Athenex Inc., of Buffalo, N.Y., expanded its strategic partnership with Guangzhou Xiangxue Pharmaceutical Co. Ltd., of Guangzhou, China, to exclusively develop and commercialize Athenex’s oncology product candidates oral paclitaxel (both the capsule and the tablet formulations), oral irinotecan and tirbanibulin (KX2-391, also known as KX-01) ointment, including for the treatment of actinic keratosis in the territory. Athenex will receive an up-front payment of $30 million and will be eligible to receive development, sales and other milestone payments up to $170 million, and tiered royalties ranging from the sub-teens to low 20s based on annual net sales of licensed products in the territory and a percentage of sublicensing revenue. The total deal size is potentially $200 million, excluding royalty payments.
Bioarctic AB, of Stockholm, said it entered a research collaboration with Tokyo-based Eisai Co. Ltd. aimed at further studying the unique profile and characterize the binding profile of investigational drug candidate BAN-2401, a monoclonal antibody that selectively binds to and eliminates soluble, toxic amyloid beta aggregates (protofibrils and oligomers) that are thought to contribute to the neurodegenerative process in Alzheimer’s disease. Under this collaboration, Bioartic could receive up to €3.25 million (US$3.62 million). The research program is planned to continue through the end of June 2021 and results are expected to be presented at future scientific conferences.
Biontech SE, of Mainz, Germany, and the European Investment Bank disclosed the signing of a contract which provides financing of €50 million (US$55.7 million) to Biontech, which will use the funds for the research and development, market access and manufacturing development for its most advanced treatments under development. The loan is backed by a guarantee from the European Fund for Strategic Investments, the heart of the Investment Plan for Europe – the Juncker Plan – under which the bank and the European Commission are working as partners.
Celsion Corp., of Lawrenceville, N.J., received approval from the New Jersey Economic Development Authority’s Technology Business Tax Certificate Transfer (NOL) program to sell $2 million of its unused New Jersey net operating losses (NOLs) for the tax years 2017 through 2018. The NOLs are typically sold at a small, single-digit discount to qualified companies with operations in New Jersey. As a result, the company anticipates it will be able to transfer this credit and receive about $1.9 million of net cash proceeds by year-end or early 2020. Celsion expects to have sufficient cash to fund operations into the first quarter of 2021.
Centogene AG, of Rostock, Germany, in an update related to Centomd, the company’s data repository of epidemiologic, phenotypic and clinical data, said that since September 2019 the number of analyzed cases has grown by 11% to more than 400,000, and the number of total variants has increased to 12.2 million from across 120 countries. Newly generated knowledge and data are based on disease-causing variants confirmed by biomarker data and include more than 12.2 million unique variants and more than 3,700 associated phenotypes.
Cerevance Inc., of Boston, formed a multiyear research alliance with Takeda Pharmaceutical Co. Ltd., of Tokyo, to identify novel target proteins expressed in the central nervous system and to develop new therapies against them for certain gastrointestinal disorders. Scientists from the companies will select, confirm and validate targets from gene expression data sets generated by Cerevance’s Netsseq technology, which sorts and profiles specific neuronal and glial cell types in post-mortem human central nervous system tissue. Under the terms, which include an upfront technology access fee and research support to Cerevance, Takeda will pay preclinical and clinical milestone payments and royalties to Cerevance as targets are validated and compounds are advanced through development and onto the market worldwide. Cerevance is eligible to receive development, commercialization and net sales-based milestone payments that may exceed $170 million on a per target basis.
Cohbar Inc., of Menlo Park, Calif., disclosed new preclinical data confirming the therapeutic potential of a novel Cohbar peptide in a preclinical model of idiopathic pulmonary fibrosis (IPF). Data show the peptide positively affected all the efficacy parameters evaluated in the study, including reduction in lung fibrosis, inflammation, and collagen levels after 14 days of administration in a therapeutic mouse model of IPF, the company said.
Destiny Pharma plc, of Brighton, U.K., noted that new guidelines from the Asia Pacific Society for Infection Control for the prevention of surgical site infections have been published in the peer-reviewed journal, Antimicrobial Resistance and Infection Control. The guidelines underline the market potential of Destiny’s lead product XF-73, the company said, which is in phase IIb trials testing its ability to kill Staphylococcus aureus bacteria in the patient's nose prior to surgery, thereby reducing the potential for serious post-surgical bacterial infections.
Follicum AB, of Lund, Sweden, released data showing peptides can release insulin in line with a GLP-1 analogue. The human data from its ex vivo peptide-based diabetes treatment studies on human Langerhans islets show positive effects on insulin release in line with results on beta cells isolated from animals. Follicum’s focus is discovering and developing peptide-based drugs.
Heron Therapeutics Inc., of San Diego, published an article in Regional Anesthesia & Pain Medicine on the mechanism of action for its pain medication HTX-011. In a postoperative pain pig model, meloxicam and bupivacaine, the components in HTX-011, lowered local tissue inflammation as demonstrated by a less acidic tissue pH, which improved the analgesic activity of the combination.
Findings from a five-year retrospective chart review by Homology Medicine Inc., of Bedford, Mass., show that phenylalanine (Phe) concentrations remain elevated in adult patients with classical phenylketonuria (PKU) even when closely monitored and on the standard-of-care highly restricted protein diet. Elevated Phe can cause neurocognitive deficits as diet alone can be insufficient to achieve target Phe levels. The retrospective review of electronic health records comprises patients 10-40 years old with hyperphenylalaninemia (HPA), or mild, moderate or classical PKU. Of the 152 patients studied, 65.8% had classical PKU, the disease’s most common and severe form. Although more than 95% of patients were prescribed a Phe-restricted diet, blood Phe concentrations in the classical PKU patients remained substantially elevated above 360 µmol/L, a level considered well-controlled based on U.S. treatment guidelines, particularly in patients with classical PKU. As Phe threshold was lowered (Phe less than 600, 360, 120 or 30 µmol/L), the number of patients with consecutive lab values below the threshold decreased, suggesting many patients’ Phe levels were inadequately controlled. Homology uses human hematopoietic stem cell-derived adeno-associated virus vectors to deliver genetic medicines in vivo either through a gene therapy or nuclease-free gene editing modality across a range of genetic disorders.
Merck & Co. made a cash tender off to purchase all outstanding shares of Arqule Inc., the company Merck announced it would acquire on Dec. 9. When the offer closes on Jan. 15, Arqule stockholders will receive $20 in cash for each share of Arqule common stock validly tendered and not validly withdrawn in the offer, without interest and less any required withholding taxes. Following that purchase, Arqule will become a wholly owned Merck subsidiary.
Newlink Genetics Corp., of Ames, Iowa, rejected the unsolicited acquisition proposal it received Nov. 5 from Evercel Inc., of Hingham, Mass. Newlink’s board of directors said the Evercel proposal is not actionable because it does not constitute, and could not reasonably be expected to lead to, a superior offer as defined in its merger agreement with Lumos Pharma Inc. for granting due diligence access or commencing negotiations. Newlink’s largest stockholder, Stine Seed Farm Inc., signed a support agreement to vote in favor of the Lumos merger.
Roche Holding AG, of Basel, Switzerland planned to complete its $4.8 billion acquisition of Spark Therapeutics Inc. on Dec. 17 without a vote or meeting of Spark’s shareholders. In the merger, all Spark shares not owned by Spark, Roche or Roche’s wholly owned subsidiaries, are converted into the right to receive the same cash consideration per share, less any applicable withholding taxes, as was paid in the tender offer. The final steps were made as Roche and Spark said the FTC and the UK Competition and Markets Authority closed their investigations and granted unconditional clearance and termination of the waiting period, which expired Dec. 16 at $114.50 per share. Once the merger is complete, Spark will become a wholly owned subsidiary of Roche and Spark’s shares will cease to be traded on Nasdaq.
China-based Shandong Fontacea Pharmaceutical Co. Ltd. said it has entered into an exclusive license, development and commercialization agreement with Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, to develop and commercialize pharmaceutical products containing a human IgG1λ anti-human IL-17A neutralizing monoclonal antibody in China, including Hong Kong, Macao, Taiwan and South Korea.
Tetra Bio-Pharma Inc., of Ottawa, Ontario, signed a signed a definitive commercialization agreement with Azevedos Indústria Farmacêutica SA to market and distribute Tetra’s cannabinoid Caumz (PPP-011) in Portugal. Tetra receives milestone payments and profit sharing on all sales in Portugal while Azevedos is responsible for registering, manufacturing marketing and distribution. Specific financial terms were not disclosed.