ADMA Biologics Inc.'s (ADMA) pivotal phase III trial for RI-002 in Primary Immune Deficiency Disease, which met its primary endpoint with zero serious bacterial infections last December, has now demonstrated encouraging secondary endpoint results.
In the multi-site study of 59 patients diagnosed with PIDD, investigators reported on the secondary endpoints that included: a total of 93 days, or 1.66 days per patient per year lost from work or school due to infection; one hospitalization due to an infection of only five days duration in the entire study and Immunoglobulin G (IgG) trough levels above those required by the FDA for IVIG (intravenous immunoglobulin) products.
The company is expected to file BLA for RI-002 in Primary Immune Deficiency Disease during the first half of 2015.
ADMA closed Monday's trading at $10.40, down 0.76%.
BioDelivery Sciences International Inc. (BDSI) is all set to receive $10 million milestone payment from Endo Pharmaceuticals Inc., a subsidiary of Endo International plc (ENDP), in conjunction with the acceptance of NDA for BELBUCA Buccal Film for chronic pain.
BELBUCA is being developed and will be commercialized through a worldwide license and development agreement between Endo Pharmaceuticals and BDSI.
The FDA's decision on BELBUCA is expected in October 2015. BDSI will be eligible for an additional milestone payment of up to $50 million upon approval of BELBUCA.
BDSI closed Monday's trading at $14.63, up 1.53%.
Bristol-Myers Squibb Co. (BMY) has entered into an agreement to acquire all of the outstanding capital stock of Flexus, a privately held biotechnology company focused on the discovery and development of novel anti-cancer therapeutics.
The transaction has a potential total consideration of $1.25 billion, including $800 million upfront and development milestones that, upon achievement, could total up to $450 million.
The deal is expected to close during the first quarter of 2015.
BMY closed Monday's trading at $61.29, up 1.27%.
Eli Lilly and Co. (LLY) and Incyte Corp.'s (INCY) investigational medicine Baricitinib has demonstrated a statistically significant improvement compared to placebo in a second consecutive phase 3 trial in rheumatoid arthritis.
The study, dubbed RA-BUILD, included patients with moderately-to-severely active rheumatoid arthritis who had an inadequate response to, or were intolerant of, at least one conventional disease-modifying antirheumatic drug.
Lilly and Incyte announced top-line results from the first phase III trial of Baricitinib, RA-BEACON, which also met its primary endpoint, in December 2014.
LLY closed Monday's trading at $71.09, down 1.10%.
Ophthotech Corp. (OPHT) is on track with respect to the execution of its pivotal Fovista phase 3 program in wet age-related macular degeneration. The company expects to have initial, top-line data from the phase 3 program in 2016.
OPHT touched a new high of $58.29 on Monday before closing the day's trading at $57.59.
Shares of PDL BioPharma Inc. (PDLI) were down nearly 6 per cent in after-hours trading on Monday as the company reported lower-than-expected profit and revenue for the fourth quarter ended December 31, 2014.
Net income for the fourth quarter of 2014 was $55.1 million or $0.32 per share on total revenues of $117.1 million, while analysts polled by Thomson Reuters expected earnings of $0.57 per share and total revenue of $158.15 million. This compared with net income of $61.1 million or $0.39 per share and revenue of $112.0 million in the same period of 2013.
PDLI closed Monday's trading at $7.34, up 0.82%. In after-hours, the stock was down 5.59% at $6.93.
Rigel Pharmaceuticals Inc. (RIGL) was up more than 26% on Monday, following a collaboration agreement with Bristol-Myers Squibb Co. (BMY) for its TGF beta receptor kinase inhibitors for use in immuno-oncology related indications.
Under the terms of the agreement, Bristol-Myers Squibb will obtain exclusive, worldwide rights to develop and commercialize small molecule therapeutics derived from Rigel's TGF beta library, including, but not limited to, those approved to treat cancer.
Bristol-Myers Squibb will pay $30 million upfront and Rigel will be eligible to receive development and regulatory milestones that could total more than $309 million for a successful compound approved in multiple indications. Rigel will also be eligible to receive tiered royalties on the net sales of any products from the collaboration.
RIGL closed Monday's trading 26.67% higher at $3.23.
Sagent Pharmaceuticals Inc. (SGNT) has initiated a nationwide voluntary recall of Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL due to FDA observations pertaining to aseptic and GMP practices at the manufacturer's site potentially impacting product sterility.
Atracurium Besylate Injection, USP, 50mg/5mL and 100mg/10mL is indicated, as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation, and is supplied in single-dose and multi-dose vials.
The product in question was manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent.
SGNT closed Monday's trading at $27.50, down 3.47%.
Theravance Inc. (THRX) has announced a cash dividend of $0.25 per share payable on March 31, 2015 to stockholders of record as of the close of business on March 12, 2015.
The company's supplemental NDA for Breo Ellipta in the expanded indication of asthma is under FDA review - with an FDA panel scheduled to make its recommendations on March 19, 2015, and a final decision slated for April 30, 2015.
Breo Ellipta, jointly developed by Theravance and GlaxoSmithKline, was approved by the FDA in May 2013 for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations.
THRX closed Monday's trading at $17.48, down 4.06%.
Trinity Biotech plc (TRIB), which temporarily suspended its FDA trials for its Meritas Troponin test last October, has recommenced the trials.
The company estimates that the entire trial process, consisting of patient sampling, data collection, cardiologist adjudication and statistical analysis, will be completed by the end of July, 2015 with FDA submission planned for August, 2015.
The Meritas Troponin I test enables fast, accurate triage and intervention for patients presenting at the emergency department with a possible myocardial infarction.
TRIB closed Monday's trading 0.39% higher at $17.89.
Valeant Pharmaceuticals International Inc. (VRX) (VRX.TO) touched an all all-time high of $200.76 on Monday after the company agreed to acquire Salix Pharmaceuticals, Ltd. (SLXP) for $158.00 per share in cash, or a total enterprise value of approximately $14.5 billion.
The transaction, which is expected to close in the second quarter of 2015, is subject to customary closing conditions and regulatory approval.
VRX closed Monday's trading at $198.75, up 14.71%.
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