Sweet Tidings From BIOD, AVNR Hits New High, CEMP Honored, Watch Out For ONTX

(RTTNews) - Biodel Inc.'s (BIOD) phase II study of BIOD-123, an investigational ultra-rapid-acting mealtime insulin, in patients with type 1 diabetes, has met the primary endpoint of non-inferiority for HbA1c relative to Eli Lilly's blockbuster diabetes medication Humalog.

HbA1c, also known as hemoglobin A1c, is a measure of average amount of sugar in our blood over the last two to three months. The HbA1c test helps to find out if the blood sugar is under control.

In the trial, dubbed Study 3-201, BIOD-123 also demonstrated comparable weight gain, mean hypoglycemia event rates, postprandial glucose excursions and safety and adverse event profiles.

In 2012, worldwide Humalog sales increased 1 percent to $2.395 billion.

BIOD closed Friday's trading at $5.03, up 4.36%.

Onconova Therapeutics Inc. (ONTX), which made its market debut on the NASDAQ in July of this year, has a couple of upcoming milestones. The company will be reporting top-line survival results from a phase III trial of its lead clinical candidate IV Rigosertib in higher risk myelodysplastic syndromes in either the fourth quarter of 2013 or the first quarter of 2014.

The company also expects interim analysis of 150 patients in a phase III trial of IV Rigosertib plus Gemcitabine in metastatic pancreatic cancer in either the fourth quarter of 2013 or the first quarter of 2014.

Avanir Pharmaceuticals Inc. (AVNR) has settled a pending patent litigation related to Nuedexta, a drug approved to help manage uncontrollable emotional outbursts, with yet another defendant - this time it is Wockhardt.

Avanir had sued Par, Actavis, Wockhardt, Impax and Watson to prevent them from marketing a generic version of NUEDEXTA. The 5 generic drug companies have submitted ANDA filings for Avanir's NUEDEXTA. (As part of an asset purchasing agreement Watson transferred its abbreviated new drug application to Sandoz last November).

A settlement agreement related to the NUEDEXTA patent suit was executed by Avanir last month and with Actavis earlier this month. Now that the patent suit has been settled with yet another company, Avanir has only two more ANDA filers on the defendant side.

AVNR touched a new 52-week high of $5.97 on Friday before closing at $5.84. In after-hours, the stock was up 0.51% to $5.87.

Cempra Inc.'s (CEMP) antibiotic candidate Solithromycin has been designated as a Qualified Infectious Disease Product for the indication of community-acquired bacterial pneumonia by the FDA.

The Qualified Infectious Disease Product status entitles Solithromycin to certain incentives including priority review, and a five year extension of new chemical entity exclusivity.

Solithromycin is under phase III testing for the treatment of moderate to moderately-severe community-acquired bacterial pneumonia (CABP).

The phase III Solithromycin clinical program in CABP consists of an oral trial and an intravenous (IV)-to-oral clinical trial.

The global phase III trial of orally-administered Solithromycin in patients with community-acquired bacterial pneumonia was initiated last December. The trial, which evaluates the efficacy and safety of oral Solithromycin (CEM-101) against oral Moxifloxacin, is designed to enroll 860 patients. The trial is expected to be completed in the first half of 2014.

Cempra is planning to initiate an intravenous-to-oral Phase 3 step-down Phase 3 trial during the second half of 2013.

CEMP closed Friday's trading at $9.12, down 0.87%.

Cellular Biomedicine Group (CBMG), whose primary target market is Greater China, on Friday announced positive interim results of its phase I/IIa clinical trial for human adipose-derived mesenchymal precursor cell (haMPC) therapy for Knee Osteoarthritis.

The phase II trial tested the safety and efficacy of intra-articular injections of autologous (patient's own) haMPCs in reducing inflammation and repairing damaged joint cartilage. The full data readout from this trial is expected before the end of the year.

CBMG.OB closed Friday's trading 7.80% higher at $5.50.