Immunomedics, Inc. (IMMU) recently declared that it has reached an exclusive global licensing agreement with Seattle Genetics, Inc. (SGEN), an innovative global biotechnology company that develops and commercializes novel antibody-drug conjugates (ADCs) for the treatment of cancer. Under the agreement, Seattle Genetics will develop, fund, manufacture and commercialize IMMU-132, Immunomedics’ proprietary solid tumor therapy candidate.
The agreement also provides that Seattle Genetics will be responsible for initiating the Phase 3 clinical trial of IMMU-132 in patients with metastatic triple-negative breast cancer (TNBC) and submitting the initial Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval. The agreement includes the development of additional indications for IMMU-132, counting urothelial cancer (UC), small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC), which are presently in Phase 2 clinical studies, together with other solid tumor indications being studied in ongoing clinical trials.
Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics, said, “We are happy to enter into this exclusive worldwide licensing agreement with Seattle Genetics to further advance IMMU-132 on behalf of patients with late-stage cancers, who have limited therapeutic options, while delivering noteworthyand compelling near- and long-term value to stockholders. Since its founding, Immunomedics has been dedicated to creating and advancing novel therapies in challenging diseases with unmet therapeutic needs. Seattle Genetics’ reputation, development portfolio and track record make them an ideal partner to advance IMMU-132. In Addition To, this agreement validates the dedication and effort by our entire internal teams in research and development, manufacturing, clinical, regulatory and general administration. In just over three years, we have brought IMMU-132 through clinical developments in multiple indications, and have advanced the TNBC indication to a potential accelerated approval and launch by late 2017 or early 2018, which could make IMMU-132 available to patients dealing with a highly malignant form of breast cancer. We are proud to have achieved this critical milestone and thank our entire team for their hard work. Immunomedics looks forward to appropriately supporting Seattle Genetics as it seeks to bring IMMU-132 to commercialization.”
Sanofi SA (ADR) (SNY) declared recently that the U.S. Food and Drug Administration (FDA) approved Xyzal® Allergy 24HR as an over-the-counter (OTC) treatment for the relief of symptoms associated with seasonal and year-round allergies. Specifically, two formulations of Xyzal are now approved for OTC use – 5 mg tablets for ages 6 years and older, in addition to 0.5 mg/mL oral solution for ages 2 years and older. Xyzal is an oral antihistamine with a proven 24-hour effect.
As many as 60 million Americans suffer from allergic rhinitis, which is also commonly known as hay fever.1 Antihistamines are the most widely used medications to relieve hay fever symptoms.2 Xyzal is an antihistamine that contains the active ingredient levocetirizine dihydrochloride, which has a well-established safety and efficacy profile. It offers 24-hour relief from runny nose, sneezing, itchy watery eyes and itching of the nose or throat, all in a single daily dose.
Sanofi Consumer Healthcare’s existing allergy portfolio includes Allegra Allergy, which was approved for OTC use in 2011 and Nasacort Allergy 24HR, which was approved for OTC use in 2013. The company anticipates that Xyzal will be made available in Spring 2017.