Astellas breaks off Vibativ partnership withTheravance
This article was originally published in Scrip
Astellas Pharma, Theravance's partner for its only commercialised drug - the antibiotic Vibativ (telavancin hydrochloride) - has decided to pull out of the collaboration.
Consequently, Theravance is now evaluating alternatives for commercialising the drug globally, either alone or with partners.
In a joint announcement, the two companies said that Astellas has exercised its right to end the licence, development and commercialisation agreement from 2005.
A spokesperson for Astellas told Scrip that the business decision was made in order to "optimise resource allocation". No further details were available.
Astellas has stopped promotional efforts for the product, and there are no termination payments required by either party. Astellas will still eligible for a 2% royalty on net sales of Vibativ for 10 years. To ensure a smooth transition, Astellas will transfer inventory to Theravance and complete certain clinical and regulatory activities with respect to Vibativ by the end of March.
Vibativ is a bactericidal, once daily injectable lipoglycopeptide agent with a dual mechanism of action against Gram-positive bacteria, inhibiting both bacterial cell wall synthesis and disrupting bacterial cell membrane function. In the US and Canada, it was approved in 2009 to treat complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria.
The EU also approved the drug use in 2011 to treat nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus or MRSA (scripintelligence.com, 15 September 2011), although the FDA had refused to accept Theravance's resubmission of the drug for nosocomial pneumonia in 2010 (scripintelligence.com, 4 February 2010).
Theravance CEO Rick Winningham said the company "will continue the focus on re-establishing consistent product supply". The company said in a regulatory filing that "due to manufacturing issues at the single-source supplier of the drug product, Vibativ is currently subject to critical product shortages and regional supply outages." It was also noted, "If these issues at the manufacturer are not promptly resolved, obtaining supply would require identifying and qualifying an alternative manufacturers, which could take 12 to 24 months."
Under its original 2005 deal with Astellas, Theravance received an upfront payment of $65 million and regulatory milestones of $165 million. The deal also provided Theravance with the potential to receive royalties ranging from high teens to upper twenties. Astellas was to lead and fund certain development.
Vibativ generated just $800,000 in royalties from $4.5 million in net sales for the most recently reported quarter, ended 30 September 2011.
The Vibativ product has not been a main focus for Theravance, as more of its share price value has lately been tied in with a partnership with GlaxoSmithKline on the once-daily respiratory drug Relovair, a drug combining fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2 agonist (LABA), for chronic obstructive pulmonary disease (COPD) and asthma. That programme, however, was hit on 9 January with mixed results from an important part of the Phase III programme, and the company’s share price took a steep nosedive.
Theravance has active collaborations with GlaxoSmithKline for LAMA/LABA (‘719/vilanterol), and MABA (bifunctional muscarinic antagonist-Beta2 agonist). It has a separate programme on an oral peripheral Mu opioid receptor antagonist.
Theravance had cash and cash equivalents of about $265 million as of 30 September.