Insulin Recombinant Human(Nektar Therapeutics)

Company appoints leading sales, market access and operations executives with decades of experience successfully launching and commercializing new oncology products New Drug Application (NDA) for avasopasem is currently under priority review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee (PDUFA) target date of August 9, 2023 MALVERN, Pa., May 01, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced the appointment of accomplished pharmaceutical sales, market access, and commercial operations executives to Galera’s senior commercial leadership team, effective immediately. Under the direction of Mark Bachleda, Pharm.D., MBA, Galera’s Chief Commercial Officer, the team will be responsible for building out the Company’s commercial operations, strategy development, and execution in preparation for the potential U.S. commercial launch of avasopasem in 2023. The Company’s appointments include: Patrick Campbell as Vice President of Sales & Account ManagementElizabeth Turner as Vice President of Market AccessHenning Thorsen as Vice President of Commercial Operations The new senior leaders join Lorraine Walker, Pharm.D., Galera’s Vice President of Marketing. “We are excited to expand our commercial team with the appointments of leading biopharmaceutical executives Pat, Liz, and Henning, who bring decades of commercialization expertise in launching market-leading oncology therapies in the U.S.,” said Dr. Bachleda. “We look forward to leveraging their leadership and commercial capabilities as Galera approaches a pivotal moment in its trajectory to becoming a commercial-stage company.” Galera’s commercial leadership team comprises: Mark Bachleda, Pharm.D., MBA, Chief Commercial OfficerDr. Mark Bachleda has 25 years of biopharmaceutical leadership experience in U.S. and international markets. Prior to joining Galera, Dr. Bachleda served as Vice President & U.S. Business Unit Head of the CAR T Cell Therapy Franchise at Bristol Myers Squibb (BMS), launching Breyanzi® (liso-cel), a CD19 CAR T in large B cell lymphoma, and Abecma® (ide-cel), the first BCMA CAR T in relapsed/refractory multiple myeloma. He held the same role at Celgene Corporation before its acquisition by BMS for $74 billion in 2019. He served as Vice President, Sales & Account Management at Juno Therapeutics before its $9 billion sale to Celgene in 2018. Previously, Dr. Bachleda worked at Amgen for 15 years in commercial operations roles of increasing responsibility up to Country President & General Manager of Amgen Czech Republic where he led an enterprise of 11 commercialized therapies including launches of Kyprolis®, Blincyto®, and Repatha®. Dr. Bachleda is a registered pharmacist and received his Doctor of Pharmacy degree (Pharm.D.) from the University of Illinois at Chicago. Dr. Bachleda completed a post-doctoral fellowship in Health Policy & Economics at Thomas Jefferson University and holds Master of Business Administration (MBA) degrees from both Columbia University and the University of California, Berkeley. Lorraine Walker, Pharm.D., Vice President, MarketingDr. Lorraine Walker has over 30 years of experience in the biopharmaceutical and healthcare industry. Dr. Walker joined Galera as Vice President of Marketing in February of 2021 and has been leading pre-launch efforts including strategy, insight generation, commercialization readiness, and brand development. Previously, Dr. Walker served in multiple global marketing roles at Novartis, including Executive Director, Global Brand Lead at Novartis Oncology, where she led the global marketing team for the successful global launch of Rydapt® for FLT3+ Acute Myeloid Leukemia (AML) and Advanced Systemic Mastocytosis (AdvSM). Dr. Walker also served as Executive Director, Global New Product Strategy at Novartis, leading global brand strategy for three GSK products that entered the Novartis portfolio. Prior to Novartis, Dr. Walker worked in U.S. medical and marketing roles at Sanofi-Aventis. Dr. Walker graduated from Rutgers University with a Pharm.D. degree and practiced at Johns Hopkins Oncology Center as a pharmacist before joining the pharmaceutical industry. Patrick Campbell, Vice President, Sales & Account ManagementPatrick Campbell has over 30 years of commercial leadership experience launching 11 new products in the oncology marketplace. Mr. Campbell joins Galera from Amgen, Inc. where he recently served as Executive National Sales Director for Amgen’s oncology solid tumor portfolio. He led the buildout of a new U.S. oncology sales division responsible for the successful launch of Lumakras® to treat KRAS G12C-mutated non-small cell lung cancer. Previously at Amgen, Mr. Campbell served in multiple sales leadership roles including Head of Sales for the sales division responsible for Xgeva® and Nplate®, regional sales for the oncology portfolio in the northeast and southern U.S., and as a sales manager in the creation of a hospital focused sales team for the launches of Neulasta® and Aranesp®. Prior to Amgen, Mr. Campbell held leadership roles in sales, marketing, and national account management at GlaxoSmithKline. Mr. Campbell earned his Master of Science from St. Thomas University in Miami, FL and his Bachelor of Science from Saint Joseph’s University in Philadelphia, PA. Elizabeth Turner, Vice President, Market Access Elizabeth Turner has nearly 20 years of commercial experience in the biopharmaceutical and healthcare industries across market access, sales, and marketing. Ms. Turner joins Galera from Anton Health, a market access consulting firm, where she served as Vice President. Before Anton Health, Ms. Turner served as Vice President, Global Market Access at Arena Pharmaceuticals and was responsible for creating their global market access platform in the U.S. and Europe including pricing, distribution, reimbursement, and patient services to support the planned commercial launch of etrasimod, prior to Arena’s acquisition by Pfizer for $6.7 billion. Previously, Ms. Turner worked at Amgen, Inc. and served in multiple executive roles in market access and sales, launching first-in-class products in oncology, osteoporosis, and migraine therapeutic areas that include buy and bill reimbursement. Prior to Amgen, Ms. Turner served as a pharmaceutical sales representative at Pfizer, where she launched Lyrica®, Exubera®, and extended-release Aricept®. Ms. Turner holds a Bachelor of Arts in Mass Communications from the University of South Florida and an M.B.A. from the University of Central Florida. Henning Thorsen, Vice President, Commercial OperationsHenning Thorsen is an accomplished commercial executive with over 30 years in the biotech industry, the last ten years focused on small biotech commercialization and product launches. Mr. Thorsen has launched multiple oncology products that require infusion with buy and bill reimbursement, leveraging his skills in market analytics, commercial insights, go-to-market design and optimization, incentives, and training. Mr. Thorsen joins Galera from Better Therapeutics where he served as Head of Commercial Operations. Prior to Better Therapeutics, Mr. Henning served in senior commercial roles at Adaptive Biotechnologies, Arrowhead Pharmaceuticals, and Alder Pharmaceuticals (acquired by Lundbeck). Previously, Mr. Thorsen served as Vice President, Commercial Operations & Chief of Staff to the Chief Commercial Officer at Juno Therapeutics (acquired by Celgene) and Senior Director of Commercial Operations at Medivation (acquired by Pfizer). Previously, Mr. Thorsen served in senior sales and operations roles at Genentech (acquired by Roche) and Amgen, Inc. Mr. Thorsen holds a Bachelor of Arts from the University of California, Santa Barbara. About Galera TherapeuticsGalera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutic candidates that have the potential to transform radiotherapy in cancer. Galera’s selective dismutase mimetic product candidate avasopasem manganese (avasopasem) is being developed for radiation-induced toxicities. A New Drug Application (NDA) for avasopasem is currently under priority review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee (PDUFA) target date of August 9, 2023 for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care treatment. The Company’s second product candidate, rucosopasem manganese (rucosopasem, or GC4711), is in clinical-stage development to augment the anti-cancer efficacy of stereotactic body radiation therapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer. Galera is headquartered in Malvern, PA. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding: the expectations surrounding the Company’s commercial team and the contributions of Patrick Campbell, Elizabeth Turner and Henning Thorsen thereto; the expectations surrounding the continued advancement of Galera’s product pipeline; the potential safety and efficacy of Galera’s product candidates and their regulatory and clinical development; the potential to obtain approval by the U.S. Food and Drug Administration for avasopasem for the treatment of radiotherapy-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer at any time, including the anticipated PDUFA target date of August 9, 2023; and the Company’s ability to achieve its goal of transforming radiotherapy in cancer treatment with its selective dismutase mimetics. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause Galera’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: Galera’s limited operating history; anticipating continued losses for the foreseeable future; substantial doubt regarding Galera’s ability to continue as a going concern; needing substantial funding and the ability to raise capital; Galera’s dependence on avasopasem manganese (GC4419); uncertainties inherent in the conduct of clinical trials; difficulties or delays enrolling patients in clinical trials; the FDA’s acceptance of data from clinical trials outside the United States; undesirable side effects from Galera’s product candidates; risks relating to the regulatory approval process; failure to capitalize on more profitable product candidates or indications; ability to receive or maintain Breakthrough Therapy Designation or Fast Track Designation for product candidates; failure to obtain regulatory approval of product candidates in the United States or other jurisdictions; ongoing regulatory obligations and continued regulatory review; risks related to commercialization; risks related to competition; ability to retain key employees and manage growth; risks related to intellectual property; inability to maintain collaborations or the failure of these collaborations; Galera’s reliance on third parties; the possibility of system failures or security breaches; liability related to the privacy of health information obtained from clinical trials and product liability lawsuits; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; environmental, health and safety laws and regulations; the impact of the COVID-19 pandemic on Galera’s business and operations, including preclinical studies and clinical trials, and general economic conditions; risks related to ownership of Galera’s common stock; and significant costs as a result of operating as a public company. These and other important factors discussed under the caption “Risk Factors” in Galera’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the U.S. Securities and Exchange Commission (SEC) and Galera’s other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any forward-looking statements speak only as of the date of this press release and are based on information available to Galera as of the date of this release, and Galera assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contacts:Christopher DegnanGalera Therapeutics, Inc.610-725-1500cdegnan@galeratx.com William WindhamSolebury Strategic Communications646-378-2946wwindham@soleburystrat.com Media Contact:Zara LockshinSolebury Strategic Communications330-417-6250zlockshin@soleburystrat.com

January 5, 2016 By Mark Terry , BioSpace.com Breaking News Staff The other shoe dropped today when Valencia, Calif.-based MannKind Corporation announced after months of rumors that its license and collaboration deal with Sanofi-Aventis U.S. LLC for Afrezza has been terminated. Early in 2014, the U.S. Food and Drug Administration approved Afrezza, an inhaled form of insulin. Right from the start, the drug did not meet sales expectations. Sanofi had a commercialization agreement with MannKind . However, at least part of the problems with Afrezza sales were related to insurance reimbursement issues. Typically insurance companies classify drugs in four tiers, 1 through 4. Tier 1 drugs are generally low-priced generic drugs. Tier 2 is typically a preferred brand name prescription drug. Tiers 3 and 4 are generally higher-cost prescription medications, and drugs that are considered effective, but not necessarily the best choice for the majority of patients. Most insurance companies placed Afrezza as Tier 3, even though MannKind and Sanofi have worked to get it placed in Tier 2. For consumers, that means that they usually pay a higher co-pay to get the drug, as well as there being possible restrictions on it. In October 2015, there were rumors that Sanofi (SNY) had frozen hiring for its Afrezza sales team. At that time, although Sanofi didn’t confirm the rumors, MannKind ’s chief financial officer, Matt Pfeffer , told in-Pharma that Sanofi ’s marketing approach was solid. “We have seen no indication that they are faltering in their commitment to the product—quite the contrary, in fact. The only changes [in sales force numbers] I am aware of have been increases. There are certainly people out there with a vested interest in our not succeeding. This would not be the first time misinformation has been circulated about us or about Afrezza.” Today’s announcement indicates that MannKind and Sanofi will immediately start transition discussions to shift Afrezza’s development and commercialization activities to MannKind over the next 90 to 180 days. The termination will be effective no later than July 4, 2016. Sanofi ’s diabetes market appears to be faltering . It recently reported that its diabetes sales worldwide decreased 6.6 percent in the third quarter to $1.975 million. This was mostly caused by lackluster sales of Lantus basal insulin sales in the U.S. Adam Feuerstein , writing for The Street in October, said, “The nascent commercial launch of Afrezza continues to resemble a train wreck. MannKind ’s signature product contributed only €2 million to Sanofi ’s sales in the third quarter. That’s flat with second quarter sales despite Sanofi ’s upgraded efforts to convince U.S. doctors to prescribe the inhaled insulin to their diabetes patients. Through nine months of 2014, Afrezza sales have totaled €5 million, well below Sanofi ’s expectations.” Not surprisingly, MannKind didn’t respond well to the news, although it’s been on a downhill slide for some time. Shares traded for $7.23 on June 8, 2015, dropped to $3.31 on Aug. 15, 2015, popped up slightly on Oct. 28, 2015 to $3.78, but are currently trading for $1.05 per share. Yesterday Zacks Investment Research shifted its rating for MannKind from “hold” to “buy,” indicating it had a $1.50 price target. Piper Jaffray continued with an “underweight” rating and a $1.50 price target back in a report on Nov. 12, 2015, and Griffin Securities on Dec. 8, 2015, shifted from a “buy” rating to a “neutral” rating. The stock as of yesterday had a concensus “hold” rating and a consensus price target of $3.05. Those may change, however, in light of the deal termination.