MorphoSys and Galapagos Sign Global License Agreement for

New Post Public Reply Private Reply Replies (0) Message Board
News Desk 2018
76
MorphoSys and Galapagos Sign Global License Agreement for MOR106 with Top Pharma Partner
  • Exclusive global license agreement with Novartis on MOR106
  • MOR106, a monoclonal antibody directed against IL-17C, will be developed further in atopic dermatitis (AtD) and potentially other indications
  • Up-front payment of EUR 95 million (USD 111 million*) and potential milestone payments of up to approximately EUR 850 million (USD 1 billion*) plus royalties up to low-teens to low-twenties
  • Novartis to bear all future research, development, manufacturing and commercialization costs related to MOR106

              Mechelen, Belgium and Planegg/Munich, Germany; 19 July 2018; 7.15 CET; regulated information - Galapagos NV (Euronext & NASDAQ: GLPG) and MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; NASDAQ: MOR) announced today that they have entered into a worldwide, exclusive agreement with Novartis Pharma AG covering the development and commercialization of their joint program MOR106.

MOR106 is an investigational, fully human, IgG1 monoclonal antibody directed against the target IL-17C that was generated in a collaboration between MorphoSys and Galapagos. Under the terms of the agreement, the parties will cooperate to broaden the existing development plan for MOR106 in AtD significantly. Novartis will be exclusively holding all rights for commercialization of any products resulting from the agreement signed today.

Upon the signing of the agreement, all future research, development, manufacturing and commercialization costs for MOR106 will be borne by Novartis. This includes the ongoing Phase 2 IGUANA trial in atopic dermatitis patients as well as a planned Phase 1 study to evaluate the safety and efficacy of a subcutaneous formulation of MOR106 in healthy volunteers and AtD patients. MorphoSys and Galapagos will conduct additional trials to support development of MOR106 in AtD. Under the terms of the agreement, Novartis will explore the potential of MOR106 in additional indications other than AtD.

In addition to the funding of the current and future MOR106 program by Novartis, MorphoSys and Galapagos will jointly receive an upfront payment of EUR 95 million (USD 111 million*). Pending achievement of certain developmental, regulatory, commercial and sales-based milestones, MorphoSys and Galapagos would jointly be eligible to receive significant milestone payments, potentially amounting up to approximately EUR 850 million (USD 1 billion*), in addition to tiered royalties on net commercial sales in the range of up to low-teens to low-twenties. Under the terms of their 2008 agreement, Galapagos and MorphoSys will share all payments equally (50/50).

The agreement between MorphoSys, Galapagos, and Novartis is subject to clearance by the US antitrust authorities under the Hart-Scott-Rodino Act, and will become effective as soon as this condition has been met.

"This collaboration with Novartis will enable us to accelerate and broaden the development of MOR106 beyond our current focus on atopic dermatitis and to exploit the potential of MOR106 to the maximum. Data from preclinical models and expression analyses suggest that the target of MOR106 might be involved in other diseases, which justifies expanding the development program. We are also very pleased that we can further strengthen our engagement in atopic dermatitis by starting additional trials together with Galapagos, which will be fully reimbursed by Novartis," commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "Securing a strong and committed partner for MOR106 helps the program, and also enables us to allocate more resources elsewhere."

"It is very gratifying to announce this collaboration with Novartis, an immunology & dermatology powerhouse, to broadly expand the development and pave the path to potential commercialization of MOR106. We look forward to working with Novartis to support further progress with MOR106," said Onno van de Stolpe, CEO of Galapagos.

MorphoSys and Galapagos concluded a Phase 1 study of MOR106 in healthy volunteers as well as in atopic dermatitis patients in 2017. A Phase 2 clinical trial (IGUANA) in moderate-to-severe atopic dermatitis patients was started in May 2018. MOR106 is the first publicly known human monoclonal antibody directed against IL-17C in clinical development worldwide. MOR106 is an investigational drug candidate and its safety and efficacy have not yet been established.

*) Converted based on current exchange rate: 1 EUR = 1.16945 USD

About MOR106 and the antibody collaboration of Galapagos and MorphoSys MOR106 is an investigational fully human IgG1 monoclonal antibody designed to selectively target IL-17C, currently being developed for treatment of inflammatory diseases. MOR106 arises from the strategic discovery and co-development alliance between Galapagos and MorphoSys, in which both companies contributed their core technologies and expertise. Galapagos has provided the disease-related biology including cellular assays and targets discovered using its target discovery platform, specifically IL-17C for MOR106, and has performed the clinical development of MOR106. MorphoSys has contributed its Ylanthia antibody technology to generate fully human antibodies directed against the target and contributed full CMC development of this compound.

About MorphoSys MorphoSys is a late-stage biopharmaceutical company devoted to the development of innovative and differentiated therapies for patients suffering from serious diseases. Based on its technological leadership in generating antibodies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 28 are currently in clinical development. This broad pipeline spans MorphoSys's two business segments: Proprietary Development, in which MorphoSys invests in product candidates for its own account, and Partnered Discovery, in which product candidates are developed exclusively for a variety of Pharma and Biotech partners. In 2017, Tremfya ® (guselkumab), marketed by Janssen, became the first therapeutic antibody based on MorphoSys's proprietary technology to receive marketing approval for the treatment of moderate-to-severe plaque psoriasis in the United States, the European Union and Canada. MorphoSys is listed on the Frankfurt Stock Exchange and on the U.S. stock exchange Nasdaq, under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com

HuCAL ® , HuCAL GOLD ® , HuCAL PLATINUM ® , CysDisplay ® , RapMAT ® , arYla ® , Ylanthia ® , 100 billion high potentials ® , Slonomics ® , Lanthio Pharma ® and LanthioPep ® are registered trademarks of the MorphoSys Group. Tremfya ® is a trademark of Janssen Biotech, Inc.

About Galapagos Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Galapagos' pipeline comprises Phase 3 through to discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. Our target discovery platform has delivered three novel mechanisms showing promising patient results in, respectively, inflammatory diseases, idiopathic pulmonary fibrosis and atopic dermatitis. Galapagos is focused on the development and commercialization of novel medicines that will improve people's lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 640 employees, operating from its Mechelen, Belgium headquarters and facilities in the Netherlands, France, Switzerland, the United States and Croatia. More information at www.glpg.com .

For more information, please contact:

MorphoSys AG Alexandra Goller Associate Director Corporate Communications & IR   Jochen Orlowski Associate Director Corporate Communications & IR   Dr. Claudia Gutjahr-Löser Investor Relations Officer   Tel: +49 (0) 89 / 899 27-404 investors@morphosys.com Galapagos NV Investors: Elizabeth Goodwin VP IR & Corporate Communications +1 781 460 1784   Paul van der Horst Director IR & Business Development +31 71 750 6707 ir@glpg.com   Media: Evelyn Fox Director Communications +31 6 53 591 999 communications@glpg.com

This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

Galapagos forward-looking statements This release may contain forward-looking statements, including, among other things, statements regarding the mechanism of action and profile of, and timing and results of clinical trials with, and potential commercialization of, MOR106, statements regarding potential future payments to be made to Galapagos under a licensing agreement for MOR106 as well as assumptions pending clearance by U.S. antitrust authorities. Galapagos cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that expectations regarding the further development of MOR106 in moderate-to-severe atopic dermatitis, including the intended targeting of IL-17C, and potential additional indications, potential future payments to be made to Galapagos under a licensing agreement for MOR106 as well as assumptions pending clearance by U.S. antitrust authorities are false, as well as Galapagos' expectations regarding the MOR106 development program may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing clinical research programs may not support registration or further development of MOR106 due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including its collaboration partners for MOR106, MorphoSys and Novartis), and estimating the commercial potential of Galapagos' product candidates. A further list and description of these risks, uncertainties and other risks can be found in Galapagos' Securities and Exchange Commission (SEC) filings and reports, including in Galapagos' most recent annual report on Form 20-F filed with the SEC and other filings and reports filed by Galapagos with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

Attachment

Scroll down for more posts ▼

Top 10 Most Recent News Articles

Regeneron Faces Class Action Over Tumultuous Trial Results

Updated Category News Views 2

Regeneron's Meltdown: A Bitter Pill for Investors Let’s dive headlong into the mess Regeneron Pharmaceuticals (NASDAQ:REGN) finds itself in—a classic nightmare scenario for investors. News broke like an old valve bursting, and suddenly, the market's love for Regeneron ran ice-cold. Who's to blame this time? Well, you might want to point a finger at the failed Phase 3...

Continue Reading
West Texas Weather Shapes Home Design Decisions

Updated Category News Views 2

West Texas Weather: A Tough Customer for Home Builders You'd think building a house is a straightforward gig, but slap it down in West Texas, and we're talking a whole different ballgame. With its brutal heat, howling winds, and wild temperature swings, Odessa isn't just painting by numbers. It's where Mother Nature is your uninvited consultant on every single...

Continue Reading
Tech Breakthroughs in Cancer and Space Energy Aired

Updated Category News Views 3

Science and Technology at the Forefront Saturday nights usually have folks kicking back with some reality shows or maybe cheering on their favorite sports team. But this September 12, savvy viewers have a chance to dive deep into the guts of cutting-edge science and tech on Bloomberg Television. We're talking about 'Advancements with Ted Danson'—where science isn’t...

Continue Reading
Aluminum Refractory Market to Hit $2.73B by 2031

Updated Category News Views 5

Riding the Aluminum Refractory Wave to 2031 Look, when you want to throw some cash in a market that's gaining steam, aluminum refractory materials might not be your first pick. But here's the thing: it's charging ahead to a cool $2.73 billion by 2031. And if you're keeping tabs on the likes of RHI Magnesita and Calderys, this is a sector that deserves a once-over. What...

Continue Reading
Huayan Robotics Hits IMTS 2026 with Cutting-Edge Tech

Updated Category News Views 2

Unveiling Robotics Prowess at IMTS 2026 Every two years, the world of manufacturing gathers at the International Manufacturing Technology Show (IMTS), and this time, the spotlight is on Huayan Robotics. With the event drawing over 90,000 professionals, everybody with a finger on the pulse of intelligent manufacturing will be keen to see what Huayan has up its sleeve. This...

Continue Reading
Jixingfeng Advances Smart Manufacturing for Socks Market

Updated Category News Views 3

Socks Evolve: From Feet Covers to Tech Gear Once upon a time, socks were merely foot covers, destined to vanish beneath pants and shoes. But not anymore. In the bustling halls of the sock world, Jixingfeng built up a robust repertoire of producing high-performance hosiery for a modern market that demands more than just warmth. They’ve turned socks into a tech-infused...

Continue Reading
Six Flags Offers Flexible Payment Plan with Flex Pay

Updated Category News Views 6

New Payment Option Brings Flexibility Seems like Six Flags isn't just about roller coasters anymore—now they're playing the long game with wallet-friendly options. Flex Pay by Upgrade is the latest spin on season pass financing, letting guests divvy up payments and kickstart their amusement park fun right away. This move could be a game-changer for folks looking to lock...

Continue Reading
Insurance 101: Know Your Limits and Deductibles

Updated Category News Views 5

It might not exactly be cocktail party fodder, but boy, skipping on understanding your homeowners insurance is a shortcut straight to financial hell. You’re living in St. Albans, WV, in a home that’s probably your biggest investment. Let’s talk about this before you find yourself in a mess you should've seen coming. Why Coverage Limits Matter a Whole Lot Listen up,...

Continue Reading
Moonlock: Award-Winning Design Elevates Cybersecurity's Importance

Updated Category News Views 2

Design Excellence Meets Cybersecurity There's a new sheriff in town when it comes to cybersecurity design, and its name is Moonlock. MacPaw's antivirus and protection app pulled off a coup by bagging the 2026 Red Dot Award in the Interface & User Experience Design category. It's a big deal in the cybersecurity realm, where functionality often overshadows finesse. But...

Continue Reading
Interventional Ophthalmology: Early Eye Care Strategies Evolve

Updated Category News Views 2

Proactive Eye Care: The New Frontier Today's eye care landscape is all about catching things early, folks. Long gone are the days of waiting for eyesight to deteriorate before rushing to the nearest eye doc. In Racine, interventional ophthalmology is shifting gears towards preventive care—looking ahead to stop eye diseases in their tracks before they muck up a person's...

Continue Reading

Top 5 Most Recently Viewed Articles

Men Finding New Confidence Through Hair Transplant Journeys

Updated Category News Views 152

Men Discovering Renewed Confidence Through Hair Transplant Journeys In recent times, a notable trend has emerged among British men who are turning to hair transplant procedures as a means of self-renewal following breakups. This shift from traditional coping mechanisms, such as nightlife escapades or new tattoos, to simpler, yet profound transformations in personal...

Continue Reading
Bausch Health Outlines RED-C Clinical Trial Findings and Future Steps

Updated Category News Views 121

Bausch Health Offers Insight on RED-C Clinical Trials Results Bausch Health Companies Inc. (NYSE: BHC) has shared pivotal insights regarding the global Phase 3 RED-C clinical trials. These studies were notably focused on evaluating amorphous-rifaximin solid soluble dispersion (SSD) for patients grappling with liver cirrhosis, aiming primarily at the prevention of hepatic...

Continue Reading
Packaging Corporation of America Announces Q4 2024 Earnings Call

Updated Category News Views 141

Packaging Corporation of America Earnings Call Details Packaging Corporation of America (NYSE: PKG) is set to hold an important conference call to discuss its operating results for the fourth quarter and full year of 2024. This call will take place on a Wednesday morning, with the exact time scheduled for 9:00 a.m. Eastern Time. Leadership from PCA, led by Mark Kowlzan,...

Continue Reading
STAAR Surgical and Alcon Merger Bid Fails, What's Next?

Updated Category News Views 142

STAAR Surgical Company's Merger Attempt with Alcon STAAR Surgical Company (NASDAQ: STAA) has recently faced a significant setback. On a momentous Tuesday, the company declared that it did not secure the crucial stockholder support required to finalize its merger agreement with Alcon Inc. (NYSE: ALC) during the Special Meeting of Stockholders. End of the Merger Agreement...

Continue Reading
Analysts Predict Growth Potential for Workday Stock WDAY

Updated Category News Views 227

Analysts See Promise in Workday's Future Workday, Inc (NASDAQ: WDAY) is generating positive attention in the financial markets as analysts present a compelling case for its growth potential. According to insights from Bank of America Securities analyst Brad Sills, the company's stock is considered 'undervalued' and positioned for significant growth. With the ongoing...

Continue Reading