BDSI Gets FDA Nod, ELGX Snaps Up TRIV, Have Eye On OPHT

(RTTNews) - BioDelivery Sciences International Inc. (BDSI) and Endo International plc (ENDP) have received FDA approval for BELBUCA buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.

Following the FDA approval of BELBUCA, BioDelivery Sciences is all set to receive a milestone payment of $50 million from Endo, pursuant to an agreement signed between the two companies in 2012. Additional payments and tiered royalties are in the offing for BioDelivery Sciences from Endo if certain sales milestones are met.

BDSI closed Monday's trading at $5.72, up 8.33%.

Merck's (MRK) approved cancer drug KEYTRUDA has shown superior overall survival compared to chemotherapy in patients with previously treated advanced non-small cell lung cancer whose tumors express PD-L1 in a pivotal phase 2/3 trial.

In the trial, dubbed KEYNOTE-010, two doses of KEYTRUDA - the FDA-approved 2mg/kg dose and a higher, investigational 10mg/kg dose, each given every 3 weeks - were compared to Docetaxel, a commonly used chemotherapy. A topline analysis revealed that treatment with both the doses of KEYTRUDA was associated with longer overall survival compared with Docetaxel treatment.

KEYTRUDA is approved by the FDA for the treatment of metastatic melanoma and metastatic non-small cell lung cancer. These indications are approved under accelerated approval based on tumor response rate and durability of response.

The label for KEYTRUDA currently says that an improvement in survival or disease-related symptoms has not yet been established, and the continued approval for these indications may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merck is planning regulatory submissions in the U.S. in late 2015 and in the European Union in early 2016.

MRK closed Monday's trading at $52.91, up 0.06%.

Ophthotech Corp. (OPHT) has completed patient recruitment for its second phase III trial of its investigational drug Fovista in combination with Roche's blockbuster Lucentis for the treatment of wet age-related macular degeneration. Patient recruitment in the first phase III trial of Fovista in combination with Lucentis was completed in May of this year.

The company expects to announce initial, topline data from both phase III trials of Fovista in combination with Lucentis in the fourth quarter of 2016.

A third phase III trial, which is investigating Fovista in combination with either Eylea or Avastin, continues to enroll patients with recruitment on track, according to the company.

OPHT closed Monday's trading at $46.82, up 0.54%.

Recro Pharma Inc. (REPH) is scheduled to initiate a pivotal Phase III clinical development program with IV Meloxicam, a long-acting, preferential COX-2 inhibitor, for the treatment of moderate to severe acute post operative pain in the first quarter of 2016.

Recro acquired IV/IM Meloxicam from Alkermes in April 2015.

REPH closed Monday's trading at $10.82, down 4.16%.

RedHill Biopharma Ltd.'s (RDHL) phase I study with YELIVA in patients with advanced solid cancers has successfully met its primary and secondary endpoints.

A phase I/II clinical study evaluating YELIVA in patients with refractory/relapsed diffuse large B-cell lymphoma (DLBCL), primarily in patients with HIV-related DLBCL is underway. A phase I/II study with YELIVA for the treatment of refractory or relapsed multiple myeloma is planned to be initiated by early 2016.

RDHL closed Monday's trading at $12.54, up 0.56%.

TriVascular Technologies Inc. (TRIV) is all set to be acquired by Endologix Inc. (ELGX) for $9.10 per share or a total of approximately $211 million, in a stock and cash transaction.

Upon completion of the merger, Endologix stockholders will own roughly 84% of the shares of the combined company on a fully diluted basis and TriVascular stockholders will own approximately 16%. The transaction is expected to close in January of 2016, subject to customary closing conditions.

TRIV closed Monday's trading at $5.04, down 1.75%. In after hours, the stock was up 54.76% at $7.80.