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Item 8.01 Other Events On August 31, 2015, Amicus Therapeutics, Inc. (the Company) issued a press release announcing the entry into an Agreement and Plan of Merger (the Merger Agreement), dated August 30, 2015, by an among the Company, Scioderm, Inc. (Scioderm), Titan Merger Sub Corp., a wholly owned subsidiary of the Company, and Fortis Advisors LLC, as the Shareholders Agent, providing for the acquisition by the Company of Scioderm (the Merger). A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. In addition, the Company will be providing supplemental information regarding the Merger in connection with a presentation to investors. Amicus estimates that EB may represent a potential $1 billion+ global market opportunity based on third party market research. The current standard of care is palliative treatments which cost $10,000 to $15,000 per month, and mainly consist of bandaging, treating the open wounds to prevent infection and trying to manage patients pain. An estimated 30,000 to 40,000+ people are currently diagnosed with EB in major markets. Amicus is a champion of the rare disease community that, together with Scioderm, understands our sense of urgency to see a treatment approved for EB, said Brett Kopelan, Executive Director of the Dystrophic Epidermolysis Bullosa Research Association of America (DebRA).
The EB community will be well-served by the experience and broad, global capabilities that Amicus adds to Scioderm. Both Amicus and Scioderm are wholly and passionately focused on patients with rare diseases, and share a common vision and similar values, said Robert Ryan, Ph.D., President and Chief Executive Officer of Scioderm. John Crowley has been a dedicated board member providing valuable counsel to Scioderm over the past several years, during which time he has been deeply involved with the EB community. This combination of Amicus and Scioderm is a major win for EB patients. With the added resources and expertise that Amicus provides for the Zorblisa program, we are more confident than ever in our potential for success and our ability to deliver significant benefits to patients and families living with the devastating effects of EB. The Transaction Amicus will acquire Scioderm in a cash and stock transaction. At closing, Amicus will pay Scioderm shareholders $229 million, of which $125 million will be paid in cash and $104 million will be paid through the issuance of 7 million newly issued Amicus shares. Amicus has agreed to pay up to an additional $361 million to Scioderm shareholders in cash or stock upon achievement of certain clinical and regulatory milestones and $257 million to Scioderm shareholders in cash or stock upon achievement of certain sales milestones. If Zorblisa is approved, EB qualifies as a rare pediatric disease and a Priority Review Voucher will be requested.
If the Priority Review voucher is obtained and subsequently sold, Amicus will pay Scioderm shareholders the lesser of $100 million or 50% of the proceeds of such sale. The transaction is subject to customary conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The Boards of both companies have approved the transaction and the companies currently anticipate that the transaction will be completed in the third quarter of 2015. Amicus intends to finance the acquisition through cash on hand and has a $50 million debt commitment from Redmile Group. Leerink Partners LLC is acting as financial advisor to Amicus.
Skadden, Arps, Slate, Meagher & Flom LLP is acting as legal counsel to Amicus. Morgan is acting as financial advisor to Scioderm.
Cooley LLP is acting as legal advisor to Scioderm. Based on the closing of the Scioderm acquisition, the anticipated debt financing and the forecasted spending on Zorblisa development, Amicus expects to end 2015 with $200 million to $225 million of cash on hand. Pro-forma cash post-closing is expected to fund the current operating plan (including Zorblisa) into 2017. Conference Call and Webcast Amicus Therapeutics will host a conference call and audio webcast today, August 31, 2015 at 8:00 a.m. ET to discuss the proposed acquisition of Scioderm.
Interested participants and investors may access the conference call at 8:00 a.m. ET by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international). An audio webcast and slide presentation can also be accessed via the Investors section of the Amicus Therapeutics corporate web site at, and will be archived for 30 days. Web participants are encouraged to go to the web site 15 minutes prior to the start of the call to register, download and install any necessary software.
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A telephonic replay of the call will be available for seven days beginning at 8:00 p.m. ET today. Access numbers for this replay are 855-859-2056 (U.S./Canada) and 404-537-3406 (international); participant code 28588321. About Epidermolysis Bullosa (EB) Epidermolysis Bullosa (EB) is a chronic, rare genetic connective tissue disorder with no approved treatment options. EB is debilitating, disfiguring, and potentially fatal. There are many genetic and symptomatic variations of EB that all share the prevalent manifestation of fragile skin that blisters and tears from minor friction or trauma. Patients with the more severe forms of EB have generalized blistering and lesions affecting a substantial percentage of their bodies that can lead to infection and scarring, and, in severe cases, death.
Internal organs and bodily systems can also be severely affected by the secondary complications and illnesses. There is currently no FDA approved treatment for EB. Current standard of care consists of bandaging and bathing the open wounds to prevent infection and trying to manage patients pain. EB affects all racial, ethnic and genders equally. About Zorblisa Phase 3 Clinical Trial (SD-005) A Phase 3 multi-center, randomized, double-blind, placebo-controlled study (SD-005) in the U.S. And Europe is currently underway and expected to support registration globally. The study is currently enrolling individuals who are 1 month and older with a diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB who have at least 1 target wound present for 21 days or more.
Half the patients receive Zorblisa cream (also known as SD-101) and the other half receive placebo cream, applied topically once daily to the entire body for 90 days. The primary outcome measure is complete target wound closure within 2 months. Secondary outcome measures include 1) median time to complete target wound closure; 2) change in lesional skin at Month 2; 3).
Change in itching at Day 7; and 4) change in pain at Day 7. Patients who complete the 90-day primary treatment period will be eligible to receive Zorblisa in an open-label extension study (SD-006). For more information please visit Scioderms website at www.sderm.com. About Scioderm Scioderm is a privately held, clinical-stage biopharmaceutical company focused on developing innovative therapies to address diseases with high unmet need, including rare diseases. Scioderm was financed initially in 2013 by Morgenthaler Ventures and Technology Partners, followed by a subsequent financing that was led by Redmile Group and included the initial investors. Ralph (Chris) Christoffersen, Ph.D., Chairman of the Board, noted that Robert Ryan and the Scioderm team have done an outstanding job in bringing Zorblisa through both preclinical and clinical studies.
It is a real pleasure to join with the excellent team at Amicus to continue the development and commercialization of this product which we believe will have a significant positive impact on the lives of EB patients and their families. The companys lead therapy, Zorblisa (SD-101), is in Phase 3 development for treatment of the skin effects associated with Epidermolysis Bullosa (EB), a rare genetic connective tissue disorder. Scioderm was selected as a 2013 Fierce Top 15 company by FierceBiotech, and considered one of the top 15 emerging companies in the biotech industry. The company is headquartered in Durham, North Carolina.
Additional information about Scioderm can be found at www.sderm.com. About Amicus Therapeutics Amicus Therapeutics (Nasdaq:FOLD) is a biotechnology company at the forefront of therapies for rare and orphan diseases. The Company is developing novel, first-in-class treatments for a broad range of human genetic diseases, with a focus on delivering new benefits to individuals with lysosomal storage disorders.
Epidermolysis Bullosa (EB) Multiple genes cause disease which results in fragility of skin and can also affect internal organs Diagnosed from infancy to adulthood Severe blistering, open wounds and scarring in response to minor friction to the skin Disfiguring, excruciatingly painful, and can be fatal Palliative treatment (standard of care) $10-15k/month (excluding hospitalizations) 30,000-40,000+ patients diagnosed in major markets1 Rare, Genetic Chronic Connective Tissue Disorder with No Approved Treatment Options 1Third Party Market Research. Active ingredient Allantoin RoA Proprietary topical cream containing 6% allantoin, applied to entire body once daily Proposed Indication All major EB subtypes (Simplex, Dystrophic and Junctional) Phase of development Phase 3 ongoing (first to enter Phase 3 for EB) First to show significant benefit in wound closure in EB clinical studies Proposed MOA. Impacts inflammatory response and promotes formation of epithelial and granulation tissue Direct bactericidal action demonstrated in vitro Loosens protein bridges (desmosomes) that hold together hyperkeratinized cells (e.g.
In calluses) Formulation Patented high concentration formulation Long-term stability of active ingredient and dose-related penetration of active ingredient in human dermal tissue Zorblisa Overview Patented High Concentration Allantoin with Breakthrough Therapy Designation Novel, Proprietary Topical Cream Promotes Healing of Wounds in EB and is Differentiated by Applicability for All Major EB Subtypes.Margraf and Covey 1977; Meixell and Mecca 1966; Settle 1969; Meixell and Mecca 1966; Flesch 1958, Fisher 1981; Cajkovac et al., 1992, Medda 1976. Amicus Rare Disease Expertise Amicus Integrated Rare Disease Capabilities Will Accelerate the Development of Zorblisa for EB Patients Senior leadership with track record of success in Fabry, Pompe, DMD, CF, and other rare diseases Experience partnering with rare disease patient communities through Patient Advocacy function Global regulatory expertise Galafold global commercial organization will be leveraged to support potential Zorblisa launch Clinical operations expertise in enrolling rare disease studies around the world. Significant Value Creation in Next 6-18 Months Amicus Vision to Have One Product Launched (Galafold for Fabry), One Product Submitted to Regulators (Zorblisa for EB), and One Product in Phase 3 Study (ATB200 for Pompe) by YE16: Each with $500M-$1B+ Global Product Sales Potential Pompe Phase 3 study initiation Submission of final (clinical) section of Zorblisa NDA Galafold U.S. PDUFA Date Zorblisa MAA submission Galafold EU launch Submission of CMC section of Zorblisa NDA Pompe Phase 1/2 interim data Phase 3 Zorblisa data Pompe observational study initiation Submission of non-clinical section of Zorblisa NDA Pompe Phase 1/2 study initiation Galafold NDA submission (Subpart H) Galafold CHMP Opinion 2H 2016 1H 2016 2H 2015.
Amicus Acquisition of Scioderm, Inc. Overview August 31, 2015 GRAPHIC4g187741mmi001.jpgGRAPHICbegin 644 g187741mmi001.jpgMCX 02D9)1@!
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