PHARMACY MARKET, PHARMA TECH
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.
PRNewswire | July 27, 2023
Everest Medicines a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today XERAVA® (eravacycline) has been successfully launched in China with its first prescription issued at Huashan Hospital affiliated to Fudan University. The commercialization of XERAVA® in China marks Everest's transformation into a commercial-stage innovative biopharmaceutical company.
XERAVA® is the world's first fluorocycline antibiotic for the treatment of infections caused by susceptible gram positive, gram negative and anaerobic pathogens including multidrug resistant ("MDR") isolates. It was approved by the National Medical Products Administration ("NMPA") of China for the treatment of complicated intra-abdominal infections ("cIAI") in adult patients in March 2023, and has been recommended by multiple treatment guidelines in China and globally, based on its broad bacterial spectrum coverage and high potency against multidrug-resistant bacterial infections.
"The commercialization of XERAVA® in China is a significant milestone for Everest as a company, as this marks the beginning of Everest as a commercial-stage biopharma company. I want to thank everyone involved in bringing XERAVA® to a successful launch," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "After the commercial launch, we will accelerate patient access to XERAVA® with a lean commercial team, following a highly efficient commercial strategy. The company will continue to advance the approval and commercialization of other first-in-class or best-in-class drug candidates such as Nefecon to further address urgent unmet needs in China and the rest of Asia."
"Eravacycline has broad antibacterial spectrum and high potency against common clinical multi-drug resistant bacteria such as ESBL-producing bacteria, CRE, CRAB, MRSA and VRE," said Dr. Zhu Duming, leader and chief physician of the Critical Care Department at Zhongshan Hospital Affiliated with Fudan University. "It has been recommended by authoritative guidelines at home and abroad for the treatment of MDR Gram-negative bacterial infections. The launch of eravacycline in China will help doctors tackle the challenges of clinical drug resistance."
"Patients with malignant hematological diseases have a high incidence of neutropenia and fever caused by radiotherapy, chemotherapy, and hematopoietic stem cell transplantation. Antibacterial treatment is very important for patients with neutropenia and fever as MDR/Carbapenem-resistant Organism ("CRO") infections have high mortality rates," said Sun Aining, chief physician at the First Affiliated Hospital of Soochow University. "As the world's first fluorocycline antibiotic, eravacycline has completed phase II/III clinical trials and multiple real-world studies around the world to demonstrate that it has good clinical efficacy and safety profiles. It is an innovative choice for the treatment of MDR/CRO infections."
In addition to XERAVA®, Everest anticipates the launch of three additional innovative drugs in China over the next two years, including Nefecon, the first-in-disease treatment for adults with primary immunoglobulin A nephropathy (IgAN) and expected to be approved in China in the second half of this year. In the infectious disease space, Everest is actively developing other important drug candidates to meet the urgent demand for innovative antibacterial treatment. The company plans to file New Drug Application for cefepime-taniborbactam in China this year for complicated urinary tract infection. In immunology, etrasimod is a next-generation, oral selective sphingosine 1-phosphate (S1P) receptor modulator with a differentiated efficacy and safety profiles. The company aims to submit NDA in Everest territories as soon as possible.
XERAVA® is a novel, fully synthetic, fluorocycline intravenous antibiotic for the treatment of infections caused by susceptible gram-positive , gram-negative and anaerobic pathogens including those multidrug resistant ("MDR") isolates. XERAVA® is currently approved for the treatment of complicated intra-abdominal infections in the US, EU, GB, Singapore, mainland China, Hong Kong and the medicine is currently under review for cIAI in Taiwan region. XERAVA® was licensed from Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of Innoviva, Inc.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders.
Businesswire | July 26, 2023
Nexus Pharmaceuticals announced it has received U.S. Food and Drug Administration (FDA) approval for Sterile Water for Injection, USP in 10mL and 20mL Single-Dose Vials.
According to the FDA and the FD&C Act, the product is considered bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sterile Water for Injection USP, of Hospira, Inc. Furthermore, the FDA has granted CGT (competitive generic therapy) designation for the 20mL presentation of sterile water for injection.
“We are proud to be a force for change in the pharmaceutical industry, and we are grateful to the FDA for recognizing the importance of this critical-need product,” said Aman Ahmed, Director of Government Relations and International Sales at Nexus. “The approval of this product is an important step in continuing our efforts to alleviate drug shortages and bring pharmaceutical manufacturing back to the U.S.”
Nexus Pharmaceuticals’ Sterile Water for Injection will be available in cartons of 25 vials.
About Sterile Water for Injection, USP
Sterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection.
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
About Nexus Pharmaceuticals LLC
Nexus Pharmaceuticals LLC., a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most.