• MorphoSys to receive a USD 20 million upfront payment and entitled to tiered, double digit royalties on net sales of MOR202 plus mile­stone payments of up to USD 100 million from I-Mab
• I-Mab receives exclusive devel­op­ment and com­mer­cial­iza­tion rights to MOR202 in China, Taiwan, Hong Kong and Macao
• I-Mab Biopharma (a fully owned affiliate of I-Mab) man­agement has extensive ex­peri­ence that is particularly well-suited to devel­op­ing MOR202 for the Greater Chinese market
• MorphoSys in­­creases its financial guidance for 2017: revenues of EUR 63 to 66 million and EBIT of EUR -66 to -71 million ex­pec­ted

Planegg / Munich, Germany (Press Release) – MorphoSys AG (FSE: MOR; Prime Standard Seg­ment, TecDAX; OTC: MPSYY) and I-Mab announced today that they have entered into an ex­clusive regional licensing agree­ment to develop and com­mer­cial­ize MOR202 in China, Taiwan, Hong Kong and Macao. MOR202 is MorphoSys's pro­pri­e­tary inves­ti­ga­tional anti­body against CD38, for which recruit­ment of a European Phase 1/2a clin­i­cal study in re­lapsed / refractory multiple myeloma has been concluded.

Under the terms of the agree­ment, I-Mab Biopharma will assume exclusive re­spon­si­bil­ity­ for all sub­se­quent devel­op­ment and com­mer­cial­iza­tion of MOR202 in the agreed territory. MorphoSys receives an im­medi­ate upfront payment of USD 20 million. MorphoSys will be entitled to receive addi­tional success-based clin­i­cal and commercial mile­stone payments from I-Mab of up to approx­i­mately USD 100 million, as well as tiered double-digit royalties on net sales of MOR202 in the territory.

In connection with the license agree­ment with I-Mab, MorphoSys has in­­creased its financial guidance. For the year 2017, MorphoSys now ex­pec­ts revenues in the range from EUR 63 to 66 million (up from pre­vi­ously EUR 46 to 51 million) and earnings before interest and taxes (EBIT) of EUR -66 to -71 million (up from pre­vi­ously EUR -75 to -85 million). Guidance for revenues and EBIT in­cludes royalty income on Tremfya(R) sales in Q3 2017, but does not in­clude any royalty income on Tremfya(R) sales in Q4 2017. Following the partnering of MOR202, pro­pri­e­tary R&D expenses will be in the range from EUR 96 to 100 million (previously EUR 85 to 95 million).

I-Mab Biopharma intends to start clin­i­cal devel­op­ment of MOR202 to treat patients with multiple myeloma in China next year.

"Our deal with I-Mab is the first step in our plan to secure the devel­op­ment and com­mer­cial­iza­tion of MOR202. In I-Mab, we have found an ideal partner with a highly dedicated and ex­peri­enced team who are committed to devel­op­ing MOR202 as fast as possible for the Chinese market", commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG.

"We are very excited to partner with MorphoSys to develop this highly dif­fer­en­ti­ated inves­ti­ga­tional on­col­ogy medicine for unmet needs in China. This part­ner­ship marks a latest addi­tion to our China portfolio of clin­i­cal stage assets, which parallels with our global immuno-oncology portfolio of inno­vative biologics", said Jingwu Zang, founder and CEO of I-Mab Biopharma.

About MOR202 and the ongoing phase 1/2a study in multiple myeloma

The inves­ti­ga­tional drug MOR202 is a human HuCAL anti­body directed against CD38, a highly expressed and val­i­dated target in multiple myeloma. Preclinical findings also sup­port an anti-CD38 ap­proach in other thera­peutic fields beyond multiple myeloma in­­clud­ing solid tumors and auto­immune diseases. MOR202 is cur­rently in a phase 1/2a, open-label, multi-center, dose-escalation clin­i­cal study conducted in several sites in Germany and Austria. The study is eval­u­ating the safety and pre­lim­i­nary efficacy of MOR202 with low dose dexa­meth­a­sone and in com­bi­na­tion with the immuno­modu­la­tory drugs (IMiDs) poma­lido­mide (POM) and lena­lido­mide (LEN) plus DEX in patients with re­lapsed / refractory multiple myeloma. The pri­mary end­points of the trial are the safety, tolerability and recommended dose of MOR202 with DEX and in com­bi­na­tion with the IMiDs. Secondary out­come measures are phar­ma­co­ki­netics and pre­lim­i­nary efficacy based on over­all response rate, duration of response, time-to-progression, and pro­gres­sion-free survival.

About Multiple Myeloma

Multiple myeloma (MM), a cancer derived from plasma cells, ranks second among hema­to­logical malig­nan­cies in many countries. In China, there would be an esti­mated 27,800 new cases each year and a total of 200,000 cases. With the acceleration of the aging process in China, it is predicted that MM, with a rapid growth in incidence, will become one of the more sig­nif­i­cant diseases that affect people's health. Patients who are refractory to the existing treat­ments have a very poor prognosis. MOR202 could be a highly dif­fer­en­ti­ated inno­va­tive medicine for the treat­ment of multiple myeloma.

About MorphoSys

MorphoSys is committed to devel­op­ing exceptional new treat­ments for patients suffering from serious diseases. A leader in the field of thera­peutic anti­bodies today, MorphoSys is driven by the ambition of creating the most valuable pipe­line of bio­pharma­ceu­ticals in the bio­technology industry. Based on its pro­pri­e­tary tech­nology plat­forms, MorphoSys, together with its partners, has built a thera­peutic pipe­line of more than 110 pro­grams in R&D, around a quarter of which is cur­rently in clin­i­cal devel­op­ment.

In its pro­pri­e­tary devel­op­ment segment, MorphoSys, alone or with partners, is devel­op­ing new thera­peutic can­di­dates, mainly focusing on cancer and inflammation. In its partnered discovery segment, MorphoSys uses its tech­nolo­gies to discover new drug can­di­dates for pharma­ceu­tical partners and par­tic­i­pates from the pro­grams' further devel­op­ment success, through success-based payments and royalties. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com.

About I-Mab

I-Mab is a dynamic and fast-growing global player committed to devel­op­ing inno­va­tive biologics in the areas of immuno-oncology and immuno-inflammation through internal R&D capabilities and global part­ner­ships. I-Mab's pipe­line is driven by the com­pany's devel­op­ment strategy to address unmet needs in China and to bring inno­va­tive assets to the world. Following the recent Series B financing of $150 million and rapid growth in internal R&D capabilities, I-Mab is now well positioned to ad­vance its China portfolio of multiple Phase 2 and Phase 3 inno­va­tive clin­i­cal assets and its global portfolio of first-in-class and best-in-class assets in China and/or US in 2018. I-Mab's long-term commitment is to deliver transformational medicines to patients globally with a focus on unmet needs in China. More in­­for­ma­tion: http://www.i-mabbiopharma.com/en/

HuCAL(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R), arYla(R), Ylanthia(R), 100 billion high poten­tials(R), Slonomics(R), Lanthio Pharma(R) and LanthioPep(R) are registered trademarks of the MorphoSys Group.

Tremfya(R) is a registered trademark of Janssen Biotech, Inc.

This communication con­tains certain forward-looking state­ments con­cern­ing the MorphoSys group of com­pa­nies, The forward-looking state­ments con­tained herein rep­re­sent the judgment of MorphoSys as of the date of this release and involve risks and un­cer­tain­ties. Should actual con­di­tions differ from the Company's assump­tions, actual results and actions may differ from those antic­i­pated, MorphoSys does not intend to update any of these forward-looking state­ments as far as the wording of the relevant press release is con­cerned.

Source: MorphoSys.