Celgene & Acceleron Enter Agreement Worth Up to $242 Million
Celgene Corporation and Acceleron Pharma, Inc. recently announced they have entered into a joint development and commercialization agreement for ACE-536 for the treatment of anemia. The companies already have a collaboration around sotatercept (ACE-011) entered in 2008. Under the new agreement, the companies will collaborate to develop both products and potentially others for treating anemia across a wide range of indications.
Celgene and Acceleron will jointly develop, manufacture, and commercialize ACE-536, a novel protein therapeutic that inhibits members of the TGF-beta superfamily involved in erythropoiesis, for the treatment of anemia. Additionally, Celgene will have an option to future Acceleron programs developed for anemia. Celgene will make an upfront payment to Acceleron of $25 million.
“Acceleron has uncovered an exciting new approach to treating disorders of erythropoiesis, and we are pleased to broaden our successful partnership with Celgene,” said John Knopf, PhD, CEO of Acceleron. “Acceleron and Celgene can now combine our strengths to develop molecules to treat a broad array of under-served diseases and conditions in which patients suffer from anemia. To that end, we look forward to initiating the Phase I clinical trial of ACE-536 within the next few months. ACE-536 is our fourth internally discovered and developed drug to enter the clinic.”
“Celgene and Acceleron have a strong partnership that continues to advance innovative therapies in areas of great unmet medical need,” said Tom Daniel, PhD, President, Research, Celgene. “The work we will embark on with ACE-536 is a natural extension of our strong presence in hematology. We look forward to exploring the potential of ACE-536 for patients with anemia worldwide.”
Under the terms of the agreement, Acceleron will be responsible for conducting the Phase I and initial Phase II clinical trials, and Celgene will conduct the subsequent Phase II and Phase III clinical studies. Acceleron will manufacture ACE-536 for the Phase I and Phase II clinical trials, and Celgene will have responsibility for the manufacture of Phase III and commercial supplies. Acceleron will pay a share of the development expenses through the end of 2012, and Celgene will be responsible for development costs thereafter. Acceleron is eligible to receive development, regulatory, and commercial milestones of up to $217 million for the ACE-536 program. The companies will co-promote the products in
ACE-536 is a ligand trap that inhibits members of the TGF-beta superfamily involved in late stages of erythropoiesis. ACE-536 and sotatercept are biochemically distinct molecules and may have unique pharmacological attributes that enable their preferential use in particular anemia indications. In preclinical studies, ACE-536 promotes red blood cell (RBC) formation in the absence of erythropoietin (EPO) signaling, has distinct effects from EPO on RBC differentiation, and acts on a different population of progenitor blood cells than EPO during RBC development.
Sotatercept, a soluble receptor fusion protein composed of extracellular domain of the human activin receptor type IIA (ActRIIA) fused to human immunoglobulin, is a biologic therapeutic. Blocking signaling through ActRIIA may be a way to increase red blood cell production, promote bone formation, and inhibit tumor growth and metastasis. Sotatercept is the first in a novel class of anemia therapies. In Phase I clinical studies in healthy volunteers, sotatercept was generally well tolerated, and increased levels of hemoglobin and hematocrit, biomarkers of bone formation, and bone mineral density. The most common clinically significant adverse events observed included increased hemoglobin and increased hematocrit, which were pharmacologic effects of the drug, and also headache, all of which were manageable and reversible. Sotatercept is currently being studied in Phase II clinical trials in patients with chemotherapy-induced anemia and in patients with end-stage renal disease on hemodialysis.
Celgene Corporation, headquartered in
Sunshine Biopharma Looking to Mimic Roche’s Billion-Dollar Cancer Drug Last year, over 260,000 new cases of breast cancer (invasive and in situ combined) were diagnosed in women in the US. Over the course of a woman’s lifetime, the odds are greater than 12% (or 1 out of every 8) that she will develop invasive breast cancer and have only about a 41% chance of surviving for 5 years if not detected until stage IIIB (odds are increased to approximately 90% if caught in stage I). Although most people don’t consider it, men aren’t removed from invasive breast cancer stats either; nearly 2,000 new cases were diagnosed in 2010 as well.
Given the high death rate for late-stage detection (odds slip all the way to a meager 15% chance of living 5 more years when detected in stage 4), there is a huge area of unmet need for new therapies to treat the disease. One company looking to make a dent in the number of breast cancer deaths is Montreal, Canada-based Sunshine Biopharma, Inc., a drug maker engaged in researching and developing drugs for a wide array of cancers with their initial focus on breast cancer.
Sunshine is taking the path less traveled by attacking drug-resistant cancers, a course of action that can be difficult, but reap impressive rewards if successful and Sunshine is showing promising results to date. The company’s flagship compound in development is Adva-27, a small molecule that targets and inhibits Topoisomerase II (Top2), an enzyme found in abundance in various types of aggressive carcinomas. It is widely known that there are two genes associated with aggressive forms of cancer: Her2 (human epidermal growth factor receptor-2) and Top2. Swiss drug maker Roche’s Herceptin (Trastuzumab) is an effective treatment for Her2-positive patients. Showcasing the magnitude of usage for a viable indication addressing one of the genes, Herceptin generated roughly $7 billion in global sales for Roche in 2010.
Recently, Sunshine announced it has completed a detailed cytotoxicity study, a measure of a drug’s ability to destroy cancer cells in vitro, of Adva-27a, in MCF-7/MDR, a multidrug-resistant breast cancer cell line. According to the company, the study’s results showed that Adva-27a is 16-times more effective at killing multidrug-resistant breast cancer cells than Etoposide, a current commonly used drug. In addition, data generated by the study revealed that Adva-27a is unaffected by the molecular machinery that are responsible for making cancer cells resistant to drugs. Multidrug resistance is a major component in the failure of many of today’s chemotherapies, so drugs that show the ability to thwart the resistance factor are heralded as particularly valuable from both a humanitarian and financial standpoint.
The life span of a biotech stock play runs in cycles with one area of common upward price movement being the commencement of clinical trials. Sunshine is nearing that milestone with
Baxter Oncology Establishes Baxter Ventures; Will Commit $200 Million in Early Stage Companies
Baxter International Inc. recently announced it has established Baxter Ventures to invest up to $200 million in equity in promising early stage companies developing therapies that complement Baxter’s existing portfolio.
“Baxter’s mission is to apply innovative science to develop therapies and medical technologies that save and sustain patients’ lives,” said Robert L. Parkinson, Jr., Chairman and CEO of Baxter. “As the company’s internal capabilities have advanced our late-stage pipeline, we have the capacity to further accelerate the early stage development of essential therapies.”
Baxter Ventures will invest globally and focus on innovative technologies with sustainable long-term growth. The company has continued to grow its internal investments in R&D and to pursue business development initiatives, collaborations, and alliances as part of its long-term growth strategy. Baxter Ventures will report into Norbert Riedel, PhD, Baxter’s Chief Scientific Officer.
“Baxter Ventures will allow us to provide companies with promising, early stage technologies with the capital and expertise needed to drive successful innovation,” said Dr. Riedel. “Through this additional investment, Baxter will expand its internal pipeline with the goal of further strengthening the company’s history of innovative firsts in medical therapies.”
Trius & Bayer Form Strategic Collaboration
Trius Therapeutics, Inc. and Bayer Pharma AG recently announced they have signed an exclusive agreement to develop and commercialize Trius’ lead Phase III antibiotic, torezolid phosphate (torezolid), in
In exchange for development and commercialization rights in its licensed territory, Bayer will pay Trius $25 million upfront and will support approximately 25% of the future development costs of torezolid required for global approval in acute bacterial skin and skin structure infections (ABSSSI) and pneumonia. In addition, Trius is eligible to receive up to $69 million upon the achievement of certain development, regulatory, and commercial milestones and will receive double-digit royalties on net sales of torezolid in the licensed territory.
“Bacterial infectious diseases represent one of the largest therapeutic areas in
“Bayer’s commitment to the infectious disease area and their depth and breadth of experience in these markets makes them an ideal partner for Trius,” added Jeffrey Stein, PhD, President and CEO of Trius. “At the same time, consistent with our strategy, we have retained rights to the
Trius Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative antibiotics for life-threatening infections. The company’s lead investigational drug, torezolid phosphate, is an IV and orally administered second-generation oxazolidinone in Phase III clinical development for the treatment of ABSSSI, the first such trial to be initiated under a Special Protocol Assessment (SPA). Trius holds an exclusive license to torezolid phosphate for territories outside of North and
Ironwood & Depomed Announce Collaboration, Research & License Agreement
Ironwood Pharmaceuticals, Inc. and Depomed, Inc. recently announced that Ironwood has licensed worldwide rights to utilize Depomed’s Acuform gastric-retentive drug delivery technology for an Ironwood early stage development program, continuing Ironwood’s efforts to augment its development pipeline beyond linaclotide. Under the terms of the agreement, Depomed will assist with initial product formulation, and Ironwood will be responsible for all development and commercialization of the product. Depomed will be paid an upfront license fee and will receive additional payments pending achievement of certain development and regulatory milestones, as well as royalties on product sales.
“We are pleased to contribute our Acuform technology and drug delivery expertise to Ironwood’s development effort, and add an important new partner to our Acuform franchise strategy,” said Thadd Vargas, Depomed’s Senior Vice President, Business Development. “We are very excited to collaborate with Ironwood on this new non GC-C related gastrointestinal disorder program.”
“Ironwood is keen to pursue appropriate collaborations that will create value and leverage each party’s area of expertise,” added Jim O’Mara, Ironwood’s Vice President, Corporate Development. “We believe the Acuform technology is highly complementary to our internal effort to create differentiated medicines and provides Ironwood with the opportunity to continue to build a portfolio of development candidates through both internal and external R&D.”
Ironwood Pharmaceuticals is an entrepreneurial pharmaceutical company dedicated to the art and science of great drug-making. Linaclotide, Ironwood’s GC-C agonist, is in Phase III clinical development for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation. The efficacy portion of linaclotide’s development program has been completed and will support the NDA submission for both indications, as well as the MAA submission for the IBS-C indication. Ironwood also has a growing pipeline of additional drug candidates in earlier stages of development.
Depomed, Inc. is a specialty pharmaceutical company with one approved product on the market and another recently approved product. Gralise (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia (PHN). Glumetza (metformin hydrochloride extended-release tablets) is approved for use in adults with type 2 diabetes and promoted by Santarus, Inc. in the
Amarin Successfully Completes All Remaining Clinical Studies for NDA
Amarin Corporation plc, a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, recently announced the successful completion of all remaining studies required for the company’s planned NDA for AMR101 for the treatment of patients with very high triglycerides (greater than or equal to 500 mg/dl). Completion of these studies is a key step in the company’s plans to submit an NDA for AMR101 by the end of September.
The company previously announced that it achieved all primary endpoints in its two pivotal Phase III clinical trials, both of which have SPA agreements with the FDA (MARINE and ANCHOR), and completed all preclinical studies. The company has now successfully completed all clinical pharmacology studies needed to characterize AMR101.
Furthermore, the company believes that it has met all of the requirements for the submission of a complete package of studies for the NDA for the treatment of patients with very high triglyceride levels. All findings from these clinical pharmacology studies were consistent with the company’s expectations with no AMR101-related inhibition in metabolism of the drugs studied. These results reinforce the company’s perspective from its Phase III clinical trials that the overall safety profile of AMR101 is comparable to placebo.
“The completion of these final studies clears the way for our NDA submission by the end of next month,” said Joseph Zakrzewski, Amarin’s Chairman and CEO. “The Amarin team is now focused on completing the final work for the AMR101 NDA package, and we are looking forward to moving into the regulatory review process.”
AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA (icosapent ethyl), that Amarin is developing as a potentially best-in-class prescription medicine for the treatment of patients with very high triglyceride levels (greater than or equal to 500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (> 200 and < 500 mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia). Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels and other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP without increasing LDL-C. AMR101 intentionally excludes DHA, which is believed to result in increases in LDL-C. AMR101 demonstrated a safety profile comparable to placebo in two complete Phase III clinical trials.
Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The company’s lead product candidate is AMR101 (icosapent ethyl). Amarin reported positive, statistically significant top-line results for both of its two pivotal Phase III clinical trials.
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