BioNotebook Deals and Data: Zosano/Novo, MacroGenics/Servier, Regulus/Sanofi, Seattle Genetics/Takeda, Sarepta
This article was originally published in Scrip
Zosano and Novo agree to make GLP-1 patches; Servier exercises option for MacroGenics antibody; Sanofi expands alliance with Regulus; Seattle Genetics earns milestone from Takeda; and Sarepta reports pulmonary data for eteplirsen.
Zosano eligible for $60m in fees for first Novo Nordisk program
Fremont, California-based Zosano Pharma may earn up to $60m in upfront and milestone fees plus research funding and royalties for the first product commercialized under an agreement with Novo Nordisk to develop a transdermal patch for semaglutide, the Danish company's glucagon-like peptide-1 (GLP-1) analog that is in Phase III clinical trials for type 2 diabetes. Zosano could earn up to $55m plus research funding and royalties for each additional GLP-1 analog from Novo that is developed in transdermal form.
The companies will run preclinical tests to make sure semaglutide can be delivered with Zosano's microneedle patch system, which is designed to provide rapid systemic delivery of medicines through the skin. Novo will have an exclusive worldwide license to commercialize Zosano's technology for GLP-1 analogs if a once-weekly patch sufficiently administers semaglutide in preclinical and clinical studies.
"Our goal in combining semaglutide with Zosano's microneedle patch system is to offer weekly dosing, room temperature stability and self-administration without the need for a subcutaneous injection," Zosano CEO Vikram Lamba said in a statement from the private company.
Zosano has a transdermal patch for the osteoporosis drug teriparatide that's ready for Phase III testing. It is licensed to Asahi Kasei in several Asian territories (scripintelligence.com, 11 October 2011).
MacroGenics earns $20m in fees from Servier
Servier exercised its right to an exclusive license to develop and commercialize the preclinical compound MGD006 outside of North America, Japan, South Korea and India, which triggered payment of a $15m license fee to the bi-specific antibody's developer MacroGenics. The Rockville, Maryland-based company also earned a $5m milestone fee after the investigational new drug (IND) application for MGD006 cleared the US FDA's 30-day review period.
MacroGenics developed the therapeutic candidate with the company's Dual-Affinity Re-Targeting (DART) technology platform. MGD006 redirected T cells via CD3 to kill CD123-expressing leukemia cells in preclinical studies and MacroGenics plans to start a Phase I clinical trial in acute myeloid leukemia (AML) during the second quarter of 2014.
The compound is subject to an agreement that MacroGenics signed with Servier in September 2012 for three novel anti-cancer therapies developed with DART. The deal is worth about $1bn in potential license and milestone fees in addition to the $40m MacroGenics earned under the collaboration so far.
MacroGenics closed down 3.6% at $35.11 per share on 5 February after it announced the Servier license for MGD006, bringing its market cap to $878.5m. The US company's stock has traded between $21.50 and $41 since it went public at $16 per share in October (scripintelligence.com, 10 October 2013).
Sanofi invests another $10m in Regulus to expand deal
Regulus Therapeutics closed 5% lower at $8.20 per share on 5 February after the developer of microRNA-targeting drugs said Sanofi purchased another $10m worth of Regulus stock to retain rights to a second preclinical program under an existing partnership. Sanofi previously owned 3.7% of outstanding Regulus stock when the San Diego-based biotech company completed its initial public offering at $4 per share in 2012 (scripintelligence.com, 5 October 2012).
Sanofi gained rights under the companies' expanded agreement to a preclinical program targeting microRNA-221/microRNA-222. The French pharma company already has rights to a preclinical fibrosis program targeting microRNA-21 for treatment of a rare genetic kidney disease called Alport syndrome and cancer.
Regulus is responsible for development of the programs through proof-of-concept at which time Sanofi can exercise its exclusive option for further development and commercialization. Regulus may earn reimbursement of its research and development costs plus royalties. The company also has an option to participate in US commercialization.
Seattle Genetics earns sales-based milestone fee from Takeda
Bothell, Washington-based Seattle Genetics earned a $5m milestone fee that was triggered when Takeda Pharmaceutical notched more than $100m in annual net sales from the antibody-drug conjugate Adcetris (brentuximab vedotin) in its territories. Seattle Genetics will recognize the payment as royalty revenue in its first quarter 2014 earnings.
Adcetris is approved in 39 countries, but Seattle Genetics has rights to the cancer therapeutic only in the US and Canada. Takeda has rights to the ADC in the rest of the world and Seattle Genetics earns sales-based milestone fees plus royalties in the mid-teens to mid-twenties from net sales in those areas. More than 30 clinical trials are ongoing to expand the lymphoma therapy's label (scripintelligence.com 14 January 2014). The companies share development costs equally in all territories except for Japan, where Takeda funds all clinical trials.
Seattle Genetics closed down 2.7% at $42.70 following the $5m milestone announcement, bringing its market cap to $5.2bn. The company will report 2013 US and Canadian sales figures for Adcetris when it reports fourth quarter and full year earnings on 11 February. The ADC was approved in the US in 2011 (scripintelligence.com, 22 August 2011).
Sarepta rises on pulmonary data for eteplirsen
Sarepta Therapeutics closed up 9.5% at $25.13 on 5 February after the company released pulmonary function test results for boys with Duchenne muscular dystrophy (DMD) who have been treated with the exon-skipping drug eteplirsen for 120 weeks in Sarepta's Phase IIb clinical trial. Since mid-January, the company's stock has regained some of the value lost in November when shares closed down 64% at $13.16 after Sarepta said the US FDA was not likely to consider early approval of eteplirsen based on six-minute walk test (6MWT) results from the 12-patient Phase IIb trial (scripintelligence.com, 13 November 2013).
In its latest update from the study, Sarepta reported a 14.6% mean increase in maximum inspiratory pressure (MIP) and a 15% mean increase in maximum expiratory pressure (MEP) from baseline through week 120 of its Phase IIb trial. There also were slight increases in MIP and MEP when the measures of respiratory muscle function were adjusted for weight and age.
Sarepta also noted a mean increase in lung volume measured in terms of forced vital capacity (FVC), including an 8.7% gain from baseline to week 120. FVC adjusted for age and height declined from 101% at baseline to 93% at week 120.
"We now have pulmonary function clinical outcome measures demonstrating general stability over a time period and in an age group where we would expect to see decline," Sarepta senior vice president and chief medical officer Edward Kaye said in a statement from the company.
Sarepta said in January that it is preparing for a Phase III confirmatory clinical trial, waiting for notes from its last meeting with the FDA, and attempting to schedule a new meeting with the regulator to discuss the path forward for eteplirsen (scripintelligence.com, 16 January 2014).