ANTH Plunges On Failed SOLUTION, All Eyes On CEMP, FDA Says No To AMPH Again

(RTTNews) - Amphastar Pharmaceuticals Inc.'s (AMPH) key over-the-counter epinephrine inhalation product candidate, Primatene Mist, intended for temporary relief of mild asthma symptoms has once again failed to get the FDA nod.

In its complete response Letter, the U.S. regulatory agency has asked the company to make further changes to the label and packaging for Primatene Mist and then conduct another Human Factor validation study to assess consumers' ability to use the product in the over-the-counter setting without the guidance of a doctor or pharmacist.

The Complete response Letter issued on May 22, 2014 had also cited the above same reasons for rejecting Primatene Mist then.

After 50 years in the market, Primatene Mist, the only OTC asthma inhaler, was taken off pharmacy shelves on Dec. 31, 2011, as part of an international environmental treaty, because the asthma inhaler used chlorofluorcarbon (CFC) propellants, which contribute to ozone depletion.

The new Primatene Mist of Amphastar is made with the same active ingredient, epinephrine that was used in the original Primatene Mist. However, the product's new inhalation delivery system no longer includes chlorofluorocarbons (CFCs), which were phased out of various products worldwide as part of an international environmental treaty, says the company.

AMPH closed Tuesday's trading at $18.57, down 9.10%.

Shares of Anthera Pharmaceuticals Inc. (ANTH) slipped over 58% in extended trading on Tuesday in the wake of its phase III trial of Sollpura in cystic fibrosis patients with exocrine pancreatic insufficiency falling short of expectations.

The trial, dubbed SOLUTION, narrowly missed the primary endpoint for change in the Coefficient of Fat Absorption (CFA) non-inferiority margin. However, by additional pre-specified analyses of CFA, Sollpura met the non-inferiority criterion, according to the company.

The study also demonstrated non-inferiority in Coefficient of Nitrogen Absorption, a measure of protein digestion and absorption and is a key requirement of Anthera's planned US FDA regulatory submission.

A new study of Sollpura that will address the scientific findings from the SOLUTION study will be initiated by the company. If all goes well as planned, a Biologics License Application for Sollpura will be filed in the first quarter of 2018.

ANTH closed Tuesday's trading at $2.01, up 2.03%. In after-hours, the stock was down 58.21% to $0.84.

For Cempra Inc. (CEMP), the FDA decision date of December 27, 2016, on its oral formulation of Solithromycin for the treatment of moderate to moderately-severe community acquired bacterial pneumonia has just passed, and no news yet as of this writing.

The FDA decision on intravenous Solithromycin is scheduled for December 28, 2016.

During a review meeting last month, an FDA panel voted 7-6 that efficacy results of Solithromycin outweigh the risks for the treatment of community-acquired bacterial pneumonia, and voted 12-1 that the risk of hepatotoxicity with Solithromycin had not been adequately characterized.

Will Solithromycin pass muster with the FDA or be sent back to the drawing board? We'll have to wait and see...

CEMP closed Tuesday's trading at $5.90, down 4.84%.

Endologix Inc. (ELGX) has imposed a temporary hold on shipments of its AFX Endovascular AAA System due to a manufacturing issue with some sizes of the device.

The AFX Endovascular AAA System was approved by the FDA in 2011 for the treatment of abdominal aortic aneurysms.

This is what John McDermott, CEO of Endologix had to say, "The temporary hold on AFX is not related to any reported events from physicians and we continue to see very good commercial clinical results with the latest versions of AFX and AFX2."

ELGX closed Tuesday's trading at $5.27, down 26.70%.

Nephros Inc. (NEPH.OB) has received FDA clearance to market its HydraGuard 10" UltraFilter.

The HydraGuard 10" UltraFilter is designed to provide hospitals and medical facilities with a long term solution to protect patients from bacteria that may be present in the potable water systems.

NEPH.OB closed Tuesday's trading at $0.30, up 2.67%.

Seattle Genetics Inc. (SGEN) dropped more than 15% on Tuesday, following a clinical hold or partial clinical hold on several early stage trials of Vadastuximab talirine in acute myeloid leukemia after 4 patient deaths.

Overall, more than 300 patients have been treated with Vadastuximab talirine in clinical trials across multiple treatment settings, according to the company.

A phase 1/2 trial of Vadastuximab talirine (SGN-CD33A) monotherapy in pre- and post-allogeneic transplant AML patients has been placed on full clinical hold while two phase I trials have been placed on partial clinical hold (no new enrollment, existing patients may continue treatment with re-consent).

In the trials, six patients who were treated with Vadastuximab talirine developed hepatotoxicity while several patients developed veno-occlusive disease, and there were four fatal events as mentioned above.

However, a phase III trial of Vadastuximab talirine in older AML patients, dubbed CASCADE, and a phase 1/2 trial in myelodysplastic syndrome, are proceeding with enrollment.

SGEN closed Tuesday's trading at $5.90, down 4.84%.

The FDA has expanded the approval of Shire plc's (SHPG) Adynovate for the treatment of hemophilia A in pediatric patients less than 12 years of age. It has also been approved for use in surgical settings for both adult and pediatric patients.

Adynovate was first approved by the FDA last November for use in adults and adolescents, aged 12 years and older, who have Hemophilia A.

ADYNOVATE was developed by Baxalta Inc. through a collaboration with Nektar Therapeutics (NKTR). Baxalta was acquired by Shire earlier this year.

SHPG closed Tuesday's trading at $168.70, up 0.03%.