Alexion Pharmaceuticals Inc., of Boston, said in a statement that it engaged with Elliott Advisors (UK) Ltd., an affiliate of Elliott Management, to hear its point of view on corporate strategies, which included a recommendation that “we immediately launch a proactive sale process.” However, the company said it does not believe that approach is the best path forward for driving shareholder value. Alexion reaffirmed that it has not received any indications of interest to acquire the company or has it rejected any such inbound proposals. Going forward, it intends to build value based on its pipeline of products, expand its current assets into new diseases and further diversify its portfolio. Shares of Alexion (NASDAQ:ALXN) closed Friday at $113.89, up $6.47.
Applied Therapeutics Inc., of New York, said it presented preclinical data at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease in Los Angeles on AT-001, a selective aldose reductase inhibitor (ARI) in phase III development for diabetic cardiomyopathy (DbCM), detailing a head-to-head comparison vs. zopolrestat in inhibiting aldose reductase. The structure and activity of AT-001 provide selectivity for aldose reductase and avoid off-target inhibition of aldehyde reductase. The company said the in vitro safety of that agent, together with the positive safety data from a phase I/II program, support the ongoing pivotal study in DbCM.
Basilea Pharmaceutica Ltd., of Basel, Switzerland, said sales of the antifungal Cresemba (isavuconazole) by New York-based Pfizer Inc. in Europe and Israel triggered a $7 million sales milestone payment. The company is entitled to receive sales milestone payments when Pfizer’s cumulative Cresemba sales in its licensed territories exceed certain thresholds. The first sales milestone of $5 million was triggered earlier this year. Under the agreements with Pfizer, Basilea is still eligible for regulatory and sales milestone payments of up to $638 million, in addition to receiving midteen royalties on sales.
Codexis Inc., of Redwood City, Calif., said it published, with Kenilworth, N.J.-based Merck & Co. Inc., a paper in Science, detailing the development of a highly efficient enzymatic cascade for the production of Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir. It describes the optimization, using Codexis’ Codeevolver protein engineering platform, of five enzymes for the synchronized synthesis of a complex pharmaceutical candidate in very few steps, starting from raw materials. The process demonstrates the utility of engineered enzymes in coordinated cascades to perform highly complex chemistry for previously difficult-to-produce molecules, the companies said. They are collaborating on the engineering of the enzymes to enable the efficient synthesis of the active pharmaceutical ingredient (API). Codexis said it is supporting Merck in the supply of enzymes for production of the API for late-phase clinical studies.
Dynavax Technologies Corp., of Emeryville, Calif., and Albertsons Cos. said they partnered to provide Heplisav-B at Albertsons’ more than 1,700 pharmacies nationwide, with a special focus on people living with diabetes. The drug is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years and older.
Enzychem Lifesciences Corp., of Englewood Cliffs, N.J., said it entered a collaborative agreement with the Armed Forces Radiobiology Research Institute (AFRRI), part of the Uniformed Services University of the Health Sciences in Bethesda, Md. Following the presentation of data on the therapeutic effects of EC-18 in preclinical animal models, it has been selected to be tested by AFRRI as a medical countermeasure candidate. The product is in development for a variety of indications, including chemotherapy induced neutropenia, chemoradiation induced oral mucositis and acute radiation syndrome.
Galectin Therapeutics Inc., of Norcross, Ga., presented its plans for an adaptively designed phase III trial (NASH-RX) of its lead compound, belapectin (GR-MD-02), in the treatment of patients with nonalcoholic steatohepatitis cirrhosis without esophageal varices during a corporate webcast. Based on feedback from the FDA, the company said it is making refinements to the study. Patient selection for inclusion will be based on clinical criteria indicative of portal hypertension, including the presence or absence of varices, platelet count, spleen size, and evidence of collaterals by imaging. First patient enrollment is anticipated at the end of the first quarter next year.
Gemphire Therapeutics Inc., of Ann Arbor, Mich., said its stockholders approved all proposals relating to its merger with Boston-based Neurobo Pharmaceuticals Inc., including a reverse stock split of Gemphire common stock, at a ratio of one new share for every 15 to 25 shares outstanding. In connection with the closing of the transaction, Gemphire will change its name to Neurobo Pharmaceuticals and the company’s shares are expected to commence trading on Nasdaq under the symbol NRBO.
Midatech Pharma plc, of London, said it received confirmation of a €2.6 million (US$3.8 million) EU grant to be used to conduct a clinical study, GlioKIDS, designed to demonstrate the efficacy of MTX-110 as a treatment for diffuse intrinsic pontine glioma, a rare and fatal form of childhood brain cancer that has an average life expectancy of 7 to 9 months. The European study, an open-label trial of about 20 patients with a one-year treatment period, is expected to begin early next year. The grant covers 70% of the expected study costs, with the remainder covered by the company.
Nicox SA, of Sophia Antipolis, France, said it signed an exclusive license agreement with South Korea-based Samil Pharmaceutical Co. Ltd. for the development and commercialization of Zerviate (cetirizine ophthalmic solution), 0.24%, for the treatment of ocular itching associated with allergic conjunctivitis in South Korea. Nicox will be eligible to receive 10% royalties on net sales in South Korea and a milestone payment of 5% of net sales for each calendar year in which net sales exceed approximately $900,000. It will also receive a license fee, and may receive approval and launch milestone payments which, together with the license fee, may total almost $250,000.
Oncolytics Biotech Inc., of San Diego, said it received written notice from Nasdaq stating that its minimum bid price deficiency has been cured and it is currently in compliance with the applicable listing standard and the matter is now closed. In order to regain compliance, the company was required to maintain a minimum closing bid price of $1 or more for at least 10 consecutive trading days.
Onconova Therapeutics Inc., of Newtown, Pa., and Inceptua Medicines Access (a business unit of the Inceptua Group), said they entered a collaboration to make available intravenous rigosertib, a small molecule that inhibits cellular signaling in cancer cells by acting as a RAS mimetic, via a pre-approval access program in selected countries around the world. Clinical development of rigosertib is centered on the therapeutic management of myelodysplastic syndromes (MDS), currently in phase III development for the treatment of higher-risk MDS. Inceptua will support Onconova through the pre-approval provision of intravenous rigosertib initially into a number of countries, including Australia, Denmark, Finland, France, Ireland, Italy, the Netherlands, Portugal and South Africa.