First Randomized Study To Evaluate IMLYGIC® (Talimogene Laherparepvec), An Oncolytic Viral Therapy, In Combination With A Checkpoint Inhibitor Published In The Journal Of Clinical Oncology
Results Demonstrated a Doubling of Objective Response Rate Compared to Ipilimumab Alone in Unresectable Advanced Melanoma Responses Were Not Limited to Injected Lesions and Favored the Combination Arm Across Subsets of Disease THOUSAND OAKS, Calif. , Oct. 5, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Journal of Clinical Oncology has published positive results from the IMLYGIC® (talimogene laherparepvec) Phase 2 '264 study. The study met its primary endpoint of objective response rate (ORR), demonstrating that IMLYGIC in combination with YERVOY® (ipilimumab) more than doubled ORR, defined as the proportion of patients with tumor size reduction, compared to ipilimumab alone in patients with unresectable stage IIIB-IV melanoma (39 percent versus 18 percent; odds ratio=2.9, 95 percent CI: 1.5, 5.5; p=0.002). Patients in the combination arm also experienced nearly double the complete response rate compared to ipilimumab alone (13 percent versus 7 percent). "Advanced melanoma is highly aggressive and can require multiple treatment approaches over the course of the disease," said Jason Chesney , M.D., lead author of the '264 study and director of the James Graham Brown Cancer Center , University of Louisville , Louisville, Ky. "Results from the study found that administration of IMLYGIC in combination with ipilimumab led to greater efficacy versus ipilimumab alone in both uninjected and visceral lesions. These data show that this combination of a checkpoint inhibitor plus IMLYGIC demonstrated a synergistic clinical effect and enhanced anti-tumor immune response in patients with metastatic melanoma." IMLYGIC is designed to rupture cancer cells causing the release of tumor-derived antigens, which along with granulocyte-macrophage colony-stimulating factor (GM-CSF), may help to initiate an anti-tumor immune response. However, the exact mechanism of action is unknown. This may be complementary to ipilimumab's mechanism of action, as the blockade of cytotoxic T-lymphocyte-associated antigen-4 has been shown to augment activation and proliferation of tumor infiltrating T-effector cells. Melanoma is one of the most dangerous types of skin cancers, especially when it spreads to other parts of the body.1 The study showed that responses occurred in both injected and uninjected lesions, including visceral lesions, demonstrating a systemic anti-tumor response. Thirty-one (32 percent) and 22 (22 percent) of the patients were shown to have visceral disease at baseline in the combination and ipilimumab arms, respectively. Of these patients, 16 (52 percent) in the combination arm and five (23 percent) in the ipilimumab arm were observed to have a decrease in visceral lesion tumor burden. Patients in the combination arm also experienced a median progression-free survival (PFS) of 8.2 months (median follow up 68 weeks) versus 6.4 months in the ipilimumab arm. The effect was not statistically significant (HR=0.83, 95 percent CI: 0.56, 1.23; p=0.35); however, the PFS analysis was not event-driven and is still ongoing. Evaluation of overall survival (OS) is ongoing and continues to be monitored. The most common adverse events in the IMLYGIC plus ipilimumab arm compared to the ipilimumab alone arm were fatigue (59 percent versus 42 percent, respectively), chills (53 percent versus 3 percent, respectively), diarrhea (42 percent versus 35 percent, respectively), pruritus (40 percent versus 36 percent, respectively), rash (39 percent versus 28 percent, respectively) and nausea (38 percent versus 24 percent, respectively). "IMLYGIC is the first and only approved oncolytic viral therapy in the U.S. and Europe , reinforcing Amgen's leadership and commitment to developing innovative therapies for difficult-to-treat cancers," said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen . "The data published today in the Journal of Clinical Oncology supports the scientific hypothesis behind the combination of IMLYGIC with an immune checkpoint inhibitor. We are excited about the promise of our diverse immuno-oncology pipeline that looks at combinations that may be effective in stimulating an immune attack on cancer cells." In the study, response rate was also higher in the combination arm across subsets of the disease. ORR for patients with stage IIIB/IIIC/IVM1a disease was 44 percent in the combination arm and 19 percent in the ipilimumab arm (overall response [OR]=3.3, 95 percent CI: 1.4, 7.8; p=0.007). In patients with stage IVM1b/IVM1c disease, ORR was 33 percent and 16 percent, respectively (OR=2.6, 95 percent CI: 0.9, 7.0; p=0.09). Among BRAF wild-type patients, ORR was 42 percent in the combination arm versus 10 percent in the ipilimumab arm (OR=6.5, 95 percent CI: 2.4, 17.4; p<0.0001). In patients with BRAF-mutant tumors, which comprised a minority of each arm at 35 (36 percent) and 34 (34 percent) for the combination and ipilimumab arms respectively, ORR was 34 percent in the combination arm versus 32 percent in the ipilimumab arm (OR=1.1, 95 percent CI: 0.4, 3.0; p=1.0). The disease control rate (DCR) was 58 percent in the combination arm and 42 percent in the ipilimumab arm (OR=1.9, 95 percent CI: 1.1, 3.4; p=0.033). DCR in all subgroups, with the exception of patients with BRAF mutations, favored the combination arm. About the '264 Study The '264 study is a Phase 1b/2, multicenter, open-label trial evaluating the safety and efficacy of IMLYGIC in combination with ipilimumab compared to ipilimumab alone in patients with unresectable stage IIIB-IV melanoma. The primary endpoint of the Phase 2 portion of study is ORR. Secondary endpoints include duration of response, DCR, PFS, OS and safety. The study randomized 198 patients, 98 in the IMLYGIC plus ipilimumab arm and 100 in the ipilimumab arm. About Metastatic Melanoma Melanoma remains a significant public health concern across the globe. Unlike some other cancers, melanoma incidence rates have doubled in the past 40 years, with 132,000 cases occurring worldwide each year.2,3 Melanoma is more dangerous than other skin cancers, especially when it spreads to other parts of the body, which is referred to as metastatic disease.1 The overall five-year risk of relapse after surgery increases as disease stage advances, from 48 percent for stage IIIA to 85 percent for stage IIIC.4 Risk of recurrence is even higher for patients in stage IV undergoing surgery, with 91 percent experiencing relapse.5 Despite new options, additional treatments are needed - particularly for patients with metastatic disease. About IMLYGIC® (talimogene laherparepvec) IMLYGIC is a genetically modified herpes simplex type 1 virus that is injected directly into tumors. IMLYGIC replicates inside tumor cells and produces GM-CSF, an immunostimulatory protein. IMLYGIC then causes the cell to rupture and die in a process called lysis. The rupture of the cancer cells causes the release of tumor-derived antigens, which together with virally derived GM-CSF may help to promote an anti-tumor immune response. However, the exact mechanism of action is unknown. IMLYGIC is the first oncolytic viral therapy approved by the U.S. Food and Drug Administration (FDA) based on therapeutic benefit demonstrated in a pivotal study. IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. IMLYGIC has not been shown to improve OS or have an effect on visceral metastases. Important U.S. Safety Information
U.S. Patent and Trademark Office Rules In Lilly's Favor On Alimta Vitamin Regimen Patent
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office (PTO) has ruled in the company's favor regarding patentability of the vitamin regimen for Alimta® (pemetrexed for injection).In the inter partes review (IPR) proceedings initiated by Neptune Generics, LLC and Sandoz Inc., the U.S. PTO found that the claims of the vitamin regimen patent are valid. If the patent is ultimately upheld through all remaining challenges, Alimta would maintain U.S. exclusivity until May 2022, preventing marketing of generic products for as long as the patent remains in force."We are pleased with today's ruling by the U.S. PTO finding the claims of the Alimta vitamin regimen patent are valid," said Michael J. Harrington, senior vice president and general counsel for Lilly. "This ruling largely confirms the earlier decision of the district court which was affirmed on appeal by a unanimous court."Harrington continued, "The significant scientific research that Lilly performed in support of the vitamin regimen patent deserves intellectual property protection, which has been confirmed in every validity challenge to date. We continue to emphasize that protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve. These rights help support the development of the next generation of innovative medicines."In March 2014, the U.S. Court for the Southern District of Indiana upheld the validity of the vitamin regimen patent. In August 2015, the same court ruled in Lilly's favor regarding infringement of the vitamin regimen patent. The U.S. Court of Appeals for the Federal Circuit confirmed these rulings in a unanimous decision in January 2017, finding the patent is valid and would be infringed by the generic challengers' proposed products.About Eli Lilly and Company Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels. C-LLYThis release contains forward-looking statements regarding the U.S. Alimta patent litigation. These statements are based on management's current expectations but actual results may differ materially. There can be no assurance that the company will prevail in any appeal. Also, the company cannot predict whether generic pemetrexed will be marketed prior to the expiration of the vitamin regimen patent. Other risk factors that may affect the company's results can be found in the company's latest Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission.Alimta® (pemetrexed, Lilly)Refer to: Lauren Zierke; firstname.lastname@example.org; (317) 989-2853 (Media)Phil Johnson; email@example.com; (317) 655-6874 (Investors)
Mylan, in Partnership with Synthon, Receives Marketing Authorization Approval in Europe for First Generic for Copaxone(R) 40 mg/mL Mylan Has Exclusive Rights for Glatiramer Acetate in Several Key European Markets
PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that partner, Synthon, received marketing authorization approval in Europe for Glatiramer Acetate Injection 40 mg/mL, a therapeutically equivalent generic version of Teva's Copaxone® 40 mg/mL, indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system. Mylan (PRNewsfoto/Mylan N.V.) This approval complements last year's approval of Glatiramer Acetate Injection 20 mg/mL, which already is available in several European markets. Granting of national marketing authorizations is expected to follow in the near future. Mylan CEO Heather Bresch commented, "We're pleased with the approval of Glatiramer Acetate Injection 40 mg/mL, and look forward to leading the marketing and selling of this important product in our European markets. Mylan recognizes the complexities of MS care and challenges faced by patients. This approval reinforces our commitment to helping patients and healthcare providers by providing alternative treatment options to better serve the needs of this community. The approval also highlights Mylan's commercial capabilities and ability to commercialize complex products around the globe." Mylan is partnered with Synthon, the developer and supplier of its European Glatiramer Acetate Injection 20 mg/mL and 40 mg/mL products, and has exclusive distribution and supply rights for the products for Germany , France , Spain , Portugal , Belgium , Italy , the Netherlands , United Kingdom , Republic of Ireland , Switzerland , Greece , Denmark , Sweden , Norway , Finland , Cyprus and Malta .
Biogen’s SPINRAZA® (nusinersen) Data Show Earlier Treatment Initiation May Lead to Improved Motor Function Across a Broad Population of People Living with Spinal Muscular Atrophy
New data from Phase 3 ENDEAR study demonstrated earlier initiation of treatment with SPINRAZA may improve motor function outcomes in infants with Spinal Muscular Atrophy (SMA) Phase 2 EMBRACE interim analysis showed greater motor milestone achievement in infants and children treated with SPINRAZA, compared to those untreated, in patient populations not studied in the pivotal trials Interim analysis of EMBRACE also supported the dosing regimen of four loading doses in the first two months, followed by the administration of SPINRAZA every four months thereafter for infantile- and later-onset SMA Category: Rare and Genetic diseases Thursday, October 5, 2017 7:30 am EDT EmailPDFPrintRSS "These studies contribute to a growing body of evidence that SPINRAZA can make a meaningful difference in the lives of people with SMA regardless of their age or stage of the disease" CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen (NASDAQ: BIIB) presented new data demonstrating that earlier initiation of treatment with SPINRAZA® (nusinersen) may improve motor function outcomes in infants and children with spinal muscular atrophy (SMA). Results continued to reinforce the favorable efficacy and safety profile of SPINRAZA. The data were shared at the 22nd International Annual Congress of the World Muscle Society in Saint Malo, France (October 3-7, 2017).A new analysis from the Phase 3 ENDEAR study showed infants with SMA who initiated treatment earlier in the disease (shorter disease duration) demonstrated greater benefit and improvement in motor function outcomes.As measured by the Hammersmith Infant Neurological Examination (HINE), significant differences in motor milestone responders were observed between infants treated with SPINRAZA compared to untreated infants with disease duration less than or equal to 12 weeks (75% vs. 0%; P<.0001) and those with disease duration greater than 12 weeks (32% vs. 0%; P=.0026). There was also a significant benefit in event-free survival in infants treated with SPINRAZA with disease duration less than or equal to 12 weeks (P=.0004).“These studies contribute to a growing body of evidence that SPINRAZA can make a meaningful difference in the lives of people with SMA regardless of their age or stage of the disease,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “Across studies, we continue to see evidence that earlier initiation of treatment with SPINRAZA can lead to improved clinical and functional outcomes.”Interim analyses were also presented from the Phase 2 EMBRACE study which was designed to assess the efficacy and safety of SPINRAZA in individuals with infantile- and later-onset SMA who were ineligible for the two earlier pivotal studies.The EMBRACE interim analysis showed a larger proportion of infants and children treated with SPINRAZA were HINE motor milestone responders compared to those who were untreated. Results from the interim analysis also supported the dosing regimen of four loading doses in the first two months, followed by the administration of SPINRAZA every four months thereafter, for individuals with infantile- and later-onset SMA.In the ENDEAR and EMBRACE studies SPINRAZA demonstrated a favorable benefit-risk profile. Safety data involving the intrathecal administration of SPINRAZA showed the incidence and nature of the most common lumbar puncture-related adverse events in the clinical studies were similar in children with later-onset SMA with or without scoliosis.For more information about SPINRAZA and prescribing information in the United States, please visit www.SPINRAZA.com. Prescribing information in the European Union is available at http://www.ema.europa.eu/ema/.About ENDEAR and EMBRACE ENDEAR is a randomized, double-blind, sham-procedure controlled 13-month study in patients with infantile-onset SMA. The end of study efficacy analysis included all patients (n=121) who had their final study visit after the interim analysis (n=78) and had the opportunity to attend the six-month study visit assessment. The Hammersmith Infant Neurological Examination (HINE) is a reliable and clinically validated tool to assess motor milestone achievement in infants with SMA.EMBRACE is a Phase 2, multicenter, randomized, double-blind, sham-procedure controlled 14-month study of SPINRAZA in infants and children not eligible to participate in ENDEAR (symptom onset less than or equal to six months, less than or equal to seven months of age at screening; 2 SMN2 copies) or CHERISH (symptom onset age greater than six months, age 2-12 years at screening).SPINRAZA Program Status SPINRAZA is the first approved medicine for the treatment of SMA and is currently approved in the United States, the European Union, Brazil, Japan and Canada. Biogen has submitted regulatory filings in additional countries and plans to initiate additional filings in other countries.Globally, in 2016, in response to the urgent need for treatment for the most severely affected individuals living with SMA, Biogen sponsored one of the largest, pre-approval Expanded Access Programs (EAP) in rare disease, free of charge.Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA from Ionis Pharmaceuticals (NASDAQ: IONS), a leader in antisense therapeutics. Biogen and Ionis conducted an innovative clinical development program that moved SPINRAZA from its first dose in humans in 2011 to its first regulatory approval in five years.About SMA 1-5 Spinal muscular atrophy (SMA) is characterized by loss of motor neurons in the spinal cord and lower brain stem, resulting in severe and progressive muscular atrophy and weakness. Ultimately, individuals with the most severe type of SMA can become paralyzed and have difficulty performing the basic functions of life, like breathing and swallowing.Due to a loss of, or defect in, the SMN1 gene, people with SMA do not produce enough SMN protein, which is critical for the maintenance of motor neurons. The severity of SMA correlates with the amount of SMN protein. People with Type 1 SMA, the form that requires the most intensive and supportive care, produce very little SMN protein and do not achieve the ability to sit without support or live beyond two years without respiratory support. People with Type 2 and Type 3 SMA produce greater amounts of SMN protein and have less severe, but still life-altering forms of SMA.About SPINRAZA ® (nusinersen) SPINRAZA is being developed globally for the treatment of SMA.SPINRAZA is an antisense oligonucleotide (ASO), using Ionis Pharmaceuticals’ proprietary antisense technology, that is designed to treat SMA caused by mutations or deletions in the SMN1 gene located in chromosome 5q that leads to SMN protein deficiency. SPINRAZA alters the splicing of SMN2 pre-mRNA in order to increase production of full-length SMN protein.6 ASOs are short synthetic strings of nucleotides designed to selectively bind to target RNA and regulate gene expression. Through use of this technology, SPINRAZA has the potential to increase the amount of full-length SMN protein in individuals with SMA.SPINRAZA must be administered via intrathecal injection, which delivers therapies directly to the cerebrospinal fluid (CSF) around the spinal cord,7 where motor neurons degenerate in individuals with SMA due to insufficient levels of survival motor neuron (SMN) protein.8SPINRAZA demonstrated a favorable benefit-risk profile. The most common adverse reactions reported for SPINRAZA were upper respiratory infection, lower respiratory infection and constipation. Serious adverse reactions of atelectasis were more frequent in SPINRAZA-treated patients. Coagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia, have been observed after administration of some antisense oligonucleotides. Individuals may be at increased risk of bleeding complications. Renal toxicity has been observed after administration of some antisense oligonucleotides. SPINRAZA is present in and excreted by the kidney.About Biogen Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.Biogen Safe Harbor This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 relating to the potential benefits, safety and efficacy of SPINRAZA, the results of certain real-world data, the status of current regulatory filings, plans for additional regulatory filings in other jurisdictions, planning and timing for commercial launch, and availability of patient access and reimbursement pathways, which may vary on a country-by-country basis. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “except,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will” and other words and terms of similar meaning. You should not place undue reliance on these statements or the scientific data presented. Drug development and commercialization involve a high degree of risk. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation uncertainty of success in commercialization of SPINRAZA, which may be impacted by, among other things, the level of preparedness of healthcare providers to treat patients, difficulties in obtaining or changes in the availability of reimbursement for SPINRAZA, the effectiveness of sales and marketing efforts, problems with the manufacturing process for SPINRAZA, the occurrence of adverse safety events, unexpected concerns that may arise from additional data or analysis; regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of Biogen’s drug candidates or expansion of product labeling; or Biogen may encounter other unexpected hurdles which may be impacted by, among other things, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to obtain regulatory approvals in other jurisdictions, failure to protect intellectual property and other proprietary rights; product liability claims; or third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on our current beliefs and expectations and speak only as of the date of this press release. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.1. Darras B, Markowitz J, Monani U, De Vivo D. Chapter 8 - Spinal Muscular Atrophies. In: Vivo BTD, ed. Neuromuscular Disorders of Infancy, Childhood, and Adolescence (Second Edition). San Diego: Academic Press; 2015:117-145.2. Lefebvre S, Burglen L, Reboullet S, et al. Identification and characterization of a spinal muscular atrophy-determining gene. Cell.1995;80(1):155-165.3. Mailman MD, Heinz JW, Papp AC, et al. Molecular analysis of spinal muscular atrophy and modification of the phenotype by SMN2. Genet Med. 2002;4(1):20-26.4. Monani UR, Lorson CL, Parsons DW, et al. A single nucleotide difference that alters splicing patterns distinguishes the SMA gene SMN1 from the copy gene SMN2. Hum Mol Genet. 1999;8(7):1177-1183.5. Peeters K, Chamova T, Jordanova A. Clinical and genetic diversity of SMN1-negative proximal spinal muscular atrophies. Brain.2014;137(Pt 11):2879-2896.6. Hua Y, Sahashi K, Hung G, Rigo F, Passini MA, Bennett CF, Krainer AR. Antisense correction of SMN2 splicing in the CNS rescues necrosis in a type III SMA mouse model. Genes Dev. 2010 Aug 1; 24(15):16344-44.7. Evers MM, Toonen LJ, van Roon-Mom WM. Antisense oligonucleotides in therapy for neurodegenerative disorders. Adv Drug Deliv Rev. 2015;87:90-103.8. Lunn MR, Wang CH. Spinal muscular atrophy. Lancet. 2008;371(9630):2120-2133.
Stockholm, Sweden and Alderley Park, England - Medivir AB (Nasdaq Stockholm: MVIR) and AMR Centre Ltd (AMRC) today announce signing of an agreement providing AMRC the exclusive worldwide rights to Medivir’s research stage metallo-β-lactamase inhibitor (MBLI) program. This key research program is aimed at tackling the threat posed by NDM-1 and other metallo-β-lactamases, enzymes that make bacteria resistant to widely used beta-lactam antibiotics such as penicillin. AMR Centre (AMRC), the leading UK organisation working to combat the global problem of drug resistance, will take forward this program.Bacteria containing NDM-1 have already caused significant fatalities and the spread of this enzyme has the potential to greatly diminish the number of treatment options for organisms such as E. coli and Klebsiella pneumoniae . First identified in 2008 in New Delhi, NDM-1 has since been detected in bacteria in Pakistan, Sweden, the United Kingdom, the United States, Canada, and Japan.A licensing agreement will see AMRC progress the development of compounds deriving from Medivir’s metallo-β-lactamase inhibitor (MBLI) program. The goal is a treatment that could be given alongside existing antibiotics that would block the resistance mechanism that the NDM-1 bacteria have developed. It would take the form of a combination therapy containing the MBLI alongside an existing β-lactam antibiotic, with the MBLI inactivating the resistance mechanism thereby restoring and maintaining the antibiotic activity.Under the terms of the agreement, AMRC, which operates from Alderley Park, Cheshire, UK, will be responsible for the future development of the MBLI program, and will share with Medivir a proportion of commercialization revenue received from any future out-licensing, sale or other commercialization of licensed know-how or compounds. No further financial details were released.AMRC’s Executive Director, Dr Peter Jackson said: “Medivir has done a lot of very good science and we are delighted to be able to take forward the MBLI program aiming to address important emerging resistance mechanisms and targeting drug-resistant Gram-negative pathogens on the WHO’s critical priority list.“There is an absolute need for international collaboration in science around the antibiotic resistance issue. Avoiding duplication of effort is one of the keys as it is still that case that there are far too few scientists, in the grand scheme of public health, working on what is acknowledged as a potentially devastating global problem. The role of the AMRC is to help support, nurture and leverage expertise in different locations – and in this case we think we can help progress important science.”Christine Lind, CEO of Medivir, said: “As Medivir focuses its efforts on developing drugs for cancer, we are pleased that AMRC will continue the development of this important program bringing new antibacterial treatments to patients.”Dr Chris Doherty, Managing Director of Alderley Park, said: “The AMRC is rapidly establishing itself as a key collaborator and researcher. This is the second international deal and we expect to see more. We are obviously delighted that the research will take place within our campus at Alderley Park – ARMC is a flagship presence in terms of antimicrobial research, and we have other businesses here working on the problem.”About the metallobetalactamase inhibitor program The diverse gene family that encodes metallo-β-lactamases is extensive and found in prevalent Gram-negative pathogens such as Escherichia coli , Klebsiella pneumoniae , Pseudomonas aeruginosa and Acinetobacter baumannii . These enzymes are also referred to as carbapenemases, as they provide resistance to carbapenem antibiotics. Carbapenemase-producing bacteria are cited as ‘superbugs’ owing to the difficulty in treating infections caused by them, as carbapenems are regarded as drugs of last resort.Given the propensity of Gram-negative bacteria to exchange genetic material, it has been predicted that the prevalence of MBLs in clinical isolates will rise. For example, horizontal gene transfer in these organisms often results in a multi-drug resistance phenotype through exchange of several resistance determinants on one transferable element. Indeed, organisms containing MBLs are often resistant to several other antibiotic classes such as aminoglycosides and fluoroquinolones.For further information, please contact: Anders Lundin, Interim CFO Medivir AB, mobile: +46 (0)73-125 1453 Richard Bethell, CSO Medivir AB, mobile +46 (0) 72 704 3211 Ian Grundy, CBO AMR Centre +44 (0) 7575 040999About Medivir Medivir is a research-based pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical needs. Medivir is listed on the Nasdaq Stockholm Mid Cap List.About the AMR Centre Established in May 2016, The AMR Centre is a key part of the UK’s response to the global threat from antimicrobial resistance. Based at Alderley Park, the AMR Centre is a joint private-public initiative to support/accelerate the development of new antibiotics and diagnostics through a fully integrated development capability, offering translational R&D from pre-clinical hits through to clinical proof of concept.
Heptares Founder Richard Henderson Receives Nobel Prize in Chemistry 2017 for Pioneering Work in cryo-EM for Visualising Biological Structures
LONDON & TOKYO--(EON: Enhanced Online News)--Heptares Therapeutics (“Heptares”), a wholly owned subsidiary of Sosei Group Corporation (“Sosei”; TOKYO Mothers Index: 4565), is delighted that one of its founders, Richard Henderson (MRC Laboratory of Molecular Biology, Cambridge, UK), was awarded the Nobel Prize in Chemistry 2017 together with Jacques Dubochet (University of Lausanne, Switzerland) and Joachim Frank (Columbia University, New York, USA) "for developing cryo-electron microscopy for the high-resolution structure determination of biomolecules in solution."“for developing cryo-electron microscopy for the high-resolution structure determination of biomolecules in solution.” Cryo-electron microscopy (cryo-EM) is a technique for determining three-dimensional information about protein structures at the molecular level. Along with traditional methods for structure determination, such as x-ray crystallography and nuclear magnetic resonance spectroscopy, cryo-EM can reveal the structure of complex molecular assemblies to near atomic level. Detailed information, such as this, is expected to improve understanding of the structure and function of proteins under investigation, and thereby advance the design of new drugs targeting specific proteins. Heptares is applying the techniques of cryo-EM to study G protein-coupled receptor (GPCR) protein complexes, the insights from which are helping to advance the discovery of potential new medicines.Malcolm Weir, CEO and co-founder Heptares, said: “We are delighted that Richard has received this most prestigious of awards. It is very well deserved and justified recognition of his outstanding contribution to science as a true pioneer of structural biology. His work on membrane protein structure in particular provided the inspiration and scientific foundation for Heptares’ work on GPCR structure-based drug design, and we continue to benefit enormously from his contributions. We would like to offer Richard and his fellow prize winners our warmest congratulations for this fantastic achie
BOSTON--(EON: Enhanced Online News)--Cerevance, a drug discovery and development company, today announced that Robert Malenka, M.D., Ph.D., has joined the company as a senior-level scientific advisor. Dr. Malenka is the Pritzker Professor of Psychiatry and Behavioral Sciences at Stanford University. For over 30 years, his research has focused on the molecular mechanisms and functions of synaptic plasticity in a number of different brain regions including the hippocampus, nucleus accumbens, dorsal striatum and ventral tegmental area.“Cerevance’s unique approach to molecularly profiling specific brain cell populations in human brain tissue provides an opportunity to identify new therapeutic targets for brain diseases without relying on animal models” Dr. Malenka’s laboratory uses molecular manipulations in combination with cell biological, optogenetic and electrophysiological assays in a variety of different in vitro and in vivo preparations. His team performs experiments that incorporate molecular manipulations of defined neuronal populations with the goal of elucidating the functions of synaptic plasticity in defined circuits and behaviors. He has been an author on over 250 peer-reviewed publications, including more than 45 papers in Nature, Science and Cell and over 65 papers in Neuron and Nature Neuroscience.“Dr. Malenka’s thoughtful and candid advice will be enormously helpful as we prioritize programs, interpret results and select targets for drug discovery,” said Brad Margus, Chief Executive Officer of Cerevance. “We look forward to drawing on his expertise as we discover new treatments aimed at psychiatric and neurological diseases.”“Cerevance’s unique approach to molecularly profiling specific brain cell populations in human brain tissue provides an opportunity to identify new therapeutic targets for brain diseases without relying on animal models,” said Dr. Malenka. “Cerevance is assembling an impressive scientific team, and I look forward to working with them.”Dr. Malenka has received numerous awards, including a Young Investigator Award from the Society for Neuroscience in 1993, the Daniel Efron Award from the American College of Neuropsychopharma-cology in 1998, a Distinguished Alumni Award from Stanford Medical School in 1998, the International Prize in Neuroscience from the Dargut and Milena Kemali Foundation in 2000, the Basic Neuroscience Research Award from the Collegium Internationale Neuropsychopharmacologicum-Lilly in 2002, the Julius Axelrod Mentorship Award from the American College of Neuropsychopharmacology in 2011, the Medical Research Award in Neuropsychiatry from the Robert and Claire Pasarow Foundation in 2011, and the Julius Axelrod Prize, Society for Neuroscience in 2016.He is also a Member of the National Academy of Medicine, a Fellow in the American Academy of Arts and Sciences, a Fellow in the American Association for the Advancement of Science, and a Member of the National Academy of Sciences.About CerevanceCerevance is a recently formed pharmaceutical company focused on central nervous system diseases. Our strengths include a powerful technology platform, a pipeline of novel discovery-stage and clinical-stage compounds and a proven team. We believe that we are well positioned to deliver life-changing therapeutics for patients who have brain-related disorders.ContactsCerevance Robert Middlebrook, +1-408-220-5722Recent Stories
Humalog Junior KwikPen combines the convenience of a prefilled pen with the ability to dose in half-unit incrementsINDIANAPOLIS, Oct. 4, 2017 /PRNewswire/ -- Humalog® Junior KwikPen® [insulin lispro injection 100 units/mL] is now available by prescription for the treatment of diabetes in the U.S. This innovation is the latest in the treatment and delivery options Eli Lilly and Company (NYSE: LLY) offers for people with type 1 or type 2 diabetes. Humalog Junior KwikPen is the only prefilled, disposable half-unit insulin pen.In June 2017, the U.S. Food and Drug Administration (FDA) approved Humalog Junior KwikPen for the treatment of diabetes. In September 2017, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for Humalog Junior KwikPen in the European Union and is pending final approval, expected later this year."Learning how to inject insulin can be overwhelming, especially for newly diagnosed children and their caregivers. People often feel shock and anxiety, and may struggle with the reality of fitting diabetes into daily life," said Sherry Martin, M.D., vice president, Global Medical Affairs, Lilly Diabetes. "We hope to help take away some of the worries about the injection process with Humalog Junior KwikPen. Because it is prefilled, there are fewer steps for people to learn, and the half-unit increments make dosing more precise."Humalog Junior KwikPen, which is lighter and shorter than other half-unit insulin pens, provides an option for people who prefer a prefilled pen and need the precision of half-unit dosing, such as those with insulin sensitivity and some older adults for whom rounding to the nearest whole-unit dose is not adequate.Until now, the only way to deliver half units of insulin with a pen was through a reusable pen, which requires users to remove and load cartridges. Humalog Junior KwikPen offers fine-tuned dosing in a convenient prefilled disposable pen.Humalog Junior KwikPen enables finer dose adjustment (0.5 vs 1 unit dose increments) for people who take relatively small doses (≤30 units at mealtimes) of Humalog® U-100 (insulin lispro injection 100 units/mL). The design of Humalog KwikPen meets or exceeds the requirements and standards for needle-based injections set by the International Organization for Standardization.For more information about Humalog Junior KwikPen, the support resources, please visit www.Humalog.com.
Companies to Jointly Develop T-Cell Engaging Bispecific Probody THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif. , Oct. 3, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and CytomX Therapeutics, Inc. , (NASDAQ:CTMX) today announced that the companies have entered into a strategic collaboration in immuno-oncology. The companies will co-develop a CytomX ProbodyTM T-cell engaging bispecific against the Epidermal Growth Factor Receptor (EGFR), a highly validated oncology target expressed on multiple human cancer types. Probody T-cell engaging bispecifics are antibody constructs capable of directing cytotoxic T-cells in tumor microenvironments. In preclinical studies, CytomX's Probody versions of EGFRxCD3 bispecific therapeutics induced tumor regressions and increased the therapeutic window for this high potential cancer target. "Our collaboration with CytomX leverages Amgen's development leadership in bispecifics and expands our immuno-oncology capabilities with an additional and complementary bispecific technology," said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen . "EGFR is a particularly compelling target on which to employ the CytomX Probody platform given its potential to localize activity within tumors while limiting potential toxicity." "Probody-based T-cell engaging bispecific antibodies offer significant potential in treating cancers by employing localized therapeutic activity within tumor tissue," said Sean McCarthy , D.Phil., president and chief executive officer of CytomX Therapeutics . "Through this collaboration, we are positioned to combine Amgen's industry-leading expertise in leveraging bispecifics to activate a patient's immune-system with CytomX's ability to design potent new therapies that exploit unique conditions in the tumor microenvironment. Development of Probody-based T-cell engaging bispecifics further validates the broad applicability of the Probody platform in addressing unmet needs in oncology." Under the terms of the agreement, Amgen and CytomX will co-develop a Probody T-cell engaging bispecific against EGFRxCD3 with CytomX leading early development. Amgen will lead later development and commercialization with global late-stage development costs shared between the two companies. Amgen will make an upfront payment of million and purchase million of CytomX common stock. CytomX will be eligible to receive up to 5 million in development, regulatory and commercial milestones for the EGFR program. Amgen will lead global commercial activities with CytomX able to opt into a profit share in the U.S. and receive tiered, double-digit royalties on net product sales outside of the U.S. Amgen will also receive exclusive worldwide rights to develop and commercialize up to three additional, undisclosed targets. Should Amgen ultimately pursue all of these targets, CytomX will be eligible to receive up to 0 million in additional upfront and milestone payments and high single-digit to mid-double digit royalty payments on any resulting products. CytomX will also receive the rights from Amgen to an undisclosed preclinical T-cell engaging bispecific program; Amgen is eligible to receive milestones and royalty payments on any resulting products from this CytomX program. Conference Call / Webcast Information CytomX will host a teleconference today at 5 p.m. ET to discuss the strategic collaboration. Sean McCarthy , D.Phil., president and chief executive officer at CytomX and Debanjan Ray , chief financial officer at CytomX, will lead the teleconference. Interested parties may access the live audio webcast of the teleconference through the Investor and News page of CytomX's website at http://ir.cytomx.com or by dialing (877) 809-6037 and using the passcode 94163867. A replay will be available on the CytomX website or by dialing (855) 859-2056 and using the passcode 94163867. The replay will be available from October 3, 2017 , at 8:00 p.m. ET until October 10, 2017 , at 8:00 p.m. ET . About Amgen Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. About CytomX Therapeutics CytomX Therapeutics is a clinical-stage biopharmaceutical company with a deep and differentiated oncology pipeline of investigational ProbodyTM therapeutics. Probody therapeutics are designed to exploit unique conditions of the tumor microenvironment to more effectively localize antibody binding and activity while limiting activity in healthy tissues. The Company's pipeline includes proprietary cancer immunotherapies against clinically-validated targets, such as PD-L1, and first-in-class Probody drug conjugates against highly attractive targets, such as CD166 and CD71, which are considered to be inaccessible to conventional antibody drug conjugates due to their presence on healthy tissue. In addition to its wholly owned programs, CytomX has strategic collaborations with AbbVie , Bristol-Myers Squibb Company , Pfizer Inc. , MD Anderson Cancer Center and ImmunoGen, Inc. For more information, visit www.cytomx.com or follow us on Twitter.
Mylan Launches Generic Gleevec(R) Tablets
PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Imatinib Mesylate Tablets, 100 mg and 400 mg, a generic version of Novartis's Gleevec® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which has multiple indications, including for several blood cancers. Mylan (PRNewsfoto/Mylan N.V.) Imatinib Mesylate Tablets, 100 mg and 400 mg, had U.S. sales of approximately .7 billion for the 12 months ending July 31, 2017 , according to QuintilesIMS. Mylan is one of the largest suppliers of cancer medicines by volume in the U.S. , with a robust oncology portfolio of more than 40 products. To enhance access for eligible commercially insured patients, Mylan will offer a Savings Card for Imatinib Mesylate Tablets,* which will help reduce a patient's out-of-pocket costs. The card provides up to 0 off the monthly out-of-pocket costs for the product and is reusable up to 12 times per calendar year. Eligible patients can participate in Mylan's Savings Card for Imatinib Mesylate Tablets program by registering online at activatethecard.com/imatinib. Currently, Mylan has 227 ANDAs pending FDA approval, representing approximately .2 billion in annual brand sales, according to QuintilesIMS. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing .5 billion in annual brand sales, for the 12 months ending July 31, 2017 , according to QuintilesIMS. Currently, one out of every 13 prescriptions filled in the U.S. - brand-name or generic - is a Mylan product. Imatinib Mesylate Tablets are a kinase inhibitor indicated for the treatment of: Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP) or in chronic phase (CP) after failure of interferon-alpha therapy Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA -approved test Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation as determined with an FDA -approved test or with c-Kit mutational status unknown Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP) *Eligibility restrictions apply. See Terms and Conditions. This offer is not valid for patients covered by Medicare, Medicaid or any other federal or state funded healthcare program or where prohibited by law. Mylan Pharmaceuticals reserves the right to amend or end this program at any time without notice. Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. View original content with multimedia:http://www.prnewswire.com/news-releases/mylan-launches-generic-gleevec-tablets-300528561.html SOURCE Mylan N.V.
Additional Delivery of Insulin Ready for Distribution in Puerto Rico
Shipment of commercial and humanitarian insulin among products sent to islandINDIANAPOLIS, Oct. 5, 2017 /PRNewswire/ -- Today, a new shipment of commercial medicines, including more than 36,000 vials and pens of insulin, arrived in Puerto Rico. The delivery by Eli Lilly and Company (NYSE: LLY) includes 3,000 vials for humanitarian distribution and enough commercial insulin to help re-stock operational pharmacies. Lilly's humanitarian donation now includes 5,400 insulin pens and vials since Hurricane Maria struck Puerto Rico on September 20."The arrival of this additional insulin will help our efforts considerably," said Angel L. Comulada, M.D., president of the Puerto Rican Society of Diabetology and Endocrinology (SPED). "The recovery effort on the island has been difficult, and people with diabetes are particularly vulnerable without a dependable supply of insulin. This is an important step in our re-building efforts."For people who can get to a pharmacy, the best way to access medicines is through normal channels. If their pharmacy is not open, insulin can be picked up at the following locations:Bayamon Health Center, 8 a.m. to 12 p.m., Monday through Friday Centro de Diabetes para Puerto Rico, 8 a.m. to 5 p.m., Tuesdays and Thursdays Hospital Municipal de San Juan, 8 a.m. to 2 p.m., Monday through Friday "We're committed to helping the people of Puerto Rico recover from the destruction of Hurricane Maria," said Enrique Conterno, president of Lilly Diabetes and Lilly USA. "Our humanitarian shipments are now being complemented with commercial insulin, allowing wholesalers to begin re-stocking products - which, in turn, will allow the people of Puerto Rico to find medicine more regularly at their pharmacies. And our humanitarian shipments will provide relief for many who may have no other options."Lilly's first humanitarian shipment, 2,400 pens and vials of insulin, arrived in San Juan on September 24. Recipients of the insulin included the Municipality of San Juan, Centro Médico, San Jorge Children's Hospital, and Guaynabo, Hato Rey and Cayey Dialysis Centers. The additional 3,000 humanitarian vials will be distributed to centers established by SPED and to other locations by Direct Relief International, in close collaboration with local health experts and authorities.Lilly knows the humanitarian needs around the island are significant and intends to make additional donations of insulin and other medicines in the weeks ahead as efforts to provide needed medical assistance continue."The devastation inflicted on Puerto Rico is beyond what many of us can imagine, and the health and safety of everyone is on all our minds," Conterno said. "This latest shipment of medicine is an important step, but much work remains. Lilly will continue to monitor developments on the island closely and work to ensure our medicines are available."Tips for Storing Insulin and Other Helpful Info1The FDA offers guidance on insulin storage in an emergency:Insulin products that are in vials or cartridges can be left unrefrigerated for up to 28 days, even if it's already been opened. Ideally, the temperature should still be between 59◦F and 86◦F, but in an emergency like this, insulin may still be used if the temperature is greater than 86◦F. Insulin can lose some of its effectiveness when exposed to extreme temperatures. The longer the exposure, the less effective insulin becomes. People using insulin exposed to high temperatures should check their blood sugar as often as possible in case more insulin than usual is needed. Insulin should be kept as cool as possible, but not frozen. People should not use insulin that has been frozen. Also keep insulin away from direct heat and out of direct sunlight. For questions about insulin or if someone is in need of insulin, contact Lilly at (800) 545-5979. The FDA can also be reached for questions at (855) 543-3784. If a patient is uncertain as to the effectiveness of his or her insulin based on difficulties with storage/exposure to extreme temperatures, and unexplained loss of glucose control is seen, it is advised that new insulin be obtained if possible.If a patient's insulin has been damaged or destroyed by the storm, he or she can talk to their pharmacy about getting a new 30-day supply. Many insurance plans have "disaster overrides" that allow people to replace their destroyed medicine for the cost of a co-pay. If they don't have a disaster override, Lilly will replenish customers with a new 30-day supply at no charge. And if patients have a high-deductible plan that normally requires patients to pay the full price for their treatment, they will receive a 30-day supply at no charge if their medicine is destroyed. Further assistance is available via The Lilly Answers Center at (800) 545-5979.About Eli Lilly and Company Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/newsroom/social-channels. C-LLYReferences1. U.S. Food and Drug Administration. Information Regarding Insulin Storage and Switching Between Products in an Emergency, Last Updated Sept. 19, 2017. Available at https://www.fda.gov/drugs/emergencypreparedness/ucm085213.htm. October 2017.CONTACT: Kelley Murphy; firstname.lastname@example.org; 317-701-4007
FOSTER CITY, Calif.--(BUSINESS WIRE)--Oct. 3, 2017-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the completion of the previously announced transaction for Dodgers Merger Sub, Inc., a wholly-owned subsidiary of Gilead (“Purchaser”), to acquire Kite Pharma, Inc. (Nasdaq: KITE) for 0 per share, net to the seller in cash, without interest, or approximately .9 billion in the aggregate.On August 28, 2017, Gilead and Kite announced that Kite, Gilead and Purchaser had signed a definitive merger agreement pursuant to which a tender offer would be made. Pursuant to the merger agreement, Gilead and Purchaser commenced a tender offer on September 5, 2017 to acquire all outstanding shares of Kite at a price of 0 per share, net to the seller in cash, without interest. On October 3, 2017, Gilead announced that it had successfully completed the tender offer for all outstanding shares of common stock of Kite and had accepted for payment all shares validly tendered and not withdrawn as of the expiration time of the tender offer and would promptly pay for such shares, which shares represented approximately 66.20% of Kite’s outstanding shares (including 2,003,002 shares delivered through Notices of Guaranteed Delivery, representing approximately 3.46% of the shares outstanding). Pursuant to the terms of the merger agreement, Purchaser merged with and into Kite on October 3, 2017. All outstanding shares of common stock of Kite, other than (i) shares owned by Gilead, Purchaser or any of their direct or indirect wholly-owned subsidiaries, (ii) shares owned by Kite (or held in Kite’s treasury) and (iii) shares held by Kite stockholders who properly demand appraisal for their shares under Delaware law, were canceled and converted into the right to receive cash equal to the 0 price per share.As a result of the completion of the merger, Kite has become a wholly-owned subsidiary of Gilead and the common stock of Kite will no longer be listed for trading on the NASDAQ Global Select Market, which is expected to take effect as of the close of market on October 3, 2017.“We are excited to welcome more than 700 talented Kite employees to the Gilead organization,” said John F. Milligan, PhD, Gilead’s President and Chief Executive Officer. “Throughout our respective histories, each company has demonstrated a deep commitment to advancing life-saving therapies for people who need them. I look forward to all that we will accomplish together, as a combined organization.”Bank of America Merrill Lynch, Lazard and Barclays acted as financial advisors to Gilead. Skadden, Arps, Slate, Meagher & Flom LLP acted as Gilead’s legal advisors.Centerview Partners acted as exclusive financial advisor to Kite. Jeffries LLC and Cowen and Company, LLC also provided advice to Kite. Sullivan & Cromwell LLP and Cooley LLP acted as Kite’s legal advisors.About KiteKite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term, durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. On March 31, 2017, Kite submitted a Biologics License Application to the FDA for its lead product candidate, axi-cel, as a treatment for patients with relapsed or refractory aggressive non-Hodgkin lymphoma who are ineligible for autologous stem cell transplant. Kite received priority review on May 29, 2017 with the Prescription Drug User Fee Act action date set for November 29, 2017. In July 2017, Kite announced the submission of a Marketing Authorization Application to the European Medicines Agency for axi-cel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), and primary mediastinal B-cell lymphoma (PMBCL) who are ineligible for autologous stem cell transplant. These submissions come after positive results from Kite’s ZUMA-1 pivotal trial with axi-cel in patients with chemorefractory aggressive non-Hodgkin lymphoma. Kite is based in Santa Monica, California. For more information on Kite, please visit www.kitepharma.com.About Gilead SciencesGilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. Gilead’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.