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Replies to post #194236 on Biotech Values
09/03/15 5:30 PM
Allergan plc…and AqueSys, Inc. a private clinical stage medical device company focused on developing ocular implants that reduce intraocular pressure (IOP) associated with glaucoma, today announced that they have entered into an agreement under which Allergan will acquire AqueSys in an all-cash transaction. Under the terms of the agreement, Allergan will acquire AqueSys for a $300 million upfront payment and regulatory approval and commercialization milestone payments related to AqueSys' lead development programs, including XEN45.
…XEN45 has received a CE mark in the European Union where it is indicated for the reduction of intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed. The CE mark allows treatment in conjunction with a cataract procedure or as a standalone procedure. XEN45 is also approved for use in Turkey, Canada and Switzerland. AqueSys is pursuing reimbursement in these countries. In the United States, XEN45 is in late-stage development, with the final US Investigational Device Exemption (IDE) clinical trial fully enrolled in the second quarter of 2015. Final approval by the U.S. Food and Drug Administration is expected by late 2016 or early 2017 via the 510K device pathway.
11/04/15 1:53 PM
Allergan plc…today announced that its wholly owned subsidiary has entered into an exclusive licensing agreement with Mimetogen Pharmaceuticals…to develop and commercialize tavilermide (MIM-D3), a topical formulation of a novel small molecule TrkA agonist for the treatment of dry eye disease.
Under the terms of the agreement, Allergan will make an upfront payment of $50 million to Mimetogen and will fund phase 3 development of tavilermide. Mimetogen will additionally be entitled to receive potential milestone payments and royalties based on commercialization of the product.
Tavilermide is a small cyclic peptidomimetic of NGF, a naturally occurring protein in the eye responsible for the maintenance of corneal nerves and epithelium. Tavilermide is differentiated from other investigational therapies in dry eye disease because it induces the production of mucin, a naturally occurring component of the tear film, and works upstream prior to inflammation.
…In a previously announced Phase 2 trial (Study Designation MIM-725) tavilermide demonstrated significant improvements in both signs and symptoms with 1% tavilermide versus placebo, together with strong safety, comfort and tolerability profiles. Tavilermide is currently being evaluated in two multi-center Phase 3 clinical studies in the United States for the treatment of dry eye disease.
