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Loxo Oncology Announces EMA Orphan Drug Designation Granted to LOXO-101 for Treatment of Soft Tissue Sarcoma

On January 15, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that the European Medicines Agency (EMA) has granted the company orphan drug designation for LOXO-101 for treatment of patients with soft tissue sarcoma (Press release, Loxo Oncology, JAN 15, 2016, View Source [SID:1234508796]).

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Soft tissue sarcomas are cancers of the body’s connective or supportive tissues, such as cartilage, fat, muscle, fibrous tissue, and blood vessels. The EMA grants orphan drug designation to support the development of medicines for underserved patient populations, or rare disorders, that affect no more than five in 10,000 individuals in the European Union (EU). Orphan drug designation provides to Loxo certain benefits, including protocol assistance, reduced fees for regulatory activities and up to ten years of market exclusivity in the EU upon marketing approval for the designated indication.

About LOXO-101

LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions. For additional information about both the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123.

Heron Therapeutics Notified by FDA That It Will Not Take Action on SUSTOL® New Drug Application by the PDUFA Date

On January 15, 2016 Heron Therapeutics, Inc. (NASDAQ:HRTX), reported that the U.S. Food and Drug Administration (FDA) has informed the Company that it has not yet completed its review of the New Drug Application (NDA) of SUSTOL (granisetron) Injection, extended release and would not be taking action by the Prescription Drug User Fee Act (PDUFA) goal date of January 17, 2016 and anticipates taking action in late February 2016 (Press release, Heron Therapeutics, JAN 15, 2016, View Source [SID:1234508795]).

SUSTOL is a long-acting formulation of the FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist granisetron being developed for the prevention of both acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). SUSTOL is formulated utilizing Heron’s proprietary Biochronomer drug delivery technology, and has been shown to maintain therapeutic drug levels of granisetron for at least five days with a single subcutaneous injection.

GP Pharm has recently launched Lutrate® Depot trimestral in Spain

On January 14, 2016 GP Pharm reported that it has recently launched Lutrate Depot trimestral in Spain (Press release, GP Pharm, JAN 14, 2016, View Source [SID1234591043]). Lutrate Depot is a new microsphere formulation of leuprolide acetate. The product is based on the in-home based patented technology of GP Pharm and is indicated for the treatment of prostate cancer. The product complements the offer of GP Pharm in the Spanish market where the 1 month formulation was currently available.

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Generex, JAN 14, 2016, View Source [SID:1234508793])

Apogenix Strengthens U.S. Patent Position for Lead Immuno-Oncology Candidate APG101

On January 14, 2016 Apogenix, a biopharmaceutical company developing next generation immuno-oncology therapeutics, reported that it has received Notices of Allowance from the U.S. Patent and Trademark Office for two key patents for lead immuno-oncology candidate APG101 (Press release, Apogenix, JAN 14, 2016, View Source [SID1234524580]). The so-called method of use patent covers the use of CD95 ligand inhibitors, such as APG101, for the treatment of glioblastoma. This patent is valid at least until 2029. The so-called composition of matter patent protects APG101 as a product as well as its manufacturing process at least until 2033.

"Apogenix already has a broad patent portfolio covering APG101. These two patents greatly expand the protection of APG101 and its use in the treatment of glioblastoma," said Thomas Hoeger, Ph.D., CEO of Apogenix. "The prospective granting of these two patents in the most important pharmaceutical market further validates our innovative drug development approach and the therapeutic potential of CD95 ligand inhibitors for the treatment of malignant brain tumors, among other indications."

The efficacy, safety, and tolerability of APG101 were demonstrated in a controlled phase II proof-of-concept trial in patients with recurrent glioblastoma. Treatment with APG101 in combination with radiotherapy has shown clinical superiority in all study endpoints compared to treatment with radiotherapy alone, resulting in an overall survival benefit in glioblastoma patients treated with APG101. Interim data of a phase I trial with APG101 for the treatment of myelodysplastic syndromes further indicate the efficacy of APG101 in this hematological disease.