Avita Back In News, GILD Gets FDA Thumbs Up, HZNP Settles Rayos Patent Suit

(RTTNews) - Medical device company Avita Medical Ltd. (AVMXY.OB) has received FDA approval to expand its Compassionate Use Investigational Device Exemption program for ReCell on twice as many patients as originally permitted.

Accordingly, the IDE program will now allow 24 patients who have insufficient healthy skin available for standard skin grafting of their injury.

ReCell is a medical device that can be used in conjunction with conventional treatments for burns and reconstructive procedures.

AVMXY.OB closed Friday's trading at $1.25, up 1.33%.

Gilead Sciences Inc.'s (GILD) Ambrisentan in combination with Eli Lilly and Co.'s (LLY) Tadalafil has been approved by the FDA for the treatment of pulmonary arterial hypertension, or PAH, to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.

Ambrisentan is marketed under the tradename Letairis in the U.S. by Gilead, and under the tradename Volibris in territories outside of the U.S. by GlaxoSmithKline (GSK) as monotherapy for PAH to improve exercise ability and delay clinical worsening.

Tadalafil, marketed as Cialis, was initially approved for PAH in the U.S. in 2009 to improve exercise ability.

The global sales of Ambrisentan were $595 million in 2014.

GILD closed Friday's trading at $98.28, up 0.01%.

Horizon Pharma plc's (HZNP) affiliate Horizon Pharma Switzerland GmbH has entered into a settlement and license agreement with Actavis Laboratories FL, Inc., a subsidiary of Allergan plc (AGN), to resolve pending patent litigation involving RAYOS Delayed-Release Tablets.

RAYOS, developed by Horizon Pharma, is approved to treat a broad range of diseases including rheumatoid arthritis, polymyalgia rheumatic, psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease.

Actavis had filed an Abbreviated New Drug Application with the FDA seeking approval to market generic Rayos in 2013. Horizon Pharma sued Actavis the same year seeking to prevent the generic version of RAYOS from being launched before the expiry of the drug's patents.

Now, with the defendant and the plaintiff entering into a license agreement, Horizon has granted Actavis the right to market a version of RAYOS in the United States, beginning December 23, 2022 or earlier under certain circumstances.

Details of the settlement have not been revealed.

HZNP closed Friday's trading at $21.11, up 3.68%.

IGI Laboratories Inc. (IG) has submitted its ninth abbreviated new drug application for this year to the FDA, which brings the company's total number of ANDA submissions now pending at the FDA to thirty-one.

According to the company, its current pipeline of thirty-one submissions, exclusive of its four partnered submissions, pending approval by the FDA now has a combined addressable market of over $1.5 billion based on August 2015 data from IMS Health.

IG closed Friday's trading 2.95% higher at $6.97.

Ultragenyx Pharmaceutical Inc. (RARE) has successfully filed a Marketing Authorization Application with the European Medicines Agency for aceneuramic acid prolonged release tablets intended for patients with GNE Myopathy.

GNE Myopathy, also known as Hereditary Inclusion Body Myopathy, is a rare, progressive muscle-wasting disease.

If a positive opinion is received from the Committee for Medicinal Products for Human Use (CHMP), a decision from the European Commission would be expected in the second half of 2016, noted the company.

RARE closed Friday's trading at $104.69, up 5.77%.