Healthcare Industry News: chronic sinusitis
News Release - July 30, 2013
Edimer Secures $18M Series B Financing Led by New Enterprise AssociatesCompany Expands Board with Additional Orphan Drug Expertise, Initiates Recruitment of Phase 2 Clinical Trial of Lead Compound EDI200
CAMBRIDGE, Mass.--(Healthcare Sales & Marketing Network)--Edimer Pharmaceuticals, a biotechnology company focused on developing an innovative therapy for the rare genetic disorder X-linked Hypohidrotic Ectodermal Dysplasia (XLHED), today announced it has secured $18 million in Series B financing. The lead investor was New Enterprise Associates (NEA), with additional new investor Sanofi-Genzyme BioVentures, and previous investors Third Rock Ventures and VI Partners.
Edimer plans to use the proceeds from this financing to advance the later stage clinical development of EDI200, the company’s novel, proprietary, recombinant protein being developed for the treatment of XLHED. If fully developed and approved, EDI200 will be the first drug to treat the symptoms of this ultra-rare genetic disorder. In addition, Edimer will explore additional opportunities to leverage its expertise and leadership position in ecotdysplasin biology. Edimer is currently looking for women that know or suspect that they are carriers of XLHED who are pregnant or thinking of expanding their families. Male infants born with XLHED may be eligible to participate in the Phase 2 clinical study.
“We are thrilled to add NEA and Sanofi-Genzyme BioVentures to our investors. Both organizations are particularly committed to helping build transformative companies dedicated to developing treatments and ultimately cures for orphan diseases,” said Neil Kirby, Ph.D., President and CEO of Edimer. “Initiation of the neonate study represents a significant accomplishment for Edimer, our scientific collaborators and the patient foundations. This collective effort and support was instrumental in achieving our success to date.”
"We are pleased to provide our capital and expertise to help further accelerate the exciting progress Edimer is making toward potentially offering a breakthrough therapy for infants affected by XLHED,” said David Mott, a General Partner at NEA. “With this financing in place, Edimer is poised to begin testing its novel therapeutic in affected newborns in the near future, and to offer the first real potential progress against this serious genetic disease."
“We are very pleased to join Edimer’s investor syndicate,” said Bernard Davitian, Vice President and Managing Director, Sanofi-Genzyme BioVentures. “The team at Edimer has done an impressive job advancing EDI200 as a treatment for XLHED. We look forward to working more directly with them as they progress the drug candidate through the next phase of development.”
In connection with the financing, David Mott will join the Board of Directors. In addition, Board observers from NEA, Third Rock Ventures, Sanofi-Genzyme and VI Partners will add to the considerable orphan drug expertise already represented on the Board.
EDI200 is an ectodysplasin-A (EDA-A1) replacement protein, representing the first of a new class of molecules rationally designed to correct a specific developmental disorder. EDI200 has been shown to bind specifically to the EDA-A1 receptor, activating the signaling pathways that lead to normal development. EDI200 has demonstrated substantial and durable efficacy in animal models of XLHED with notable reduction in mortality and morbidity. The U.S. Food and Drug Administration (FDA) granted Orphan Drug designation and Fast Track status to EDI200. EDI200 also has orphan drug designation in Europe.
XLHED (also known as Christ-Siemens-Touraine Syndrome) is a rare disorder of development resulting from genetic mutations in the ectodysplasin gene (EDA). Patients affected by XLHED are at risk for life-threatening hyperthermia based on their inability to regulate body temperature, and for clinically-significant pneumonias resulting from their abnormality in respiratory secretions. Cardinal signs and symptoms in XLHED include diminished/absent sweat, reduced and abnormal airway secretions, few and often misshapen teeth, and absent or early hair loss from face and scalp.
XLHED patients surviving infancy are predisposed to atopy presenting with eczema and asthma, chronic sinusitis, recurrent nose bleeds, and dry eye complications. Almost uniformly they require dental interventions including early prostheses and later implants. Their susceptibility to hyperthermia, facial appearance, abnormal dentition and hair loss may impact normal participation in outdoor activities, sports and school attendance. Both medical and self-esteem issues are life-long in this disorder. As is generally true with X-linked inheritance, males are fully affected while females are variably affected.
New Enterprise Associates, Inc. (NEA) is a leading venture capital firm focused on helping entrepreneurs build transformational businesses across multiple stages, sectors and geographies. With more than $13 billion in committed capital, NEA invests in information technology, healthcare and energy technology companies at all stages in a company’s lifecycle, from seed stage through IPO. The firm's long track record includes more than 175 portfolio company IPOs and more than 290 acquisitions. In the U.S., NEA has offices in the Washington, D.C. metropolitan area; Menlo Park, California; and New York City. In addition, New Enterprise Associates (India) Pvt. Ltd. has offices in Bangalore and Mumbai, India and New Enterprise Associates (Beijing), Ltd. has offices in Beijing and Shanghai, China. For additional information, visit www.nea.com.
About Sanofi-Genzyme BioVentures
Sanofi-Genzyme BioVentures (SGBV), previously known as Genzyme Ventures, is a strategic fund that invests primarily in early-stage innovative companies in the core areas of interest of Sanofi and Genzyme. SGBV’s investments focus on rare diseases, oncology, vaccines and infectious diseases, and breakthrough therapies in other core areas of interest of the Group, as well as integrated care solutions. For more information about SGBV, please visit us on sanofi.com or genzyme.com.
About Edimer Pharmaceuticals
Edimer is a privately held biotechnology company based in Cambridge, Massachusetts dedicated to delivering a significant and durable improvement in the health and quality of life for future generations affected by XLHED. Edimer was established in 2009 with investment from Third Rock Ventures and VI Partners.
For further information on Edimer Pharmaceuticals, please visit www.edimerpharma.com. To receive regular updates about Edimer Pharmaceuticals’ progress please join the XLHED network at www.xlhednetwork.com.
Source: Edimer Pharmaceuticals
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