Merck commences late-stage trial for breast cancer vaccine
DARMSTADT, Germany A late-stage trial that began Monday will test an investigational vaccine for breast cancer.
Merck KGaA announced the initiation of a phase 3 study to evaluate the safety and efficacy of Stimuvax (BLP25 liposome vaccine, L-BLP25) in patients with advanced, inoperable breast cancer. The study, which will enroll 900 patients at around 180 sites in more than 30 countries, will determine whether the vaccine can extend the survival in patients treated with hormonal therapy who have locally advanced, recurrent, hormone receptor-positive or metastatic breast cancer while also preventing progression.
“Advanced-stage breast cancer remains an ultimately fatal and challenging disease, and we urgently need new treatment options,” principal investigator Lawrence Shulman said in a statement. Shulman is chief medical officer and SVP medical affairs at the Dana-Farber Cancer Institute in Boston.
Merck KGaA, based in Darmstadt, Germany, is distinct from Whitehouse Station, N.J.-based Merck & Co.
NAMI releases PSA initiative regarding psychological disorders
ARLINGTON, Va. A nonprofit organization hopes that a new series of public service announcements it has released will encourage people to connect with each other to help themselves, their families and friends who live with psychological disorders.
The National Alliance on Mental Illness announced this week that it had released a PSA initiative called “Puzzle Pieces” that includes four 60-second and three 30-second radio PSAs featuring testimonials from individuals and families that describe their experiences with mental illnesses and the role NAMI played in their recovery.
“We know that with early detection, appropriate treatment and support from family and friends, people with mental illness can lead healthy, rewarding lives,” NAMI executive director Michael Fitzpatrick said. “NAMI members connect to educate each other and encourage their loved ones during their personal journeys to wellness.”
The organization said that an estimated 1-in-5 American families is affected by mental illnesses, including major depression, bipolar disorder, schizophrenia and post-traumatic stress disorder.
KV Pharmaceutical, Gedeon Richter announce licensing agreement
BUDAPEST, Hungary An American drug maker has signed a licensing agreement with a Hungarian pharmaceutical company.
KV Pharmaceutical Co. announced that it had entered into an agreement with Budapest, Hungary-based Gedeon Richter and its American subsidiary for licensing rights to KV technologies and products in the women’s health category.
Under the agreement, Gedeon Richter will have the right to manufacture and distribute certain proprietary technologies and products from KV in the European Union and other areas where it does business, while KV will receive undisclosed milestones and royalties for products that the two companies develop. KV will retain U.S. rights.
“KV Pharmaceutical and Gedeon Richter have for many years enjoyed an excellent relationship and business collaboration, and we are very pleased to extend it in this fashion,” KV Pharmaceutical Co. interim CEO David Van Vliet stated. “We believe this agreement allows both Richter and KV to offer additional enhanced products to more completely serve physicians and their patients.”