throbber
Case 1:14-cv-01498-JBS-KMW Document 28-7 Filed 07/11/14 Page 1 of 3 PageID: 200
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`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
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket