BIND In A Fix, APRI To File NDA In Q3, TSRO Abuzz

(RTTNews) - With the merger deal with Pfizer Inc. (PFE) being called off, Allergan plc. (AGN) has entered into a global R&D and commercialization partnership with Heptares Therapeutics in a bid to boost its CNS (central nervous system) pipeline.

As per the agreement terms, Allergan will license exclusive global rights to a broad portfolio of novel subtype-selective muscarinic receptor agonists in development for the treatment of major neurological disorders, including Alzheimer's disease.

Heptares will receive an upfront payment of $125 million and is eligible to receive contingent milestone payments of up to approximately $665 million associated with successful clinical development and launch of the first three licensed compounds for multiple indications and up to approximately $2.5 billion associated with achieving certain annual sales thresholds during the several years following launch.

In addition, Heptares is eligible to receive up to double-digit tiered royalties on net sales of all products resulting from the partnership. Allergan is also committing up to $50 million to a research and development program to be conducted jointly by Allergan and Heptares aimed at advancing multiple candidates through Phase 2 clinical studies. Allergan will be responsible for the development of licensed compounds upon initiation of Phase 2b studies and for subsequent manufacturing and commercialization of the products.

AGN closed Wednesday's trading at $244.74, up 3.46%.

Apricus Biosciences Inc. (APRI) expects to re-submit its NDA for Vitaros for the treatment of erectile dysfunction in the third quarter of this year. The FDA in 2008 had turned down the NDA for Vitaros.

Vitaros, for the treatment of erectile dysfunction, is approved in Europe and Canada and is being commercialized in several countries in Europe.

Warner Chilcott, now a subsidiary of Allergan, had gained U.S. rights to Vitaros from Apricus in 2009. Last September, Apricus in-licensed the U.S. development and commercialization rights for Vitaros from Allergan.

In order to keep a tight lid on expenses, the company has planned to reduce staff, including the executive team, by approximately 30%; reduce Board of Directors expenses by decreasing the size of the Board and reducing the Board's cash compensation; and cut down operating expenses by approximately 30% in 2016 and 60% in 2017 compared to last year.

APRI closed Wednesday's trading at $0.59, up 0.17%.

BIND Therapeutics Inc.'s (BIND) phase II trial of BIND-014 in advanced non-small cell lung cancer of squamous histology, dubbed iNSITE 1, has shown a 52.5% 6-week disease control rate (6wDCR) for the intent-to-treat population and a 70.0% 6wDCR in the per protocol population, which exceeded the protocol defined criteria for success of 65%. The company intends to seek licensing or collaboration opportunities for further development of BIND-014 in non-small cell lung cancer.

In the phase II trial of BIND-014 in cervical and head and neck cancers, dubbed iNSITE 2, there was an objective response rate of 10 percent in the head and neck cancer cohort while there were no objective responses in the cervical cancer cohort. Based on the results, BIND has decided to halt further enrollment in the iNSITE 2 trial in advanced cervical and head and neck cancers.

In order to streamline operations and reduce its operating expenses, BIND has decided to reduce its workforce by 38%, which is expected to be completed by the end of this month, and evaluate options for its wholly owned subsidiary in Moscow.

The strategic actions undertaken are expected to bring BIND's quarterly cash burn rate to approximately $6 million per quarter by the third quarter of 2016.

BIND plunged 24.17% on Wednesday to close the day's trading at $1.82.

Bristol-Myers Squibb Co.'s (BMY) Opdivo monotherapy has been approved by the European Commission in advanced renal cell carcinoma after prior therapy in adults.

The drug is already approved in Europe to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be surgically removed, and for squamous non-small cell lung cancer (NSCLC, a type of lung cancer) that has spread locally or to other parts of the body in adults who have previously been treated with other cancer medicines (chemotherapy).

Opdivo monotherapy for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy was approved in the U.S. last November.

Opdivo raked in sales of $942 million in 2015, its first full year on the market.

BMY closed Wednesday's trading at $66.54, up 1.19%.

The Female Health Co. (FHCO) has entered into a definitive merger agreement with Aspen Park Pharmaceuticals Inc., a privately held company focused on oncology and men's and women's health therapeutics and consumer health products.

Subsequent to merger, the combined company will establish both a Men's Health Division and a Women's Health Division offering pharmaceuticals as well as consumer health products.

The proposed merger, subject to certain closing conditions, including approval by a two-thirds vote of Female Health's stockholders, is expected to close in the third quarter of 2016 and has been approved by the boards of both companies.

FHCO closed Wednesday's trading at $1.41, down 18.02%.

Galapagos NV (GLPG) has started its exploratory phase IIa study with GLPG1690 in idiopathic pulmonary fibrosis patients.

The trial, dubbed FLORA, will investigate a once daily oral dose of GLPG1690 administered for 12 weeks in 24 IPF patients. Galapagos expects to complete patient recruitment before end 2016, and to report topline results in Q2 2017.

GLPG closed Wednesday's trading 6.35% higher at $44.75.

Incyte Corp. (INCY) has acquired the rights to develop and commercialize Jakafi, its proprietary JAK1/JAK2 inhibitor, for graft-versus-host disease from Eli Lilly and Co. (LLY).

Additionally, Incyte has amended its Collaboration and License Agreement with Novartis, granting Novartis exclusive research, development and commercialization rights for Jakafi in graft-versus-host disease outside the U.S.

For full year 2015, Jakafi generated sales of $601 million, up 68% over 2014.

INCY closed Wednesday's trading at $81.87, up 11.62%.

TESARO Inc. (TSRO) has entered into a collaboration and license agreement with Janssen Biotech to develop Niraparib.

Niraparib is an oral, once daily, potent, and highly selective PARP inhibitor that is currently being evaluated in phase III clinical trials for ovarian and breast cancer. Separately, Johnson & Johnson Innovation - JJDC, Inc. is making a $50 million equity investment in TESARO at a price of $44.24 per share, which is based upon the 5-day volume weighted average share price through the day prior to execution of the agreement.

TSRO closed Wednesday's trading at $47.59, up 11.19%.