3 days, 5 approvals-Celgene, AbbVie, Roche meds push FDA tally to 23 for the year

FiercePharma | August 19, 2019

Lawmakers may have left the nations capital for summer vacation, but regulators at the FDA are staying busy. The agency churned out five approvals just last week from companies large and small and five more decisions are due by months end. Three of last weeks green lights opened the way for launches worth half a billion or more in annual sales. But the week started with a couple of OKs smaller on the sales side, if still significant for the organizations that developed them. Pretomanid, a tuberculosis med developed by the nonprofit TB Alliance, kicked things off Wednesday with an FDA nod in drug-resistant forms of the disease. On the same day, Philly-area pharma company Harmony Biosciences picked up its first FDA nod ever, passing agency gatekeepers with narcolepsy med Wakix. GlobalData pharma analyst Sarah Elsayed said she expects Wakix to pick up a “small share” of the $1.5 billion narcolepsy market. The drug is a “welcome addition” for doctors and patients, she said, but key opinion leaders told the firm they “believe that Wakix is not as effective" as Jazz Pharma's competing Xyrem, the analyst said. After those Wednesday approvals, the agency stayed busy Thursday and Friday. Regulators signed off on Roche’s targeted cancer drug Rozlytrek, Celgene’s myelofibrosis med Inrebic and AbbVie’s rheumatoid arthritis treatment Rinvoq in quick succession.

Spotlight

Injection systems that are attached to the patient's body (on-body delivery system OBDS) minimize possible risks, that can occur when drugs are administered by conventional needle-based injection systems (NIS). 

Spotlight

Injection systems that are attached to the patient's body (on-body delivery system OBDS) minimize possible risks, that can occur when drugs are administered by conventional needle-based injection systems (NIS). 

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Business Insights

TriRx Partnership with Liverpool City Region Advances Biotech Capabilities

PRnewswire | July 28, 2023

TriRx Pharmaceutical Services, LLC, a Contract Development and Manufacturing Organization (CDMO), welcomed the UK Government's recent announcement on England's second Investment Zone, focused on Life Sciences in the Liverpool City Region. TriRx Speke Ltd. is the first investor and is well-positioned to further advance its capabilities by adding upstream technologies to manufacture monoclonal antibodies to an existing large-scale biotech purification facility. The current facility has significant capacity to support the high-growth large-molecule pharmaceutical market. Monoclonal antibodies (also referred to as mAbs) are a type of immunotherapy that work by blocking certain diseases from affecting healthy cells and are used to treat numerous types of diseases including cancers, arthritis and skin conditions. This additional investment to augment the TriRx facility at Speke will foster economic growth, create high-value jobs and complement the existing Speke Biopharmaceutical cluster in the region. "We are delighted to be expanding our capability in this critical immunotherapy area, to become a worldwide center of technical excellence located in the UK in the monoclonal antibody development and manufacturing field to serve the human and animal pharmaceutical markets," said Tim Tyson, Chairman and CEO of TriRx. About TriRx Pharmaceutical Services: TriRx Pharmaceutical Services is a global contract development and manufacturing organization (CDMO) serving global pharmaceutical, biopharmaceutical and animal health markets. Headquartered approximately 50 miles outside of New York City in Norwalk, Connecticut, TriRx operates facilities in multiple regions providing state-of-the-art laboratory, manufacturing, packaging, warehousing, and technical service capabilities. Founded and led by a team of pharmaceutical industry executives, who have served as both contract service providers and outsourcing customers, TriRx has a profound and multifaceted understanding of client needs. It has the knowledge and commitment to deliver an exceptional experience on every project, consistently meeting or exceeding quality standards, regulatory requirements, on-time-in-full (OTIF) delivery, and all other customer requirements and expectations.

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PHARMACY MARKET, PHARMA TECH

Timber Pharmaceuticals to be Acquired by LEO Pharma

Globenewswire | August 22, 2023

Timber Pharmaceuticals, Inc. announced that it has entered into a definitive agreement to be acquired by LEO US Holding, Inc. a wholly-owned subsidiary of LEO Pharma A/S, in a total transaction value of up to $36 million with (i) an initial upfront consideration of $14 million and (ii) up to an additional $22.0 million in contingent value rights (CVRs) payable upon achievement of certain milestones described below. All of the issued and outstanding shares of capital stock and other equity interests of Timber will be converted into the right to receive the initial upfront consideration, less the payments for certain outstanding warrants that contain a Black Scholes cash payout value. For example, based on a current estimate of the Black Scholes value of such warrants of approximately $5.1 million, subject to change based on the assumptions detailed below, Timber expects the initial amount per share to be paid to Timber stockholders to be approximately $2.62 based on approximately 3.4 million shares of Timber common stock and restricted stock issued and outstanding as of August 20, 2023. The current estimated value to stockholders is based on an implied value assigned to certain outstanding warrants based on Black Scholes option pricing model as of August 18, 2023. This value will not be finalized until the closing of the merger and is subject to increase or decrease based on certain variables, including the actual trading price of Timber at the time of the merger and the trading volatility of Timber common stock prior to the merger. The CVRs that Timber stockholders will receive provide for the payment of up to an additional $22 million with respect to specific milestones for TMB-001, of which up to $12 million is related to FDA approval of TMB-001 by October 1, 2025 for the treatment of congenital ichthyosis, and up to $10 million of which is related to the first achievement of TMB-001 net sales exceeding $100 million within four consecutive calendar quarters by December 31, 2028. As part of the transaction, LEO Pharma has agreed to provide Timber with a bridge loan of up to $3.0 million, subject to certain conditions. The payments of the CVRs are subject to certain deductions relating to the repayment of 50% of the bridge loan provided by LEO Pharma to Timber in connection with the merger. John Koconis, Chairman and Chief Executive Officer of Timber, said, “We are very pleased to deliver a transaction that will maximize long term value for Timber’s shareholders. LEO Pharma is a leader in global dermatology with a mission that matches our own - a relentless pursuit to help patients suffering from skin diseases. “LEO’s expertise and global footprint make it the best choice to advance and achieve the full potential of Timber’s portfolio of product candidates. We believe that LEO has the potential to establish TMB-001 as the standard of care in the treatment of congenital ichthyosis, a devastating, rare disease. “Finally, I would like to sincerely thank our dedicated team at Timber for their tireless efforts, and the clinical investigators, medical professionals, patients and families whose personal contributions have been instrumental in shaping our understanding of TMB-001.” The transaction has been unanimously approved by the Boards of Directors of both companies and is expected to close in the fourth quarter of 2023, subject to customary closing conditions, including approval by the holders of a majority of the shares of Timber’s common stock. Following completion of the transaction, Timber will become a privately held company and shares of Timber’s common stock will no longer be listed on any public market. Timber will file a Current Report on Form 8-K with the Securities and Exchange Commission (“SEC”) that will include a copy of the merger agreement and the CVR agreement and will contain a more detailed description of the merger and the consideration to be received by Timber stockholders. About LEO Pharma LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 4,700 people, serving millions of patients across the world. In 2022, LEO Pharma generated net sales of DKK 10.6 billion. About Timber Pharmaceuticals, Inc. Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company's investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing, and control) and safety profiles. Timber is focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases. For more information, visit www.timberpharma.com.

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Pharmacy Market

TailorMed Joins Forces with TwelveStone Health Partners to Improve Medication Access and Affordability

Businesswire | August 24, 2023

TailorMed, a leading technology company offering the nation’s largest network of patients, providers, pharmacies, life science companies, and other partners dedicated to improving healthcare affordability, today announced it is collaborating with TwelveStone Health Partners. TwelveStone, which provides comprehensive chronic care medication services, has confidently invested in TailorMed’s best-in-class solutions to remove financial barriers for patients with high-cost conditions. The cost of specialty drugs, including infused therapies, is rising rapidly. In fact, the average annual cost for one specialty medication is estimated to be at least $84,000. These staggering expenses often lead to medication nonadherence and prescription abandonment. Financial assistance programs help eligible patients pay for treatment, yet these resources remain underutilized. TailorMed offers a comprehensive solution by empowering providers and pharmacies to proactively flag patients in need. The technology then matches patients with relevant funding opportunities, drawing on more than 6,000 resources ranging from drug manufacturer copay assistance to foundation grants. TwelveStone Health Partners will use the company’s enterprise platform to improve access to critical therapies for patients who could not otherwise afford them. “This partnership enhances our commitment to expanding patient access and addressing affordability to ensure that those who need them most can receive innovative medications in a warm, caring, patient-centric care environment,” said Shane Reeves, chief executive officer, TwelveStone Health Partners. “TailorMed’s technology provides real value to our patients who deserve a higher level of care and support.” The process of connecting patients with financial assistance has historically been an arduous and highly manual process. The TailorMed platform will significantly reduce the administrative burden for TwelveStone Health Partners, allowing staff to efficiently address patients’ financial needs. The company’s Pharmacy solution will also enable staff to streamline the management and tracking of free and replacement drug orders. “We’re very proud to collaborate with leading specialty pharmacies and infusion centers such as TwelveStone Health Partners as our network continues to expand,” said Bryan Bloom, head of enterprise sales at TailorMed. “By leveraging our solutions to tackle affordability, TwelveStone will be better equipped to provide superior patient experiences, while ensuring no one falls through the cracks due to costs.” Srulik Dvorsky, co-founder and chief executive officer at TailorMed, also shared: “We are especially pleased to add TwelveStone Health Partners to our growing list of infusion center clients. As a company committed to innovating at scale, we want to do everything we can to ensure our partners can also deliver care at scale.” About TailorMed TailorMed offers the nation’s largest network of patients, providers, pharmacies, partners, and life science companies focused on ensuring all patients across all medical conditions can afford treatment. Driven by TailorMed's best-in-class platform, network constituents can proactively identify, match, and enroll patients in financial assistance programs to deliver a world-class patient financial experience while reducing the cost of care delivery and increasing revenues. TailorMed’s secure, web-based financial assistance solutions are deployed across more than 1,000 sites of care, including Providence Health, UnityPoint Health, Yale-New Haven Health, and Advocate Aurora Health. About TwelveStone Health Partners TwelveStone Health Partners incorporates the objective of glorifying God into its mission by delivering a higher level of service to partners and patients. As an organization, TwelveStone supports the transition from acute to post-acute care environments and the transition from sickness to health. Founded in 2016 TwelveStone is the third iteration of pharmacy organizations founded by Shane Reeves and the Reeves family. Today TwelveStone is rapidly expanding across the Southeast anchored by spa-like infusion centers conveniently located in suburban communities supported by additional services including package medications, home infusion, enteral and injections. TwelveStone is dedicated to providing the highest level of care to those with chronic, complex conditions in the environment that is most convenient for both the patient and their loved ones.

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