Antares Pharma, a company that specializes in self-injection pharmaceutical products and topical gel-based medicines, has licensed to Pfizer’s consumer healthcare business unit one of its drug-delivery technologies to develop an undisclosed product on an exclusive basis for North America. Pfizer will assume full cost and responsibility for all clinical development, manufacturing, and commercialization of the product in the licensed territory, which also includes certain nonexclusive territories outside of North America. Antares will receive undisclosed upfront payments, development milestones, and sales-based milestones, as well as royalties on net sales for three years post launch in the United States.
AstraZeneca has announced that its investigational compound olaparib will not progress into Phase III development for the treatment of ovarian cancer. In addition, AstraZeneca announced that the second renaissance Phase III study of TC-5214 for patients with major depressive disorder did not meet its primary end point. As a result, AstraZeneca will take pretax impairment charges totaling $381.5 million to R&D expense in the fourth quarter of 2011. The company confirms its expectation for full-year Core EPS in the range of $7.20 to $7.40, but Core EPS is likely to be in the lower half of this range. AstraZeneca’s decision to discontinue olaparib’s development in ovarian cancer was made following a review of an interim analysis of a Phase II study (study 19) which indicated that the previously reported progression-free survival benefit is unlikely to translate into an overall survival benefit, the definitive measure of patient benefit in ovarian cancer.
In other news, AstraZeneca has agreed to acquire Guangdong BeiKang Pharmaceutical Company, a generic-drug manufacturing company based in Conghua City, China. Under the acquisition, AstraZeneca will be responsible for the manufacture and commercialization of injectable medicines in China. The agreement is contingent on the approval of certain regulatory authorities, including the approval of the Ministry of Commerce in China. The transaction is expected to close in the first quarter of 2012.
GlaxoSmithKline has reached an agreement to divest brands in the United States and Canada to Prestige Brands Holdings for £426 million ($660 million). The process will continue for divesting brands outside these markets and global rights for Alli (orlistat). In February 2011, GSK announced its intention to divest noncore consumer healthcare over-the-counter (OTC) products predominantly in the United States and Europe with aggregate annual sales of approximately £500 million ($783 million). GSK’s brands in the US and Canada have reached an agreement to divest the previously identified noncore OTC brands in the US and Canada to Prestige Brands Holdings for £426 million ($660 million) in cash. The brands being divested include BC, Goody’s, Beano, Ecotrin, Fiber Choice, and Tagamet, and generated sales of approximately £134 million ($210 million) in 2010 and £98 million ($154 million) in the first nine months of 2011. The divestment is expected to be completed in the first half of fiscal year 2012, and is subject to regulatory approval. The net cash proceeds from the transaction are expected to be approximately £242 million ($379 million).
Exelixis, a biotechnology company, has agreed to license to Merck its PI3K-delta research and development program, which includes XL499, a preclinical PI3K-delta inhibitor, and other related compounds. Under the agreement, Merck will have a worldwide exclusive license and have sole responsibility to research, develop, and commercialize compounds originating from the program. Merck will make an upfront payment of $12 million to Exelixis, and Exelixis will be eligible for potential development and regulatory milestone payments for multiple indications of up to $239 million. Exelixis will also be eligible for potential combined sales performance milestones and royalties on net sales of products emerging from the agreement.
The biopharmaceutical company OPKO Health has agreed to acquire FineTech Pharmaceutical, a developer and producer of high-potency APIs. The transaction is expected to close on Dec. 29, 2011.
Pall Corporation has agreed to acquire ForteBio, a provider of analytical systems for the discovery and development of biotechnology drugs. The transaction is expected to close by February 2012.
Takeda has announced its decision to integrate two wholly owned subsidiaries, Takeda San Diego (TSD) and Takeda San Francisco (TSF) on Jan. 1, 2012. TSD will become the surviving company and change its name to Takeda California (TCAL) the same day. Keith Wilson, current president of TSD, will become the president of the new company.
In other news, Takeda has agreed to acquire Intellikine, a developer of small-molecule drugs. Takeda expects that the transaction will be finalized in January 2012. Under the agreement, Takeda subsidiary Takeda America Holdings will acquire Intellikine for $190 million upfront and up to $120 million in additional potential clinical-development milestone payments.
Takeda has announced management changes to several of the company’s organizations, effective Jan. 1, 2012. Ken Araka will move from senior director of the company’s corporate strategy and planning department to vice-president of the global licensing and business development department. Kouji Iwasaki has been appointed to director of Takeda’s new strategic medical research planning organization.