ENZ Settles Suit With AFFX, PTLA On Fast Track, XTLB Given Enough Time

(RTTNews) - Enzo Biochem Inc. (ENZ) has reached a $10 million settlement with Affymetrix Inc. (AFFX) in a patent infringement suit related to technology for nucleic acid analysis.

The settlement with Affymetrix impacts only one of 11 cases originally brought by Enzo in the United States District Court for the District of Delaware alleging patent infringements against various companies, nine of which remain pending.

ENZ closed Tuesday's trading at $3.79, up 1.61%.

Ironwood Pharmaceuticals Inc.'s (IRWD) phase III clinical trial of its 72 mcg dose of Linaclotide in adults with chronic idiopathic constipation has met the primary endpoint of Complete Spontaneous Bowel Movements Overall Responder endpoint.

Linaclotide, marketed under the brand name Linzess, is currently approved by the FDA as a 145 mcg capsule to be taken once per day for the treatment of adults with chronic idiopathic constipation (CIC) and as a 290 mcg capsule to be taken once per day for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).

In the U.S., Ironwood and Allergan are co-promoting Linzess. A supplemental new drug application to the FDA is expected to be submitted in the first half of 2016.

Linaclotide is marketed by Almirall S.A. for the treatment of adults with moderate to severe IBS-C in Europe under the brand name Constella. Ironwood also has partnered with Astellas Pharma Inc. for development and commercialization of Linaclotide in Japan and with AstraZeneca AB for development and commercialization in China.

The net sales of Linzess in the U.S. were $112.1 million in the second quarter of 2015, an approximately 79% increase compared to the second quarter of 2014.

IRWD closed Tuesday's trading at $10.72, down 3.86%.

Portola Pharmaceuticals' (PTLA) investigational oral anticoagulant Betrixaban for the prevention of venous thromboembolism, or blood clots, in acute medically ill patients has been granted Fast Track designation by the FDA.

Betrixaban is currently under a phase III trial for the prevention of VTE in acute medically ill patients. The study, dubbed APEX, is expected to complete patient enrollment by the end of 2015. Top-line data from this study are anticipated in the first quarter of 2016.

The company expects to submit a New Drug Application for Betrixaban later in 2016 under the Fast Track designation.

PTLA closed Tuesday's trading at $41.63, down 3.63%.

TherapeuticsMD Inc. (TXMD) has completed patient enrollment in its phase III trial evaluating TX-001HR, the first bio-identical combination product candidate to treat vasomotor symptoms of menopause.

The 12-month trial, dubbed Replenish, has enrolled more than 1,750 healthy postmenopausal women (age 40 to 65 years old) in approximately 110 sites across the United States.

The primary efficacy objective is to determine whether TX-001HR given daily is effective at reducing the frequency and severity of moderate to severe vasomotor symptoms associated with menopause when compared to placebo treatment at weeks 4 and 12.

TXMD closed Tuesday's trading at $5.94, down 6.31%.

Ultragenyx Pharmaceutical Inc. (RARE) has reported positive interim data from a phase II study of UX007 in long-chain fatty acid oxidation disorder, or LC-FAOD, patients.

LC-FAOD are a group of autosomal recessive genetic disorders characterized by metabolic deficiencies in which the body is unable to convert long-chain fatty acids into energy. The inability to produce energy from fat can lead to severe depletion of glucose in the body, and serious liver, muscle, and heart disease, which can lead to hospitalizations or early death.

The phase II study evaluated UX007 in 29 pediatric and adult patients across three main symptom groups (musculoskeletal, liver/hypoglycemia, and cardiac).

According to the study results, overall major medical events appeared to decrease in the 25 patients who completed the 24 weeks of treatment when compared to the reported event rate in these patients in the 18-24 months prior to treatment with UX007.

The 25 patients will continue to be treated for a total of 78 weeks. Data after 78 weeks, including rates of major medical events before and after treatment with UX007, are expected to be released in the second half of 2016.

RARE closed Tuesday's trading at $82.49, down 8.23%.

The license Agreement between XTL Biopharmaceuticals Ltd. (XTLB) and Yeda Research and Development Co. Ltd., signed last January 2014, for the development of hCDR1 for the treatment of systemic lupus erythematosus is all set to be amended.

The amended agreement extends the time for achievement of key development milestones by roughly five additional months including delivery to Yeda of a full protocol for an upcoming clinical trial on hCDR1, raising an aggregate of US$5 million (of which US$4 million was raised in April 2015), and commencing a clinical trial on hCDR1 by January 2017.

In a phase II study of hCDR1, dubbed PRELUDE, the primary efficacy endpoint based on the SLEDAI scale was not achieved. However, the trial showed encouraging results in its secondary clinical endpoint, the BILAG index, according to the company.

XTLB closed Tuesday's trading at $1.87, up 0.97%.

Zosano Pharma Corp.'s (ZSAN) phase 2 clinical trial of its proprietary, rapid onset, transdermal ZP-Glucagon patch for severe hypoglycemia has yielded positive results.

The phase II study evaluated the safety and efficacy of the ZP-Glucagon patch against standard-of-care in reversing insulin induced hypoglycemia in adult subjects with Type 1 diabetes.

Two doses of the ZP-Glucagon patch (0.5mg and 1.0mg) were compared to two doses of intramuscular injections (0.5mg and 1.0mg) in the four-way crossover study.

According to the study results, both ZP-Glucagon patch doses normalized blood sugar in 100 percent of the subjects. Both patch doses had rapid onset of action and time to glucose response was similar among the two modes of administration. All treatments were well tolerated and no new safety issues were identified.

ZSAN closed Tuesday's trading at $2.60, down 6.81%.