders. Now we have to evaluate whether the company has all the basics to go this step. “
The FDA 510(K) registration is based on the FDA 510(K) for the INJEX system under Rösch Medizintechnik AG. INJEX Pharma GmbH is the new registered manufacturer and exporter. The FDA 510(K) by Rösch AG was still valid, but had to be reactivated by the new manufacturer. An important milestone for INJEX Pharma AG began as a new startup company with worldwide sales and marketing at the end of February 2012.
The management of the company will go on a road show in New York next week and will present the new concept for worldwide sales and marketing to investment groups on Wall Street. About 20 presentations are scheduled right now.
According to Sylwin Grinman, President of INJEX Pharma USA:
“USA/North America is a powerful market for any new and unique technology that wants to establish itself in its respective market place. This needle free injection system will create remarkable changes for all people.
Its applications are numerous and constantly emerging in areas of dentistry, diabetes, cosmetic & beauty care, vaccines, ED dysfunction.
We have developed a new concept in the beauty & cosmetic industry with our new line of Shireen, which will be used in wrinkle treatments. Shireen will revolutionize the cosmetic market.
INJEX the needle free injection system is now a global commodity and it is the beginning of a new era in medical device technology. It is simple, easy to use and will fit perfectly into the American lifestyle.”
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