Aclaris Therapeutics Inc., of Wayne, Pa., said it has divested Rhofade (oxymetazoline hydrochloride) cream and related intellectual property assets to EPI Health LLC, of Charleston, S.C. The company said the transaction is a key component in its plan to refocus resources on the development of its immuno-inflammatory development programs. Aclaris will receive a total cash consideration of up to $55 million, comprising an up-front payment of $35 million and potential sales milestone payments of up to $20 million upon the achievement of specified levels of net sales of products covered by the agreement. In addition, EPI Health has agreed to pay a specified high-single-digit royalty calculated as a percentage of net sales, on a product-by-product and country-by-country basis, subject to specified reductions, limitations and adjustments, and 25% of any up-front, license, milestone, maintenance or fixed payment received by EPI Health from a licensee or sublicensee in any territory outside of the U.S. Concurrent with the closing of the transaction, Aclaris said it repaid in full its $30 million term loan (plus fees and expenses) with Oxford Finance LLC. EPI Health has agreed to assume the obligation to pay specified royalties and milestone payments under Aclaris' existing agreements with Allergan Sales LLC, Aspect Pharmaceuticals LLC and Vicept Therapeutics Inc. As a result, Aclaris anticipates that its current cash, cash equivalents and marketable securities on hand will be sufficient to fund its operations into the third quarter of 2021. Shares of Aclaris (NASDAQ:ACRS) gained 19% on the news Friday, closing at $1.42.
CMAB Biopharma Inc., of Suzhou, China, and Shanghai-based BJ Bioscience Inc. said they established an agreement for the development and manufacturing of a bifunctional antibody (BJ-005). CMAB will provide a full range of CMC research and manufacturing services that meet the IND application requirements of both China and the U.S. The deal will support the clinical development of BJ-005 worldwide by BJ Bioscience.
Five Prime Therapeutics Inc., of South San Francisco, said it is restructuring to extend its cash runway without impacting or delaying the data timelines of its clinical programs. As a result, it will eliminate approximately 70 positions across all functions with 70% of those positions eliminated by the end of the year and the remainder occurring in 2020. The company is also initiating activities to reduce its corporate facilities footprint by either subletting a significant portion of its leased space or subletting the entirety of its building and relocating to smaller facilities. Five Prime expects that it will achieve $20 million in annualized cost savings and estimates that it will incur approximately $3 million of pre-tax charges for severance and other costs related to the restructuring, primarily in 2019. The company is reaffirming its financial guidance and anticipates ending 2019 with $148 million to $153 million in cash, cash equivalents and marketable securities.
H. Lundbeck A/S, of Valby, Denmark, and Alder Biopharmaceuticals Inc., of Bothell, Wash., filed updated tender offer material with the SEC regarding Lundbeck's pending offer for all outstanding Alder shares. Alder stockholders are being offered an up-front $18 per share in cash and one nontradeable contingent value right (CVR) entitling them to an additional $2 per share upon approval of Alder's lead candidate, eptinezumab, by the EMA, representing a total potential consideration of $20 per share. On Oct. 10, Lundbeck filed an amended Schedule TO to the SEC revising the purchase offer to include additional disclosure relating to the material terms of the CVR and the related CVR agreement. On Oct. 11, Alder filed an amended Schedule 14D-9 revising the offer's solicitation and recommendation statement to include further detail on the share holdings of Alder's directors and executive officers. Lundbeck offered to acquire Alder for up to $1.95 billion net of cash. (See BioWorld, Sept. 17, 2019.)
Kitov Pharma Ltd., of Tel Aviv, said it amended the marketing and distribution agreement with Pittsburgh-based Coeptis Pharmaceuticals Inc. for commercialization of Consensi, a fixed-dose combination of celecoxib, a nonsteroidal anti-inflammatory drug for the treatment of pain caused by osteoarthritis, and amlodipine besylate, a drug designed to treat hypertension. Under the terms of the amended agreement, Kitov will receive 20% in royalties on net sales of Consensi with minimum royalties of $4.5 million over the next three years. In addition, Kitov is entitled to receive up to $99.5 million in milestone and reimbursement payments, of which $1 million was previously received; $1.5 million is expected before the end of the year in connection with the manufacturing of the initial commercial batches; an additional $1 million is due following the first commercial sale of Consensi in the U.S.; and $96 million, subject to certain predefined commercial milestones. Coeptis said it has engaged a distribution partner with an established sales network and access to thousands of pharmacies to drive the launch of the drug. In addition, a marketing plan and pricing strategy have been finalized. Shipping of the commercial batches to the U.S. will take place shortly.
In a settlement with the SEC, Northwest Biotherapeutics Inc., of Bethesda, Md., will pay a $250,000 fine and neither admit nor deny any violations of past internal controls weaknesses. Northwest also will retain an additional independent consultant to help remedy any remaining weaknesses. Northwest develops immune therapies for solid tumor cancers.
Pfenex Inc., of San Diego, said its partner, Alvogen Inc., entered exclusive commercialization agreements for PF-708 to treat osteoporosis in patients at high risk of fracture with Pharmbio Korea, Jamp Pharma in Canada and Kamada Ltd. in Israel. Under the agreement, Pfenex is eligible to receive milestone payments and a percentage of net sales or transfer price.
Shionogi & Co. Ltd., of Osaka, Japan, and Hsiri Therapeutics Inc., of Media, Pa., agreed to research and develop therapeutics for nontuberculous mycobacterial diseases and tuberculosis. Shionogi has exclusive worldwide rights to develop, manufacture and commercialize compounds generated from the collaboration. Hsiri receives an up-front license fee, potential development milestones and royalty payments based on sales from Shionogi.
Therapix Biosciences Ltd., of Tel Aviv, Israel, offered Destiny Biosciences Global Corp. a longer period to complete its due diligence as the companies move toward a proposed merger. The companies had originally agreed to allow until Oct. 31 to complete the definitive agreement. Destiny has retained an investment bank to create a relative valuation analysis of both companies. Therapix is developing cannabinoid-based treatments.