`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Exhibit 3
`
`
`
`Case 1:14-cv-01498-JBS-KMW Document 28-7 Filed 07/11/14 Page 2 of 3 PageID: 201
`7/2/2014 Case 1:14-WWQEaJBSeMWAWEWMWDTUQ MMIQIKWPNMMeMngZMaBHBAQW: 201
`
`medac
`
`PHARMfi
`
`Concentrated Methotrexate Solutions at More Than 30 mg/ml
`
`Potential U.S. Commercialization Targete
`Parent Company Concurrently Secures US. Patent Allowance for Treating Autoim
`
`MEDAC PHARMA, INC. SECURES FDA ACCEPTANCE OF A NEW DRUG APPLICATION (N DA) FOR
`
`METHOTREXATE-CONTAINING AUTOPEN
`
`Potential U.S. Commercialization Targeted for 2014
`
`Parent Company Concurrently Secures US. Patent Allowance for Treating Autoimmune
`Diseases with Concentrated Methotrexate Solutions at More Than 30 mg/ml
`
`Chicago. IL. January 27. 2014 — Medac Pharma. Inc.. a privately held pharmaceutical company focused on the development of new
`molecules and improving the effectiveness of existing medicines. announced the FDA acceptance of its New Drug Application (NDA) for its
`lead product candidate. MPI-2505. a subcutaneous injectable methotrexate (MTX) in a ready-to—use injection device, for which the proposed
`indications are rheumatoid arthritis (RA). poly—articular—coursejuvenile RA and psoriasis. Concurrently. medac GmbH. the parent company of
`Medac Pharma. Inc.. announced the allowance of a US. patent application directed to a method for the treatment of inflammatory
`autoimmune diseases by subcutaneously administering MTX at a concentration of more than 30 mg/ml.
`
`The subcutaneous mode of delivery of MPI—2505. with a wide range of dosing options. has been designed to improve bioavailability and
`overcome tolerability issues associated with today's oral MTX therapies. Additionally. by providing patients with a ready—to-use autopen
`and concentrated formulations that allow for reduced drug volume. the MTX subcutaneous autopen addresses the stigmas associated with
`injectable medicines.
`
`"The FDA's acceptance of Medac Pharma |nc.‘s NDA marks a significant milestone not only for our company. but also patients seeking a
`more personalized method for managing their disease.“ said Terri Shoemaker, President and CEO of Medac Pharma. Inc. “\X/hile
`methotrexate has proven itself as a highly effective medicine for treating several forms of arthritis. there remains a substantial need to make
`treatment for this patient demographic more manageable. As a newly-founded company. we believe this inflection point. combined with
`our patent allowance for a broad dosing range of methotrexate. serve as stepping stones for our commitment to providing valuable
`resources for the immunology market.“
`
`"Securing the US. patent allowance is an additional step in medac GmbH's effort to be a global leader in the treatment of inflammatory
`autoimmune diseases with subcutaneous methotrexate." said Dr. Ulrich Kosciessa. Managing Director of medac GmbH.
`
`Medac Pharma. Inc. expects to self commercialize its subcutaneous MTX autopen device in the US. later this year upon FDA approval. As a
`wholly owned subsidiary of medac GmbH. a global pharmaceutical company that has been developing. manufacturing and marketing
`pharmaceuticals for more than 40 years in 70 countries. Medac Pharma. Inc. will receive a continuous supply of MTX for its product.
`
`Rheumatologist Eric Ruderman. MD. Professor of Medicine. Northwestern University Feinberg School of Medicine. remarked. “As we work to
`manage our patients with a wide—range of immunological disorders. it is enormously helpful to have additional effective treatment options
`that can enhance their quality of life."
`
`Among the multiple indications for which MPI-2505 is expected include RA. an incurable. progressive. inflammatory. autoimmune disease
`affecting the lining of joints resulting in pain. swelling. reduced mobility and requires lifelong treatment with potent drugs. with MTX
`remaining the first-in-line therapy. Medac Pharma Inc.‘s fully integrated infrastructure with experienced management team and significant
`resources make it well positioned to develop. in—license and commercialize personalized therapies in autoimmune and oncology
`therapeutics.
`
`About Medac Pharma. Inc.
`
`http://imvwmedacpharmacom/medac- pharma-i nc-securec-fda—acceptance-of-a— new-drug -app| icati on- nda-for- methotremte—contai ni ng -autopen/
`
`1/2
`
`
`
`Case 1:14-cv-01498-JBS-KMW Document 28-7 Filed 07/11/14 Page 3 of 3 PageID: 202
`7/22014 Case 1:14-WWQ83JI859MWAMEWWWDTUQ Nimi®7WPAIID4MefiHg€e33ma®iri§ag®fl: 202
`Medac Pharma, Inc. is the wholly owned subsidiary of medac GmbH. a well known and respected global pharmaceutical company that has
`been making scientific and therapeutic discoveries for more than 40 years.
`
`Medac Pharma, Inc. is focused on developing therapies with the potential to make meaningful differences in patients' lives. The company‘s
`approach is to improve existing agents by enhancing the mode of delivery. addressing safety profiles and inventing ways to maximize
`efficacy.
`
`For more information, please visit www.medacpharmacom.
`
`For Media:
`
`Tiberend Strategic Advisors Inc.
`Andrew Mielach
`
`amielach@tiberend.com: (212) 375—2694
`
`TERMS OF USE
`
`PRIVACY POLICY
`SITE MAP
`MEDAC GMBH
`CONTACT US
`
`© 2014 Medac Pharma. Inc All Rights Reserved
`
`Location
`
`Medac Pharma, Inc.
`29 North \X/acker Drive Suite 704
`Chicago. IL 60606
`Tel. 312 854 0500
`Fax. 312 750 1082
`
`http://vwwvmedacpharma.com/rnedac- pharma—i nc-secures-fda—acceptance-of-a— new-dr ug -app| icati on- nda-for- methotremte—contai ni ng -autopen/
`
`2/2
`
`