Shire, the pharmaceutical company is also given the once over by Tempus. Quite a busy day for the company. It pulled out of an application to sell its Fabry disease treatment, Replagal, in the US after a misunderstanding with the Food and Drug Administration. It then announced a $100m purchase of FerroKin BioSciences, a company which makes treatments for excess iron following blood transfusions. The company had a storming 2011 and Tempus thinks despite a turbulent Thursday, the stock is worth buying on any weakness.
Shire's Specialty Pharmaceuticals Senior Vice President, Hematology, Ross Murdoch says:
"There remains a significant unmet need for a once-a-day, oral iron chelator in a convenient dosage form for the treatment of transfusional iron overload with a better safety profile than currently available treatments(2). We believe FBS0701 has the potential to meet that need. We hope to use our expertise in hematology coupled with our proven ability to progress products through the development pipeline to bring FBS0701 to the global marketplace. This acquisition marks an important step for Shire in building a business that serves the growing needs of specialty hematologists and their patients."
FerroKin BioSciences' key employees, including Founder and CEO, Dr. Hugh Young Rienhoff, Jr. will provide consulting services to Shire during the transition period. "An important factor for FerroKin BioSciences in agreeing to this transaction was Shire's drive, capability and vision to bring new products to the hematology market that promise to raise the standard of care for patients. In Shire's hands, FBS0701 has greater potential to fulfill that promise," said Dr. Rienhoff.
The closing of the acquisition is subject to customary conditions, including (i) adoption of the Merger Agreement by a required proportion of FerroKin's equityholders; (ii) holders of no more than 2% of FerroKin's capital stock having exercised or being entitled to exercise appraisal rights under Delaware law and (iii) the absence of a material adverse effect on FerroKin BioSciences
Shire to acquire FerroKin BioSciences, Inc., and its Phase 2 iron chelator treatment
Dublin, Ireland - March 15, 2012 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has signed an agreement to acquire FerroKin BioSciences, Inc., for an upfront payment of $100 million, payable in cash at closing, plus potential post-closing milestone payments of up to $225 million, depending upon the achievement of certain clinical development, regulatory and net sales targets.
* A strategic step in building Shire's hematology business (which already includes Xagrid and a growing development pipeline)
* Adds a differentiated product in development (iron chelator FBS0701), with global rights, in a global market currently worth over $900 million and growing(1)
* Serves chronic patient need for treatment of iron overload following numerous blood transfusions. Excess iron in vital organs such as the liver and heart increases the risk of organ failure and is the principal cause of death in transfusion-dependent patients(2)
* Consistent with Shire strategy of developing and commercializing differentiated specialist products prescribed by specialist physicians (hematologists/ hematologist-oncologists) served by a small sales force
* FBS0701 will be developed to demonstrate clinical efficacy and an attractive safety profile relative to currently approved chelating agents:
* Global filing planned for indications for Myelodysplastic Syndrome and hemoglobinopathies initially
* Phase 2 studies underway with additional trials planned
"Shire has had a close partnership with the global Fabry patient community for over 10 years, and we are extremely disappointed that we feel compelled to make this decision," said Sylvie Grégoire, President, Shire HGT.
Price Announcements Fundamentals News Article RSS Shire plc (SHP) Add to Alerts list Print Mail a friend Thursday 15 March, 2012 Shire plc Shire Update on US BLA Filing for REPLAGAL®
Shire Provides Update on US Biologics License Application Filing for REPLAGAL® (agalsidase alfa)
Lexington, Massachusetts, US - March 14, 2012 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced today that it has withdrawn its Biologics License Application (BLA) for REPLAGAL® (agalsidase alfa) with the US Food and Drug Administration (FDA).
Shire has been in ongoing dialogue with the FDA since the supply shortage of the only US approved treatment for Fabry disease. In 2009, and again in 2011, the FDA encouraged Shire to submit an application for the approval of REPLAGAL. The information in the application included relevant updates such as manufacturing and open long-term clinical trial data. These discussions led the Company to file a BLA last November in anticipation of a quick review process and eventual approval - allowing Shire to supply more US patients with a therapy they desperately needed at the time.
Recent interactions with the FDA have led the Company to believe that the agency will require additional controlled trials for approval. No concerns over the product's safety profile were raised by the FDA. Shire has concluded that the likely additional studies would cause a significant delay, and an approval of REPLAGAL for US patients would only be possible in the distant future. Shire has therefore decided to withdraw its BLA.
Shore Capital kept its "buy" rating for Shire (SHP) after the European Medicines Agency approved the use of its Lexinton facility, in the US, for the manufacture of its Human Genetic Therapy treatment for Gaucher disease, VPRIV. The broker noted that this will free up capacity at its Alewife facility for the production of its Fabry disease treatment, Replagal. Additionally, Shore said that FDA approval for the sale of Replagal would significantly increase its market share in the US for the treatment of Farby disease
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