By RTT News,
July 15, 2014, 01:24:00 AM EDT
(RTTNews.com) - Anthera Pharmaceuticals Inc. ( ANTH ) has acquired Sollpura, a novel investigational Pancreatic Enzyme Replacement Therapy, from Eli Lilly and Co. (LLY).
Sollpura is intended for the treatment of patients with low digestive enzyme levels, or Exocrine Pancreatic Insufficiency (EPI), due to cystic fibrosis, and potentially other diseases.
The FDA rejected Eli Lilly's new drug application for Sollpura in April 2011, and had requested the company to conduct an additional clinical trial prior to re-submission. Last December, Eli Lilly announced its decision to discontinue further development of Sollpura.
Now, with Sollpura coming into Anthera's fold, a new subsidiary named Alkira Therapeutics has been formed to resume all development activities related to the investigational drug.
Accordingly, Chuck Olson has been appointed as President of Alkira, and he will oversee development activities for Sollpura including product manufacturing for the upcoming phase III clinical trial to begin in mid 2015.
ANTH closed Monday's trading at $3.23, up 0.31%. In after-hours, the stock rose another 3.72% to $3.35.
Alcobra Ltd. ( ADHD ) has completed patient recruitment in its phase III clinical trial of Metadoxine Extended Release in adult Attention Deficit Hyperactivity Disorder patients. The company expects reporting topline results from the study later this quarter.
ADHD closed Monday's trading 1.22% higher at $19.10.
Aerie Pharmaceuticals Inc. ( AERI ) has initiated phase III registration clinical trials of Rhopressa, a novel once-daily, triple-action eye drop being tested for its ability to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.
Two phase III trials, named "Rocket 1" and "Rocket 2," will be conducted in the U.S. where the primary efficacy endpoint will be to demonstrate non-inferiority of IOP lowering for Rhopressa compared to *Timolol, while the third phase III registration study named "Rocket 3," will be conducted in Canada, and it will be a safety-only study.
*Timolol is the most commonly used beta-blocker eye drop, sold under brand names Timoptic, Timoptic XE, Betimol, Istalol, for glaucoma treatment.
AERI closed Monday's trading at $25.55, down 1.62%. In after-hours, the stock gained 0.02% to $25.56.
Exelixis Inc. ( EXEL ) rose more than 23 percent to $4.09 on Monday, following positive top-line results from a phase III trial evaluating its investigational drug Cobimetinib in combination with approved drug Zelboraf (vemurafenib) in previously untreated patients with unresectable locally advanced or metastatic melanoma harboring the BRAFV600 mutation.
The trial, dubbed coBRIM, met its primary endpoint, delivering a statistically significant increase in progression-free survival for the combination of Cobimetinib plus Vemurafenib compared to Vemurafenib alone, according to the company.
Shares of Female Health Co. ( FHCO ) dropped more than 14 percent to $4.79 on Monday after the company announced its decision to suspend the payment of quarterly dividends in order to pursue a growth strategy and devote cash flows towards strategic initiatives.
The company is slated to report Q3, 2014 results on July 31, 2014. For the third quarter, the company foresees sales of approximately 13.7 million units of FC2 Female Condom (FC2), an increase of approximately 9% over the comparable prior-year quarter and an 88% improvement relative to the second quarter of FY2014.
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