HOUSTON, Jan. 03, 2018 (GLOBE NEWSWIRE) -- Fabre-Kramer Pharmaceuticals, Inc. (Fabre-Kramer) of Houston, TX, and Mission Pharmacal Company (Mission) of San Antonio, TX, announced today that they have signed agreements providing for Mission to complete the technology transfer to develop and manufacture the registration batches of Fabre-Kramer’s novel antidepressant, Travivo (gepirone HCl) Extended Release Tablets. Data from these batches will be used to support the submission of the NDA Amendment for Travivo to the Food and Drug Administration (FDA) for review and approval. The two companies also expect to enter into an agreement for Mission to manufacture and package the commercial supplies of Travivo once approved.
Mission will produce over 11 million Travivo tablets in 4 dosage strengths under current Good Manufacturing Practice (cGMP) as part of the registrational program. Analytical data from each batch produced will be collected by Mission and will be part of the NDA amendment submission later in 2018. These tablets will also be suitable for future commercial sale upon FDA approval.
Fabre-Kramer is executing on its program to complete the update of Travivo’s NDA agreed with the FDA in 2017. In addition to the manufacture, bioequivalency and stability testing of the registration batches, work is ongoing on several small in-vivo and in-vitro studies to provide pharmacokinetic data to include in proposed labeling.
Fabre-Kramer is targeting a late 2018 submission of the Travivo NDA amendment, which will have a six month review period under PDUFA. Travivo represents a new class of antidepressant that effectively treats major depression via a novel, highly targeted mechanism of action (MoA). Travivo acts as a specific agonist at the 5HT1a receptor. It is not a reuptake inhibitor and has no material norepinephrine or dopamine activity. This single receptor MoA is unique among antidepressants and results in significant benefits to patients relative to all other pharmacologic therapies.
Although numerous treatment options exist for adults with MDD, virtually all rely on neurotransmitter reuptake inhibition as the primary MoA. These drugs such as SSRIs and SNRIs are not always optimal since they are often associated with side effects including sexual dysfunction that limit their use. Travivo has been shown to effectively treat the disorder without causing sexual dysfunction and with fewer other side effects than other antidepressants. Stephen Kramer, MD, CEO of Fabre-Kramer, commented, “We are delighted to be partnering with Mission Pharmacal for our Travivo program. They were chosen after an extensive and careful review of several highly qualified potential manufacturers. Mission has the perfect combination of facilities, equipment, experience, and capabilities to ensure the registrational program goes smoothly and expeditiously, as well as the capacity to manufacture Travivo tablets in the 100 million+ annual commercial volumes we anticipate once approved.”
Mission Pharmacal Company’s advanced pharmaceutical manufacturing facilities feature 300,000 square feet of product and warehousing space. Using the latest high-capacity equipment, Mission produces gels, liquids, creams, and semi-solids, along with more than 1.5 billion tablets a year.
These environmentally controlled, highly secure facilities are meticulously maintained on its expansive Boerne, Texas campus. Mission strictly adheres to cGMP regulations enforced by the FDA.
Mission manufactures many products and offers its state-of-the-art capabilities to other companies through select partnership agreements. Mission makes an ideal partner for other pharmaceutical companies, providing customized packages of complete manufacturing, printing, packaging, distribution, and sales services tailored exactly to each customer’s needs.
“Fabre-Kramer’s Travivo program is an exciting new partnering relationship for Mission. Travivo has the potential to garner a significant share of the US branded antidepressant market and thus represent a large-scale ongoing customer for Mission’s range of services. We look forward to leveraging our extensive related expertise to ramp up the registrational batch manufacturing and packaging smoothly, to working with Fabre-Kramer to satisfy all of FDA’s CMC requirements for Travivo’s NDA amendment and to transitioning to an important commercial supply contract once Travivo is approved,” said Neill Walsdorf, Jr., President of Mission Pharmacal.
About Fabre-Kramer
Fabre-Kramer is committed to developing and bringing to market advanced new medications to help physicians treat patients’ unmet medical needs in the therapeutic areas of psychiatry and neurology. The Company focuses on compounds to license-in, develop for global registration, and license-out to commercial partners. The Company is active in discussions with potential partners and investors to participate in bringing Travivo to market. To learn more, please visit fabrekramer.com.
About Mission Pharmacal Company
Mission Pharmacal Company is a privately held pharmaceutical company based in San Antonio, Texas. For more than seven decades, the company has been improving the lives of people through every stage of life by manufacturing and delivering innovative, high-quality prescription, over-the-counter, and dietary supplement products in the therapeutic areas of women’s health, urology, pediatrics, dermatology, primary care, and long-term care. Using a novel business model, Mission created the Mission Family of Companies, a collection of wholly-owned subsidiaries including BioComp Pharma, Inc., a generic drug marketer; Alamo Pharma Services, Inc., a specialized contract sales organization; ProSolus, Inc., a transdermal drug developer and manufacturer; Espada Dermatology, Inc., a prescription and esthetic dermatology company; as well as BexR Logistix, LLC and their subsidiary company, EPIC Fulfillment, Inc., the logistics and fulfillment arms of the organization. To learn more, please visit missionfamilyofcompanies.com.
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A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/864deae1-0739-4d21-8f38-2c682eb7a519
Attachments:
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/0897f3bd-4a59-4167-9b8a-addf4cf2e9bf