Abbott Diabetes Care (Alameda, CA) is working with the US Food and Drug Administration to recall 359 different lots of glucose test strips marketed under the following brand names: Precision Xceed Pro; Precision Xtra; Medisense Optium; Optium; OptiumEZ; and ReliOn Ultima. These strips are used with Abbott’s Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, Optium EZ, and ReliOn Ultima blood-glucose-monitoring systems. As many as 359 million strips may be affected by the recall, according to an FDA press release. The agency stressed that blood-glucose-monitoring systems are not affected by this recall.
AstraZeneca (London) and Abbott (Abbott Park, IL) ended their development program for Certriad (rosuvastatin calcium and fenofibric acid), a potential treatment for mixed dyslipidemia. The companies received a Complete Response Letter (CRL) from FDA for the drug’s new drug application in March 2010 and have decided to end the program after evaluation of the CRL, according to a company statement.
Biopharmaceutical company Cephalon (Frazer, PA) decided to stop development of Nuvigil (armodafinil) tablets [C-IV] for the treatment excessive sleepiness associated with jet-lag disorder. The company received a second CRL from FDA that reiterated the agency’s previously stated concerns about the drug.
Cepheid (Sunnyvale, CA), a molecular diagnostics company, released Xpert Flu diagnostic test in Europe. The test, which runs on the company’s GeneXpert system, simultaneously detects and differentiates Flu A, Flu B, and 2009 H1N1 influenza virus in about one hour. The test was released as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Since the beginning of the 2010-11 flu season, Europe has seen a resurgence of the 2009 H1N1 virus, according to a company press release.
Dey Pharma (Basking Ridge, NJ), a subsidiary of Mylan (Canonsburg, PA), will partner with Meda (Solna, Sweden) a specialty pharma company, for the exclusive marketing and distribution rights of EpiPen (epinephrine) Auto-Injector in Europe. EpiPen Auto-Injector is used for emergency treatment of severe allergic reactions (anaphylaxis).
EpiTherapeutics (Copenhagen) and Abbott (Abbott Park, IL) formed a three-year agreement to develop anticancer drugs by making small-molecule inhibitors against selected epigenetic oncology targets. EpiTherapeutics will receive an upfront payment, funding for its research activities, and possible milestone payments and royalties. Additional financial details were not disclosed.
Merrion Pharmaceuticals (Dublin), a product development company, signed a pact with Novo Nordisk (Bagsværd, Denmark) to evaluate the ability of Merrion's proprietary Gipet drug-delivery technology to boost the oral bioavailability of an undisclosed proprietary compound. Following the feasibility studies, Novo Nordisk will have the option to enter into a further licensing agreement for the Gipet technology. Under the agreement, Merrion has granted Novo Nordisk a 20-day warrant to acquire up to EUR 1.5 million ($1.97 million) in ordinary shares at EUR 2.73 ($3.58) per share. In addition, Merrion can request Novo Nordisk to acquire up to EUR 500,000 ($656,000) worth of shares. The companies have license agreements for oral GLP-1 and insulin.
Mylan (Canonsburg, PA) agreed to pay $65 million to settle pricing lawsuits brought against it on behalf of the federal government and the state of Texas pertaining to Medicaid reimbursements paid by the federal government and the state of Texas to pharmacists and other healthcare providers. The settlement reflects the finalization of an agreement made in principle among the parties early in 2010 and reported in the company's 2009 Form 10-K. According to a company statement, the settlement agreement confirms that the resolution of the cases does not constitute an admission, finding, or evidence of fault, liability, or wrongdoing by Mylan.
Biopharmaceutical company Transition Therapeutics (Toronto) and Elan (Dublin), a biotechnology company, agreed to modify their collaboration agreement for the development and commercialization of ELND005 (scyllo-inositol), an investigational treatment for Alzheimer's disease. Under the terms of the modification, in lieu of a contractually required Phase III milestone payment, Transition will receive a payment of $9 million at the time of signing and will be eligible to receive a $11 million payment at the start of the next ELND005 clinical trial. Transition also will be eligible to receive up to $93 million in additional regulatory and commercial launch-related milestone payments plus tiered royalties ranging from 8% to 15% based on net sales of ELND005. Transition will no longer fund the development or commercialization of ELND005 and will relinquish its 30% ownership of ELND005 to Elan.
VAC-U-MAX (Belleville, NJ), a provider of pneumatic conveying systems and industrial vacuum cleaners, moved into its new 71,000-ft2 facility that houses the company’s assembly, fabrication, inventory, and corporate offices. The new facility also includes a 6000-ft2 test and demonstration facility that can simulate conditions at a customer’s site.
Cephalon (Frazer, PA) appointed J. Kevin Buchi as CEO and a member of the board of directors. Former Founder, Chairman, and CEO Frank Baldino, Jr. passed away earlier this month. The company said its board will address the role of company chairman in the future. William P. Egan will continue to serve as Cephalon's independent presiding director.
Lonza (Basel) appointed Harry Boot as the new COO for its Life Science Ingredients sector and as a member of the Lonza Management Committee, effective Mar.1, 2011. He takes over the position from CEO Stefan Borgas, who headed the sector on an interim bases since June 2010.
eResearchTechnology (ERT, Philadelphia), a global provider of technology and services, confirmed that the effective date of the previously announced retirement of President and CEO Michael J. McKelvey was Dec. 21, 2010. Joel Morganroth, currently ERT's chairman and chief scientific officer, will serve as interim president and CEO until the company hires a permanent replacement.
Lotus Pharmaceuticals (Beijing), appointed four new members of its board of directors following the resignation of four board members. Michael Toups, Lijun Fan, Zhaohui Li, and Jun Lu have been appointed to serve on the company's board of directors. They will replace current directors Li Ping, Liu Jin, Xian Xuemei, and Song Zhenghong.
The Pharmaceutical Research and Manufacturers of America (PhRMA) elected the following four new members to its board of directors: Ian Read, president and CEO of Pfizer (New York); Jerzy Gruhn, president of Novo Nordisk (Bagsværd, Denmark); Mark Iwicki, president and CEO of Sunovion Pharmaceuticals (Marlborough, MA); and Staffan Schuberg, president Lundbeck (Copenhagen).
US Oncology (The Woodlands, TX), an integrated oncology company, named Karen Gibson senior vice-president and chief information officer.