Celgene
 | |
| Public | |
| Traded as |
NASDAQ: CELG NASDAQ-100 Component S&P 500 Component |
| Industry | Biotechnology |
| Founded | 1986 |
| Headquarters | Summit, New Jersey, U.S. |
Key people |
Sol J. Barer (Chairman) Mark Alles (CEO) |
| Products |
Thalomid Revlimid |
| Revenue | |
| Total assets | |
| Total equity | |
Number of employees | 4,182 (December 2010)[3] |
| Website |
www |
Celgene Corporation is an American biotechnology company that manufactures drug therapies for cancer and inflammatory disorders. It is incorporated in Delaware and headquartered in Summit, New Jersey. The company's major products are Thalomid (thalidomide), which is approved for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum ("ENL"), as well as in combination with dexamethasone for patients with newly diagnosed multiple myeloma, and Revlimid (lenalidomide), for which the company has received FDA and EMA approval in combination with dexamethasone for the treatment of multiple myeloma patients who have received at least one prior therapy. Revlimid is also approved in the United States for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk Myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Both Thalomid and Revlimid are sold through proprietary risk-management distribution programs to ensure safe and appropriate use of these pharmaceuticals. Vidaza is approved for the treatment of patients with MDS. Celgene also receives royalties from Novartis Pharma AG on sales of the entire Ritalin family of drugs, which are widely used to treat Attention Deficit Hyperactivity Disorder (ADHD).
Celgene Cellular Therapeutics, a subsidiary, is a public cord blood bank.
History
In 1986, Celgene, originally a unit of the Celanese Corporation, was spun off as an independent company following the merger of Celanese Corporation with American Hoechst Corporation.
In July 1998, Celgene received approval from the FDA to market Thalamid for the acute treatment of the cutaneous manifestations of moderate to severe ENL.
In April 2000, Celgene reached an agreement with Novartis Pharma AG to license d-MPH, Celgene's chirally pure version of RITALIN. The FDA subsequently granted approval to market d-MPH, or Focalin, in November 2001.
In August 2000, Celgene acquired Signal Pharmaceuticals, Inc., a privately held company that searches for and develops pharmaceuticals that regulate disease-related genes. Signal Pharmaceuticals, Inc. now operates as Celgene Research San Diego, a wholly owned subsidiary of Celgene Corporation.
In December 2002, Celgene acquired Anthrogenesis, a privately held New Jersey-based biotherapeutics company and cord blood banking business, which is developing technology for the recovery of stem cells from placental tissues following the completion of full-term successful pregnancies. Anthrogenesis now operates as Celgene Cellular Therapeutics, a wholly owned subsidiary of Celgene.
In December 2005, Celgene received approval from the FDA to market Revlimid for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
In May 2006, Celgene received approval for Thalamid in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma.
In June 2007, Celgene received full marketing authorization for Revlimid in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy by the European Commission.
In March 2008, Celgene closed its $2.9 billion acquisition of Pharmion Corporation.
In December 2009, Celgene announced the acquisition of Gloucester Pharmaceuticals.[4]
In June 2010 Celgene Corporation and Abraxis BioScience Inc. jointly announced the signing of a definitive merger agreement in which Celgene has agreed to acquire Abraxis BioScience.[5]
In 2010 Celgene looked to relocate its UK headquarters from Riverside House in Windsor to a new development Stockley Park, Uxbridge.[6]
In January 2012, Celgene and Avila Therapeutics, Inc., a privately held biotechnology company developing targeted covalent drugs that treat diseases through protein silencing, announced a definitive merger agreement under which Celgene Corporation will acquire Avila Therapeutics, Inc. Under the terms of the merger agreement, Celgene will acquire Avila Therapeutics, Inc. for $350 million in cash, plus up to $195 million for milestones contingent upon the development and regulatory approval of AVL-292, as well as up to $380 million in potential milestone payments contingent upon the development and approval of candidates generated from the Avilomics platform.[7]
Citing a market capitalization of US$67 billion, and stock appreciation of 107%, Celgene was Forbes Magazine's number 2 ranked drug company of 2013.[8]
In 2014, Celgene and OncoMed Pharmaceuticals entered into a cancer stem cell therapeutic development agreement encompasing demcizumab and five other biologics from OnoMed's pipeline.[9]
Also in 2014, Sutro Biopharma entered into a strategic collaboration and option agreement with Celgene Corporation to discover and develop multispecific antibodies and antibody drug conjugates (ADCs). This new agreement follows the December 2012 collaboration between the two companies and focuses on the field of immuno-oncology, while further broadening the Sutro platform for discovery, development, and manufacture of best-in-class biotherapeutics.[10]
In April 2015, Celgene announced it would commence a collaboration with Astrazeneca, worth $450 million, studying their Phase III immuno-oncology drug candidate MEDI4736.[11] Later in the same month Celgene annonuced it would acquire Quanticel for up to $485 million aimed at enhancing their cancer drug pipeline through Quanticels epigenetic modifier targeting applications.[12] In June 2015 Celgene announced it had licensed Lyceras RORgamma agonist portfolio for up to $105 million and continue to develop its Phase I lead compound LYC-30937 for the treatment of inflammatory bowel disease. The licensing opportunity gives Celgene the option to acquire Lycera.[13] In July 2015, the company announced it would acquire Receptos for $7.2 billion in a move to strengthen the company's inflammation and immunology areas.[14] News of the deal sent Celgene shares up 5.7% in after hours trading.
Specialty pharmacy
In 2006 Celegene certified McKesson Specialty, a specialty pharmacy, as one of a select group of RevAssist(SM) Program contract pharmacies to launch (lenalidomide (trade name Revlimid). As a specialty drug, lenalidomide requires special handling and is therefore only available through the RevAssist program, a unique distribution network employing only certified, contracted specialty pharmacies.[15]
Acquisition history
The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| |
Products
| Brand Name | Drug Name(s) | Indication | Date Approved (USA)[16] | Partner |
|---|---|---|---|---|
| Vidaza | azacitidine | treatment of patients with refractory anemia,chronic myelomonocytic leukemia | 05-19-2004 | |
| Revlimid | lenalidomide | transfusion dependent anemia due to low or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5 q cytogenetic abnormality with or without additional cytogenetic abnormalities | 12-27-2005 | |
| Revlimid | lenalidomide | (in combination with dexamethasone) treatment of multiple myeloma patients who have received at least one prior therapy | 06-29-2006 | |
| Thalomid | thalidomide | acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrences | 07-16-1998 | |
| Thalomid | thalidomide | (in combination with dexamethasone) treatment of patients with newly diagnosed multiple myeloma | 05-25-2006 | GlaxoSmithKline |
| Alkeran | melphalan | palliative treatment of multiple myeloma and for the palliation of non-resectable epithelial carcinoma of the ovary | 01-17-1964 | GlaxoSmithKline |
| Alkeran | melphalan hydrochloride | the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate | 11-18-1992 | GlaxoSmithKline |
| Focalin | dexmethlyphenidate hydrochloride CII | attention deficit hyperactivity disorder (ADHD) in children and adolescents | 11-13-2001 | Novartis |
| Focalin XR | dexmethlyphenidate hydrochloride CII | attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults | 05-26-2005 | Novartis |
Litigation
Anti-trust allegations In 2009, Dr. Reddy’s Laboratories requested, and Celgene refused to provide, a samples of Celgene's anticancer drug THALOMID® (thalidomide). Dr. Reddy's Laboratories sought the material for bioequivalency studies required to bring its own, generic, version of thalidomide to market. In response to the refusal, Dr. Reddy's Laboratories filed a Citizen's Petition with the FDA asking the Agency to adopt procedures that would ensure generic applicants the right to buy sufficient samples to perform bioequivalence testing of drugs that were subject to REMS distribution restrictions.
Celgene denied that it had behaved anticompetitively, arguing that the legislative history strongly suggested that Congress considered and rejected a proposed guaranteed access procedure like the one proposed by Dr. Reddy’s. Celgene further argued that requiring innovator companies to sell their products to potential generic competitors would violate its intellectual property rights and subject it to liability risks in the event that patients were harmed in Dr. Reddy's studies.
Generic manufacturer Lannett Company initiated antitrust litigation that accused Celgene of using its REMS for THALOMID® (thalidomide) to violate the anti-monopolization provisions of the Sherman Act. In early 2011, the district court denied Celgene’s motion to dismiss. The case was set for trial beginning in February 2012, but the parties settled before the trial began, thereby postponing further judicial review of antitrust claims premised on alleged abuse of REMS distribution restrictions.[17]
See also
References
- 1 2 3 4 5 6 7 8 9 "CELGENE CORP /DE/ 2013 Annual Report Form (10-K)" (XBRL). United States Securities and Exchange Commission. February 13, 2014.
- ↑ "CELGENE CORP /DE/ 2014 Q1 Quarterly Report Form (10-Q)" (XBRL). United States Securities and Exchange Commission. April 29, 2014.
- ↑ "2010 Form 10-K, Celgene Corporation". United States Securities and Exchange Commission.
- ↑ Celgene to Acquire Gloucester Pharmaceuticals, Dec. 7, 2009
- ↑ Celgene to Acquire Abraxis BioScience Inc., Jun. 30, 2010
- ↑ "New Head Quarters for Celgene - Stockley Park greets new tenant". UK Construction magazine. 13 october 2011. Check date values in:
|date=(help) - ↑ (PDF) http://www.avilatx.com/news/2012_0126_AvilaCelgene.pdf. Missing or empty
|title=(help) - ↑ "Grading Pharma in 2013". Forbes. December 31, 2013.
- ↑ Staff (January 1, 2014). "OncoMed, Celgene in $3.3B+ Cancer Stem Cell Collaboration". Industry Watch. Gen. Eng. Biotechnol. News. p. 8.
- ↑ "Sutro Biopharma and Celgene Corporation Enter Multi-Year Strategic Collaboration and Option to Acquire Agreement".
- ↑ "GEN - News Highlights:AstraZeneca Inks $1.8B in Immuno-Oncology Deals as Q1 Profit Dips". GEN.
- ↑ "GEN - News Highlights:Celgene to Acquire Quanticel for Up-to-$485M". GEN.
- ↑ http://www.genengnews.com/gen-news-highlights/celgene-licenses-lycera-s-immune-modulators-in-up-to-105m-deal/81251366/
- ↑ http://www.genengnews.com/gen-news-highlights/celgene-to-acquire-receptos-for-7-2b/81251504/
- ↑ "Celgene Selects McKesson Specialty as a RevAssist Program Pharmacy Vendor to Launch REVLIMID: McKesson Specialty to Provide Dispensing, Reimbursement and Clinical Services", PRNewswire (Harahan, La.), 13 February 2006, retrieved 5 November 2015
- ↑ "Drugs@FDA: FDA Approved Drug Products". Food and Drug Administration. Retrieved 2007-09-03.
- ↑ Botts LLP, Baker. "Life Science Update". Baker Botts LLP. Retrieved February 28, 2012.