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03.10.2016 05:20:40

DEPO Wins Patent Suit, EBS Surges On BARDA Funding, REGN's Eylea Combo Fails

(RTTNews) - Shares of Depomed Inc. (DEPO) touched a new 52-week high on Friday, thanks to the patent infringement suit related to NUCYNTA franchise going in favor of the company. The NUCYNTA franchise includes: NUCYNTA ER extended release tablets indicated for the management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), severe enough to require daily, around-the-clock, long-term opioid treatment; NUCYNTA for management of moderate to severe acute pain in adults; and NUCYNTA oral solution, an approved oral form of tapentadol that has not been launched.

Actavis Inc., Alkem Laboratories Ltd. and Roxane Laboratories, Inc., along with certain of their affiliated companies had sought approval to market a generic version of NUCYNTA ER.

Now that the court has confirmed the validity and strengths of NUCYNTA patents, Depomed expects market exclusivity until December 2025.

In the second quarter of 2016, NUCYNTA franchise revenue was $72 million compared to $57 million in the year-ago quarter. NUCYNTA franchise revenue made up nearly 62% of the company's total revenue in Q2, 2016.

DEPO touched a new 52-week high of $27.02 on Friday, before closing the day's trading at $24.97, up 4.52%.

Shares of Emergent BioSolutions Inc. (EBS) rose more than 13% on Friday, following a BARDA contract, valued at up to $1.6 billion, for advanced development and delivery of NuThrax, a next generation anthrax vaccine.

The company anticipates that NuThrax could get the FDA nod for emergency use as early as 2018, triggering deliveries of the vaccine to the Strategic National Stockpile in 2019.

Since 2008, Emergent has received five grants and contracts funded by BARDA and the National Institute of Allergy and Infectious Diseases totaling approximately $127 million for the early stage and advanced development of NuThrax, including development of a dry formulation for the vaccine candidate.

EBS closed Friday's trading 13.58% higher at $31.53.

MorphoSys AG's (MPSYY.OB) licensee Janssen Research & Development LLC, on Friday, reported positive results from a phase III study of Guselkumab in patients with moderate to severe plaque psoriasis.

The study, dubbed VOYAGE 1, showed significant efficacy versus placebo, and superiority of Guselkumab versus Humira in treatment of moderate to severe plaque psoriasis. Guselkumab also demonstrated significant efficacy compared with Humira across all major study endpoints through 48 weeks of treatment.

MPSYY.OB closed Friday's trading at $20.90, up 1.95%.

Regeneron Pharmaceuticals Inc.'s (REGN) phase II study of intravitreal REGN2176-3, a combo therapy of Eylea and Rinucumab, has not shown any benefit over intravitreal Eylea mono therapy in patients with neovascular age-related macular degeneration.

In the study, dubbed CAPELLA, patients were randomized to receive Eylea 2mg monotherapy, Eylea 2mg/Rinucumab 1mg or Eylea 2mg/Rinucumab 3mg.

According to the trial results, at 12 weeks, patients in the two combination arms showed a 5.8 letter improvement in best corrected visual acuity while patients treated with Eylea alone showed a 7.5 letter improvement in BCVA.

The study is ongoing, and data will be evaluated at 28 weeks and again at 52 weeks, when the study is completed.

REGN closed Friday's trading at $402.02, down 1.07%.

The Centers for Medicare and Medicaid Services has finalized the gapfill rate of Veracyte Inc.'s (VCYT) Afirma Gene Expression Classifier for 2017 at $2,864.45, which is higher than the preliminary gapfill rate of $2,240.16, proposed by the agency in June of this year.

Afirma GEC is used to help patients avoid an unnecessary thyroid surgery when their biopsy results are ambiguous. Medicare represents approximately 20 percent of Afirma GEC test volume.

Medicare currently reimburses $3,200 per test for the Afirma GEC.

VCYT closed Friday's trading at $7.61, up 2.28%.

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Emergent BioSolutions Inc. 9,45 -0,40% Emergent BioSolutions Inc.
Regeneron Pharmaceuticals Inc. 715,40 0,00% Regeneron Pharmaceuticals Inc.
Veracyte Inc 40,80 2,00% Veracyte Inc