AMGN Crosses BRIDGE, Anxiety Over PTCT's Translarna Eases, EGRX Opens Wallet

(RTTNews) - Amgen's (AMGN) phase III study of investigational drug Romosozumab in men with osteoporosis has achieved the primary endpoint.

In the study, dubbed BRIDGE, Romosozumab demonstrated significant increase in bone mineral density at the lumbar spine, total hip and femoral neck compared to placebo at six and 12 months.

Romosozumab is being co-developed by Amgen and UCB. This compound is under FDA review for the treatment of osteoporosis in postmenopausal women at increased risk of fracture, with a decision expected on July 19, 2017.

In other news, the company won the European Commission's nod for Parsabiv for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis. Parsabiv was turned down by the FDA in August of this year.

AMGN closed Friday's trading at $149.04, down 1.67%.

AstraZeneca PLC's (AZN) SYMBICORT, an asthma and COPD treatment, has demonstrated its appropriateness as step-up therapy in pediatric patients between 6 to <12 years of age with asthma in a phase III study.

As you may know, the FDA, in April 2009, had turned down the company's request to approve SYMBICORT for the long-term maintenance treatment of asthma in pediatric patients ages 6-11 years as no adequate data was furnished then.

In the recently completed phase III study, dubbed CHASE, SYMBICORT significantly improved lung function in pediatric patients between 6 to <12 years of age with asthma compared to asthma drug Budesonide.

SYMBICORT was approved in the U.S. in July 2006 for the long-term maintenance treatment of asthma in patients 12 years of age and older and in February 2009 for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

AZN closed Friday's trading at $27.98, up 1.08%.

Eagle Pharmaceuticals (EGRX) has agreed to acquire privately-held Arsia Therapeutics for $78 million, thus marking its entry into biologics, the fastest growing sector of the pharmaceuticals market.

As per the agreement terms, Eagle will pay approximately $30 million at closing and up to $48 million in additional payments upon the completion of certain milestones. The closing of the acquisition is expected to occur within the next week, subject to the satisfaction of various customary closing conditions.

EGRX closed Friday's trading at $79.50, down 5.60%.

Shares of PTC Therapeutics Inc. (PTCT) jumped over 88% on Friday as CHMP's recommendation of the conditional marketing authorization of Translarna has removed the uncertainty over its continued availability in the European Union.

Translarna, which was given conditional approval by the European Medicines Agency for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older in August 2014, has been available in the European Union since December 2014.

However, with the CHMP issuing a request for supplemental information, including a request categorized as a major objection, last month, many were expecting a withdrawal of the marketing authorization for Translarna.

Now that the CHMP has issued a positive opinion in favor of the renewal of Translarna's marketing authorization, PTC Therapeutics can breathe easy.

Translarna recorded net sales of $22 million in Q3, 2016, representing 125% year-over-year growth. The company expects Translarna net sales to be in the middle of its guidance of $65 to $85 million for full year 2016.

PTCT closed Friday's trading at $11.30, up 88.33%.

Ultragenyx Pharmaceutical Inc. (RARE) has withdrawn its conditional Marketing Authorization Application from the European Medicines Agency for Aceneuramic Acid Prolonged Release for the treatment of adult patients with GNE Myopathy.

GNE Myopathy, also known as Hereditary Inclusion Body Myopathy, is a rare, severe, progressive, genetic neuromuscular disease that causes muscles to slowly waste away, leading to severe disability.

The decision to withdraw the application was based on the observation of the Committee for Medicinal Products for Human Use, which pointed out that the Phase 2 study of Aceneuramic Acid Prolonged Release was encouraging but did not provide a sufficient amount of evidence to support an approval at this time.

Ultragenyx intends to obtain additional efficacy data from its fully-enrolled global phase 3 study to confirm the effects of Ace-ER, and plans to submit an MAA for full approval after data from this study are available in the second half of 2017.

RARE closed Friday's trading at $82.06, up 4.24%.