Hikma Pharmaceuticals plc, of London, said its U.S. subsidiary, Hikma Pharmaceuticals USA Inc., received FDA approval for its icosapent ethyl capsules, 1 gram, the generic equivalent to Vascepa (Amarin Corp. plc). In March, the U.S. District Court for the District of Nevada invalidated six key Vascepa patents owned by Amarin. That decision is currently being appealed.
Hutchison China Meditech Ltd. (Chi-Med), of Hong Kong, and Beigene Ltd., of Beijing, said they agreed to collaborate in the U.S., Europe, China and Australia on evaluating the safety, tolerability and efficacy of combining Chi-Med’s candidates, surufatinib and fruquintinib (Elunate), with Beigene’s anti-PD-1 antibody, tislelizumab, to treat solid tumors. Terms call for each company to explore development of combinations of VEGF inhibitors surufatinib, under review by the NMPA to treat advanced non-pancreatic neuroendocrine tumors, or fruquintinib with tislelizumab in different indications and regions. The companies agreed to provide mutual drug supply and other support. Additional terms were not disclosed.
Debiopharm International SA, of Lausanne, Switzerland, said portfolio company Kaiku Health Oy, of Helsinki, Finland, a digital therapeutics developer, was acquired by precision radiation medicine firm Elekta AB, of Stockholm. Financial terms were not revealed.
Ipsen SA, of Paris, reported findings from two surveys with combined responses of more than 400 individuals in five countries who were diagnosed with spasticity or cervical dystonia and received botulinum neurotoxin type A (Bont-A) injections. More than 80% of respondents in the first survey said symptoms of spasticity returned between two sessions of Bont-A, with 59% of those experiencing a return within three months of their last treatment, affecting their quality of life. In the second survey, 88% reported the reappearance of pre-existing symptoms between Bont-A injections, compromising their personal lives. Two-thirds of working respondents in this survey also reported impacts on their professional life. In both surveys, more than 70% of respondents expressed the desire for longer lasting treatment benefits. Results of the Carenity 2 survey in spasticity were published in Frontiers in Neurology.
Novasep Group SAS, of Lyon, France, and Lysogene SA, of Paris, said they inked an agreement to develop and manufacture LYS-GM101, an AAVrh10-based gene therapy candidate to treat GM1 gangliosidosis, a rare neuronopathic lysosomal storage disorder. Terms were not disclosed.
Oncodesign SA, of Dijon, France, and Hitgen Inc., of Chengdu, China, said they formed a strategic alliance in integrated drug discovery services to identify and advance new chemical entities from hit finding to IND preparation. Hitgen plans to apply its DNA encoded library (DEL) platform and collection of diverse and drug-like DELs, while Oncodesign will use its drug integrative discovery, or DRIVE, process to design and deliver leads and preclinical candidates.
Pfizer Inc., of New York, together with its wholly owned Wyeth subsidiary, advised shareholders to reject an unsolicited tender offer from Huguenot Bond Liquidity LLC to purchase up to $162.5 million of Pfizer’s outstanding 7.2% notes due 2039 and up to $130 million of Wyeth’s 5.95% notes due 2037, noting that Huguenot did not inform Pfizer of the offer and provided no information about a financing source in its solicitation. Additionally, Pfizer pointed out that the tender offer, calculated using a reference date of May 21, 2020, was approximately 7% below the last trade price of $166 per $100 principal for the Pfizer notes and approximately 8% lower than the last trade price of $145 per $100 principal for the Wyeth notes, both on May 21, 2020.
Pharmacyte Biotech Inc., of Laguna Hills, Calif., said the final major study required by the FDA to submit the IND application for its live-cell encapsulation technology, Cell-in-a-Box, was initiated. The rolling two-year stability study is designed to show how the frozen clinical trial product manufactured by Austrianova Singapore to treat individuals with locally advanced, inoperable pancreatic cancer performs over time after being frozen for certain periods of time, thawed and tested for functionality. Three months of stability data are required for the IND filing, according to Pharmacyte. Data from the balance of the study will be provided to the FDA as they become available.
Poxel SA, of Lyon, France, reported preclinical results for PXL-770, lead molecule in the company’s adenosine monophosphate-activated protein kinase (AMPK) platform, from a diet-induced obese mouse model of nonalcoholic steatohepatitis (NASH) alone and in combination with other NASH agents in development, including the FXR agonist obeticholic acid (Ocaliva, Intercept Pharmaceuticals Inc.), the GLP-1 receptor agonist semaglutide (Ozempic, Novo Nordisk A/S) and the thyroid receptor beta agonist MGL-3196 (resmetirom, Madrigal Pharmaceuticals Inc.). Studies of PXL-770 alone confirmed potential efficacy in comparison with each of the other agents, while combination treatment with obeticholic acid and with semaglutide resulted in improvements in several disease-related parameters and combination with MGL-3196 resulted in improvements in liver lipid content. In collaboration with Paul Mulder, professor at Rouen University Medical School, PXL-770 was evaluated in a rat model of diabetic nephropathy and metabolic disease-induced heart failure, where it prevented disease progression and showed improvement in kidney function and albuminuria compared to untreated rats. In collaboration with Jaspreet Singh, of Henry Ford Health, patient-derived cell studies conducted to assess the effects of direct AMPK activation in adrenoleukodystrophy/adrenomyeloneuropathy models showed that PXL-770 suppressed pathologic elevated levels of very long chain fatty acids. Alternative fatty acid transporters ABCD2/3 also were up-regulated.
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said it initiated an underwritten public secondary offering of its common shares (NASDAQ:REGN) to effect the exit of investment by long-time partner Sanofi SA, of Paris, which intends to sell approximately 12.8 million of its approximately 23.2 million Regeneron shares, or approximately 20.6% ownership in the company, and to grant underwriters a 30-day option to purchase an additional 10% of shares. The shares being offered by Sanofi will be sold in a global underwritten public offering led by Bofa Securities and Goldman Sachs as joint bookrunners. Regeneron will not receive any proceeds from the sale of shares in the global offering. Immediately following close of its secondary offering, Regeneron said it plans to repurchase approximately $5 billion of its common stock directly from Sanofi at a price equal to the net offering price per share, funding the purchase with a combination of $3.5 billion of cash on hand and $1.5 billion of fully committed bridge financing from Goldman Sachs Bank USA. Following the offering and Regeneron's share repurchase, and assuming full exercise by underwriters of their option to purchase additional shares, Sanofi said it will have disposed of all but 400,000 Regeneron shares, which it intends to retain. Both companies said the registered offering and share repurchase, approved by their respective boards, will have no impact on their ongoing business collaboration. On May 26, 2020, REGN shares lost $24.70, or about 4%, to close at $545.21 while Sanofi’s shares (NASDAQ:SNY) lost 3 cents, finishing at $47.27.
Ritter Pharmaceuticals Inc., of Los Angeles, said it completed its merger with Qualigen Inc. to form Qualigen Therapeutics Inc., based in Carlsbad, Calif., which will continue to focus on Qualigen’s business model of developing therapeutic products to treat cancer and infectious diseases and of marketing its Fastpack rapid diagnostic platform. The company’s common stock began trading at the May 26 opening of Nasdaq under the ticker QLGN, closing at $7.80 for a loss of $3.40. Immediately prior to and in connection with the merger, Qualigen Inc. completed a private placement of preferred stock to an institutional investor resulting in gross proceeds of approximately $4 million in exchange for convertible preferred shares and warrants. Qualigen Therapeutics also issued common shares in the merger in exchange for Qualigen Inc.'s common shares, with most of the newly issued shares subject to a six-month lockup agreement.
Seranovo BV, of Leiden, the Netherlands, said it signed a second license agreement with Carna Biosciences Inc., of Kobe, Japan, to expand their existing collaboration. Using its deep eutectic solvent, or DES, formulation platform, Seranovo is seeking to formulate one of Carna’s legacy drugs to increase its oral bioavailability.
Shanghai Junshi Biosciences Co. Ltd., of Shanghai, said research findings from its efforts to generate therapeutic COVID-19 neutralizing antibodies were published in Nature. The article reported the identification and characterization of two human monoclonal antibodies (CA1 and CB6) isolated from a recovered COVID-19 patient that showed neutralization activity in vitro against SARS-CoV-2, with CB6 exhibiting superior neutralizing activities. CB6 reduced virus levels by about 3 logs in rhesus monkeys when administered one day after infection. When given one day before viral challenge, CB6 suppressed viral load to no more than 103 RNA copies/ml. Structural studies showed that CB6 recognizes epitopes in the SARS-CoV-2 receptor binding domain that overlap with angiotensin converting enzyme 2-binding sites, directly obstructing virus/receptor interactions. Junshi and partner Eli Lilly and Co., of Indianapolis, expect to file an IND of the neutralizing antibodies, dubbed JS-016, and to initiate trials in the U.S. and China in the second quarter of 2020.
Takara Bio USA Inc., of Mountain View, Calif., said parent company Takara Bio Inc. completed construction of the Center for Gene and Cell Therapy Processing II in Shiga, Japan, an expansion of the company’s original Center for Gene and Cell Processing, established in 2014 to manufacture gene and cell therapy products. In addition to ISO 9001 certification, the new facility provides additional capacity for GMP viral vector production, process development, aseptic filling and quality-testing facilities, with room for future expansion.
Tavotek Biotherapeutics, of Ambler, Pa., said it forged a research agreement with Genmab A/S, of Copenhagen, to create and develop bispecific antibodies using Genmab's Duobody technology platform against disease-relevant target antigens. Tavotek will use its Tavoselect platform, with VHO phage and Fab phage libraries, to identify lead molecules for generating bispecific antibodies against validated target combinations with the objective of developing an immune-modulator bispecific antibody for autoimmune and inflammatory-related conditions.
Tetra Therapeutics, of Grand Rapids, Mich., said it inked a definitive merger agreement for its acquisition by Shionogi & Co. Ltd., of Osaka, Japan, including global rights to Tetra’s portfolio of compounds to treat brain disorders associated with cognitive and memory deficits, notably BPN-14770, a phosphodiesterase‐4D inhibitor in phase II development in fragile X syndrome and Alzheimer’s disease. The transaction was said to have a potential value of up to $500 million, based on the achievement of predetermined regulatory and commercial milestones. Tetra, which inked a partnership with Shionogi in 2018 that was expanded in 2020, will operate as a wholly owned subsidiary.