The NBA’s business intelligence follows company profitability, business forecasts, capital raisings or returns, mergers and takeovers, arrangements for joint research and/or development, contracts for supply of manufacturing inputs, and marketing agreements. Companies considered include suppliers, potential suppliers and developers of products which may be of interest.
Swedish Orphan Biovitrum (Sobi) announced the company has decided to exercise its opt-in right to take over final development and commercialisation of Alprolix (rFIXFc for haemophilia B) for Europe, North Africa, Russia and some Middle Eastern markets. Sobi will pay Biogen $US 10 million to be held in escrow awaiting the regulatory approval of Alprolix in Europe11. Biogen has led development for Alprolix, has manufacturing rights, and has commercialisation rights in North America and other regions in the world excluding the Sobi territory.
Cerus Corporation announced that Unyts had signed a three-year purchase agreement for the INTERCEPT Blood System for platelets and plasma. Unyts, headquartered in Buffalo, services eight counties in Western New York with 5,000 platelet and 11,000 plasma units annually. Cerus had already signed a three-year purchase agreement for the INTERCEPT Blood System for platelets and plasma with Bonfils Blood Center. Bonfils supplies blood and blood products to over 100 facilities in Colorado and further afield, providing 20,000 platelet and 25,000 plasma units annually. Bonfils is an affiliate of Blood Systems Inc., a major blood product supplier in the US.
Baxalta reported revenues for the second quarter and first half of 2015, which exceeded expectations. Haematology revenues (excluding the impact of foreign currency) grew 6 per cent in the second quarter driven by demand for Advate, and double-digit growth of FEIBA. Also contributing to growth were new products Rixubis (for haemophilia B) and Obizur (for acquired hemophilia A). Immunology sales (excluding the impact of foreign currency) grew 10 per cent driven by demand for immunoglobulin therapies and continued success of Hyqvia (10% concentration), the once-monthly subcutaneous treatment available for adults with primary immunodeficiency. Baxalta has submitted a European Marketing Authorization Application for approval of its investigational 20% concentration subcutaneous immune globulin treatment for primary immunodeficiencies. This higher potency treatment would offer faster infusions with less volume. Baxalta expects to file for US approval before the end of 2015.
Baxalta has established UK headquarters for 100 employees in Staines-upon-Thames.
The Board of Directors of Baxalta declared its first quarterly cash dividend of $US0.07 per share of common stock. It will be paid on October 1, 2015, to stockholders of record at close of business on September 4. The Board also approved a share repurchase authorization for up to $US 1 billion of its common stock in the open market at times and amounts determined by the company.
Baxalta has a contract fractionation agreement with Stichting Sanquin Bloedvoorziening (Sanquin Blood Supply Foundation) to enhance supply and support growth in global demand for plasma-based therapies. Sanquin has submitted the production line for approval in Europe, which will provide additional manufacturing flexibility.
On 4 August, Shire went public with a $30 billion bid for Baxalta that had already been made privately12 and been rejected. Baxalta said later that day that Shire's $US 45.23-per-share bid "significantly undervalues" the young company13. Baxalta’s CEO had already questioned the logic behind a merger, writing: “we do not think the combination would generate substantial operational or revenue synergies, which would be critical to any potential value creation". However, by 10 August there were reports that Baxter directors were proposed to negotiate with Shire for a significantly increased bid.
CSL announced that it had secured the necessary approvals required to proceed with the acquisition of the influenza vaccines business of Novartis, and that it was working with Novartis to bring forward the close date for the transaction. The new CSL subsidiary resulting from the acquisition will be called Seqirus. CSL’s Chief Financial Officer, Gordon Naylor, will lead the new business, and the corporate office will be located in Maidenhead, outside London.
CSL is recruiting 1200 patients for a Phase IIB study of its drug CSL112 for acute coronary syndrome, designed to prevent a second heart attack after a patient has already suffered the first.
Pfizer has offered concessions in seeking EU regulatory approval for its $US 15 billion takeover of rival Hospira. The EU competition authority could approve the deal or begin a full-scale investigation.
Abeona Therapeutics, formerly PlasmaTech Biopharmaceuticals, is focussed on developing and delivering gene therapy and plasma-based products for severe and rare diseases, including Fanconi anaemia and other rare blood diseases. The company offers two platforms: Salt Diafiltration (SDF) Process and Polymer Hydrogel Technology (PHT). It recently raised $US 8.5 million in equity financing from its current institutional investors and directors, with its SDF Alpha (alpha-1 protease inhibitor) for inherited chronic obstructive pulmonary diseases cited as the major recipient of funding.
Tekmira Pharmaceuticals Corporation announced in British Columbia and Pennsylvania its plans to change its corporate name without delay to Arbutus Biopharma Corporation, a therapeutic solutions company dedicated to developing a cure for chronic hepatitis B virus infection (HBV).
Eisai Co of Tokyo announced that its US subsidiary Eisai Inc. will transfer ownership of its manufacturing facility in Research Triangle Park, North Carolina, to Biogen, whose US headquarters is in Massachusetts. Biogen will manufacture some products for Eisai.
Ra Pharmaceuticals, of Cambridge, Massachusetts, secured $US58.5 million in Series B financing to support development of its lead molecule, RA101495, for treating paroxysmal nocturnal haemoglobinuria (PNH)14. Doug Treco, founder and CEO of Ra Pharma said: “…..preclinical data demonstrate a near complete inhibition of hemolysis, the hallmark of PNH, in non-human primates”.
