Celgene to Collaborate with Zymeworks on Bispecific Antibodies
Jan 22 15
Zymeworks has announced that it has entered into a collaboration and licensing agreement with Celgene that focuses on the development of bispecific antibody therapeutics by leveraging the Zymeworks' proprietary Azymetric platform. Based on the terms of the agreement, the two partners will collaborate on early research for several Azymetric-generated antibodies, and Celgene will retain the option to advance the bispecific candidates through clinical development towards commercialisation. In return, Zymeworks will be entitled to an upfront payment, as well as an equity investment from Celgene. Zymeworks will also be eligible to further receive up to USD 164 million in clinical, regulatory, and commercial milestone payments for each candidate, as well as royalties on worldwide net sales. The collaboration between Zymeworks and Celgene builds on the promising features of the Azymetric drug-discovery platform to generate biotherapeutics with the ability to bind to two targets simultaneously in order to potentially create additive or synergistic responses. Privately held Zymeworks will benefit from the financial investment greatly and will focus its efforts on developing its own internal oncology pipeline, with multiple Investigational New Drug approvals anticipated starting from 2016. Bispecific candidates could be developed for a range of indications within oncology, autoimmunity, and inflammatory diseases. If the partnership is successful, Celgene's portfolio will be strengthened considerably with first-in-class therapies.
European Commission Approves Celgene International's Oral OTEZLA for the Treatment of Both Patients with Psoriasis and Psoriatic Arthritis
Jan 16 15
Celgene International announced that the European Commission has granted marketing authorization for OTEZLA (apremilast), the company’s oral selective inhibitor of phosphodiesterase (PDE4), in two therapeutic indications: For the treatment of moderate-to-severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). Alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. OTEZLA is the first in a new class of medicines for the treatment of both psoriasis and psoriatic arthritis, two diseases involving dysregulated immune system activity. Psoriasis is a systemic inflammatory condition characterized by raised scaly lesions on the skin. It affects approximately 14 million people across Europe and about 125 million people worldwide. Plaque psoriasis, also called psoriasis vulgaris, is the most common form of the disease, representing approximately 80% of cases. Additionally, up to 30% of people with psoriasis may develop psoriatic arthritis. Psoriatic arthritis, which is also an immune-mediated disease, is estimated to affect nearly 38 million people worldwide. It is a chronic condition characterized by pain, stiffness, swelling and tenderness of the joints, and a decrease in physical functioning. Enthesitis (inflammation at sites where tendons or ligaments insert into bone) and dactylitis (inflammation of fingers and toes, commonly known as “sausage fingers and toes”) are specific disease manifestations related to psoriatic arthritis, which can contribute to significant disability. The marketing authorization is based on efficacy and safety data from two Phase III programs, ESTEEM AND PALACE, which demonstrate a maintained clinical response among patients with psoriasis (ESTEEM) and psoriatic arthritis (PALACE) treated with OTEZLA® through 52 weeks, across multiple endpoints. In the ESTEEM studies, treatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI-75 (a 75% improvement in the Psoriasis Area Severity Index) scores at week 16, the primary endpoint. Patients on apremilast also benefited from significant improvements in difficult to treat areas, such as nail and scalp, and itch, known to have a marked impact on patients’ quality of life and perception of disease severity. In the PALACE program, treatment resulted in significant and clinically meaningful improvements in the signs and symptoms of psoriatic arthritis, as measured by the modified ACR-20 (a 20% improvement in the American College of Rheumatology disease activity criteria) response at week 16, the primary endpoint. Patients on apremilast showed improvement across multiple disease manifestations specific to psoriatic arthritis, such as swollen and tender joints, dactylitis, enthesitis and overall physical function and quality of life. Consistently, across these Phase III clinical studies, the most commonly reported adverse reactions were diarrhoea, nausea, upper respiratory tract infection, tension headache and headache. Gastrointestinal (GI) adverse reactions were mostly mild to moderate in severity, with 0.3% of diarrhoea and 0.3% of nausea reported as being severe. These adverse reactions generally occurred within the first two weeks of treatment and usually resolved within four weeks. Overall, most adverse reactions were considered to be mild or moderate in severity. The EC decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in November 2014. OTEZLA® will be launched in the European Union in the coming months in accordance with local requirements.
Celgene Corporation Provides Earnings Outlook for the Year 2014 and 2015 and Sales Outlook for the Fourth Quarter of 2014
Jan 12 15
Celgene Corporation provided earnings outlook for the year 2014 and 2015. For the year 2014, the company’s total net product sales are expected to be approximately $7,560 million, up 19% year-over-year. Adjusted operating margin is expected to be approximately 50.6% for the full year, up 220 basis points (bps) year-over-year. GAAP operating margin is expected to be approximately 32.8%, an increase of 490 bps year-over-year, primarily due to decreased upfront payments to collaboration partners in 2014. Adjusted diluted EPS is expected to be approximately $3.71, a 24% year-over-year increase, on a split-adjusted basis. GAAP diluted EPS is expected to be in the range of $2.38 to $2.41. For the fourth quarter of 2014 adjusted diluted EPS is expected to be approximately $1.01. GAAP diluted EPS is expected to be in the range of $0.71 to $0.74. Fourth quarter of 2014 net product sales is expected to be approximately $2,050 million.
In 2015, total net product sales are expected to be approximately $9,000 million to $9,500 million, a 22% increase year-over-year, based on the mid-point of the range. The negative impact of foreign exchange on net product sales is expected to approach $100 million in 2015 compared to 2014. For the full-year 2015, REVLIMID® net sales are expected to be in the range of $5,600 million to $5,700 million. Adjusted diluted earnings per share (EPS) for the full-year 2015 are expected to be in the range of $4.60 to $4.75, a 26% increase year-over-year, based on the mid-point of the range. Based on U.S. Generally Accepted Accounting Principles (GAAP), diluted EPS is expected to be in the range of $3.68 to $3.92.