Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

 Foundation’s Mental Health and Well-Being initiative, launched in 2011, is awarding 10 grants totaling $3.28 million to fund new programs that will establish sustainable community-based support systems for veterans and their families.

The Foundation’s 2013 Mental Health and Well-Being grant recipients are:

New York Legal Assistance Group and Connecticut Veterans Legal Clinic will receive two-year grants to partner with the Department of Veterans Affairs (VA) to study how civil legal services impact mental health and quality of life outcomes for veterans treated in VA mental health and homeless programs. 

Points of Light, National Council for Behavioral Health, and Massachusetts General Hospital will each receive two-year grants to partner with Outside the Wire on its Theater of War performances to military and civilian audiences in 25 US cities. Outside the Wire is a social impact company that uses theater to address a number of pressing public health issues. 

Minnesota Veterans Medical Research and Education Foundation will receive a two-year grant for a new program called Building Spiritual Strength that will use pastoral counselors to address the issues of moral injury – killing or wounding others – among combat trauma survivors. 

Rush University Medical Center Department of Behavioral Sciences will receive a one-year grant to complete an efficacy trial of the mental health services provided by Vets Prevail and recruit and enroll more than 6,200 additional veterans into the program, which received funding from the Foundation last year.

Boston University School of Public Health will receive a two-year grant to transform a pilot version of a self-directed, web-based intervention that focuses on self-management to control alcohol consumption as a critical approach to managing PTSD into a consumer-ready version. 

National Alliance on Mental Illness (NAMI) received a three-year matching grant to adapt the evidence-based NAMI Family-to-Family Education Program to the needs of families of active duty military personnel and veterans. 

Carter Center received a grant to conduct the Mental Health & Well-Being Grantees Summit in Atlanta, Georgia, in June 2013. 

Articles

The Bristol-Myers Squibb Foundation is awarding 10 grants to fund programs for veterans and their families.

BMS Grants Support Mental Health Needs of US Military Veterans

, a specialty pharmaceutical company, reported that the FDA has approved Orenitram (treprostinil) extended-release tablets for the treatment of pulmonary arterial hypertension (PAH) in WHO Group I patients to improve exercise capacity.

Supernus developed the extended release formulation of Orenitram under a development and license agreement with United Therapeutics Corporation. The product uses EnSoTrol, Supernus' osmotic technology platform. Per the license agreement between Supernus and United Therapeutics, United Therapeutics will pay Supernus certain milestone fees and royalties associated with the commercialization of the product worldwide.

Supernus Pharmaceuticals receives FDA approval of Orenitram for the treatment of pulmonary arterial hypertension.

Supernus Announces FDA Approval of Orenitram

, part of Capsugel’s Dosage Form Solutions business unit, will collaborate with Lipocine, a specialty pharmaceutical company, to manufacture Phase III clinical trial and ICH stability registration batches of Lipocine’s oral testosterone product, LPCN 1021. The product will be manufactured in the company’s high-potency suite at its Livingston, Scotland, R&D site. LPCN 1021 is under development as a testosterone product to treat symptoms related to currently marketed testosterone replacement products. The investigational drug is designed for twice-daily oral dosing.

Encap has completed the transfer of the manufacturing process and validation of all related test methods (in-process and finished product) for LPCN 1021 to its site in Livingston. In addition, Encap has manufactured all the investigational new drug registration batches for the upcoming Phase III clinical supply and stability registration.

Encap will collaborate with Lipocine to manufacture Lipcine's oral testosterone product, LPCN 1021, for Phase III clinical trials.

Encap, Lipocine Partner

 a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called Accurins, has amended its development and commercialization collaboration agreement with Amgen to extend the period during which Amgen may exercise its option by six months. Bind entered into a collaboration agreement with Amgen on Jan. 7, 2013 to develop and commercialize a kinase inhibitor nanomedicine for treating a range of solid tumors based on Bind's platform for targeted and programmable nanomedicines and Amgen's undisclosed proprietary kinase inhibitor. Under the agreement, Amgen had twelve months from the effective date to exercise its option to select a novel Accurin candidate for further development. The option period under the amended collaboration agreement has been extended to July 7, 2014 to allow for completion of the research plan. None of the other terms of the original agreement have been changed.

Amgen has the exclusive right to pursue development and commercialization of an Accurin kinase inhibitor against solid tumor targets to be selected by Amgen. Both companies are working together on preclinical development and agreed that Amgen would assume responsibility for any future development and commercialization. Bind is eligible to receive upfront and development milestone payments totaling $46.5 million, up to an additional $134 million in regulatory and sales milestone payments for the first therapeutic indication and additional payments for target exclusivity. Bind will receive tiered royalties on potential future sales.

Bind Therapeutics amends its development and commercialization collaboration agreement with Amgen.

Bind, Amgen Amend Pact

, a privately held specialty pharmaceutical company and a subsidiary of Exeltis, headquarted in Madrid, Spain, has acquired Quinnova Pharmaceuticals, from parent company Amneal Enterprises. 

The acquisition will result in the strategic expansion of Everett into the US dermatology market. 

Everett Laboratories acquires Quinnova Pharmaceuticals, a specialty pharmaceutical company.

Evertt Laboratories Acquires Quinnova Pharmaceuticals

 announced the initiation of a clinical trial to evaluate the combination of the company’s investigational anti-PD-1 immunotherapy, MK-3475, and GlaxoSmithKline’s (GSK) orally administered kinase inhibitor, pazopanib, for the treatment of advanced renal-cell carcinoma.

Merck and GSK entered a collaboration to study MK-3475 with pazopanib and other agents in the GSK portfolio. This Phase I and Phase II clinical trial is designed to evaluate the safety and efficacy of a combination of MK-3475 and pazopanib in treatment naïve patients with advanced renal-cell carcinoma. 

Merck and GlaxoSmithKline begin clinical trial of pazopanib for the treatment of advanced renal-cell carcinoma.