Newton, Mass. and Jerusalem, Israel, February 27, 2015– Chiasma, Inc., a U.S. privately-held biopharma company developing octreotide capsules, its lead product for the orphan condition acromegaly, today announced the closing of a $70 million Series E financing round. Participants in the financing included new investors Rock Springs Capital and Sofinnova Ventures, and an undisclosed blue chip public investment fund, as well as existing investors MPM Capital, F2 Capital, 7 Med Health Ventures, Abingworth and ARCH Venture Partners.
Chiasma intends to use the new capital to build its sales and marketing capabilities and prepare for the U.S. commercial launch of its lead product, octreotide capsules for adults with acromegaly, a rare endocrine disease. The company intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for octreotide capsules in the second quarter of 2015 and, if the NDA is approved, to launch the product in the U.S. soon thereafter. If approved, octreotide capsules would be the first and only oral somatostatin analog, providing another option to patients currently receiving painful injections.
Chiasma will also conduct additional clinical studies for octreotide capsules to support approval in the European Union and advance new product candidates based on its proprietary Transient Permeability Enhancer (TPE®) technology into preclinical development.
"The commitment from both new and existing investors provide us with the resources to advance our regulatory efforts, prepare for a successful launch of octreotide capsules, test oral octreotide capsules for additional indications and further invest in earlier-stage TPE programs that can fuel our growth over the long term," stated Roni Mamluk, Ph.D., chief executive officer of Chiasma. "With this financing in place, we are well positioned to advance a portfolio of oral drugs that address unmet needs in orphan indications."
Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone (GH), ultimately leading to significant health problems and early death if untreated. Common features of acromegaly are facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet and tongue. Serious associated health conditions include diabetes, hypertension, cardiac and cerebrovascular disease and respiratory disorders.
Current treatment options include surgery to remove the tumor, radiation therapy which destroys any lingering tumor cells and/or medical treatment in cases where these approaches are not possible or fully effective. Medical treatments available currently include dopamine agonists, GH antagonists and injectable somatostatin analogs, the current standard of care. Currently available somatostatin analogs require large-bore needles, for injection into muscle (octreotide) or deep into the tissue underlying the skin (lanreotide).
Researchers estimate that three to four out of every million people develop acromegaly each year. According to the National Organization for Rare Disorders, acromegaly occurs in approximately 60 people per million in the United States. Because symptoms often develop slowly, diagnosis may be delayed by years or decades, making it difficult to determine the total number of people with the disease.
About Octreotide Capsules
Octreotide capsules are an investigational oral form of the peptide octreotide, a somatostatin analog that is currently available only by injection. Octreotide capsules use a proprietary technology developed by Chiasma, Inc., called Transient Permeability Enhancer (TPE®) that facilitates gastrointestinal absorption of unmodified drug into the bloodstream. Chiasma is independently leading the clinical and regulatory development and commercialization of octreotide capsules for the potential treatment of acromegaly and neuroendocrine tumors.
Chiasma is a biopharmaceutical company dedicated to improving the lives of patients with rare diseases by developing and commercializing oral medications that were previously available by injection only. The company's lead candidate is octreotide capsules, which has received orphan drug designation from the FDA and EMA. Chiasma is evaluating additional proteins, peptides and small molecule drugs that that are currently only available by injection but could potentially be converted to oral delivery using the company's TPE® technology. Chiasma is a Delaware corporation with a wholly owned Israeli subsidiary
Additional information can be found at www.ChiasmaPharma.com.
Roni Mamluk, Ph.D.
Chief Executive Officer
+972 2 548 1926
JPA Health Communications